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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.

ABSTRACT: 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-naïve patients with previously untreated ES-SCLC.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).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.The RR to the BP regimen was non-inferior to the EP regimen in chemotherapy- and radiotherapy-naïve 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.ClinicalTrials.gov identifier NCT00826644 . Date of Registration: January 21, 2009.

SUBMITTER: Oh IJ

PROVIDER: S-EPMC5002146 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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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.

Oh In-Jae IJ Kim Kyu-Sik KS Park Cheol-Kyu CK Kim Young-Chul YC Lee Kwan-Ho KH Jeong Jin-Hong JH Kim Sun-Young SY Lee Jeong-Eun JE Shin Kye-Chul KC Jang Tae-Won TW Lee Hyun-Kyung HK Lee Kye-Young KY Lee Sung-Yong SY

BMC cancer 20160826

<h4>Background</h4>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-naïve patients with previously untreated ES-SCLC.<h4>Methods</h4>We conducted a multi-center, randomized, open-label, parallel-group, phase III clin ...[more]

PMID: 27566413

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Project description:BackgroundDue to the high incidence and mortality of lung cancer, and etoposide is the standard first-line chemotherapy for small cell lung cancer, to evaluate the efficacy and safety of etoposide capsules at different doses as maintenance therapy for patients with extensive-stage small cell lung cancer (ES-SCLC) who show a response to etoposide plus platinum.MethodsThe study was divided into two stages: stage I, a single-center, one-arm prospective study, and stage II, a multicenter, controlled non-randomized prospective study (patients were chosen from ClinicalTrials.gov Identifier: NCT02179528). All patients received six cycles of etoposide plus platinum. Patients who were evaluated as complete remission (CR) or partial remission (PR) entered the maintenance treatment (MT) (etoposide capsule, once a day for 20 days, every 28 days as a cycle, until disease progression). In stage I, the dose of etoposide was 25 mg; in stage II, patients were non-randomized into etoposide capsule (25 mg/50 mg) and observation groups. In this study, the primary endpoints were progression-free survival (PFS) and safety; the secondary endpoint was overall survival (OS). Toxicity was graded according to the Common Terminology Criteria for Adverse Events v3.0.ResultsNinety-two patients were enrolled. In stage I, the median PFS was 6.700 months (95% CI: 6.408-6.992). In stage II, the median PFS of the MT group was better than that in the NMT group (8.930 vs. 5.900 months, P=0.002). In the pooled analysis, the overall median PFS of the MT group was better than that of the NMT group (7.870 vs. 5.900 months, P=0.003). However, there was no significant difference in OS between the groups (15.030 vs. 14.330 months, P=0.813). Multivariate Cox regression analysis showed that maintenance therapy was an independent protective factor for PFS in patients with ES-SCLC.ConclusionsEtoposide capsules as maintenance therapy significantly prolonged the PFS of patients with ES-SCLC who responded to etoposide plus platinum, with acceptable tolerability.

Project description:BackgroundSouthwest Oncology Group 0124 was a large North American phase 3 trial that failed to confirm a survival benefit for cisplatin/irinotecan over cisplatin/etoposide in patients with extensive stage small cell lung cancer (SCLC). These results were contrary to Japan Clinical Oncology Group 9511, a phase 3 trial exclusively in Japanese patients. Because 0124 and 9511 used identical treatment regimens and similar eligibility criteria, patient-level data were pooled from both trials, and a common arm analysis was performed to explore potential reasons for the divergent results.MethodsPatients with documented extensive stage SCLC and adequate end-organ function were randomized to intravenously receive either cisplatin 60 mg/m(2) Day 1 + irinotecan 60 mg/m(2) Days 1, 8, and 15 every 4 weeks or cisplatin 80 mg/m(2) Day 1 + etoposide 100 mg/m(2) Days 1-3 every 3 weeks. Demographic and outcome data were compared among 805 patients enrolled in 9511 and 0124 receiving identical treatment using a logistic model adjusted for age, sex, and performance status (PS).ResultsOf 671 patients in 0124, 651 eligible patients were included, as were all 154 patients from 9511. Significant differences in sex and PS distribution as well as toxicity were seen between trials. There were also significant differences in response rates (87% vs 60%, P<.001) and median overall survival (12.8 vs 9.8 months, P<.001) when the cisplatin/irinotecan arms from both trials were compared.ConclusionsSignificant differences in patient demographics, toxicity, and efficacy were identified in the 9511 and 0124 populations. These results, relevant in the current era of clinical trials globalization, warrant: 1) consideration of differential patient characteristics and outcomes among populations receiving identical therapy; 2) utilization of the common arm model in prospective trials; and 3) inclusion of pharmacogenomic correlates in cancer trials where ethnic/racial differences in drug disposition are expected.

Dataset Information

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

Publications

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

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