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Observational Study
. 2024 May;31(5):2892-2901.
doi: 10.1245/s10434-024-14951-4. Epub 2024 Jan 29.

Adjuvant Therapy After Upfront Resection of Resectable Pancreatic Cancer: Patterns of Omission and Use-A Prospective Real-Life Study

Salvatore Paiella  1 , Giuseppe Malleo  2 , Gabriella Lionetto  2 , Alice Cattelani  2 , Fabio Casciani  2 , Erica Secchettin  3 , Matteo De Pastena  2 , Claudio Bassi  2 , Roberto Salvia  4
Affiliations
Observational Study

Adjuvant Therapy After Upfront Resection of Resectable Pancreatic Cancer: Patterns of Omission and Use-A Prospective Real-Life Study

Salvatore Paiella et al. Ann Surg Oncol. 2024 May.

Abstract

Background: Little is known about adjuvant therapy (AT) omission and use outside of randomized trials. We aimed to assess the patterns of AT omission and use in a cohort of upfront resected pancreatic cancer patients in a real-life scenario.

Methods: From January 2019 to July 2022, 317 patients with resected pancreatic cancer and operated upfront were prospectively enrolled in this prospective observational trial according to the previously calculated sample size. The association between perioperative variables and the risk of AT omission and AT delay was analyzed using multivariable logistic regression.

Results: Eighty patients (25.2%) did not receive AT. The main reasons for AT omission were postoperative complications (38.8%), oncologist's choice (21.2%), baseline comorbidities (20%), patient's choice (10%), and early recurrence (10%). At the multivariable analysis, the odds of not receiving AT increased significantly for older patients (odds ratio [OR] 1.1, p < 0.001), those having an American Society of Anesthesiologists score ≥II (OR 2.03, p = 0.015), or developing postoperative pancreatic fistula (OR 2.5, p = 0.019). The likelihood of not receiving FOLFIRINOX as AT increased for older patients (OR 1.1, p < 0.001), in the presence of early-stage disease (stage I-IIa vs. IIb-III, OR 2.82, p =0.031; N0 vs. N+, OR 3, p = 0.03), and for patients who experienced postoperative major complications (OR 4.7, p = 0.009). A twofold increased likelihood of delay in AT was found in patients experiencing postoperative complications (OR 3.86, p = 0.011).

Conclusions: AT is not delivered in about one-quarter of upfront resected pancreatic cancer patients. Age, comorbidities, and postoperative complications are the main drivers of AT omission and mFOLFIRINOX non-use.

Clinicaltrials registration: NCT03788382.

Keywords: Adjuvant therapy; Failure to rescue; Pancreatic cancer; Pancreatic surgery; Postoperative complications.

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Conflict of interest statement

Salvatore Paiella and Erica Secchettin receive consultancy honoraria from AlphaTau. Giuseppe Malleo, Gabriella Lionetto, Alice Cattelani, Fabio Casciani, Matteo De Pastena, Claudio Bassi, and Roberto Salvia have no conflicts of interest to declare in relation to this work.

Figures

Fig. 1
Fig. 1
ROC curve analysis for prediction of adjuvant therapy omission (left) and mFOLFIRINOX omission (right). ROC receiver operating characteristic, AUC area under the curve
Fig. 2
Fig. 2
Chemotherapy regimens prescribed during the study period (for guideline adherence evaluation; study period November 2019–July 2022). Gem gemcitabine, mono monotherapy
See this image and copyright information in PMC

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