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Annals of Oncology Advance Access published online on April 18, 2005
Annals of Oncology, doi:10.1093/annonc/mdi185
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© 2005 European Society for Medical Oncology
Received December 22, 2004
Revised January 11, 2005
Accepted January 12, 2005

Original article

Oxaliplatin plus high-dose folinic acid and 5-fluorouracil i.v. bolus (OXAFAFU) versus irinotecan plus high-dose folinic acid and 5-fluorouracil i.v. bolus (IRIFAFU) in patients with metastatic colorectal carcinoma: a Southern Italy Cooperative Oncology Group phase III trial

P. Comella 1*, B. Massidda 2, G. Filippelli 3, S. Palmeri 4, D. Natale 5, A. Farris 6, F. De Vita 7, F. Buzzi 8, S. Tafuto 9, L. Maiorino 10, S. Mancarella 11, S. Leo 12, V. Lorusso 13, L. De Lucia 14, and M. Roselli 15

1 Department of Medical Oncology, National Tumour Institute, Naples, Italy;
2 Chair of Medical Oncology, University Medical School, Cagliary, Italy;
3 Medical Oncology, City Hospital, Paola, Italy;
4 Chair of Medical Oncology, University Medical School, Palermo, Italy;
5 Medical Oncology, City Hospital, Penne, Italy;
6 Chair of Medical Oncology, University Medical School, Sassari, Italy;
7 Chair of Medical Oncology, Second University Medical School, Naples, Italy;
8 Medical Oncology, City Hospital, Terni, Italy;
9 Medical Oncology, City Hospital, Pozzuoli, Italy;
10 Medical Oncology, San Gennaro Hospital, Naples, Italy;
11 Medical Oncology, City Hospital, Campi Salentina, Italy;
12 Medical Oncology, IRCCS, Castellana Grotte, Italy;
13 Department of Medical Oncology, National Tumour Institute, Bari, Italy;
14 Medical Oncology, City Hospital, Caserta, Italy;
15 Department of Surgical Oncology, Tor Vergata University Medical School, Rome, Italy

* To whom correspondence should be addressed.
P. Comella, E-mail: pasqualecomella{at}libero.it


  Abstract

Purpose: The primary end point of this phase III trial was to compare the response rate (RR) of oxaliplatin (OXA) plus levo-folinic acid (l-FA) and 5-fluorouracil (5-FU) bolus with that of irinotecan (IRI) plus l-FA and 5-FU bolus in advanced colorectal carcinoma.

Patients and methods: Patients with measurable metastatic colorectal carcinoma were randomly allocated to receive: IRI 200 mg/m2 on day 1, l-FA 250 mg/m2 intravenously plus 5-FU 850 mg/m2 on day 2 (IRIFAFU); or OXA 100 mg/m2 on day 1, l-FA 250 mg/m2 plus 5-FU 1050 mg/m2 on day 2 [OXAFAFU high dose (hd)]. Cycles were given every 2 weeks. After a planned interim analysis, OXA was reduced to 85 mg/m2 and 5-FU to 850 mg/m2 [OXAFAFU low dose (ld)].

Results: Two hundred and seventy-four patients (IRIFAFU, 135; OXAFAFUhd, 71; OXAFAFUld, 68) were treated. Forty-two confirmed responses were achieved with IRIFAFU, 29 with OXAFAFUhd and 32 with OXAFAFUld. The response rate with OXAFAFU [44%; 95% confidence interval (CI) 35% to 52%] was significantly higher (P=0.029) than that of IRIFAFU (31%; 95% CI 23% to 40%). Occurrence of grade ≥3 neutropenia with OXAFAFUld was similar to that for IRIFAFU (29% versus 31%), while severe diarrhoea was significantly lower (12% versus 24%). Median failure-free survival (7 versus 5.8 months; P=0.046) and overall survival of patients (18.9 versus 15.6 months; P=0.032) were significantly prolonged with OXAFAFU.

Conclusions: OXAFAFU was more active and less toxic than IRIFAFU, and it should be preferred in the first-line treatment of advanced colorectal cancer patients.

Keywords: 5-fluorouracil; irinotecan; metastatic colorectal carcinoma; oxaliplatin; randomized trial..

{dagger}Other Southern Italy Cooperative Oncology Group (SICOG) investigators and institutions taking part in this trial are listed in the Acknowledgements.


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