Publications by authors named "Ranjeeta Mallick"

122 Publications

Characteristics and outcomes of patients on concurrent direct oral anticoagulants and targeted anticancer therapies-TacDOAC registry: Communication from the ISTH SSC Subcommittee on Hemostasis and Malignancy.

J Thromb Haemost 2021 Aug;19(8):2068-2081

Department of Medicine, The Ottawa Hospital and Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.

Background: Cancer patients are increasingly prescribed direct oral anticoagulants (DOACs) and targeted anticancer therapies, but limited data are available on the outcomes during concurrent use.

Objectives: We conducted an international registry through the Scientific and Standardization Committee of the ISTH to evaluate the characteristics, bleeding, and thrombotic outcomes in patients receiving concurrent DOACs and targeted anticancer therapies.

Patients/methods: Patients receiving concurrent DOACs for venous thromboembolism (VTE) or atrial fibrillation and selected targeted anticancer therapies were followed for 6 months after the start of concurrent use. Data including patient and cancer characteristics, major bleeding, non-major bleeding events, and venous or arterial thromboses were collected.

Results: Two hundred and two patients were included from six institutions in the United States and Israel. The most common malignancies were hematologic (N = 57, 28.2%), followed by breast (N = 50, 24.8%) and lung (N = 44, 21.8%). The most common anticancer therapies were epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors (N = 43, 21.3%), followed by Bruton's tyrosine kinase (BTK) inhibitors (N = 42, 20.8%) and palbociclib (N = 42, 20.8%). During follow-up, there were 9 major bleeding and 12 non-major bleeding events, corresponding to cumulative incidences of 4% (95% confidence interval [CI]: 2-8%) and 6% (95% CI: 3-10%), respectively. The cumulative incidence of major bleeding events was highest in BTK inhibitor users (10%). There were 3 VTE and 2 arterial thromboses, corresponding to cumulative incidences of 1.5% (95% CI: 0.4-4.0%) and 1.0% (95% CI: 0.2-3.3%), respectively.

Conclusions: In this cohort receiving concurrent DOACs and targeted anticancer therapies, the incidence of bleeding is higher compared to thrombosis, particularly with BTK inhibitors. Future larger prospective studies are needed.
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http://dx.doi.org/10.1111/jth.15367DOI Listing
August 2021

The increasing use of renal tumor biopsy amongst Canadian urologists: When is biopsy most utilized?

Urol Oncol 2021 Jun 26. Epub 2021 Jun 26.

Department of Urology, Centre Hospitalier Universitaire de Sherbrooke and Centre de Recherche du CHUS, Sherbrooke, QC, Canada. Electronic address:

Introduction: The role of renal tumor biopsy (RTB) in the management of small renal masses (SRMs) is progressively being recognized as a tool to decrease overtreatment. While an increasing number of studies assessing its role in diagnostics are becoming available, RTB remains variably used amongst urologists. Many patient-, tumor-, and institution-related factors may influence urologists on whether to perform a RTB to help guide management.

Objective: We aimed at identifying factors associated with the use of RTB for localized SRMs within a number of centers contributing data to the Canadian Kidney Cancer information system.

Material And Methods: We identified 3,838 patients diagnosed with a localized SRM (≤4 cm) between January 2011 and December 2018. Patients were stratified based on whether a RTB was performed prior to the primary therapeutic intervention. Factors associated with use of RTB were assessed using univariable and multivariable logistic regression models.

Results: A total of 993 patients (25.9%) underwent an RTB. There was an overall increase in RTB use over time (P < 0.001), with patients diagnosed between 2015 and 2018 undergoing more RTB than patients diagnosed between 2011 and 2014 (29.8% vs. 22.2%, respectively; P < 0.001). Patients managed in centers with the highest patient-volume had RTB more frequently than patients managed in low-volume centers. On multivariable analysis, increasing year of diagnosis was significantly associated with more RTB use. Patients treated with surgery underwent RTB statistically less often than patients undergoing thermal ablation (P < 0.001) or managed with active surveillance (P < 0.001). Larger SRMs were associated with more RTB use in patients on active surveillance (P = 0.009), but with less RTB in patients undergoing surgery (P = 0.045).

Conclusion: This large multicenter cohort study reveals an increasing adoption and overall use of RTB amongst Canadian urologists. Patients managed in high-volume centers and those undergoing non-surgical management were associated with greater use of RTB. Tumor size was also associated with RTB use. This study highlights the influence that physician perceptions and clinical factors may have in the decision to use RTB prior to initiating a therapeutic approach.
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http://dx.doi.org/10.1016/j.urolonc.2021.05.026DOI Listing
June 2021

Use of video education in postoperative patient counselling: A quality improvement initiative.

Can Urol Assoc J 2021 Jun 22. Epub 2021 Jun 22.

Division of Urology, Department of Surgery, The Ottawa Hospital and University of Ottawa, Ottawa, ON, Canada.

Introduction: This quality improvement study examined if a video-based resource could reduce delayed discharges after robotic prostatectomy while maintaining high levels of patient satisfaction.

Methods: From April 2018 to February 2020, all patients undergoing robotic-assisted radical prostatectomy (RARP) were asked to complete an anonymous survey evaluating their perioperative experience. The quality improvement (QI) intervention started in March 2019 with a series of six educational videos being shown to all patients. The videos were used to supplement postoperative instruction. The discharge times of all patients were obtained from The Ottawa Hospital Data Repositories. A run chart analysis was used to detect change in discharge time (outcome measure). Patient satisfaction (balancing measure) was analyzed using Chi-squared analysis and descriptive statistics.

Results: A total of 425 robotic prostatectomies (199 pre-intervention, 226 post-intervention) were available. Analysis of the run chart revealed non-random change favoring earlier discharge in the intervention group (p<0.05), with a pre-intervention late discharge rate of 64% and a post-intervention late discharge rate of 55%. A total of 140 surveys (59 pre-intervention, 81 post-intervention) assessing patient satisfaction were completed, corresponding with a response rate of 29.6% and 35.8%, respectively. Median score on a 10-point scale for overall satisfaction was equal between the intervention and non-intervention groups (9 [interquartile range (IQR 8-10) vs. 10 [IQR 8-10], p=0.92).

Conclusions: Patient satisfaction with care and education was high for all patients and was not negatively impacted by this intervention. Video education tools may be one method to help improve the discharge process following RARP.
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http://dx.doi.org/10.5489/cuaj.7240DOI Listing
June 2021

Association between radical cystectomy prophylactic antimicrobial regimen and postoperative infection.

Can Urol Assoc J 2021 Jun 22. Epub 2021 Jun 22.

Department of Surgery, Division of Urology, University of Ottawa, Ottawa, ON, Canada.

Introduction: Infections are common after radical cystectomy. The objective of this study was to determine the association between antimicrobial prophylactic regimen and infection after radical cystectomy.

Methods: A retrospective cohort study was performed on patients who underwent radical cystectomy at one tertiary Canadian center between January 2016 and April 2020. Patients received antimicrobial prophylaxis based on surgeon preference (cefazolin/metronidazole or ampicillin/ciprofloxacin/metronidazole or other). A univariable and multivariable logistic regression model was created to determine the association between antimicrobial regimen and postoperative infection within 30 days. The association between patient demographic factors, as well as preoperative and intraoperative variables and infection was also determined. Infection characteristics, including type, timing, and antimicrobial susceptibilities were reported.

Results: One hundred and sixty-five patients were included. Mean age was 69.8 years, 121 (73.3%) were male, and 72 (43.6%) received orthotopic neobladder diversion. Ninety-six patients (58%) received cefazolin/metronidazole prophylaxis, 50 (30%) received ampicillin/ciprofloxacin/metronidazole, and 19 (11.5%) received another regimen. Fifty-four patients (32.7%) developed a postoperative infection (surgical site infection or urinary tract infection). Surgical site infection occurred in 35 patients (21.2%) and urinary tract infection occurred in 34 (21.0%). There was no association between antimicrobial regimen and incidence of postoperative infection (surgical site infection or urinary tract infection, relative risk [RR] 0.99, 95% confidence interval [CI] 0.50-1.99).

Conclusions: The overall incidence of infection was 32.7% following radical cystectomy. The preoperative prophylactic antibiotic regimen used was not associated with incidence of postoperative infection.
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http://dx.doi.org/10.5489/cuaj.7158DOI Listing
June 2021

Adrenalectomy During Radical Nephrectomy- Incidence and Oncologic Outcomes From the Canadian Kidney Cancer Information System (CKCis) -A Modern Era, Nationwide, Multicenter Cohort.

Urology 2021 Jun 12. Epub 2021 Jun 12.

Urology Division, Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada. Electronic address:

Objective: To characterize proportion of patients receiving adrenalectomy, adrenal involvement prevalence and oncologic outcomes of routine adrenalectomy in contemporary practice. Ipsilateral adrenalectomy was once standard during radical nephrectomy. However, benefit of routine adrenalectomy has been questioned because adrenal involvement of renal cell carcinoma (RCC) is low.

Methods: All patients receiving radical nephrectomy in the Canadian Kidney Cancer information system, a collaborative prospective cohort populated by 14 major Canadian centers, between January 2011 to February 2020 were included. Patients were excluded if they had non-RCC histology, multiple tumors, contralateral tumors, metastatic disease or previous history of RCC. Patient demographic, clinical, and surgical information were summarized and compared. Cox-proportional hazards was used for multivariable analysis.

Results: During study period, 2759 patients received radical nephrectomy, of these, 831(30.1%) had concomitant adrenalectomy. Pathological adrenal involvement was identified in 102 (3.7%overall; 12.3%of adrenalectomy). Median follow-up was 21.6months (Interquartile range 7.0-46.5). Patients with adrenalectomy had higher venous tumor thrombus (30.3% vs 9.6%; P <.0001), higher T stage (71.1% vs 43.4% pT3/4; P <.0001), lymph node metastases (17.6% vs 10.7%; P = .0035), Fuhrman grades (71.4% of Fuhrman grades 3/4 vs 56.2%; P <.0001) and increased proportion of clear cell histology (79.3% vs 74.5%; P = .0074) compared to the no adrenalectomy group. Adrenalectomy patients had higher risk of recurrence (HR 1.23; 95% CI 1.04-1.47; P = .019) and no difference in survival (HR 1.09, 95% CI 0.86-1.38, P = .48).

Conclusion: Adrenalectomy is not associated with better oncological outcome of recurrence/survival. Adrenalectomy should be reserved for patients with radiographic adrenal involvement and/or intra-operative adrenal involvement.
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http://dx.doi.org/10.1016/j.urology.2021.05.053DOI Listing
June 2021

Thromboprophylaxis with rivaroxaban in patients with malignancy and central venous lines (TRIM-Line): A two-center open-label pilot randomized controlled trial.

Res Pract Thromb Haemost 2021 May 5;5(4):e12517. Epub 2021 May 5.

Department of Medicine Ottawa Hospital Research Institute University of Ottawa Ottawa ON Canada.

Background: Central venous catheter (CVC) insertion is an important risk factor for venous thromboembolism (VTE) among patients with cancer. Routine use of primary thromboprophylaxis in this patient population is not currently recommended. We sought to assess the feasibility of conducting a randomized controlled trial (RCT) assessing the safety and efficacy of rivaroxaban (10 mg daily) to prevent VTE complications in this patient population.

Methods: This is a two-center prospective, randomized, open blinded end point pilot trial including patients with active cancer and a newly inserted CVC. Patients were randomly assigned 1:1 to rivaroxaban or observation for 90 days. The primary feasibility outcome of this pilot study was the number of participants recruited per month. Secondary clinical outcomes included thrombotic complications, major VTE, and major bleeding episodes.

Results: Overall, 105 patients were enrolled over 11 months. The average enrollment rates were 7.5 and 2 patients per month at the two participating centers, respectively. Overall, thrombotic complications occurred in 3 patients in the rivaroxaban group (5.8%; 95% confidence interval [CI], 1.2-16.0) compared with 5 patients in the control group (9.4%; 95% CI, 3.1-20.7) (HR, 0.58; 95% CI, 0.14-2.5). Major VTE occurred in 2 (3.9%; 95% CI, 0.5-13.2) and 3 (5.7%; 95% CI, 1.2-15.7) patients in the rivaroxaban and control group, respectively (HR, 0.66; 95% CI, 0.11-3.9). One patient (1.9%) receiving rivaroxaban had a major bleeding event.

Conclusions: Thrombotic complications are common in patients with cancer and a newly inserted CVC. The pilot trial achieved its enrollment targets and supports that a large multicenter RCT is feasible in this area. ClinicalTrials.gov (NCT03506815).
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http://dx.doi.org/10.1002/rth2.12517DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8116834PMC
May 2021

Cost-effectiveness analysis of 3 months of weekly rifapentine and isoniazid compared to isoniazid monotherapy in a Canadian arctic setting.

BMJ Open 2021 05 13;11(5):e047514. Epub 2021 May 13.

School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.

Objective: To assess the cost effectiveness of once weekly rifapentine and isoniazid for 12 weeks (3HP) to the current standard care for latent tuberculosis (TB) infection (LTBI) in Iqaluit, Nunavut.

Design: A cost-effectiveness analysis using a Markov model reflecting local practices for LTBI treatment.

Setting: A remote Canadian arctic community with a high incidence of TB.

Participants: Hypothetical patients with LTBI.

Interventions: The cost effectiveness of 3HP was compared with the existing standard of care in the study region which consists of 9 months of twice weekly isoniazid (9H) given by directly observed therapy.

Outcome Measures: Effectiveness was measured in quality-adjusted life years (QALYs) with model parameters were derived from historical programmatic data, a local implementation study of 3HP and published literature. Costs from the perspective of the Nunavut healthcare system were measured in 2019 US dollars and were obtained primarily from local, empirically collected data. Secondary health outcomes included estimated TB cases and TB deaths averted using 3HP versus 9H. One way and probabilistic sensitivity analyses were performed.

Results: The 3HP regimen was dominant over 9H: costs were lower (US$628 vs US$924/person) and health outcomes slightly improved (20.14 vs 20.13 QALYs/person). In comparison to 9H, 3HP treatment resulted in fewer TB cases (27.89 vs 30.16/1000 persons) and TB deaths (2.29 vs 2.48/1000 persons). 3HP completion, initiation and risk of fatal adverse events were the primary drivers of cost effectiveness.

Conclusion: In a remote Canadian arctic setting, using 3HP instead of 9H for LTBI treatment may result in cost savings and similar or improved health outcomes.
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http://dx.doi.org/10.1136/bmjopen-2020-047514DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8126298PMC
May 2021

Efficacy and safety of apixaban for primary prevention in gastrointestinal cancers: A post-hoc analysis of the AVERT trial.

Thromb Res 2021 06 21;202:151-154. Epub 2021 Mar 21.

Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, Ontario, Canada; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada. Electronic address:

Background: Recent trials have demonstrated that thromboprophylaxis using direct oral anticoagulants is effective but associated with a higher rate of major bleeding in intermediate-to-high risk (Khorana score ≥ 2) patients with cancer initiating systemic chemotherapy. Patients with gastrointestinal cancer may be at higher risk of major bleeding complications. We sought to assess the efficacy and safety of using thromboprophylaxis with apixaban in this patient population.

Methods: This is a post-hoc analysis of the AVERT trial, which was a randomized, placebo-controlled, double-blind clinical trial. The primary efficacy outcome was objectively documented venous thromboembolism within 180 days of randomization. The primary safety outcome was a major bleeding episode. Time-to-event analyses were performed in patients with gastrointestinal cancers (upper gastrointestinal, pancreatic/hepatobiliary and colorectal cancers).

Results: A total of 130 patients from the original AVERT trial were included, with 65 patients allocated to each of the apixaban and placebo groups. VTE occurred in 3 (4.6%) patients in the apixaban group and 13 (20%) patients in the placebo group (HR: 0.27; 95% CI: 0.13-0.54; p = 0.0002). Major bleeding occurred in 2 (3.1%) patients in the apixaban group and 1 (1.5%) patient in the placebo group (HR 2.39, 95% CI 0.29-19.78, p = 0.42). None of the major bleeding events occurred in patients with upper gastrointestinal or colorectal cancers.

Conclusion: Primary thromboprophylaxis with apixaban therapy seems to be safe and effective in patients with gastrointestinal cancers. Major bleeding complications are uncommon in our cohort. (Funded by the CIHR and Bristol-Myers Squibb-Pfizer Alliance; NCT02048865).
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http://dx.doi.org/10.1016/j.thromres.2021.03.013DOI Listing
June 2021

Performance Feedback May Not Improve Radical Prostatectomy Outcomes: The Surgical Report Card (SuRep) Study.

J Urol 2021 Aug 5;206(2):346-353. Epub 2021 Apr 5.

Division of Urology, Department of Surgery, The Ottawa Hospital, University of Ottawa, Ottawa, ON, Canada.

Purpose: Oncologic, urinary, and sexual outcomes are important to patients receiving prostate cancer surgery. The objective of this study was to determine if providing surgical report cards (SuReps) to surgeons resulted in improved patient outcomes.

Materials And Methods: A prospective before-and-after study was conducted at The Ottawa Hospital. A total of 422 consecutive patients undergoing radical prostatectomy were enrolled. The intervention was provision of report cards to surgeons. The control cohort was patients treated before report card feedback (pre-SuRep), and the intervention cohort was patients treated after report card feedback (post-SuRep). The primary outcomes were postoperative erectile function, urinary continence, and positive surgical margins.

Results: Baseline characteristics were similar between groups. Almost all patients (99%) were continent and the majority (59%) were potent prior to surgery. Complete 1-year followup was available for 400 patients (95%). Nerve sparing surgery increased from 70% pre-SuRep to 82% post-SuRep (p=0.01). There was a nonstatistically significant increase in the proportion of patients with a positive surgical margin post-SuRep (31% pre-SuRep vs 39% post-SuRep, p=0.08). There was no difference in postoperative erectile function (17% vs 18%, p=0.7) and a decrease in continence (75% vs 65%, p=0.02) at 1 year postoperatively.

Conclusions: The SuRep platform allows accurate reporting of surgical outcomes that can be used for patient counseling. However, the provision of surgical report cards did not improve functional or oncologic outcomes. Longer durations of feedback, report card modifications, or targeted interventions are likely necessary to improve outcomes.
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http://dx.doi.org/10.1097/JU.0000000000001764DOI Listing
August 2021

Lymph node dissection during radical nephrectomy: A Canadian multi-institutional analysis.

Urol Oncol 2021 06 27;39(6):371.e17-371.e25. Epub 2021 Mar 27.

The University of Texas MD Anderson Cancer Center, Houston, TX. Electronic address:

Objectives: To determine the association between lymph node dissection (LND) at the time of radical nephrectomy and survival in a large, multi-institutional cohort using a propensity score matching design.

Subjects And Methods: The Canadian Kidney Cancer information system was used to identify patients undergoing radical nephrectomy for nonmetastatic renal cell carcinoma. Associations between LND with overall survival , recurrence free survival and cancer specific survival were determined using various propensity score techniques in the overall cohort and in patients with varying probabilities of pN1. Cox models were used to determine association of lymph node removed with outcomes.

Results: Of the 2,699 eligible patients, 812 (30%) underwent LND. Of the LND patients, 88 (10.8%) had nodal metastases. There was no association between LND and improved overall survival, recurrence free survival or cancer specific survival using various propensity score techniques (stratification by propensity score quintile, matched pairs, inverse treatment probability weighting and adjusted for propensity score quintile). There was no association between LND and a therapeutic benefit in patients with increased threshold probabilities of nodal metastases. Increased number of lymph nodes removed was not associated with improved survival outcomes.

Conclusions: LND at the time of radical nephrectomy for renal cell carcinoma is not associated with improved outcomes. There was no benefit in patients at high risk for nodal metastases, and the number of nodes removed did not correlate with survival. Further studies are needed to determine which high risk patients may benefit from LND.
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http://dx.doi.org/10.1016/j.urolonc.2021.02.025DOI Listing
June 2021

Returning to the emergency room: An analysis of emergency encounters following urologic outpatient surgery.

Can Urol Assoc J 2021 Mar 18. Epub 2021 Mar 18.

Division of Urology, Department of Surgery, The Ottawa Hospital and University of Ottawa, Ottawa, ON, Canada.

Introduction: Previous reports indicate urologic surgeries are associated with high rates of hospital re-admission. This study aims to identify factors associated with emergency room (ER) encounters following urologic outpatient surgery.

Methods: All outpatient surgeries performed at The Ottawa Hospital between April 1, 2008, and March 31, 2018 by urology, general surgery, gynecology, and thoracic surgery were identified. All ER encounters within 90 days of surgery were captured. Rates of ER encounters by surgical service and procedure type were determined. Patient and surgical factors associated with ER encounters were identified. Factors included age, sex, marital status, presence of primary care provider, procedure, and American Society of Anesthesiologists (ASA) score.

Results: A total of 38 377 outpatient surgeries by the included surgical services were performed during the study period, of which urology performed 16 552 (43.1%). Overall, 5641 (14.7%) ER encounters were identified within 90 days of surgery, including 2681 (47.5%) after urologic surgery. On multivariable analysis, higher ASA score IV vs. I was associated with higher risk of ER encounter (relative risk [RR] 1.95, 95% confidence interval (CI) 1.46-2.5) and being married was associated with a lower risk of ER encounter (RR 0.85, 95% CI 0.77-0.93). Urologic surgeries with the highest risk of ER encounters, compared to the lowest risk procedure (circumcision), were greenlight laser photo vaporization of the prostate (PVP) (RR 3.2, 95% CI 1.8-5.61), ureteroscopy (RR 3.2, 95% CI 1.9-5.4), and ureteric stent insertion (RR 3.1, 95% CI 1.8-5.5).

Conclusions: ER encounters following outpatient surgery are common. This study identifies risk factors to recognize patients that may benefit from additional support to reduce ER care needs.
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http://dx.doi.org/10.5489/cuaj.7063DOI Listing
March 2021

Technicity in Canada: A Nationwide Whole-Population Analysis of Temporal Trends and Variation in Minimally Invasive Hysterectomies.

J Minim Invasive Gynecol 2021 May 18;28(5):1041-1050. Epub 2021 Jan 18.

Department of Obstetrics and Gynaecology, Laval University, Quebec City, Quebec (Dr. Maheux-Lacroix and Laberge).

Study Objective: The objective of our study was to provide a contemporary description of hysterectomy practice and temporal trends in Canada.

Design: A national whole-population retrospective analysis of data from the Canadian Institute for Health Information.

Setting: Canada.

Patients: All women who underwent hysterectomy for benign indication from April 1, 2007, to March 31, 2017, in Canada.

Interventions: Hysterectomy.

Measurements And Main Results: A total of 369 520 hysterectomies were performed in Canada during the 10-year period, during which the hysterectomy rate decreased from 313 to 243 per 100 000 women. The proportion of abdominal hysterectomies decreased (59.5% to 36.9%), laparoscopic hysterectomies increased (10.8% to 38.6%), and vaginal hysterectomies decreased (29.7% to 24.5%), whereas the national technicity index increased from 40.5% to 63.1% (p <.001, all trends). The median length of stay decreased from 3 (interquartile range 2-4) days to 2 (interquartile range 1-3), and the proportion of patients discharged within 24 hours increased from 2.1% to 7.2%. In year 2016-17, women aged 40 to 49 years had significantly increased risk of abdominal hysterectomy compared with women undergoing hysterectomy in other age categories (p <.001). Comparing women with menstrual bleeding disorders, women undergoing hysterectomy for endometriosis (adjusted relative risk [aRR] 1.36; 95% confidence interval [CI], 1.28-1.44) and myomas (aRR 2.01; 95% CI, 1.94-2.08) were at increased risk of abdominal hysterectomy, whereas women undergoing hysterectomy for pelvic organ prolapse and pelvic pain (aRR 1.47; 95% CI, 1.41-1.53) were at decreased risk. Using Ontario as the comparator, Nova Scotia (aRR 1.35; 95% CI, 1.27-1.43), New Brunswick (aRR 1.25; 95% CI, 1.18-1.32]), Manitoba (aRR 1.35; 95% CI, 1.28-1.43), and Newfoundland and Labrador (aRR 1.18; 95% CI, 1.10-1.27) had significantly higher risks of abdominal hysterectomy. In contrast, Saskatchewan (aRR 0.75; 95% CI, 0.74-0.77) and British Columbia (aRR 0.86; 95% CI, 0.85-0.88) had significantly lower risks, whereas Prince Edward Island, Quebec, and Alberta were not significantly different.

Conclusion: The proportion of minimally invasive hysterectomies for benign indication has increased significantly in Canada. The declining use of vaginal approaches and the variation among provinces are of concern and necessitate further study.
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http://dx.doi.org/10.1016/j.jmig.2021.01.010DOI Listing
May 2021

Do androgen-directed therapies improve outcomes in prostate cancer patients undergoing radical prostatectomy? A systematic review and meta-analysis.

Can Urol Assoc J 2021 Jan 8. Epub 2021 Jan 8.

Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.

Introduction: Approximately 50% of patients with non-metastatic prostate cancer are treated with radical prostatectomy. While some men will be cured with surgery alone, a substantial proportion will experience cancer recurrence. Androgen-directed therapy (ADT) is an effective adjuvant therapy for patients treated with prostate radiation. Comparatively, the efficacy of ADT in surgical patients has not been well studied.

Methods: A systematic search of MEDLINE, Embase, and the Cochrane Library from inception to July 2020 was performed. Randomized trials comparing ADT with radical prostatectomy vs. prostatectomy alone in patients with clinically localized prostate cancer were included. Neoadjuvant ADT and adjuvant ADT interventions were assessed separately. The primary outcomes were cancer recurrence-free survival (RFS) and overall survival (OS). Pathologic outcomes following neoadjuvant ADT were also evaluated.

Results: Fifteen randomized trials met eligibility criteria; 11 evaluated neoadjuvant ADT (n=2322) and four evaluated adjuvant ADT (n=5205). Neoadjuvant ADT (three months of treatment) did not improve RFS (hazard ratio [HR] 0.90, 95% confidence interval [CI] 0.74-1.11) or OS (HR 1.22, 95% CI 0.62-2.41). Neoadjuvant ADT significantly decreased the risk of positive surgical margins (relative risk [RR] 0.48, 95% CI 0.41-0.56) and extraprostatic tumor extension (RR 0.75, 95% CI 0.64-0.89). Adjuvant ADT improved RFS (HR 0.65, 95% CI 0.45-0.93) but did not improve OS (HR 1.02, 95% CI 0.84-1.24).

Conclusions: Neoadjuvant ADT causes a pathologic downstaging of prostate tumors, but has not been found to delay cancer recurrence nor extend survival. Few studies evaluated adjuvant ADT. Trials are needed to determine the benefits and harms of intermediate or long-term adjuvant ADT for radical prostatectomy patients.
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http://dx.doi.org/10.5489/cuaj.7041DOI Listing
January 2021

Hypothermia During Partial Nephrectomy for Patients with Renal Tumors: A Randomized Controlled Trial.

J Urol 2021 May 21;205(5):1303-1309. Epub 2020 Dec 21.

Division of Urology, Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.

Purpose: Surgeons induce renal hypothermia during partial nephrectomy to preserve kidney function, without strong evidence of benefit. This trial examined the effectiveness and safety of renal hypothermia during partial nephrectomy.

Materials And Methods: We conducted a parallel randomized controlled trial of hypothermia versus no hypothermia (control group) during partial nephrectomy at 6 academic hospitals. Eligible patients had a planned open partial nephrectomy for the treatment of a renal tumor. During surgery, after clamping the renal hilum, patients were randomized to the intervention or control arm in a 1:1 ratio using permuted blocks of variable lengths (2 and 4), stratified by institution, using a computer-based program. Surgeons and study coordinators were masked to treatment allocation until the renal hilum was clamped. Overall glomerular filtration rates were determined before, and 1-year after, surgery. The primary outcome was measured glomerular filtration rate (mGFR) assessed by the plasma clearance of Tc-DTPA. The trial (NCT01529658) was designed with 90% power to detect a minimal clinically important difference in mGFR of 10 ml/minute/1.73 m at a 5% significance level.

Results: Of the 184 patients randomized, hypothermia and control patients had similar baseline mean mGFR (87.1 vs 81.0 ml/minute/1.73 m). One hundred and sixty-one (79 hypothermia, 82 control) were alive with primary outcome data 1 year after surgery. The change in mGFR 1 year after surgery was -6.6 ml/minute/1.73 m in the hypothermia group and -7.8 ml/minute/1.73 m in the control group (mean difference 1.2 ml/minute/1.73 m, 95% CI -3.3 to 5.6). Operated-kidney change in mGFR was similar between groups (-5.8 vs -6.3 ml/minute/1.73 m; mean difference 0.5 ml/minute/1.73 m, 95% CI -2.9 to 3.8). No clinically significant difference in the mGFR was observed when patients were stratified by pre-planned subgroups. Renal hypothermia did not impact the secondary outcomes of surgical complications and patient reported quality of life.

Conclusions: Renal hypothermia during partial nephrectomy does not preserve kidney function in patients with normal or mildly impaired renal function.
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http://dx.doi.org/10.1097/JU.0000000000001517DOI Listing
May 2021

Determining generalizability of the Canadian Kidney Cancer information system (CKCis) to the entire Canadian kidney cancer population.

Can Urol Assoc J 2020 Oct;14(10):E499-E506

Department of Medicine and Urology, Dalhousie University, Halifax, NS, Canada.

Introduction: The Canadian Kidney Cancer information system (CKCis) has prospectively collected data on patients with renal tumors since January 1, 2011 from 16 sites within 14 academic centers in six provinces. Canadian kidney cancer experts have used CKCis data to address several research questions. The goal of this study was to determine if the CKCis cohort is representative of the entire Canadian kidney cancer population, specifically regarding demographic and geographic distributions.

Methods: The CKCis prospective cohort was analyzed up to December 31, 2018. Baseline demographics and tumor characteristics were analyzed, including location of patients' residence at the time of CKCis entry. Geographic data is presented by province, rural vs. urban via postal code information (2 digit=0) and by Canadian urban boundary files. To determine the proportion of renal cell carcinoma (RCC) patients that CKCis captures, CKCis accruals were compared to projected Canadian Cancer Society RCC incidence in 2016-2017 and the incidence from the 2016 Canadian Cancer Registry. To determine if the CKCis baseline data is representative, it was compared to registry data and other published data when registry data was not available.

Results: This CKCis cohort includes 10 298 eligible patients: 66.6% male, median age 62.6 years; 14.6% had metastatic disease at the time of diagnosis and 70.4% had clear-cell carcinomas. The CKCis cohort captures about 1250 patients per year, which represents approximately 20% of the total kidney cancer incidence. The proportion of patients captured per province did vary from 13-43%. Rural patients make up 17% of patients, with some baseline differences between rural and urban patients. There appears to be no major differences between CKCis patient demographics and disease characteristics compared to national data sources. Canadian heat maps detailing patient location are presented.

Conclusions: CKCis contains prospective data on >10 000 Canadian kidney cancer patients, making it a valuable resource for kidney cancer research. The baseline demographic and geographic data do appear to include a broad cross-section of patients and seem to be highly representative of the Canadian kidney cancer population. Moving forward, future projects will include determining if CKCis cancer outcomes are also representative of the entire Canadian kidney cancer population and studying variations across provinces and within rural vs. urban areas.
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http://dx.doi.org/10.5489/cuaj.6716DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7716824PMC
October 2020

Venous Thromboembolism After Blood Transfusions in Women Undergoing Hysterectomy for Non-Malignant Indications: A Retrospective Cohort Study.

J Obstet Gynaecol Can 2021 02 30;43(2):167-174. Epub 2020 Sep 30.

Department of Obstetrics and Gynecology, University of Ottawa, Ottawa, ON; Ottawa Hospital Research Institute, Ottawa, ON. Electronic address:

Objective: To quantify the effect of blood transfusion on the risk of venous thromboembolism (VTE) among women undergoing hysterectomy for non-malignant indications.

Methods: A retrospective cohort study using the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) was conducted. Women who underwent hysterectomy for non-malignant indications between 2011 and 2016 were identified using the Current Procedural Terminology and Internationally Classification of Diseases codes. The primary outcome was development of VTE. Data on patient demographics and perioperative variables were obtained. Pair-wise comparison using χ tests were performed to compare women with and without VTE. Multivariable logistic regression was performed to adjust for potential confounders and identify independent predictors of VTE.

Results: Between 2011 and 2016, 169 593 women underwent hysterectomy for non-malignant indications. The overall incidence of VTE was 0.32%. Patient characteristics associated with VTE included obesity and higher American Society of Anesthesiologists (ASA) status. Associated operative factors included abdominal surgery, blood transfusion, and prolonged operative time (P < 0.05 for all). Following adjustment for potential confounders, abdominal hysterectomy was associated with greater odds of VTE than laparoscopic or vaginal approaches (adjusted odds ratio [aOR] 1.81; 95% CI 1.48-2.21 and aOR 2.31; 95% CI 1.62-3.28, respectively). Greater odds of VTE were also observed with OR time >150 minutes (aOR 1.88; 95% CI 1.46-2.42), ASA class ≥III (aOR 1.53; 95% CI 1.05-2.26), and intra- and postoperative transfusion (aOR 2.65; 95% CI 1.78-3.95 and aOR 2.98; 95% CI 1.95-4.55, respectively).

Conclusion: The risk of VTE is low in women undergoing hysterectomy for non-malignant indications. Blood transfusion was associated with the highest risk of VTE.
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http://dx.doi.org/10.1016/j.jogc.2020.09.016DOI Listing
February 2021

Safety and efficacy of apixaban thromboprophylaxis in cancer patients with metastatic disease: A post-hoc analysis of the AVERT trial.

Thromb Res 2021 01 1;197:13-15. Epub 2020 Nov 1.

Department of Medicine University of Ottawa, the Ottawa Hospital Research Institute, Ottawa, Canada. Electronic address:

Background: The risk of venous thromboembolism (VTE) is increased in patients with active cancer and the risk is highest in those with metastatic disease. The risks and benefits of thromboprophylaxis among cancer patients with metastatic disease initiating chemotherapy treatment are unknown. To address this important knowledge gap, we evaluated the efficacy and safety of apixaban thromboprophylaxis in patients with and without metastatic disease.

Methods: Post-hoc analysis of the AVERT trial, which was a randomized, placebo-controlled, double-blind trial comparing apixaban therapy to placebo for VTE prophylaxis among cancer patients who were intermediate-to-high risk for VTE and who were initiating chemotherapy. The hazards ratios (HRs) for VTE and major bleeding episodes in patients with and without metastatic disease were calculated using a Cox regression model controlling for age, gender, and center.

Results: A total of 574 patients underwent randomization and 365 patients could be stratified according to the presence (n = 138) or absence (n = 227) of metastatic disease. In patients with metastatic disease, those receiving apixaban had a significantly lower risk of VTE (HR 0.55; 95% CI 0.32 to 0.97) without a significant increase in major bleeding complications (HR 1.36 95% CI 0.27 to 6.93) compared to those on placebo. In patients without metastatic disease, the use of apixaban was also associated with a significantly lower risk of VTE (HR 0.34 95% CI 0.19 to 0.60) without a significant increase in major bleeding complications (HR 1.14 95% CI 0.08 to 15.91).

Conclusions: In patients with and without metastatic disease, apixaban thromboprophylaxis was associated with a significantly lower rate of VTE compared to placebo.
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http://dx.doi.org/10.1016/j.thromres.2020.10.026DOI Listing
January 2021

Thromboprophylaxis for patients with newly diagnosed vs. recurrent cancers: a post-hoc analysis of the avert trial.

J Thromb Thrombolysis 2021 Apr 20;51(3):720-724. Epub 2020 Oct 20.

Department of Medicine, University of Ottawa, the Ottawa Hospital Research Institute, 501 Smyth Road, Box 201 a, Ottawa, ON, K1H 8L6, Canada.

Venous thromboembolic disease (VTE) is a common complication among patients with cancer. Data reporting risk of VTE among patients receiving chemotherapy for recurrent cancer compared to those with newly diagnosed tumors is scarce. Furthermore, it is unclear if thromboprophylaxis is beneficial and safe in these specific patient populations. Post-hoc analysis of the AVERT trial which was a randomized, placebo-controlled, double-blind trial comparing apixaban therapy to placebo for VTE prophylaxis among cancer patients who were intermediate-to-high risk for VTE and who were initiating chemotherapy. The HRs for recurrent VTE and major bleeding episodes in patients with newly diagnosed and recurrent cancers were calculated using a Cox regression model controlling for age, gender, and center. Of the 563 included patients 469 and 93 patients had newly diagnosed and recurrent cancers, respectively. Patients with recurrent cancer have a higher risk of VTE (Hazard ratio (HR): 1.53 (95% CI 1.0 to 2.33; p = 0.047) and major bleeding episodes (HR 2.89 (95% CI 1.52 to 5.49; p = 0.001) compared to those with newly diagnosed cancer. In patients with newly diagnosed cancers, the use of apixaban was associated with a significantly lower risk of VTE (HR 0.45; 95% CI 0.27-0.76; p = 0.002) and a higher rate of major bleeding (HR 2.10; 95% CI 1.09-4.08; p = 0.028). In patients with recurrent cancer, apixaban was associated with a significant lower rate of VTE (HR 0.26; 95% CI 0.13-0.53; p < 0.001) without an associated significantly increased risk of major bleeding (HR 1.82; 95% CI 0.36-9.15; p = 0.466). Patients with recurrent cancer seem to be at higher risk of recurrent VTE and major bleeding complications compared to those with newly diagnosed tumors. Apixaban appears to be safe and effective in these patient populations.
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http://dx.doi.org/10.1007/s11239-020-02317-yDOI Listing
April 2021

Biomarker-enhanced VTE risk stratification in ambulatory patients with cancer.

Thromb Res 2020 12 8;196:437-443. Epub 2020 Oct 8.

Department of Medicine, University of Ottawa, and the Ottawa Hospital Research Institute, Ottawa, Canada. Electronic address:

Introduction: Risk assessment models are used to stratify cancer patients according to their underlying risk of VTE. The CATS score has been shown to enhance VTE risk stratification as compared to the modified Khorana score by incorporating d-dimer and soluble p-selectin measurements. Our aim was to evaluate the performance of the CATS score with respect to VTE risk stratification.

Materials And Methods: Analysis of a subset of the AVERT trial population for whom biomarker data was available. All patients included in the AVERT trial were at increased risk of VTE based on a modified Khorana score of ≥2. Patients were stratified according to the modified Khorana score and CATS score. Kaplan-Meier analysis was used to calculate the 6-month cumulative probabilities of VTE.

Results: A total of 466 patients were included in the analysis, 229 and 237 patients in the placebo and apixaban arms, respectively. The 6-month cumulative probability of VTE among patients with a modified Khorana score ≥ 3 was 13% [95% CI 7 to 23], whereas it was 20% [95% CI 11 to 35] for patients with a CATS score ≥ 4. The absolute risk reduction achieved with apixaban VTE prophylaxis among patients with modified Khorana ≥2, modified Khorana ≥3 and CATS ≥4 was -5.9% [-10.9 to -0.8], -5.8% [-16.0 to 4.5] and -10.1% [-22.9 to 2.6], respectively. Apixaban VTE prophylaxis among patients with increasing modified Khorana or CATS scores was not associated with an increased risk of bleeding events.

Conclusions: The use of a CATS score of ≥4 to identify ambulatory cancer patients at very high risk of VTE could enhance the benefit/risk ratio achieved with apixaban VTE prophylaxis.
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http://dx.doi.org/10.1016/j.thromres.2020.09.035DOI Listing
December 2020

The Top 20 Surgical Procedures Associated with the Highest Risk for Blood Transfusion.

Br J Surg 2020 12 3;107(13):e642-e643. Epub 2020 Oct 3.

Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario.

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http://dx.doi.org/10.1002/bjs.12005DOI Listing
December 2020

Prognostic impact of paraneoplastic syndromes on patients with non-metastatic renal cell carcinoma undergoing surgery: Results from Canadian Kidney Cancer information system.

Can Urol Assoc J 2021 Apr;15(4):132-137

Department of Surgery, University of Manitoba, Winnipeg, MB, Canada.

Introduction: The impact of paraneoplastic syndromes (PNS) on survival in patients with renal cell carcinoma (RCC) is uncertain. This study was conducted to analyze the association of PNS with recurrence and survival of patients with non-metastatic RCC undergoing nephrectomy.

Methods: The Canadian Kidney Cancer information system is a multi-institutional cohort of patients started in January 2011. Patients with nephrectomy for non-metastatic RCC were identified. PNS included anemia, polycythemia, hypercalcemia, and weight loss. Associations between PNS and recurrence or death were assessed using Kaplan-Meier curves and multivariable analysis.

Results: Of 4337 patients, 1314 (30.3%) had evidence of one or more PNS. Patients with PNS were older, had higher comorbidity, and had more advanced clinical and pathological tumor characteristics as compared to patients without PNS (all p<0.05). Kaplan-Meier five-year estimated recurrence-free survival (RFS), cancer-specific survival (CSS), and overall survival (OS) were significantly worse in patients with PNS (63.7%, 84.3%, and 79.6%, respectively, for patients with PNS vs. 73.9%, 90.8%, and 90.1%, respectively, for patients without PNS, all p<0.005). On univariable analysis, presence of PNS increased risk of recurrence (hazard ratio [HR] 1.67, 95% confidence interval [CI] 1.48-1.90, p<0.0001) and cancer-related death (HR 1.85, 95% CI 1.34-2.54, p=0.0002). Adjusting for known prognostic factors, PNS was not associated with recurrence or survival.

Conclusions: In non-metastatic RCC patients undergoing surgery, presence of PNS is associated with older age, higher Charlson comorbidity index score, advanced tumor stage, and aggressive tumor histology. Following surgery, baseline PNS is not strongly independently associated with recurrence or death.
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http://dx.doi.org/10.5489/cuaj.6833DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8021432PMC
April 2021

D-Dimer Enhances Risk-Targeted Thromboprophylaxis in Ambulatory Patients with Cancer.

Oncologist 2020 12 12;25(12):1075-1083. Epub 2020 Oct 12.

Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, Ottawa, Canada.

Background: Thromboprophylaxis for ambulatory patients with cancer is effective, although uncertainties remain on who should be targeted. Using D-dimer values from individuals enrolled to the AVERT trial, we sought to identify and validate a more efficient venous thromboembolism (VTE) risk threshold for thromboprophylaxis.

Materials And Methods: The AVERT trial compared thromboprophylaxis with apixaban with placebo among patients with cancer with a Khorana Risk Score ≥2. The D-dimer measured at randomization was used to calculate an individualized 6-month VTE risk using the validated CATScore. A modified intention-to-treat analysis was used to assess efficacy (VTE) and safety (major and overall bleeding) in the (a) complete cohort and (b) ≥8% and < 8% 6-month VTE risk thresholds.

Results: Five hundred seventy-four patients were randomized in the AVERT trial; 466 (81%) with baseline D-dimer were included in the study. Two hundred thirty-seven subjects received apixaban; 229 received placebo. In the complete cohort, there were 13 (5.5%) VTE events in the apixaban arm compared with 26 (11.4%) events in the placebo arm (adjusted hazard ratio [aHR] 0.49 [0.25-0.95], p < .05). Number needed to treat (NNT) to prevent one VTE = 17. Eighty-two (35%) and 72 (31%) patients in the apixaban and placebo arms, respectively, had a 6-month VTE risk ≥8%. In this subgroup, 7 (8.4%) VTE events occurred with apixaban and 19 (26.3%) events with placebo (aHR 0.33 [0.14-0.81], p < .05), NNT = 6. Individuals with a VTE risk <8% derived no benefit from apixaban thromboprophylaxis (aHR 0.89 [0.30-2.65), p = .84). Increased rates of overall bleeding were observed with apixaban in both the complete (aHR 2.11 [1.09-4.09], p < .05) and ≥ 8% predicted risk cohorts (aHR 2.87 [0.91-9.13], p = .07).

Conclusion: A 6-month VTE risk threshold of ≥8% increases the efficiency of risk-targeted thromboprophylaxis in ambulatory patients with cancer.

Implications For Practice: Ambulatory patients with cancer receiving chemotherapy have an increased risk of venous thromboembolism (VTE). A Khorana Risk Score (KRS) ≥2 is currently the suggested threshold for thromboprophylaxis. Using baseline D-dimer values from individuals enrolled to the AVERT trial, this retrospective validation study identifies a 6-month VTE risk of ≥8% as a more efficient threshold for thromboprophylaxis. At this threshold, the number needed to treat to prevent one VTE is 6, compared with 17 when using a KRS ≥2. Conversely, individuals with a predicted risk of <8% derive no clinical benefit from thromboprophylaxis. Future prospective studies should validate this threshold for outpatient thromboprophylaxis.
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http://dx.doi.org/10.1002/onco.13540DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938400PMC
December 2020

Cyclophosphamide-Glucocorticoids versus Lenalidomide-Dexamethasone as Treatment for Multiple Myeloma at First Relapse after Autologous Stem Cell Transplantation - A Retrospective Analysis.

Hematol Transfus Cell Ther 2020 Sep 13. Epub 2020 Sep 13.

University of Ottawa, Ottawa, Ontario, Canada; Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.

There have been significant improvements in therapeutic options for relapsed multiple myeloma (MM) over the past two decades, with many novel agents including proteasome inhibitors, immunomodulatory agents, and more recently monoclonal antibodies demonstrating efficacy in this setting. However, there is a paucity of real-world data comparing outcomes seen in patients treated with novel agents as opposed to older agents. We report a historical single center cohort of patients diagnosed with myeloma between the years 1991-2012 in order to explore possible differences in outcomes. A total of 139 patients who underwent stem cell transplantation were included in our study. In our study, 88 patients were treated with cyclophosphamide and steroids alone at relapse whereas 51 patients were treated with Len-Dex. In the multivariate analysis, TTNT was shorter for patients who received Cyclo compared to Len-Dex (HR=1.74; 95% CI, 1.01-2.99; p=0.04); however, we could not detect an overall survival benefit (HR=1.20; 95% CI 0.63-2.29; p=0.57). Adverse event rates were similar in the two groups. In this retrospective single center analysis, Len-Dex was associated with longer TTNT compared with Cyclo at first relapse following autoSCT in MM; however its effect on overall survival in this setting was less clear.
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http://dx.doi.org/10.1016/j.htct.2020.07.007DOI Listing
September 2020

Risk Factors for Bowel Injury in Hysterectomy for Benign Indications.

Obstet Gynecol 2020 10;136(4):803-810

Department of Obstetrics and Gynecology, University of Ottawa, the Ottawa Hospital, the Ottawa Hospital Research Institute, and the Departments of Surgery and Biochemistry, Microbiology, and Immunology, University of Ottawa, the Ottawa Hospital, Ottawa, and the Department of Obstetrics and Gynecology, University of Toronto, Mount Sinai Hospital, Toronto, Ontario, Canada.

Objective: To estimate the incidence and risk factors for bowel injury in women undergoing hysterectomy for benign indications.

Methods: A retrospective cohort study was conducted among women undergoing hysterectomy for benign indications from 2012 to 2016 at institutes participating in the American College of Surgeons National Surgical Quality Improvement Program, including both inpatient and outpatient settings. Bowel injury was identified using Current Procedural Terminology codes as patients who underwent bowel repair at the time of hysterectomy or postoperatively within 30 days. Multivariate logistic regression models were used to control for patient clinical factors and perioperative factors.

Results: Bowel injury occurred in 610 of 155,557 (0.39%) included women. After bivariate analysis, factors associated with bowel injury included age, race, body mass index, American Society of Anesthesiologists classification, increased operative time, surgical approach, type of hysterectomy, lysis of adhesions, and operative indication. After adjusting for potential confounders, bowel injury was found associated with older age, surgical indication of endometriosis, and abdominal surgical approach. Compared with the surgical indication of endometriosis (n=63/10,625), the surgical indications of menstrual disorder (odds ratio [OR] 0.33, 95% CI 0.23-0.47; adjusted odds ratio [aOR] 0.33, 95% CI 0.23-0.48; n=67/34,168), uterine leiomyomas (OR 0.80, 95% CI 0.61-1.05; aOR 0.44, 95% CI 0.33-0.59; n=243/51,232), and genital prolapse (OR 0.30, 95% CI 0.20-0.45; aOR 0.41, 95% CI 0.25-0.67; n=36/20,384) were each associated with lower odds of bowel injury. Compared with the vaginal approach to hysterectomy (n=27/27,434), the abdominal approach was found to have significantly increased odds of bowel injury (OR 10.80, 95% CI 7.31-15.95; aOR 10.49 95% CI 6.42-17.12; n=401/38,106); the laparoscopic approach had smaller but significantly increased odds (OR 2.06, 95% CI 1.37-3.08; aOR 2.03 95% CI 1.24-3.34; n=182/90,017) as well.

Conclusion: Increased risk of bowel injury is associated with endometriosis and the abdominal surgical approach to hysterectomy. These findings have implications for the surgical care of women with benign uterine disease.
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http://dx.doi.org/10.1097/AOG.0000000000004007DOI Listing
October 2020

Biomarkers in cancer patients at risk for venous thromboembolism: data from the AVERT study.

Thromb Res 2020 07;191 Suppl 1:S31-S36

Department of Medicine, University of North Carolina, Chapel Hill, NC, USA; Department of Pathology and Laboratory Medicine, University of North Carolina, Chapel Hill, NC, USA. Electronic address:

Background: The mechanisms surrounding cancer-associated venous thromboembolism (VTE) are not well characterized. AVERT, a randomized placebo controlled thromboprophylaxis study in ambulatory cancer patients, provides a unique opportunity to gain insights into thrombotic mechanism(s).

Methods: All available citrated platelet-free plasma samples collected at the point of randomization from individuals enrolled in the AVERT study were evaluated for the expression of D-dimer, soluble P-selectin (sP- selectin), active plasminogen activator inhibitor 1 (aPAI-1), clot lysis time (CLT) and activated factor XIa-C1 inhibitor complex (FXIa-C1). We compared the differential expression of sP-selectin, aPAI-1, CLT and FXIa-C1 among individual tumor types with normal controls. We evaluated the impact of disease type (hematologic versus solid organ malignancy) and stage (metastatic versus non-metastatic) on individual biomarker expression.

Results: We included 449 AVERT participants in this analysis. Baseline expression of the selected thrombosis biomarkers differed significantly by individual tumor type compared with normal controls. Levels of aPAI-1, CLT, FXIa-C1 and sP-selectin were significantly elevated in individuals with lymphoma compared to individuals with non-metastatic solid organ malignancies (p<0.05). Individuals with metastatic solid organ disease had elevated levels of D-dimer and sP-selectin compared to those with non-metastatic disease (p<0.05).

Conclusion: Among a cohort of ambulatory patients at intermediate to high risk of VTE, these exploratory findings suggest that baseline activation of coagulation and fibrinolysis pathways vary significantly by tumor type and disease stage.
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http://dx.doi.org/10.1016/S0049-3848(20)30394-7DOI Listing
July 2020

Does renal tumor biopsies for small renal carcinoma increase the risk of upstaging on final surgery pathology report and the risk of recurrence?

Urol Oncol 2020 10 18;38(10):798.e9-798.e16. Epub 2020 Jul 18.

Urology, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada. Electronic address:

Background: Renal tumor biopsies (RTB) have been proposed as a means to diminish overtreatment of small renal masses. A potential concern of RTB is tumor seeding along the biopsy tract leading to worse clinical outcomes.

Objectives: To evaluate whether RTB was associated with greater upstaging to pT3a compared to patients without a biopsy and to determine if pathologic upstaging affects the risk of recurrence.

Design, Setting And Participants: The Canadian Kidney Cancer information system was used to identify patients who underwent radical or partial nephrectomy for malignant renal tumors ≤ 4cm (cT1a) between January 1, 2011 and July 2, 2019.

Intervention: RTB prior to nephrectomy or nephrectomy without biopsy.

Outcomes Measurements And Statistical Analysis: Upstaging to pT3a and cancer recurrence were compared between subjects that had a RTB compared to those who did not. A multivariable analysis was used to evaluate factors associated with disease upstaging and recurrence.

Results And Limitations: The cohort consisted of 1993 cT1a patients, followed for a median of 17.5 months. Of these patients, 502 (25%) had a preoperative RTB. There was no difference in the proportion with tumor upstaging to pT3a between patients that had RTB compared to those who did not (7.2% vs. 6.3%; P = 0.5). On multivariable analysis, RTB was not associated with pathological upstaging (Odds Ratio 0.90; 95% Confidence Interval 0.61-1.34) or recurrence (Odds Ratio 1.04; 95% Confidence Interval 0.57-1.89). The main limitation is that the study is underpowered to detect small differences between groups.

Conclusions: In this large, multi-institution cohort, RTB was not associated with increased risk of tumor upstaging or recurrence. Hence, tumor tract seeding, although possible, should not be a clinical deterrent to using RTBs as a means of personalizing renal masses management and diminishing overtreatment.

Patient Summary: Recent evidence suggests that tumor seeding following RTB may be more common than initially perceived. Our results have demonstrated that RTB was not associated with an increased risk of tumor upstaging or disease recurrence.
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http://dx.doi.org/10.1016/j.urolonc.2020.06.001DOI Listing
October 2020

Impact of Time to Surgery and Surgical Delay on Oncologic Outcomes for Renal Cell Carcinoma.

J Urol 2021 Jan 2;205(1):78-85. Epub 2020 Jul 2.

Section of Urology, University of Manitoba, Winnipeg, Manitoba, Canada.

Purpose: The time between radiographic identification of a renal tumor and surgery can be concerning for patients and clinicians due to fears of tumor progression while awaiting treatment. This study aimed to evaluate the association between surgical wait time and oncologic outcomes for patients with renal cell carcinoma.

Materials And Methods: The Canadian Kidney Cancer Information System is a multi-institutional prospective cohort initiated in January 2011. Patients with clinical stage T1b or greater renal cell carcinoma diagnosed between January 2011 and December 2019 were included in this analysis. Outcomes of interest were pathological up staging, cancer recurrence, cancer specific survival and overall survival. Time to recurrence and death were estimated using Kaplan-Meier estimates and associations were determined using Cox proportional hazards models.

Results: A total of 1,769 patients satisfied the study criteria. Median wait times were 54 days (IQR 29-86) for the overall cohort and 81 days (IQR 49-127) for cT1b tumors (1,166 patients), 45 days (IQR 27-71) for cT2 tumors (672 cases) and 35 days (IQR 18-61) for cT3/4 tumors (563). Adjusting for comorbidity, tumor size, grade, histological subtype, margin status and pathological stage, there was no association between prolonged wait time and cancer recurrence or death.

Conclusions: In the context of current surgeon triaging practices surgical wait times up to 24 weeks were not associated with adverse oncologic outcomes after 2 years of followup.
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http://dx.doi.org/10.1097/JU.0000000000001230DOI Listing
January 2021

A novel prevention bundle to reduce incisional infections after radical cystectomy.

Urol Oncol 2020 07 12;38(7):638.e1-638.e6. Epub 2020 May 12.

Department of Surgery, Division of Urology, University of Ottawa, Ottawa, ON, Canada; Ottawa Hospital Research Institute, Ottawa, ON, Canada; School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada. Electronic address:

Purpose: Our institution implemented a novel intervention bundle to reduce incisional surgical site infections (SSIs) for patients undergoing radical cystectomy. The primary objective of this study was to evaluate the efficacy of the bundle in reducing incisional SSIs post-cystectomy.

Material And Methods: A before-after cohort study was performed on all patients who underwent radical cystectomy by urologic oncologists at The Ottawa Hospital from January 2016 to March 2019. Thirty-day postoperative incisional SSIs were identified from the medical record and were compared to institutionally collected National Surgical Quality Improvement Program data. The SSI reduction strategy was implemented as of March 1st, 2018. Adjusted associations between the SSI intervention with the risk of incisional SSI were determined. Cystectomy incisional SSI rates were compared to all other National Surgical Quality Improvement Program-collected surgeries at The Ottawa Hospital during the same time period.

Results: One hundred and thirty-two patients were included; 41 following implementation of the SSI reduction bundle. Mean age was 69 years, 104 (79%) were male, and 59 (45%) received neobladders. The risk of incisional SSI decreased from 16.5% preintervention to 2.4% post intervention (risk ratio 0.17; P = 0.004). Intraoperative transfusion and diabetes were independently associated with an increased risk of incisional SSI (P < 0.05). The SSI rate for all other surgical procedures at our institution remained stable during the same time period.

Conclusions: The risk of SSI after radical cystectomy is high. Use of an SSI reduction bundle was associated with a large reduction in incisional SSIs. Further evaluation of this intervention in other centers is warranted.
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http://dx.doi.org/10.1016/j.urolonc.2020.04.016DOI Listing
July 2020

Performance Characteristics of Spirometry With Negative Bronchodilator Response and Methacholine Challenge Testing and Implications for Asthma Diagnosis.

Chest 2020 08 13;158(2):479-490. Epub 2020 Apr 13.

Keenan Research Center in the Li Ka Shing Knowledge Institute of St. Michael's Hospital, University of Toronto, Toronto, ON, Canada; Department of Medicine, Division of Respirology, St. Michael's Hospital, Toronto, ON. Electronic address:

Background: In patients with a history suggestive of asthma, diagnosis is usually confirmed by spirometry with bronchodilator response (BDR) or confirmatory methacholine challenge testing (MCT).

Research Question: We examined the proportion of participants with negative BDR testing who had a positive MCT (and its predictors) result and characteristics of MCT, including effects of controller medication tapering and temporal variability (and predictors of MCT result change), and concordance between MCT and pulmonologist asthma diagnosis.

Study Design And Methods: Adults with self-reported physician-diagnosed asthma were recruited by random-digit dialing across Canada. Subjects performed spirometry with BDR testing and returned for MCT if testing was nondiagnostic for asthma. Subjects on controllers underwent medication tapering with serial MCTs over 3 to 6 weeks. Subjects with a negative MCT (the provocative concentration of methacholine that results in a 20% drop in FEV [PC] > 8 mg/mL) off medications were examined by a pulmonologist and had serial MCTs after 6 and 12 months.

Results: Of 500 subjects (50.5 ± 16.6 years old, 68.0% female) with a negative BDR test for asthma, 215 (43.0%) had a positive MCT. Subjects with prebronchodilator airflow limitation were more likely to have a positive MCT (OR, 1.90; 95% CI, 1.17-3.04). MCT converted from negative to positive, with medication tapering in 18 of 94 (19.1%) participants, and spontaneously over time in 25 of 165 (15.2%) participants. Of 231 subjects with negative MCT, 28 (12.1%) subsequently received an asthma diagnosis from a pulmonologist.

Interpretation: In subjects with a self-reported physician diagnosis of asthma, absence of bronchodilator reversibility had a negative predictive value of only 57% to exclude asthma. A finding of spirometric airflow limitation significantly increased chances of asthma. MCT results varied with medication taper and over time, and pulmonologists were sometimes prepared to give a clinical diagnosis of asthma despite negative MCT. Correspondingly, in patients for whom a high clinical suspicion of asthma exists, repeat testing appears to be warranted.
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http://dx.doi.org/10.1016/j.chest.2020.03.052DOI Listing
August 2020
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