Bo Qiu1, Mai Xiong2, YiFeng Luo3, QiWen Li1, NaiBin Chen1, Li Chen1, SuPing Guo1, Bin Wang1, XiaoYan Huang1, MaoSheng Lin1, Nan Hu1, JinYu Guo1, Ying Liang4, Yi Fang5, JiBin Li6, YunPeng Yang7, Yan Huang7, Li Zhang7, SiYu Wang8, Hui Liu9. 1. Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou; State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou; Lung Cancer Institute of Sun Yat-sen University, Guangzhou.; Guangdong Association Study of Thoracic Oncology, Guangzhou. 2. Department of Cardiac Surgery, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou. 3. Pulmonary and Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou. 4. Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou; State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou; Lung Cancer Institute of Sun Yat-sen University, Guangzhou.; Guangdong Association Study of Thoracic Oncology, Guangzhou. 5. Intensive Care Unit, Sun Yat-sen University Cancer Center, Guangzhou; State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou. 6. Clinical Research, Sun Yat-sen University Cancer Center, Guangzhou; State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou. Electronic address: lijib@sysucc.org.cn. 7. Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou; State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou; Lung Cancer Institute of Sun Yat-sen University, Guangzhou. 8. Thoracic Surgery, Sun Yat-sen University Cancer Center, Guangzhou; State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou; Guangdong Association Study of Thoracic Oncology, Guangzhou. 9. Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou; State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou; Lung Cancer Institute of Sun Yat-sen University, Guangzhou.; Guangdong Association Study of Thoracic Oncology, Guangzhou. Electronic address: liuhuisysucc@sina.com.
Abstract
PURPOSE: We aimed to explore the efficacy and toxicity of split-course hypofractionated radiotherapy with concurrent chemotherapy (HRT-CHT) in patients with locally advanced non-small cell lung cancer (LANSCLC) in this single-arm, phase II study. METHODS: LANSCLC patients were considered eligible if their forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC%) and carbon monoxide diffusing capacity (DLCO%) were ≥40% and ≥45%, respectively. HRT-CHT using the IMRT technique was administered with 51 Gy in 17 fractions as the first course followed by a break. Patients without disease progression or persistent ≥grade 2 toxicities had an HRT-CHT of 15-18 Gy in 5-6 fractions as a boost. The primary endpoint was progression-free survival (PFS), and the secondary endpoint was overall survival (OS). RESULTS: Eighty-nine patients were enrolled and analyzed. The median follow-up was 29.5 months for all patients and 35.3 months for the survivors. The objective response rate was 97.8%; the median PFS and OS were 11.0 months and 27.0 months, respectively. Grade 3 acute esophagitis/pneumonitis occurred in 15 (16.9%)/7 (7.9%) patients. Grade 3/5 late pneumonitis occurred in 2 (2.2%)/1 (1.1%) patients. Of the 78 (87.6%) who completed the split-course HRT-CHT per protocol, patients with better FEV1/FVC% and DLCO% after the break had significantly better OS (for the FEV/FVC1%≥80% vs 60-79% vs 41-59% groups, 2-year OS values were 57.2% vs 56.9% vs 0%, respectively, p=0.024; for the DLCO%≥80% vs 60-79% vs 45-59% groups, 2-year OS values were 70.4% vs 48.4% vs 37.5%, respectively, p=0.049). CONCLUSIONS: Split-course HRT-CHT achieved a promising response rate and survival with tolerable toxicity in LANSCLC. Pulmonary function tests are necessary indicators for radiation treatment planning and dose escalation.
PURPOSE: We aimed to explore the efficacy and toxicity of split-course hypofractionated radiotherapy with concurrent chemotherapy (HRT-CHT) in patients with locally advanced non-small cell lung cancer (LANSCLC) in this single-arm, phase II study. METHODS: LANSCLC patients were considered eligible if their forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC%) and carbon monoxide diffusing capacity (DLCO%) were ≥40% and ≥45%, respectively. HRT-CHT using the IMRT technique was administered with 51 Gy in 17 fractions as the first course followed by a break. Patients without disease progression or persistent ≥grade 2 toxicities had an HRT-CHT of 15-18 Gy in 5-6 fractions as a boost. The primary endpoint was progression-free survival (PFS), and the secondary endpoint was overall survival (OS). RESULTS: Eighty-nine patients were enrolled and analyzed. The median follow-up was 29.5 months for all patients and 35.3 months for the survivors. The objective response rate was 97.8%; the median PFS and OS were 11.0 months and 27.0 months, respectively. Grade 3 acute esophagitis/pneumonitis occurred in 15 (16.9%)/7 (7.9%) patients. Grade 3/5 late pneumonitis occurred in 2 (2.2%)/1 (1.1%) patients. Of the 78 (87.6%) who completed the split-course HRT-CHT per protocol, patients with better FEV1/FVC% and DLCO% after the break had significantly better OS (for the FEV/FVC1%≥80% vs 60-79% vs 41-59% groups, 2-year OS values were 57.2% vs 56.9% vs 0%, respectively, p=0.024; for the DLCO%≥80% vs 60-79% vs 45-59% groups, 2-year OS values were 70.4% vs 48.4% vs 37.5%, respectively, p=0.049). CONCLUSIONS: Split-course HRT-CHT achieved a promising response rate and survival with tolerable toxicity in LANSCLC. Pulmonary function tests are necessary indicators for radiation treatment planning and dose escalation.