Regret affects the choice between neoadjuvant therapy and upfront surgery for potentially resectable pancreatic cancer

Cucchetti, Alessandro; Djulbegoviĉ, Benjamin; Crippa, Stefano; Hozo, Iztok; Sbrancia, Monica; Tsalatsanis, Athanasios; Binda, Cecilia; Fabbri, Carlo; Salvia, Roberto; Falconi, Massimo; Ercolani, Giorgio; Alfieri, Sergio; Amato, Arnaldo; Amisano, Marco F.; Anderloni, Andrea; Maestri, A; Coluccio, Chiara; Brandi, Giovanni; Casadei‐Gardini, Andrea; Cennamo, Vincenzo; Crinò, Stefano Francesco; Valle, Raffaele Dalla; Angelis, Claudio De; Battista, Monica Di; Maïo, Massimo Di; Marco, Mariacristina Di; Marco, Marco Di; Matteo, Francesco Di; Mitri, R. Di; Ettorre, Giuseppe Maria; Facciorusso, Antonio; Farina, Gabriella; Ferrari, Giovanni; Fornaro, Lorenzo; Frigerio, Isabella; Frisone, Daniele; Fuccio, Lorenzo; Gardini, Andrea Casadei; Garufi, Carlo; Grazi, Gian Luca; Jovine, Elio; Kauffmann, Emanuele Federico; Langella, Serena; Larghi, Alberto; Manno, Mauro; Marciano, Emanuele; Marzioni, Marco; Merighi, A.; Mutignani, Massimiliano; Nardo, Bruno; Niger, Monica; Palmisano, Valentina; Partelli, Stefano; Pinto, Carmine; Piras, Enrico Maria; Rapposelli, Ilario Giovanni; Reni, Michele; Ricci, Claudio; Rimassa, Lorenza; Siena, Salvatore; Spada, Cristiano; Sperti, Elisa; Spezzaferro, M.; Sposito, Carlo; Tamberi, Stefano; Troisi, Roberto; Veneroni, Luigi; Vivarelli, Marco; Zerbi, Alessandro

doi:10.1016/j.surg.2023.01.016

Cited by 5 publications

(5 citation statements)

References 23 publications

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“…2 Percentage of responders who consider the IPD omission as the least regrettable choice based on the risk of CR-POPF. The x-axis represents the Fistula Risk Score categories (FRS); the blue line reports the risk of CR-POPF related to each category of FRS according to Trudeau et al [ 22 ]; the orange line reports the percentage of responders who perceived the IPD omission as the least regrettable choice for the related risk of CR-POPF …”

Section: Resultsmentioning

confidence: 99%

“…Regret of omission was reduced in centers at high volume for pancreatic surgery (> 30 pancreatic resections/year). Surgeons who work in high-volume hospitals can rely on key expertise and resources, such as interventional radiology [ 22 ] and operative endoscopy [ 23 ], that can manage peri-anastomotic fluid collections and other life-threatening complications related to POPF (i.e., post-pancreatectomy hemorrhage). At the same time, dedicated pancreatic surgeons perceived and feared, more than other surgeons, the devastating potential effects of undrained CR-POPF.…”

Section: Discussionmentioning

confidence: 99%

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Intraperitoneal prophylactic drain after pancreaticoduodenectomy: an Italian survey

Ricci,

Pecorelli,

Esposito

et al. 2024

Updates Surg

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Intraperitoneal prophylactic drain (IPD) use in pancreaticoduodenectomy (PD) is still controversial. A survey was designed to investigate surgeons’ use of IPD in PD patients through 23 questions and one clinical vignette. For the clinical scenario, respondents were asked to report their regret of omission and commission regarding the use of IPD elicited on a scale between 0 (no regret) and 100 (maximum regret). The threshold model and a multilevel mixed regression were applied. One hundred three (97.2%) respondents confirmed using at least two IPDs. The median regret due to the omission of IPD was 84 (67–100, IQR). The median regret due to the commission of IPD was 10 (3.5–20, IQR). The CR-POPF probability threshold at which drainage omission was the less regrettable choice was 3% (1–50, IQR). The threshold was lower for those surgeons who performed minimally invasive PD (P = 0.048), adopted late removal (P = 0.002), perceived FRS able to predict the risk (P = 0.006), and IPD able to avoid relaparotomy P = 0.036). Drain management policies after PD remain heterogeneous among surgeons. The regret model suggested that IPD omission could be performed in low-risk patients.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Intraperitoneal prophylactic drain after pancreaticoduodenectomy: an Italian survey

Ricci,

Pecorelli,

Esposito

et al. 2024

Updates Surg

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“…Other theories, such as regret theory and dual processing theories, consider intuition and emotions in shaping patients' V&P and weighing the benefits and harms of health interventions. [28][29][30][31][32][33] This is because, similarly to the previously published DCAs 1-3 which advocate a holistic assessment of benefits and harms to define threshold [Equation (1), left part], we also retained a holistic assessment of RV using the sum of all harms (Appendix). In fact, gDCA is agnostic toward the methods used for eliciting RV and provides a more flexible and natural comparison of multiple treatment effects.…”

Section: Discussionmentioning

confidence: 99%

Generalised decision curve analysis for explicit comparison of treatment effects

Hozo,

Djulbegovic

2023

Evaluation Clinical Practice

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RationaleDecision curve analysis (DCA) helps integrate prediction models with treatment assessments to guide personalised therapeutic choices among multiple treatment options. However, the current versions of DCA do not explicitly model treatment effects in the analysis but implicitly or holistically assess therapeutic benefits and harms. In addition, the existing DCA cannot allow the comparison of multiple treatments using a standard metric.Aims and ObjectivesTo develop a generalised version of DCA (gDCA) by decomposing holistically assessed net benefits and harms into patient preferences versus empirical evidence (as obtained in the trials, meta‐analyses of clinical studies, etc.) to allow individualised comparison of single or multiple treatments using a common metric.MethodsWe reformulated DCA by (1) decomposing holistic, implicit utilities into specific utilities related to treatment effects and patient's relative values (RV) about disease outcomes versus treatment harms, (2) explicitly modelling each treatment effect at the level of probabilities and/or utilities (outcomes) in a decision tree, and (3) avoiding scaling effects employed in the original DCA to enable comparison of treatment effects against the common metrics. We used data from a published network meta‐analysis of randomised trials to inform the use of statin treatment according to Framingham Risk Model.ResultsWe illustrate the analysis by modelling the effects of three statins in the primary prevention of cardiovascular disease. We performed simultaneous comparisons against standard metrics (RV) for all treatments. We examined for which RV values, a predictive model for guiding personalised treatment, outperformed the strategies of treating everyone or treating no one. We found that the magnitude of benefits (efficacy) seems more important than the simple ratio of efficacy/harms.ConclusionWe describe gDCA for evaluating single or multiple treatments to help tailor therapy toward individual risk characteristics. gDCA further helps integrate the principles of evidence‐based medicine with decision analysis.

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“…First, we assumed that very early recurrence/death is primarily related to an undetected micrometastatic disease or an incomplete resection . Second, we assumed that neoadjuvant treatment would have been a viable alternative in case of a futile up-front pancreatectomy . In this framework, the 6-month time mark corresponds to the immortal time relative to a neoadjuvant therapy course in previous trials and landmark analyses …”

Section: Methodsmentioning

confidence: 99%

“… Second, we assumed that neoadjuvant treatment would have been a viable alternative in case of a futile up-front pancreatectomy. In this framework, the 6-month time mark corresponds to the immortal time relative to a neoadjuvant therapy course in previous trials and landmark analyses. …”

Section: Methodsmentioning

confidence: 99%

Futility of Up-Front Resection for Anatomically Resectable Pancreatic Cancer

Crippa,

Malleo,

Mazzaferro

et al. 2024

JAMA Surg

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ImportanceThere are currently no clinically relevant criteria to predict a futile up-front pancreatectomy in patients with anatomically resectable pancreatic ductal adenocarcinoma.ObjectivesTo 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 ParticipantsThis 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.ExposureStandard management, per existing guidelines.Main Outcomes and MeasuresThe 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.ResultsThis 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 relevanceIn 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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Regret affects the choice between neoadjuvant therapy and upfront surgery for potentially resectable pancreatic cancer

Cited by 5 publications

References 23 publications

Intraperitoneal prophylactic drain after pancreaticoduodenectomy: an Italian survey

Intraperitoneal prophylactic drain after pancreaticoduodenectomy: an Italian survey

Generalised decision curve analysis for explicit comparison of treatment effects

Futility of Up-Front Resection for Anatomically Resectable Pancreatic Cancer

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