Randomized phase II study of paclitaxel/carboplatin intercalated with gefitinib compared to paclitaxel/carboplatin alone for chemotherapy-naive non-small cell lung cancer in a clinically selected population excluding patients with nonsmoking adenocarcinoma or mutated EGFR
DC Field | Value | Language |
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dc.contributor.author | Choi, Yoon Ji | - |
dc.contributor.author | Lee, Dae Ho | - |
dc.contributor.author | Choi, Chang Min | - |
dc.contributor.author | Lee, Jung Shin | - |
dc.contributor.author | Lee, Seung Jin | - |
dc.contributor.author | Ahn, Jin-Hee | - |
dc.contributor.author | Kim, Sang-We | - |
dc.date.accessioned | 2021-09-04T11:22:13Z | - |
dc.date.available | 2021-09-04T11:22:13Z | - |
dc.date.created | 2021-06-10 | - |
dc.date.issued | 2015-10-22 | - |
dc.identifier.issn | 1471-2407 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/92172 | - |
dc.description.abstract | Background: Considering cell cycle dependent cytotoxicity, intercalation of chemotherapy and epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) may be a treatment option in non-small cell lung cancer (NSCLC). This randomized phase 2 study compared the efficacy of paclitaxel and carboplatin (PC) intercalated with gefitinib (G) versus PC alone in a selected, chemotherapy-naive population of advanced NSCLC patients with a history of smoking or wild-type EGFR. Methods: Eligible patients were chemotherapy-naive advanced NSCLC patients with Eastern Cooperative Oncology Group performance status of 0-2. Non-smoking patients with adenocarcinoma or patients with activating EGFR mutation were excluded because they could benefit from gefitinib alone. Eligible patients were randomized to one of the following treatment arms: PCG, P 175 mg/m(2), and C AUC 5 administered intravenously on day 1 intercalated with G 250 mg orally on days 2 through 15 every 3 weeks for four cycles followed by G 250 mg orally until progressive disease; or PC, same dosing schedule for four cycles only. The primary endpoint was the objective response rate (ORR), and the secondary endpoints included progression-free survival (PFS), overall survival (OS), and toxicity profile. Results: A total of 90 patients participated in the study. The ORRs were 41.9 % (95 % confidence interval (CI) 27.057.9 %) for the PCG arm and 39.5 % (95 % CI 25.0-55.6 %) for the PC arm (P = 0.826). No differences in PFS (4.1 vs. 4.1 months, P = 0.781) or OS (9.3 vs. 10.5 months, P = 0.827) were observed between the PCG and PC arms. Safety analyses showed a similar incidence of drug-related grade 3/4 toxicity. Rash and pruritus were more frequent in the PCG than in the PC arm. Conclusions: PCG did not improve ORR, PFS, and OS compared to PC chemotherapy alone for NSCLC in a clinically selected population excluding non-smoking adenocarcinoma or mutated EGFR. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | BIOMED CENTRAL LTD | - |
dc.subject | ACTIVATING MUTATIONS | - |
dc.subject | 1ST-LINE TREATMENT | - |
dc.subject | NEVER-SMOKERS | - |
dc.subject | OPEN-LABEL | - |
dc.subject | ERLOTINIB | - |
dc.subject | TRIAL | - |
dc.subject | COMBINATION | - |
dc.subject | MULTICENTER | - |
dc.subject | CARBOPLATIN | - |
dc.subject | PACLITAXEL | - |
dc.title | Randomized phase II study of paclitaxel/carboplatin intercalated with gefitinib compared to paclitaxel/carboplatin alone for chemotherapy-naive non-small cell lung cancer in a clinically selected population excluding patients with nonsmoking adenocarcinoma or mutated EGFR | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Choi, Yoon Ji | - |
dc.identifier.doi | 10.1186/s12885-015-1714-y | - |
dc.identifier.scopusid | 2-s2.0-84944754194 | - |
dc.identifier.wosid | 000363106600001 | - |
dc.identifier.bibliographicCitation | BMC CANCER, v.15 | - |
dc.relation.isPartOf | BMC CANCER | - |
dc.citation.title | BMC CANCER | - |
dc.citation.volume | 15 | - |
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 | ACTIVATING MUTATIONS | - |
dc.subject.keywordPlus | 1ST-LINE TREATMENT | - |
dc.subject.keywordPlus | NEVER-SMOKERS | - |
dc.subject.keywordPlus | OPEN-LABEL | - |
dc.subject.keywordPlus | ERLOTINIB | - |
dc.subject.keywordPlus | TRIAL | - |
dc.subject.keywordPlus | COMBINATION | - |
dc.subject.keywordPlus | MULTICENTER | - |
dc.subject.keywordPlus | CARBOPLATIN | - |
dc.subject.keywordPlus | PACLITAXEL | - |
dc.subject.keywordAuthor | Non-small cell lung cancer | - |
dc.subject.keywordAuthor | Intercalated chemotherapy | - |
dc.subject.keywordAuthor | Gefitinib | - |
dc.subject.keywordAuthor | Smoker | - |
dc.subject.keywordAuthor | Wild-Type EGFR | - |
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