Akira Yokomizo1,2, Hirofumi Koga1,2, Kazuto Ito3, Yutaka Takezawa4, Motokiyo Komiyama5, Kazuo Nishimura6, Junji Yonese7, Katsuyoshi Hashine8, Naoya Masumori9, Gaku Arai10, Shiro Saito11, Mitsuru Shinohara12, Nobuaki Shimizu13, Atsushi Yamauchi14, Takefumi Satoh15, Tatsuo Tochigi16, Mikio Kobayashi4, Hiroyuki Fujimoto5, Ken-Ichi Kakimoto6, Iwao Fukui7, Taiji Tsukamoto17, Miwako Nozaki18, Katsuyuki Karasawa19, Masaru Hasumi13, Mikinobu Ohtani14, Hiromichi Ishiyama20, Masaaki Kuwahara21, Masaoki Harada22, Yasuo Ohashi23, Toshihiko Kotake24, Tadao Kakizoe25, Kazuhiro Suzuki3, Seiji Naito1, Hidetoshi Yamanaka26. 1. Department of Urology, Graduate School of Medicine, Kyusyu University, Fukuoka, Japan. 2. Department of Urology, Harasanshin Hospital, Fukuoka, Japan. 3. Department of Urology, Gunma University Graduate School of Medicine, Maebashi, Japan. 4. Department of Urology, Isesaki Municipal Hospital, Isesaki, Japan. 5. Department of Urology, National Cancer Center Hospital, Tokyo, Japan. 6. Department of Urology, Osaka International Cancer Institute, Osaka, Japan. 7. Department of Urology, Cancer Institute Hospital, Tokyo, Japan. 8. Department of Urology, Shikoku Cancer Center, Matsuyama, Japan. 9. Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan. 10. Department of Urology, Dokkyo University Koshigaya Hospital, Koshigaya, Japan. 11. Department of Urology, Tokyo Medical Center, Tokyo, Japan. 12. Department of Urology, Tokyo Metropolitan Komagome Hospital, Tokyo, Japan. 13. Department of Urology, Gunma Cancer Center Hospital, Ohta, Japan. 14. Department of Urology, Ibaraki Prefectural Central Hospital, Kasama, Japan. 15. Department of Urology, Kitasato University School of Medicine, Sagamihara, Japan. 16. Department of Urology, Miyagi Cancer Center, Natori, Japan. 17. Sapporo Medical University School of Medicine, Sapporo, Japan. 18. Department of Radiation Oncology, Dokkyo University Koshigaya Hospital, Koshigaya, Japan. 19. Department of Radiation Oncology, Tokyo Metropolitan Komagome Hospital, Tokyo, Japan. 20. Department of Radiation and Radiation Oncology, Kitasato University, Sagamihara, Japan. 21. Sendai Jin-hinyokika, Sendai, Japan. 22. Kanagawa Cancer Center, Yokohama, Japan. 23. University of Tokyo, Tokyo, Japan. 24. Kotake Clinic, Osaka, Japan. 25. President, Japan Cancer Society, Tokyo, Japan. 26. Institute for Preventive Medicine, Kurosawa Hospital, Takasaki, Japan.
Abstract
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.
RCT Entities:
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.