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Adjuvant Gemcitabine Versus Neoadjuvant/Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer: The Randomized Multicenter Phase II NEPAFOX Trial

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Title: Adjuvant Gemcitabine Versus Neoadjuvant/Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer: The Randomized Multicenter Phase II NEPAFOX Trial
Authors: Goetze, Thorsten O., Reichart, Alexander, Bankstahl, Ulli S., Pauligk, Claudia, Loose, Maria, Kraus, Thomas W., Elshafei, Moustafa, Bechstein, Wolf O., Trojan, Jörg, Behrend, Matthias, Homann, Nils, Venerito, Marino, Bohle, Wolfram, Varvenne, Michael, Bolling, Claus, Behringer, Dirk M., Kratz-Albers, Karsten, Siegler, Gabriele M., Hozaeel, Wael, Al-Batran, Salah-Eddin
Source: Ann Surg Oncol
Publisher Information: Springer Science and Business Media LLC, 2024.
Publication Year: 2024
Subject Terms: Male, Adult, Leucovorin, Pancreatic Tumors, Middle Aged, Irinotecan, Prognosis, Deoxycytidine, Gemcitabine, FOLFIRINOX, Leucovorin/administration, Aged [MeSH], Pancreatic Neoplasms/pathology [MeSH], Deoxycytidine/administration, Oxaliplatin/therapeutic use [MeSH], Irinotecan/therapeutic use [MeSH], Neoadjuvant Therapy [MeSH], Male [MeSH], Adenocarcinoma/drug therapy [MeSH], Adenocarcinoma/pathology [MeSH], Pancreatectomy [MeSH], Pancreatic Neoplasms/surgery [MeSH], Fluorouracil/administration, Oxaliplatin/administration, Female [MeSH], Follow-Up Studies [MeSH], Leucovorin/therapeutic use [MeSH], Adult [MeSH], Humans [MeSH], Irinotecan/administration, Middle Aged [MeSH], Neoadjuvant, Pancreatic Neoplasms/drug therapy [MeSH], Antineoplastic Combined Chemotherapy Protocols/therapeutic use [MeSH], Gemcitabine [MeSH], Survival Rate [MeSH], Chemotherapy, Adjuvant [MeSH], Resectable pancreatic cancer, Adjuvant, Deoxycytidine/analogs, Prognosis [MeSH], Adenocarcinoma/mortality [MeSH], Adenocarcinoma/surgery [MeSH], Neoadjuvant Therapy, Pancreatic Neoplasms, Oxaliplatin, Survival Rate, 03 medical and health sciences, Pancreatectomy, 0302 clinical medicine, Chemotherapy, Adjuvant, Antineoplastic Combined Chemotherapy Protocols, Humans, Female, Fluorouracil, Aged, Follow-Up Studies
Description: Background Although addition of adjuvant chemotherapy is the current standard, the prognosis of pancreatic cancers still remains poor. The NEPAFOX trial evaluated perioperative treatment with FOLFIRINOX in resectable pancreatic cancer. Patients and Methods This multicenter phase II trial randomized patients with resectable or borderline resectable pancreatic cancer without metastases into arm (A,) upfront surgery plus adjuvant gemcitabine, or arm (B,) perioperative FOLFIRINOX. The primary endpoint was overall survival (OS). Results Owing to poor accrual, recruitment was prematurely stopped after randomization of 40 of the planned 126 patients (A: 21, B: 19). Overall, approximately three-quarters were classified as primarily resectable (A: 16, B: 15), and the remaining patients were classified as borderline resectable (A: 5, B: 4). Of the 12 evaluable patients, 3 achieved partial response under neoadjuvant FOLFIRINOX. Of the 21 patients in arm A and 19 patients in arm B, 17 and 7 underwent curative surgery, and R0-resection was achieved in 77% and 71%, respectively. Perioperative morbidity occurred in 72% in arm A and 46% in arm B, whereas non-surgical toxicity was comparable in both arms. Median RFS/PFS was almost doubled in arm B (14.1 months) compared with arm A (8.4 months) in the population with surgical resection, whereas median OS was comparable between both arms. Conclusions Although the analysis was only descriptive owing to small patient numbers, no safety issues regarding surgical complications were observed in the perioperative FOLFIRINOX arm. Thus, considering the small number of patients, perioperative treatment approach appears feasible and potentially effective in well-selected cohorts of patients. In pancreatic cancer, patient selection before initiation of neoadjuvant therapy appears to be critical.
Document Type: Article
Other literature type
Language: English
ISSN: 1534-4681
1068-9265
DOI: 10.1245/s10434-024-15011-7
Access URL: https://pubmed.ncbi.nlm.nih.gov/38459418
https://repository.publisso.de/resource/frl:6502185
Rights: CC BY
Accession Number: edsair.doi.dedup.....7b4ce11c691e9689130e7a2b3b172481
Database: OpenAIRE
Description
Abstract:Background Although addition of adjuvant chemotherapy is the current standard, the prognosis of pancreatic cancers still remains poor. The NEPAFOX trial evaluated perioperative treatment with FOLFIRINOX in resectable pancreatic cancer. Patients and Methods This multicenter phase II trial randomized patients with resectable or borderline resectable pancreatic cancer without metastases into arm (A,) upfront surgery plus adjuvant gemcitabine, or arm (B,) perioperative FOLFIRINOX. The primary endpoint was overall survival (OS). Results Owing to poor accrual, recruitment was prematurely stopped after randomization of 40 of the planned 126 patients (A: 21, B: 19). Overall, approximately three-quarters were classified as primarily resectable (A: 16, B: 15), and the remaining patients were classified as borderline resectable (A: 5, B: 4). Of the 12 evaluable patients, 3 achieved partial response under neoadjuvant FOLFIRINOX. Of the 21 patients in arm A and 19 patients in arm B, 17 and 7 underwent curative surgery, and R0-resection was achieved in 77% and 71%, respectively. Perioperative morbidity occurred in 72% in arm A and 46% in arm B, whereas non-surgical toxicity was comparable in both arms. Median RFS/PFS was almost doubled in arm B (14.1 months) compared with arm A (8.4 months) in the population with surgical resection, whereas median OS was comparable between both arms. Conclusions Although the analysis was only descriptive owing to small patient numbers, no safety issues regarding surgical complications were observed in the perioperative FOLFIRINOX arm. Thus, considering the small number of patients, perioperative treatment approach appears feasible and potentially effective in well-selected cohorts of patients. In pancreatic cancer, patient selection before initiation of neoadjuvant therapy appears to be critical.
ISSN:15344681
10689265
DOI:10.1245/s10434-024-15011-7