Annals of Oncology 15:467-473, 2004
© 2004 European Society for Medical Oncology
Original Paper |
Randomized phase II study evaluating oxaliplatin alone, oxaliplatin combined with infusional 5-FU, and infusional 5-FU alone in advanced pancreatic carcinoma patients
Received 26 June 2003; revised 21 October 2003; accepted 17 December 2003Background:
A randomized phase II, open-label multicenter study evaluating oxaliplatin alone (OXA), infusional 5-fluorouracil alone (5-FU) and an oxaliplatin/infusional 5-FU combination (OXFU) in untreated, advanced pancreatic carcinoma (APC).
Patients and methods:
Chemotherapy-naïve patients with advanced or metastatic, histologically/cytologically proven pancreatic carcinoma with measurable disease, received OXA [130 mg/m2, 2-h intravenous (i.v.) infusion] alone, OXA combined with 5-FU (1000 mg/m2/day, continuous i.v., days 1–4), or 5-FU alone, every 3 weeks.
Results:
Sixty-three patients (42 males/21 females) were treated: 17 patients/52 cycles OXA, 31 patients/ 175 cycles OXFU, 15 patients/41 cycles 5-FU, with a median of three, six and two cycles/patient, respectively. Patient characteristics were similar in all arms. Median age was 57 years (range 21–75), and 83% of patients had PS 0–1. Most patients (62%) had moderate to well-differentiated tumors, 90% had metastatic disease, 81% with liver metastases. All responses (three partial responses; WHO) occurred in the OXFU arm (10% response rate). Five of 32 patients evaluable for clinical benefit were responders (OXA, 14%; OXFU, 21%). Median time to progression and overall survival were higher in the combination arm (4.2 and 9.0 months, respectively) than either single-agent arm (OXA, 2.0 and 3.4 months; 5-FU, 1.5 and 2.4 months, respectively). Moderate hematotoxicity without morbidity was seen in all arms. Two OXFU patients had grade 3 oxaliplatin neurosensory toxicity.
Conclusions:
With a 10% response rate, median overall survival of 9 months and an encouraging safety profile, the OXFU combination is effective, appears superior to infusional 5-FU and warrants further studies in APC patients.
1 Institut Gustave Roussy, Villejuif; 2 Hôpital Ambroise Paré, Boulogne; 3 Cvitkovic et Associés Consultants, Kremlin-Bicêtre; 4 Centre Paoli Calmettes, Marseille; 5 Centre Claudius Regaud, Toulouse; 6 Hôpital Avicenne, Bobigny; 7 CHU Robert Debré, Reims; 8 Clinique Armoricaine de Radiologie, St-Brieuc; 9 Centre Hospitalier Intercommunal, Villeneuve-St-Georges; 10 Centre Hospitalier R. Dubos, Pontoise, France
Key words: advanced pancreatic carcinoma, DACH-platinum, 5-fluorouracil, oxaliplatin
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