title: 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.
abstract: 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.
  
  
  
  A total of 148 chemotherapy-naive patients lacking driver mutations were randomized into 21-day regimens of cisplatin 70 mg/m2with 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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Department of Internal Medicine, Chonnam National University Hwasun Hospital, Jeonnam, Korea.
authors.forename: Cheol-Kyu
authors.initials: CK
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Chonnam National University Hwasun Hospital, Jeonnam, Korea.
authors.forename: In-Jae
authors.initials: IJ
authors.lastname: Oh
authors.affiliation: Department of Internal Medicine, Chonnam National University Hwasun Hospital, Jeonnam, Korea.
authors.forename: Kyu-Sik
authors.initials: KS
authors.lastname: Kim
authors.affiliation: Department of Pathology, Chonnam National University Medical School, Gwangju, Korea.
authors.forename: Yoo-Duk
authors.initials: YD
authors.lastname: Choi
authors.affiliation: Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Korea.
authors.forename: Tae-Won
authors.initials: TW
authors.lastname: Jang
authors.affiliation: Department of Internal Medicine, Dankook University Hospital, Cheonan, Korea.
authors.forename: Youn-Seup
authors.initials: YS
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Youngnam University Hospital, Daegu, Korea.
authors.forename: Kwan-Ho
authors.initials: KH
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Youngnam University Hospital, Daegu, Korea.
authors.forename: Kyeong-Cheol
authors.initials: KC
authors.lastname: Shin
authors.affiliation: Department of Internal Medicine, Daegu Catholic University Hospital, Daegu, Korea.
authors.forename: Chi Young
authors.initials: CY
authors.lastname: Jung
authors.affiliation: Department of Internal Medicine, Wonkwang University Hospital, Iksan, Korea.
authors.forename: Sei-Hoon
authors.initials: SH
authors.lastname: Yang
authors.affiliation: Department of Internal Medicine, Inha University Hospital, Incheon, Korea.
authors.forename: Jeong-Seon
authors.initials: JS
authors.lastname: Ryu
authors.affiliation: Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea.
authors.forename: Seung-Hun
authors.initials: SH
authors.lastname: Jang
authors.affiliation: Department of Internal Medicine, Kyungpook National University Chilgok Hospital, Daegu, Korea.
authors.forename: Seung-Soo
authors.initials: SS
authors.lastname: Yoo
authors.affiliation: Department of Internal Medicine, Wonju Severance Christian Hospital, Wonju, Korea.
authors.forename: Suk-Joong
authors.initials: SJ
authors.lastname: Yong
authors.affiliation: Department of Internal Medicine, Konkuk University Hospital, Seoul, Korea.
authors.forename: Kye Young
authors.initials: KY
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Korea University Anam Hospital, Seoul, Korea.
authors.forename: Kwang-Ho
authors.initials: KH
authors.lastname: In
authors.affiliation: Department of Internal Medicine, Pusan National University Hospital, Busan, Korea.
authors.forename: Min-Ki
authors.initials: MK
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Chonnam National University Hwasun Hospital, Jeonnam, Korea. Electronic address: kyc0923@jnu.ac.kr.
authors.forename: Young-Chul
authors.initials: YC
authors.lastname: Kim
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000627:therapeutic use*; D000077143:Docetaxel; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000209:etiology; D000068437:Pemetrexed / Q000627:therapeutic use*; D016019:Survival Analysis; D043823:Taxoids / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000068437:Pemetrexed; D000077143:Docetaxel; D002945:Cisplatin
keywords: Chemotherapy; Drug toxicity; East Asia; Progression-free survival; Treatment efficacy