Xiao Hu1, Yong Bao2, Yu-Jin Xu1, Hui-Neng Zhu3, Jin-Shi Liu4, Li Zhang5, Ying Guo6, Ying Jin7, Jin Wang1, Hong-Lian Ma1, Xiao-Ling Xu7, Zheng-Bo Song7, Hua-Rong Tang1, Fang Peng2, Min Fang1, Yue Kong1, Meng-Yuan Chen1, Bai-Qiang Dong1, Liang Zhu3, Chang Yu3, Xin-Min Yu7, Wei Hong7, Yun Fan7, Yi-Ping Zhang7, Peng-Cheng Chen4, Qiang Zhao4, You-Hua Jiang4, Xin-Ming Zhou4, Qi-Xun Chen4, Wen-Yong Sun3, Wei-Min Mao4, Ming Chen1. 1. Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China. 2. Department of Radiation Oncology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. 3. Department of Pathology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China. 4. Department of Thoracic Surgery, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China. 5. Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China. 6. Clinical Trials Center, Sun Yat-sen University Cancer Center, Guangzhou, China. 7. Department of Medical Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.
Abstract
BACKGROUND: The thoracic radiotherapy (TRT) target volume for limited-stage small-cell lung cancer (SCLC) has been controversial for decades. In this report, the final results of a prospective randomized trial on the TRT target volume before and after induction chemotherapy are presented. METHODS: After 2 cycles of etoposide and cisplatin, patients arm were randomized to receive TRT to the postchemotherapy or prechemotherapy tumor volume in a study arm and a control arm. Involved-field radiotherapy was received in both arms. TRT consisted of 1.5 grays (Gy) twice daily in 30 fractions to up to a total dose of 45 Gy. Lymph node regions were contoured, and intentional and incidental radiation doses were recorded. RESULTS: The study was halted early because of slow accrual. Between 2002 and 2017, 159 and 150 patients were randomized to the study arm or the control arm, respectively; and 21.4% and 19.1% of patients, respectively, were staged using positron emission tomography/computed tomography (P = .31). With a median follow-up of 54.1 months (range, 19.9-165.0 months) in survivors, the 3-year local/regional progression-free probability was 58.2% and 65.5% in the study and control arms, respectively (P = .44), and the absolute difference was -7.3% (95% CI, -18.2%, 3.7%). In the study and control arms, the median overall survival was 21.9 months and 26.6 months, respectively, and the 5-year overall survival rate was 22.8% and 28.1%, respectively (P = .26). Grade 3 esophagitis was observed in 5.9% of patients in the study arm versus 15.5% of those in the control arm (P = .01). The isolated out-of-field failure rate was 2.6% in the study arm versus 4.1% in the control arm (P = .46), and all such failures were located in the supraclavicular fossa or contralateral hilum. The regions 7, 3P, 4L, 6, 4R, 5, and 2L received incidental radiation doses >30 Gy. CONCLUSIONS:TRT could be limited to the postchemotherapy tumor volume, and involved-field radiotherapy could be routinely applied for limited-stage SCLC.
RCT Entities:
BACKGROUND: The thoracic radiotherapy (TRT) target volume for limited-stage small-cell lung cancer (SCLC) has been controversial for decades. In this report, the final results of a prospective randomized trial on the TRT target volume before and after induction chemotherapy are presented. METHODS: After 2 cycles of etoposide and cisplatin, patients arm were randomized to receive TRT to the postchemotherapy or prechemotherapy tumor volume in a study arm and a control arm. Involved-field radiotherapy was received in both arms. TRT consisted of 1.5 grays (Gy) twice daily in 30 fractions to up to a total dose of 45 Gy. Lymph node regions were contoured, and intentional and incidental radiation doses were recorded. RESULTS: The study was halted early because of slow accrual. Between 2002 and 2017, 159 and 150 patients were randomized to the study arm or the control arm, respectively; and 21.4% and 19.1% of patients, respectively, were staged using positron emission tomography/computed tomography (P = .31). With a median follow-up of 54.1 months (range, 19.9-165.0 months) in survivors, the 3-year local/regional progression-free probability was 58.2% and 65.5% in the study and control arms, respectively (P = .44), and the absolute difference was -7.3% (95% CI, -18.2%, 3.7%). In the study and control arms, the median overall survival was 21.9 months and 26.6 months, respectively, and the 5-year overall survival rate was 22.8% and 28.1%, respectively (P = .26). Grade 3 esophagitis was observed in 5.9% of patients in the study arm versus 15.5% of those in the control arm (P = .01). The isolated out-of-field failure rate was 2.6% in the study arm versus 4.1% in the control arm (P = .46), and all such failures were located in the supraclavicular fossa or contralateral hilum. The regions 7, 3P, 4L, 6, 4R, 5, and 2L received incidental radiation doses >30 Gy. CONCLUSIONS:TRT could be limited to the postchemotherapy tumor volume, and involved-field radiotherapy could be routinely applied for limited-stage SCLC.