title: A multicentre phase II study of carboplatin plus pegylated liposomal doxorubicin as first-line chemotherapy for patients with advanced or recurrent endometrial carcinoma: the END-1 study of the MITO (Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies) group.
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 < or = 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.
authors.affiliation: Instituto Nazionale Tumori, UOC Oncologia Medica B, Napoli, Italy. sandro.pignata@fondazionepascale.it
authors.forename: S
authors.initials: S
authors.lastname: Pignata
authors.forename: G
authors.initials: G
authors.lastname: Scambia
authors.forename: C
authors.initials: C
authors.lastname: Pisano
authors.forename: E
authors.initials: E
authors.lastname: Breda
authors.forename: M
authors.initials: M
authors.lastname: Di Maio
authors.forename: S
authors.initials: S
authors.lastname: Greggi
authors.forename: G
authors.initials: G
authors.lastname: Ferrandina
authors.forename: D
authors.initials: D
authors.lastname: Lorusso
authors.forename: V
authors.initials: V
authors.lastname: Zagonel
authors.forename: A
authors.initials: A
authors.lastname: Febbraro
authors.forename: N
authors.initials: N
authors.lastname: Riva
authors.forename: V
authors.initials: V
authors.lastname: De Rosa
authors.forename: C
authors.initials: C
authors.lastname: Gallo
authors.forename: F
authors.initials: F
authors.lastname: Perrone
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects; D018269:Carcinoma, Endometrioid / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016889:Endometrial Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D007558:Italy; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D010051:Ovarian Neoplasms / Q000188:drug therapy; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin; D016190:Carboplatin