Evaluation of pegylated liposomal doxorubicin (Doxil) as second-line chemotherapy of squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group.
OBJECTIVE
Doxorubicin has reported activity in advanced and recurrent cervical cancer but hematologic toxicity has limited its use in some combinations. To determine the level of activity and potential for use in future combinations, a phase II trial of pegylated liposomal doxorubicin as second-line therapy in advanced and recurrent cervical cancer was performed.


METHODS
Eligible patients had squamous cell carcinoma of the cervix, measurable disease, one prior chemotherapy regimen which did not include an anthracycline, absolute neutrophil count (ANC) > 1500/microl, platelet count > 100,000/microl, and adequate hepatic function. Pegylated liposomal doxorubicin 40 mg/m(2) was administered intravenously over 1 h every 4 weeks.


RESULTS
Twenty-seven patients were entered on this study. All patients were evaluable for toxicity and 26 were evaluable for response. A median of 2 courses of therapy (range 1-10) was given. No grade 4 toxicities were noted. Three patients (11.1%) had partial responses.


CONCLUSIONS
Liposomal doxorubicin has limited activity, at the dose and schedule employed in previously-treated cervical cancer.
Division of Gynecologic Oncology, Case Western Reserve University, Cleveland, OH 44106, USA. rosep@ccf.org
Peter G
PG
Rose
John A
JA
Blessing
Shashikant
S
Lele
Ovadia
O
Abulafia
D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D004317:Doxorubicin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*
D000903:Antibiotics, Antineoplastic; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin