Article
Phase II trial of Docetaxel and Carboplatinum in recurrent platinum sensitive ovarian, peritoneal and tubal cancer - final results
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Published: | March 20, 2006 |
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Recurrent ovarian, peritoneal or tubal cancer is associated with poor prognosis and short survival after salvage chemotherapy. We evaluated the efficacy and toxicity of combined chemotherapy with Docetaxel 75 mg/m2 – day 1 and Carboplatinum AUC 5 – day 1, every three weeks with a maximum of 6 cycles in platinum sensitive recurrent ovarian, peritoneal and tubal cancer. All patients included in our study had a recurrence free interval > 6 months after first line therapy. Either a histological confirmation of recurrence without measurable tumor by imaging associated with an elevated serum CA 125 > 35 U/ml or a bidimensionally measurable tumor was mandatory. An elevated serum CA 125 alone was not a sufficient entry criterion. Toxicities were graded according to the common toxicity criteria. 25 patients (22 ovarian, 2 peritoneal and 1 tubal cancer) were treated between 1999 and 2004 (median age 59.8 yrs., range 31 – 73 / performance status 0-2). 23/25 patients had at least two courses of chemotherapy and were evaluable for response and all patients were evaluable for toxicity. One patient refused further therapy after a single course without any reason; another patient due to a hypersensitivity reaction to Docetaxel in the first course. 22 / 25 patients (88.0%) had CA 125-sensitive recurrent tumor. The overall response rate was 78.3% (CR 69.6%, PR 8.7%). After a median follow-up of 29.4 months (range 7- 62) 14/16 patients with complete remission are alive, 10 still have no evidence of disease. The therapy was generally tolerated well and alopecia was ubiquitary. Grade 3-4 neutropenia was the predominant hematological toxicity (15 / 25 pts., 60%), but it was only in 1 patient associated with a febrile complication. GCSF was given in 15 / 103 courses (8 pts.). Grad 3 thrombocytopenia occurred in 5 / 25 pts. (20 %); Grade 4 thrombocytopenia in 1 patient. G3 diarrhea (3 pts.) and G3 depressive mood alterations (1 pt.) were the only G3 non-hematological toxicities. Combined treatment of Docetaxel and Carboplatinum represents a promising option for patients with platinum sensitive recurrent ovarian cancer, with an acceptable and manageable toxicity.