Open AccessPatient‐reported outcomes following neoadjuvant endocrine therapy, external beam radiation, and adjuvant continuous/intermittent endocrine therapy for locally advanced prostate cancer: A randomized phase III trial
Author(s) -
Yokomizo Akira,
Koga Hirofumi,
Ito Kazuto,
Takezawa Yutaka,
Komiyama Motokiyo,
Nishimura Kazuo,
Yonese Junji,
Hashine Katsuyoshi,
Masumori Naoya,
Arai Gaku,
Saito Shiro,
Shinohara Mitsuru,
Shimizu Nobuaki,
Yamauchi Atsushi,
Satoh Takefumi,
Tochigi Tatsuo,
Kobayashi Mikio,
Fujimoto Hiroyuki,
Kakimoto Kenichi,
Fukui Iwao,
Tsukamoto Taiji,
Nozaki Miwako,
Karasawa Katsuyuki,
Hasumi Masaru,
Ohtani Mikinobu,
Ishiyama Hiromichi,
Kuwahara Masaaki,
Harada Masaoki,
Ohashi Yasuo,
Kotake Toshihiko,
Kakizoe Tadao,
Suzuki Kazuhiro,
Naito Seiji,
Yamanaka Hidetoshi
Publication year - 2021
Publication title -
cancer medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.403
H-Index - 53
ISSN - 2045-7634
DOI - 10.1002/cam4.3895
Subject(s) - medicine , prostate cancer , randomized controlled trial , urology , androgen deprivation therapy , radiation therapy , external beam radiotherapy , androgen suppression , adjuvant , cancer , oncology
Background We evaluated patient‐reported outcomes (PRO) during neoadjuvant androgen deprivation therapy (ADT) plus external beam radiation therapy (EBRT) followed by either adjuvant continuous ADT (CADT) or intermittent ADT (IADT) for patients with locally advanced prostate cancer (Pca). Methods A multicenter, randomized phase III trial enrolled 303 patients with locally advanced Pca. The patients were treated with 6 months (M) of ADT followed by 72 Gy of EBRT, and were randomly assigned to CADT or IADT after 14 M. The PROs were evaluated at sic points: baseline, 6 M, 8 M, 14 M, 20 M, and 38 M using FACT‐P questionnaires and EPIC urinary, bowel, and sexual bother subscales. Results The FACT‐P total scores were significantly better ( p < 0.05) in IADT versus CADT at 20 M (121.6 vs.115.4) and at 38 M (119.9 vs. 115.2). The physical well‐being scores (PWB) were significantly better ( p < 0.05) in IADT versus CADT at 38 M (25.4 vs. 24.0). The functional scores were significantly better in IADT than those in CADT at 14 M (20.2 vs18.7, p < 0.05) and at 20 M (21.0 vs.18.9, p < 0.05). Conclusion The PRO was significantly favorable in IADT on FACT‐P total score at 20 M and 38 M, PWB and functional scores at 38 M.