By ecancer reporter Sharan Sharma

Platinum-Paclitaxel combination has been in use for advanced epithelial ovarian cancer as a first-line treatment. Several attempts have been made to increase the efficacy of the treatment and one method is the addition of non-cross-resistant drug: gemcitabine to the regimen. A Gynecologic research group from several European countries performed a randomised, phase III study to compare gemcitabine and Carboplatin plus paclitaxel (TCG) with carboplatin plus paclitaxel (TC) alone in ovarian cancer. Their final report was published in the print issue of Journal of Clinical Oncology September 20, 2010.

The researchers performed a prospective, randomised phase III, trial to compare carboplatin plus paclitaxel with the same combination and additional gemcitabine in previously untreated patients with advanced epithelial ovarian cancer.TC was administered intravenously (IV) on day 1 every 21 days for a planned minimum of six courses. Gemcitabine was administered by IV on days 1 and 8 of each cycle in the TCG arm. They randomly assigned 882 to the TC arm and 860 to the TCG arm. Patients getting the 3-drug combination had more Grade 3 to 4 haematologic toxicity and fatigue. A quality of life analysis during chemotherapy showed a disadvantage in the TCG arm. Although objective response was slightly higher in the TCG arm, this did not translate into improved progression-free survival (PFS) or overall survival (OS). Median PFS was 17.8 months for the TCG arm and 19.3 months for the TC arm (hazard ratio [HR], 1.18; 95% CI, 1.06 to 1.32; P = .0044). Median OS was 49.5 for the TCG arm and 51.5 months for the TC arm (HR, 1.05; 95% CI, 0.91 to 1.20; P = .5106).

The researchers comment "These trials showed unanimously that the addition of the third drug did not provide any relevant benefit regarding overall survival or progression free survival but was commonly associated with more toxicities and treatment burden".