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ICACT: Hormone-Refractory Prostate Cancer Responds to Combination of Vinorelbine, Mitoxantrone, and Prednisone By Paula Moyer PARIS, FRANCE -- February 16, 2004 -- A chemotherapy regimen combining vinorelbine (Navelbine) and mitoxantrone (Novantrone) with the corticosteroid prednisone is effective in the treatment of hormone-refractory prostate cancer, according to researchers. "This treatment is feasible in hormone-refractory prostate cancer, and we should offer it to symptomatic patients earlier in their disease," said principal investigator Vittorio D. Ferrari, MD. Presenting study findings here February 12th at the 15th International Congress of Anti-Cancer Therapy, Dr. Vittorio, a medical oncologist at the Beretta Foundation in Brescia, Italy, added that a larger phase 2 study of this treatment regimen is planned. From a group of 66 patients who had advanced prostate cancer, the investigators recruited 12 for whom previous hormone therapy had failed in at least 3 lines of treatment. The investigators included patients who had undergone palliative radiotherapy at any point during their disease. The patients' median age was 67 years, with a range of 60 to 81 years. The patients' median Eastern Cooperative Oncology Group performance status was 1, with a range of 0 to 2. All the patients had bone metastases, some with multiple sites. One patient had lymph node metastasis, and 1 had visceral disease. Three patients had significant ischaemic heart disease. Each treatment cycle consisted of 10 to 12 mg/m2 of mitoxantrone on day 1, followed by 20 mg/m2 of vinorelbine on days 1 through 8. This cycle was repeated every 3 weeks. The patients also received 12.5 mg daily of prednisone. A total of 95 cycles were given, with a median of 7 cycles per patient and a range of 5 to 9 cycles per patient. Two patients repeated the treatment at 6 months and 12 months after the initial treatment. Among these patients, 50% had a marked decrease in pain and improvement in ECOG performance status, according to Dr. Ferrari. In 8 cycles, due to the response to treatment, the dose of vinorelbine was reduced 50% and in 4 cycles it was reduced 75%. The mitoxantrone dose was reduced 50% in 5 cycles. Although 1 patient had a drop in prostate specific antigen (PSA) of more than 50%, the computed tomography findings did not show an equivalent response. The patients' median time to progression was 10 months, with a range of 6 months to over 20 months. Two patients are living; 8 died due to disease progression; and 2 died of other causes. The toxicity episodes consisted of 6 neutropaenic events, all afebrile. Otherwise, the investigators documented no Grade 4 haematological toxicity and no non-haematological toxicity. [Study title: "Vinorelbine plus mitoxantrone and prednisone in hormone refractory prostate cancer: a phase 1-2 study." Abstract P10] E-mail this page to a friend or colleague! To print, use this version