Publications by authors named "Constance M Barysauskas"

22 Publications

  • Page 1 of 1

Impact of Clinical Process Improvement Training in an Integrated Delivery System.

Am J Med Qual 2020 Jul 31:1062860620943960. Epub 2020 Jul 31.

Harvard Medical School, Boston, MA.

Multiple integrated health systems use frontline staff training in quality and process improvement, although the optimal method to determine training success remains unknown. The authors assessed the Partners Clinical Process Improvement Leadership Program's short-term impact by evaluating data in project presentations during 14 courses between 2010 and 2016. Long-term impact was assessed via a graduate survey. Among 262 interprofessional teams, 180 (69%) achieved short-term improvement, including 78 (30%) achieving and 102 (39%) demonstrating improvement toward their project goal. Projects implementing ≥2 interventions were more likely to succeed. Of 231 graduates surveyed, 79% reported the ability to lead and 67% reported actual work on additional quality improvement projects. Ninety-seven percent of alumni reported a positive career impact. Hospital leadership support of clinical process improvement training meets short-term improvement needs and promotes long-term capacity for learning health systems.
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http://dx.doi.org/10.1177/1062860620943960DOI Listing
July 2020

Phase I Study of Rapid Alternation of Sunitinib and Regorafenib for the Treatment of Tyrosine Kinase Inhibitor Refractory Gastrointestinal Stromal Tumors.

Clin Cancer Res 2019 12 30;25(24):7287-7293. Epub 2019 Aug 30.

Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.

Purpose: Polyclonal emergence of KIT secondary mutations is a main mechanism of imatinib progression in gastrointestinal stromal tumor (GIST). Approved KIT inhibitors sunitinib and regorafenib have complementary activity against KIT resistance mutations. Preclinical evidence suggests that rapid alternation of sunitinib and regorafenib broadens the spectrum of imatinib-resistant subclones targeted.

Patients And Methods: Phase Ib study investigating continuous treatment with cycles of sunitinib (3 days) followed by regorafenib (4 days) in patients with tyrosine kinase inhibitor (TKI)-refractory GIST. A 3+3 dosing schema was utilized to determine the recommended phase II dose (RP2D). Plasma samples were analyzed for pharmacokinetics and circulating tumor DNA (ctDNA) studies using targeted error correction sequencing (TEC-seq) and droplet digital PCR (ddPCR).

Results: Of the 14 patients enrolled, 2 experienced dose-limiting toxicities at dose level 2 (asymptomatic grade 3 hypophosphatemia). Sunitinib 37.5 mg/day and regorafenib 120 mg/day was the RP2D. Treatment was well-tolerated and no unexpected toxicities resulted from the combination. Stable disease was the best response in 4 patients, and median progression-free survival was 1.9 months. Combined assessment of ctDNA with TEC-seq and ddPCR detected plasma mutations in 11 of 12 patients (92%). ctDNA studies showed that KIT secondary mutations remain the main mechanism of resistance in TKI-refractory GIST, revealing effective suppression of KIT-mutant subpopulations in patients benefiting from the combination.

Conclusions: Sunitinib and regorafenib combination is feasible and tolerable. Rapid alternation of TKIs with complementary activity might be effective when combining drugs with favorable pharmacokinetics, potentially allowing active doses while minimizing adverse events. Serial monitoring with ctDNA may guide treatment in patients with GIST.
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http://dx.doi.org/10.1158/1078-0432.CCR-19-2150DOI Listing
December 2019

A Comparison of Outcomes and Prognostic Features for Radiation-Associated Angiosarcoma of the Breast and Other Radiation-Associated Sarcomas.

Int J Radiat Oncol Biol Phys 2019 06 29;104(2):425-435. Epub 2019 Jan 29.

Department of Pathology, Brigham and Women's Hospital and Dana-Farber Cancer Institute, Boston, Massachusetts. Electronic address:

Purpose: Radiation-associated sarcomas (RAS) are considered to have a poor prognosis. Although the incidence is anticipated to rise, contemporary data regarding predictors of outcomes are few. We performed a retrospective analysis to identify RAS prognostic factors and subset analyses for radiation-associated angiosarcoma arising after treatment for breast cancer (RAAB) and other RAS subtypes (other-RAS).

Methods And Materials: Patients with localized RAS evaluated at an institutional multidisciplinary sarcoma clinic were identified. Clinical and histologic review was performed, and outcomes were assessed to identify prognostic features. A subset of cases underwent molecular analysis by next-generation sequencing.

Results: Among 176 patients, histologic subtypes of RAS included angiosarcoma (41%), undifferentiated/unclassified sarcoma (40%), leiomyosarcoma (8%), malignant peripheral nerve sheath tumor (6%), and osteosarcoma (2%). Sixty-seven patients (38%) had RAAB, and 109 (62%) had other-RAS. RAAB had significantly shorter latency from time of initial radiation compared with other-RAS (8 vs. 15 years; P < .001). Treatment approaches included surgery (91%), chemotherapy (44%), and radiation therapy (27%). Median follow-up was 3.2 years; 3-year overall survival (OS) was 74%. On multivariate analysis, positive margins (P < .0001), deep tumor location (intrathoracic/intra-abdominal, P = .002), and high grade (P < .0001) were associated with worse OS. In particular, 3-year OS with negative versus positive margins was 90% versus 66%. Patients with RAAB versus other-RAS showed a trend for higher 3-year OS (84% vs 68%; P = .09), significantly higher 3-year metastasis-free survival (82% vs 67%; P = .001), but similar 3-year local recurrence-free survival (54% vs 61%; P = .28). Next-generation sequencing identified overall low tumor mutational burden, recurrent MYC amplification in RAAB, and few clinically actionable mutations.

Conclusions: Margin negative excision, superficial tumor location, and low tumor grade are determinants of improved OS for RAS, suggesting that complete surgical excision, when possible, is an optimal component of treatment. RAAB is a clinicopathologically distinct type of RAS with shorter latency from initial RT, different recurrence patterns, and when aggressively managed has potentially better outcomes compared with other-RAS.
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http://dx.doi.org/10.1016/j.ijrobp.2019.01.082DOI Listing
June 2019

Surgical resection for recurrent retroperitoneal leiomyosarcoma and liposarcoma.

World J Surg Oncol 2018 Oct 11;16(1):203. Epub 2018 Oct 11.

University of Maryland, Greenebaum Cancer Center, South Greene Street Suite 9d10 Baltimore, Baltimore, MD, 21201, USA.

Background: Retroperitoneal soft tissue sarcomas (STS) include a number of histologies but are rare, with approximately 3000 cases in the USA per year. Retroperitoneal STS have a high incidence of local and distant recurrence. The purpose of this study was to review the University of Maryland Medical Center's (UMMC) treatment experience of retroperitoneal STS, where the patient population served represents a diverse socioeconomic and ethnic catchment.

Methods: IRB approval was obtained. We constructed a de-identified database of patients diagnosed with retroperitoneal liposarcomas (LPS) or leiomyosarcomas (LMS) treated at UMMC between 2000 and 2013. A total of 49 patients (Pts) with retroperitoneal STS met our eligibility criteria. Kaplan-Meier plots were used to graphically portray progression-free survival (PFS) and overall survival (OS). The log-rank test was used to compare time-to-event distributions.

Results: The median OS for all patients (Pts) was 6.3 years, and the 2-year OS rate was 81%. The median PFS for all Pts was 1.8 years, and the 2-year PFS rate was 45%. There was no difference in OS and PFS among LMS and LPS patients; the median OS for LMS was 3.8 years vs. LPS 6.4 years (p = 0.33), and the median PFS for LMS was 1.2 years vs. LPS 2.5 years (p = 0.28). There was a significant difference between histology and race (p = 0.001). LPS were primarily Caucasian 86% vs. 14% black, whereas LMS were primarily black 52% vs. 33% Caucasian. OS was influenced by functional status, gender, American Joint Committee on Cancer (AJCC) stage, grade, histology, tumor size, and extent of resection. PFS was influenced by AJCC stage, grade, and extent of resection. Neither adjuvant chemotherapy (1 Pt) nor neoadjuvant/adjuvant radiation therapy (18 Pts) influenced OS or PFS. There was a non-significant difference that Pts who could undergo resection of local recurrence had improved 2-year OS, with 100% LMS and LPS compared to 2-year OS of 71% (LMS) and 78% (LPS) not undergoing resection of local recurrence.

Conclusions: This study suggests a higher incidence of leiomyosarcoma in the African-American population. This study confirms the prognostic importance of grade, tumor size, AJCC stage, histology, and extent of resection in patient outcomes, at a large substantially diverse academic medical center. Future research into the biological features of liposarcoma and leiomyosarcoma Pts imparting these characteristics will be important to define.
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http://dx.doi.org/10.1186/s12957-018-1505-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6182828PMC
October 2018

Impact of elimination of contact precautions on noninfectious adverse events among MRSA and VRE patients.

Infect Control Hosp Epidemiol 2018 10 31;39(10):1272-1273. Epub 2018 Aug 31.

6Division of Infectious Disease and Immunology,University of Massachusetts Medical School,Worcester,Massachusetts.

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http://dx.doi.org/10.1017/ice.2018.204DOI Listing
October 2018

Oncology Patient Portal Enrollment at a Comprehensive Cancer Center: A Quality Improvement Initiative.

J Oncol Pract 2018 08;14(8):e451-e461

Dana-Farber/Partners Cancer Care; and Dana-Farber Cancer Institute, Boston, MA.

Purpose: Patient portals (PPs) provide patients access to their electronic health record and may facilitate active engagement in their care. Because PP use has not been well studied among patients with cancer, we sought to: understand the willingness of patients with cancer to use the PP, identify barriers to PP use, and improve PP accessibility.

Materials And Methods: As part of an institutional quality improvement initiative, we used a stakeholder-driven approach to examine PP use at the Dana-Farber Cancer Institute (Boston, MA). We conducted a survey across all ambulatory oncology practices as well as staff and patient focus groups in one ambulatory practice. We deployed three interventions to address barriers: staff education, staff-assisted enrollment support, and independent enrollment support.

Results: In October 2015, 1,019 (87%) of 1,178 eligible patients completed the survey (PP enrolled, 57%; non-PP enrolled, 43%). PP-enrolled patients reported reviewing test results and appointment schedules. Non-PP-enrolled patients cited difficult PP enrollment, lack of computer access, and concern about sharing data electronically as barriers to PP enrollment. Focus groups (staff, n = 20; patient representatives, n = 5) also identified lack of awareness of PP benefits as a barrier. The interventions, deployed from November to December 2015, increased PP enrollment from 47% to 53% by January 2016.

Conclusion: Patients with cancer want to communicate with their team through the PP, but barriers to enrollment impede use. Straightforward system-level interventions may increase enrollment. Further work is necessary to ascertain the degree to which increased PP enrollment leads to greater engagement and better outcomes.
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http://dx.doi.org/10.1200/JOP.17.00008DOI Listing
August 2018

A Phase 1 Study of Nilotinib Plus Radiation in High-Risk Chordoma.

Int J Radiat Oncol Biol Phys 2018 12 3;102(5):1496-1504. Epub 2018 Aug 3.

Division of Hematology-Oncology, Massachusetts General Hospital, Boston, Massachusetts; Center for Sarcoma and Connective Tissue Oncology, Massachusetts General Hospital, Boston, Massachusetts.

Purpose: Chordomas are malignant tumors arising from remnant notochordal tissue. Despite improved local control with preoperative/postoperative radiation therapy (RT), progression-free survival and overall survival (OS) remain poor in patients with high-risk features. Chordoma has been identified to express and activate platelet-derived growth factor receptor signaling. We conducted a phase 1 trial to identify the maximum tolerated dose (MTD), safety, and feasibility of nilotinib with RT as either preoperative or definitive treatment for patients with high-risk chordoma.

Methods And Materials: We recruited 23 patients with high-risk, nonmetastatic chordoma. High risk was defined as the presence of any of the following: local recurrence after surgery, previous intralesional resection, unplanned incomplete resection, unresectable or marginally resectable disease based on locally advanced stage, or declining surgery because of excessive morbidity. Patients were treated with nilotinib and concurrent RT to 50.4 Gy relative biological effectiveness (RBE) followed by surgery and postoperative RT to a cumulative dose up to 70.2 Gy RBE or definitively up to 77.4 Gy RBE without surgery. On completion of RT, patients were eligible to continue nilotinib until disease progression.

Results: In patients receiving nilotinib 200 mg twice daily with RT, 3 dose-limiting toxicities (DLT) occurred in 5 patients. One DLT was seen among 6 patients receiving nilotinib 200 mg daily with RT. Therefore, 200 mg daily was declared the maximum tolerated dose. Eleven additional patients received nilotinib with RT at the maximum tolerated dose, and 1 additional DLT occurred. The objective best response rate was 6% (1 of 18 patients, 95% confidence interval [CI], 0.1%-27%). The median progression-free survival was 58.15 months (95% CI, 39.10-∞). The median OS was 61.5 months (43.1-∞), and the 2-year OS rate was 95%.

Conclusions: Nilotinib 200 mg/d with RT is safe and tolerated in patients with high-risk chordoma. Long-term follow-up is needed to understand whether nilotinib combined with RT, with or without surgery, adds greater improvement to progression-free survival or OS than with RT with or without surgery alone in patients with high-risk chordoma.
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http://dx.doi.org/10.1016/j.ijrobp.2018.07.2013DOI Listing
December 2018

Taking a "Snapshot": Evaluation of a Conversation Aid for Identifying Psychosocial Needs in Young Adults with Cancer.

J Adolesc Young Adult Oncol 2018 10 21;7(5):565-571. Epub 2018 May 21.

1 Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute , Boston, Massachusetts.

Purpose: Young adults (YAs) aged 18-35 years with cancer often experience unmet psychosocial needs. We aimed to evaluate a conversation aid ("Snapshot") that offered a framework for discussing YA-specific psychosocial concerns between patients and clinicians.

Methods: We developed and implemented Snapshot between 2014 and 2016 as part of a quality improvement initiative at Dana-Farber Cancer Institute. We extracted pre- and postimplementation data from chart documentation of psychosocial concerns. YAs and social workers provided qualitative feedback on the use of Snapshot in clinical care.

Results: Postintervention chart reviews revealed a significant increase in the median number of topics documented in charts after implementation of Snapshot (preintervention median = 9 [range: 1-15] vs. postintervention median = 11 [range 6-15]; p = 0.003). Overall, YAs and social workers reported that using Snapshot improved communication and consistency of psychosocial care, with documented improvement in the following domains: understanding illness (p < 0.001), sexuality and intimacy (p = 0.03), symptom burden (p = 0.003), care planning (p < 0.001), support for caregivers and children (p = 0.02), and social, work, and home changes (p = 0.05).

Conclusion: Snapshot improved the quality of psychosocial needs assessment among YAs with cancer. Implementation was successful in reducing variability identified in the preintervention cohort and increasing the number of YA-specific psychosocial topics discussed. A standardized conversation aid has the potential to improve quality of care for YAs by enabling early identification and intervention of psychosocial issues for all patients.
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http://dx.doi.org/10.1089/jayao.2018.0027DOI Listing
October 2018

Characteristics of Volunteer Coaches in a Clinical Process Improvement Program.

Qual Manag Health Care 2018 Apr/Jun;27(2):81-86

Department of Medicine (Drs Morley and Rao) and Center for Quality and Safety (Dr Cummings), Massachusetts General Hospital, Boston; Harvard Medical School (Drs Morley, Rao, Jacobson, and Cummings), Boston, Massachusetts; Departments of Biostatistics and Computational Biology (Ms Barysauskas) and Quality and Patient Safety (Dr Jacobson), Dana-Farber Cancer Institute, Boston, Massachusetts; and Department of Quality, Safety & Value (Dr Cummings and Mss Carballo and Kalibatas), and Department of Population Health Management (Dr Rao), Partners HealthCare, Boston, Massachusetts.

Introduction: The Partners Clinical Process Improvement Leadership Program provides quality improvement training for clinicians and administrators, utilizing graduates as volunteer peer coaches for mentorship. We sought to understand the factors associated with volunteer coach participation and gain insight into how to improve and sustain this program.

Methods: Review of coach characteristics from course database and survey of frequent coaches.

Results: Out of 516 Partners Clinical Process Improvement Leadership Program graduates from March 2010 to June 2015, 117 (23%) individuals volunteered as coaches. Sixty-one (52%) individuals coached once, 31 (27%) coached twice, and 25 (21%) coached 3 or more times. There were statistically significant associations between coaching and occupation (P = .005), Partners Clinical Process Improvement Leadership Program course taken (P = .001), and course location (P = .007). Administrators were more likely to coach than physicians (odds ratio: 1.75, P = .04). Reasons for volunteering as a coach included further development of skills, desire to stay involved with program, and enjoying mentoring. Reasons for repeated coaching included maintaining quality improvement skills, expanding skills to a wider variety of projects, and networking.

Conclusions: A peer graduate volunteer coach model is a viable strategy for interprofessional quality improvement mentorship. Strategies that support repeat coaching and engage clinicians should be promoted to ensure an experienced and diversified group of coaches.
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http://dx.doi.org/10.1097/QMH.0000000000000163DOI Listing
July 2019

Localized Adult Ewing Sarcoma: Favorable Outcomes with Alternating Vincristine, Doxorubicin, Cyclophosphamide, and Ifosfamide, Etoposide (VDC/IE)-Based Multimodality Therapy.

Oncologist 2017 10 26;22(10):1265-1270. Epub 2017 May 26.

Department of Radiation Oncology, Dana-Farber Cancer Institute and Brigham & Women's Hospital, Boston, Massachusetts, USA

Background: In children with localized Ewing sarcoma (ES), addition of ifosfamide and etoposide to cyclophosphamide, doxorubicin, and vincristine (VDC/IE) improved 5-year overall survival (OS) to 70%-80%. Prior to delivery of VDC/IE in adults, 5-year OS was <50%. We reviewed our institutional outcomes for adults with ES who received VDC/IE-based treatment.

Materials And Methods: Between 1997-2013, 67 adults with localized ES were treated with curative intent. Local recurrence-free survival (LRFS), progression-free survival (PFS), and OS were determined using Kaplan-Meier method; comparisons were assessed with log-rank. Proportional hazard models were used to determine predictive factors.

Results: All patients received VDC/IE (median 14 cycles.) Local therapy was surgery for 33, radiation therapy for 17, or both for 17. Median follow-up for living patients was 5.2 years. Six patients had disease progression on therapy. Site of first failure was local for three, local and distant for two, and distant for ten. Five-year LRFS was 91%; 5-year LRFS was 96% for nonpelvic disease and 64% for pelvic disease ( = .003). Five-year PFS was 66%, and 5-year OS was 79%. On multivariate analysis, pelvic site had a 3.3 times increased risk of progression ( = .01).

Conclusion: Survival for adults with localized ES treated with VDC/IE-based multimodality therapy appears to be better than historical data and similar to excellent outcomes in children. Pelvic site of disease remains a predictor of worse outcome. Given the paucity of literature for adult ES, these data help validate VDC/IE-based therapy as an appropriate treatment approach for this rare disease in adults.

Implications For Practice: Ewing sarcoma (ES) is rare in adults. Treatment approaches for adults have been extrapolated from the pediatric experience, and there is a sense that adults fare less well than children. We reviewed treatment outcomes in adults with localized ES treated with cyclophosphamide, doxorubicin, and vincristine in alternation with ifosfamide and etoposide (VDC/IE) as part of multimodality therapy. Survival outcomes appear to be better than historical data for adults and similar to the excellent outcomes for children. These data help validate VDC/IE-based therapy as an appropriate treatment approach for this rare disease in adults.
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http://dx.doi.org/10.1634/theoncologist.2016-0463DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5634761PMC
October 2017

Histologic Appearance After Preoperative Radiation Therapy for Soft Tissue Sarcoma: Assessment of the European Organization for Research and Treatment of Cancer-Soft Tissue and Bone Sarcoma Group Response Score.

Int J Radiat Oncol Biol Phys 2017 06 24;98(2):375-383. Epub 2017 Feb 24.

Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts; Department of Radiation Oncology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address:

Purpose: To critically assess the prognostic value of the European Organization for Research and Treatment of Cancer-Soft Tissue and Bone Sarcoma Group (EORTC-STBSG) response score and define histologic appearance after preoperative radiation therapy (RT) for soft tissue sarcoma (STS).

Methods And Materials: For a cohort of 100 patients with STS of the extremity/trunk treated at our institution with preoperative RT followed by resection, 2 expert sarcoma pathologists evaluated the resected specimens for percent residual viable cells, necrosis, hyalinization/fibrosis, and infarction. The EORTC response score and other predictors of recurrence-free survival (RFS) and overall survival (OS) were assessed by Kaplan-Meier and proportional hazard models.

Results: Median tumor size was 7.5 cm; 92% were intermediate or high grade. Most common histologies were unclassified sarcoma (34%) and myxofibrosarcoma (25%). Median follow-up was 60 months. The 5-year local recurrence rate was 5%, 5-year RFS was 68%, and 5-year OS was 75%. Distribution of cases according to EORTC response score tiers was as follows: no residual viable tumor for 9 cases (9% pathologic complete response); <1% viable tumor for 0, ≥1% to <10% for 9, ≥10% to <50% for 44, and ≥50% for 38. There was no association between EORTC-STBSG response score and RFS or OS. Conversely, hyalinization/fibrosis was a significant independent favorable predictor for RFS (hazard ratio 0.49, P=.007) and OS (hazard ratio 0.36, P=.02).

Conclusion: Histologic evaluation after preoperative RT for STS showed a 9% pathologic complete response rate. The EORTC-STBSG response score and percent viable cells were not prognostic. Hyalinization/fibrosis was associated with favorable outcome, and if validated, may become a valid endpoint for neoadjuvant trials.
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http://dx.doi.org/10.1016/j.ijrobp.2017.02.087DOI Listing
June 2017

Immunotherapy with single agent nivolumab for advanced leiomyosarcoma of the uterus: Results of a phase 2 study.

Cancer 2017 Sep 25;123(17):3285-3290. Epub 2017 Apr 25.

Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.

Background: Immunotherapy has changed the therapeutic landscape in oncology. Advanced uterine leiomyosarcoma (ULMS) remains an incurable disease in most cases, and despite new drug approvals, improvements in overall survival have been modest at best. The goal of this study was to evaluate programmed-death 1 (PD-1) inhibition with nivolumab in this patient population.

Methods: This single-center phase 2 trial completed enrollment between May and October 2015. Patients received 3 mg/kg of intravenous nivolumab on day 1 of each 2-week cycle until disease progression or unacceptable toxicity. The primary endpoint was objective response rate. We assessed PD-1, PD-ligand 1 (PD-L1), and PD-L2 expression in archival tumor samples and variations in immune-phenotyping of circulating immune cells during treatment.

Results: Twelve patients were enrolled in the first stage of the 2-stage design. A median of 5 (range, 2-6) 2-week cycles of nivolumab were administered. Of the 12 patients, none responded to treatment. The overall median progression-free survival was 1.8 months (95% confidence interval, 0.8-unknown). The study did not open the second stage due to lack of benefit as defined by the statistical plan. Archival samples were available for 83% of patients. PD-1 (>3% of cells), PD-L1, and PD-L2 (>5% and >10% of tumor cells, respectively) expression were observed in 20%, 20%, and 90% of samples, respectively. No significant differences were observed between pre- and posttreatment cell phenotypes.

Conclusion: Single-agent nivolumab did not demonstrate a benefit in this cohort of previously treated advanced ULMS patients. Further biomarker-driven approaches and studies evaluating combined immune checkpoint-modulators should be considered. Cancer 2017;123:3285-90. © 2017 American Cancer Society.
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http://dx.doi.org/10.1002/cncr.30738DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5762200PMC
September 2017

Surveillance Imaging Patterns and Outcomes Following Radiation Therapy and Radical Resection for Localized Extremity and Trunk Soft Tissue Sarcoma.

Ann Surg Oncol 2017 Jun 5;24(6):1588-1595. Epub 2017 Jan 5.

Center for Bone and Soft Tissue Sarcoma, Brigham and Women's Hospital/Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.

Background: Optimal surveillance imaging (SI) regimens following radiation therapy (RT) and radical resection for localized soft tissue sarcoma (STS) are unknown and practice patterns vary.

Methods: Between 2006 and 2014, 94 patients with localized STS of the extremity/trunk treated with preoperative RT and radical resection were identified. Timing of local recurrence (LR), distant recurrence (DR), and SI were evaluated. The Kaplan-Meier method was used to determine recurrence-free and overall survival (OS), and the method of recurrence detection (SI or due to signs/symptoms) was determined.

Results: Median tumor size was 7.5 cm, and 92% were intermediate/high grade. After a median follow-up of 60 months for surviving patients, 30 patients (32%) recurred, including 5 LRs and 26 DRs. The median time to LR and DR was 36.2 months (range 14.4-65.7) and 10.4 months (range 5.2-76.9), respectively, and the 5-year local recurrence-free survival (RFS), distant RFS, and OS was 95, 71, and 76%, respectively. Local SI was performed for 90% of patients, mostly by magnetic resonance imaging (MRI; 91%). Of the five LRs, two were detected by SI and three had signs/symptoms preceding imaging. All patients underwent distant SI. Of the 26 DRs, 23 (88%) were in the lung. SI detected 22 (85%) DRs, and only 4 of 26 had signs/symptoms prompting imaging.

Conclusion: Given excellent local control with RT and radical resection for intermediate/high-grade STS of the extremity/trunk, SI of the primary site should be reserved for select patients at high risk of LR. Conversely, due to frequent occurrence of asymptomatic DR in the lungs, periodic lung SI is appropriate. Routine abdominopelvic SI may not be indicated for most histologies.
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http://dx.doi.org/10.1245/s10434-016-5755-5DOI Listing
June 2017

An Assessment of the Quality Oncology Practice Initiative: Lessons Learned From a Detailed Assessment of a Well-Established Profession-Based Performance Measurement Program.

J Healthc Qual 2017 Jul/Aug;39(4):e49-e58

Background: National performance measurement programs used to improve quality and/or accountability are prevalent. Professional society-based programs largely assess practice or provider performance. We tested the limitations of the Quality Oncology Practice Initiative (QOPI), a well-established program.

Methods: We investigated the potential limitations of the QOPI limited sampling strategy and end-of-life (EOL) metrics through a retrospective review of all decedents meeting the QOPI eligibility criteria at a large three-site community oncology practice. Relative precision for each EOL metric was measured and simulated scenarios modeled via log-normal distributions were compared.

Results: A total of 246 deaths were identified; only 14% of decedents were included in the QOPI limited sample. Important differences in relative precision between samples were evident. Chemotherapy administered at the EOL was 2.8 times greater among the full cohort compared to the sample.

Conclusion: The limited sampling strategy demonstrated the lack of precision explained by sampling variability confounded in smaller sample sizes. Our analyses demonstrated that practices reporting the same metric may stem from very different underlying distributions, which limits the ability to understand complex practice patterns and improve care. These findings may be of significance to other performance measurement programs that utilize similar testing strategies.
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http://dx.doi.org/10.1097/JHQ.0000000000000054DOI Listing
April 2018

Comparison of performance of various tumor response criteria in assessment of sunitinib activity in advanced gastrointestinal stromal tumors.

Clin Imaging 2016 Sep-Oct;40(5):880-4. Epub 2016 Apr 26.

Department of Imaging, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA 02215, USA; Department of Radiology, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA.

Purpose: To compare the performance of various tumor response criteria (TRC) in the assessment of patients with advanced gastrointestinal stromal tumor (GIST) treated with sunitinib after failure of imatinib.

Methods: Sixty-two participants with advanced GIST in two clinical trials received oral sunitinib after prior failure of imatinib (median duration 24 weeks; interquartile range 14-56) and were followed with contrast-enhanced computed tomography at baseline and thereafter at median intervals of 6 weeks (IRQ 6-9). Tumor response was prospectively determined using Response Evaluation Criteria in Solid Tumors (RECIST) 1.0, and retrospectively reassessed for comparison using RECIST 1.1, Choi criteria, and modified Choi (mChoi) criteria using the original target lesions. For mChoi criteria, progressive disease was defined as 20% increase in sum of the longest dimension, similar to RECIST 1.1. Clinical benefit rate (CBR; complete response, partial response, or stable disease ≥12 weeks) and progression-free survival were compared between various TRCs using kappa statistics.

Results: While partial response as the best response was more frequent by Choi and mChoi criteria (50% each) than RECIST 1.1 (15%) and RECIST 1.0 (13%), CBR was similar between various TRCs (overall CBR 60%-77%, 77%-94% agreement between all TRC pairs). Time to best response was shorter for Choi and mChoi criteria (median 11 weeks each) compared to RECIST 1.1 and RECIST 1.0 (median 25 and 24 weeks, respectively). PFS was similar for RECIST 1.1, RECIST 1.0, and mChoi (median 35 weeks each), and shortest for Choi criteria (median 23 weeks).

Conclusions: CBR was similar among the various TRCs, although Choi criteria led to earlier determination of disease progression. Therefore, RECIST 1.1 and mChoi criteria may be preferred for response assessment in patients with advanced GIST.
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http://dx.doi.org/10.1016/j.clinimag.2016.04.007DOI Listing
December 2016

Measuring Chemotherapy Appointment Duration and Variation Using Real-Time Location Systems.

J Healthc Qual 2016 Nov/Dec;38(6):353-358

Introduction: Clinical schedules drive resource utilization, cost, and patient wait time. Accurate appointment duration allocation ensures appropriate staffing ratios to daily caseloads and maximizes scarce resources. Dana-Farber Cancer Institute (DFCI) infusion appointment duration is adjusted by regimen using a consensus method of experts including pharmacists, nurses, and administrators. Using real-time location system (RTLS), we examined the accuracy of observed appointment duration compared with the scheduled duration.

Methods: Appointment duration was calculated using RTLS at DFCI between August 1, 2013, and September 30, 2013. Duration was defined as the total time a patient occupied an infusion chair. The top 10 administered infusion regimens were investigated (n = 805).

Results: Median observed appointment durations were statistically different than the scheduled durations. Appointment durations were shorter than scheduled 98% (C), 95% (I), and 75% (F) of the time and longer than scheduled 77% (A) and 76% (G) of the time. Fifty-six percent of the longer than scheduled (A) appointments were at least 30 minute longer.

Conclusion: RTLS provides reliable and unbiased data to improve schedule accuracy. Replacing consensus with system-based data may improve clinic flow, relieve staff stress, and increase patient satisfaction. Further investigation is warranted to elucidate factors that impact variation in appointment duration.
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http://dx.doi.org/10.1097/JHQ.0000000000000020DOI Listing
April 2018

Acute gastrointestinal toxicity and bowel bag dose-volume parameters for preoperative radiation therapy for retroperitoneal sarcoma.

Pract Radiat Oncol 2016 Sep-Oct;6(5):360-366. Epub 2015 Dec 19.

Department of Radiation Oncology, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, Massachusetts; Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts. Electronic address:

Purpose: Acute gastrointestinal (GI) toxicity has been studied in GI and gynecological (GYN) cancers, with volume receiving 15 Gy (V15) <830 mL, V25 <650 mL, and V45 <195 mL identified as dose constraints for the peritoneal space (bowel bag [BB]). There are no reported constraints derived from retroperitoneal sarcoma (RPS), and prospective trials for RPS have adopted some of the GI and GYN constraints. This study quantified GI toxicity during preoperative radiation therapy (RT) for RPS, assessed toxicity using published constraints, and evaluated predictors for toxicity.

Methods And Materials: From 2003 to 2013, 56 patients with RPS underwent preoperative RT at 2 institutions. Toxicity was scored using Radiation Therapy Oncology Group criteria for upper and lower acute GI toxicity. BB was contoured on planning computed tomography scans per Radiation Therapy Oncology Group atlas guidelines with review by a radiologist. Relationships among toxicity, clinical factors, and BB dose were analyzed.

Results: Three patients (5%) developed grade ≥3 acute GI toxicity: 2 grade 3 toxicities (anorexia and nausea) and 1 grade 5 toxicity (tumor-bowel fistula). Thirty-six patients (64%) had grade 2 toxicity (nausea, 55%; diarrhea, 23%; pain, 20%). Tumor size was the only significant clinical predictor of grade ≥2 acute GI toxicity. Larger mean BB volumes predicted for grade ≥2 toxicity (P = .001). On receiver operating characteristics analysis, V30 was the best discriminator for toxicity (P = .0001). Median BB V15 was 1375 mL; 75% of patients had V15 ≥830 mL. Median V25 was 1083 mL; 68% had V25 ≥650 mL. Median V45 was 575 mL; 82% had V45 ≥195 mL. V25 ≥650 mL was significantly associated with grade ≥2 toxicity (P = .01).

Conclusions: Among patients treated with preoperative RT for RPS, significant acute GI toxicity was very low despite BB dose exceeding established constraints for most cases. Acceptable dose constraints for RPS may be higher than those for GI or GYN cancers. Further assessment of dose-volume constraints for RPS is needed.
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http://dx.doi.org/10.1016/j.prro.2015.12.005DOI Listing
March 2017

Accidental Needlestick Exposures linked to the Administration of Local Anesthesia by Healthcare Workers.

Infect Control Hosp Epidemiol 2015 Dec 9;36(12):1487-8. Epub 2015 Oct 9.

1University of Massachusetts Medical School,Worcester,Massachusetts.

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http://dx.doi.org/10.1017/ice.2015.229DOI Listing
December 2015

A Prospective Controlled Trial of an Electronic Hand Hygiene Reminder System.

Open Forum Infect Dis 2015 Dec 26;2(4):ofv121. Epub 2015 Aug 26.

Department of Quantitative Health Sciences , University of Massachusetts Medical School , Worcester.

Background.  The use of electronic hand hygiene reminder systems has been proposed as an approach to improve hand hygiene compliance among healthcare workers, although information on efficacy is limited. We prospectively assessed whether hand hygiene activities among healthcare workers could be increased using an electronic hand hygiene monitoring and reminder system. Methods.  A prospective controlled clinical trial was conducted in 2 medical intensive care units (ICUs) at an academic medical center with comparable patient populations, healthcare staff, and physical layout. Hand hygiene activity was monitored concurrently in both ICUs, and the reminder system was installed in the test ICU. The reminder system was tested during 3 administered phases including: room entry/exit chimes, display of real-time hand hygiene activity, and a combination of the 2. Results.  In the test ICU, the mean number of hand hygiene events increased from 1538 per day at baseline to 1911 per day (24% increase) with the use of a combination of room entry/exit chimes, real-time displays of hand hygiene activity, and manager reports (P < .001); in addition, the ratio of hand hygiene to room entry/exit events also increased from 26.1% to 36.6% (40% increase, P < .001). The performance returned to baseline (1473 hand hygiene events per day) during the follow-up phase. There was no significant change in hand hygiene activity in the control ICU during the course of the trial. Conclusions.  In an ICU setting, an electronic hand hygiene reminder system that provided real-time feedback on overall unit-wide hand hygiene performance significantly increased hand hygiene activity.
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http://dx.doi.org/10.1093/ofid/ofv121DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4589647PMC
December 2015

Oral adverse events in cancer patients treated with VEGFR-directed multitargeted tyrosine kinase inhibitors.

Oral Oncol 2015 Nov 5;51(11):1026-1033. Epub 2015 Oct 5.

Division of Oral Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA; Department of Oral Medicine, Infection, and Immunity, Harvard School of Dental Medicine, 188 Longwood Avenue, Boston, MA 02115, USA.

Objectives: This study characterized the incidence and clinical features of oral adverse events among cancer patients who received VEGFR-directed multitargeted tyrosine kinase inhibitor (VR-TKI) therapies.

Methods: Electronic medical records of adult cancer patients treated with sunitinib, sorafenib, regorafenib, pazopanib, cabozantinib, imatinib, and bevacizumab therapy at Dana-Farber Cancer Institute from 2009 to 2012 were reviewed. Data collected included patient characteristics, oral and non-oral adverse events, and time to onset. Time oral adverse event-free was the primary outcome.

Results: A total of 747 patients with 806 individual courses of therapy were treated for a median of 3.9months with sunitinib (n=161), sorafenib (n=172), regorafenib (n=15), pazopanib (n=132), cabozantinib (n=23), imatinib (n=144), or bevacizumab (n=159) for lung cancer (21%), gastrointestinal stromal tumor (15%), and metastatic renal cell carcinoma (13%). An oral adverse event was reported in 23.7% of patients at a median of 1.9months after starting therapy. The most commonly reported oral adverse event was oral mucosal sensitivity (dysesthesia), occurring in 12% of patients, typically without clinical findings. Multivariate models showed patients who received VR-TKI therapy were at greater risk of any oral adverse event compared with patients treated with imatinib or bevacizumab. Patients receiving VR-TKI therapy who developed an oral adverse event were also at increased risk for hand-foot skin reaction (15.9%).

Conclusions: VR-TKI associated oral adverse events are characterized primarily by dysesthesia with lack of clinical signs. Oral dysesthesia is more commonly associated with VR-TKIs than with bevacizumab or imatinib. Management is largely empirical and requires further investigation.
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http://dx.doi.org/10.1016/j.oraloncology.2015.09.003DOI Listing
November 2015

Reduced frequencies of polyfunctional CMV-specific T cell responses in infants with congenital CMV infection.

J Clin Immunol 2015 Apr 25;35(3):289-301. Epub 2015 Feb 25.

Department of Medicine, University of Massachusetts Medical School, Worcester, MA, 01605, USA,

Purpose: CMV infection remains a priority for vaccine development. Vaccination of infants could modify congenital infection and provide lifetime immunity. Properties of CMV-specific T cells associated with control of viral replication in early life have not been fully defined.

Methods: CMV-specific CD4 and CD8 T cell responses were investigated in infants with congenital CMV infection and compared to adults with primary or chronic infection. PBMC were stimulated with UL83 (pp65) or UL122 (IE-2) peptide pools then stained with antibodies to markers of T cell subset (CD4 or CD8), phenotype (CD45RA, CCR7), or function (MIP1β, CD107, IFNγ, IL2) for flow cytometry analysis.

Results: Detection of CMV pp65-specific CD4 T cells was less common in infants than adults. Responder cells were primarily effector memory (EM, CD45RA-CCR7-) in adults, but mixed memory subsets in infants. Detection of CMV pp65-specific CD8 T cells did not differ between the groups, but infants had lower frequencies of total responding cells and of MIP1β- or CD107-expressing cells. Responder cells were EM or effector memory RA (CD45RA + CCR7-) in all groups. Polyfunctional T cells were less commonly detected in infants than adults. Responses to IE-2 were detected in adults but not infants. All infants had detectable circulating CMV DNA at initial study (versus 60 % of adults with primary infection) despite longer duration of CMV infection.

Conclusions: Reduced frequencies and altered functional profile of CMV-specific CD4 and CD8 T cell responses were detected in infants compared to adults, and were associated with persistent CMV DNA in peripheral blood.
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http://dx.doi.org/10.1007/s10875-015-0139-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4366322PMC
April 2015

Psychometric evaluation of the Care Transition Measure in TRACE-CORE: do we need a better measure?

J Am Heart Assoc 2014 Jun 4;3(3):e001053. Epub 2014 Jun 4.

Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA (M.D.A., R.L.K., C.I.K., A.S.A., L.L., J.J.A.).

Background: The quality of transitional care is associated with important health outcomes such as rehospitalization and costs. The widely used Care Transitions Measure (CTM-15) was developed with a classic test theory approach; its short version (CTM-3) was included in the CAHPS Hospital Survey. We conducted a psychometric evaluation of both measures and explored whether item response theory (IRT) could produce a more precise measure.

Methods And Results: As part of the Transitions, Risks, and Actions in Coronary Events Center for Outcomes Research and Education, 1545 participants were interviewed during an acute coronary syndrome hospitalization, providing information on general health status (Short Form-36), CTM-15, health utilization, and care process questions at 1 month postdischarge. We used classic and IRT analyses and compared the measurement precision of CTM-15-, CTM-3-, and CTM-IRT-based score using relative validity. Participants were 79% non-Hispanic white and 67% male, with an average age of 62 years. The CTM-15 had good internal consistency (Cronbach's α=0.95) but demonstrated acquiescence bias (8.7% participants responded "Strongly agree" and 19% responded "Agree" to all items) and limited score variability. These problems were more pronounced for the CTM-3. The CTM-15 differentiated between patient groups defined by self-reported health status, health care utilization, and care transition process indicators. Differences between groups were small (2 to 3 points). There was no gain in measurement precision from IRT scoring. The CTM-3 was not significantly lower for patients reporting rehospitalization or emergency department visits.

Conclusion: We identified psychometric challenges of the CTM, which may limit its value in research and practice. These results are in line with emerging evidence of gaps in the validity of the measure.
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http://dx.doi.org/10.1161/JAHA.114.001053DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4309102PMC
June 2014