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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 
Influence of hydrogel spacer placement with prostate brachytherapy on rectal and urinary toxicity
Teyateeti, Achiraya; Grossman, Craig; Kollmeier, Marisa A; Fiasconaro, Megan; Hopkins, Margaret; McBride, Sean; Gorovets, Daniel; Shasha, Daniel; Cohen, Gilad; Zhang, Zhigang; Lesser, David J; Damato, Antonio; Zelefsky, Michael J
OBJECTIVE:To determine the influence of rectal hydrogel spacer placement (HSP) on late rectal toxicity outcomes in prostate cancer patients treated with low-dose-rate (LDR) brachytherapy, with or without supplemental external beam radiotherapy (EBRT). PATIENTS AND METHODS:A total of 224 patients underwent LDR brachytherapy with HSP, as monotherapy or combined with EBRT, between January 2016 and December 2019. Dosimetric variables reflecting the extent of rectal sparing and late rectal toxicity outcomes were evaluated. This spacer cohort was retrospectively compared to a similar patient group (n = 139) in whom HSP was not used. RESULTS:Hydrogel spacer placement was associated with significantly reduced rectal doses for all dosimetric variables; the median percentage rectal dose to 1 cc of rectum and rectal dose to 2 cc of rectum of the spacer cohort were all significantly lower compared to the non-spacer cohort. The incidence rates of overall (any grade) and grade ≥2 rectal toxicity were lower in patients with HSP compared to patients who did not undergo HSP: 12% and 1.8% vs 31% and 5.8%, respectively. The 3-year cumulative incidence of overall rectal toxicity was significantly lower with HSP than without (15% vs 33%; P < 0.001), corresponding to an overall rectal toxicity reduction on univariable analysis (hazard ratio 0.45, 95% confidence interval 0.28-0.73; P = 0.001). In this patient cohort treated with prostate brachytherapy, none of the urethral dosimetric variables or the presence or absence of HSP was associated with late urinary toxicity. CONCLUSION:Hydrogel rectal spacer placement is a safe procedure, associated with significantly reduced rectal dose. HSP translates to a decrease in overall late rectal toxicity in patients receiving dose-escalated brachytherapy-based procedures.
PMCID:9472451
PMID: 34388295
ISSN: 1464-410x 
CID: 5529582 
Superior Post-Treatment Biopsy Outcomes with High Dose SBRT Compared to High-Dose Conventionally Fractionated IMRT for Clinically Localized Prostate Cancer [Meeting Abstract]
Zelefsky, M. J.; Kollmeier, M. A.; White, C.; Zhang, Z.; Reuter, V.; Ehdaie, B.; Moore, A.; Samson, F.; Gorovets, D.; Damato, A. L.; Elsayegh, A.; McBride, S. M.
ISI:000892639302209
ISSN: 0360-3016 
CID: 5531392 
Determining interobserver variability in prostate bed CTV target delineation using MRI [Meeting Abstract]
Sritharan, K.; Akhiat, H.; Cahill, D.; Choi, S. L.; Choudhury, A.; Chung, P.; Diaz, J.; Dysager, L.; Hall, W.; Kerkmeijer, L.; Lawton, C. A.; Murray, J.; Nyborg, C. J.; Pos, F. J.; Rigo, M.; Schytte, T.; Sidhom, M.; Sohaib, A.; Tan, A.; van Zyp, J. van der Voort; Vesprini, D.; Zelefsky, M. J.; Tree, A.
ISI:000806764200144
ISSN: 0167-8140 
CID: 5531322 
Favorable toxicity of chemoradiation for muscle-invasive bladder cancer in elderly, frail patients. [Meeting Abstract]
Moore, Assaf; Zhang, Zhigang; Bochner, Bernard H.; Donahue, Timothy F.; Rosenberg, Jonathan E.; Iyer, Gopa; Funt, Samuel Aaron; Bajorin, Dean F.; Teo, Min Yuen; Aggen, David Henry; Gorovets, Daniel; Guttmann, David; Zelefsky, Michael J.; Kollmeier, Marisa
ISI:000771008900514
ISSN: 0732-183x 
CID: 5531312 
A Multicenter Prospective Trial of Electronic Skin Surface Brachytherapy (ESSB) for Cutaneous Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC): Cosmesis, Quality of Life (QoL) and Adverse Events (AEs) [Meeting Abstract]
Kuo, A. M. S.; Lee, E. H.; Rossi, A. M.; Nehal, K. S.; Cordova, M. A.; Steckler, A. M.; Lian, M.; Cohen, G.; Zhang, Z.; Zelefsky, M. J.; Kasper, M. E.; Barker, C. A.
ISI:000892639302032
ISSN: 0360-3016 
CID: 5531372 
Combined Brachytherapy and Ultra-Hypofractionated Radiotherapy for Intermediate-Risk Prostate Cancer: Comparison of Toxicity Outcomes Using a High-Dose Rate (HDR) vs. Low-Dose Rate (LDR) Brachytherapy Boost [Meeting Abstract]
Kollmeier, M. A.; Gorovets, D.; Flynn, J.; McBride, S.; Brennan, V. S.; Beaudry, J.; Cohen, G.; Damato, A. L.; Zhang, Z.; Zelefsky, M. J.
ISI:000892639300487
ISSN: 0360-3016 
CID: 5531362 
Discordance of patient- and physician-reported toxicities in two prospective trials of stereotactic body radiotherapy (SBRT) for localized prostate cancer. [Meeting Abstract]
Patel, Akshat; Badia, Rohit R.; Amini, Armon; Kung, Christopher; Kusin, Samuel B.; Neufeld, Sarah; Mannala, Samantha; Garant, Aurelie; Hannan, Raquibul; Timmerman, Robert D.; Zelefsky, Michael J.; Folkert, Michael Ryan; Desai, Neil Bipinchandra
ISI:000771008900250
ISSN: 0732-183x 
CID: 5531302 
Radiation therapy for de novo anorectal cancer in patients with a history of prostate radiation therapy
Hilal, Lara; Wu, Abraham J; Reyngold, Marsha; Cuaron, John J; Navilio, John; Romesser, Paul B; Dreyfuss, Alexandra; Yin, Sean; Zhang, Zhigang; Bai, Xing; Berry, Sean L; Zinovoy, Melissa; Nusrat, Maliha; Pappou, Emmanouil; Zelefsky, Michael J; Crane, Christopher H; Hajj, Carla
INTRODUCTION/UNASSIGNED:anorectal cancers previously treated with RT for prostate cancer. MATERIALS/METHODS/UNASSIGNED:We conducted a single-institution retrospective study of men treated with RT for rectal or anal cancer after prior prostate RT. Toxicity data were collected. Treatment plans were extracted to assess doses to organs at risk and target coverage. Cumulative incidence was calculated for local and distant progression. Kaplan-Meier curves were used to estimate overall survival (OS) and progression-free survival (PFS). RESULTS/UNASSIGNED:We identified 26 patients who received anorectal RT after prostate cancer RT: 17 for rectal cancer and 9 for anal cancer. None had metastatic disease. Prior prostate RT was delivered using low dose rate brachytherapy (LDR), external beam RT (EBRT), or EBRT + LDR. RT for rectal cancer was delivered most commonly using 50.4Gy/28 fractions (fr) or 1.5 Gy twice-daily to 30-45 Gy. The most used RT dose for anal cancer was 50Gy/25 fr. Median interval between prostate and anorectal RT was 12.3 years (range:0.5 - 25.3). 65% and 89% of rectal and anal cancer patients received concurrent chemotherapy, respectively. There were no reported ≥Grade 4 acute toxicities. Two patients developed fistulae; one was urinary-cutaneous after prostate LDR and 45Gy/25fr for rectal cancer, and the other was recto-vesicular after prostate LDR and 50Gy/25fr for anal cancer. In 11 patients with available dosimetry, coverage for anorectal cancers was adequate. With a median follow up of 84.4 months, 5-yr local progression and OS were 30% and 31% for rectal cancer, and 35% and 49% for anal cancer patients, respectively. CONCLUSION/UNASSIGNED:RT for anorectal cancer after prior prostate cancer RT is feasible but should be delivered with caution since it poses a risk of fistulae and possibly bleeding, especially in patients treated with prior LDR brachytherapy. Further studies, perhaps using proton therapy and/or rectal hydrogel spacers, are needed to further decrease toxicity and improve outcomes.
PMCID:9521738
PMID: 36185296
ISSN: 2234-943x 
CID: 5529662 
Quantitative Relaxometry for Target Localization and Response Assessment in Ultra-Hypofractionated MR-Guided Radiotherapy to the Prostate and DIL [Meeting Abstract]
Subashi, E.; LoCastro, E.; Apte, A.; Zelefsky, M. J.; Tyagi, N.
ISI:000892639302093
ISSN: 0360-3016 
CID: 5531382