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Original Investigation
May 29, 2019

Role of Adjuvant Multimodality Therapy After Curative-Intent Resection of Ampullary Carcinoma

Author Affiliations
  • 1Department of Surgery, University of Pennsylvania Perelman School of Medicine, Philadelphia
  • 2Department of Surgery, University of Tennessee Health Science Center, Memphis
  • 3Department of Surgery, University of Verona, Pancreas Institute, Verona, Italy
  • 4Department of Surgery, Indiana University School of Medicine, Indianapolis
  • 5Department of Surgery, University of Calgary, Calgary, Alberta, Canada
  • 6Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts
  • 7Department of Surgery, Jefferson Medical College, Philadelphia, Pennsylvania
  • 8Department of Surgery, Baylor College of Medicine, Houston, Texas
  • 9Department of Surgery, University of Alabama School of Medicine, Birmingham
  • 10Department of Surgery, Yale School of Medicine, New Haven, Connecticut
  • 11Department of Surgery, The Ohio State University Wexner Medical Center, Columbus
  • 12Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
JAMA Surg. Published online May 29, 2019. doi:10.1001/jamasurg.2019.1170
Key Points

Question  What is the role of adjuvant therapy after curative-intent resection of ampullary adenocarcinoma?

Findings  In this cohort study that assessed 357 operative resections, neither fluorouracil-based nor gemcitabine-based regimens were associated with improved survival, even when assessed relative to intestinal or pancreatobiliary histologic subtype.

Meaning  The use of adjuvant chemotherapy, with or without radiotherapy, is not associated with improved long-term survival after curative-intent resection of ampullary adenocarcinoma.

Abstract

Importance  Ampullary adenocarcinoma is a rare malignant neoplasm that arises within the duodenal ampullary complex. The role of adjuvant therapy (AT) in the treatment of ampullary adenocarcinoma has not been clearly defined.

Objective  To determine if long-term survival after curative-intent resection of ampullary adenocarcinoma may be improved by selection of patients for AT directed by histologic subtype.

Design, Setting, and Participants  This multinational, retrospective cohort study was conducted at 12 institutions from April 1, 2000, to July 31, 2017, among 357 patients with resected, nonmetastatic ampullary adenocarcinoma receiving surgery alone or AT. Cox proportional hazards regression was used to identify covariates associated with overall survival. The surgery alone and AT cohorts were matched 1:1 by propensity scores based on the likelihood of receiving AT or by survival hazard from Cox modeling. Overall survival was compared with Kaplan-Meier estimates.

Exposures  Adjuvant chemotherapy (fluorouracil- or gemcitabine-based) with or without radiotherapy.

Main Outcomes and Measures  Overall survival.

Results  A total of 357 patients (156 women and 201 men; median age, 65.8 years [interquartile range, 58-74 years]) underwent curative-intent resection of ampullary adenocarcinoma. Patients with intestinal subtype had a longer median overall survival compared with those with pancreatobiliary subtype (77 vs 54 months; P = .05). Histologic subtype was not associated with AT administration (intestinal, 52.9% [101 of 191]; and pancreatobiliary, 59.5% [78 of 131]; P = .24). Patients with pancreatobiliary histologic subtype most commonly received gemcitabine-based regimens (71.0% [22 of 31]) or combinations of gemcitabine and fluorouracil (12.9% [4 of 31]), whereas treatment of those with intestinal histologic subtype was more varied (fluorouracil, 50.0% [17 of 34]; gemcitabine, 44.1% [15 of 34]; P = .01). In the propensity score–matched cohort, AT was not associated with a survival benefit for either histologic subtype (intestinal: hazard ratio, 1.21; 95% CI, 0.67-2.16; P = .53; pancreatobiliary: hazard ratio, 1.35; 95% CI, 0.66-2.76; P = .41).

Conclusions and Relevance  Adjuvant therapy was more frequently used in patients with poor prognostic factors but was not associated with demonstrable improvements in survival, regardless of tumor histologic subtype. The value of a multimodality regimen remains poorly defined.

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