Cisplatin plus gemcitabine in previously treated squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group.
OBJECTIVE
This trial was conducted to evaluate the safety and efficacy of cisplatin plus gemcitabine in previously treated squamous cell carcinoma of the cervix.


METHODS
All women had measurable histologically confirmed squamous cell cervical cancer and a GOG performance status less than or equal to 2. The women were to receive cisplatin at 30 mg/m(2) plus gemcitabine at 800 mg/m(2) day 1 and day 8 every 28 days.


RESULTS
Between February 2001 and May 2002, 32 eligible patients were entered. All women had received prior chemotherapy and 29 had received radiation. Twenty patients received platinum previously twice. The median time from primary treatment to recurrence was 21 months, but the median time from last prior chemotherapy was less than 2 months. A second phase of accrual was not indicated per the established stopping rules. There were 7 (21.9%) partial responses and median response duration was 2.1 months. Twelve additional women (37.5%) had stable disease. Nine women (28.1%) had increasing disease. Median time to progression was 3.5 months. There were no treatment-related deaths. Six women had grade 4 neutropenia, three had grade 4 anemia, and two had grade 4 thrombocytopenia. Grade 4 gastrointestinal toxicity occurred in two women and grade 4 anorexia occurred in one.


CONCLUSIONS
This study suggests modest activity for the gemcitabine plus cisplatin doublet in previously treated squamous cell carcinoma of the cervix. The objective response rate of 22% is comparable to that of other active agents and combinations tested in this setting. Toxicities were primarily hematologic and generally manageable with dose reductions.
Brewer
Cheryl A
CA
Division of Gynecologic Oncology, University of California Irvine Medical Center, Orange, CA 92868, USA. brewer@peoriago.com
Blessing
John A
JA
Nagourney
Robert A
RA
McMeekin
D Scott
DS
Lele
Shashikant
S
Zweizig
Susan L
SL
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D008875:Middle Aged; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*; D000093542:Gemcitabine
D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine