MATTERHORN: phase III study of durvalumab plus FLOT chemotherapy in resectable gastric/gastroesophageal junction cancer
Standard-of-care for resectable gastric/gastroesophageal junction cancer includes surgery and neoadjuvant-adjuvant 5-fluorouracil-leucovorin-oxaliplatin-docetaxel (FLOT) chemotherapy. Early-phase clinical studies support further clinical development of the immune checkpoint inhibitor (ICI); durvalum...
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| Veröffentlicht in: | Future oncology (London, England) Jg. 18; H. 20; S. 2465 |
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| Sprache: | Englisch |
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01.06.2022
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| ISSN: | 1744-8301, 1744-8301 |
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| Abstract | Standard-of-care for resectable gastric/gastroesophageal junction cancer includes surgery and neoadjuvant-adjuvant 5-fluorouracil-leucovorin-oxaliplatin-docetaxel (FLOT) chemotherapy. Early-phase clinical studies support further clinical development of the immune checkpoint inhibitor (ICI); durvalumab, an anti-PD-L1 antibody, in patients with gastric/gastroesophageal junction cancer. Accumulating evidence indicates that ICIs combined with FLOT chemotherapy improve clinical outcomes in patients with advanced or metastatic cancer. We describe the rationale for and the design of MATTERHORN, a randomized, double-blind, placebo-controlled, phase III study investigating the efficacy and safety of neoadjuvant-adjuvant durvalumab and FLOT chemotherapy followed by adjuvant durvalumab monotherapy in patients with resectable gastric/gastroesophageal junction cancer. The planned sample size is 900 patients, the primary end point is event-free survival and safety and tolerability will be evaluated. Clinical trial registration: NCT04592913 (ClinicalTrials.gov). |
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| AbstractList | Standard-of-care for resectable gastric/gastroesophageal junction cancer includes surgery and neoadjuvant-adjuvant 5-fluorouracil-leucovorin-oxaliplatin-docetaxel (FLOT) chemotherapy. Early-phase clinical studies support further clinical development of the immune checkpoint inhibitor (ICI); durvalumab, an anti-PD-L1 antibody, in patients with gastric/gastroesophageal junction cancer. Accumulating evidence indicates that ICIs combined with FLOT chemotherapy improve clinical outcomes in patients with advanced or metastatic cancer. We describe the rationale for and the design of MATTERHORN, a randomized, double-blind, placebo-controlled, phase III study investigating the efficacy and safety of neoadjuvant-adjuvant durvalumab and FLOT chemotherapy followed by adjuvant durvalumab monotherapy in patients with resectable gastric/gastroesophageal junction cancer. The planned sample size is 900 patients, the primary end point is event-free survival and safety and tolerability will be evaluated. Clinical trial registration: NCT04592913 (ClinicalTrials.gov).Standard-of-care for resectable gastric/gastroesophageal junction cancer includes surgery and neoadjuvant-adjuvant 5-fluorouracil-leucovorin-oxaliplatin-docetaxel (FLOT) chemotherapy. Early-phase clinical studies support further clinical development of the immune checkpoint inhibitor (ICI); durvalumab, an anti-PD-L1 antibody, in patients with gastric/gastroesophageal junction cancer. Accumulating evidence indicates that ICIs combined with FLOT chemotherapy improve clinical outcomes in patients with advanced or metastatic cancer. We describe the rationale for and the design of MATTERHORN, a randomized, double-blind, placebo-controlled, phase III study investigating the efficacy and safety of neoadjuvant-adjuvant durvalumab and FLOT chemotherapy followed by adjuvant durvalumab monotherapy in patients with resectable gastric/gastroesophageal junction cancer. The planned sample size is 900 patients, the primary end point is event-free survival and safety and tolerability will be evaluated. Clinical trial registration: NCT04592913 (ClinicalTrials.gov). Standard-of-care for resectable gastric/gastroesophageal junction cancer includes surgery and neoadjuvant-adjuvant 5-fluorouracil-leucovorin-oxaliplatin-docetaxel (FLOT) chemotherapy. Early-phase clinical studies support further clinical development of the immune checkpoint inhibitor (ICI); durvalumab, an anti-PD-L1 antibody, in patients with gastric/gastroesophageal junction cancer. Accumulating evidence indicates that ICIs combined with FLOT chemotherapy improve clinical outcomes in patients with advanced or metastatic cancer. We describe the rationale for and the design of MATTERHORN, a randomized, double-blind, placebo-controlled, phase III study investigating the efficacy and safety of neoadjuvant-adjuvant durvalumab and FLOT chemotherapy followed by adjuvant durvalumab monotherapy in patients with resectable gastric/gastroesophageal junction cancer. The planned sample size is 900 patients, the primary end point is event-free survival and safety and tolerability will be evaluated. Clinical trial registration: NCT04592913 (ClinicalTrials.gov). |
| Author | Van Cutsem, Eric Wainberg, Zev Marcovitz, Michelle Al-Batran, Salah-Eddin Molena, Daniela Hyung, Woo Jin Robbins, Scott H Janjigian, Yelena Y Muro, Kei Tabernero, Josep Negro, Alejandra Ruscica, Dario |
| Author_xml | – sequence: 1 givenname: Yelena Y orcidid: 0000-0002-5357-5858 surname: Janjigian fullname: Janjigian, Yelena Y organization: Gastrointestinal Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA – sequence: 2 givenname: Eric surname: Van Cutsem fullname: Van Cutsem, Eric organization: Department of Gastroenterology/Digestive Oncology, University Hospitals Leuven & KU Leuven, Leuven, 3000, Belgium – sequence: 3 givenname: Kei surname: Muro fullname: Muro, Kei organization: Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, 464-8681, Japan – sequence: 4 givenname: Zev surname: Wainberg fullname: Wainberg, Zev organization: Department of Gastrointestinal Medical Oncology, David Geffen School of Medicine at UCLA, Los Angeles, CA 90404, USA – sequence: 5 givenname: Salah-Eddin surname: Al-Batran fullname: Al-Batran, Salah-Eddin organization: Institute of Clinical Cancer Research, Krankenhaus Nordwest, University Cancer Center, Frankfurt, 60488, Germany – sequence: 6 givenname: Woo Jin surname: Hyung fullname: Hyung, Woo Jin organization: Department of Surgery, Yonsei University College of Medicine, Seoul, 03722, South Korea – sequence: 7 givenname: Daniela surname: Molena fullname: Molena, Daniela organization: Esophageal Surgery Program, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA – sequence: 8 givenname: Michelle surname: Marcovitz fullname: Marcovitz, Michelle organization: Statistics, AstraZeneca, Gaithersburg, MD 20878, USA – sequence: 9 givenname: Dario surname: Ruscica fullname: Ruscica, Dario organization: Global Clinical Development, AstraZeneca, Cambridge, CB2 8PA, UK – sequence: 10 givenname: Scott H surname: Robbins fullname: Robbins, Scott H organization: Global Clinical Development, AstraZeneca, Gaithersburg, MD 20878, USA – sequence: 11 givenname: Alejandra surname: Negro fullname: Negro, Alejandra organization: Global Clinical Development, AstraZeneca, Gaithersburg, MD 20878, USA – sequence: 12 givenname: Josep surname: Tabernero fullname: Tabernero, Josep organization: Medical Oncology Department, Vall d'Hebron Hospital Campus & Institute of Oncology (VHIO), IOB-Quiron, UVic-UCC, Barcelona, 08035, Spain |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/35535555$$D View this record in MEDLINE/PubMed |
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| Keywords | neoadjuvant-adjuvant resectable durvalumab gastric cancer immunotherapy PD-L1 gastroesophageal junction cancer immune checkpoint inhibitors chemotherapy |
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| Title | MATTERHORN: phase III study of durvalumab plus FLOT chemotherapy in resectable gastric/gastroesophageal junction cancer |
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