Randomized Phase III Study of Docetaxel Plus Cisplatin Versus Pemetrexed Plus Cisplatin as First-line Treatment of Nonsquamous Non-Small-cell Lung Cancer: A TRAIL Trial
- Authors
- Park, Cheol-Kyu; Oh, In-Jae; Kim, Kyu-Sik; Choi, Yoo-Duk; Jang, Tae-Won; Kim, Youn-Seup; Lee, Kwan-Ho; Shin, Kyeong-Cheol; Jung, Chi Young; Yang, Sei-Hoon; Ryu, Jeong-Seon; Jang, Seung-Hun; Yoo, Seung-Soo; Yong, Suk-Joong; Lee, Kye Young; In, Kwang-Ho; Lee, Min-Ki; Kim, Young-Chul
- Issue Date
- 7월-2017
- Publisher
- CIG MEDIA GROUP, LP
- Keywords
- Chemotherapy; Drug toxicity; East Asia; Progression-free survival; Treatment efficacy
- Citation
- CLINICAL LUNG CANCER, v.18, no.4, pp.E289 - E296
- Indexed
- SCIE
SCOPUS
- Journal Title
- CLINICAL LUNG CANCER
- Volume
- 18
- Number
- 4
- Start Page
- E289
- End Page
- E296
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/82935
- DOI
- 10.1016/j.cllc.2017.01.002
- ISSN
- 1525-7304
- Abstract
- No prospective phase III trials have directly compared the efficacy of pemetrexed plus cisplatin (Pem-Cis) with docetaxel plus cisplatin (Doc-Cis) in nonsquamous non-small-cell lung cancer. A total of 148 chemotherapynaive patients lacking driver mutations were randomized to the Pem-Cis or Doc-Cis arm. The progression-free survival and response rate was similar between the 2 arms, although adverse events and more severe toxicities were observed more frequently in the Doc-Cis arm. Introduction: To date, no prospective phase III trials have directly compared the efficacy of pemetrexed plus cisplatin (PemCis) with docetaxel plus cisplatin (Doc-Cis) in patients with nonsquamous non-small-cell lung cancer. Materials and Methods: A total of 148 chemotherapy-naive patients lacking driver mutations were randomized into 21-day regimens of cisplatin 70mg/m(2) with either docetaxel 60 mg/m(2) (n = 71) or pemetrexed 500 mg/m(2) (n = 77) for <= 4 cycles. The primary objective was to assess the noninferiority of progression-free survival (PFS) for patients receiving the Doc-Cis regimen. The secondary endpoints were the response rates, overall survival, and toxicity profiles. Results: Partial remission was observed in 24 (31.2%) and 24 (33.8%) patients in the Pem-Cis and Doc-Cis groups, respectively. The median PFS was 4.7 months (95% confidence interval [CI], 4.4-5.0) in the Pem-Cis arm and 4.4 months (95% CI, 3.7-5.1) in the Doc-Cis arm (P > .05). The median overall survival was longer in the Doc-Cis arm (13.3 months; 95% CI, 8.1-18.5) than in the Pem-Cis arm (11.7 months; 95% CI, 8.6-14.8; P > .05). Between the 2 arms, no significant difference was found in the subsequent treatments after failure of first-line treatment. The rate of grade 3 or 4 neutropenia and febrile neutropenia was greater in the Doc-Cis arm than in the Pem-Cis arm. Conclusion: In nonsquamous non-small-cell lung cancer patients lacking driver mutations, the PFS and response rates were similar between the 2 arms, and toxicity was tolerable, although adverse events and more severe toxicities were observed more frequently in the Doc-Cis arm.
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