Phase II Study of Cisplatin and 5-Fluorouracil (PF) and Mitomycin C, Vincristine, Cisplatin and 5-Fluorouracil (MVPF) in Patients with Metastatic Large Bowel Cancer: An Eastern Cooperative Oncology Group Study (EST 1285)Pandya K.J.a · Lefkopoulou M.b · Petrelli N.J.c · Vaughn D.J.d · Smith T.J.e · Harris J.E.f · Haller D.G.d
aUniversity of Rochester Cancer Center, Rochester, N.Y., bDana-Farber Cancer Institute, Boston, Mass., cRoswell Park Memorial Institute, Buffalo, N.Y., dUniversity of Pennsylvania Cancer Center, Philadelphia, Pa., eMorristown Memorial Hospital, Morristown, N.J., and fRush-Presbyterian-St. Luke’s Medical Center, Chicago, Ill., USA
Purpose: To compare the efficacy and the toxicity of cisplatin and 5-fluorouracil (PF) and mitomycin C, vincristine, cisplatin and 5-fluorouracil (MVPF) in patients with metastatic large bowel cancer. Patients and Methods: A total of 94 patients with no prior chemotherapy and measurable metastatic large bowel cancer were randomly assigned to one of the two treatment regimens. Eastern Cooperative Oncology Group (ECOG) criteria were used to evaluate response and toxicity. Results: Fifty patients were randomized to PF and 44 to MVPF. Toxicity was evaluable in all patients except one; response was evaluable in 40 and 31, with response rate of 13 and 42%, respectively. Intent-to-treat analysis showed a response rate of 12 and 32%, respectively (p = 0.076), where it was assumed that none of the ineligible or unevaluable patients responded. Median survival for all patients was 9 months, with no difference between PF and MVPF. ECOG Performance Status (0 vs. 1), weight loss (≤10 vs. >10%) and site of metastatic lesion had statistically significant impact on survival. MVPF was definitely more toxic than PF (p < 0.000005). Conclusion: Both treatment regimens showed clinical activity. The MVPF regimen resulted in more responses than PF, no improvement in survival, and more toxicity.
© 2004 S. Karger AG, Basel
Received: February 24, 2003
Accepted after revision: July 15, 2003
Number of Print Pages : 8
Number of Figures : 1, Number of Tables : 5, Number of References : 36
Oncology (International Journal of Cancer Research and Treatment)
Founded 1948 as ‘Oncologia’ by H.R. Schinz; Continued by V. Richards (1967–1975), H. Wrba (1976–1992), P.P. Carbone (1993–2002)
Vol. 66, No. 2, Year 2004 (Cover Date: Released May 2004)
Journal Editor: D.L. Trump, Buffalo, N.Y.
ISSN: 0030–2414 (print), 1423–0232 (Online)
For additional information: http://www.karger.com/onc