| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 6184589 | Gynecologic Oncology | 2012 | 6 Pages |
BackgroundEpithelial growth factor receptor over-expression correlates with poor outcomes in cervical cancer. This study assessed the safety of chemoradiation with cetuximab in the treatment of women with newly diagnosed locally advanced cervical cancer.MethodsPatients received weekly cisplatin 30 and 40Â mg/m2 [dose level (DL) 1 and 2] and cetuximab 400Â mg/m2 loading dose and then 250Â mg/m2 for a total of six weeks with radiotherapy (RT). Patients with nodal metastases received extended field radiation therapy (EFRT). At the maximum tolerated dose, feasibility was evaluated in a 20 patient two-stage, sequential design.ResultsIn patients receiving pelvic RT, seven were treated at DL 1 with one dose-limiting toxicity (DLT) (febrile neutropenia with grade 3 diarrhea) and three at DL 2 with two DLTs (grade 3 rash and delay in RT >Â 8Â weeks). The feasibility phase was opened at DL1. Of the 21 patients treated there was one DLT (grade 4 CVA). Median RT duration was 50Â days (range, 42-70). In patients receiving EFRT, nine were treated at DL 1 with 1 DLT (grade 3 mucositis) and 24 in the feasibility phase with eight DLTs [delay in RT >Â 8Â weeks due to toxicity (2) and one each with grade 3 or 4 small bowel obstruction, embolism, mucositis, mucositis with hypokalemia, pain with headache, and platelets with mucositis and headache]. Median EFRT duration was 56Â days (range, 36-74).ConclusionsFor patients receiving pelvic RT, cisplatin and cetuximab were feasible. For patients receiving EFRT, combination of cisplatin and cetuximab was not feasible.
⺠Epithelial Growth Factor Receptor (EGFR) is overexpressed in 50-70% of cervical cancers making it a rationale therapeutic target. ⺠When added to weekly cisplatin and whole pelvic radiation, the EGFR monoclonal antibody, cetuximab was feasible. ⺠When combined with cisplatin and extended field radiation, cetuximab resulted in excessive metabolic and gastrointestinal toxicity and was not feasible.
