RT Journal Article
SR Electronic
T1 A Phase II Trial of Erlotinib in Recurrent Squamous Cell Carcinoma of the Cervix: A Gynecologic Oncology Group Study
JF International Journal of Gynecologic Cancer
JO Int J Gynecol Cancer
FD BMJ Publishing Group Ltd
SP 929-933
OP 929-933
DO 10.1111/IGC.0b013e3181a83467
VO 19
IS 5
A1 Russell J. Schilder
A1 Michael W. Sill
A1 Yi-Chun Lee
A1 Robert Mannel
YR 2009
UL http://ijgc.bmj.com/content/19/5/929-933.abstract
AB Objectives: To determine the proportion of patients with tumor response, the proportion who survived progression-free for at least 6 months (progression-free survival ≥ 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.