The NCCN Ovarian Cancer Guidelines recently added ifosfomide to its recommendations for recurrent ovarian cancer. Specific regimens were added for patients who have recurrence after complete remission and their relapse is greater than 6 months after chemotherapy. The regimens include gemcitabine (Gemzar, Lilly)/carboplatin (Paraplatin, Bristol Myers-Squibb) and carboplatin/paclitaxel (Taxol, Bristol Myers-Squibb). The Ovarian Cancer Guidelines panel broadened the listing of acceptable recurrence modalities for ovarian cancer to include anastrazole (Arimidex, AstraZeneca), bevacizumab (Avastin, Genentech), irinotecan (Camptosar, Pfizer), ifosfamide (Ifex, Bristol Myers-Squibb) and letrozole (Femara, Novartis). Mesna is a uropritector against ifosfomide toxicity and not in itself an active agent.
The siutation with combination of Txol and Ifosfomide is as follows. The regimen was first reproted in 1997 , with the conclusion: “The combination of ifosfamide and paclitaxel was well tolerated and showed activity in patients with ovarian cancer who had previously undergone platinum-based chemotherapy.” Subsequent phase tdies confirmed its effectiveness. It had also been reproted with cisplatin.
The plan considers treatments in phase II or III tirals to be investigational. I do not consider this combination investigational as it is no longer in phase II trials and phase III trials are not expected. Only a rare relapsed patient these days is not Taxol refractory and trials of this combination are logistically impossible. However, for a occasional non-paclitaxel refractory pateint, or foe a pateint more than 6-12 months since previous therapy, the data available recommends this regimen among others. Experts would not propose addtional trials of this regimen at this time.
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