Presented in part at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium; January 20–21, 2011; San Francisco, California.
A multi-institutional phase 2 study of neoadjuvant gemcitabine and oxaliplatin with radiation therapy in patients with pancreatic cancer
Article first published online: 29 MAY 2013
© 2013 American Cancer Society
Volume 119, Issue 15, pages 2692–2700, 1 August 2013
How to Cite
Kim, E. J., Ben-Josef, E., Herman, J. M., Bekaii-Saab, T., Dawson, L. A., Griffith, K. A., Francis, I. R., Greenson, J. K., Simeone, D. M., Lawrence, T. S., Laheru, D., Wolfgang, C. L., Williams, T., Bloomston, M., Moore, M. J., Wei, A. and Zalupski, M. M. (2013), A multi-institutional phase 2 study of neoadjuvant gemcitabine and oxaliplatin with radiation therapy in patients with pancreatic cancer. Cancer, 119: 2692–2700. doi: 10.1002/cncr.28117
We thank Stephanie Gaulrapp, Helen Kim, K. P. Singh, and Barbara Kleiber for data management support.
- Issue published online: 18 JUL 2013
- Article first published online: 29 MAY 2013
- Manuscript Accepted: 20 MAR 2013
- Manuscript Revised: 18 MAR 2013
- Manuscript Received: 18 FEB 2013
- pancreatic cancer;
The purpose of this study was to evaluate preoperative treatment with full-dose gemcitabine, oxaliplatin, and radiation therapy (RT) in patients with localized pancreatic cancer.
Eligibility included confirmation of adenocarcinoma, resectable or borderline resectable disease, a performance status ≤2, and adequate organ function. Treatment consisted of two 28-day cycles of gemcitabine (1 g/m2 over 30 minutes on days 1, 8, and 15) and oxaliplatin (85 mg/m2 on days 1 and 15) with RT during cycle 1 (30 Gray [Gy] in 2-Gy fractions). Patients were evaluated for surgery after cycle 2. Patients who underwent resection received 2 cycles of adjuvant chemotherapy.
Sixty-eight evaluable patients received treatment at 4 centers. By central radiology review, 23 patients had resectable disease, 39 patients had borderline resectable disease, and 6 patients had unresectable disease. Sixty-six patients (97%) completed cycle 1 with RT, and 61 patients (90%) completed cycle 2. Grade ≥3 adverse events during preoperative therapy included neutropenia (32%), thrombocytopenia (25%), and biliary obstruction/cholangitis (14%). Forty-three patients underwent resection (63%), and complete (R0) resection was achieved in 36 of those 43 patients (84%). The median overall survival was 18.2 months (95% confidence interval, 13–26.9 months) for all patients, 27.1 months (95% confidence interval, 21.2–47.1 months) for those who underwent resection, and 10.9 months (95% confidence interval, 6.1–12.6 months) for those who did not undergo resection. A decrease in CA 19-9 level after neoadjuvant therapy was associated with R0 resection (P = .02), which resulted in a median survival of 34.6 months (95% confidence interval, 20.3–47.1 months). Fourteen patients (21%) are alive and disease free at a median follow-up of 31.4 months (range, 24–47.6 months).
Preoperative therapy with full-dose gemcitabine, oxaliplatin, and RT was feasible and resulted in a high percentage of R0 resections. The current results are particularly encouraging, because the majority of patients had borderline resectable disease. Cancer 2013;119:2692–2700. © 2013 American Cancer Society.