Yung-Jue Bang, Eduardo Yañez Ruiz, Eric Van Cutsem, Wook-Lee Lee, Lucjan Wyrwicz, Michael Schenker, Maria Alsina, Min-Hee Ryu, Hyun-Choel Chung, Ludovic Evesque, Salah-Eddin al- Batran, Se Hoon Park, Mikhail Lichinitser, Narikazu Boku, Markus Möhler, Janet Hong, Huiling Xiong, Roland Hallwachs, Ilaria Conti, Julien Taieb
- 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.
MetadatenAuthor: | Yung-Jue Bang, Eduardo Yañez Ruiz, Eric Van Cutsem, Wook-Lee Lee, Lucjan Wyrwicz, Michael Schenker, Maria Alsina, Min-Hee Ryu, Hyun-Choel Chung, Ludovic Evesque, Salah-Eddin al- BatranORCiDGND, Se Hoon Park, Mikhail Lichinitser, Narikazu Boku, Markus Möhler, Janet Hong, Huiling Xiong, Roland Hallwachs, Ilaria Conti, Julien TaiebORCiD |
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URN: | urn:nbn:de:hebis:30:3-535672 |
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DOI: | https://doi.org/10.1093/annonc/mdy264 |
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ISSN: | 1569-8041 |
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ISSN: | 0923-7534 |
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Pubmed Id: | https://pubmed.ncbi.nlm.nih.gov/30052729 |
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Parent Title (English): | Annals of oncology |
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Publisher: | Oxford Univ. Press |
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Place of publication: | Oxford |
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Document Type: | Article |
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Language: | English |
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Year of Completion: | 2018 |
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Date of first Publication: | 2018/07/24 |
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Publishing Institution: | Universitätsbibliothek Johann Christian Senckenberg |
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Release Date: | 2020/05/20 |
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Tag: | PD-L1; avelumab; chemotherapy; gastric cancer; gastro-oesophageal junction cancer; phase III |
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Volume: | 29 |
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Issue: | 10 |
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Page Number: | 9 |
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First Page: | 2052 |
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Last Page: | 2060 |
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Note: | 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 |
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HeBIS-PPN: | 465004709 |
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Institutes: | Medizin / Medizin |
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Dewey Decimal Classification: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
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Sammlungen: | Universitätspublikationen |
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Licence (English): | Creative Commons - Namensnennung-Nicht kommerziell 4.0 |
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