Ovarian Epithelial Cancer Treatment (PDQ®): Treatment - Health Professional Information [NCI] - Stage III and Stage IV Ovarian Epithelial Cancer Treatment
The PFS surpassed expectations at the 1.5-year follow-up after cessation of treatment. The weekly regimen had a median PFS of 28.0 months (95% CI, 22.3–35.4 months), and the intermittent median PFS was 17.2 months (15.7–21.1; HR, 0.71), favoring the weekly regimen (P = .0015). The 3-year OS also favored the weekly regimen (P = .03). The 2013 updated results revealed unexpected median survival results for the weekly regimen (median OS, 8.3 years vs. 5.1 years; P = .040); the intermittent regimen results are also noteworthy relative to other clinical trials of weekly dosing schedules.
Other than ethnicity, this trial population differed from other studies in the following ways:
- A lower median age (57 years).
- 20% stage II.
- 11% treated in the neoadjuvant setting.
- 33% with histologies other than high-grade serous or endometrioid.
- 33% without high-grade histologies.
Treatment Options for Patients With Suboptimally Cytoreduced Stage III and Stage IV Disease
The value of interval cytoreductive surgery has been the subject of two large phase III trials. In the first study, performed by the EORTC, patients subjected to debulking after four cycles of cyclophosphamide and cisplatin (with additional cycles given later) had an improved survival rate compared with patients who completed six cycles of this chemotherapy without surgery.[Level of evidence: 1iiB] The GOG-0162 trial was designed to answer a very similar question but used the then-standard paclitaxel-plus-cisplatin regimen as the chemotherapy. This trial did not demonstrate any advantage from the use of interval cytoreductive surgery. The divergence of results may be caused by the efficacy of the chemotherapy obscuring any effects of interval cytoreduction, the wider use of maximal surgical effort at the time of diagnosis by U.S. gynecologic oncologists, or unknown factors. Although many patients with stage IV disease also undergo cytoreductive surgery at diagnosis, whether this improves survival has not been established.
Table 2. Paclitaxel/Platinum Combinations Versus Comparator Arms in Trials
|Trial||Treatment Regimens||No. of Patients||% Early Crossover||Progression-free Survival (mo)||Overall Survival (mo)|
|AUC = area under the curve.|
|a Statistically inferior result (P< .001–< .05).|
|GOG-132||Paclitaxel (135 mg/m2, 24 h) and cisplatin (75 mg/m2)||201||22%||14.2||26.6|
|Cisplatin (100 mg/m2)||200||40%||16.4||30.2|
|Paclitaxel (200 mg/m2, 24 h)||213||23%||11.2a||26|
|MRC-ICON3||Paclitaxel (175 mg/m2, 3 h) and carboplatin AUC 6||478||23%||17.3||36.1|
|Carboplatin AUC 6||943||25%||16.1||35.4|
|Paclitaxel (175 mg/m2, 3 h) and carboplatin AUC 6||232||23%||17||40|
|Cyclophosphamide (500 mg/m2) and doxorubicin (50 mg/m2) and cisplatin (50 mg/m2)||421||20%||17||40|
|GOG-111||Paclitaxel (135 mg/m2, 24 h) and cisplatin (75 mg/m2)||184||None||18||38|
|Cyclophosphamide (750 mg/m2) and cisplatin (75 mg/m2)||202||None||13a||24a|
|EORTC-55931||Paclitaxel (175 mg/m2, 3 h) and cisplatin (75 mg/m2)||162||None||15.5||35.6|
|Cyclophosphamide (750 mg/m2) and cisplatin (75 mg/m2)||161||4%||11.5a||25.8a|