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

Cheol Kyu Park, In Jae Oh, Kyu Sik Kim, Yoo Duk Choi, Tae Won Jang, Youn Seup Kim, Kwan Ho Lee, Kyeong Cheol Shin, Chi Young Jung, Sei Hoon Yang, Jeong Seon Ryu, Seung Hun Jang, Seung Soo Yoo, Suk Joong Yong, Kye Young Lee, Kwang Ho In, Min Ki Lee, Young Chul Kim

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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 chemotherapy-naive 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 (Pem-Cis) 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 70 mg/m2 with either docetaxel 60 mg/m2 (n = 71) or pemetrexed 500 mg/m2 (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.

Original languageEnglish
Pages (from-to)e289-e296
JournalClinical Lung Cancer
Volume18
Issue number4
DOIs
Publication statusPublished - 2017 Jul 1

Keywords

  • Chemotherapy
  • Drug toxicity
  • East Asia
  • Progression-free survival
  • Treatment efficacy

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

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    Park, C. K., Oh, I. J., Kim, K. S., Choi, Y. D., Jang, T. W., Kim, Y. S., Lee, K. H., Shin, K. C., Jung, C. Y., Yang, S. H., Ryu, J. S., Jang, S. H., Yoo, S. S., Yong, S. J., Lee, K. Y., In, K. H., Lee, M. K., & Kim, Y. C. (2017). 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. Clinical Lung Cancer, 18(4), e289-e296. https://doi.org/10.1016/j.cllc.2017.01.002