Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 25, No 18S (June 20 Supplement), 2007: 4520
© 2007 American Society of Clinical Oncology

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Abstract

Postoperative adjuvant gemcitabine plus oxaliplatin (GemOx) chemotherapy followed by chemoradiation in patients with pancreatic carcinoma: A multicenter phase II study

Centre Hospitalier Lyon Sud, Lyon, France; Centre Hospitalier Tenon, Paris, France; Hopital Saint Antoine, Paris, France; CHU la Timone, Marseille, France; Centre Val d’Aurelle, Montpellier, France; Clinique Saint Jean, Lyon, France; Centre Hospitalier Universitaire, Grenoble, France

4520

Background: Gemcitabine (Gem) is an active drug in metastatic pancreatic cancer and a very good radiosensitizer. We evaluated the safety and potential activity of adjuvant GemOx chemotherapy followed by concurrent Gem and irradiation (RT) after curative resection of pancreatic cancer. Methods: Fifty four patients were enrolled from October 2002 to January 2005 in this trial with potentially curative resection of pathologically confirmed adenocarcinoma of the pancreas with negative resection margins (R0). Gem 1000 mg/m² (100 min) on d1 then Ox 100 mg/m² (120 min) on d2 were given (q2w for 6 cycles) followed 4 weeks after by Gem 100 mg/m² (30 min) combined with RT 50 Gy (2Gy fraction) for 5 weeks in patients with no residual toxicity nor recurrence. Results: The treated population (at least 2 induction cycles) included 49 patients (91%). Characteristics at baseline: median age: 59.2 yrs; Karnofsky performance status =80: 96%; stage TX: 10%, T1: 8%, T2: 41%, T3:39%; T4: 2% (TNM classification, 5^th edition); lymph node positive: 43%; median time from surgery to inclusion was 43 days. Forty six patients (85%) received the 6 planned induction cycles and 41 patients (76%) completed chemoradiation. The recurrence free 1-year survival rate is 71% (N=49); (95% CI 0.581–0 845). Forty one patients (98% of the irradiated population) received the total 50 Gy radiation dose. The most common Gr 3/4 toxicities during induction chemotherapy (N=51) were: neutropenia 18%, thrombocytopenia 14%; nausea, vomiting, diarrhea:16%, neurotoxicity (Gr 3 only) 4%. Acute Gr 3/4 toxicities during chemoradiation (N=42): neutropenia 19%, thrombocytopenia 7.0%, neurotoxicity (Gr 3 only) 7%. No toxic death occurred on treatment. Conclusions: GemOX in adjuvant followed by Gem + Radiotherapy have a manageable toxicity profile with a promising 71% 1 year RFS. Data of OS will be communicated during the meeting.

No significant financial relationships to disclose.

Abstract presentation from the 2007 ASCO Annual Meeting