IMPORTANCE Chemotherapy is the recommended induction strategy in borderline resectable and locally advanced pancreatic ductal adenocarcinoma. However, the associated results on an intention-to-treat basis are poorly understood. OBJECTIVE To investigate pragmatically the treatment compliance, conversion to surgery, and survival outcomes of patients with borderline resectable and locally advanced pancreatic ductal adenocarcinoma undergoing primary chemotherapy. DESIGN, SETTING, AND PARTICIPANTS This prospective study took place in a national referral center for pancreatic diseases in Italy. Consecutive patients with borderline resectable and locally advanced pancreatic ductal adenocarcinoma were enrolled at the time of diagnosis (January 2013 through December 2015) and followed up to June 2018. EXPOSURES The chemotherapy regimen, assigned based on multidisciplinary evaluation,was delivered either at a hub center or at spoke centers. By convention, primary chemotherapywas considered completed after 6 months. After restaging, surgical candidateswere selected based on radiologic and biochemical response. All surgerieswere carried out at the hub center. MAIN OUTCOMES AND MEASURES Rates of receipt and completion of chemotherapy, rates of conversion to surgery, and disease-specific survival. RESULTS Of 680 patients, 267 (39.3%) had borderline resectable and 413 (60.7%) had locally advanced pancreatic ductal adenocarcinoma. Overall, 66 patients (9.7%)were lost to follow-up. The rate of chemotherapy receiptwas 92.9%(n = 570). The chemotherapeutic regimens most commonly used included FOLFIRINOX (fluorouracil, leucovorin, oxaliplatin, and irinotecan) (260 [45.6%]) and gemcitabine plus nanoparticle albumin-bound–paclitaxel (123 [21.6%]). Nineteen patients (3.3%) receiving chemotherapy died within 6 months, mainly for disease progression. The treatment completion ratewas 71.6%(408 of 570). The overall rate of resectionwas 15.1% (93 of 614) (borderline resectable, 60 of 249 [24.1%]; locally advanced, 33 of 365 [9%]; resection:exploration ratio, 63.3%). Independent predictors of resectionwere age, borderline resectable disease, chemotherapy completion, radiologic response, and biochemical response. The median survival for the whole cohortwas 12.8 (95%CI, 11.7-13.9) months. Factors independently associated with survivalwere completion of chemotherapy, receipt of complementary radiation therapy, and resection. In patients who underwent resection, the median survivalwas 35.4 (95%CI, 27.0-43.7) months for initially borderline resectable and 41.8 (95%CI, 27.5-56.1) months for initially locally advanced disease.No pretreatment and posttreatment factorswere associated with survival after pancreatectomy. CONCLUSIONS AND RELEVANCE This pragmatic observational cohort study with an intention-to-treat design provides real-world evidence of outcomes associated with the most current primary chemotherapy regimens used for borderline resectable and locally advanced pancreatic ductal adenocarcinoma.
Maggino, Laura;Malleo, Giuseppe
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