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- Title
Pathological Complete Response in Patients With Resected Pancreatic Adenocarcinoma After Preoperative Chemotherapy.
- Authors
Stoop, Thomas F.; Oba, Atsushi; Wu, Y. H. Andrew; Beaty, Laurel E.; Colborn, Kathryn L.; Janssen, Boris V.; Al-Musawi, Mohammed H.; Franco, Salvador Rodriguez; Sugawara, Toshitaka; Franklin, Oskar; Jain, Ajay; Saiura, Akio; Sauvanet, Alain; Coppola, Alessandro; Javed, Ammar A.; Groot Koerkamp, Bas; Miller, Braden N.; Mack, Claudia E.; Hashimoto, Daisuke; Caputo, Damiano
- Abstract
Key Points: Question: What are the incidence, outcome, and associated factors of pathological complete response (pCR) in patients with resected pancreatic adenocarcinoma after chemo(radio)therapy? Findings: This cohort study of 1758 patients found a pCR rate of 4.8%, which was associated with longer overall survival compared with no pCR. Factors associated with pCR included preoperative (modified) FOLFIRINOX, preoperative radiotherapy (particularly stereotactic body radiation therapy), radiologic response, and normal(ized) serum carbohydrate antigen 19-9. Meaning: Although pCR does not reflect cure, these findings suggest that it is associated with improved OS, and the identified factors associated with pCR may have implications for treatment strategies. This cohort study analyzes the incidence, outcome, and factors associated with pathological complete response in patients with pancreatic adenocarcinoma who underwent preoperative chemo(radio)therapy followed by surgical resection. Importance: Preoperative chemo(radio)therapy is increasingly used in patients with localized pancreatic adenocarcinoma, leading to pathological complete response (pCR) in a small subset of patients. However, multicenter studies with in-depth data about pCR are lacking. Objective: To investigate the incidence, outcome, and risk factors of pCR after preoperative chemo(radio)therapy. Design, Setting, and Participants: This observational, international, multicenter cohort study assessed all consecutive patients with pathology-proven localized pancreatic adenocarcinoma who underwent resection after 2 or more cycles of chemotherapy (with or without radiotherapy) in 19 centers from 8 countries (January 1, 2010, to December 31, 2018). Data collection was performed from February 1, 2020, to April 30, 2022, and analyses from January 1, 2022, to December 31, 2023. Median follow-up was 19 months. Exposures: Preoperative chemotherapy (with or without radiotherapy) followed by resection. Main Outcomes and Measures: The incidence of pCR (defined as absence of vital tumor cells in the sampled pancreas specimen after resection), its association with OS from surgery, and factors associated with pCR. Factors associated with overall survival (OS) and pCR were investigated with Cox proportional hazards and logistic regression models, respectively. Results: Overall, 1758 patients (mean [SD] age, 64 [9] years; 879 [50.0%] male) were studied. The rate of pCR was 4.8% (n = 85), and pCR was associated with OS (hazard ratio, 0.46; 95% CI, 0.26-0.83). The 1-, 3-, and 5-year OS rates were 95%, 82%, and 63% in patients with pCR vs 80%, 46%, and 30% in patients without pCR, respectively (P <.001). Factors associated with pCR included preoperative multiagent chemotherapy other than (m)FOLFIRINOX ([modified] leucovorin calcium [folinic acid], fluorouracil, irinotecan hydrochloride, and oxaliplatin) (odds ratio [OR], 0.48; 95% CI, 0.26-0.87), preoperative conventional radiotherapy (OR, 2.03; 95% CI, 1.00-4.10), preoperative stereotactic body radiotherapy (OR, 8.91; 95% CI, 4.17-19.05), radiologic response (OR, 13.00; 95% CI, 7.02-24.08), and normal(ized) serum carbohydrate antigen 19-9 after preoperative therapy (OR, 3.76; 95% CI, 1.79-7.89). Conclusions and Relevance: This international, retrospective cohort study found that pCR occurred in 4.8% of patients with resected localized pancreatic adenocarcinoma after preoperative chemo(radio)therapy. Although pCR does not reflect cure, it is associated with improved OS, with a doubled 5-year OS of 63% compared with 30% in patients without pCR. Factors associated with pCR related to preoperative chemo(radio)therapy regimens and anatomical and biological disease response features may have implications for treatment strategies that require validation in prospective studies because they may not universally apply to all patients with pancreatic adenocarcinoma.
- Subjects
COLORADO; THERAPEUTIC use of antineoplastic agents; ADENOCARCINOMA; RISK assessment; IRINOTECAN; T-test (Statistics); PATHOLOGIC complete response; SCIENTIFIC observation; FISHER exact test; LOGISTIC regression analysis; PREOPERATIVE care; CANCER patients; CHEMORADIOTHERAPY; DESCRIPTIVE statistics; RADIOSURGERY; CHI-squared test; MANN Whitney U Test; PANCREATIC tumors; CANCER chemotherapy; LONGITUDINAL method; PANCREAS; ODDS ratio; RESEARCH; FOLINIC acid; OXALIPLATIN; COLLECTION &; preservation of biological specimens; CONFIDENCE intervals; FLUOROURACIL; DATA analysis software; PROPORTIONAL hazards models
- Publication
JAMA Network Open, 2024, Vol 7, Issue 6, pe2417625
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2024.17625