Elucidating the Causes of Improved Survival in Clinical Trials of Randomized Adjuvant Pancreatic Ductal Adenocarcinoma (
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ORIGINAL ARTICLE – PANCREATIC TUMORS
Elucidating the Causes of Improved Survival in Clinical Trials of Randomized Adjuvant Pancreatic Ductal Adenocarcinoma (PDAC) Andre Alabd, MD1, Andrew Alabd, MD2, Oloruntoba Bolaji, DO3, Kavin Sugumar, MD4, John Ammori, MD4, Jeffrey Hardacre, MD4, and Jordan M. Winter, MD4 1
Indiana Health University Hospital, Indianapolis, IN; 2Cooper University Hospital, Camden, NJ; 3Christiana Care Health System, Christiana, DE; 4University Hospitals Cleveland Medical Center, Cleveland, OH
ABSTRACT Background. Overall survival (OS) has increased in recent adjuvant clinical trials of pancreatic ductal adenocarcinoma (PDAC). Although oncologists have taken notice, the root causes have not been fully examined. Methods. All phase 3 adjuvant PDAC clinical trials were screened (n = 13), and eight trials (2007–2019) that met a study requirement of having a gemcitabine monotherapy arm to serve as a uniform comparative anchor across trials were identified. Patient enrollment eligibility criteria were compared across trials and categorized as tumor- or patient-related factors. Disease-free survival (DFS) and OS in the gemcitabine-only and non-gemcitabine arms were plotted and compared over time using linear regression. Results. In the non-gemcitabine arms, OS increased over time, but the slope did not achieve statistical significance (p = 0.0815). Interestingly, OS improved for patients receiving only gemcitabine (slope, 1.99 months; p = 0.0018), whereas DFS remained constant (p = 0.897). Carbohydrate antigen (CA) 19-9 values and pathologic profiles of tumors were only marginally different across all cohorts. Recent adjuvant trials had stricter inclusion
Electronic supplementary material The online version of this article (https://doi.org/10.1245/s10434-020-08859-y) contains supplementary material, which is available to authorized users. Ó Society of Surgical Oncology 2020 First Received: 16 January 2020 Accepted: 27 June 2020 J. M. Winter, MD e-mail: [email protected]
criteria (i.e., more patients were excluded for medical reasons; linear regression, p = 0.010). Conclusion. Survival for patients with resected PDAC has roughly doubled in phase 3 adjuvant trials during the past decade. Improved outcomes likely are attributable to improved adjuvant therapeutic regimens, but also reflect healthier patients enrolled in the more recent trials.
In 2011, the Pancreatic Cancer Action Network set a goal to double pancreatic cancer survival by 2020. The data are mixed on whether this ambitious goal was achieved or not. Broadly speaking, to date, two principal types of studies have been used to assess progress in survival outcomes for patients with resectable PDAC: (1) singleinstitution studies and (2) large administrative studies. Both types of studies show minimal survival improvement for patients with resectable PDAC. For example, cohorts the from Memorial Sloan Kettering Cancer Center and Johns Hopkins University showed that survival rates in 2000 were comparable with those in the 1980s.1,2
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