Abstract
PurposeThe phase III ToGA trial established cisplatin, fluoropyrimidine and trastuzumab as the standard treatment in HER2-positive advanced gastric cancer (AGC). However, as demonstrated in HER2-negative AGC, oxaliplatin-based regimens could improve tolerance remaining effective. The aim of this trial was to explore the potential activity and safety of capecitabine, oxaliplatin (XELOX) and trastuzumab in patients with HER-2 positive advanced gastric cancer.MethodsWe conducted a multicentre, prospective, non-randomised, non-controlled, open-label and national (Spanish) phase II study. Patients with HER2-positive advanced gastric or gastro-oesophageal junction (EGJ) cancer received XELOX and trastuzumab as first-line treatment. Primary endpoint was objective tumour response rate (ORR).Results45 patients from ten hospitals in Spain were included from September 2011 to December 2013. Median age was 65 years, 82.2% were male, 69% had gastric cancer and 31% had EGJ tumours. At a median follow-up of 13.7 months (7.1–20.9), the estimated median progression-free survival and overall survival were 7.1 (95% CI 5.5–8.7) and 13.8 months (95% CI 10.1–17.4), respectively, with 8.9%, 37.8% and 31.1% of patients achieving complete response, partial response and stable disease. Regarding safety, 44.4% of the patients had grade 3 or greater adverse events, being the most frequent diarrhoea (26.6%), fatigue (15.5%), nausea (20%) and vomiting (13.3%). Only two patients (4.4%) developed asymptomatic grade 2 left ventricle ejection fraction reduction.ConclusionsXELOX-trastuzumab is a promising and effective therapy as first-line treatment for patients with HER2-positive AGC, with comparable results to the ones obtained with other “platinum-based” regimens. This scheme is feasible and tolerable with a low incidence of cardiac toxicity.
Highlights
Gastric cancer (GC) is the second most commonly diagnosed cancer in the world
We considered as human epidermal growth factor receptor 2 (HER2)-positive tumours, primary or metastatic samples with HER2 overexpression defined by immunohistochemistry +++ (IHC3+) or ++ (ICH2+) confirmed by fluorescence in situ hybridisation (FISH)/SISH (FISH/SISH+)
Included patients had measurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1, age was ≥ 18 years, Eastern Cooperative Oncology Group (ECOG) score was 0–2, life expectancy was more than 3 months, and they had adequate renal, liver and bone marrow function
Summary
Gastric cancer (GC) is the second most commonly diagnosed cancer in the world. There are important geographical differences in terms of incidence and mortality. In Europe, 140,000 new cases were diagnosed in 2012. 107,000 patients died, being the fourth leading cause of cancer deaths [1]. One of the reasons for such a high mortality rate in GC is the difficulties for an early diagnosis, and its high relapse rate even in resectable tumours. Despite significant advances in the treatment of advanced disease (metastatic, unresectable locally advanced or relapsed disease), its prognosis remains very poor. New therapeutic options need to be investigated
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