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Belotecan/cisplatin versus etoposide/cisplatin in previously untreated patients with extensive-stage small cell lung carcinoma: a multi-center randomized phase III trial

Authors
Oh, In-JaeKim, Kyu-SikPark, Cheol-KyuKim, Young-ChulLee, Kwan-HoJeong, Jin-HongKim, Sun-YoungLee, Jeong-EunShin, Kye-ChulJang, Tae-WonLee, Hyun-KyungLee, Kye-YoungLee, Sung-Yong
Issue Date
26-8월-2016
Publisher
BIOMED CENTRAL LTD
Keywords
Small cell lung carcinoma; Extensive stage disease; Phase III study; Chemotherapy; First-line; Belotecan
Citation
BMC CANCER, v.16
Indexed
SCIE
SCOPUS
Journal Title
BMC CANCER
Volume
16
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/87784
DOI
10.1186/s12885-016-2741-z
ISSN
1471-2407
Abstract
Background: No novel chemotherapeutic combinations have demonstrated superior efficacy to etoposide/cisplatin (EP), a standard treatment regimen for extensive-stage small cell lung carcinoma (ES-SCLC) over the past decade. We aimed to compare the efficacy and safety of belotecan/cisplatin (BP) and EP regimens in chemotherapy-and radiotherapy-naive patients with previously untreated ES-SCLC. Methods: We conducted a multi-center, randomized, open-label, parallel-group, phase III clinical study. A total of 157 patients were recruited at 14 centers with 147 patients meeting the inclusion/exclusion criteria and randomized to either BP (n = 71) or EP (n = 76) treatment arms. A non-inferior response rate (RR) in the BP arm, analyzed by intent-to-treat analysis according to Response Evaluation Criteria in Solid Tumors version 1.0 criteria, was used as the primary endpoint. The secondary endpoints were progression-free survival (PFS) and overall survival (OS). Results: In the BP arm, one patient had a complete response, 41 had a partial response (PR), and 17 had stable disease (SD). In the EP arm, 35 patients had PR and 28 had SD. The RR in the BP arm was non-inferior to the EP regimen in patients with ES-SCLC (BP: 59.2 %, EP: 46.1 %, difference: 13.1 %, 90 % two-sided confidence interval: -0. 3-26.5, meeting the predefined non-inferiority criterion of -15.0 %). No significant differences in OS or PFS were observed between the treatment arms. Hematologic toxicities, including grade 3/4 anemia and thrombocytopenia, were significantly more prevalent in the BP arm than the EP arm. Conclusions: The RR to the BP regimen was non-inferior to the EP regimen in chemotherapy-and radiotherapy-naive patients with previously untreated ES-SCLC. Hematologic toxicities were significantly more prevalent in the BP group, indicating that BP should be used with care, particularly in patients with a poor performance status. Further studies assessing PFS and OS are required to validate the superiority of the BP regimen.
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