Phase II study of carboplatin in patients with advanced or recurrent endometrial carcinoma. A trial of the EORTC Gynaecological Cancer Group
Articolo
Data di Pubblicazione:
2003
Citazione:
Phase II study of carboplatin in patients with advanced or
recurrent endometrial carcinoma. A trial of the EORTC Gynaecological Cancer Group / F.H. van Wijk, C. Lhommé, G. Bolis, V. Scotto di Palumbo, S. Tumolo, M. Nooij, C.F. de Oliveira, J.B. Vermorken. - In: EUROPEAN JOURNAL OF CANCER. - ISSN 0959-8049. - 39:1(2003 Jan), pp. 78-85. [10.1016/S0959-8049(02)00504-X]
Abstract:
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/m2) or second- (dose: 300 mg/m2) 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/m2 (range 290–3879 mg/m2). 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.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
Adenocarcinoma ; Carboplatin ; Chemotherapy ; Clinical trial phase II ; Endometrial carcinoma
Elenco autori:
F.H. van Wijk, C. Lhommé, G. Bolis, V. Scotto di Palumbo, S. Tumolo, M. Nooij, C.F. de Oliveira, J.B. Vermorken
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