Abstract
In the present multicentre randomized phase II trial, the activity and toxicity of three platinum-based combination regimens for the treatment of advanced non-small-cell lung cancer (NSCLC) were evaluated. The three regimens were: MVP (mitomycin-C 6 mg m(-2) on day 1, vindesine 3 mg m(-2) on days 1 and 15, and cisplatin 80 mg m(-2) on day 1 every 28 days), PIN (cisplatin 80 mg m(-2) day 1, ifosfamide 3 g m(-2) day 1 and vinorelbine 25 mg m(-2) day 1 and 8 every 21 days) and CaN (carboplatin 350 mg m(-2) day 1 and vinorelbine 25 mg m(-2) days 1 and 8 every 28 days). A total of 140 chemotherapy-naive patients entered the study; 49 patients were treated with MVP, 48 with PIN and 43 with CaN. Sixty-seven per cent of the patients had stage IV disease. Response rates, calculated on an 'intention to treat' basis, were as follows: MVP, 14.3% (95% CI 5.94-27.2%); PIN, 16.7% (95% CI 7.4-30.2%); and CaN, 14% (95% CI 5.3-27.9%). The overall median survivals were 256, 269 and 243 days for patients treated with MVP, PIN and CaN respectively. Myelosuppression was the most frequent toxicity: grade 3-4 leucopenia was observed in 14.3%, 25% and 18.6% of patients treated with MVP, PIN and CaN respectively. This multicentre phase II randomized trial shows that MVP, PIN and CaN can be administered on an outpatient basis with acceptable toxicities. Unfortunately, the three regimens showed an activity significantly lower than that reported in previous single-institution phase II trials.
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- Ardizzoni A., Addamo G. F., Baldini E., Borghini U., Portalone L., De Marinis F., Lionetto R., Conte P. F., Bruzzi P., Pennucci M. C. Mitomycin-ifosfamide-cisplatinum (MIP) vs MIP-interferon vs cisplatinum-carboplatin in metastatic non-small-cell lung cancer: a FONICAP randomised phase II study. Italian Lung Cancer Task Force. Br J Cancer. 1995 Jan;71(1):115–119. doi: 10.1038/bjc.1995.23. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Baldini E., Tibaldi C., Chella A., Angeletti C. A., Romanini A., Andrei A., Algeri R., Silvano G., Conte P. F. Combination chemotherapy with vinorelbine, ifosfamide, and cisplatin: a phase II study in stage IIIB-IV non-small cell lung cancer. Semin Oncol. 1994 Jun;21(3 Suppl 4):12–15. [PubMed] [Google Scholar]
- Baldini E., Tibaldi C., Chella A., Angeletti C. A., Silvano G., Andrei A., Algeri R., Conte P. F. Phase II study of vinorelbine/ifosfamide/cisplatin for the treatment of advanced non-small-cell lung cancer. Ann Oncol. 1996 Sep;7(7):747–749. doi: 10.1093/oxfordjournals.annonc.a010726. [DOI] [PubMed] [Google Scholar]
- Crinò L., Clerici M., Figoli F., Carlini P., Ceci G., Cortesi E., Carpi A., Santini A., Di Costanzo F., Boni C. Chemotherapy of advanced non-small-cell lung cancer: a comparison of three active regimens. A randomized trial of the Italian Oncology Group for Clinical Research (G.O.I.R.C.). Ann Oncol. 1995 Apr;6(4):347–353. doi: 10.1093/oxfordjournals.annonc.a059183. [DOI] [PubMed] [Google Scholar]
- Depierre A., Lemarie E., Dabouis G., Garnier G., Jacoulet P., Dalphin J. C. A phase II study of Navelbine (vinorelbine) in the treatment of non-small-cell lung cancer. Am J Clin Oncol. 1991 Apr;14(2):115–119. doi: 10.1097/00000421-199104000-00004. [DOI] [PubMed] [Google Scholar]
- Le Chevalier T., Brisgand D., Douillard J. Y., Pujol J. L., Alberola V., Monnier A., Riviere A., Lianes P., Chomy P., Cigolari S. Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin versus vinorelbine alone in advanced non-small-cell lung cancer: results of a European multicenter trial including 612 patients. J Clin Oncol. 1994 Feb;12(2):360–367. doi: 10.1200/JCO.1994.12.2.360. [DOI] [PubMed] [Google Scholar]
- Miller A. B., Hoogstraten B., Staquet M., Winkler A. Reporting results of cancer treatment. Cancer. 1981 Jan 1;47(1):207–214. doi: 10.1002/1097-0142(19810101)47:1<207::aid-cncr2820470134>3.0.co;2-6. [DOI] [PubMed] [Google Scholar]
- Pronzato P., Ghio E., Losardo P. L., Landucci M., Vaira F., Vigani A. Carboplatin and vinorelbine in advanced non-small-cell lung cancer. Cancer Chemother Pharmacol. 1996;37(6):610–612. doi: 10.1007/s002800050436. [DOI] [PubMed] [Google Scholar]
- Ruckdeschel J. C., Finkelstein D. M., Ettinger D. S., Creech R. H., Mason B. A., Joss R. A., Vogl S. A randomized trial of the four most active regimens for metastatic non-small-cell lung cancer. J Clin Oncol. 1986 Jan;4(1):14–22. doi: 10.1200/JCO.1986.4.1.14. [DOI] [PubMed] [Google Scholar]
- Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1–10. doi: 10.1016/0197-2456(89)90015-9. [DOI] [PubMed] [Google Scholar]