Belotecan/cisplatin versus etoposide/cisplatin in previously untreated patients with extensive-stage small cell lung carcinoma: a multi-center randomized phase III trial
DC Field | Value | Language |
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dc.contributor.author | Oh, In-Jae | - |
dc.contributor.author | Kim, Kyu-Sik | - |
dc.contributor.author | Park, Cheol-Kyu | - |
dc.contributor.author | Kim, Young-Chul | - |
dc.contributor.author | Lee, Kwan-Ho | - |
dc.contributor.author | Jeong, Jin-Hong | - |
dc.contributor.author | Kim, Sun-Young | - |
dc.contributor.author | Lee, Jeong-Eun | - |
dc.contributor.author | Shin, Kye-Chul | - |
dc.contributor.author | Jang, Tae-Won | - |
dc.contributor.author | Lee, Hyun-Kyung | - |
dc.contributor.author | Lee, Kye-Young | - |
dc.contributor.author | Lee, Sung-Yong | - |
dc.date.accessioned | 2021-09-03T20:59:46Z | - |
dc.date.available | 2021-09-03T20:59:46Z | - |
dc.date.created | 2021-06-18 | - |
dc.date.issued | 2016-08-26 | - |
dc.identifier.issn | 1471-2407 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/87784 | - |
dc.description.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. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | BIOMED CENTRAL LTD | - |
dc.subject | CHEMOTHERAPY-NAIVE PATIENTS | - |
dc.subject | CAMPTOTHECIN ANALOG | - |
dc.subject | CANCER | - |
dc.subject | CISPLATIN | - |
dc.subject | BELOTECAN | - |
dc.subject | EPIDEMIOLOGY | - |
dc.subject | COMBINATION | - |
dc.subject | IRINOTECAN/CISPLATIN | - |
dc.subject | ETOPOSIDE | - |
dc.title | Belotecan/cisplatin versus etoposide/cisplatin in previously untreated patients with extensive-stage small cell lung carcinoma: a multi-center randomized phase III trial | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Lee, Sung-Yong | - |
dc.identifier.doi | 10.1186/s12885-016-2741-z | - |
dc.identifier.scopusid | 2-s2.0-84983628498 | - |
dc.identifier.wosid | 000384479600001 | - |
dc.identifier.bibliographicCitation | BMC CANCER, v.16 | - |
dc.relation.isPartOf | BMC CANCER | - |
dc.citation.title | BMC CANCER | - |
dc.citation.volume | 16 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.subject.keywordPlus | CHEMOTHERAPY-NAIVE PATIENTS | - |
dc.subject.keywordPlus | CAMPTOTHECIN ANALOG | - |
dc.subject.keywordPlus | CANCER | - |
dc.subject.keywordPlus | CISPLATIN | - |
dc.subject.keywordPlus | BELOTECAN | - |
dc.subject.keywordPlus | EPIDEMIOLOGY | - |
dc.subject.keywordPlus | COMBINATION | - |
dc.subject.keywordPlus | IRINOTECAN/CISPLATIN | - |
dc.subject.keywordPlus | ETOPOSIDE | - |
dc.subject.keywordAuthor | Small cell lung carcinoma | - |
dc.subject.keywordAuthor | Extensive stage disease | - |
dc.subject.keywordAuthor | Phase III study | - |
dc.subject.keywordAuthor | Chemotherapy | - |
dc.subject.keywordAuthor | First-line | - |
dc.subject.keywordAuthor | Belotecan | - |
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