Annals of Oncology 14:1086-1093, 2003
© 2003 European Society for Medical Oncology
Original Paper |
Phase III multicenter randomized trial of amifostine as cytoprotectant in first-line chemotherapy in ovarian cancer patients
1 Department of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome; 2 Department of Obstetrics and Gynecology, University of Pisa; 3 Fondazione G. Pascale, National Cancer Institute, Naples; 4 Department of Gynecology, San Matteo Hospital, Pavia; 5 Department of Oncology, Mariano Santo Hospital, Cosenza; 6 Department of Oncology, San Carlo Hospital, Potenza; 7 Department of Obstetrics and Gynecology, University of Bari, Bari; 8 Department of Oncology, San Vincenzo Hospital, Taormina, Italy
Received 30 October 2002; revised 24 March 2003; accepted 1 April 2003
Background:
A phase III multicenter randomized trial has been designed in order to address whether amifostine (WR-2721, Ethyol), an organic thiophosphate cytoprotector, can protect ovarian cancer patients from toxicity induced by carboplatin–paclitaxel chemotherapy.
Patients and methods:
Patients were randomly assigned to receive carboplatin [area under the curve (AUC) 5 mg·min/ml] and paclitaxel (175 mg/m2) with (arm A) or without (arm B) amifostine (910 mg/m2) every 21 days for six cycles.
Results:
One-hundred and eighty-seven patients were accrued: 93 patients in arm A and 94 patients in arm B. There was no difference in terms of erythrocytopenia between the two arms; grade 3–4 thrombocytopenia was higher in arm A (3.3% versus 0.6%; P = 0.0010). There was no significant reduction of grade 3–4 leukopenia in arm A (11.8% versus 13.8%). The incidence of grade 3–4 neutropenia was lower in arm A (31.3% versus 37.9%; P = 0.03), as was the incidence of severe mucositis (4.7% versus 15.4% in arm A versus arm B, respectively; P <0.0001). Finally, amifostine appears to be protective against neurotoxicity (grade 3–4 neurotoxicity 3.7% versus 7.2%; P = 0.02). With a median follow-up of 24 months (range 2–41), time to progression was similar between the two groups.
Conclusions:
We showed that amifostine can exert some protection from the cumulative toxicity associated with this regimen. The results need to be confirmed in other randomized trials with this combination.
Key words: amifostine, carboplatin, ovarian cancer, paclitaxel
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