Phase 2 trial of neoadjuvant toripalimab with chemotherapy for resectable stage III non-small-cell lung cancer

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 AJC...

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Autores principales:	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, Hao Long
Formato:	article
Lenguaje:	EN
Publicado:	Taylor & Francis Group 2021
Materias:	lung cancer neoadjuvant immunotherapy chemotherapy toripalimab Immunologic diseases. Allergy RC581-607 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/d071f34e1bff4d239614d466b1517629
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spelling	oai:doaj.org-article:d071f34e1bff4d239614d466b15176292021-11-04T15:00:45ZPhase 2 trial of neoadjuvant toripalimab with chemotherapy for resectable stage III non-small-cell lung cancer2162-402X10.1080/2162402X.2021.1996000https://doaj.org/article/d071f34e1bff4d239614d466b15176292021-01-01T00:00:00Zhttp://dx.doi.org/10.1080/2162402X.2021.1996000https://doaj.org/toc/2162-402XMultimodality 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)Ze-Rui ZhaoChao-Pin YangSi ChenHui YuYong-Bin LinYao-Bin LinHan QiJie-Tian JinShan-Shan LianYi-Zhi WangJin-Qi YouWen-Yu ZhaiHao LongTaylor & Francis Grouparticlelung cancerneoadjuvantimmunotherapychemotherapytoripalimabImmunologic diseases. AllergyRC581-607Neoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENOncoImmunology, Vol 10, Iss 1 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	lung cancer neoadjuvant immunotherapy chemotherapy toripalimab Immunologic diseases. Allergy RC581-607 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	lung cancer neoadjuvant immunotherapy chemotherapy toripalimab Immunologic diseases. Allergy RC581-607 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 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 Hao Long Phase 2 trial of neoadjuvant toripalimab with chemotherapy for resectable stage III non-small-cell lung cancer
description	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)
format	article
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 Hao Long
author_facet	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 Hao Long
author_sort	Ze-Rui Zhao
title	Phase 2 trial of neoadjuvant toripalimab with chemotherapy for resectable stage III non-small-cell lung cancer
title_short	Phase 2 trial of neoadjuvant toripalimab with chemotherapy for resectable stage III non-small-cell lung cancer
title_full	Phase 2 trial of neoadjuvant toripalimab with chemotherapy for resectable stage III non-small-cell lung cancer
title_fullStr	Phase 2 trial of neoadjuvant toripalimab with chemotherapy for resectable stage III non-small-cell lung cancer
title_full_unstemmed	Phase 2 trial of neoadjuvant toripalimab with chemotherapy for resectable stage III non-small-cell lung cancer
title_sort	phase 2 trial of neoadjuvant toripalimab with chemotherapy for resectable stage iii non-small-cell lung cancer
publisher	Taylor & Francis Group
publishDate	2021
url	https://doaj.org/article/d071f34e1bff4d239614d466b1517629
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Phase 2 trial of neoadjuvant toripalimab with chemotherapy for resectable stage III non-small-cell lung cancer

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