Perioperative trastuzumab, capecitabine and oxaliplatin in patients with HER2-positive resectable gastric or gastro-oesophageal junction adenocarcinoma: NEOHX phase II trial
Perioperative chemotherapy improves overall survival (OS) and disease-free survival (DFS) compared with surgery alone in patients with resectable gastric adenocarcinoma (GA) or gastro-oesophageal junction adenocarcinoma (GEJA). The addition of trastuzumab to chemotherapy improves outcomes in patient...
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| Veröffentlicht in: | European journal of cancer (1990) 2021-03, Vol.145, p.158-167 |
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| creator | Rivera, Fernando Izquierdo-Manuel, Marta García-Alfonso, Pilar Martínez de Castro, Eva Gallego, Javier Limón, María Luisa Alsina, María López, Luis Galán, Maica Falcó, Esther Manzano, José Luis González, Encarna Muñoz-Unceta, Nerea López, Carlos Aranda, Enrique Fernández, Eva Jorge, Mónica Jiménez-Fonseca, Paula |
| description | Perioperative chemotherapy improves overall survival (OS) and disease-free survival (DFS) compared with surgery alone in patients with resectable gastric adenocarcinoma (GA) or gastro-oesophageal junction adenocarcinoma (GEJA). The addition of trastuzumab to chemotherapy improves outcomes in patients with HER2-positive advanced gastric cancer (GC), and we aimed to explore its role in the perioperative setting.
This Spanish, multicentre, open-label phase II trial evaluated the efficacy and toxicity of perioperative capecitabine, oxaliplatin and trastuzumab (XELOX-T) in patients with HER2-positive resectable GA or GEJA. The primary end-point was 18-months DFS; and secondary end-points included pathological complete response (pCR) rate, R0 resection rate, OS and toxicity (NCT01130337).
Thirty-six patients were included. After three cycles of preoperative treatment, 14 patients (38% of the intention-to-treat population) had partial response and 18 (50%) had stable disease. Surgery was performed in 31 patients: 28 (90%) had R0 resection, three (9.6%) had a pCR and three (9.6%) died due to surgical complications. A total of 24 patients received post-operative XELOX-T, 22 of whom completed trastuzumab maintenance. Main grade III/IV toxicities included diarrhoea (33%), nausea and vomiting (8%). After a median follow-up of 24.1 months, 18-month DFS was 71% (95% confidence interval [CI], 53–83%); and an update after 102 months of follow-up showed a median OS of 79.9 months and a 60-month OS of 58% (95% CI, 40–73%).
These data suggest that perioperative XELOX-T in patients with HER2-positive GA and GEJA is feasible and active. Further investigation in randomised studies is warranted.
•Perioperative administration of XELOX-T is safe and tolerable.•Beyond expectation, 70% patients achieved a disease-free survival of 18 months.•This scheme should be further investigated in larger randomised clinical trial. |
| doi_str_mv | 10.1016/j.ejca.2020.12.005 |
| format | Article |
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This Spanish, multicentre, open-label phase II trial evaluated the efficacy and toxicity of perioperative capecitabine, oxaliplatin and trastuzumab (XELOX-T) in patients with HER2-positive resectable GA or GEJA. The primary end-point was 18-months DFS; and secondary end-points included pathological complete response (pCR) rate, R0 resection rate, OS and toxicity (NCT01130337).
Thirty-six patients were included. After three cycles of preoperative treatment, 14 patients (38% of the intention-to-treat population) had partial response and 18 (50%) had stable disease. Surgery was performed in 31 patients: 28 (90%) had R0 resection, three (9.6%) had a pCR and three (9.6%) died due to surgical complications. A total of 24 patients received post-operative XELOX-T, 22 of whom completed trastuzumab maintenance. Main grade III/IV toxicities included diarrhoea (33%), nausea and vomiting (8%). After a median follow-up of 24.1 months, 18-month DFS was 71% (95% confidence interval [CI], 53–83%); and an update after 102 months of follow-up showed a median OS of 79.9 months and a 60-month OS of 58% (95% CI, 40–73%).
These data suggest that perioperative XELOX-T in patients with HER2-positive GA and GEJA is feasible and active. Further investigation in randomised studies is warranted.
•Perioperative administration of XELOX-T is safe and tolerable.•Beyond expectation, 70% patients achieved a disease-free survival of 18 months.•This scheme should be further investigated in larger randomised clinical trial.</description><identifier>ISSN: 0959-8049</identifier><identifier>EISSN: 1879-0852</identifier><identifier>DOI: 10.1016/j.ejca.2020.12.005</identifier><identifier>PMID: 33485079</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Adenocarcinoma ; Capecitabine ; Chemotherapy ; Complications ; Confidence intervals ; Diarrhea ; ErbB-2 protein ; Esophagus ; Gastric cancer ; HER2-positive ; Locally advanced gastric cancer ; Monoclonal antibodies ; Nausea ; Oxaliplatin ; Patients ; Perioperative chemotherapy ; Phase II clinical trial ; Surgery ; Surgical outcomes ; Survival ; Targeted cancer therapy ; Toxicity ; Trastuzumab ; Vomiting</subject><ispartof>European journal of cancer (1990), 2021-03, Vol.145, p.158-167</ispartof><rights>2020 Elsevier Ltd</rights><rights>Copyright © 2020 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Science Ltd. Mar 2021</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c384t-be0970c4521296918e54eee33c63cf3d5282a5facffe4992a938340a6cb4cc303</citedby><cites>FETCH-LOGICAL-c384t-be0970c4521296918e54eee33c63cf3d5282a5facffe4992a938340a6cb4cc303</cites><orcidid>0000-0002-0584-1242</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0959804920314179$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3536,27903,27904,65309</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33485079$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rivera, Fernando</creatorcontrib><creatorcontrib>Izquierdo-Manuel, Marta</creatorcontrib><creatorcontrib>García-Alfonso, Pilar</creatorcontrib><creatorcontrib>Martínez de Castro, Eva</creatorcontrib><creatorcontrib>Gallego, Javier</creatorcontrib><creatorcontrib>Limón, María Luisa</creatorcontrib><creatorcontrib>Alsina, María</creatorcontrib><creatorcontrib>López, Luis</creatorcontrib><creatorcontrib>Galán, Maica</creatorcontrib><creatorcontrib>Falcó, Esther</creatorcontrib><creatorcontrib>Manzano, José Luis</creatorcontrib><creatorcontrib>González, Encarna</creatorcontrib><creatorcontrib>Muñoz-Unceta, Nerea</creatorcontrib><creatorcontrib>López, Carlos</creatorcontrib><creatorcontrib>Aranda, Enrique</creatorcontrib><creatorcontrib>Fernández, Eva</creatorcontrib><creatorcontrib>Jorge, Mónica</creatorcontrib><creatorcontrib>Jiménez-Fonseca, Paula</creatorcontrib><title>Perioperative trastuzumab, capecitabine and oxaliplatin in patients with HER2-positive resectable gastric or gastro-oesophageal junction adenocarcinoma: NEOHX phase II trial</title><title>European journal of cancer (1990)</title><addtitle>Eur J Cancer</addtitle><description>Perioperative chemotherapy improves overall survival (OS) and disease-free survival (DFS) compared with surgery alone in patients with resectable gastric adenocarcinoma (GA) or gastro-oesophageal junction adenocarcinoma (GEJA). The addition of trastuzumab to chemotherapy improves outcomes in patients with HER2-positive advanced gastric cancer (GC), and we aimed to explore its role in the perioperative setting.
This Spanish, multicentre, open-label phase II trial evaluated the efficacy and toxicity of perioperative capecitabine, oxaliplatin and trastuzumab (XELOX-T) in patients with HER2-positive resectable GA or GEJA. The primary end-point was 18-months DFS; and secondary end-points included pathological complete response (pCR) rate, R0 resection rate, OS and toxicity (NCT01130337).
Thirty-six patients were included. After three cycles of preoperative treatment, 14 patients (38% of the intention-to-treat population) had partial response and 18 (50%) had stable disease. Surgery was performed in 31 patients: 28 (90%) had R0 resection, three (9.6%) had a pCR and three (9.6%) died due to surgical complications. A total of 24 patients received post-operative XELOX-T, 22 of whom completed trastuzumab maintenance. Main grade III/IV toxicities included diarrhoea (33%), nausea and vomiting (8%). After a median follow-up of 24.1 months, 18-month DFS was 71% (95% confidence interval [CI], 53–83%); and an update after 102 months of follow-up showed a median OS of 79.9 months and a 60-month OS of 58% (95% CI, 40–73%).
These data suggest that perioperative XELOX-T in patients with HER2-positive GA and GEJA is feasible and active. Further investigation in randomised studies is warranted.
•Perioperative administration of XELOX-T is safe and tolerable.•Beyond expectation, 70% patients achieved a disease-free survival of 18 months.•This scheme should be further investigated in larger randomised clinical trial.</description><subject>Adenocarcinoma</subject><subject>Capecitabine</subject><subject>Chemotherapy</subject><subject>Complications</subject><subject>Confidence intervals</subject><subject>Diarrhea</subject><subject>ErbB-2 protein</subject><subject>Esophagus</subject><subject>Gastric cancer</subject><subject>HER2-positive</subject><subject>Locally advanced gastric cancer</subject><subject>Monoclonal antibodies</subject><subject>Nausea</subject><subject>Oxaliplatin</subject><subject>Patients</subject><subject>Perioperative chemotherapy</subject><subject>Phase II clinical trial</subject><subject>Surgery</subject><subject>Surgical outcomes</subject><subject>Survival</subject><subject>Targeted cancer therapy</subject><subject>Toxicity</subject><subject>Trastuzumab</subject><subject>Vomiting</subject><issn>0959-8049</issn><issn>1879-0852</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNp9kc-KFDEQh4Mo7rj6Ah4k4MWDPabzpycRL7KMzsDiiih4C9Xp6t003Z026V7dfSff0YyzevAgBFIUX_0o6iPkacnWJSurV90aOwdrznhu8DVj6h5ZlXpjCqYVv09WzChTaCbNCXmUUscY22jJHpITIaRWbGNW5OdHjD5MGGH210jnCGlebpcB6pfUwYTOz1D7ESmMDQ0_oPdTn9GR5jflAsc50e9-vqK77SdeTCH530ERE7o82iO9zJHROxrisQxFwBSmK7hE6Gm3jG72YaTQ4BgcROfHMMBr-mF7sftKM5aQ7vd5Mw_9Y_KghT7hk7v_lHx5t_18tivOL97vz96eF05oORc1MrNhTipeclOZUqOSiCiEq4RrRaO45qBacG2L0hgORmghGVSuls4JJk7Ji2PuFMO3BdNsB58c9j2MGJZkudRMlUYYmdHn_6BdWOKYt7NcZQ9aV0Znih8pF0NKEVs7RT9AvLElsweZtrMHmfYg05bcZpl56Nld9FIP2Pwd-WMvA2-OAOZbXHuMNrlsxGHjY76-bYL_X_4v7GOzTQ</recordid><startdate>202103</startdate><enddate>202103</enddate><creator>Rivera, Fernando</creator><creator>Izquierdo-Manuel, Marta</creator><creator>García-Alfonso, Pilar</creator><creator>Martínez de Castro, Eva</creator><creator>Gallego, Javier</creator><creator>Limón, María Luisa</creator><creator>Alsina, María</creator><creator>López, Luis</creator><creator>Galán, Maica</creator><creator>Falcó, Esther</creator><creator>Manzano, José Luis</creator><creator>González, Encarna</creator><creator>Muñoz-Unceta, Nerea</creator><creator>López, Carlos</creator><creator>Aranda, Enrique</creator><creator>Fernández, Eva</creator><creator>Jorge, Mónica</creator><creator>Jiménez-Fonseca, Paula</creator><general>Elsevier Ltd</general><general>Elsevier Science Ltd</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7TO</scope><scope>7U7</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-0584-1242</orcidid></search><sort><creationdate>202103</creationdate><title>Perioperative trastuzumab, capecitabine and oxaliplatin in patients with HER2-positive resectable gastric or gastro-oesophageal junction adenocarcinoma: NEOHX phase II trial</title><author>Rivera, Fernando ; 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The addition of trastuzumab to chemotherapy improves outcomes in patients with HER2-positive advanced gastric cancer (GC), and we aimed to explore its role in the perioperative setting.
This Spanish, multicentre, open-label phase II trial evaluated the efficacy and toxicity of perioperative capecitabine, oxaliplatin and trastuzumab (XELOX-T) in patients with HER2-positive resectable GA or GEJA. The primary end-point was 18-months DFS; and secondary end-points included pathological complete response (pCR) rate, R0 resection rate, OS and toxicity (NCT01130337).
Thirty-six patients were included. After three cycles of preoperative treatment, 14 patients (38% of the intention-to-treat population) had partial response and 18 (50%) had stable disease. Surgery was performed in 31 patients: 28 (90%) had R0 resection, three (9.6%) had a pCR and three (9.6%) died due to surgical complications. A total of 24 patients received post-operative XELOX-T, 22 of whom completed trastuzumab maintenance. Main grade III/IV toxicities included diarrhoea (33%), nausea and vomiting (8%). After a median follow-up of 24.1 months, 18-month DFS was 71% (95% confidence interval [CI], 53–83%); and an update after 102 months of follow-up showed a median OS of 79.9 months and a 60-month OS of 58% (95% CI, 40–73%).
These data suggest that perioperative XELOX-T in patients with HER2-positive GA and GEJA is feasible and active. Further investigation in randomised studies is warranted.
•Perioperative administration of XELOX-T is safe and tolerable.•Beyond expectation, 70% patients achieved a disease-free survival of 18 months.•This scheme should be further investigated in larger randomised clinical trial.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>33485079</pmid><doi>10.1016/j.ejca.2020.12.005</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-0584-1242</orcidid></addata></record> |
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| source | Elsevier ScienceDirect Journals |
| subjects | Adenocarcinoma Capecitabine Chemotherapy Complications Confidence intervals Diarrhea ErbB-2 protein Esophagus Gastric cancer HER2-positive Locally advanced gastric cancer Monoclonal antibodies Nausea Oxaliplatin Patients Perioperative chemotherapy Phase II clinical trial Surgery Surgical outcomes Survival Targeted cancer therapy Toxicity Trastuzumab Vomiting |
| title | Perioperative trastuzumab, capecitabine and oxaliplatin in patients with HER2-positive resectable gastric or gastro-oesophageal junction adenocarcinoma: NEOHX phase II trial |
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