Format

Send to

Choose Destination
BMC Cancer. 2015 Oct 22;15:763. doi: 10.1186/s12885-015-1714-y.

Randomized phase II study of paclitaxel/carboplatin intercalated with gefitinib compared to paclitaxel/carboplatin alone for chemotherapy-naïve non-small cell lung cancer in a clinically selected population excluding patients with non-smoking adenocarcinoma or mutated EGFR.

Choi YJ1,2, Lee DH3,4,5, Choi CM6,7,8, Lee JS9,10,11, Lee SJ12, Ahn JH13,14,15, Kim SW16,17,18.

Author information

1
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro-43-gil, Songpa-gu, Seoul, 138-736, Korea. yoonji23@hanmail.net.
2
Division of Hemato-oncology, Department of Internal Medicine, Korea University Anam Hospital, Seoul, Korea. yoonji23@hanmail.net.
3
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro-43-gil, Songpa-gu, Seoul, 138-736, Korea. leedaeho@amc.seoul.kr.
4
Asan Institute for Life Science, Asan Medical Center, Institute for Innovative Cancer Research, Seoul, Korea. leedaeho@amc.seoul.kr.
5
University of Ulsan College of Medicine, Ulsan, Korea. leedaeho@amc.seoul.kr.
6
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro-43-gil, Songpa-gu, Seoul, 138-736, Korea. ccm@amc.seoul.kr.
7
Asan Institute for Life Science, Asan Medical Center, Institute for Innovative Cancer Research, Seoul, Korea. ccm@amc.seoul.kr.
8
University of Ulsan College of Medicine, Ulsan, Korea. ccm@amc.seoul.kr.
9
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro-43-gil, Songpa-gu, Seoul, 138-736, Korea. jayslee@amc.seoul.kr.
10
Asan Institute for Life Science, Asan Medical Center, Institute for Innovative Cancer Research, Seoul, Korea. jayslee@amc.seoul.kr.
11
University of Ulsan College of Medicine, Ulsan, Korea. jayslee@amc.seoul.kr.
12
Asan Institute for Life Science, Asan Medical Center, Institute for Innovative Cancer Research, Seoul, Korea. sj_lee@amc.seoul.kr.
13
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro-43-gil, Songpa-gu, Seoul, 138-736, Korea. drjiny@amc.seoul.kr.
14
Asan Institute for Life Science, Asan Medical Center, Institute for Innovative Cancer Research, Seoul, Korea. drjiny@amc.seoul.kr.
15
University of Ulsan College of Medicine, Ulsan, Korea. drjiny@amc.seoul.kr.
16
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro-43-gil, Songpa-gu, Seoul, 138-736, Korea. swkim@amc.seoul.kr.
17
Asan Institute for Life Science, Asan Medical Center, Institute for Innovative Cancer Research, Seoul, Korea. swkim@amc.seoul.kr.
18
University of Ulsan College of Medicine, Ulsan, Korea. swkim@amc.seoul.kr.

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-naïve population of advanced NSCLC patients with a history of smoking or wild-type EGFR.

METHODS:

Eligible patients were chemotherapy-naïve 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) 27.0-57.9 %) 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.

TRIAL REGISTRATION:

The study is registered with ClinicalTrials.gov ( NCT01196234 ). Registration date is 08/09/2010.

PMID:
26493267
PMCID:
PMC4619194
DOI:
10.1186/s12885-015-1714-y
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for BioMed Central Icon for PubMed Central
Loading ...
Support Center