scholarly journals Induction gemcitabine and oxaliplatin therapy followed by a twice-weekly infusion of gemcitabine and concurrent external-beam radiation for neoadjuvant treatment of locally advanced pancreatic cancer

Cancer ◽  
2012 ◽  
Vol 119 (2) ◽  
pp. 277-284 ◽  
Author(s):  
Francesco Leone ◽  
Marco Gatti ◽  
Paolo Massucco ◽  
Federica Colombi ◽  
Elisa Sperti ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Advanced Pancreatic Cancer ◽  
Locally Advanced Pancreatic Cancer ◽  
External Beam Radiation ◽  
External Beam ◽  
Beam Radiation ◽  
Weekly Infusion

Phase II trial of induction GEMOX followed by a twice-weekly infusion of gemcitabine and concurrent external beam radiation for the treatment of locally advanced pancreatic cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14019-14019
Author(s):  
F. Leone ◽  
E. Sperti ◽  
S. Aliberti ◽  
M. Gatti ◽  
P. Massucco ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Locally Advanced Pancreatic Cancer ◽  
External Beam Radiation ◽  
Hematologic Toxicity ◽  
External Beam ◽  
Beam Radiation ◽  
Locally Advanced Pancreatic Adenocarcinoma ◽  
Upper Abdominal

14019 Background: Combined chemo-radiation therapy may render curative resection feasible in pancreatic cancer deemed unresectable for vascular invasion. We previously demonstrated that primary radiotherapy with concurrent gemcitabine is feasible and allows clinical benefit. However, the percentage of resected patients was low. Methods: Patients with locally advanced pancreatic adenocarcinoma, received induction with 4 cycle GEMOX (gemcitabine 1000 mg/mq, day 1 and oxaliplatin 100 mg/mq, day 2) each 2-week cycle. Patients without disease progression received gemcitabine twice weekly (50 mg/mq/day) for 5 weeks concurrent with upper abdominal radiation (50.4 Gy over 5.5 weeks) and were re-evaluated for resectability. Results: From 7/2003 to 11/2005, 20 patients entered this study, of whom 17 are evaluable for toxicity and 15 for treatment response. Twelve men and 8 women (median age 63 years; range 43–71) received a median of 3.5 cycles GEMOX (range 2–4). Fourteen patients completed the treatment with external beam radiation and received a median of 7 cycles with gemcitabine (range 3–10). In two patients chemotherapy during radiotherapy was omitted for previous toxicity, and one stopped also radiotherapy for gastrointestinal toxicity. No grade IV toxicities or deaths due to therapy were observed. Gastrointestinal grade III toxicities were observed in 3/17 patients (17.6%) after GEMOX and 6/16 patients (37.5%) during radiotherapy. Grades III hematologic toxicity and fatigue occurred in 4/16 (25%) and 2/16 (12.5%) respectively during radiotherapy. A disease control was obtained in 10/15 evaluable patients. One patient progressed after GEMOX and 4 after chemoradiotherapy. Eight patients (53%) appeared to be resectable: 1 patient is planned for surgery, 2 patients were found unresectable at lapaproscopy for peritoneal carcinomatosis or local extension; 5 patients underwent resection and in 4 of them (26%) margins were negative. Conclusions: Induction GEMOX followed by twice-weekly gemcitabine and upper abdominal radiation is feasible in patients with locally advanced pancreatic cancer and seems to induce a high resectability rate. This protocol warrants further evaluation. No significant financial relationships to disclose.

Phase II study evaluating trimodal therapy with cetuximab intensity modulated radiotherapy (IMRT) and gemcitabine for patients with locally advanced pancreatic cancer [ISRCTN56652283]

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4100-4100 ◽  
Author(s):  
R. C. Krempien ◽  
M. W. Münter ◽  
C. Timke ◽  
P. E. Huber ◽  
H. Friess ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Pancreatic Adenocarcinoma ◽  
Phase Ii ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Advanced Pancreatic Cancer ◽  
Intensity Modulated Radiotherapy ◽  
Locally Advanced Pancreatic Cancer ◽  
Trimodal Therapy ◽  
Tumor Bleeding

4100 Background: The induction of EGFR targeting with cetuximab in radiation based therapy of solid tumors has yielded promising results. Thus, we initiated a prospective Phase II trial designed to analyze the feasibility and effectivity of trimodal therapy with gemcitabine-based chemoradiation and cetuximab in locally advanced inoperable pancreatic cancer. Methods: In this phase 2 study, pts with locally advanced pancreatic cancer without prior cytotoxic therapy were treated with radiotherapy (RT), gemcitabine weekly (300 mg/m2), and cetuximab weekly (loading dose 400 mg/m2 day 1, and concomitant with radiation day 8,15,22,29,36 250 mg/m2). RT was delivered by using an integrated IMRT boost concept (54 Gy GTV, 45 Gy CTV) over 5 weeks. RT was followed by gemcitabine (1000 mg/m2) weekly × 3 in 4 weeks. Response evaluation using computed tomography followed at week 12. All amenable patients were intended for surgical treatment between week 12–15. Results: 24 pts were enrolled until now. Preliminary results are presented on 20 pts with the following characteristics: pancreatic adenocarcinoma c2 T4 N1 20/20, median age = 63.5 (range 51–79); M/F = 13/7; ECOG PS 0/1/2 = 2/12/6; median days on treatment: 90 (range 70–100). Treatment-related toxicities were observed in 16 pts. Grade 3 toxicities included diarrhea (n = 4), fatigue (n = 2), nausea (n = 3), neutropenia (n = 6), thrombocytopenia (n = 2), and vomiting (n = 2). 18/20 pts developed some acneiforme rush during therapy. No omittance of cetuximab therapy was necessary. 1 patient died during RT due to tumor bleeding. Median follow-up at present is 6 month, median survival has not been reached. Partial remissions 8/20, stable disease 9/20, progressive disease 3/20. 12/20 patients were amenable for secondary potentially curative resection. 4 patients could be resected, while 3 patients were found to have abdominal metastatic spread. Conclusions: Early data from trimodal therapy in pancreatic adenocarcinoma with chemoradiation (IMRT), gemcitabine, and cetuximab indicate feasibility without increased toxicity profile. The local response appears to be very promising in pancreatic cancer, potentially allowing neoadjuvant treatment. [Table: see text]

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