Nivolumab safety and efficacy in advanced, platinum-resistant, non-small cell lung cancer, radical radiotherapy-ineligible patients: A phase II study in Taiwan
Journal
Journal of the Formosan Medical Association
Date Issued
2020
Author(s)
Chen Y.-M.
Su W.-C.
Chong I.-W.
Hsia T.-C.
Lin M.-C.
Chang G.-C.
Chiu C.-H.
Wu S.-Y.
Hung J.-Y.
Wang C.-C.
Yang T.-Y.
Abstract
Background/Purpose: There is a lack of data on nivolumab treatment outcomes in Taiwanese patients with advanced or recurrent non-small cell lung cancer (NSCLC) ineligible for radical radiotherapy and resistant to platinum-based chemotherapy. We investigated the safety and efficacy of nivolumab in this population. Methods: In this ongoing, multicenter, open-label, single-arm, phase II study, patients aged ?20 years with a performance status of 0–1 and stage IIIB/IV or recurrent NSCLC received nivolumab 3 mg/kg every 2 weeks in 6-week cycles. Interim data obtained between 27 January 2016 and 21 May 2017 were analyzed. Safety, based on adverse event (AE) reporting, was the primary endpoint. Efficacy assessment parameters included overall response rate (ORR), overall survival (OS), and progression-free survival (PFS). Results: Among 53 treated patients with advanced NSCLC (median age 61.0 years; 62.3% male), mean treatment duration was 99.7 days. AEs (any grade) and serious AEs were reported by 92.5% and 47.2% of patients, respectively. Adverse drug reactions (ADRs; any) occurred in 58.5% of patients; grade ?3 ADRs occurred in 13.2% of patients. Five deaths occurred; two cases (neoplasm progression and septic shock) were considered treatment-emergent. Common ADRs were fatigue (17.0%) and rash (13.2%). Common immune-related treatment-emergent AEs were rash (17.0%) and pruritus (13.2%). The centrally assessed ORR was 9.4% (5/53). The median OS and median PFS were 11.5 months and 1.4 months, respectively. Conclusion: Nivolumab appeared to be safe and effective in Taiwanese patients. These interim results suggest that nivolumab is a suitable treatment option for this population. Clinical trial registration: NCT02582125. ? 2020
SDGs
Other Subjects
afatinib; bevacizumab; carboplatin; ceritinib; cisplatin; crizotinib; docetaxel; drug antibody; epidermal growth factor receptor; erlotinib; gefitinib; gemcitabine; nivolumab; paclitaxel; pemetrexed; programmed death 1 ligand 1; tegafur; vinorelbine tartrate; nivolumab; platinum; acute respiratory failure; adult; advanced cancer; adverse drug reaction; aged; anemia; Article; backache; cancer growth; cancer radiotherapy; cancer resistance; cancer staging; cancer survival; cause of death; clinical assessment; constipation; coughing; decreased appetite; drug effect; drug efficacy; drug safety; drug withdrawal; dyspnea; exertional dyspnea; fatigue; female; fever; human; major clinical study; male; multicenter study; multiple cycle treatment; non small cell lung cancer; overall response rate; overall survival; peripheral edema; phase 2 clinical trial; pneumonia; population; progression free survival; pruritus; rash; septic shock; Taiwan; treatment duration; treatment interruption; treatment outcome; urinary tract infection; chemoradiotherapy; clinical trial; drug resistance; lung tumor; middle aged; non small cell lung cancer; tumor recurrence; Carcinoma, Non-Small-Cell Lung; Chemoradiotherapy; Drug Resistance, Neoplasm; Female; Humans; Lung Neoplasms; Male; Middle Aged; Neoplasm Recurrence, Local; Nivolumab; Platinum; Taiwan
Publisher
Elsevier B.V.
Type
journal article