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Original Investigation
July 24, 2019

Outcomes of Primary Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma

Author Affiliations
  • 1Unit of General and Pancreatic Surgery, Department of Surgery and Oncology, University of Verona Hospital Trust, Verona, Italy
  • 2Unit of Medical Oncology, Department of Surgery and Oncology, University of Verona Hospital Trust, Verona, Italy
  • 3Unit of Radiology, Department of Pathology and Diagnostics, University of Verona Hospital Trust, Verona, Italy
JAMA Surg. 2019;154(10):932-942. doi:10.1001/jamasurg.2019.2277
Key Points

Question  What are the outcomes of patients with borderline resectable and locally advanced pancreatic ductal adenocarcinoma receiving primary chemotherapy?

Findings  In this study including 680 patients with new diagnoses of pancreatic ductal adenocarcinoma, the rates of chemotherapy receipt and completion were 92.9% and 71.6%, respectively. Rate of surgical resection was 24% in patients with borderline resectable disease and 9% in patients with locally advanced disease; the median survival was 12.8 months in the whole cohort and in excess of 35 months in patients who underwent surgical resection.

Meaning  This article provides real-world outcomes of primary chemotherapy in an unselected cohort of patients with borderline resectable and locally advanced pancreatic ductal adenocarcinoma.

Abstract

Importance  Chemotherapy is the recommended induction strategy in borderline resectable and locally advanced pancreatic ductal adenocarcinoma. However, the associated results on an intention-to-treat basis are poorly understood.

Objective  To investigate pragmatically the treatment compliance, conversion to surgery, and survival outcomes of patients with borderline resectable and locally advanced pancreatic ductal adenocarcinoma undergoing primary chemotherapy.

Design, Setting, and Participants  This prospective study took place in a national referral center for pancreatic diseases in Italy. Consecutive patients with borderline resectable and locally advanced pancreatic ductal adenocarcinoma were enrolled at the time of diagnosis (January 2013 through December 2015) and followed up to June 2018.

Exposures  The chemotherapy regimen, assigned based on multidisciplinary evaluation, was delivered either at a hub center or at spoke centers. By convention, primary chemotherapy was considered completed after 6 months. After restaging, surgical candidates were selected based on radiologic and biochemical response. All surgeries were carried out at the hub center.

Main Outcomes and Measures  Rates of receipt and completion of chemotherapy, rates of conversion to surgery, and disease-specific survival.

Results  Of 680 patients, 267 (39.3%) had borderline resectable and 413 (60.7%) had locally advanced pancreatic ductal adenocarcinoma. Overall, 66 patients (9.7%) were lost to follow-up. The rate of chemotherapy receipt was 92.9% (n = 570). The chemotherapeutic regimens most commonly used included FOLFIRINOX (fluorouracil, leucovorin, oxaliplatin, and irinotecan) (260 [45.6%]) and gemcitabine plus nanoparticle albumin-bound–paclitaxel (123 [21.6%]). Nineteen patients (3.3%) receiving chemotherapy died within 6 months, mainly for disease progression. The treatment completion rate was 71.6% (408 of 570). The overall rate of resection was 15.1% (93 of 614) (borderline resectable, 60 of 249 [24.1%]; locally advanced, 33 of 365 [9%]; resection:exploration ratio, 63.3%). Independent predictors of resection were age, borderline resectable disease, chemotherapy completion, radiologic response, and biochemical response. The median survival for the whole cohort was 12.8 (95% CI, 11.7-13.9) months. Factors independently associated with survival were completion of chemotherapy, receipt of complementary radiation therapy, and resection. In patients who underwent resection, the median survival was 35.4 (95% CI, 27.0-43.7) months for initially borderline resectable and 41.8 (95% CI, 27.5-56.1) months for initially locally advanced disease. No pretreatment and posttreatment factors were associated with survival after pancreatectomy.

Conclusions and Relevance  This pragmatic observational cohort study with an intention-to-treat design provides real-world evidence of outcomes associated with the most current primary chemotherapy regimens used for borderline resectable and locally advanced pancreatic ductal adenocarcinoma.

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