Bradford S Hoppe1, Randal Henderson2, Dat Pham3, James D Cury3, Abubakr Bajwa3, Christopher G Morris2, Harry D'Agostino4, Stella Flampouri2, Soon Huh2, Zuofeng Li2, Barry McCook5, Romaine C Nichols2. 1. University of Florida Health Proton Therapy Institute, Jacksonville, Florida. Electronic address: bhoppe@floridaproton.org. 2. University of Florida Health Proton Therapy Institute, Jacksonville, Florida. 3. Department of Medicine, University of Florida College of Medicine, Jacksonville, Florida. 4. Department of Surgery, University of Florida College of Medicine, Jacksonville, Florida. 5. Department of Radiology, University of Florida College of Medicine, Jacksonville, Florida.
Abstract
PURPOSE: Proton therapy has been shown to reduce radiation dose to organs at risk (OAR) and could be used to safely escalate the radiation dose. We analyzed outcomes in a group of phase 2 study patients treated with dose-escalated proton therapy with concurrent chemotherapy for stage 3 non-small cell lung cancer (NSCLC). METHODS AND MATERIALS: From 2009 through 2013, LU02, a phase 2 trial of proton therapy delivering 74 to 80 Gy at 2 Gy/fraction with concurrent chemotherapy for stage 3 NSCLC, was opened to accrual at our institution. Due to slow accrual and competing trials, the study was closed after just 14 patients (stage IIIA, 9 patients; stage IIIB, 5 patients) were accrued over 4 years. During that same time period, 55 additional stage III patients were treated with high-dose proton therapy, including 7 in multi-institutional proton clinical trials, 4 not enrolled due to physician preference, and 44 who were ineligible based on strict entry criteria. An unknown number of patients were ineligible for enrollment due to insurance coverage issues and thus were treated with photon radiation. Median follow-up of surviving patients was 52 months. RESULTS: Two-year overall survival and progression-free survival rates were 57% and 25%, respectively. Median lengths of overall survival and progression-free survival were 33 months and 14 months, respectively. There were no acute grade 3 toxicities related to proton therapy. Late grade 3 gastrointestinal toxicity and pulmonary toxicity each occurred in 1 patient. CONCLUSIONS: Dose-escalated proton therapy with concurrent chemotherapy was well tolerated with encouraging results among a small cohort of patients. Unfortunately, single-institution proton studies may be difficult to accrue and consideration for pragmatic and/or multicenter trial design should be considered when developing future proton clinical trials.
PURPOSE: Proton therapy has been shown to reduce radiation dose to organs at risk (OAR) and could be used to safely escalate the radiation dose. We analyzed outcomes in a group of phase 2 study patients treated with dose-escalated proton therapy with concurrent chemotherapy for stage 3 non-small cell lung cancer (NSCLC). METHODS AND MATERIALS: From 2009 through 2013, LU02, a phase 2 trial of proton therapy delivering 74 to 80 Gy at 2 Gy/fraction with concurrent chemotherapy for stage 3 NSCLC, was opened to accrual at our institution. Due to slow accrual and competing trials, the study was closed after just 14 patients (stage IIIA, 9 patients; stage IIIB, 5 patients) were accrued over 4 years. During that same time period, 55 additional stage III patients were treated with high-dose proton therapy, including 7 in multi-institutional proton clinical trials, 4 not enrolled due to physician preference, and 44 who were ineligible based on strict entry criteria. An unknown number of patients were ineligible for enrollment due to insurance coverage issues and thus were treated with photon radiation. Median follow-up of surviving patients was 52 months. RESULTS: Two-year overall survival and progression-free survival rates were 57% and 25%, respectively. Median lengths of overall survival and progression-free survival were 33 months and 14 months, respectively. There were no acute grade 3 toxicities related to proton therapy. Late grade 3 gastrointestinal toxicity and pulmonary toxicity each occurred in 1 patient. CONCLUSIONS: Dose-escalated proton therapy with concurrent chemotherapy was well tolerated with encouraging results among a small cohort of patients. Unfortunately, single-institution proton studies may be difficult to accrue and consideration for pragmatic and/or multicenter trial design should be considered when developing future proton clinical trials.
Authors: Tejan P Diwanji; Pranshu Mohindra; Melissa Vyfhuis; James W Snider; Chaitanya Kalavagunta; Sina Mossahebi; Jen Yu; Steven Feigenberg; Shahed N Badiyan Journal: Transl Lung Cancer Res Date: 2017-04
Authors: Joe Y Chang; Vivek Verma; Ming Li; Wencheng Zhang; Ritsuko Komaki; Charles Lu; Pamela K Allen; Zhongxing Liao; James Welsh; Steven H Lin; Daniel Gomez; Melenda Jeter; Michael O'Reilly; Ronald X Zhu; Xiaodong Zhang; Heng Li; Radhe Mohan; John V Heymach; Ara A Vaporciyan; Stephen Hahn; James D Cox Journal: JAMA Oncol Date: 2017-08-10 Impact factor: 31.777