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SCOTROC 2A: Carboplatin followed by docetaxel or docetaxel-gemcitabine as first-line chemotherapy for ovarian cancer

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posted on 2016-03-23, 16:34 authored by P. A. Vasey, R. Atkinson, R. Osborn, D. Parkin, Raymond Symonds, J. Paul, L. Lewsley, R. Coleman, N. S. Reed, S. Kaye, G. J. S. Rustin
The feasibility of sequential carboplatin followed by docetaxel-based therapy for untreated ovarian cancer was determined. Patients received four q3w cycles of carboplatin AUC 7, then four q3w cycles of either docetaxel 100 mg m−2 (day 1) (arm A); docetaxel 75 mg m−2 (day 8) and gemcitabine 1250 mg m−2 (days 1,8) (arm B) or docetaxel 25 mg m−2 and gemcitabine 800 mg m−2 (both given weekly (days 1,8,15)) (arm C). A total of 44 patients were randomised to each treatment arm. None of the arms demonstrated an eight cycle completion rate (70.5/72.7/45.5% in arms A/B/C, respectively), which was statistically greater than 60% (P=0.102, P=0.056, P=0.982) which was our formal feasibility criteria, although only the completion rate in arm C was clearly worse than this level. The overall response rate (ORR) after carboplatin was 65.7% in 70 evaluable patients. In evaluable patients, ORRs after docetaxel-based cycles were: arm A 84.0% (21 out of 25); arm B 77.3% (17 out of 22); arm C 69.6% (16 out of 23). At follow-up (median 30 months), median progression-free survival times were: arm A 15.5 months (95% CI: 10.5–20.6); arm B 18.1 months (95% CI: 15.9–20.3); arm C, 13.7 months (95% CI: 12.8–14.6). Neutropenia was the predominant grade 3–4 haematological toxicity: 77.8/85.7/54.4% in arms A/B/C, respectively. Dyspnoea was markedly increased in both gemcitabine-containing arms (P=0.001) but was worse in arm C. Although just failing to rule out eight cycle completion rates less than 60%, within the statistical limitations of these small cohorts, the overall results for arms A and B are encouraging. Larger phase III studies are required to test these combinations.



British Journal of Cancer, 2006, 94, pp. 62-68

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/Organisation/COLLEGE OF MEDICINE, BIOLOGICAL SCIENCES AND PSYCHOLOGY/MBSP Non-Medical Departments/Department of Genetics


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