A Phase II Study of the Combination of Oxaliplatin, Capecitabine, and Trastuzumab and Chemoradiotherapy in the Adjuvant Setting in Operated Patients With HER2-positive Gastric or Gastroesophageal Junction Cancer (TOXAG Study) A Turkish Oncology Group Study

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dc.contributor.authorAbali, Huseyin
dc.contributor.authorYalcin, Suayib
dc.contributor.authorOnal, Huseyin C.
dc.contributor.authorDane, Faysal
dc.contributor.authorOksuzoglu, Berna
dc.contributor.authorOzdemir, Nuriye
dc.contributor.authorMertsoylu, Huseyin
dc.date.accessioned2024-02-23T14:21:06Z
dc.date.available2024-02-23T14:21:06Z
dc.date.issued2021
dc.departmentNEÜen_US
dc.description.abstractBackground: Trastuzumab prolonged the overall survival in patients with advanced gastric cancer with human epidermal growth factor receptor 2 (HER2) overexpression in combination with chemotherapy. In this phase II open-label prospective study, the tolerability and safety of trastuzumab with chemotherapy, and chemoradiotherapy for curatively resected patients with HER2-positive gastric carcinoma was investigated. Methods: The patients with HER2-positive gastric, or gastroesophageal junction adenocarcinoma, after gastrectomy plus D2 dissection, were included. They received 3 cycles of oxaliplatin (100 mg/m(2) intravenously day 1) plus capecitabine (850 mg/m(2) orally days 1 to 14), trastuzumab (8 mg/kg intravenously day 1 in cycle 1, 6 mg/kg thereafter) every 21 days, followed by chemoradiotherapy. Trastuzumab was given for 1 year. Results: Of the 212 patients screened, 35 were eligible, and 34 were treated. The median age was 56 years (minimum to maximum: 35 to 75 y), male patients constituted 73.5% (n=25), and 33 (97.1%) had gastric adenocarcinoma. R0 resection was performed in 30 (88.2%). The majority (26, 61.7%) were in stage III disease. Most of the adverse events were grade I/II, the most frequent grade III side effects were nausea (3, 8.8%), vomiting (3, 8.8%), diarrhea (2, 5.9%), and weight loss (n=2, 5.9%). Two patients died during the first 3 cycles of chemotherapy and chemoradiotherapy; 1 secondary to pulmonary thromboembolism, and the other due to cerebral ischemia. After excluding 2 with early progression and 1 consent withdrawal, of the remaining 31 patients, 28 (90.3%) were able to complete the chemotherapy and chemoradiotherapy part of the trial. After the 25 months follow-up period, 21 patients (61.8%) were alive. Overall survival at 12 and 24 months was 75.0% and 58.0%, while disease-free survival at 12 and 24 months was 65.7% and 55.0%, respectively. Conclusions: Trastuzumab in combination with capecitabine, oxaliplatin following chemoradiotherapy as the adjuvant therapy for gastric or gastroesophageal junction adenocarcinoma was considered as safe and tolerable. The frequency of HER2 overexpression in curatively resected patients is comparable to that in patients with metastatic diseaseen_US
dc.description.sponsorshipRoche Pharmaceuticals Inc., Turkeyen_US
dc.description.sponsorshipThe study was fully sponsored by Roche Pharmaceuticals Inc., Turkey.en_US
dc.identifier.doi10.1097/COC.0000000000000825
dc.identifier.endpage307en_US
dc.identifier.issn0277-3732
dc.identifier.issn1537-453X
dc.identifier.issue7en_US
dc.identifier.pmid33979100en_US
dc.identifier.scopus2-s2.0-85106972248en_US
dc.identifier.scopusqualityQ2en_US
dc.identifier.startpage301en_US
dc.identifier.urihttps://doi.org/10.1097/COC.0000000000000825
dc.identifier.urihttps://hdl.handle.net/20.500.12452/13445
dc.identifier.volume44en_US
dc.identifier.wosWOS:000668267100002en_US
dc.identifier.wosqualityQ4en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherLippincott Williams & Wilkinsen_US
dc.relation.ispartofAmerican Journal Of Clinical Oncology-Cancer Clinical Trialsen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.subjectGastricen_US
dc.subjectGastroesophagealen_US
dc.subjectHer2en_US
dc.subjectTrastuzumaben_US
dc.subjectGastrectomyen_US
dc.subjectD2 Dissectionen_US
dc.titleA Phase II Study of the Combination of Oxaliplatin, Capecitabine, and Trastuzumab and Chemoradiotherapy in the Adjuvant Setting in Operated Patients With HER2-positive Gastric or Gastroesophageal Junction Cancer (TOXAG Study) A Turkish Oncology Group Studyen_US
dc.typeArticleen_US

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