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Effectiveness and toxicity of five-fraction prone accelerated partial breast irradiation
Hardy-Abeloos, Camille; Xiao, Julie; Oh, Cheongeun; Barbee, David; Shah, Bhartesh; Maisonet, Olivier; Perez, Carmen; Adams, Sylvia; Schnabel, Freya; Axelrod, Deborah; Guth, Amber; Karp, Nolan; Cahlon, Oren; Gerber, Naamit
PURPOSE/OBJECTIVE:Our institution was an early adopter of 5-fraction accelerated partial breast irradiation (ABPI) to treat women with early-stage breast cancer. This study reports long-term oncologic and cosmetic outcomes. METHODS:We included patients receiving APBI 600 cGy × 5 fx delivered every other day or every day between 2010 and 2022. Logistic regression models were used to identify factors associated with development of late toxicities, clinician, and patient-rated cosmesis. Kaplan-Meier methodology was used to calculate overall survival (OS), disease-free survival (DFS), and locoregional recurrence-free survival (LR-RFS). RESULTS:442 patients received APBI either daily (56%) or every other day (44%) in the prone position (92%). At a median follow-up of 48 months (range: 5.96-155 months), 12 (2.7%) patients developed a local recurrence (LR). Out of 258 patients with > 3-month toxicity data available, the most common late grade ≥ 2 adverse event was breast fibrosis (6.2%). On multivariate analysis, daily APBI treatment (vs every other day) did not correlate with an increased risk of any late grade ≥ 2 toxicity though it did correlate with a lower risk of any late grade ≥ 2 fibrosis. Overall, at a median follow-up of 80 months, the rates of good-excellent physician and patient-rated cosmesis were 95% and 85%, respectively, with no difference between patients treated on consecutive vs. every other day. On multivariate analysis, patients who did not receive any adjuvant therapy were at increased risk of developing a LR. Five-year OS, LRFS, and DFS were 97.2%, 97.7%, and 89.5%, respectively. CONCLUSIONS:Five-fraction APBI delivered primarily in the prone position either daily or every other day was effective with low rates of local recurrence, minimal toxicity, and excellent cosmesis at long-term follow-up.
PMID: 38183516
ISSN: 1573-7217
CID: 5644242
Effectiveness and toxicity of five-fraction prone accelerated partial breast irradiation
Hardy-Abeloos, Camille; Xiao, Julie; Oh, Cheongeun; Barbee, David; Shah, Bhartesh; Maisonet, Olivier; Perez, Carmen; Adams, Sylvia; Schnabel, Freya; Axelrod, Deborah; Guth, Amber; Karp, Nolan; Cahlon, Oren; Gerber, Naamit
Purpose: Our institution was an early adopter of 5-fraction accelerated partial breast irradiation (ABPI) to treat women with early-stage breast cancer. This study reports long-term oncologic and cosmetic outcomes. Methods: We included patients receiving APBI 600 cGy × 5 fx delivered every other day or every day between 2010 and 2022. Logistic regression models were used to identify factors associated with development of late toxicities, clinician, and patient-rated cosmesis. Kaplan"“Meier methodology was used to calculate overall survival (OS), disease-free survival (DFS), and locoregional recurrence-free survival (LR-RFS). Results: 442 patients received APBI either daily (56%) or every other day (44%) in the prone position (92%). At a median follow-up of 48 months (range: 5.96"“155 months), 12 (2.7%) patients developed a local recurrence (LR). Out of 258 patients with > 3-month toxicity data available, the most common late grade ≥ 2 adverse event was breast fibrosis (6.2%). On multivariate analysis, daily APBI treatment (vs every other day) did not correlate with an increased risk of any late grade ≥ 2 toxicity though it did correlate with a lower risk of any late grade ≥ 2 fibrosis. Overall, at a median follow-up of 80 months, the rates of good"“excellent physician and patient-rated cosmesis were 95% and 85%, respectively, with no difference between patients treated on consecutive vs. every other day. On multivariate analysis, patients who did not receive any adjuvant therapy were at increased risk of developing a LR. Five-year OS, LRFS, and DFS were 97.2%, 97.7%, and 89.5%, respectively. Conclusions: Five-fraction APBI delivered primarily in the prone position either daily or every other day was effective with low rates of local recurrence, minimal toxicity, and excellent cosmesis at long-term follow-up.
SCOPUS:85181487903
ISSN: 0167-6806
CID: 5630272
Validation of Patient-Reported Outcomes in Patients With Nonmetastatic Breast Cancer Receiving Comprehensive Nodal Irradiation in the RadComp Trial
Hahn, Elizabeth A.; Pugh, Stephanie L.; Lu, Hien L.; Vela, Alyssa M.; Gillespie, Erin F.; Nichols, Elizabeth M.; Wright, Jean L.; MacDonald, Shannon M.; Cahlon, Oren; Baas, Carole; Braunstein, Lior Z.; Fang, L. Christine; Freedman, Gary M.; Jimenez, Rachel B.; Kesslering, Christy M.; Mishra, Mark V.; Mutter, Robert W.; Ohri, Nisha; Rosen, Lane R.; Urbanic, James J.; Jagsi, Reshma; Mitchell, Sandra A.; Bekelman, Justin E.; Cella, David; Godette, Karen D.; Patel, Sagar; Langen, Katja M.; Zielan, Ryan R.; DeBlois, David; Pang, Dalong; Rudra, Sonali; Benhabib, Sidi; Chawla, Ashish; Chen, Kuanling; Dadkhah, Hossein; Majithia, Lonika; Rao, Avani D.; Stephenson, Lisa; Wang, Peng; Croog, Victoria J.; Li, Heng; Smith, Karen; Stinson, Susan; Walker, Amanda J.; Devisetty, Kiran; Hyde, Christian; Depauw, Nicholas; Godishala, Anuradha; Ho, Alice; Paganetti, Harald; Soto, Daniel; Suero-Abreu, Giselle; Taghian, Alphonse G.; Corbin, Kimberly S.; Halyard, Michele Y.; Jackson, Amanda; Liang, Xiaoying; Manke, Heather; McGee, Lisa A.; Pafundi, Deanna H.; Remmes, Nicholas B.; Shumway, Dean A.; Yan, Elizabeth S.; Bakhoum, Samuel F.; Barron, David A.; Bernstein, Michael; Cuaron, John J.; Dover, Laura; Gelblum, Daphna Y.; Gilbo, Philip; Gewanter, Richard M.; Guttman, David M.; Hong, Linda; Khan, Atif; LaPlant, Quincey; Mann, Justin; McCormick, Beryl; Mueller, Boris A.; Mychalczak, Borys; Parikh, Dhwani; Powell, Simon N.; Romesser, Paul B.; Roth O'Brien, Diana; Schupak, Karen D.; Shepherd, Annemarie F.; Xu, Amy; Yu, Anthony; Zinovoy, Melissa; Bennouna, Jaafar; Fagundes, Marcio; Panoff, Joseph; Amelia Rodrigues, Maria; Yu, Jen; Lee, Choonsik; Chen, Chin Cheng; Choi, J. Isabelle; Lin, Haibo; Akthar, Adil S.; Akhter, Nausheen; Mihalcik, Stephen A.; Pankuch, Mark; Parhar, Preeti K.; Stutz, Michael D.; Thukral, Arpi D.; Mah, Dennis; Tsai, Henry K.; Paulus, Rebecca; Haffty, Bruce G.; Goyal, Sharad; Yue, Ning J.; Sturgeon, Jared D.; Wilkinson, J. Ben; Boggs, D. Hunter; Cardan, Rex A.; Dalton, Allison; McDonald, Andrew; Prior, Fred; Mayadev, Jyoti S.; Moiseenko, Vitali; Narezkina, Anya; Phreaner, Nicholas; Rash, Dominique; Seibert, Tyler; Yashar, Catheryn; Daugherty, Emily C.; Mascia, Anthony; Medek, Sara A.; Meier, Teresa; Bradley, Julie A.; Lockney, Natalie; Mailhot, Raymond B.; Mendenhall, Nancy; Rutenberg, Michael; Harris, Eleanor E.; Lyons, Janice; Hong, Jack J.; Kunaprayoon, Dan K.; McAvoy, Sarah A.; Manu Mysore, ; Nowak Choi, Kamila A.; Patel, Akshar N.; Vyfhuis, Melissa A.L.; Wilson, Joelle; Algan, Ozer; Chen, Yong; Henson, Christina E.; Dvorak, Tomas; Willoughby, Twyla; Zeidan, Omar; Berman, Abigail T.; Chen, Et tsu; Dong, Lei; Driscoll, Amanda; Feigenberg, Steven J.; Feriozzi, Ashley; Hencek, Carolyn; Kolker, James D.; Konski, Andre A.; Ky, Bonnie; Lin, Lilie L.; Novick, Kristina L.; Reza, Nosheen; Siegal, Ann Marie; Tabakha, Sara; Taunk, Neil K.; Wilcox, Nicholas; Zou, Wei; Bhooshan, Neha; Croley, Richard; Weksberg, David C.; Ahmad, Neelour; Hoffman, Karen E.; Joyner, Melissa M.; Mitchell, Melissa P.; Poenisch, Falk; Smith, Benjamin D.; Strom, Eric A.; Vallabhaneni, Srilakshmi; Cheng, Richard; Kang, Kylie H.; Kim, H. Katherine; Kim, Janice N.; Wang, Waylene A.; Wong, Tony; Bosch, Walter; Mitchell, Joshua; Straube, William; Zoberi, Imran; Balanescu, Dinu; Chen, Peter Y.; Dilworth, Joshua T.; Ding, Xuanfeng; Donisan, Teodora; Hamstra, Daniel A.; Daniella Dang, Phuong; Katz, Stanford; Wang, Chiachien J.; Terry Wu,
Purpose: Our purpose was to evaluate the measurement properties of patient-reported outcome (PRO) measures used in the ongoing RadComp pragmatic randomized clinical trial (PRCT). Methods and Materials: The deidentified and blinded data set included 774 English-speaking female participants who completed their 6-month posttreatment assessment. Eleven PRO measures were evaluated, including the Trial Outcome Index from the Functional Assessment of Cancer Therapy-Breast (FACT-B), Satisfaction with Breast Cosmetic Outcomes, the BREAST-Q, and selected Patient-Reported Outcomes Measurement Information System (PROMIS) measures. PROs were measured at 3 timepoints: baseline, completion of radiation therapy (RT), and 6 months post-RT. Ten variables were used as validity anchors. Pearson or Spearman correlations were calculated between PROs and convergent validity indicators. Mean PRO differences between clinically distinct categories were compared with analysis of variance methods (known-groups validity). PRO change scores were mapped to change in other variables (sensitivity to change). Results: Most correlations between PROs and validity indicators were large (≥0.5). Mean score for Satisfaction with Breast Cosmetic Outcomes was higher (better) for those with a lumpectomy compared with those with a mastectomy (P < .001). Mean scores for the FACT-B Trial Outcome Index and for PROMIS Fatigue and Ability to Participate in Social Roles and Activities were better for those with good baseline performance status compared with those with poorer baseline performance status (P < .05). At completion of RT and post-RT, mean scores for Satisfaction with Breast Cosmetic Outcomes and BREAST-Q Radiation were significantly different (P < .001) across categories for all Functional Assessment of Chronic Illness Therapy -Treatment Satisfaction "“ General items. There were medium-sized correlations between change scores for FACT-B Trial Outcome Index, Fatigue, Anxiety, and Ability to Participate in Social Roles and change scores in the Visual Analog Scale. Conclusions: For patients with nonmetastatic breast cancer receiving radiation in the RadComp PRCT, our findings demonstrate high reliability and validity for important PRO measures, supporting their psychometric strength and usefulness to reflect the effect of RT on health-related quality of life.
SCOPUS:85192746169
ISSN: 0360-3016
CID: 5661252
A Radiation Therapy Contouring Atlas for Delineation of the Level I and II Axillae in the Prone Position: A Single-Institution Experience
Purswani, Juhi M; Goldberg, Eliana; Cahlon, Oren; Schnabel, Freya; Axelrod, Deborah; Guth, Amber; Perez, Carmen A; Shaikh, Fauzia; Tam, Moses; Formenti, Silvia C; Reig, Beatriu; Gerber, Naamit K
PURPOSE/OBJECTIVE:With transition from supine to prone position, tenting of the pectoralis major occurs, displacing the muscle from the chest wall and shifting the level I and II axillary spaces. For patients for whom we aim to treat the level I and II axillae using the prone technique, accurate delineation of these nodal regions is necessary. Although different consensus guidelines exist for delineation of nodal anatomy in supine position, to our knowledge, there are no contouring guidelines in the prone position that account for this change in nodal anatomy. METHODS AND MATERIALS/METHODS:The level I and II nodal contours from the Radiation Therapy Oncology Group (RTOG) breast cancer supine atlas were adapted for prone position by 2 radiation oncologists and a breast radiologist based on anatomic changes observed from supine to prone positioning on preoperative diagnostic imaging. Forty-three patients from a single institution treated with prone high tangents from 2012 to 2018 were identified as representative cases to delineate the revised level I and II axillae on noncontrast computed tomography (CT) scans obtained during radiation simulation. The revised nodal contours were reviewed by an expanded expert multidisciplinary panel including breast radiologists, radiation oncologists, and surgical oncologists for consistency and reproducibility. RESULTS:Consensus was achieved among the panel in order to create modifications from the RTOG breast atlas for CT-based contouring of the level I and II axillae in prone position using bone, muscle, and skin as landmarks. This atlas provides representative examples and accompanying descriptions for the changes described to the caudal and anterior borders of level II and the anterior, posterior, medial, and lateral borders of level I. A step-by-step guide is provided for properly identifying the revised anterior border of the level I axilla. CONCLUSIONS:The adaptations to the RTOG breast cancer atlas for prone positioning will enable radiation oncologists to more accurately target the level I and II axillae when the axillae are targets in addition to the breast.
PMID: 38729261
ISSN: 1879-8519
CID: 5687062
Proton Reirradiation for High-Risk Recurrent or New Primary Breast Cancer
Chakraborty, Molly A.; Khan, Atif J.; Cahlon, Oren; Xu, Amy J.; Braunstein, Lior Z.; Powell, Simon N.; Choi, J. Isabelle
Radiotherapy is an integral component of multidisciplinary breast cancer care. Given how commonly radiotherapy is used in the treatment of breast cancer, many patients with recurrences have received previous radiotherapy. Patients with new primary breast cancer may also have received previous radiotherapy to the thoracic region. Curative doses and comprehensive field photon reirradiation (reRT) have often been avoided in these patients due to concerns for severe toxicities to organs-at-risk (OARs), such as the heart, lungs, brachial plexus, and soft tissue. However, many patients may benefit from definitive-intent reRT, such as patients with high-risk disease features such as lymph node involvement and dermal/epidermal invasion. Proton therapy is a potentially advantageous treatment option for delivery of reRT due to its lack of exit dose and greater conformality that allow for enhanced non-target tissue sparing of previously irradiated tissues. In this review, we discuss the clinical applications of proton therapy for patients with breast cancer requiring reRT, the currently available literature and how it compares to historical photon reRT outcomes, treatment planning considerations, and questions in this area warranting further study. Given the dosimetric advantages of protons and the data reported to date, proton therapy is a promising option for patients who would benefit from the added locoregional disease control provided by reRT for recurrent or new primary breast cancer.
SCOPUS:85180676955
ISSN: 2072-6694
CID: 5630602
Prospective Clinical Evaluation of Integrating a Radiation Anatomist for Contouring in Routine Radiation Treatment Planning
Zhang, Helen; Onochie, Ifeanyirochukwu; Hilal, Lara; Wijetunga, N Ari; Hipp, Elizabeth; Guttmann, David M; Cahlon, Oren; Washington, Charles; Gomez, Daniel R; Gillespie, Erin F
Purpose/UNASSIGNED:A radiation anatomist was trained and integrated into clinical practice at a multi-site academic center. The primary objective of this quality improvement study was to determine whether a radiation anatomist improves the quality of organ-at-risk (OAR) contours, and secondarily to determine the impact on efficiency in the treatment planning process. Methods and Materials/UNASSIGNED:From March to August 2020, all patients undergoing computed tomography-based radiation planning at 2 clinics at Memorial Sloan Kettering Cancer Center were assigned using an "every other" process to either (1) OAR contouring by a radiation anatomist (intervention) or (2) contouring by the treating physician (standard of care). Blinded dosimetrists reported OAR contour quality using a 3-point scoring system based on a common clinical trial protocol deviation scale (1, acceptable; 2, minor deviation; and 3, major deviation). Physicians reported time spent contouring for all cases. Analyses included the Fisher exact test and multivariable ordinal logistic regression. Results/UNASSIGNED: = .002), respectively. Qualitative comments most often indicated edits required to bowel contours (n = 14). Conclusions/UNASSIGNED:These findings support improvements in both OAR contour quality and workflow efficiency with implementation of a radiation anatomist in routine practice. Findings could also inform development of autosegmentation by identifying disease sites and specific OARs contributing to low clinical efficiency. Future research is needed to determine the potential effect of reduced physician time spent contouring OARs on burnout.
PMCID:9449753
PMID: 36092987
ISSN: 2452-1094
CID: 5339452
Outcomes and toxicities after proton partial breast radiotherapy for early stage, hormone receptor positive breast cancer: 3-Year results of a phase II multi-center trial
Choi, J Isabelle; Prabhu, Kiran; Hartsell, William F; DeWees, Todd; Sinesi, Christopher; Vargas, Carlos; Benda, Rashmi K; Cahlon, Oren; Chang, Andrew L
Purpose/UNASSIGNED:Proton therapy (PT) for partial breast irradiation (PBI) in early-stage breast cancer can decrease morbidity versus photon PBI with superior organs-at-risk sparing. We report 3-year outcomes of the first prospective, multicenter, phase II trial of proton PBI. Methods and Materials/UNASSIGNED:This Proton Collaborative Group phase II trial (PCG BRE007-12) recruited women ≥ 50 years with node-negative, estrogen receptor (ER)-positive, ≤3cm, invasive ductal carcinoma (IDC) or ductal carcinoma in situ undergoing breast conserving surgery followed by proton PBI (40 Gy(RBE), 10 daily fractions). Primary endpoint was freedom from ipsilateral breast cancer recurrence. Adverse events were prospectively graded using CTCAEv4.0. Breast Cancer Treatment Outcome Scale (BCTOS) assessed patient-reported quality of life (PRQOL). Results/UNASSIGNED:Thirty-eight evaluable patients enrolled between 2/2013-11/2016. Median age was 67 years (range 50-79); 55 % had left-sided disease, and median tumor size was 0.9 cm. Treatment was delivered in ≥ 2 fields predominantly with uniform scanning PT (n = 37). At 35-month median follow-up (12-62), all patients were alive, and none had local, regional or distant disease progression. One patient developed an ER-negative contralateral IDC. Seven grade 2 adverse events occurred; no radiotherapy-related grade ≥ 3 toxicities occurred. Changes in BCTOS subdomain mean scores were maximum 0.36, indicating no meaningful change in PRQOL. Median heart volume receiving 5 Gy (V5Gy), lung V20Gy, and lung V10Gy were 0 %, 0 % and 0.19 %, respectively. Conclusion/UNASSIGNED:At 3 years, proton PBI provided 100 % cancer control for early-stage, ER-positive breast cancer. Toxicities are minimal, and PRQOL remains acceptable with continued follow-up. These findings support PT as a safe and effective PBI delivery option.
PMCID:9450061
PMID: 36093343
ISSN: 2405-6308
CID: 5339462
Radiation Oncology AcaDemic Mentorship Program (ROADMAP) for Junior Faculty: 1-Year Results of a Prospective Single Institution Initiative
Lin, Diana; Gomez, Daniel R; Zhang, Yue Helen; Gennarelli, Renee; Efstathiou, Jason A; Barker, Chris A; Gelblum, Daphna; Shah, Monika K; Liberman, Laura; Hirsch, Ariel E; Cahlon, Oren; Gillespie, Erin F
PURPOSE/OBJECTIVE:Although mentorship has been associated with promotion, job satisfaction and retention, data are limited on a) mentorship experience of clinical vs research track physicians and b) feasibility and relative priority of formal program components. METHODS AND MATERIALS/METHODS:Within a single institution multi-site academic network, we implemented a Radiation Oncology AcaDemic Mentorship Program (ROADMAP) for junior faculty. Validated surveys assessing mentee satisfaction were distributed at baseline and one year. Statistical analysis included Wilcoxon rank sum and signed tests. Mentees assessed the "likelihood to recommend" each program component (10-point Likert-type scale), and means with standard error (SE) are reported. RESULTS:Among 42 eligible junior faculty, 36 (86%) opted into the program. Median time since residency was 2.5 years (IQR 1.75, 5.25) on the clinical track (n=12) and 3 years (IQR 2.75, 5) on the research track (n=24). At baseline, research track physicians reported higher satisfaction with mentoring than physicians on the clinical track (2.92 vs 2.16, respectively, p=0.02). Among 32 physicians completing one-year, overall satisfaction with mentoring increased compared to baseline (2.72 vs 3.87, respectively, p<0.001), which persisted on subset analysis for both clinical (2.16 vs 4.03, p<0.001) and research track physicians (2.99 vs 3.77, p=0.005). At one year, 28 mentees (88%) opted to continue the program. Program components were rated 8.25 (SE 0.37) for mentor/mentee pairings, 7.22 (SE 0.39) for goal setting, 6.84 (SE 0.47) for administrative support, 6.69 (SE 0.44) for peer mentoring, and 6.53 (SE 0.45) for Steering Committee oversight. Ratings of peer mentoring were not associated with track (p=0.59) or years in practice (p=0.29). CONCLUSIONS:Clinical track physicians may be less satisfied with mentorship than research track faculty. But all junior faculty, regardless of track, appear to benefit from formalizing dyadic mentor-mentee relationships, goal setting, and peer mentoring. Further work is needed to determine the role of mentorship in addressing physician burnout.
PMID: 35644504
ISSN: 1879-355x
CID: 5239352
Bilateral Regional Nodal Irradiation Using Volumetric Modulated Arc Therapy: Dosimetric Analysis and Feasibility
Bernstein, Michael B; Walker, Katherine; Gillespie, Erin; Mueller, Boris; Cuaron, John; Xu, Amy; McCormick, Beryl; Khan, Atif; Cahlon, Oren; Powell, Simon; Braunstein, Lior Z
PURPOSE/OBJECTIVE:Dosimetric and technical challenges often limit radiation therapy (RT) target coverage for patients with breast cancer who require bilateral breast/chest wall and regional nodal irradiation (RNI). We evaluated the feasibility of using volumetric modulated arc therapy (VMAT) to administer bilateral comprehensive RNI including the internal mammary nodes. METHODS AND MATERIALS/METHODS:We analyzed all patients treated at our institution with bilateral RNI using VMAT between 2017 and 2020. Medical records were reviewed to ascertain clinicopathologic features, radiotherapeutic parameters, and treatment-related adverse events. RESULTS:) for the bilateral lungs was 96.1% (range, 84.5%-99.8%), and median volume of the lung receiving 20 Gy for each lung was 27.5% (range, 14.9%-38.1%). The cardiac mean dose was a median of 699 cGy (range, 527-1117 cGy). Five patients (41%) developed grade 1 cough/dyspnea, with one patient developing grade 3 dyspnea. Of note, 3 of these patients (60%) were current or former smokers. No patient received glucocorticoid therapy or required respiratory intervention, and none developed longer-term pulmonary complaints. A decline in ejection fraction occurred in one patient with a preexisting cardiac condition who also received anthracycline-based chemotherapy and trastuzumab. Only one patient experienced a locoregional recurrence with synchronous distant progression, and subsequently succumbed to the disease. No secondary cancers have been noted to date. CONCLUSIONS:is not predictive for complications.
PMCID:9081150
PMID: 35045364
ISSN: 1879-8519
CID: 5239302
Implementation Strategies to Increase Clinical Trial Enrollment in a Community-Academic Partnership and Impact on Hispanic Representation: An Interrupted Time Series Analysis
Ledesma Vicioso, Nahomy; Lin, Diana; Gomez, Daniel R; Yang, Jonathan T; Lee, Nancy Y; Rimner, Andreas; Yamada, Yoshiya; Zelefsky, Michael J; Kalman, Noah S; Rutter, Charles E; Kotecha, Rupesh R; Mehta, Minesh P; Panoff, Joseph E; Chuong, Michael D; Salner, Andrew L; Ostroff, Jamie S; Diamond, Lisa C; Mathis, Noah J; Cahlon, Oren; Pfister, David G; Zhang, Zhigang; Chino, Fumiko; Tsai, Jillian; Gillespie, Erin F
PURPOSE/UNASSIGNED:Community-academic partnerships have the potential to improve access to clinical trials for under-represented minority patients who more often receive cancer treatment in community settings. In 2017, the Memorial Sloan Kettering (MSK) Cancer Center began opening investigator-initiated clinical trials in radiation oncology in targeted community-based partner sites with a high potential to improve diverse population accrual. This study evaluates the effectiveness of a set of implementation strategies for increasing overall community-based enrollment and the resulting proportional enrollment of Hispanic patients on trials on the basis of availability in community-based partner sites. METHODS/UNASSIGNED:An interrupted time series analysis evaluating implementation strategies was conducted from April 2018 to September 2021. Descriptive analysis ofHispanic enrollment on investigator-initiated randomized therapeutic radiation trials open at community-based sites was compared with those open only at themain academic center. RESULTS/UNASSIGNED:Overall, 84 patients were enrolled in clinical trials in the MSK Alliance, of which 48 (56%) identified as Hispanic. The quarterly patient enrollment pre- vs postimplementation increased from 1.39 (95% CI, -3.67 to 6.46) to 9.42 (95% CI, 2.05 to 16.78; P5 .017). In the investigator-initiated randomized therapeutic radiation trials open in the MSK Alliance, Hispanic representation was 11.5% and 35.9% in twometastatic trials and 14.2% in a proton versus photon trial. Inmatched trials open only at the main academic center, Hispanic representation was 5.6%, 6.0%, and 4.0%, respectively. CONCLUSION/UNASSIGNED:A combination of practice-level and physician-level strategies implemented at community-based partner sites was associated with increased clinical trial enrollment, which translated to improved Hispanic representation. This supports the role Q:2 of strategic community-academic partnerships in addressing disparities in clinical trial enrollment.
PMID: 35544650
ISSN: 2688-1535
CID: 5239342