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Clin Lung Cancer. 2017 Jul;18(4):e289-e296. doi: 10.1016/j.cllc.2017.01.002. Epub 2017 Jan 11.

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.

Author information

1
Department of Internal Medicine, Chonnam National University Hwasun Hospital, Jeonnam, Korea.
2
Department of Pathology, Chonnam National University Medical School, Gwangju, Korea.
3
Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Korea.
4
Department of Internal Medicine, Dankook University Hospital, Cheonan, Korea.
5
Department of Internal Medicine, Youngnam University Hospital, Daegu, Korea.
6
Department of Internal Medicine, Daegu Catholic University Hospital, Daegu, Korea.
7
Department of Internal Medicine, Wonkwang University Hospital, Iksan, Korea.
8
Department of Internal Medicine, Inha University Hospital, Incheon, Korea.
9
Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea.
10
Department of Internal Medicine, Kyungpook National University Chilgok Hospital, Daegu, Korea.
11
Department of Internal Medicine, Wonju Severance Christian Hospital, Wonju, Korea.
12
Department of Internal Medicine, Konkuk University Hospital, Seoul, Korea.
13
Department of Internal Medicine, Korea University Anam Hospital, Seoul, Korea.
14
Department of Internal Medicine, Pusan National University Hospital, Busan, Korea.
15
Department of Internal Medicine, Chonnam National University Hwasun Hospital, Jeonnam, Korea. Electronic address: kyc0923@jnu.ac.kr.

Abstract

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.

KEYWORDS:

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

PMID:
28185792
DOI:
10.1016/j.cllc.2017.01.002
[Indexed for MEDLINE]

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