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The impact of neoadjuvant and adjuvant immunotherapy on the survival of pancreatic cancer patients: a retrospective analysis.

ABSTRACT: BACKGROUND:Immunotherapy has become an essential part of cancer treatment after showing great efficacy in various malignancies. However, its effectiveness in pancreatic ductal adenocarcinoma (PDAC), especially in resectable pancreatic cancer, has not been studied. The primary objective of this study is to compare the OS impact of immunotherapy between PDAC patients who receive neoadjuvant immunotherapy and patients who receive adjuvant immunotherapy. The secondary objective is to investigate the impact of neoadjuvant and adjuvant immunotherapy in combination with chemotherapy and chemoradiation by performing subset analyses of these two groups. METHODS:Patients diagnosed with PDAC between 2004 and 2016 were identified from the National Cancer Database (NCDB). Multivariable Cox proportional hazard analysis was performed to examine the effect of neoadjuvant and adjuvant immunotherapy in combination with chemotherapy and chemoradiation on the OS of the patients. The multivariable analysis was adjusted for essential factors such as the age at diagnosis, sex, race, education, income, place of living insurance status, hospital type, comorbidity score, and year of diagnosis. RESULTS:Overall, 526 patients received immunotherapy. Among whom, 408/526 (77.57%) received neoadjuvant immunotherapy, and the remaining 118/526 (22.43%) received adjuvant immunotherapy. There was no significant difference in OS between neoadjuvant and adjuvant immunotherapy (HR: 1.06, CI: 0.79-1.41; p

SUBMITTER: Amin S

PROVIDER: S-EPMC7285784 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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The impact of neoadjuvant and adjuvant immunotherapy on the survival of pancreatic cancer patients: a retrospective analysis.

Amin Saber S Baine Michael M Meza Jane J Lin Chi C

BMC cancer 20200609 1

<h4>Background</h4>Immunotherapy has become an essential part of cancer treatment after showing great efficacy in various malignancies. However, its effectiveness in pancreatic ductal adenocarcinoma (PDAC), especially in resectable pancreatic cancer, has not been studied. The primary objective of this study is to compare the OS impact of immunotherapy between PDAC patients who receive neoadjuvant immunotherapy and patients who receive adjuvant immunotherapy. The secondary objective is to investi ...[more]

PMID: 32517661

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Project description:ImportanceThe benefit of adjuvant chemotherapy after resection of pancreatic cancer following neoadjuvant combination treatment with folinic acid, fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX) is unclear.ObjectiveTo assess the association of adjuvant chemotherapy with overall survival (OS) in patients after pancreatic cancer resection and neoadjuvant FOLFIRINOX treatment.Design, setting, and participantsThis international, multicenter, retrospective cohort study was conducted from January 1, 2012, to December 31, 2018. An existing cohort of patients undergoing resection of pancreatic cancer after FOLFIRINOX was updated and expanded for the purpose of this study. All consecutive patients who underwent pancreatic surgery after at least 2 cycles of neoadjuvant FOLFIRINOX chemotherapy for nonmetastatic pancreatic cancer were retrospectively identified from institutional databases. Patients with resectable pancreatic cancer, borderline resectable pancreatic cancer, and locally advanced pancreatic cancer were eligible for this study. Patients with in-hospital mortality or who died within 3 months after surgery were excluded.ExposuresThe association of adjuvant chemotherapy with OS was evaluated in different subgroups including interaction terms for clinicopathological parameters with adjuvant treatment in a multivariable Cox model. Overall survival was defined as the time starting from surgery plus 3 months (moment eligible for adjuvant therapy), unless mentioned otherwise.ResultsWe included 520 patients (median [interquartile range] age, 61 [53-66] years; 279 [53.7%] men) from 31 centers in 19 countries. The median number of neoadjuvant cycles of FOLFIRINOX was 6 (interquartile range, 5-8). Overall, 343 patients (66.0%) received adjuvant chemotherapy, of whom 68 (19.8%) received FOLFIRINOX, 201 (58.6%) received gemcitabine-based chemotherapy, 14 (4.1%) received capecitabine, 45 (13.1%) received a combination or other agents, and 15 (4.4%) received an unknown type of adjuvant chemotherapy. Median OS was 38 months (95% CI, 36-46 months) after diagnosis and 31 months (95% CI, 29-37 months) after surgery. No survival difference was found for patients who received adjuvant chemotherapy vs those who did not (median OS, 29 vs 29 months, univariable hazard ratio [HR], 0.99; 95% CI, 0.77-1.28; P = .93). In multivariable analysis, only the interaction term for lymph node stage with adjuvant therapy was statistically significant: In patients with pathology-proven node-positive disease, adjuvant chemotherapy was associated with improved survival (median OS, 26 vs 13 months; multivariable HR, 0.41 [95% CI, 0.22-0.75]; P = .004). In patients with node-negative disease, adjuvant chemotherapy was not associated with improved survival (median OS, 38 vs 54 months; multivariable HR, 0.85; 95% CI, 0.35-2.10; P = .73).Conclusions and relevanceThese results suggest that adjuvant chemotherapy after neoadjuvant FOLFIRINOX and resection of pancreatic cancer was associated with improved survival only in patients with pathology-proven node-positive disease. Future randomized studies should be conducted to confirm this finding.

Project description:Background: Immunotherapy has shown great success in various malignancies. However, its efficacy in pancreatic ductal adenocarcinoma (PDAC) remains a challenge, and the lack of understanding about the appropriate timing of immunotherapy with other standard-of-care cancer treatments may be one of the causes. The objective of the current study is to investigate the impact of the timing of immunotherapy with chemotherapy and radiation therapy (RT) on the overall survival (OS) of PDAC patients who did not receive surgical resection of the pancreatic tumor. Materials and Methods: Patients with pancreatic adenocarcinoma who did not receive surgical resection of the pancreatic tumor were identified from the National Cancer Database (NCDB). Cox proportional hazard models were employed to compare the OS between patients who received immunotherapy with chemotherapy or RT with a different sequence of treatment. The multivariable analysis was adjusted for age of diagnosis, race, sex, place of living, income, education, treatment facility type, insurance status, and year of diagnosis. Results: In total, 705 patients received chemotherapy and immunotherapy, while 226 received radiation therapy and immunotherapy. In the multivariable analysis, there was no significant difference in the OS of patients who started immunotherapy 31-90 days before the start of chemotherapy with a hazard ratio (HR) of [HR:1.057 (CI: 0.716-1.56; p < 0.781)] and patients who started immunotherapy 91-180 days before the start of chemotherapy [HR: 0.900 (CI: 0.584-1.388; p < 0.635)] compared to patients who started chemotherapy and immunotherapy within 30 days of each other. There was also no significant difference in the OS of patients who started RT> 30 days before the start of immunotherapy [HR: 0.636 (CI: 0.346-1.171; p < 0.146)] and patients who started immunotherapy > 30 days before the start of RT [HR: 0.660 (CI: 0.328-1.329; p < 0.246)] compared to patients who started RT and immunotherapy within 30 days of each other. Conclusion: The sequence of immunotherapy with chemotherapy or RT was not associated with improved OS. Future studies with a larger subgroup sample size investigating the impact of the timing of immunotherapy with chemotherapy and RT on the OS of PDAC patients who do not receive surgical resection of the pancreatic tumor are needed.

Dataset Information

The impact of neoadjuvant and adjuvant immunotherapy on the survival of pancreatic cancer patients: a retrospective analysis.

Publications

The impact of neoadjuvant and adjuvant immunotherapy on the survival of pancreatic cancer patients: a retrospective analysis.

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