| Title | A Phase II Trial of Erlotinib in Recurrent Squamous Cell Carcinoma of the Cervix: A Gynecologic Oncology Group Study. | | Author(s) | Schilder RJ, Sill MW, Lee YC, Mannel R | | Institution | *Fox Chase Cancer Center, Philadelphia, PA; daggerGOG Statistical and Data Center, Buffalo, NY; double daggerSUNY Health Science Center at Brooklyn, Brooklyn, NY; section signUniversity of Oklahoma, Oklahoma City, OK. | | Source | Int J Gynecol Cancer 2009 Jul; 19(5):929-933. | | 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. | | Language | ENG | | Pub Type(s) | JOURNAL ARTICLE
| | PubMed ID | 19574787 |
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