FIVB plus GM-CSF in metastatic colorectal cancer
- 20 Downloads
The response rate of patients with metastatic colorectal cancer to the 4-drug combination [5-Fluorouracil (5-FU), dacarbazine, vincristine and bis-chloronitrosourea given 5 weekly (FIVB)] was better than the response rate to 5-FU. The dose limiting toxicity of the FIVB was myelosuppression. The present study investigates the effect of FIVB given with GM-CSF so that drug cycles could be given every 4 weeks.
Thirty-five ambulatory patients with measurable metastatic colorectal cancer were treated with FIVB plus GM-CSF 4 weekly. All patients were evaluable for toxicity. Among the 163 cycles given only 4 were delayed because of leucopenia and 8 cycles were delayed because of gastrointestinal (GI) toxicity. A 50% dose reduction was given to 10 patients who had Grade 2 and 3 GI toxicity. Four of the 35 patients developed thromboembolic complications, 2 of which were lethal. Two patients were not evaluable for response as they were removed from study early because of toxicity. There were 2 complete responses and 6 partial responses. The median time to treatment failure was 3.8 months and median survival time 9.9 months.
The addition of GM-CSF to FIVB decreased the expected leucopenia allowing drug treatment to be given 4 weekly to most patients. GI toxicity was dose limiting. Despite the increased dose intensity that could be delivered (to two thirds of patients), response rates were not definitely increased, no survival benefit was seen and important thromboembolic complications occurred.
Key wordsmetastatic colorectal cancer chemotherapy GM-CSF
Unable to display preview. Download preview PDF.
- 1.Steinke B, Günter E, Hirchmann WD, Sondern W, Koniczek KH, Wander HE, Natt F, Wagner T, Hinrichs HF, Werdier D: Fluorouracil versus folinic acid/fluorouracil in advanced colorectal cancer — Preliminary results of a randomized trial. Semin Oncol 19(3): 141–147, 1992Google Scholar
- 2.Di Costanzo F, Bartolucci R, Calabresi F, Sofra M, Marzola M, Belsanti V, Boni C, Bacchi M: Fluorouracilalone versus high-dose folinic acid and fluorouracil in advanced colorectal cancer: A randomized trial of the Italian Oncology Group for Clinical Research (GOIRC). Annals of Oncol 3:371–376, 1992Google Scholar
- 3.Nobile MT, Rosso R, Sertoli MR, Rubagotti A, Vidili MG, Giglielmi A, Venturini M, Canobbio L, Fassio T, Gallo L, Galligioni E, Gallotti P, Bruzzi P, Sobrero A: Randomised comparison of weekly bolus 5-fluorouracil with or without leucovorin in metastatic colorectal carcinoma. Eur J Cancer 28A: 1823–1827, 1992Google Scholar
- 4.Martoni A, Cricca A, Guraldi M, Covizzi M, Farris A, Pannuti F: Randomized clinical trial with a weekly regimen of 5-Fu vs 5-Fu + intermediate-dose folinic acid in the treatment of advanced colorectal cancer. Ann Oncol 3:87–88, 1992Google Scholar
- 5.Falkson G, Van Eden EB, Falkson HC: Fluorouracil, imidazole, carboxamide, dimethyl, triazeno, vincristine, and bis-chloroethyl nitrosourea in colon cancer. Cancer 33:1207–1209, 1974Google Scholar
- 6.Douwes FR: Chemotherapy of colon cancer with the FIVB regimen. Blood Therapy Journal (International) 1:20, 1980Google Scholar
- 7.Falkson G, Falkson HC: Fluorouracil, imidazole, carboxamide, dimethyl, triazeno, vincristine, and bis-chloroethyl nitrosourea (FIVB) in colon cancer. Cancer Chemother Pharmacol 6:31–34, 1981Google Scholar
- 8.Falkson G, Falkson HC: A five drug combination in the treatment of metastatic breast cancer. Cancer Clin Trials 4:81–85, 1981Google Scholar
- 9.Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP: Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 5:649–655, 1982Google Scholar
- 10.Piedbois P, Buyse M, Raslum Y, Machover D, Erlichman C, Carlson RW, Valone F, Labianca R, Doroshow JH, Perrelli N: Advanced colorectal cancer meta-analysis project. Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: evidence in terms of response rate. J Clin Oncol 10:896–903, 1993Google Scholar