Abstract
4586 Background: Patients with advanced cholangiocarcinoma have a poor prognosis and until now, no standard palliative chemotherapy has been defined. The purpose of this prospective single-centre phase II study was to investigate the therapeutic efficacy and saftey of cetuximab in combination with gemcitabine and oxaliplatin in the palliative first line treatment of these patients. Methods: Patients with locally advanced or metastatic cholangiocarcinoma or gallbladder cancer with no prior palliative chemotherapy were eligible. cetuximab 500 mg/m² on day 1 followed by 1,000mg/m² gemcitabine (day 1) and 100mg/m² oxaliplatin on day 2 were administered every second week. The primary endpoint was response rate; secondary endpoints were toxicity, progression free and overall survival. Results: From October 2006 until December 2007 twenty-two patients (11 male, 11 female) with a median age of 65 were enrolled. The overall response rate of evaluable patients (19) was 58%, including one patient with a complete response. 6 patients (32%) achieved stable disease and only 2 patients (11%) progressed under chemotherapy after a median of 6.5 cycles (SD ± 2.8). The response was significantly correlated with the grade of acne-like rash (p < 0.002). Six initially unresectable patients underwent a curative resection after major response was observed (32%). Any WHO grade 3/4 drug-related adverse events occurred in 7 patients (35%), consisting of skin toxicity in 2 patients, thrombopenia in 1, nausea in 1, diarrhoe in 1 and PNP in 3 patients. The median PFS was 9.0 months (95% CI 3.1–14.9). Four patients are currently without evidence of disease after a median follow-up of 6.3 months post curative liver resection. Conclusions: Cetuximab in combination with gemcitabine and oxaliplatin seems a well tolerated regimen in patients with cholangiocarcinoma. The first results demonstrate promising efficacy for both response rates and progression-free survival. Therefore cetuximab in combination with GEMOX deserves further evaluation in prospective randomized trials. No significant financial relationships to disclose.
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