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Title: Multi-Institutional Phase II Study of Proton Beam Therapy for Organ-Confined Prostate Cancer Focusing on the Incidence of Late Rectal Toxicities

Abstract

Purpose: Proton beam therapy (PBT) is theoretically an excellent modality for external beam radiotherapy, providing an ideal dose distribution. However, it is not clear whether PBT for prostate cancer can clinically control toxicities. The purpose of the present study was to estimate prospectively the incidence of late rectal toxicities after PBT for organ-confined prostate cancer. Methods and Materials: The major eligibility criteria included clinical Stage T1-T2N0M0; initial prostate-specific antigen level of {<=}20 ng/mL and Gleason score {<=}7; no hormonal therapy or hormonal therapy within 12 months before registration; and written informed consent. The primary endpoint was the incidence of late Grade 2 or greater rectal toxicity at 2 years. Three institutions in Japan participated in the present study after institutional review board approval from each. PBT was delivered to a total dose of 74 GyE in 37 fractions. The patients were prospectively followed up to collect the data on toxicities using the National Cancer Institute-Common Toxicity Criteria, version 2.0. Results: Between 2004 and 2007, 151 patients were enrolled in the present study. Of the 151 patients, 75, 49, 9, 17, and 1 had Stage T1c, T2a, T2b, T2c, and T3a, respectively. The Gleason score was 4, 5, 6, and 7more » in 5, 15, 80 and 51 patients, respectively. The initial prostate-specific antigen level was <10 or 10-20 ng/mL in 102 and 49 patients, respectively, and 42 patients had received hormonal therapy and 109 had not. The median follow-up period was 43.4 months. Acute Grade 2 rectal and bladder toxicity temporarily developed in 0.7% and 12%, respectively. Of the 147 patients who had been followed up for >2 years, the incidence of late Grade 2 or greater rectal and bladder toxicity was 2.0% (95% confidence interval, 0-4.3%) and 4.1% (95% confidence interval, 0.9-7.3%) at 2 years, respectively. Conclusion: The results of the present prospective study have revealed a valuable piece of evidence that PBT for localized prostate cancer can achieve a low incidence of late Grade 2 or greater rectal toxicities.« less

Authors:
 [1]; ;  [1]; ;  [2]; ;  [3]
  1. Radiation Oncology Division, National Cancer Center Hospital East, Kashiwa (Japan)
  2. Proton Therapy Division, Shizuoka Cancer Center, Shizuoka (Japan)
  3. Department of Radiology, Hyogo Ion Beam Medical Center, Hyogo (Japan)
Publication Date:
OSTI Identifier:
21587736
Resource Type:
Journal Article
Journal Name:
International Journal of Radiation Oncology, Biology and Physics
Additional Journal Information:
Journal Volume: 81; Journal Issue: 2; Other Information: DOI: 10.1016/j.ijrobp.2010.05.027; PII: S0360-3016(10)00750-9; Copyright (c) 2011 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; Country of input: International Atomic Energy Agency (IAEA); Journal ID: ISSN 0360-3016
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; ANTIGENS; BLADDER; CLINICAL TRIALS; HORMONES; NEOPLASMS; PROSTATE; PROTON BEAMS; RADIATION DOSE DISTRIBUTIONS; RADIATION DOSES; RADIOTHERAPY; RECTUM; TOXICITY; BEAMS; BODY; DIGESTIVE SYSTEM; DISEASES; DOSES; GASTROINTESTINAL TRACT; GLANDS; INTESTINES; LARGE INTESTINE; MALE GENITALS; MEDICINE; NUCLEAR MEDICINE; NUCLEON BEAMS; ORGANS; PARTICLE BEAMS; RADIOLOGY; TESTING; THERAPY; URINARY TRACT

Citation Formats

Nihei, Keiji, E-mail: knihei@east.ncc.go.jp, Ogino, Takashi, Onozawa, Masakatsu, Murayama, Shigeyuki, Fuji, Hiroshi, Murakami, Masao, and Hishikawa, Yoshio. Multi-Institutional Phase II Study of Proton Beam Therapy for Organ-Confined Prostate Cancer Focusing on the Incidence of Late Rectal Toxicities. United States: N. p., 2011. Web. doi:10.1016/j.ijrobp.2010.05.027.
Nihei, Keiji, E-mail: knihei@east.ncc.go.jp, Ogino, Takashi, Onozawa, Masakatsu, Murayama, Shigeyuki, Fuji, Hiroshi, Murakami, Masao, & Hishikawa, Yoshio. Multi-Institutional Phase II Study of Proton Beam Therapy for Organ-Confined Prostate Cancer Focusing on the Incidence of Late Rectal Toxicities. United States. doi:10.1016/j.ijrobp.2010.05.027.
Nihei, Keiji, E-mail: knihei@east.ncc.go.jp, Ogino, Takashi, Onozawa, Masakatsu, Murayama, Shigeyuki, Fuji, Hiroshi, Murakami, Masao, and Hishikawa, Yoshio. Sat . "Multi-Institutional Phase II Study of Proton Beam Therapy for Organ-Confined Prostate Cancer Focusing on the Incidence of Late Rectal Toxicities". United States. doi:10.1016/j.ijrobp.2010.05.027.
@article{osti_21587736,
title = {Multi-Institutional Phase II Study of Proton Beam Therapy for Organ-Confined Prostate Cancer Focusing on the Incidence of Late Rectal Toxicities},
author = {Nihei, Keiji, E-mail: knihei@east.ncc.go.jp and Ogino, Takashi and Onozawa, Masakatsu and Murayama, Shigeyuki and Fuji, Hiroshi and Murakami, Masao and Hishikawa, Yoshio},
abstractNote = {Purpose: Proton beam therapy (PBT) is theoretically an excellent modality for external beam radiotherapy, providing an ideal dose distribution. However, it is not clear whether PBT for prostate cancer can clinically control toxicities. The purpose of the present study was to estimate prospectively the incidence of late rectal toxicities after PBT for organ-confined prostate cancer. Methods and Materials: The major eligibility criteria included clinical Stage T1-T2N0M0; initial prostate-specific antigen level of {<=}20 ng/mL and Gleason score {<=}7; no hormonal therapy or hormonal therapy within 12 months before registration; and written informed consent. The primary endpoint was the incidence of late Grade 2 or greater rectal toxicity at 2 years. Three institutions in Japan participated in the present study after institutional review board approval from each. PBT was delivered to a total dose of 74 GyE in 37 fractions. The patients were prospectively followed up to collect the data on toxicities using the National Cancer Institute-Common Toxicity Criteria, version 2.0. Results: Between 2004 and 2007, 151 patients were enrolled in the present study. Of the 151 patients, 75, 49, 9, 17, and 1 had Stage T1c, T2a, T2b, T2c, and T3a, respectively. The Gleason score was 4, 5, 6, and 7 in 5, 15, 80 and 51 patients, respectively. The initial prostate-specific antigen level was <10 or 10-20 ng/mL in 102 and 49 patients, respectively, and 42 patients had received hormonal therapy and 109 had not. The median follow-up period was 43.4 months. Acute Grade 2 rectal and bladder toxicity temporarily developed in 0.7% and 12%, respectively. Of the 147 patients who had been followed up for >2 years, the incidence of late Grade 2 or greater rectal and bladder toxicity was 2.0% (95% confidence interval, 0-4.3%) and 4.1% (95% confidence interval, 0.9-7.3%) at 2 years, respectively. Conclusion: The results of the present prospective study have revealed a valuable piece of evidence that PBT for localized prostate cancer can achieve a low incidence of late Grade 2 or greater rectal toxicities.},
doi = {10.1016/j.ijrobp.2010.05.027},
journal = {International Journal of Radiation Oncology, Biology and Physics},
issn = {0360-3016},
number = 2,
volume = 81,
place = {United States},
year = {2011},
month = {10}
}