TY  - JOUR
A1  - Bang, Yung-Jue
A1  - Yañez Ruiz, Eduardo
A1  - Van Cutsem, Eric
A1  - Lee, Wook-Lee
A1  - Wyrwicz, Lucjan
A1  - Schenker, Michael
A1  - Alsina, Maria
A1  - Ryu, Min-Hee
A1  - Chung, Hyun-Choel
A1  - Evesque, Ludovic
A1  - Batran, Salah-Eddin al-
A1  - Park, Se Hoon
A1  - Lichinitser, Mikhail
A1  - Boku, Narikazu
A1  - Möhler, Markus
A1  - Hong, Janet
A1  - Xiong, Huiling
A1  - Hallwachs, Roland
A1  - Conti, Ilaria
A1  - Taieb, Julien
T1  - Phase III, randomised trial of avelumab versus physician's choice of chemotherapy as third-line treatment of patients with advanced gastric or gastro-oesophageal junction cancer: primary analysis of JAVELIN Gastric 300
T2  - Annals of oncology
N2  - Background: There currently are no internationally recognised treatment guidelines for patients with advanced gastric cancer/gastro-oesophageal junction cancer (GC/GEJC) in whom two prior lines of therapy have failed. The randomised, phase III JAVELIN Gastric 300 trial compared avelumab versus physician’s choice of chemotherapy as third-line therapy in patients with advanced GC/GEJC.
Patients and methods: Patients with unresectable, recurrent, locally advanced, or metastatic GC/GEJC were recruited at 147 sites globally. All patients were randomised to receive either avelumab 10 mg/kg by intravenous infusion every 2 weeks or physician’s choice of chemotherapy (paclitaxel 80 mg/m2 on days 1, 8, and 15 or irinotecan 150 mg/m2 on days 1 and 15, each of a 4-week treatment cycle); patients ineligible for chemotherapy received best supportive care. The primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety.
Results: A total of 371 patients were randomised. The trial did not meet its primary end point of improving OS {median, 4.6 versus 5.0 months; hazard ratio (HR)=1.1 [95% confidence interval (CI) 0.9–1.4]; P= 0.81} or the secondary end points of PFS [median, 1.4 versus 2.7 months; HR=1.73 (95% CI 1.4–2.2); P> 0.99] or ORR (2.2% versus 4.3%) in the avelumab versus chemotherapy arms, respectively. Treatment-related adverse events (TRAEs) of any grade occurred in 90 patients (48.9%) and 131 patients (74.0%) in the avelumab and chemotherapy arms, respectively. Grade ≥3 TRAEs occurred in 17 patients (9.2%) in the avelumab arm and in 56 patients (31.6%) in the chemotherapy arm.
Conclusions: Treatment of patients with GC/GEJC with single-agent avelumab in the third-line setting did not result in an improvement in OS or PFS compared with chemotherapy. Avelumab showed a more manageable safety profile than chemotherapy.
Trial registration: ClinicalTrials.gov: NCT02625623.
KW  - PD-L1
KW  - avelumab
KW  - chemotherapy
KW  - gastric cancer
KW  - gastro-oesophageal junction cancer
KW  - phase III
Y1  - 2018
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/53567
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-535672
SN  - 1569-8041
SN  - 0923-7534
N1  - This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
VL  - 29
IS  - 10
SP  - 2052
EP  - 2060
PB  - Oxford Univ. Press
CY  - Oxford
ER  -