A phase II trial of erlotinib in recurrent squamous cell carcinoma of the cervix: a Gynecologic Oncology Group Study.
OBJECTIVE
To determine the proportion of patients with tumor response, the proportion who survived progression-free for at least 6 months (progression-free survival >or= 6 months), and the frequency and severity of toxicities of patients with recurrent squamous cell carcinoma of the uterine cervix treated with erlotinib.


METHODS
This was a multicenter, open-label, single-arm trial evaluating the toxicity and efficacy of oral erlotinib at an initial dosage of 150 mg daily until progressive disease or adverse effects prohibited further therapy.


RESULTS
Twenty-eight patients with squamous cell carcinoma were enrolled onto this trial. Twenty-five patients were evaluable. There were no objective responses, with 4 (16%) patients achieving stable disease; only 1 patient had a progression-free survival of 6 months (4%) or more. The 1-sided 90% confidence interval for response was 0.0% to 8.8%. The 2-sided 90% confidence interval for the proportion of patients surviving progression-free for at least 6 months is 0.2% to 17.6%. Erlotinib was well tolerated, with the most common drug-related adverse events being gastrointestinal toxicities, fatigue, and rash.


CONCLUSIONS
Erlotinib is inactive as monotherapy in patients with recurrent squamous cell carcinoma of the uterine cervix.
Schilder
Russell J
RJ
Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, PA 19111, USA.
Sill
Michael W
MW
Lee
Yi-Chun
YC
Mannel
Robert
R
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000556:secondary; D066246:ErbB Receptors / Q000037:antagonists & inhibitors; D000069347:Erlotinib Hydrochloride; D005260:Female; D006801:Humans; D008875:Middle Aged; D011379:Prognosis; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use*; D011799:Quinazolines / Q000627:therapeutic use*; D015996:Survival Rate; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology
D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D000069347:Erlotinib Hydrochloride; D066246:ErbB Receptors