@article {Schilder929-933, author = {Russell J. Schilder and Michael W. Sill and Yi-Chun Lee and Robert Mannel}, title = {A Phase II Trial of Erlotinib in Recurrent Squamous Cell Carcinoma of the Cervix: A Gynecologic Oncology Group Study}, volume = {19}, number = {5}, pages = {929-933--929-933}, year = {2009}, doi = {10.1111/IGC.0b013e3181a83467}, publisher = {BMJ Specialist Journals}, abstract = {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.}, issn = {1048-891X}, URL = {https://ijgc.bmj.com/content/19/5/929-933}, eprint = {https://ijgc.bmj.com/content/19/5/929-933.full.pdf}, journal = {International Journal of Gynecologic Cancer} }