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Multicenter Study
. 2024 Oct 1;159(10):1139-1147.
doi: 10.1001/jamasurg.2024.2485.

Futility of Up-Front Resection for Anatomically Resectable Pancreatic Cancer

Stefano Crippa  1 , Giuseppe Malleo  2 , Vincenzo Mazzaferro  3 , Serena Langella  4 , Claudio Ricci  5   6 , Fabio Casciani  2 , Giulio Belfiori  1 , Sara Galati  4 , Vincenzo D'Ambra  5   6 , Gabriella Lionetto  2 , Alessandro Ferrero  4 , Riccardo Casadei  5   6 , Giorgio Ercolani  6   7 , Roberto Salvia  2 , Massimo Falconi  1 , Alessandro Cucchetti  6   7
Affiliations
Multicenter Study

Futility of Up-Front Resection for Anatomically Resectable Pancreatic Cancer

Stefano Crippa et al. JAMA Surg. .

Abstract

Importance: There are currently no clinically relevant criteria to predict a futile up-front pancreatectomy in patients with anatomically resectable pancreatic ductal adenocarcinoma.

Objectives: To develop a futility risk model using a multi-institutional database and provide unified criteria associated with a futility likelihood below a safety threshold of 20%.

Design, setting, and participants: This retrospective study took place from January 2010 through December 2021 at 5 high- or very high-volume centers in Italy. Data were analyzed during April 2024. Participants included consecutive patients undergoing up-front pancreatectomy at the participating institutions.

Exposure: Standard management, per existing guidelines.

Main outcomes and measures: The main outcome measure was the rate of futile pancreatectomy, defined as an operation resulting in patient death or disease recurrence within 6 months. Dichotomous criteria were constructed to maintain the futility likelihood below 20%, corresponding to the chance of not receiving postneoadjuvant resection from existing pooled data.

Results: This study included 1426 patients. The median age was 69 (interquartile range, 62-75) years, 759 patients were male (53.2%), and 1076 had head cancer (75.4%). The rate of adjuvant treatment receipt was 73.7%. For the model construction, the study sample was split into a derivation (n = 885) and a validation cohort (n = 541). The rate of futile pancreatectomy was 18.9% (19.2% in the development and 18.6% in the validation cohort). Preoperative variables associated with futile resection were American Society of Anesthesiologists class (95% CI for coefficients, 0.68-0.87), cancer antigen (CA) 19.9 serum levels (95% CI, for coefficients 0.05-0.75), and tumor size (95% CI for coefficients, 0.28-0.46). Three risk groups associated with an escalating likelihood of futile resection, worse pathological features, and worse outcomes were identified. Four discrete conditions (defined as CA 19.9 levels-adjusted-to-size criteria: tumor size less than 2 cm with CA 19.9 levels less than 1000 U/mL; tumor size less than 3 cm with CA 19.9 levels less than 500 U/mL; tumor size less than 4 cm with CA 19.9 levels less than 150 U/mL; and tumor size less than 5 cm with CA 19.9 levels less than 50 U/mL) were associated with a futility likelihood below 20%. Both disease-free survival and overall survival were significantly longer in patients fulfilling the criteria.

Conclusions and relevance: In this study, a preoperative model (MetroPancreas) and dichotomous criteria to determine the risk of futile pancreatectomy were developed. This might help in selecting patients for up-front resection or neoadjuvant therapy.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Malleo reported personal fees from Oncosil Medical outside the submitted work. Dr Mazzaferro reported personal fees from Roche outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Contour Plot Outlining the Likelihood of Futile Up-Front Pancreatectomy as a Function of Tumor Size and Serum Carbohydrate Antigen (CA) 19.9
The dotted line represents the futility threshold, set at 20% (A). Dichotomous (in/out) criteria associated with a likelihood of futile pancreatectomy below the 20% threshold (B).
Figure 2.
Figure 2.. Disease-Free Survival and Overall Survival After Up-Front Resection in Patients Who Fulfilled the Cancer Antigen 19-9-Adjusted-to-Size Criteria and Those Who Did Not
See this image and copyright information in PMC

Comment on

References

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