Gastrointestinal Cancer

PD 05 - GI 2 - Poster Discussion

1042 - Surgical and Pathologic Outcomes in Patients on a Phase II Trial of Neoadjuvant Chemotherapy and Hypofractionated Image-Guided Intensity Modulated Radiation Therapy (HIGRT) in Resectable and Borderline Resectable Pancreatic Cancer

Monday, October 22
11:21 AM - 11:27 AM
Location: Room 217 A/B

Surgical and Pathologic Outcomes in Patients on a Phase II Trial of Neoadjuvant Chemotherapy and Hypofractionated Image-Guided Intensity Modulated Radiation Therapy (HIGRT) in Resectable and Borderline Resectable Pancreatic Cancer
S. J. Stephens1, B. Czito1, X. Zhang1, E. Duffy1, M. Malicki1, B. Pitcher1, D. Niedzwiecki1, J. Abbruzzese1, H. Uronis1, G. Blobe1, D. G. Blazer1, C. G. Willett1, and M. Palta2; 1Duke University Medical Center, Durham, NC, 2Department of Radiation Oncology, Duke University Medical Center, Durham, NC

Purpose/Objective(s): Pancreatic cancer remains a leading cause of cancer-related death. Despite ongoing research efforts in this area, there has been little progress over the past three decades. The rates of local and distant recurrences following surgical resection highlight the need for improvement in both local and systemic therapies. The primary objective of this study was to evaluate the feasibility and acute toxicity of neoadjuvant gemcitabine/nab-paclitaxel and HIGRT in patients with potentially resectable pancreatic cancer. Secondarily, we evaluated the surgical and pathologic outcomes of these patients.

Materials/Methods: Patients with newly diagnosed, previously untreated, non-metastatic pancreatic ductal adenocarcinoma with Karnofsky performance scores (KPS) of 70 or higher who were planned for surgical resection were prospectively enrolled on this single arm study. Patients received 2 cycles of gemcitabine/nab-paclitaxel followed by 25 Gy in 5 fractions HIGRT. Following neoadjuvant therapy patients were restaged and surgical resection was performed approximately 3-6 weeks post therapy. Patients received adjuvant chemotherapy at the discretion of the treating medical oncologist.

Results: Twenty-five patients were prospectively enrolled from 2015 to 2017. The median patient age was 68 (range 38-81). Twenty-eight percent of patients were considered resectable and 72% were borderline resectable (NCCN criteria) prior to initiation of neoadjuvant treatment, with 28% of patients being clinically node positive. Twenty-four of the 25 patients were able to undergo the full complement of neoadjuvant chemotherapy and radiation. Ultimately, 17 patients (68%) proceeded to surgical resection with 93% undergoing an R0 resection. Histologic grading of tumor response was assessed on surgical specimens and demonstrated marked response in 1 patient (6%), minimal to moderate response in 8 patients (47%), and poor response in 6 patients (35%). The median % of viable tumor and % fibrosis in the surgical specimens were 35% and 65%, respectively. Two patients were noted to have grade 2 adverse surgical events (wound infection, wound dehiscence) and there were no high grade (CTCAE grades 3-5) adverse surgical events appreciated.

Conclusion: Neoadjuvant chemotherapy with gemcitabine/nab-paclitaxel and HIGRT is well-tolerated in patients with resectable or borderline resectable pancreatic cancer, with high rates of R0 resection and acceptable rates of post-operative complications. Given robust patient accrual, the initial enrollment was expanded to 40 patients to increase statistical power and accrual is ongoing.

Author Disclosure: S.J. Stephens: None. B. Czito: Research Grant; Abbvie. Honoraria; Oakstone Institute. Royalty; UptoDate, Springer. Chair of Committee; ASTRO. X. Zhang: None. M. Malicki: None. D. Niedzwiecki: None. H. Uronis: None. D.G. Blazer: None. C.G. Willett: Employee; Mary Sunday. Honoraria; Oakstone Institute. Advisory Board; Extrinsic Health Solutions. M. Palta: Research Grant; Merck. Honoraria; Oakstone, UptoDate. Co-Chair; ASTRO Pancreas Cancer Guideline Taskforce Co-chair. Member; GI ASCO Steering Committee.

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1042 - Surgical and Pathologic Outcomes in Patients on a Phase II Trial of Neoadjuvant Chemotherapy and Hypofractionated Image-Guided Intensity Modulated Radiation Therapy (HIGRT) in Resectable and Borderline Resectable Pancreatic Cancer



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