Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 26, No 15S (May 20 Supplement), 2008: 4613
© 2008 American Society of Clinical Oncology

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Abstract

Final results of a phase II trial [PARC-Study ISRCTN56652283] for patients with primary inoperable locally advanced pancreatic cancer combining intensity modulated radiotherapy (IMRT) with cetuximab and gemcitabine

University of Heidelberg, Heidelberg, Germany; German Cancer Research Center, Heidelberg, Germany; Technical University, Munich, Germany; National Center of Tumor Disease, Heidelberg, Germany; Merck KGaA, Darmstadt, Germany; Helios-Hospital Berlin-Buch, Berlin, Germany

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Background: To evaluate the feasibility and efficacy of trimodal therapy using cetuximab in combination with IMRT and gemcitabine in locally advanced pancreatic cancer. Methods: In this randomized Phase II trial (planned sample size 66 pts), chemotherapy-naive pts. with primary inoperable locally advanced pancreatic cancer were eligible. For both arms initial treatment consisted of radiotherapy, gemcitabine weekly (300 mg/m²), and cetuximab weekly (loading dose 400 mg/m² day 1, concomitant with RT 250 mg/m²). After trimodal therapy pts in arm A received gemcitabine weekly (1,000 mg/m²) over 4 weeks, and pts in study arm B received gemcitabine weekly (1,000 mg/m²) over 4 weeks and cetuximab (250 mg/m²) weekly over 12 weeks. IMRT was delivered using an integrated boost concept (54 Gy GTV, 45 Gy CTV) over 5 weeks. Response evaluation (CT) followed at week 12 and every 3 months. All pts were treated with gemcitabine weekly (1,000 mg/m²) over 3 months after end of study. Primary study end point was response; secondary end points were overall survival, secondary resection rate and adverse events. Results: Between 2/05 and 4/07 68 pts were enrolled (characteristics: pancreatic adenocarcinoma c2 T4 N1 68/68, median age = 62 (range 48–79); M/F = 38/30; ECOG PS 0/1/2 = 17/45/6). Complete response in 1/68, partial response in 23/68, no change in 41/68 and progressive disease in 3/68 pts was found according the RECIST criteria in the CT controls. Median follow-up at present is 11 months, 1-and 2- year survival is 61% and 20 %, respectively, median survival is 15 months. No statistical significance was reached concerning overall survival between the treatment arms. 40/68 pts were amenable for secondary potentially curative resection. 14 pts could be resected. Overall toxicity was acceptable and consistent with the profiles of the individual agents. Conclusions: Trimodal therapy for primary inoperable locally advanced inoperable pancreatic carcinoma is safe and resulted in excellent local control and overall survival. No statistical significant difference between the two treatment arms could be found. Distant metastases were the main cause of failure.

No significant financial relationships to disclose.

Abstract presentation from the 2008 ASCO Annual Meeting