CAELYX/
DOXIL,
pegylated liposomal doxorubicin, has shown antitumour activity and reduced toxicity compared with standard
doxorubicin in other tumour types. In this prospective randomised trial, 94 eligible patients with advanced
soft-tissue sarcoma (STS) were treated, 50 with
CAELYX (50 mg/m(2) by a 1 h intravenous (i.v.) infusion every 4 weeks) and 44 with
doxorubicin (75 mg/m(2) by an i.v. bolus every 3 weeks). Histological subtypes were evenly matched, 33% were
leiomyosarcoma (
CAELYX: 18;
doxorubicin: 13). Primary disease sites were well matched.
CAELYX was significantly less myelosuppressive, only 3 (6%) patients had grade 3 and 4
neutropenia, versus 33 (77%) on
doxorubicin;
febrile neutropenia occurred in 7 (16%) patients given
doxorubicin, but only 1 (2%) given
CAELYX. 37 (86%) patients on
doxorubicin had grade 2-3
alopecia, but only 3 (6%) on
CAELYX, and the major toxicity with
CAELYX was to the skin. Palmar-plantar erythrodysesthesia with
CAELYX was grade 1: 4 (8%) patients, grade 2: 11 (22%) patients, grade 3: 9 (18%) patients and grade 4: 1 (2%) patient. Other non-haematological grade 3 and 4 toxicities were rare. Confirmed responses were observed with both agents:
CAELYX: complete response (CR) 1 (uterine), partial response (PR) 4 (response rate (RR) 10%); and
doxorubicin: CR 1, PR 3 (RR of 9%); with the best response being stable disease (NC) in 16 and 18 patients, respectively. The reason for the low response rate is unknown, but it may be due partly to a high proportion of gastrointestinal stromal tumours. In conclusion,
CAELYX has equivalent activity to
doxorubicin in STS with an improved toxicity profile and should be considered for further investigation in combination with other agents such as
ifosfamide.