Background
Neoadjuvant chemotherapy can facilitate pancreatic resection in patients with initially
unresectable pancreatic cancer (PC). We report the results of a phase II trial of
gemcitabine-oxaliplatin neoadjuvant chemotherapy for patients with locally advanced,
nonmetastatic PC.
Methods
A prospective, phase II clinical trial using neoadjuvant chemotherapy, consisting
of gemcitabine (900 mg/m2) and oxaliplatin (60 mg/m2) given as intravenous infusion once a week at day 1 of each treatment cycle (NeoGemOx
protocol). Patients received 6–9 cycles of chemotherapy. Those patients with sufficient
tumor regression subsequently underwent pancreatic resection and were followed postoperatively
to assess long-term survival.
Results
A total of 33 patients were eligible and were included in the intent-to-treat and
evaluable population. On centralized review of the imaging studies, 18 patients had
unresectable disease at inclusion, and 15 patients had borderline resectable PC. Eventually,
13 patients (39%) had a curative resection after neoadjuvant therapy. The R0 resection
rate was 69%. Median overall survival of patients who underwent tumor resection was
22 months (95% confidence interval [CI], 14–30) compared with 12 months (95% CI, 9–15)
for those without resection (P = .046). The median recurrence-free survival rate after resection was 10 months (95%
CI, 4–17).
Conclusion
Neoadjuvant gemcitabine plus oxaliplatin is well tolerated and safe. Substantive tumor
regression occurs in some patients with locally advanced PC treated with this neoadjuvant
protocol, offering the potential for curative resection and improvement in overall
survival. Additional studies involving the NeoGemOx protocol should be considered
to further evaluate the safety and efficacy of this combination.
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Article info
Publication history
Published online: September 13, 2010
Accepted:
July 22,
2010
Identification
Copyright
© 2011 Mosby, Inc. Published by Elsevier Inc. All rights reserved.
