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Schilder RJ , Sill MW , Lee YC , Mannel R
A phase II trial of erlotinib in recurrent squamous cell carcinoma of the cervix: a Gynecologic Oncology Group Study
Int J Gynecol Cancer. 2009 Jul;19(5) :929-33
PMID: 19574787 PMCID: PMC2722934
AbstractOBJECTIVES: 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.
NotesSchilder, Russell J Sill, Michael W Lee, Yi-Chun Mannel, Robert CA 27469/CA/NCI NIH HHS/United States CA 37517/CA/NCI NIH HHS/United States Clinical Trial, Phase II Multicenter Study Research Support, N.I.H., Extramural United States International journal of gynecological cancer : official journal of the International Gynecological Cancer Society Int J Gynecol Cancer. 2009 Jul;19(5):929-33.