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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

Cited 169 time in Web of Science Cited 168 time in Scopus
Authors
Bang, Yung-Jue; Ruiz, E. Yanez; Van Cutsem, E.; Lee, K. -W.; Wyrwicz, L.; Schenker, M.; Alsina, M.; Ryu, M. -H.; Chung, H. -C.; Evesque, L.; Al-Batran, S. -E.; Park, S. H.; Lichinitser, M.; Boku, N.; Moehler, M. H.; Hong, J.; Xiong, H.; Hallwachs, R.; Conti, I.; Taieb, J.
Issue Date
2018-10
Citation
Annals of Oncology, Vol.29 No.10, pp.2052-2060
Keywords
PD-L1avelumabchemotherapygastric cancergastro-oesophageal junction cancerphase III
Abstract
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/m(2) on days 1, 8, and 15 or irinotecan 150 mg/m(2) 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.
ISSN
0923-7534
URI
https://hdl.handle.net/10371/173182
DOI
https://doi.org/10.1093/annonc/mdy264
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College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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