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DURHAM, NC – Treatment with neoadjuvant 5-FU, oxaliplatin, irinotecan, and leucovorin (FOLFIRINOX) followed by chemoradiation shows substantial activity in patients with locally advanced pancreatic cancer, with conversion to surgical resectability with curative intent in more than 20% of patients. In a retrospective study published in The Oncologist, Jason Faris, M.D., Medical Oncologist at the Massachusetts General Hospital Cancer Center in Boston, and colleagues described their institutional experience with the FOLFIRINOX treatment protocol in patients with locally advanced pancreatic cancer.
Nearly one-third of patients with newly diagnosed pancreatic cancer present with locally advanced disease, which is associated with a median overall survival of approximately one year. Effective treatment of locally advanced pancreatic cancer may permit resection for patients with initially unresectable disease, but to date no standard of care has been defined for this patient population. Although treatment with FOLFIRINOX is associated with improved response rate, progression-free survival, and overall survival in the metastatic setting, this regimen has not been studied extensively in patents with locally advanced pancreatic cancer.
The current study included all patients (n = 22) with locally advanced prostate cancer who began treatment with FOLFIRINOX between July 2010 and February 2012 at the Massachusetts General Hospital Cancer Center. The neoadjuvant FOLFIRINOX regimen consisted of 5-FU administered as a bolus of 400mg/m2, bolus leucovorin 400mg/m2 followed by continuous infusion at 1200mg/m2/day for 46 hours, oxaliplatin 85mg/m2, and irinotecan 180mg/m2. For 20 patients, FOLFIRINOX was followed by chemoradiation with continuous infusion 5-FU or capecitabine and intensity-modulated radiation therapy (50.4 Gy).
Patients received a median of 8 cycles of neoadjuvant FOLFIRINOX, including a median of 2.5 full-dose cycles. The median follow-up was 19.3 months. The overall response rate was 27.3% while on FOLFIRINOX and 36.4% after chemoradiation. Following neoadjuvant FOLFIRINOX and chemoradiation, 5 of 22 patients (23%) were able to undergo R0 resections. Of these, however, 3 patients experienced distant recurrence at a median of 81 days after surgery. The median progression-free survival for all patients was 11.7 months.
“We believe the results are promising for this strategy, in a group of patients where the historical possibility for resection is low and the overall prognosis quite dismal,” Dr. Faris said. “However, this promise must be evaluated against the recurrences observed in the patients who were able to undergo resection, as well as the toxicity signal that is present with this multidrug regimen. Prospective evaluation of therapies for patients with locally advanced pancreatic cancer will be critical to improving treatments and outcomes for this group of patients. ”
The risk of toxicity was high, with 7 patients (32%) requiring at least one emergency department visit or hospitalization during treatment with FOLFIRINOX. Two patients discontinued FOLFIRINOX for treatment-related toxicity.
These findings raise the question of whether a patient with initially unresectable pancreatic cancer who achieves an R0 resection after neoadjuvant FOLFIRINOX is really curable, the study authors said, given the high rate of distant recurrence after surgery. Alternatively, palliative systemic chemotherapy and/or chemoradiation may allow patients to achieve the same outcome, while avoiding the known morbidity and potential mortality of surgical resection.
Researchers will continue to explore the utility of FOLFIRINOX at the Massachusetts General Hospital Cancer Center, where separate treatment protocols are in use for patients with clearly resectable disease, borderline resectable disease, and locally advanced pancreatic cancer.
“It is hopfully a start toward controlling locally advanced disease. Obviously it will take more and better drugs and irradiation," said Bruce A. Chabner, M.D., Director of Clinical Research at MGH Cancer Center, Massachusetts General Hospital and Editor of The Oncologist.
The full article, titled “FOLFIRINOX in Locally Advanced Pancreatic Cancer: The Massachusetts General Hospital Cancer Center Experience,” can be accessed at www.TheOncologist.com.
About The Oncologist
Established by oncologists to help physicians better manage their practices in an ever-changing environment, The Oncologist® is the official journal of the Society for Translational Oncology (STO). Now in its 18th year, this internationally peer-reviewed journal focuses on clear and concise interpretation addressing the multimodality diagnosis, treatment, and quality of life of the cancer patient. Each issue is meant to impact the practice of oncology and to facilitate significant communication in the introduction of new medical treatments and technologies. For more information, visit www.TheOncologist.com.
About AlphaMed Press
Established in 1983, AlphaMed Press, with offices in Durham, NC, San Francisco, CA, and Belfast, Northern Ireland, publishes three internationally renowned peer-reviewed journals with globally recognized editorial boards dedicated to advancing knowledge and education in their focused disciplines. STEM CELLS® (www.StemCells.com), which celebrated its 31st year in 2013, is the world's first journal devoted to this fast paced field of research. The Oncologist® (www.TheOncologist.com), entering its 18th year, is devoted to community and hospital-based oncologists and physicians entrusted with cancer patient care. STEM CELLS TRANSLATIONAL MEDICINE® (www.StemCellsTM.com), in its second year, is dedicated to significantly advancing the clinical utilization of stem cell molecular and cellular biology. By bridging stem cell research and clinical trials, SCTM will help move applications of these critical investigations closer to accepted best practices.
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