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A randomised dose intensity study in ovarian carcinoma comparing chemotherapy given at four week intervals for six cycles with half dose chemotherapy given for twelve cycles |
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| Authors: | Murphy D; Crowther D; Renninson J; Prendiville J; Ranson M; Lind M; Patel U; Dougal M; Buckley C H; Tindall V R |
| Institution: | 1CRC Department of Medical Oncology Manchester, U.K 2Department of Diagnostic Radiology Manchester, U.K 3Department of Medical Statistics, Christie Hospital NHS Trust Manchester, U.K 4University Department of Reproductive Pathology, St Mary's Hospital Manchester, U.K 5University Department of Obstetrics and Gynaecology, St Mary's Hospital Manchester, U.K |
| Abstract: | BACKGROUND:: The importance of dose intensity has not been clearly definedin ovarian cancer and we present a prospectively randomisedtrial of dose intensity in patients with ovarian cancer. PATIENTS AND METHODS:: Ninety-nine patients with FIGO stage Ic, II, III and IV epithelialovarian cancer were randomised to receive cycles of standarddose cyclophosphamide (600 mg/m2) and carboplatin (300 mg/m2)alternating with adriamycin (50 mg/m2) and ifosfamide (5 G/m2)for 6 cycles at monthly intervals (49 patients) or cycles ofhalf dose cyclophosphamide (300 mg/m2) and carboplatin (150mg/m2) alternating with adriamycin (25 mg/m2) and ifosfamide(2.5 G/m2) for 12 cycles at monthly intervals (50 patients).Patients in each arm were well balanced for major prognosticfactors. RESULTS:: The combined clinical response rate (complete response and partialresponse) on the 6 month arm was 76% compared with 48% on thelow dose intensity arm (p = 0.009). With a median follow upof 25.7 months the median survival on the low dose intensityarm is 20.9 months. The median survival point on the 6 montharm has not yet been reached. The median progression free intervalon the 12 month arm was 19.8 months, the median value has notyet been reached on the standard arm. The amount of residualtumour following initial laparotomy was the only significantindependent variable affecting survival (p = 0.0001). The meanreceived dose intensity of each drug was greater than 80% ofthe planned dose intensity. More patients had clinical diseaseprogression during treatment on the low dose intensity arm (42%)when compared to the standard dose intensity arm (8%) (p = 0.0003).Fifteen patients on the standard dose arm experienced a totalof 18 delays and 5 patients on the low dose arm experienced17 delays. Nausea, vomiting and diarrhoea were similar for bothstandard and low dose cycles of chemotherapy with a consequentbenefit for patients receiving fewer cycles even though thesewere of higher dose. CONCLUSIONS:: The combination studied was more effective when given at thehigher dose intensity and the improved response and survivalwas not accompanied by a significant increase in toxicity. dose intensity, combination chemotherapy, ovarian carcinoma, toxicity |
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