Ovarian Epithelial Cancer Treatment - Stage III and Stage IV Ovarian Epithelial Cancer Treatment
Consolidation and/or maintenance therapy
In an effort to improve on the modest results achieved in suboptimally debulked patients (in contrast to those achieved after optimal cytoreduction and IP therapy), trials of consolidation and/or maintenance therapy have been carried out with drugs that contribute to the treatment of recurrent ovarian cancer. Presently, not one of the treatments given after the initial platinum/paclitaxel induction has been shown to improve survival; these treatments include the following:
- IP cisplatin (four cycles). 
- Yttrium-labeled radioimmunoconjugate plus IP chemotherapy. 
- IV topotecan (four cycles).
- Oregovomab vaccination (randomized trial vs. placebo).
- High-dose chemotherapy with hematopoietic support. 
- Monthly paclitaxel (12 cycles).[32,33]
A GOG-178 study of 277 patients compared three doses versus twelve doses of monthly paclitaxel given every 4 weeks following a clinically defined complete response at the time of completion of platinum/paclitaxel induction. However, the study was stopped early because of a very significant difference in PFS (28 months vs. 21 months).[Level of evidence: 1iiDiii] Subsequent updates of this data have raised the possibility that a subset with low CA 125s might show a survival benefit. A trial to confirm the value of maintenance with taxanes versus observation is being conducted by the GOG.
A smaller Italian study entered 200 patients over 7 years who were randomly assigned to either 12 similar courses of monthly paclitaxel or observation; patients were in clinical complete response (n = 95) or pathologic complete response (n = 105) complete response after induction therapy at the time of their random assignment. Sensory neuropathy was the most prominent toxicity and was grade 2 in 21.3% of the patients and grade 3 in 6.7% of the patients. The median PFS for the maintenance paclitaxel arm was 34 months (95% CI, 20-43 months) and 30 months (95% CI, 17-53 months) for the observation arm. Neither PFS nor OS differences were significant.
An accompanying editorial points out the weaknesses of both studies in order to draw conclusions (both stopped early and were noninformative for survival endpoint). Also, although both studies addressed the issue of maintenance paclitaxel administered monthly, the patient populations differed. This was reflected by the considerably better outcome in both arms of the Italian study. Taken together, paclitaxel maintenance is of unproven value and requires validation by the ongoing and larger GOG-178 study cited above.
Treatment options under clinical evaluation:
- Additional IP radioimmunoconjugates, vaccines, and targeted drugs are under clinical evaluation, primarily as consolidation therapy.
Information about ongoing clinical trials is available from the NCI Web site.
Current Clinical Trials
Check for U.S. clinical trials from NCI's list of cancer clinical trials that are now accepting patients with stage III ovarian epithelial cancer and stage IV ovarian epithelial cancer. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.