The aim of this study was to investigate the efficacy and toxicity of
carboplatin given as monotherapy in endometrial
adenocarcinoma.
Cisplatin is one of the most active drugs in gynaecological
cancer types, but at the cost of an associated high toxicity. In this high-risk population of
endometrial cancer patients, it is necessary to have
chemotherapy regimens with a low toxicity. Patients eligible for this study were those with histologically-confirmed endometrial
adenocarcinoma with evidence of recurrent and/or metastatic disease.
Carboplatin was administered every 4 weeks as a first- (dose: 400 mg/m(2)) or second- (dose: 300 mg/m(2)) line
chemotherapy. Of the 64 patients who entered the trial, 60 were eligible, 53 patients were evaluable for toxicity and 47 for efficacy. A total of 169 cycles of
carboplatin was given with a median of 2 cycles per patient (range 1-11 cycles) to a median cumulative dose of 798 mg/m(2) (range 290-3879 mg/m(2)). No grade 4 toxicity or toxic deaths occurred. White Blood Cell (WBC) toxicity grade 3 was noted five times, mainly in the
radiotherapy pre-treated patients. Grade 3 non-haematological toxicity consisted mainly of
nausea and
vomiting (21%). There was a total of eight responses (3 Complete Responses (CR) and 5 Partial Responses (PR) with an overall response rate (ORR) of 13% (95% Confidence Interval (CI) 6-25). No responses occurred in patients treated with prior
chemotherapy. In evaluable patients, the ORR in all patients (n=47) and in those receiving first-line
chemotherapy (n=33) were, 17% (95% CI 8-31) and 24% (95% CI 11-42), respectively. After a median follow-up of 379 days, the median duration of response was 488 days (range 141-5303 days) with two very long responses in patients with a CR.
Carboplatin has a low toxicity and is active in
chemotherapy-naive advanced
endometrial carcinoma patients. These results lead us to propose its use in association in first-line
chemotherapy in recurrent or advanced
endometrial carcinoma patients. The choice of the initial dose can be determined according to whether the patients have received prior
radiotherapy treatment.