Gemcitabine Plus Carboplatin Compared With Carboplatin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer: An Intergroup Trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG

• DOI: 10.1200/jco.2006.06.0913
• Publication Date: 2006-09-12T00:46:58Z
• Authors: Jacobus Pfisterer; Marie Plante; Ignace Vergote; Andreas du Bois; Hal Hirte; Angel J. Lacave; Uwe Wagner; Anne Stähle; Gavin Stuart; Rainer Kimmig; Sigrid Olbricht; Tien Le; Janusz Emerich; Walther Kuhn; James Bentley; Christian Jackisch; Hans-Joachim Lück; Justine Rochon; Annamaria Hayden ...; Elizabeth Eisenhauer
• Keywords: Carboplatin; Regimen

Most patients with advanced ovarian cancer develop recurrent disease. For those who recur at least 6 months after initial therapy, paclitaxel platinum has shown a modest survival advantage over without paclitaxel; however, many clinically relevant neurotoxicity, frequently resulting in treatment discontinuation. Thus, an alternative regimen significant neurotoxicity was evaluated by comparing gemcitabine plus carboplatin single-agent platinum-sensitive patients.Patients were randomly assigned to receive either or alone, every 21 days. The primary objective compare progression-free (PFS).Three hundred fifty-six (178 carboplatin; 178 carboplatin) assigned. Patients received median of six cycles both arms. With follow-up 17 months, PFS 8.6 (95% CI, 7.9 9.7 months) for and 5.8 5.2 7.1 carboplatin. hazard ration (HR) 0.72 0.58 0.90; P = .0031). Response rate 47.2% 39.9% 54.5%) 30.9% 24.1% 37.7%) (P .0016). HR overall 0.96 0.75 to1.23; .7349). While myelosuppression significantly more common the combination, sequelae such as febrile neutropenia infections uncommon. No statistically differences quality life scores between arms noted.Gemcitabine improves response worsening cancer.