Dear COMPPARE team, participants, stakeholders and friends,
I am pleased to announce that on December 14, 2021 Hampton University Proton Therapy Institute enrolled our 2,000th COMPPARE participant! This means we are now two-thirds of the way through with accrual, an exceptional accomplishment given the ongoing challenges presented by COVID-19. Congratulations to the COMPPARE Administration Team as well as the research teams at all of our participating sites for this accomplishment.
We are also excited to report that we have recently onboarded Kaiser Permanente in Los Angeles and the H.F. Mabry Cancer Center in Orangeburg, S.C. We believe these two sites will bolster our efforts to enroll more IMRT (conventional photon radiation therapy) patients on COMPPARE and we are delighted to be working with both institutions.
As you know, IMRT enrollment has lagged behind proton enrollment on COMPPARE, and remains quite a hurdle as we continue to navigate the uncertain COVID-19 landscape. As we searched for additional factors that might be causing this lag, we have become aware of practice pattern changes affecting IMRT accrual, specifically the increased utilization of ultra-hypofractionated radiation (stereotactic body radiation therapy, or SBRT). Reports from early and five-year results in two large trials — HYPO-RT-PC and PACE-B [1][2]— comparing conventionally fractionated or ultra-hypofractionated arms shows no difference in outcomes between short and long course IMRT, leading to acceptance of these much shorter treatment regimens as standard of care (SOC) when using IMRT.
At the time of COMPPARE design, no comparative effectiveness data existed for ultra-hypofractionated radiation (5-7 treatments) compared with conventional or moderately hypofractionated radiation with IMRT, nor was there any published pilot data on the ultra-hypofractionation regimens with proton therapy. So, ultra-hypofractionation was not considered standard of care and therefore not permitted on COMPPARE. A survey of IMRT sites this past summer suggested that with these recent publications, as well as COVID pressures, ultrahypofractionation was being used more frequently and now considered in most sites as standard of care. We discussed this development with our PCORI sponsors, research team, and scientific advisors and have obtained IRB approval to permit ultrahypofractionation with IMRT. (This change does not pertain to the Proton Cohort as the pragmatic portion of the Proton Cohort enrollment is complete.)
As we close this year, I am deeply grateful to all of you — patients, stakeholders, research staff, physician investigators, and physicists — for your continued dedication to this COMPPARE study. I wish you health, peace, and happiness in 2022. Despite our challenges, which include the postponement of our annual Workshop this month, we have so much to be grateful for in the new year, and I am very appreciative of the outstanding efforts made by our collaborative research teams, our Patient Stakeholder and Minority Engagement Groups, and most of all our COMPPARE enrollees. In this season of hope, our thoughts are with all current and future prostate cancer patients and their loved ones as we work toward improving their ability to make informed treatment decisions.
To learn more about the COMPPARE study, visit https://comppare.org/about/study-details/.
In good health,
Nancy Mendenhall, MD
____________________
[1] Widmark A, Gunnlaugsson A, Beckman L, Thellenberg-Karlsson C, Hoyer M, Lagerlund M, Kindblom J, Ginman C, Johansson B, Björnlinger K, Seke M, Agrup M, Fransson P, Tavelin B, Norman D, Zackrisson B, Anderson H, Kjellén E, Franzén L, Nilsson P. Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial. The Lancet. 2019 Aug 3;394(10196):385-395.
[2] Brand, DH, Tree, AC, Ostler, P, van der Voet, H, Loblaw, A, Chu, W, Ford, D, Tolan, S, Jain, S, Martin, A, Staffurth, J, Camilleri, P. Kancherla, K, Frew, J, Chan, A, Dayes, IS, Henderson, D, Brown, S, Cruickshank, C, Burnett, S, Duffton, A, Griffin, C, Hinder, V, Morrison, K, Naismith, O, Hall, Emma, van As, N, Dodds, D, Lartigau, E, Patton, S, Thompson, A, Winkler, M, Wells, P, Lymberiou, T, Saunders, D, Vilarino-Varela, M, Vavassis, P, Tsakiridis, T, Carlson, R, Rodrigues, G, Tanguay, J, Iqbal, S, Winkler, M, Morgan, S, Mihai, A, Li, A, Din, O, Panades, M, Wade, R, Rimmer, Y, Armstrong, J, Panades, M, Oommen, N. Intensity-modulated fractionated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): acute toxicity findings from an international, randomised, open-label, phase 3, non-inferiority trial. The Lancet Oncology. 2019 Nov 1; 20(11):1531-1543.