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Prospective Phase II Trial of Neoadjuvant Chemotherapy With Gemcitabine and Cisplatin for Resectable Adenocarcinoma of the Pancreatic Head

Stefan Heinrich, Bernhard C. Pestalozzi, Markus Schäfer, Achim Weber, Peter Bauerfeind, Alexander Knuth, Pierre-Alain Clavien

From the Departments of Visceral and Transplantation Surgery, Medical Oncology, and Gastroenterology, and Institute of Surgical Pathology, Swiss Hepato-Pancreato-Biliary Center, Zurich, Switzerland

Corresponding author: Pierre-Alain Clavien, MD, PhD, Swiss Hepato-Pancreato-Biliary Center, Visceral and Transplantation Surgery, University Hospital of Zurich, Raemistrasse 100, 8091 Zurich, Switzerland; e-mail: clavien{at}chir.uzh.ch

Purpose To test the safety of neoadjuvant chemotherapy for resectable pancreatic cancer.

Patients and Methods Patients with cytologically proven resectable adenocarcinoma of the pancreatic head were eligible for this prospective phase II trial. After confirmation of resectability by contrast-enhanced computed tomography (ceCT), positron emission tomography/CT, laparoscopy, and endoscopic ultrasound, patients received four biweekly cycles of gemcitabine 1,000 mg/m² and cisplatin 50 mg/m². Thereafter, staging was repeated and patients underwent surgery. Quality of life (QoL) and prealbumin serum levels were determined pre- and postchemotherapy. Follow-up included 3-month CA 19-9 measurements and ceCT after 6, 12, 18, and 24 months. Histologic tumor response was assessed by two scoring systems.

Results Twenty-eight patients entered this study. Adverse effects were mainly gastrointestinal and hematologic, most often mild, and never of grade 4. Twenty-six patients (93%) had resectable cancer on restaging examinations, and the R0 resection rate was 80%. Histologic tumor response and cytopathic effects were documented in 54% and 83% of patients, respectively. On intention-to-treat analysis, disease-free and overall survival were 9.2 months (95% CI, 5.6 to 12.9 months) and 26.5 months (95% CI, 11.4 to 41.5 months) and 9 months (95% CI, 6.99 to 10.1 months) and 19.1 months (95% CI, 15 to 23.1 months) for ductal adenocarcinoma, respectively. QoL improved in two items and was unchanged in all other items. Moreover, prealbumin serum levels significantly improved during chemotherapy (P = .008).

Conclusion Neoadjuvant chemotherapy with gemcitabine and cisplatin is well tolerated and does not impair resectability of pancreatic cancer. Furthermore, it improves the QoL and the nutritional status of affected patients with favorable overall and disease-free survival.

Presented in part at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL (abstr 4610).

S.H. and B.C.P. contributed equally to this article.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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