Originally published as JCO Early Release 10.1200/JCO.2006.06.0913 on September 11 2006

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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

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 Zimmermann, Elizabeth Eisenhauer

From the Klinik für Gynäkologie und Geburtshilfe Campus Kiel, Universitätsklinikum Schleswig-Holstein, Kiel; Dr Horst Schmidt Klinik (HSK), Wiesbaden; Universitäts-Frauenklinik, Tübingen; St Vincentius-Krankenhäuser, Karlsruhe; Frauenklinik Klinikum Großhadern der Ludwig-Maximilians-Universität, München; Universitäts-Frauenklinik, Magdeburg; Klinikum rechts der Isar der Technischen Universität, München; Frauenklinik der Westfälischen Wilhelms-Universität, Münster; Frauenklinik Medizinische Hochschule, Hannover; KKS Marburg, Klinikum der Philipps-Universität Marburg, Germany; University of British Columbia, Vancouver; Centre Hospitalier Universitaire De Quebec, Quebec; Hamilton Regional Cancer Center, Hamilton, Ontario; Saskatoon Cancer Center, University of Saskatchewan; QEII Health Sciences, Halifax; National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario, Canada; University Hospital, Leuven, Belgium; Hospital Central De Asturias, Oviedo Asturias, Spain; Medical University, Gdansk, Poland; and the Eli Lilly and Co, Indianapolis, IN

Address reprint requests to Jacobus Pfisterer, MD, PhD, Klinik für Gynäkologie und Geburtshilfe, Campus Kiel, Universitätsklinikum Schleswig-Holstein, Michaelisstr 16, D-24105 Kiel, Germany; e-mail: jpfisterer{at}e-mail.uni-kiel.de

PURPOSE: Most patients with advanced ovarian cancer develop recurrent disease. For those patients who recur at least 6 months after initial therapy, paclitaxel platinum has shown a modest survival advantage over platinum without paclitaxel; however, many patients develop clinically relevant neurotoxicity, frequently resulting in treatment discontinuation. Thus, an alternative regimen without significant neurotoxicity was evaluated by comparing gemcitabine plus carboplatin with single-agent carboplatin in platinum-sensitive recurrent ovarian cancer patients.

METHODS: Patients with platinum-sensitive recurrent ovarian cancer were randomly assigned to receive either gemcitabine plus carboplatin or carboplatin alone, every 21 days. The primary objective was to compare progression-free survival (PFS).

RESULTS: Three hundred fifty-six patients (178 gemcitabine plus carboplatin; 178 carboplatin) were randomly assigned. Patients received a median of six cycles in both arms. With a median follow-up of 17 months, median PFS was 8.6 months (95% CI, 7.9 to 9.7 months) for gemcitabine plus carboplatin and 5.8 months (95% CI, 5.2 to 7.1 months) for carboplatin. The hazard ration (HR) for PFS was 0.72 (95% CI, 0.58 to 0.90; P = .0031). Response rate was 47.2% (95% CI, 39.9% to 54.5%) for gemcitabine plus carboplatin and 30.9% (95% CI, 24.1% to 37.7%) for carboplatin (P = .0016). The HR for overall survival was 0.96 (95% CI, 0.75 to1.23; P = .7349). While myelosuppression was significantly more common in the combination, sequelae such as febrile neutropenia or infections were uncommon. No statistically significant differences in quality of life scores between arms were noted.

CONCLUSION: Gemcitabine plus carboplatin significantly improves PFS and response rate without worsening quality of life for patients with platinum-sensitive recurrent ovarian cancer.

published online ahead of print at www.jco.org on September 11, 2006.

Supported by Lilly Deutschland GmbH, Bad Homburg, Germany.

Presented in part at the 40th Annual Meeting of the American Society of Clinical Oncology, New Orleans, LA, June 5-8, 2004 and at the 10th Biennial Meeting of the International Gynecologic Cancer Society, Edinburgh, Scotland, October 3-7, 2004.

Terms in blue are defined in the glossary, found at the end of this article and online at www.jco.org.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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