Publications by authors named "Atul Batra"

59 Publications

Real-world evidence on first- and second-line palliative chemotherapy in advanced pancreatic cancer.

World J Clin Oncol 2021 Sep;12(9):787-799

Department of Biomedical and Clinical Sciences, Linköping University, Linköping 58185, Sweden.

In spite of recent diagnostic and therapeutic advances, the prognosis of pancreatic ductal adenocarcinoma (PDAC) remains very poor. As most patients are not amenable to curative intent treatments, optimized palliative management is highly needed. One key question is to what extent promising results produced by randomized controlled trials (RCTs) correspond to clinically meaningful outcomes in patients treated outside the strict frames of a clinical trial. To answer such questions, real-world evidence is necessary. The present paper reviews and discusses the current literature on first- and second-line palliative chemotherapy in PDAC. Notably, a growing number of studies report that the outcomes of the two predominant first-line multidrug regimens, gemcitabine plus nab-paclitaxel (GnP) and folfirinox (FFX), is similar in RCTs and real-life populations. Outcomes of second-line therapy following failure of first-line regimens are still dismal, and considerable uncertainty of the optimal management remains. Additional RCTs and real-world evidence studies focusing on the optimal treatment sequence, such as FFX followed by GnP or vice versa, are urgently needed. Finally, the review highlights the need for prognostic and predictive biomarkers to inform clinical decision making and enable personalized management in advanced PDAC.
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http://dx.doi.org/10.5306/wjco.v12.i9.787DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8479347PMC
September 2021

Profile of Pathogenic Mutations and Evaluation of Germline Genetic Testing Criteria in Consecutive Breast Cancer Patients Treated at a North Indian Tertiary Care Center.

Ann Surg Oncol 2021 Oct 2. Epub 2021 Oct 2.

Department of Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.

Background: The burden of hereditary breast cancer in India is not well defined. Moreover, genetic testing criteria (National Comprehensive Cancer Network [NCCN] and Mainstreaming Cancer Genetics [MCG] Plus) have never been validated in the Indian population.

Methods: All new female breast cancer patients from 1st March 2019 to 28th February 2020 were screened. Those providing informed consent and without previous genetic testing were recruited. Multigene panel testing (107 genes) by next-generation sequencing was performed for all patients. The frequency of pathogenic/likely pathogenic (P/LP) mutations between patients qualifying and not qualifying the testing criteria was compared and their sensitivity was computed.

Results: Overall, 275 breast cancer patients were screened and 236 patients were included (median age 45 years); 30 patients did not consent and 9 patients previously underwent genetic testing. Thirty-four (14%) women had a positive family history and 35% had triple-negative breast cancer. P/LP mutations were found in 44/236 (18.64%) women; mutations in BRCA1 (22/47, 46.8%) and BRCA2 (9/47, 19.1%) were the most common, with 34% of mutations present in non-BRCA genes. Patients qualifying the testing criteria had a higher risk of having a P/LP mutation (NCCN: 23.6% vs. 7.04%, p = 0.03; MCG plus: 24.8% vs. 7.2%, p = 0.01). The sensitivity of the NCCN criteria was 88.6% (75.4-96.2) and 86.36% (72.65-94.83) for MCG plus. More than 95% sensitivity was achieved if all women up to 60 years of age were tested. Cascade testing was performed in 31 previous (16/44 families), with 23 testing positive.

Conclusions: The frequency of P/LP mutations in India is high, with significant contribution of non-BRCA genes. Testing criteria need modification to expand access to testing.
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http://dx.doi.org/10.1245/s10434-021-10870-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8487333PMC
October 2021

A Population-based Study of Treatment Patterns and Survival of Patients With De Novo Stage IV Non-Small Cell Lung Cancer.

Am J Clin Oncol 2021 Oct;44(10):512-518

Alberta Health Services (AHS), Edmonton, AB.

Background: Treatment strategies for metastatic non-small cell lung cancer (NSCLC) are evolving rapidly and can be highly variable. Real-world evidence of treatment patterns and outcomes can provide an understanding of our current practice and offer insights on ways to incorporate emerging therapies into our treatment paradigm. In this population-based study, we investigated treatments and outcomes of stage IV NSCLC patients from a large Canadian province.

Methods: Patients diagnosed with de novo stage IV NSCLC from April 1, 2010 to March 31, 2015 were identified. Data for baseline characteristics, treatments, and outcomes were obtained from provincial data sources, including the cancer registry and electronic medical records. We classified systemic treatments as chemotherapy, targeted therapy (anti-epidermal growth factor receptor, and anti-anaplastic lymphoma kinase) and immunotherapy (checkpoint inhibitors) and characterized clinical outcomes by treatment type.

Results: A total of 6438 patients were identified with NSCLC, of whom 3606 (56%) had de novo stage IV disease. The median age of diagnosis was 69 (range: 20 to 100) years and 52.4% were men. First-line palliative treatments included: chemotherapy in 19.5% (n=703), targeted agents in 5.7% (n=204), immunotherapy in 1% (n=1), radiotherapy in 6.8% (n=246), and best supportive care in 74.8% (n=2,698). Median overall survival (mOS) from diagnosis for the whole cohort was 3.8 months. Within subgroups, mOS was 18.0 months for targeted therapies, 9.4 months for chemotherapy, and 2.5 months for best supportive care. Only 1.0% of patients (n=34) received immunotherapy at any line.

Conclusions: Survival benefit was dependent on type of treatment received, with significantly better mOS observed with the use of small-molecule targeted therapy against epidermal growth factor receptor mutations and anaplastic lymphoma kinase rearrangements, as compared with best supportive care.
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http://dx.doi.org/10.1097/COC.0000000000000857DOI Listing
October 2021

Prognostic Significance of Disease Control at 12 Weeks in Patients With Advanced Pancreatic Cancer Receiving FOLFIRINOX as First-line Chemotherapy.

Am J Clin Oncol 2021 Oct;44(10):519-525

Department of Medical Oncology, Tom Baker Cancer Center, Calgary, AB, Canada.

Objectives: The POLO (Pancreas Cancer Olaparib Ongoing) trial demonstrated improvement in progression-free survival (PFS) with olaparib maintenance in advanced pancreatic cancer (APC) patients with germline BRCA1/2 mutations who had disease control after 16 weeks of platinum-based first-line therapy. However, in the real-world, the first assessment is usually performed at 12 weeks. Therefore, this study aimed to identify the proportion of real-world patients with APC that have disease control at 12 weeks (DC12) after FOLFIRINOX, assess any associations of baseline variables with DC12, and to determine the effect of DC12 on PFS and overall survival (OS).

Methods: APC patients treated with first-line FOLFIRINOX from 2011 to 2018 in Alberta, Canada, were identified. We conducted an analysis of baseline characteristics to identify factors associated with DC12 and to compare the PFS and OS of patients with DC12 to those with earlier disease progression.

Results: We identified 165 APC patients treated with FOLFIRINOX with unknown BRCA1/2 status, of which 56% were men, and the median age at diagnosis was 59 years (interquartile range, 38 to 75 y). Of these, 72 (44%) had DC12. Lower serum carbohydrate antigen 19.9 and normal serum albumin were associated with a higher likelihood of DC12. The PFS and OS of patients with DC12 was significantly higher than those with earlier progression (9.3 vs. 2.5 mo; hazard ratio, 0.22; 95% confidence interval, 0.15-0.32; P<0.001; 21.6 vs. 8.9 mo; hazard ratio, 0.35; 95% confidence interval, 0.25-0.49; P<0.0001).

Conclusion: Less than half of real-world patients treated with first-line FOLFIRINOX have DC12. Patients with APC who have higher carbohydrate antigen 19.9 and low albumin are less likely to have DC12. DC12 is significantly associated with longer PFS and OS.
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http://dx.doi.org/10.1097/COC.0000000000000856DOI Listing
October 2021

Video laryngoscopy vs. direct laryngoscopy for nasotracheal intubation in oromaxillofacial surgery: a systematic review and meta-analysis of randomized controlled trials.

Korean J Anesthesiol 2021 Oct 9;74(5):439-448. Epub 2021 Aug 9.

Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences, New Delhi, India.

Background: Nasotracheal intubation (NTI) is commonly performed in oromaxillofacial surgeries. We did this metanalysis to ascertain whether use of video laryngoscopy (VL) provided better NTI characteristics as compared to direct laryngoscopy (DL) in patients undergoing oromaxillofacial surgeries.

Methods: We performed a systematic search to identify randomized controlled trials comparing VL with DL for NTI in adults undergoing elective oromaxillofacial surgery. The primary outcome was time to intubation. Secondary outcomes included the first attempt success, overall success, incidence of nasal bleeding, Cormack and Lehane grade, and maneuvers required.

Results: Of the 456 studies identified following a systematic search, 10 were included. Meta-analysis showed a significantly lower time to tracheal intubation favoring VL (mean difference: -9.04, 95% CI [-12.71, -5.36], P < 0.001; I2 = 59%). VL was also associated with a greater first attempt success (relative risk [RR]: 1.10, 95% CI [1.04, 1.16], P = 0.001). Maneuvers to facilitate intubation were less with VL (RR: 0.22, 95% CI [0.10, 0.51], P < 0.001). There was no difference in overall intubation success (RR: 1.04, 95% CI [0.98, 1.10], P = 0.17). The incidence of bleeding did not differ between the DL and VL groups (RR: 0.59, 95% CI [0.32, 1.08], P = 0.09).

Conclusions: Evidence as per this meta-analysis suggests VL leads to a shorter time to NTI, a greater first attempt success rate, and reduced need for maneuvers when compared to DL. The present study supports use of VL as a first line device for NTI in oral-maxillofacial surgeries in experienced hands.
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http://dx.doi.org/10.4097/kja.21234DOI Listing
October 2021

Associations of Socioeconomic Status and Rurality With New-Onset Cardiovascular Disease in Cancer Survivors: A Population-Based Analysis.

JCO Oncol Pract 2021 Aug 9;17(8):e1189-e1201. Epub 2021 Jul 9.

Department of Medical Oncology, Tom Baker Cancer Center, Calgary, AB, Canada.

Purpose: Patients with cancer are predisposed to develop new-onset cardiovascular disease (CVD). We aimed to assess if rural residence and low socioeconomic status modify such a risk.

Methods: Patients diagnosed with solid organ cancers without any baseline CVD and on a follow-up of at least 1 year in a large Canadian province from 2004 to 2017 were identified using the population-based registry. We performed logistic regression analyses to examine the associations of rural residence and low socioeconomic status with the development of CVD.

Results: We identified 81,418 patients eligible for the analysis. The median age was 62 years, and 54.3% were women. At a median follow-up of 68 months, 29.4% were diagnosed with new CVD. The median time from cancer diagnosis to CVD diagnosis was 29 months. Rural patients (32.3% 28.5%; < .001) and those with low income (30.4% 25.9%; < .001) or low educational attainment (30.7% 27.6%; < .001) experienced higher rates of CVD. After adjusting for baseline factors and treatment, rural residence (odds ratio [OR], 1.07; 95% CI, 1.04 to 1.11; < .001), low income (OR, 1.17; 95% CI, 1.12 to 1.21; < .001), and low education (OR, 1.08; 95% CI, 1.04 to 1.11; < .001) continued to be associated with higher odds of CVD. A multivariate Cox regression model showed that patients with low socioeconomic status were more likely to die, but patients residing rurally were not.

Conclusion: Despite universal health care, marginalized populations experience different CVD risk profiles that should be considered when operationalizing lifestyle modification strategies and cardiac surveillance programs for the growing number of cancer survivors.
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http://dx.doi.org/10.1200/OP.20.01053DOI Listing
August 2021

First-Line Treatment with a Cyclin-Dependent Kinase 4/6 Inhibitor Plus an Aromatase Inhibitor for Metastatic Breast Cancer in Alberta.

Curr Oncol 2021 06 18;28(3):2270-2280. Epub 2021 Jun 18.

Tom Baker Cancer Centre, Calgary, AB T2N 1N4, Canada.

In this analysis, we describe population-based outcomes for first-line treatment with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) combined with an aromatase inhibitor (AI). All patients who were prescribed CDK4/6i + AI from January 2016 through June 2019 were included. Patient demographics, tumour and treatment characteristics were collected and described. Survival distributions were estimated using the Kaplan-Meier method. Multivariate analysis (MVA) was constructed to examine associations between potentially prognostic clinical variables and progression-free survival (PFS). In total, 316 patients were included. The median age was 61 years. After a median follow-up of 28.1 months, the median PFS was 37.9 months (95% CI, 26.7-NR). In the MVA, PR-negative tumour (HR, 2.37; 95% CI, 1.45-3.88; = 0.001) and CDK4/6i dose reduction (HR, 1.51; 95% CI, 1.06-2.16; = 0.022) predicted worse PFS. Median overall survival (OS) was not reached. The 30-month and 36-month OS rates were 74% and 68%, respectively. Of patients who progressed, 89% received second-line treatment. Median time to progression on second-line chemotherapy was 9.0 (5.8-17.6) months, and median time to progression on second-line hormonal therapy +/- targeted agent was 4.0 (3.4-8.6) months ( = 0.012). CDK4/6i + AI as first-line treatment for HR-positive, HER2-negative MBC in Alberta is justified based on favourable PFS and early OS outcomes.
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http://dx.doi.org/10.3390/curroncol28030209DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8293123PMC
June 2021

Developing a clinical-pathologic model to predict genomic risk of recurrence in patients with hormone receptor positive, human epidermal growth factor receptor-2 negative, node negative breast cancer.

Cancer Treat Res Commun 2021 26;28:100401. Epub 2021 May 26.

Department of Medical Oncology, Tom Baker Cancer Center, Calgary, Alberta, Canada; Cumming School of Medicine, University of Calgary, Alberta, Canada. Electronic address:

Introduction: Patients with hormone receptor (HR)-positive, human epidermal growth factor receptor-2 (HER2)-negative, node negative (NN) breast cancer may be offered a gene expression profiling (GEP) test to determine recurrence risk and benefit of adjuvant chemotherapy. We developed a clinical-pathologic (CP) model to predict genomic recurrence risk and examined its performance characteristics.

Methods: Patients diagnosed with HR-positive, HER2-negative, NN breast cancer with a tumour size < 30 mm and who underwent a GEP test [OncotypeDX or Prosigna] in Alberta from October 2017 through March 2019 were identified. Patients were classified as low or high genomic risk. Multivariable logistic regression analysis was performed to examine the associations of CP factors with genomic risk. A CP model was developed using coefficients of regression and sensitivity analyses were performed.

Results: A total of 366 patients were eligible (135 were tested using OncotypeDX and 231 with Prosigna). Of these, 64 (17.5%) patients were classified as high genomic risk. On multivariable logistic regression, tumour size > 20 mm (odds ratio [OR], 3.58; 95% confidence interval [CI], 1.84-6.98; P<0.001), low expression of progesterone receptor (OR, 3.46; 95% CI, 1.76-6.82; P<0.001), and histological grade III (OR, 7.24; 95% CI, 3.82-13.70; P<0.001) predicted high genomic risk. A CP model using these variables was developed to provide a score of 0-4. A CP cut-point of 0, identified 56% of genomic low risk patients with a specificity of 98.4%.

Conclusions: A CP model could be used to narrow the population of breast cancer patients undergoing GEP testing.
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http://dx.doi.org/10.1016/j.ctarc.2021.100401DOI Listing
May 2021

Reply to D. O'Reilly et al.

JCO Glob Oncol 2021 04;7:648

Amol Patel, MD, DM, Army Hospital Research & Referral, New Delhi, India; Vineet Govinda Gupta, MD, DM, Artemis Hospitals, Gurugram, India; Bivas Biswas, MD, DM; and Sandip Ganguly, MD, DM, Tata Medical Center, Kolkata, India; Chandan K. Das, MD, DM, Post Graduate Institute of Medical Education and Research, Chandigarh, India; Atul Batra, MD, DM, All India Institute of Medical Sciences, New Delhi, India; and Sainath Bhethanabhotla, MD, DM, Care Cancer Institute, Hyderabad, India.

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http://dx.doi.org/10.1200/GO.21.00077DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8162974PMC
April 2021

Adjuvant trastuzumab emtansine in human epidermal growth factor receptor 2-positive breast cancer: Take-home points from the KATHERINE trial.

Natl Med J India 2020 May-Jun;33(3):158-159

Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.

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http://dx.doi.org/10.4103/0970-258X.314006DOI Listing
June 2021

Four Cycles of Docetaxel-Cyclophosphamide versus Anthracycline-Taxane as Adjuvant Chemotherapy for HER2-Negative, Axillary Lymph Node Negative Breast Cancer: A Real-World Comparison of Alberta Patients Treated 2008-2012.

Curr Oncol 2021 03 4;28(2):1137-1142. Epub 2021 Mar 4.

Department of Medical Oncology, Tom Baker Cancer Center, 1331 29 ST NW, Calgary, AB T2N 4N2, Canada.

Uncertainty exists around the need to include an anthracycline if taxane-based adjuvant chemotherapy is being used for human epidermal growth factor receptor-2 (HER2) negative and axillary lymph node negative (LNN) breast cancer. We identified all patients who were diagnosed with HER2-negative, LNN breast cancer treated with docetaxel-cyclophosphamide for four cycles (DC4) or an anthracycline-taxane (AT) regimen following surgical resection in Alberta from 2008 through 2012. We used propensity score methods to match each patient treated with AT to up to four patients treated with DC4 on potentially confounding clinicopathologic and treatment variables. We compared the 10-year invasive disease free survival (iDFS), breast cancer specific-survival (BCSS) and overall survival (OS) and assessed the effect of the type of adjuvant chemotherapy on these outcomes using Cox regression. Of the 726 eligible patients, 657 (90.5%) were treated with DC4 and 69 (9.5%) were treated with AT. Matching created a group of 202 women treated with DC4 and eliminated differences in clinicopathologic and treatment factors. There was no statistically significant difference for the treatment effects of matched DC4 patients compared to the AT patients on iDFS (75.7% vs. 76.8%, = 0.75; hazard ratio (HR) = 1.05, 95% CI = 0.65 to 1.8), BCSS (88.1% vs. 87%, = 0.8; HR = 0.91, 95% CI = 0.42 to 1.9), or OS (87.1% vs. 86.9%, = 0.96; HR = 0.98, 95% CI = 0.46 to 2.1). Four cycles of DC as compared with an AT regimen yielded similar 10-year iDFS, BCSS and OS amongst patients with HER2-negative, LNN breast cancer.
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http://dx.doi.org/10.3390/curroncol28020109DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8025747PMC
March 2021

Association of a Shortened Duration of Adjuvant Chemotherapy With Overall Survival Among Individuals With Stage III Colon Cancer.

JAMA Netw Open 2021 03 1;4(3):e213587. Epub 2021 Mar 1.

Oncology Outcomes Initiative, University of Calgary, Calgary, Alberta, Canada.

Importance: Several real-world oncology studies have produced findings that contradict those from randomized clinical trials. Such disparities may be associated with methodological shortcomings.

Objective: To examine the association between a shortened duration of adjuvant chemotherapy among individuals with stage III colon cancer using real-world data.

Design, Setting, And Participants: This comparative effectiveness study included individuals diagnosed with stage III colon cancer between January 2004 and December 2015 who initiated adjuvant chemotherapy at oncology clinics within the province of Alberta, Canada. Patients were identified through record linkage of various administrative databases and were followed up until September 2017. Eligibility criteria were modeled after those used in the International Duration Evaluation of Adjuvant (IDEA) trial. A target trial emulation and naive observational analysis were conducted. Results from both cohorts were benchmarked against findings from the IDEA trial. Data analysis was conducted from March to December 2020.

Exposure: A shortened duration of adjuvant 5-fluorouracil/leucovorin plus oxaliplatin (FOLFOX) or capecitabine plus oxaliplatin (CAPOX) chemotherapy, defined as 3 to 5 months of treatment vs 6 months.

Main Outcomes And Measures: Overall survival assessed via vital statistics. The per-protocol hazard ratio (HR) was estimated using a weighted pooled logistic regression model. Subgroup analyses were conducted by treatment regimen (ie, FOLFOX vs CAPOX) and cancer stage (ie, T1-3 and N1 vs T4 or N2).

Results: From an initial cohort of 3086 patients, 485 (16%) were eligible for inclusion in the target trial analysis. The median age was 59 years (range, 19-81 years), and 230 (47%) were women. The maximum follow-up was 11.6 years. Median overall survival was not reached. A total of 90 patients (19%) died. The 5-year Kaplan Meier overall survival estimate was 0.79 (95% CI, 0.75-0.84). Estimates from the trial emulation were similar to those from the IDEA trial. For example, a shortened duration of adjuvant chemotherapy was not associated with overall survival among patients prescribed CAPOX in the IDEA trial (HR, 0.96; 95% CI, 0.85-1.08) or in the trial emulation (HR, 0.96; 95% CI, 0.43-2.14). In contrast, the naive observational analysis suggested that a shortened duration of CAPOX was significantly associated with worse survival (HR, 3.33; 95% CI, 1.04-10.65).

Conclusions And Relevance: In this study, the explicit emulation of a target trial better approximated results from an analogous well-conducted randomized clinical trial.
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http://dx.doi.org/10.1001/jamanetworkopen.2021.3587DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8010592PMC
March 2021

Utility of 18F-FDG-PET/CT in management and prognostication of treatment naïve late-stage soft tissue sarcomas.

Nucl Med Commun 2021 Jul;42(7):818-825

Department of Nuclear Medicine, All India Institute of Medical Sciences, New Delhi, India.

Objective: This study evaluated the utility of 18F-fluorodexoyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) in staging, grading, and prognostication of Stage III and IV soft tissue sarcomas (STSs).

Methods: Forty patients (Median age = 32.5 years; 25 men) with histologically proven STSs, prospectively underwent 18F-FDG-PET/CTs at baseline. Three-dimensional region of interests were drawn encompassing the lesions to calculate standardized uptake values (SUVs) and metabolic tumor volumes (MTVs). After segmentation, Haralick statistical texture analysis was performed. Follow-up was available for 35 patients. Survival at 6 months was 71.4% and at 1 year was 57.1%.

Results: American Joint Committee on Cancer Stage III was seen in 23 and Stage IV in 17 patients. None of the baseline quantitative and semi-quantitative parameters could predict response or progression. Only reduction in SUVmax in interim PET/CT correlated with baseline SUVmax (Spearman's Rho = 0.533; P = 0.019). Textural parameters namely 'contrast' in CT (P = 0.039) and 'difference entropy' in PET/CT (P = 0.051) could differentiate intermediate from high-grade lesions, with corresponding area under curves being 0.736 (0.533-0.889) and 0.700 (0.518-0.882). M1 disease [Hazard ratio (HR): 3.184 (1.179-8.595); P = 0.022], absence of surgical treatment [HR 0.305 (0.106-0.873), P = 0.027 with surgery], lower MTV/total tumor volume (TTV) [HR: 0.975 (0.953-0.997; P = 0.028] and progressive disease in interim PET/CT [3.483 (0.898-13.515); P = 0.056] were predictors of lower survival in univariate analysis. Only M1 disease was found to be reaching significance in multivariate analysis [HR = 2.683 (0.949-7.580); P = 0.063]. Baseline PET/CT changed management in 12.5% of patients [compared to local-imaging and high-resolution CT chest]; with detection of extra-pulmonary metastases. Though, interim and end of treatment PET/CTs detected more metastatic lesions, management was not impacted.

Conclusion: 18F-FDG-PET/CT allows for more accurate M-staging in late-stage STSs, which in turn influences the option of curative surgical resection and thus impacts patient prognosis. Lower baseline MTV/TTV and progression in interim PET/CT are also associated with lower survival. Textural analysis may have a role in noninvasive grading.
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http://dx.doi.org/10.1097/MNM.0000000000001401DOI Listing
July 2021

Prognostic Value of Serum Procalcitonin Levels in Patients With Febrile Neutropenia Presenting to the Emergency Department.

J Emerg Med 2021 May 28;60(5):641-647. Epub 2021 Jan 28.

Department of Emergency Medicine, All India Institute of Medical Sciences, New Delhi, India.

Background: Various risk-stratification scores have been developed to identify low-risk febrile neutropenia (FN). The Multinational Association of Supportive Care in Cancer (MASCC) score is a commonly used validated scoring system, although its performance varies due to its subjectivity. Biomarkers like procalcitonin (PCT) are being used in patients with FN to detect bacteremia and additional complications.

Objective: Our objective was to compare the performance of MASCC score with PCT in predicting adverse outcomes in patients with FN.

Methods: This was a prospective observational study that included chemotherapy-induced FN in hematologic or solid malignancy. The MASCC score, PCT levels, and blood cultures were taken at the first point of contact, and patient treatment was managed according to routine institutional protocol. The primary outcome was mortality at 30 days.

Results: A total of 100 patients were recruited, of which 92 had hematologic malignancy and 8 had solid malignancy. Forty-six patients were classified as low risk by MASCC score (≥21). The PCT threshold, 1.42 ng/mL, was taken as a cutoff value, with area under the receiver operating characteristic curve (AUROC) of 0.664 (95% confidence interval [CI] -0.55 to 0.77) for predicting mortality. AUROC for MASCC was 0.586 (95% CI 0.462 to 0.711).

Conclusions: PCT is a useful marker with better prognostic efficacy than MASCC score in patients with FN and can be used as an adjunct to the score in risk-stratifying patients with FN.
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http://dx.doi.org/10.1016/j.jemermed.2020.12.010DOI Listing
May 2021

Effect of Adjuvant Paclitaxel and Carboplatin on Survival in Early Triple-Negative Breast Cancer.

JAMA Oncol 2021 Mar;7(3):460-461

Department of Medical Oncology, Dr. BRA Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.

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http://dx.doi.org/10.1001/jamaoncol.2020.7157DOI Listing
March 2021

HER2 positivity in patients with estrogen receptor (ER) positive breast cancer: Is it really prognostic?

Breast 2021 02 30;55:136. Epub 2020 Nov 30.

Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.

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http://dx.doi.org/10.1016/j.breast.2020.11.017DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7878443PMC
February 2021

Platelet Normalized Serum Vascular Endothelial Growth Factor Levels in Progressive Pediatric Solid Malignancies.

Authors:
Atul Batra

Indian Pediatr 2020 12;57(12):1188

Department of Medical Oncology, Tom Baker Cancer Center; and University of Calgary, Calgary, Alberta, Canada.

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December 2020

Real-world Safety and Efficacy of Raltitrexed in Patients With Metastatic Colorectal Cancer.

Clin Colorectal Cancer 2021 06 18;20(2):e75-e81. Epub 2020 Sep 18.

Department of Medical Oncology, Tom Baker Cancer Center, Calgary, Alberta, Canada; University of Calgary, Calgary, Alberta, Canada. Electronic address:

Background: Use of fluoropyrimidine-based therapy in patients with metastatic colorectal cancer is associated with significant toxicities. This study aimed to assess the safety and efficacy of raltitrexed use in patients with metastatic colorectal cancer who developed significant toxicities after fluoropyrimidine-based treatment.

Patients And Methods: We identified patients with metastatic colorectal cancer who were treated with raltitrexed-based systemic therapy after developing serious adverse events with fluoropyrimidine-based treatment in a large Canadian province from 2004 to 2018. Demographic, tumor, and treatment characteristics were retrieved from the electronic medical records. Progression-free and overall survival were assessed from the start of raltitrexed-based therapy.

Results: A total of 86 patients were identified for the study. The median age was 66.5 years, and 58.1% of patients were men. The primary cancer site was right, left, and transverse colon in 38.4%, 27.9%, and 9.3%, respectively. The remaining 24.4% had rectal cancer. Among all patients, 43.0% had received more than 2 prior systemic therapies, and 37.6% had developed previous cardiotoxicity to fluoropyrimidine-based treatment. The median progression-free and overall survival were 8.5 and 10.2 months, respectively. On multivariable Cox regression model, patients with left-sided colon cancer (hazard ratio [HR], 0.33; 95% confidence interval [CI], 0.12-0.97; P = .044) and the Eastern Cooperative Oncology Group performance status of 0/1 (HR, 0.10; 95% CI, 0.01-0.82; P = .032) had a longer progression-free survival, whereas left-sidedness of colon cancer was the only factor that predicted overall survival (HR, 0.30; 95% CI, 0.10-0.88; P = .029). Raltitrexed was well-tolerated with common adverse events that included anemia in 41.7% of patients and chemotherapy-induced nausea and vomiting in 27.4%. Most toxicities were grade 1/2, but 16.7% of patients experienced grade 3. There were no cardiac events and treatment-related deaths.

Conclusions: Raltitrexed in patients with colorectal cancer who were previously treated with fluoropyrimidine-based systemic therapy is effective and well-tolerated.
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http://dx.doi.org/10.1016/j.clcc.2020.09.006DOI Listing
June 2021

Eligibility of real-world patients with metastatic breast cancer for clinical trials.

Breast 2020 Dec 17;54:171-178. Epub 2020 Oct 17.

Department of Medical Oncology, Tom Baker Cancer Center, Calgary, Canada; University of Calgary, Canada. Electronic address:

Introduction: The results of clinical trials in metastatic breast cancer (MBC) are generalized to real-world patients. This study determines the proportion of real-world patients who would be eligible for clinical trials and compares outcomes in eligible versus ineligible patients.

Methods: Patients diagnosed with MBC from 2004 to 2015 in a large Canadian province were included. Patients with one of the following criteria were considered ineligible: the presence of comorbid conditions (anemia, uncontrolled diabetes, heart disease, liver disease, and kidney disease) or a history of immunosuppression or prior malignancy. The likelihood of receiving cancer therapy was analysed using logistic regression models and factors affecting overall survival (OS) were assessed by Cox proportional hazards models.

Results: A total of 1585 patients with MBC were identified. The median age at diagnosis was 63 years. Of these, 512 (32.3%) patients were deemed ineligible in whom the two most common reasons for ineligibility were renal dysfunction (17.2%), and previous immunosuppression (7.8%). In the real world, ineligible patients were less likely to receive chemotherapy (29.5% vs 45.8%; P < 0.001) but not radiation treatment (7.6% vs 9.6%; P = 0.196) or hormonal therapy (57.6% vs 60.6%; P = 0.261). The 5-year OS of ineligible patients who received systemic therapy in the real-world was significantly better than those who did not.

Conclusions: Despite being ineligible for clinical trials based on common eligibility criteria, many real-world patients receive systemic treatment and derive possible benefit. Broadening of inclusion criteria in clinical trials will enhance the representation of real-world patients and increase the generalizability of results.
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http://dx.doi.org/10.1016/j.breast.2020.10.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7586241PMC
December 2020

Symptom burden in patients with common cancers near end-of-life and its associations with clinical characteristics: a real-world study.

Support Care Cancer 2021 Jun 26;29(6):3299-3309. Epub 2020 Oct 26.

Department of Medical Oncology, Tom Baker Cancer Center, Calgary, Alberta, Canada.

Background: Patients dying with cancer can experience various physical and psychological symptoms. We aimed to determine the type and severity of symptoms within the last 6 months of life in a large real-world cohort of patients with cancer.

Methods: We examined prospectively collected patient-reported outcomes of patients with lung, colorectal, breast, prostate or pancreatic cancer using the revised Edmonton Symptom Assessment System (ESASr) questionnaire from a large province in Canada from 2016 to 2017. The ESASr was categorized into physical and psychological symptom subscores and total symptom score, and each was classified as none to mild (0-3) or moderate to severe (4-10) based on intensity. Multivariable logistic regression analyses were performed to evaluate the relationship between clinical characteristics and symptom scores.

Results: We identified 1159 patients eligible for analysis, of whom 52.2% were men and median age was 68 years. There were 613, 192, 149, 111 and 94 patients with lung, colorectal, breast, prostate and pancreatic cancer, respectively. While approximately half of patients reported moderate to severe physical symptom subscores and total symptom scores, only one-third reported moderate to severe psychological subscores. On multivariable logistic regression analyses, women were more likely to report moderate to severe physical (odds ratio [OR], 1.52; 95% confidence interval [CI], 1.08-2.12; P = 0.016), psychological (OR, 1.60; 95% CI, 1.14-2.26; P = 0.006) and total symptom scores (OR, 1.80; 95% CI, 1.28-2.51; P = 0.001). Patients with lung cancer were also more likely to report moderate to severe physical and psychological subscores (OR, 1.95; 95% CI, 1.28-2.96; P = 0.002 and OR, 1.78; 95% CI, 1.13-2.81; P = 0.013) and total symptom scores (OR, 1.83; 95% CI, 1.20-2.81; P = 0.005). Finally, those closer to death were more likely to report moderate to severe physical symptom subscores (OR, 2.07; 95% CI, 1.33-3.23; P = 0.001) and total symptom scores (OR, 2.29; 95% CI, 1.46-3.60; P < 0.001), but not psychological symptom scores (OR, 1.34; 95% CI, 0.84-2.14; P = 0.210).

Conclusions: There is significant symptom burden in patients with cancer near the end-of-life. Further, physical symptoms appear to be more intense than psychological symptoms. Symptom-directed care is still needed to improve the quality of end-of-life.
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http://dx.doi.org/10.1007/s00520-020-05827-wDOI Listing
June 2021

Impact of pre-existing cardiovascular disease on treatment patterns and survival outcomes in patients with lung cancer.

BMC Cancer 2020 Oct 15;20(1):1004. Epub 2020 Oct 15.

Department of Medical Oncology, Tom Baker Cancer Center, 1331 29 ST NW, Calgary, Alberta, T2N 4N2, Canada.

Background: Baseline cardiovascular disease (CVD) can impact the patterns of treatment and hence the outcomes of patients with lung cancer. This study aimed to characterize treatment trends and survival outcomes of patients with pre-existing CVD prior to their diagnosis of lung cancer.

Methods: We conducted a retrospective, population-based cohort study of patients with lung cancer diagnosed from 2004 to 2015 in a large Canadian province. Multivariable logistic regression and Cox regression models were constructed to determine the associations between CVD and treatment patterns, and its impact on overall (OS) and cancer-specific survival (CSS), respectively. A competing risk multistate model was developed to determine the excess mortality risk of patients with pre-existing CVD.

Results: A total of 20,689 patients with lung cancer were eligible for the current analysis. Men comprised 55%, and the median age at diagnosis was 70 years. One-third had at least one CVD, with the most common being congestive heart failure in 15% of patients. Pre-existing CVD was associated with a lower likelihood of receiving chemotherapy (odds ratio [OR], 0.53; 95% confidence interval [CI], 0.48-0.58; P < .0001), radiotherapy (OR, 0.76; 95% CI, 0.7-0.82; P < .0001), and surgery (OR, 0.56; 95% CI, 0.44-0.7; P < .0001). Adjusting for measured confounders, the presence of pre-existing CVD predicted for inferior OS (hazard ratio [HR], 1.1; 95% CI, 1.1-1.2; P < .0001) and CSS (HR, 1.1; 95% CI, 1.1-1.1; P < .0001). However, in the competing risk multistate model that adjusted for baseline characteristics, prior CVD was associated with increased risk of non-cancer related death (HR, 1.48; 95% CI, 1.33-1.64; P < 0.0001) but not cancer related death (HR, 0.98; 95% CI, 0.94-1.03; P = 0.460).

Conclusions: Patients with lung cancer and pre-existing CVD are less likely to receive any modality of cancer treatment and are at a higher risk of non-cancer related deaths. As effective therapies such as immuno-oncology drugs are introduced, early cardio-oncology consultation may optimize management of lung cancer.
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http://dx.doi.org/10.1186/s12885-020-07487-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7559447PMC
October 2020

Patient-Reported Symptom Burden Near the End of Life in Patients With Gynaecologic Cancers.

J Obstet Gynaecol Can 2021 01 6;43(1):26-33. Epub 2020 Jul 6.

Tom Baker Cancer Centre, Calgary, AB. Electronic address:

Objective: There are limited data on patient-reported outcomes near the end of life in patients with gynaecologic cancers. This study aimed to assess the symptom burden in the last 6 months of life in a real-world cohort.

Methods: Patients diagnosed with metastatic gynaecologic malignancies from 2016 to 2019 who completed the revised Edmonton Symptom Assessment System (ESASr) questionnaire within 6 months of death in a large Canadian province were identified. Patient-reported symptom scores were categorized as none to mild (0-3) and moderate to severe (4-10). Individual symptoms were subsequently grouped into physical, psychological, and total subscores. The severity of symptoms was further analyzed for any associations with age, time to death, and primary tumour site (ovarian vs. uterocervical and vulvovaginal).

Results: We identified 107 patients with gynaecologic malignancies including 59 ovarian, 29 uterocervical, and 19 vulvovaginal cancers. The median ages at diagnosis and questionnaire completion were 64 and 65 years, respectively. The median time from completing the ESASr questionnaire to death was 65 days. Overall, physical and psychological symptoms were moderate to severe in 57.9% and 40.2% of patients, respectively. Among the individual symptoms, tiredness was the most commonly reported moderate to severe symptom (74.9%), while shortness of breath was least commonly reported (31.6%). While physical (P < 0.001) and total symptom (P = 0.009) subscores were more likely to be moderate to severe in intensity as death approached, the psychological subscore (P = 0.744) had no relationship with time to death. Longer time to death was predictive of lower physical (P = 0.002) and total symptom (P = 0.002) subscores, while a primary uterocervical cancer site was associated with a lower psychological symptom subscore (P = 0.042).

Conclusions: In the real-world setting, unique symptom trajectories can emerge for patients with gynaecologic cancer near the end of life. Knowledge of these specific symptom patterns can help inform the development and delivery of targeted palliative interventions to improve quality of life for these patients.
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http://dx.doi.org/10.1016/j.jogc.2020.06.017DOI Listing
January 2021

Factors Affecting Overall Survival in Premenopausal Women With Uterine Leiomyosarcoma: A Retrospective Analysis With Long-Term Follow-Up.

J Obstet Gynaecol Can 2020 Dec 17;42(12):1483-1488. Epub 2020 Jun 17.

Tom Baker Cancer Centre, Calgary, AB.

Objective: Premenopausal women with uterine leiomyosarcoma experience different issues than menopausal women with this malignancy. This study evaluated the clinical profile and factors affecting survival outcomes in premenopausal women with uterine leiomyosarcoma.

Methods: We conducted a retrospective analysis of patients with uterine leiomyosarcoma, diagnosed between January 2008 and December 2016. Data were collected from the Alberta Cancer Registry, which reflects all patients in the province. Thirty-eight patients were included in the study, of whom 21 were alive on the last date of review (31 December, 2019).

Results: The median follow-up period was 86 months. Mean patient age was 44.6 ± 5.7 years. The 5-year survival rate was 34.2%; 45% of patients presented with stage I or II disease and 55%, with stage III or IV. There was no clinical suspicion of malignancy prior to surgery in about 60% of cases. Ovarian preservation was performed in about 34% of cases. Forty-five percent of patients had received chemotherapy and 26%, radiotherapy. Almost 90% had unspecified leiomyosarcoma. Univariate analysis of factors likely to affect overall survival showed that older age at diagnosis (HR 1.19; 95% CI 1.05-1.34, P = 0.005), lymphovascular invasion (HR 9.81; 95% CI 2.88-33.51, P = 0.00), and no radiation therapy (HR 2.60; 95% CI 0.99-6.87, P = 0.05) were associated with worse overall survival. A multivariate analysis of these risk factors showed only lymphovascular invasion of the tumour to be a significant risk factor affecting overall survival. (HR 18.07; 95% CI 4.23-77.15, P =0.00).

Conclusion: Multivariate analysis showed lymphovascular invasion of tumour to be a significant risk factor affecting overall survival in premenopausal women with uterine leiomyosarcoma. Ovarian preservation, lymph node positivity, age, treatment strategy, hormone receptor status, and grade of tumour were not found out to be significant prognostic variables.
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http://dx.doi.org/10.1016/j.jogc.2020.05.016DOI Listing
December 2020

Four cycles of docetaxel and cyclophosphamide as adjuvant chemotherapy in node negative breast cancer: A real-world study.

Breast 2020 Dec 13;54:1-7. Epub 2020 Aug 13.

Department of Medical Oncology, Tom Baker Cancer Center, 1331 29 ST NW, Calgary, Alberta, T2N 4N2, Canada; Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada. Electronic address:

Introduction: The optimal number of cycles of adjuvant docetaxel and cyclophosphamide (DC) in patients with node negative breast cancer is not known. We aimed to analyse the survival outcomes of patients with node negative and human epidermal growth factor receptor (HER2)-negative breast cancer treated with four cycles of DC.

Methods: Patients with node negative and HER2-negative breast cancer treated with four cycles of DC after surgery in a large Canadian province from 2008 to 2012 were identified. We analysed the 4-year and 9-year invasive disease free survival (iDFS) and overall survival (OS). Cox regression models were constructed to examine the associations of clinical characteristics with survival outcomes.

Results: A total of 657 patients were eligible for the current analysis. The median age was 53 years and 71.2% of patients had hormone receptor-positive breast cancer. Approximately three-fourths of patients had grade III tumours. At a median follow-up of nine years, the 4-year iDFS and OS were 91.0% and 95.5% and the corresponding 9-year rates were 80.5% and 88.0%, respectively. On multivariable Cox regression analysis, grade III tumour predicted worse iDFS (hazard ratio [HR], 2.15; 95% confidence interval [CI], 1.09-4.21; P = 0.026) and OS (HR, 3.15; 95% CI, 1.18-8.45; P = 0.022).

Conclusions: Adjuvant chemotherapy with four cycles of DC in a select population of node negative breast cancer was associated with encouraging long-term survival. In the absence of a randomized comparison between four and six cycles of DC, this study presents real-world evidence to consider four cycles of DC as a reasonable option.
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http://dx.doi.org/10.1016/j.breast.2020.08.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7475113PMC
December 2020

Adjuvant chemotherapy in early breast cancer: Are we over-treating patients?

Natl Med J India 2019 Jul-Aug;32(4):230-231

Department of Medical Oncology, Dr BR Ambedkar Institute Research Hospital, All India Institute of Medical Sciences, New Delhi, India.

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http://dx.doi.org/10.4103/0970-258X.291305DOI Listing
August 2020

Factors associated with the initiation of chemotherapy within 90 days of death in metastatic colorectal cancer patients: a population-based study.

Support Care Cancer 2021 Mar 29;29(3):1535-1542. Epub 2020 Jul 29.

Department of Medical Oncology, Tom Baker Cancer Center, 1331 29 ST NW, Calgary, Alberta, T2N 4N2, Canada.

Introduction: Initiation of chemotherapy in patients with cancer near end-of-life (EOL) has become more frequent due to an increasing number of treatment options. We aimed to analyze the proportion of metastatic colorectal cancer patients (mCRC) in Alberta, Canada, who were started on a new chemotherapy regimen within 90 days of death.

Methods: This was a retrospective, population-based study using data from the cancer measurement outcomes and evaluation (C-MORE) database. All patients who received chemotherapy for mCRC in a large Canadian province from January 1, 2011, to December 31, 2016, were included in the current analysis. We identified the proportion of patients who initiated chemotherapy near EOL. Further, we analyzed the associations of baseline factors with initiation of chemotherapy near EOL.

Results: We identified 511 patients with mCRC who received chemotherapy. Of these, 132 (25.8%) initiated chemotherapy near EOL. Charlson's comorbidity index (CCI) score (score 1: OR, 0.524; 95% CI, 0.279-0.985; P = 0.045; CCI score > 1: OR, 0.366; 95% CI, 0.180-0.746; P = 0.006) and Eastern cooperative oncology group performance status (ECOG PS) (ECOG PS 2: OR, 4.457; 95% CI 2.518-7.890; P < 0.0001; ECOG PS > 2: OR 7.725; 95% CI 3.465-17.222; P < 0.0001) were predictive of initiation of chemotherapy near EOL. The most frequent chemotherapy regimens initiated were FOLFIRI (17%), capecitabine (15%), and panitumumab (15%), respectively.

Conclusions: Chemotherapy is frequently initiated near EOL in patients with mCRC. Routine clinical assessments including ECOG PS and comorbid medical conditions can help select patients with mCRC who are unlikely to benefit from palliative chemotherapy and prevent the adverse events and healthcare costs associated with such interventions near EOL.
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http://dx.doi.org/10.1007/s00520-020-05655-yDOI Listing
March 2021

Real-world evidence on adjuvant chemotherapy in older adults with stage II/III colon cancer.

World J Gastrointest Oncol 2020 Jun;12(6):604-618

Department of Oncology, University of Calgary, Calgary, Alberta T2N 4N2, Canada.

Colon cancer represents one of the most common cancers diagnosed in older adults worldwide. The standard of care in resected stage II and stage III colon cancer continues to evolve. While there is unequivocal evidence to suggest both disease free and overall survival benefits with the use of combination chemotherapy in patients with stage III colon cancer, data regarding its use in patients with stage II colon cancer are less clear. Further, although colon cancer is a disease that affects older adults, there is considerable debate on the value of adjuvant chemotherapy in the aging population. In particular, many older patients are undertreated when compared to their younger counterparts. In this review, we will describe the clinical trials that contributed to the current adjuvant chemotherapy approach in colon cancer, discuss representation of older adults in trials and the specific challenges associated with the management of this sub-population, and highlight the role of comprehensive geriatric assessments. We will also review how real-world evidence complements the data gaps from clinical trials of early stage colon cancer.
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http://dx.doi.org/10.4251/wjgo.v12.i6.604DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7340998PMC
June 2020

Associations between baseline symptom burden as assessed by patient-reported outcomes and overall survival of patients with metastatic cancer.

Support Care Cancer 2021 Mar 16;29(3):1423-1431. Epub 2020 Jul 16.

Department of Oncology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.

Background: Serial symptom assessments using patient-reported outcomes may be challenging to implement in routine clinical practices. We aimed to determine if a single measurement of symptom burden at the time of metastatic diagnosis is associated with survival.

Methods: We examined baseline patient-reported outcomes (within 90 days of diagnosis) of patients newly diagnosed with metastatic breast, lung, colorectal, or prostate cancer using the revised Edmonton Symptom Assessment System (ESASr) questionnaire. The ESASr was categorized into physical, psychological, and total symptom domains whereby scores were classified as none to mild (0-3) or moderate to severe (4-10). Multivariable Cox proportional hazards models were constructed to evaluate the effect of baseline symptom scores on overall survival.

Results: We identified 1316 patients eligible for analysis. There were 181, 601, 240, and 294 patients with breast, lung, colorectal, and prostate cancer, respectively. Approximately one-quarter of all patients reported moderate to severe physical, psychological, and total symptom subscores. On multivariable Cox regression analysis, older age (P < 0.001), male sex (P = 0.002), primary lung cancer (P < 0.001), and smoking in the previous month (P = 0.007) were predictive of inferior overall survival as were baseline moderate to severe physical (hazard ratio, 1.49; 95% confidence interval, 1.16-1.90; P = 0.002) and total symptom subscores (hazard ratio, 1.38; 95% confidence interval, 1.06-1.81; P = 0.017).

Conclusions: A single assessment of baseline symptom burden using the ESASr in patients with metastatic cancer has significant prognostic value. This may represent a feasible first step towards routine collection of patient-reported outcomes in real-world settings where serial symptom measurements can be challenging to implement.
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http://dx.doi.org/10.1007/s00520-020-05623-6DOI Listing
March 2021
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