1. Phase 2 trial of neoadjuvant toripalimab with chemotherapy for resectable stage III non-small-cell lung cancer.
- Author
-
Ze-Rui Zhao, Chao-Pin Yang, Si Chen, Hui Yu, Yong-Bin Lin, Yao-Bin Lin, Han Qi, Jie-Tian Jin, Shan-Shan Lian, Yi-Zhi Wang, Jin-Qi You, Wen-Yu Zhai, and Hao Long
- Subjects
- *
NON-small-cell lung carcinoma , *NEOADJUVANT chemotherapy , *CHEMORADIOTHERAPY , *PANCREATIC surgery , *ADVERSE health care events , *RECTAL cancer , *SURGICAL complications , *PERIPHERAL neuropathy - Abstract
Multimodality treatment provides modest survival benefits for patients with locally advanced (stage III) non-small-cell lung cancer (NSCLC). Nevertheless, preoperative immunotherapy has continuously been shown to be promising in treating resectable NSCLC. This phase 2 trial enrolled patients with AJCC-defined stage IIIA or T3-4N2 IIIB NSCLC deemed surgically resectable. Patients received three cycles of neoadjuvant treatment with intravenous PD-1 inhibitor toripalimab (240 mg), carboplatin (area under the curve 5), and pemetrexed (500 mg/m² for adenocarcinoma) or nab-paclitaxel (260 mg/m² for other subtypes) on day 1 of each 21-day cycle. Surgical resection was performed 4-5 weeks afterward. The primary endpoint was major pathological response (MPR), defined as less than 10% residual tumor remaining at the time of surgery. Thirty-three patients were enrolled, of whom 13 (39.4%) had T3-4N2 stage IIIB disease. Thirty (90.9%) patients underwent resection and all except one (96.7%) achieved R0 resection. Twenty patients (60.6%) in the intention-to-treat population achieved an MPR, including 15 patients (45.5%) who achieved a pathological complete response (pCR). The MPR and pCR rates in the per-protocol population were 66.7% and 50.0%, respectively. The surgical complications included three cases of arrhythmias, one case of a prolonged air leak, and one case of chylothorax. The most common grade 3 treatment-related adverse event (TRAE) was anemia (2, [6.1%]). Severe TRAEs included one (3.0%) case of grade 3 peripheral neuropathy that resulted in surgical cancellation.Toripalimab plus platinum-based doublet chemotherapy yields a high MPR rate, manageable toxicity, and feasible resection in stage III NSCLC.Trial ClinicalTrials.gov (NCT04304248) [ABSTRACT FROM AUTHOR]
- Published
- 2021
- Full Text
- View/download PDF