1. ¹Instituto Nazionale Tumori, UOC Oncologia Medica B, Napoli, Italy
2. ²Università Cattolica del Sacro Cuore, UOC Ginecologia Oncologica, Roma, Italy
3. ³Ospedale S. Giovanni Calabita- Fatebenefratelli, UOC Oncologia Medica, Roma, Italy
4. ⁴Istituto Nazionale Tumori , UOC Sperimentazioni cliniche, Napoli, Italy
5. ⁵Istituto Nazionale Tumori , UOC Ginecologia Oncologica, Napoli, Italy
6. ⁶Università Cattolica del Sacro Cuore, UOC Ginecologia Oncologica, Campobasso, Italy
7. ⁷Ospedale FatebeneFratelli, UOC Oncologia Medica, Benevento, Italy
8. ⁸Azienda Ospedaliera Pierantoni, UOC Oncologia Medica, Forlì, Italy
9. ⁹Istituto Nazionale Tumori, UOC Radiologia, Napoli, Italy
10. ¹⁰Seconda Università di Napoli, Cattedra di Biostatistica, Napoli, Italy

Correspondence: Dr S Pignata, Division of Medical Oncology B, National Cancer Institute of Naples, via Mariano, Semmola, Naples 80131, Italy. E-mail: sandro.pignata@fondazionepascale.it

Received 31 January 2007; Revised 18 April 2007; Accepted 18 April 2007; Published online 8 May 2007.

Abstract

Anthracyclines and platinum derivates are active drugs for advanced endometrial carcinoma (AEC), but new schedules with higher efficacy and better tolerability are needed. A phase II study was conducted to describe activity and tolerability of carboplatin (C)+pegylated liposomal doxorubicin (PLD) in patients with AEC. Patients with chemonaive AEC, PS 2, aged <75 years, with at least one measurable lesion were eligible. Treatment was C (area under curve 5)+PLD (40 mg m^-2) on day 1 every 4 weeks, up to six cycles. Forty-two patients were needed in a single-stage design, with at least 13 objective responses to define the treatment active. Forty-two patients were enrolled. Median age was 64 years (31–74). A total of 64% of patients were recurrent while 36% were advanced. Three complete (7%) and 22 partial responses (52%) were observed, for an overall response rate of 59.5% (95% exact CI: 43.3–74.3). One death potentially related to treatment was recorded (death at home for unknown reasons after 6th cycle). Other relevant toxicities (% of patients) were grade 3/4 neutropaenia 33%/14%, febrile neutropaenia 5%, grade 3/4 thrombocytopaenia 17%/5%, grade 3/4 anaemia 31%/2%. Skin toxicity was mild: grade 1 14%, grade 2 10%, grade 3 5%. Hair loss: complete 5%, partial 12%. The combination of carboplatin and PLD shows good activity and favourable toxicity as first-line chemotherapy of patients with AEC, deserving further studies in this setting.