Changes to This Summary (02/08/2015)
The PDQ cancer information summaries are reviewed regularly and updated as new information becomes available. This section describes the latest changes made to this summary as of the date above.
The name of this summary and the major section titles and subtitles throughout were changed to include fallopian tube cancers and peritoneal cancer treatment.
Updated statistics with estimated new cases and deaths for 2015 (cited American Cancer Society as reference 5).
Added text to state that treatment options for patients with all stages of ovarian epithelial, fallopian tube, and primary peritoneal cancer have consisted of surgery followed by platinum-based chemotherapy; and, early stage refers to stages I and II, but because of a high recurrence rate for stage II patients in all Gynecologic Oncology Group (GOG) early-stage disease trials, stage II cancers have been included in clinical trials together with the more advanced stages since 2009. Also stated that going forward, stage I will remain a separate category for treatment considerations, but high-grade serous stage II cancers are likely to be included with more advanced stages.
Added text to state that GOG-0157 evaluated whether six cycles were superior to three cycles of chemotherapy for patients with early stage, high-risk epithelial ovarian cancer after primary surgery. Eligible patients were those with stage IA grade 3 or clear-cell histology, stage IB grade 3 or clear-cell histology, all stage IC, and all stage II; no significant difference was found in recurrence or overall survival (OS) when three cycles were compared with six cycles (cited Bell et al. as reference 16 and level of evidence: 1iiDi).
Added text to state that as expected, the use of six cycles was associated with increased grade 3 or 4 neurologic toxic effects and increased grade 4 hematologic toxic effects. Given the increased risk of recurrence in patients with stage II disease and combined with an earlier trial, the Ovarian Committee of the GOG has opted to include patients with stage II disease in advanced ovarian cancer trials. The interpretation of this study, including findings on subset analyses, has been the source of controversy.
Added text to state that because of a high recurrence rate for stage II patients in all GOG early-stage disease trials, stage II cancers have been included in clinical trials together with the more advanced stages since 2009. Also added that going forward, stage I will remain a separate category for treatment considerations, but high-grade serous stage II cancers are likely to be included with more advanced stages.
Added text to state that the extent of cytoreduction is unpredictable, and most current studies do not follow clinical trial paths, with the exception of those studies using IP treatment.
Added text to state that for patients unable to undergo surgery, or for those with greater than 1 cm residual disease following surgery, intravenous chemotherapy is the standard. Also added that the foundation is the platinum agents: cisplatin, or its second-generation analog, carboplatin, given either alone or in combination with other drugs.
Revised text to state that a trial of the Japanese Gynecologic Oncology Group (JGOG-3601) accrued 637 patients and randomly assigned them to a range of six to nine cycles of the weekly 80 mg/m2 of paclitaxel or to the usual every-21-days schedule of paclitaxel at 180 mg/m2.
Added text to state that this trial has stimulated a number of other trials that address weekly dosing schedules versus the conventional every-3-weeks dosing in first-line ovarian epithelial cancer (cited 2009 Katsumata et al. as reference 25, 2013 Katsumata et al. as reference 26, Scambia et al., as reference 27).
Added text to state that in a phase III trial (MITO-7), the outcomes of 406 patients assigned to weekly paclitaxel administered with a weekly carboplatin were compared with those of 404 patients receiving the conventional every-3-weeks regimen of paclitaxel and carboplatin (cited Pignata et al. as reference 28 and level of evidence 1iiA).
Revised table title to Selected Phase III Studies of Intravenous Adjuvant Therapy for Advanced Ovarian Cancer Following Initial Surgery and added data for new regimens.
Added text to include erlotinib in the list of treatments that have not been shown to improve survival and are given after the initial platinum-plus-paclitaxel induction trials (cited Vergote et al. as reference 38).
Added text to state that the AURELIA trial was an open-label randomized trial designed to evaluate the effect of adding bevacizumab to standard chemotherapy in patients with platinum-resistant recurrent ovarian cancer (cited Pujade-Lauraine et al. as reference 44) and described eligibility criteria and three chemotherapy regimens.
Added text to state that patients were then randomly assigned to receive either chemotherapy alone or chemotherapy with bevacizumab and described crossover requirements, primary outcome, and secondary endpoints. Also added the enrollment and median follow-up times for each of the study arms.
Added text to state that the primary endpoint for the quality-of-life portion of the study was a 15% or greater absolute improvement in the abdominal-GI–symptom portion of the assessment modules at week 8 to week 9 of the protocol for patients in the chemotherapy-plus-bevacizumab arm.
Added text to state that the U.S. Food and Drug Administration has approved the use of bevacizumab in combination with pegylated liposomal doxorubicin, paclitaxel, or topotecan as a result of these trials.
Added text to state that consistent effects of bevacizumab have been shown to improve relative risk and PFS rates in platinum-sensitive and platinum-resistant recurrences more than the improvement that is achieved with chemotherapy alone; however, there is the cost of anticipated bevacizumab-related toxic effects.
Added text to include bevacizumab plus chemotherapy to the list of drugs used to treat platinum-refractory or platinum-resistant recurrence and described the AURELIA trial (refer to the description above).
This summary is written and maintained by the PDQ Adult Treatment Editorial Board, which is editorially independent of NCI. The summary reflects an independent review of the literature and does not represent a policy statement of NCI or NIH. More information about summary policies and the role of the PDQ Editorial Boards in maintaining the PDQ summaries can be found on the About This PDQ Summary and PDQ NCI's Comprehensive Cancer Database pages.