MATTERHORN: Phase III study of durvalumab plus FLOT chemotherapy in resectable gastric/gastroesophageal junction cancer Review
| Authors: | Janjigian, Y. Y.; Van Cutsem, E.; Muro, K.; Wainberg, Z.; Al-Batran, S. E.; Hyung, W. J.; Molena, D.; Marcovitz, M.; Ruscica, D.; Robbins, S. H.; Negro, A.; Tabernero, J. |
| Review Title: | MATTERHORN: Phase III study of durvalumab plus FLOT chemotherapy in resectable gastric/gastroesophageal junction cancer |
| 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. © 2022 The Authors. |
| Keywords: | adult; controlled study; event free survival; major clinical study; drug tolerability; fluorouracil; placebo; drug efficacy; drug safety; monotherapy; adjuvant therapy; cancer patient; neoadjuvant therapy; chemotherapy; outcome assessment; antineoplastic agent; adenocarcinoma; multiple cycle treatment; antineoplastic combined chemotherapy protocols; randomized controlled trials as topic; pathology; docetaxel; monoclonal antibody; antibodies, monoclonal; immunotherapy; clinical trials, phase iii as topic; multicenter study; folinic acid; stomach cancer; phase 3 clinical trial; oxaliplatin; esophagus cancer; double blind procedure; stomach neoplasms; stomach tumor; sample size; gastric cancer; esophagogastric junction; programmed death 1 receptor; randomized controlled trial (topic); phase 3 clinical trial (topic); pd-l1; gastroesophageal junction cancer; gastroesophageal junction; resectable; immune checkpoint inhibitor; humans; human; male; female; article; durvalumab; immune checkpoint inhibitors; clinical trial protocol; neoadjuvant-adjuvant |
| Journal Title: | Future Oncology |
| Volume: | 18 |
| Issue: | 20 |
| ISSN: | 1479-6694 |
| Publisher: | Future Medicine |
| Date Published: | 2022-06-01 |
| Start Page: | 2465 |
| End Page: | 2473 |
| Language: | English |
| DOI: | 10.2217/fon-2022-0093 |
| PUBMED: | 35535555 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 July 2022 -- Source: Scopus |
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