Wu Leilei, Zhu Yaoyao, Yuan Xiaoshuai, Liu Yu, Wu Qiongya, Xu Qinghua, Hu Min, Kang Jingjing, Fu Jiamei, Gong Xiaomei, Wu Hongyu, Cai Yong, Wang Lixin, Lu Yi, Li Yan, Liu Hui, Xu Yaping
Department of Radiation Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.
Department of Traditional Chinese Medicine, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.
Ann Transl Med. 2022 Jul;10(14):800. doi: 10.21037/atm-22-2814.
Traditional Chinese medicine (TCM) makes a synergistic and attenuative effect when combined with chemoradiotherapy. However, strong evidence-based studies are lacking. The study sought to investigate whether Zengxiao Jiandu decoction as an adjunctive therapy is superior to definitive concurrent chemoradiotherapy (DCCRT) alone in unresectable, locally advanced (LA), stage III non-small cell lung cancer (NSCLC).
Patients with unresectable LA-NSCLC were randomly assigned to receive DCCRT either combined with Zengxiao Jiandu decoction (TCM arm) or placebo therapy (Control arm), by computer-generated random assignment lists using a central randomization system. The patients were routinely followed-up every 3 months for the first 2 years after the therapy, and every 6 months for the subsequent 3 years, or earlier if clinically indicated. The primary endpoint was grade ≥3 chemoradiotherapy-related toxicities, while secondary endpoints included the completion rate of chemoradiotherapy, the clinical objective response rate (ORR), and survival. The placebo achieved full consistency in color, aroma, taste and appearance with the Zengxiao Jiandu decoction.
From February 2019 to December 2020, 163 patients were randomly allocated to TCM arm (n=82) or Control arm (n=81). Fifty-nine (72.0%) patients in TCM arm finished chemoradiotherapy per protocol and 79 (96.3%) received protocol-specified Zengxiao Jiandu decoction. Forty-two patients in Control arm finished chemoradiotherapy per protocol. The incidence of grade ≥3 chemoradiotherapy-related toxicities was higher in Control arm than TCM arm (44.4% 31.7%, P=0.094). Grade ≥3 radiation pneumonitis occurred more frequently in Control arm than TCM arm (13.6% 3.7%, P=0.024). The completion rate of the protocol-specified chemotherapy was significantly higher in TCM arm than Control arm (79.3% 64.2%, P=0.033), but the completion rates of the definitive-dose radiotherapy were similar. There were no significant differences in ORR between the 2 arms. The progression-free survival (PFS) of TCM arm was significantly better than Control arm (median PFS, 12.0 9.0 months, P=0.035). However, Zengxiao Jiandu decoction was not found to produce any significant benefit in overall survival.
The Zengxiao Jiandu decoction adjunctive therapy, as compared to DCCRT alone, reduced grade ≥3 radiation pneumonitis, improved the completion rate of DCCRT, and prolonged PFS for unresectable LA-NSCLC.
Chinese Clinical Trial Registry ChiCTR2000031667.
中药与放化疗联合应用时具有协同增效和减毒作用。然而，缺乏强有力的循证医学研究。本研究旨在探讨增效解毒汤作为辅助治疗在不可切除的局部晚期（LA）Ⅲ期非小细胞肺癌（NSCLC）中是否优于单纯根治性同步放化疗（DCCRT）。
采用中央随机系统通过计算机生成随机分配列表，将不可切除的LA-NSCLC患者随机分配接受DCCRT联合增效解毒汤（中药组）或安慰剂治疗（对照组）。治疗后的前2年，患者每3个月进行常规随访，随后3年每6个月随访一次，如有临床指征则提前随访。主要终点为≥3级放化疗相关毒性，次要终点包括放化疗完成率、临床客观缓解率（ORR）和生存率。安慰剂在颜色、气味、味道和外观上与增效解毒汤完全一致。
2019年2月至2020年12月，163例患者被随机分配至中药组（n = 82）或对照组（n = 81）。中药组59例（72.0%）患者按方案完成放化疗，79例（96.3%）接受了方案规定的增效解毒汤治疗。对照组42例患者按方案完成放化疗。对照组≥3级放化疗相关毒性的发生率高于中药组（44.4%对31.7%，P = 0.094）。对照组≥3级放射性肺炎的发生率高于中药组（13.6%对3.7%，P = 0.024）。中药组方案规定化疗的完成率显著高于对照组（79.3%对64.2%，P = 0.033），但根治性剂量放疗的完成率相似。两组的ORR无显著差异。中药组的无进展生存期（PFS）显著优于对照组（中位PFS，12.0对9.0个月，P = 0.035）。然而，未发现增效解毒汤对总生存期有任何显著益处。
与单纯DCCRT相比，增效解毒汤辅助治疗可降低≥3级放射性肺炎的发生率，提高DCCRT的完成率，并延长不可切除LA-NSCLC的PFS。
中国临床试验注册中心ChiCTR2000031667。
