Annals of Oncology 13:251-257, 2002
© 2002 European Society for Medical Oncology
Chemotherapy versus hormonal treatment in platinum- and paclitaxel-refractory ovarian cancer: a randomised trial of the German Arbeitsgemeinschaft Gynaekologische Onkologie (AGO) Study Group Ovarian Cancer
1Department of Gynecology & Gynecologic Oncology, Dr-Horst-Schmidt-Kliniken Wiesbaden; 2Department of Gynecology & Obstetrics, St Vincentius Krankenhaus Karlsruhe; 3Department of Gynecology & Obstetrics, ev. Krankenhaus Düsseldorf; 4Universitaetsfrauenklinik München-Grosshadern; 5Department of Gynecologic Oncology, Universitaetsfrauenklinik Hannover; 6Universitaetsfrauenklinik Göttingen; 7Universitaetsfrauenklinik Marburg; 8Department of Gynecology & Obstetrics, Städtische Kliniken Frankfurt-Höchst; 9Universitaetsfrauenklinik Ulm; 10Department of Gynecologic Oncology, Zentralkrankenhaus Bremen; 11Universitaetsfrauenklinik Aachen; 12Universitaetsfrauenklinik Frankfurt; 13Universitaetsfrauenklinik Bonn; 14Universitaetsfrauenklinik Freiburg; 15Universitaetsfrauenklinik Magdeburg; 16Universitaetsfrauenklinik Münster; 17Universitaetsfrauenklinik Dresden; 18Universitaetsfrauenklinik Tübingen, Germany
Received 30 April 2001; revised 8 August 2001; accepted 24 August 2001.
Background
The majority of patients with ovarian cancer are not cured by first-line treatment. Until now, no study could demonstrate any substantial benefit when exposing ovarian cancer patients to second-line chemotherapy. However, most treatment regimens induce toxicity, thus negatively influencing the quality of rather limited life spans. Here we evaluate whether a second-line chemotherapy can offer any benefit compared with a less toxic hormonal treatment.
Patients and methods
Patients with ovarian cancer progressing during platinum-paclitaxel containing first-line therapy or experiencing relapse within 6 months were eligible. Patients were stratified for response to primary treatment (progression versus no change/response), and measurable versus non-measurable disease. Treatment consisted of either treosulfan 7 g/m2 infused over 30 min or leuprorelin 3.75 mg injected subcutaneously or intramuscularly. Both regimens were repeated every 4 weeks.
Results
This study began in late 1996, and after 2.5 years accrual an interim analysis was performed when several investigators reported their concern about a suspected lack of efficacy. Following this analysis the recruitment was stopped early and the 78 patients already enrolled were followed up. The majority of patients received treatment until progressive disease was diagnosed or death occurred. Treatment delay was observed rarely and dose reduction was performed only in the treosulfan arm in 5% of 150 courses. Overall, both treatment arms were well tolerated. No objective responses were observed. The median survival time was 36 and 30 weeks in the treosulfan and leuprorelin arms, respectively. Overall survival did not differ between patients with relapse 3–6 months after first-line chemotherapy compared with patients with progressive disease within 3 months.
Conclusions
The selected patient population represents a subgroup with extremely poor prognosis. Accordingly, results were not impressive. Both treatment arms showed favourable toxicity data, but failed to show remarkable activity, thus adding only limited evidence to the issue of whether patients with refractory ovarian cancer might benefit from second-line chemotherapy. Even stratified analysis did not identify any subgroup of patients in whom the administration of second-line chemotherapy could demonstrate a clinically relevant survival benefit.
Key words: chemotherapy, hormonal treatment, ovarian cancer, relapse, second-line therapy
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