TY - JOUR
T1 - Paclitaxel plus ifosfamide in advanced ovarian cancer. A multicenter phase II study
AU - Miglietta, L.
AU - Amoroso, D.
AU - Bruzzone, M.
AU - Granetto, C.
AU - Catsafados, E.
AU - Mammoliti, S.
AU - Guarneri, D.
AU - Pedullà, F.
AU - Foglia, G.
AU - Ragni, N.
AU - Martini, M. C.
AU - Brema, F.
AU - Addamo, G.
AU - Moraglio, L.
AU - Pastorino, G.
AU - Boccardo, F.
PY - 1997/3
Y1 - 1997/3
N2 - Background: While ovarian cancer is one of the most sensitive cancers to cytotoxic drugs, with objective response rates of 60-80% routinely being reported in previously untreated patients, the majority of individuals with advanced disease ultimately relapse. Paclitaxel, a new and novel antimicrotubule agent, has shown activity as a salvage therapy in epithelial ovarian cancer. More importantly, in a prior study, it has been shown to be active in tumors that have displayed resistance to platinum compounds, with a reported response rate of 20%. Ifosfamide has shown activity in the treatment of patients who previously demonstrated clinical resistance to a platinum-cyclophosphamide combination. Recently, a synergistic activity of Taxol combined with ifosfamide has been reported in ovarian cell lines. Based on these data, a phase I/II study of a combination treatment with paclitaxel and ifosfamide was performed. Patients and methods: Thirty-one patients with recurrent ovarian cancer or ovarian cancer refractory to cisplatin (CDDP)-containing regimens were treated with paclitaxel at a dose of 135 mg/m
2 on day 1; ifosfamide was administered at 1 g/m
2 on days 2 and 3 for the first cycle and 1.5 and 2 g/m
2 with the same schedule in cycles 2 and 3, respectively. In the absence of toxicity, the dose of ifosfamide was maintained at 2 g/m
2 for the last three cycles. Cytotoxic therapy was repeated every 3 weeks. Results: A 30% overall objective response rate was achieved in the 30 patients assessable for response. Among 21 platinum-resistant patients, 4 partial responses (19%) were observed, while in the 9 platinum-sensitive patients 2 complete responses and 3 partial responses (55%) were observed. Myelosuppression was the predominant toxicity. Leukopenia (WHO grade 3-4) occurred in 10% of patients who received ifosfamide at a dose of 1 g/m
2 and in 18% of patients treated with ifosfamide at 1.5 g/m
2. Conclusion: Our results confirmed a low activity of paclitaxel in platinum-resistant patients. The results of this combination treatment with paclitaxel-ifosfamide in our platinum-sensitive patients support further investigations in a randomized study of the combination regimen against paclitaxel alone or retreatment with organoplatinum compounds.
AB - Background: While ovarian cancer is one of the most sensitive cancers to cytotoxic drugs, with objective response rates of 60-80% routinely being reported in previously untreated patients, the majority of individuals with advanced disease ultimately relapse. Paclitaxel, a new and novel antimicrotubule agent, has shown activity as a salvage therapy in epithelial ovarian cancer. More importantly, in a prior study, it has been shown to be active in tumors that have displayed resistance to platinum compounds, with a reported response rate of 20%. Ifosfamide has shown activity in the treatment of patients who previously demonstrated clinical resistance to a platinum-cyclophosphamide combination. Recently, a synergistic activity of Taxol combined with ifosfamide has been reported in ovarian cell lines. Based on these data, a phase I/II study of a combination treatment with paclitaxel and ifosfamide was performed. Patients and methods: Thirty-one patients with recurrent ovarian cancer or ovarian cancer refractory to cisplatin (CDDP)-containing regimens were treated with paclitaxel at a dose of 135 mg/m
2 on day 1; ifosfamide was administered at 1 g/m
2 on days 2 and 3 for the first cycle and 1.5 and 2 g/m
2 with the same schedule in cycles 2 and 3, respectively. In the absence of toxicity, the dose of ifosfamide was maintained at 2 g/m
2 for the last three cycles. Cytotoxic therapy was repeated every 3 weeks. Results: A 30% overall objective response rate was achieved in the 30 patients assessable for response. Among 21 platinum-resistant patients, 4 partial responses (19%) were observed, while in the 9 platinum-sensitive patients 2 complete responses and 3 partial responses (55%) were observed. Myelosuppression was the predominant toxicity. Leukopenia (WHO grade 3-4) occurred in 10% of patients who received ifosfamide at a dose of 1 g/m
2 and in 18% of patients treated with ifosfamide at 1.5 g/m
2. Conclusion: Our results confirmed a low activity of paclitaxel in platinum-resistant patients. The results of this combination treatment with paclitaxel-ifosfamide in our platinum-sensitive patients support further investigations in a randomized study of the combination regimen against paclitaxel alone or retreatment with organoplatinum compounds.
KW - Advanced ovarian cancer
KW - Ifosfamide
KW - Paclitaxel
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M3 - Article
C2 - 9075779
AN - SCOPUS:0031054375
VL - 54
SP - 102
EP - 107
JO - Oncology
JF - Oncology
SN - 0030-2414
IS - 2
ER -