Seufferlein, T., Uhl, W., Kornmann, M., Alguel, H., Friess, H., Koenig, A., Ghadimi, M., Gallmeier, E., Bartsch, D. K., Lutz, M. P., Metzger, R., Wille, K., Gerdes, B., Schimanski, C. C., Graupe, F., Kunzmann, V., Klein, I., Geissler, M., Staib, L., Waldschmidt, D., Bruns, C., Wittel, U., Fichtner-Feigl, S., Daum, S., Hinke, A., Blome, L., Tannapfel, A., Kleger, A., Berger, A. W., Kestler, A. M. R., Schuhbaur, J. S., Perkhofer, L., Tempero, M., Reinacher-Schick, A. C. and Ettrich, T. J. (2023). Perioperative or only adjuvant gemcitabine plus nab-paclitaxel for resectable pancreatic cancer (NEONAX)da randomized phase II trial of the AIO pancreatic cancer group. Ann. Oncol., 34 (1). S. 91 - 101. AMSTERDAM: ELSEVIER. ISSN 1569-8041

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Abstract

Background: Data on perioperative chemotherapy in resectable pancreatic ductal adenocarcinoma (rPDAC) are limited. NEONAX examined perioperative or adjuvant chemotherapy with gemcitabine plus nab-paclitaxel in rPDAC (National Comprehensive Cancer Network criteria).Patients and methods: NEONAX is a prospective, randomized phase II trial with two independent experimental arms. One hundred twenty-seven rPDAC patients in 22 German centers were randomized 1 : 1 to perioperative (two preoperative and four post-operative cycles, arm A) or adjuvant (six cycles, arm B) gemcitabine (1000 mg/m2) and nabpaclitaxel (125 mg/m2) on days 1, 8 and 15 of a 28-day cycle.Results: The primary endpoint was disease-free survival (DFS) at 18 months in the modified intention-to-treat (ITT) population [R0/R1-resected patients who started neoadjuvant chemotherapy (CTX) (A) or adjuvant CTX (B)]. The predefined DFS rate of 55% at 18 months was not reached in both arms [A: 33.3% (95% confidence interval [CI] 18.5% to 48.1%), B: 41.4% (95% CI 20.7% to 62.0%)]. Ninety percent of patients in arm A completed neoadjuvant treatment, and 42% of patients in arm B started adjuvant chemotherapy. R0 resection rate was 88% (arm A) and 67% (arm B), respectively. Median overall survival (mOS) (ITT population) as a secondary endpoint was 25.5 months (95% CI 19.7-29.7 months) in arm A and 16.7 months (95% CI 11.6-22.2 months) in the upfront surgery arm. This difference corresponds to a median DFS (mDFS) (ITT) of 11.5 months (95% CI 8.8-14.5 months) in arm A and 5.9 months (95% CI 3.6-11.5 months) in arm B. Treatment was safe and well tolerable in both arms.Conclusions: The primary endpoint, DFS rate of 55% at 18 months (mITT population), was not reached in either arm of the trial and numerically favored the upfront surgery arm B. mOS (ITT population), a secondary endpoint, numerically favored the neoadjuvant arm A [25.5 months (95% CI 19.7-29.7months); arm B 16.7 months (95% CI 11.6-22.2 months)]. There was a difference in chemotherapy exposure with 90% of patients in arm A completing pre-operative chemotherapy and 58% of patients starting adjuvant chemotherapy in arm B. Neoadjuvant/ perioperative treatment is a novel option for patients with resectable PDAC. However, the optimal treatment regimen has yet to be defined.The trial is registered with ClinicalTrials.gov (NCT02047513) and the European Clinical Trials Database (EudraCT 2013 e005559-34).

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Seufferlein, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Uhl, W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kornmann, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Alguel, H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Friess, H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Koenig, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ghadimi, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gallmeier, E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bartsch, D. K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lutz, M. P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Metzger, R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wille, K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gerdes, B.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schimanski, C. C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Graupe, F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kunzmann, V.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Klein, I.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Geissler, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Staib, L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Waldschmidt, D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bruns, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wittel, U.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fichtner-Feigl, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Daum, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hinke, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Blome, L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tannapfel, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kleger, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Berger, A. W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kestler, A. M. R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schuhbaur, J. S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Perkhofer, L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tempero, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reinacher-Schick, A. C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ettrich, T. J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-694902
DOI: 10.1016/j.annonc.2022.09.161
Journal or Publication Title: Ann. Oncol.
Volume: 34
Number: 1
Page Range: S. 91 - 101
Date: 2023
Publisher: ELSEVIER
Place of Publication: AMSTERDAM
ISSN: 1569-8041
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
CHEMOTHERAPY; CHEMORADIOTHERAPY; RESECTION; SURGERYMultiple languages
OncologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/69490

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