A SIMPLE MATHEMATICAL PROBLEM

1.

Am J Clin Oncol. 2011 Jan 26. [Epub ahead of print] Phase II Trial of Pegylated Liposomal Doxorubicin in Combination With Gemcitabine in Metastatic Breast Cancer Patients. Jacquin JP, Chargari C, Thorin J, Mille D, Mélis A, Orfeuvre H, Clavreul G, Chaigneau L, Nourissat A, Dumanoir C, Savary J, Merrouche Y, Magné N. Departments of*Medical Oncology ‡Public Health, Statistical Unit **Radiotherapy, Institut de Cancérologie de la Loire, St Priest en Jarez †Service of Oncology Radiotherapy, Hôpital d'Instruction des Armées du Val-de-Grâce ¶Department of Oncology Development, Laboratoire Schering Plough ♯Department of Oncology Development, Laboratoire Elli Lilly, Paris §Department of Medical Oncology, Centre Hospitalier de Bourg en Bresse, Bourg en Bresse ∥Department of Medical Oncology, Centre Hospitalier Universitaire Jean Minjoz, Besançon, France. Abstract OBJECTIVE: To assess the efficacy and toxicity of pegylated liposomal doxorubicin combined with gemcitabine as first-line chemotherapy in metastatic breast cancer patients in a phase II trial. PATIENTS AND METHODS: All breast cancer patients with HER2-negative status, hormone refractory tumor, assessable targets, with preserved performance status, and who had not received chemotherapy earlier as treatment for their metastatic disease were eligible. The patients received pegylated liposomal doxorubicin (30 mg/m, venous injection, day 1) concurrently with gemcitabine (1000 mg/m, venous injection, days 1 and 8), 1 cycle every 3 weeks. RESULTS: Although 38 patients should have been included, this study was prematurely discontinued after recruiting 20 patients because of excessive toxicity: 75% of the patients experienced grade 3 or 4 treatment-related toxicity, including neutropenia, thrombopenia, hand-foot syndrome, and stomatitis, which significantly affected the quality of life. Cardiac toxicity was mild. With regard to efficacy, 50% of the patients (95% confidence interval, 26%-74%) experienced tumor response. The response rate was 40% in patients who had earlier received anthracyclines as adjuvant therapy. Median progression-free survival and median overall survival were 8.8 months and 19 months, respectively. CONCLUSIONS: This combination was efficient, but not well tolerated. From these results, we could not recommend these doses for further assessment and lower doses should be preferred.