Phase III trial of gemcitabine and carboplatin versus mitomycin, ifosfamide, and cisplatin or mitomycin, vinblastine, and cisplatin in patients with advanced nonsmall cell lung carcinoma

Danson, S., Middleton, M. R., O'Byrne, Kenneth J., Clemons, M., Ranson, M., Hassan, J., Anderson, H., Burt, P. A., Fairve-Finn, C., Stout, R., Dowd, I., Ashcroft, L., Beresford, C., & Thatcher, N. (2003) Phase III trial of gemcitabine and carboplatin versus mitomycin, ifosfamide, and cisplatin or mitomycin, vinblastine, and cisplatin in patients with advanced nonsmall cell lung carcinoma. Cancer, 98(3), pp. 542-553.

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Abstract

BACKGROUND. The authors compared gemcitabine and carboplatin (GC) with mitomycin, ifosfamide, and cisplatin (MIC) or mitomycin, vinblastine, and cisplatin (MVP) in patients with advanced nonsmall cell lung carcinoma (NSCLC). The primary objective was survival. Secondary objectives were time to disease progression, response rates, evaluation of toxicity, disease-related symptoms, World Health Organization performance status (PS), and quality of life (QoL). METHODS. Three hundred seventy-two chemotherapy-naïve patients with International Staging System Stage III/IV NSCLC who were ineligible for curative radiotherapy or surgery were randomized to receive either 4 cycles of gemcitabine (1000 mg/m2 on Days 1, 8, and 15) plus carboplatin (area under the serum concentration-time curve, 5; given on Day 1) every 4 weeks (the GC arm) or MIC/MVP every 3 weeks (the MIC/MVP arm).

RESULTS. There was no significant difference in median survival (248 days in the MIC/MVP arm vs. 236 days in the GC arm) or time to progression (225 days in the MIC/MVP arm vs. 218 days in the GC arm) between the 2 treatment arms. The 2-year survival rate was 11.8% in the MIC/MVP arm and 6.9% in the GC arm. The 1-year survival rate was 32.5% in the MIC/MVP arm and 33.2% in the GC arm. In the MIC/MVP arm, 33% of patients responded (4 complete responses [CRs] and 57 partial responses [PRs]) whereas in the GC arm, 30% of patients responded (3 CRs and 54 PRs). Nonhematologic toxicity was comparable for patients with Grade 3-4 symptoms, except there was more alopecia among patients in the MIC/MVP arm. GC appeared to produce more hematologic toxicity and necessitated more transfusions. There was no difference in performance status, disease-related symptoms, of QoL between patients in the two treatment arms. Fewer inpatient stays for complications were required with GC.

CONCLUSIONS. The results of the current study failed to demonstrate any difference in efficacy between the newer regimen of GC and the older regimens of MIC and MVP. © 2003 American Cancer Society.

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ID Code: 64965
Item Type: Journal Article
Refereed: Yes
Additional URLs:
Keywords: Carboplatin, Chemotherapy, Gemcitabine, Nonsmall cell lung carcinoma (NSCLC), cisplatin, dexamethasone, ifosfamide, metoclopramide, mitomycin, ondansetron, paclitaxel, vinblastine, adult, advanced cancer, aged, alopecia, article, blood toxicity, cancer survival, clinical trial, controlled clinical trial, controlled study, disease course, edema, flu like syndrome, hearing impairment, human, lung non small cell cancer, major clinical study, mucosa inflammation, neutropenia, performance, peripheral neuropathy, phase 3 clinical trial, priority journal, quality of life, randomized controlled trial, rash, thorax pain, thrombocytopenia, tinnitus, treatment outcome, Adenocarcinoma, Antineoplastic Combined Chemotherapy Protocols, Anxiety, Carcinoma, Large Cell, Carcinoma, Non-Small-Cell Lung, Deoxycytidine, Disease Progression, Dose-Response Relationship, Drug, Female, Humans, Lung Neoplasms, Male, Middle Aged, Mitomycins, Neoplasm Staging, Survival Rate, Time Factors
DOI: 10.1002/cncr.11535
ISSN: 0008-543X
Divisions: Current > Schools > School of Biomedical Sciences
Current > QUT Faculties and Divisions > Faculty of Health
Current > Institutes > Institute of Health and Biomedical Innovation
Copyright Owner: Copyright 2003 John Wiley & Sons, Inc.
Deposited On: 02 Dec 2013 02:13
Last Modified: 02 Dec 2013 02:13

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