Phase II study of gemcitabine, oxaliplatin, and cetuximab in advanced pancreatic cancer.

Merchan JR, Ferrell A, Macintyre J, Ciombor KK, Levi J, Ribeiro A, Sleeman D, Flores A, Lopes G, Rocha-Lima CM
Am J Clin Oncol. 2012 35 (5): 446-50

PMID: 21552097 · DOI:10.1097/COC.0b013e31821862fb

OBJECTIVE - Little progress has been made in the treatment of pancreatic cancer (PC). This study evaluated the clinical activity of gemcitabine, oxaliplatin, and cetuximab (GOC) in patients with locally advanced or metastatic PC.

METHODS - The study primary endpoint was progression-free survival (PFS). Eligible, chemotherapy-naive PC patients were treated with gemcitabine (1000 mg/m(2) over 100 min) on day 1, oxaliplatin (100 mg/m(2)) on day 2, every 2 weeks, and weekly cetuximab, (loading dose of 400 mg/m(2) on cycle 1 day 1 and 250 mg/m(2) thereafter). It was expected that GOC treatment would extend the median PFS from 5.8 to 7.54 months, a relative increase of 30%, compared with gemcitabine and oxaliplatin (historical control).

RESULTS - A total of 41 evaluable patients were enrolled. The overall response rate was 24%. Median PFS time was 6.9 months and median overall survival (OS) was 11.3 months. Patients with locally advanced disease had longer median PFS (12.4 vs. 4.7 mo) and OS (15.7 vs. 6.4 mo) compared with patients with metastatic disease. The most common grade 3 to 4 toxicities included neutropenia (32%), infection (with normal or grade 1 to 2 neutropenia, in 24%), neuropathy (17%), fatigue (15%), and rash (7%). Five patients (12%) discontinued study treatment without evidence of progression. Rash was not a significant prognostic factor affecting PFS or OS.

CONCLUSIONS - GOC is a feasible combination with an acceptable toxicity profile. However, GOC did not significantly extend PFS in the overall patient population to consider it for further development.

MeSH Terms (21)

Adenocarcinoma Adult Aged Antibodies, Monoclonal Antibodies, Monoclonal, Humanized Antineoplastic Combined Chemotherapy Protocols Carcinoma, Pancreatic Ductal Carcinoma, Squamous Cell Cetuximab Deoxycytidine Female Follow-Up Studies Humans Male Middle Aged Neoplasm Staging Organoplatinum Compounds Oxaliplatin Pancreatic Neoplasms Survival Rate Treatment Outcome

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