Abstract
BACKGROUND: Lung cancer ranks as the most prevalent solid cancer in the world. The non-small-cell lung cancer (NSCLC) histological subtype accounts for the largest proportion of lung cancers. Even though neoadjuvant therapy has shown encouraging efficacy for resectable NSCLC, there is a lack of clinical data on the treatment of stage IIIA NSCLC patients. Therefore, we carried out an evaluation of the safety and efficacy of programmed cell death 1 (PD-1) inhibitor as an addition to neoadjuvant chemotherapy. METHODS: This prospective study involved 72 treatment-naive adult subjects with stage IIIA NSCLC between September 2019 and July 2020. Two circles PD-1 inhibitor with chemotherapy (Albumin paclitaxel 100 mg/m(2) d1,8 + Carboplatin AUC 5 d1) were administered intravenously every 3 weeks. The patients were operated on between 3 and 5 weeks following the second cycle. Feasibility and safety served as the primary endpoints for this study. The rates of pathologic complete response, complete resection, response rate, and operative and postoperative complications among the patients were also analyzed. RESULTS: Seventy-two patients with untreated stage IIIA NSCLC were enrolled. The postoperative pathological specimens of 21 (29.1%) and 47 (65.2%) patients suggested pathologic complete response and partial remission, respectively. Neoadjuvant PD-1 inhibitor with chemotherapy had an acceptable side effect profile, and none of the subjects withdrew from the study preoperatively due to disease progression or toxicity. According to Response Evaluation Criteria in Solid Tumors (RESIST), responses evaluated by CT scan before surgery, 21 and 47 patients achieved complete response (CR) and partial response (PR), respectively, and a single patient was evaluated as stable disease (SD). There were no postoperative deaths. CONCLUSIONS: The outcomes of PD-1 inhibitor with chemotherapy as a novel treatment for stage IIIA NSCLC in the neoadjuvant setting are satisfactory with respect to the high R0 resection rate and low toxicity profile. Prospective comparative and longer follow-up trials are needed to confirm the long-term outcomes of this novel treatment and to reach definitive conclusions.