Prolonged oral etoposide in recurrent or advanced non-squamous cell carcinoma of the cervix: a Gynecologic Oncology Group study.
OBJECTIVE
Previous studies by the Gynecologic Oncology Group have demonstrated a 7% response rate with bolus etoposide as second-line therapy in nonsquamous cell carcinoma of the cervix. Prolonged oral etoposide, which exploits the schedule dependency of this agent, has demonstrated increased activity in squamous carcinoma of the cervix compared with bolus administration. To evaluate prolonged oral etoposide in nonsquamous cell carcinoma of the cervix, the current phase II trial was conducted.


METHODS
Eligibility included nonsquamous cell cancer of the cervix, measurable disease, no more than one prior chemotherapy regimen no prior etoposide, WBC > or = 3000/microl, platelets > or = 100,000/microl, serum creatinine < or = 2 mg%, and adequate hepatic function. The starting dose was 50 mg/m(2)/day (40 mg/m(2)/day for prior radiotherapy) for 21 days, every 28 days. Based on toxicity, dose escalation to a maximum dose of 60 mg/m(2)/day was prescribed.


RESULTS
Fifty-two patients were entered on this study, with 47 evaluable for toxicity and 42 evaluable for response. A median of three (range: 1-12) courses were given. Thirty-four patients received prior radiation therapy and 15 received prior chemotherapy. Oral etoposide was well tolerated, with grade 4 neutropenia occurring in 29.8% and grade 4 thrombocytopenia occurring in 8.5% of patients. Three complete (7.1%) and two partial (4.8%) responses were observed. All of the responses were seen in chemotherapy-naïve patients (5/27); four of five had disease in nonirradiated sites.


CONCLUSIONS
Prior radiation therapy significantly limited our ability to deliver prolonged oral etoposide. At this dose, this regimen is moderately active in chemotherapy-naïve patients with nonsquamous cell carcinoma of the cervix.
Rose
Peter G
PG
Division of Gynecologic Oncology, Case Western Reserve University, University Hospitals of Cleveland, OH 44106, USA. prose@metrohealth.org
Blessing
John A
JA
Buller
Richard E
RE
Mannel
Robert S
RS
Webster
Kenneth D
KD
D000230:Adenocarcinoma / Q000188:drug therapy*; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects; D018196:Carcinoma, Adenosquamous / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005047:Etoposide / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008875:Middle Aged; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*
D000972:Antineoplastic Agents, Phytogenic; D005047:Etoposide