Long-Term Follow-up of a Randomized Controlled Trial on Accelerated Radiation Therapy Versus Standard Fractionated Radiation Therapy for Early Glottic Cancer (JCOG0701A3)

被引：4

作者：

Kodaira, Takeshi ^{[1
]}

Kagami, Yoshikazu ^{[2
]}

Machida, Ryunosuke ^{[3
]}

Shikama, Naoto ^{[4
]}

Sekino, Yuta ^{[3
]}

Ito, Yoshinori ^{[2
]}

Ishikura, Satoshi ^{[5
]}

Saito, Yoshihiro ^{[6
]}

Matsumoto, Yasuo ^{[7
]}

Konishi, Koji ^{[8
]}

Murakami, Naoya ^{[9
]}

Akimoto, Tetsuo ^{[10
]}

Fukushima, Yuuki ^{[11
]}

Toshiyasu, Takashi ^{[12
]}

Katano, Atsuto ^{[13
]}

Nagata, Yasushi ^{[14
]}

Ogawa, Hirofumi ^{[15
]}

Uno, Takashi ^{[16
]}

Hamamoto, Yasushi ^{[17
]}

Nishimura, Yasumasa ^{[18
]}

Mizowaki, Takashi ^{[19
]}

机构：

[1] Aichi Canc Ctr, Dept Radiat Oncol, Nagoya, Japan

[2] Showa Univ, Sch Med, Dept Radiat Oncol, Tokyo, Japan

[3] Natl Canc Ctr, JCOG Data Ctr, Operat Off, Tokyo, Japan

[4] Juntendo Univ, Dept Radiat Oncol, Tokyo, Japan

[5] Tokyo Bay Makuhari Clin Adv Imaging, Div Radiat Oncol, Canc Screening & High Precis Radiotherapy, Chiba, Japan

[6] Saitama Canc Ctr Hosp, Dept Radiat Oncol, Saitama, Japan

[7] Niigata Canc Ctr Hosp, Dept Radiat Oncol, Niigata, Japan

[8] Osaka Int Canc Inst, Dept Radiat Oncol, Osaka, Japan

[9] Natl Canc Ctr, Dept Radiat Oncol, Tokyo, Japan

[10] Natl Canc Ctr Hosp East, Dept Radiat Oncol, Kashiwa, Japan

[11] Sapporo Med Univ, Dept Radiol, Sapporo, Hokkaido, Japan

[12] Canc Inst Hosp JFCR, Dept Radiat Oncol, Tokyo, Japan

[13] Univ Tokyo Hosp, Dept Radiol, Tokyo, Japan

[14] Hiroshima Univ, Dept Radiat Oncol, Hiroshima, Japan

[15] Shizuoka Canc Ctr, Div Radiat Oncol, Shizuoka, Japan

[16] Chiba Univ Hosp, Dept Radiol, Chiba, Japan

[17] Shikoku Canc Ctr, Dept Radiat Oncol, Natl Hosp Org, Matsuyama, Japan

[18] Kindai Univ, Fac Med, Dept Radiat Oncol, Osakasayama, Japan

[19] Kyoto Univ, Grad Sch Med, Dept Radiat Oncol & Image Appl Therapy, Kyoto, Japan

来源：

INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS | 2023年 / 117卷 / 05期

关键词：

LOCAL-CONTROL; RADIOTHERAPY; CARCINOMA; RISK;

D O I：

10.1016/j.ijrobp.2023.06.251

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Purpose: We previously reported the primary results of JCOG0701, a randomized, multicenter, phase 3, noninferiority trial comparing accelerated fractionation (Ax) to standard fractionation (SF) for early glottic cancer. In the primary results, although the similar efficacy of 3-year progression-free survival and toxicity of Ax compared with SF was observed, the nonin-feriority of Ax was not confirmed statistically. To evaluate the long-term follow-up results of JCOG0701, we conducted JCOG0701A3 as an ancillary study of JCOG0701.Methods and Materials: In JCOG0701, 370 patients were randomly assigned to receive SF of 66 to 70 Gy (33-35 fractions; n = 184) or Ax of 60 to 64.8 Gy (25-27 fractions; n = 186). The data cutoff date for this analysis was in June 2020. Overall sur-vival, progression-free survival, and late adverse events including central nervous system ischemia were analyzed.Results: With a median follow-up period of 7.1 years (range, 0.1-12.4), progression-free survival of the SF and Ax arms were 76.2% and 78.2% at 5 years and 72.7% and 74.8% at 7 years (P = .44). OS of the SF and Ax arms were 92.7% and 89.6% at 5 years and 90.8% and 86.5% at 7 years (P = .92). Among 366 patients with a protocol treatment, the cumulative incidence of late adverse events of the SF and Ax arms were 11.9% and 7.4% at 8 years (hazard ratio, 0.53; 95% CI, 0.28-1.01; P = .06). Cen-tral nervous system ischemia of grade 2 or higher was observed in 4.1% for the SF arm and 1.1% for the Ax arm (P = .098).Conclusions: After long-term follow-up, Ax showed comparable efficacy to SF and a tendency for better safety. Ax may be suitable for early glottic cancer because of its convenience in minimizing treatment time, cost, and labor.(c) 2023 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)

引用

页码：1118 / 1124

页数：7

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