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ToGA: Trastuzumab plus chemotherapy improved survival in HER2-positive gastric cancer
Trastuzumab, a recombinant monoclonal antibody against HER2, plus standard chemotherapy reduced the risk for death by 26% in patients with HER2-positive gastric cancer, according to data from the ToGA trial. These data suggest that adding trastuzumab to chemotherapy could be the new standard of care for HER2-positive patients.
“Trastuzumab is safe in this setting. This is the first targeted approach of individualized treatment in patients with gastric cancer,” Eric Van Cutsem, MD, PhD, University Hospital Gasthuisberg, Leuven, Belgium, said during his presentation at the 2009 ASCO Annual Meeting.
The randomized, prospective, multicenter, phase-3 trial included 3,807 patients with locally advanced, recurrent or metastatic gastroesophageal and gastric adenocarcinoma. Tumors were tested for HER2 status; 22.1% of patients were HER2-positive.
Patients were randomly assigned standard chemotherapy with 5-FU or capecitabine plus cisplatin (n=290) or standard chemotherapy plus trastuzumab (n=294). Trastuzumab was given until disease progression. The primary endpoint was OS; secondary endpoints included overall response rate, PFS, time-to-progression, duration of response and safety.
Compared with standard chemotherapy, trastuzumab plus chemotherapy was associated with increased OS: 11.1 months vs. 13.8 months (HR=0.74; 95% CI, 0.60-0.91). Additionally, trastuzumab plus chemotherapy was associated with an improved overall response rate: 47.3% vs. 34.5% (P=.0017).
The treatment was generally well tolerated with no unexpected adverse effects in the trastuzumab group.
According to Van Cutsem, based on these data patients with gastric cancer should be aware of the option to test for HER2 status based on protein expression or fluorescent in situ hybridization. - by Stacey L. Adams
This is one of the first large chemotherapy trials in gastric cancer to demonstrate survival longer than a year and it also shows a significant survival improvement for the addition of trastuzumab to chemotherapy compared to chemotherapy alone. This may lead to a new standard of care in gastric cancer. Patients with metastatic gastric cancer should be tested for HER2 overexpression and they should be candidates for treatment with chemotherapy plus trastuzumab based on the survival benefits seen with this study.
Improvements in response rates and improvements in OS suggest that we should now start potentially testing patients with gastric cancer for HER2 overexpression, and in the metastatic setting consider a combination of trastuzumab with chemotherapy in patients that overexpress HER2.
– David H. Ilson, MD
HemOnc Today Editorial Board member
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