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ToGA

ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer

Phase 3N = 594NCT01041404

Population
Advanced gastric or gastro-oesophageal junction cancer with HER2 protein overexpression by immunohistochemistry or gene amplification by fluorescence in-situ hybridisation (FISH). Prior-treatment eligibility is not stated in the abstract.
Design
Open-label international phase 3 randomised trial in 122 centres in 24 countries. Patients were randomly assigned 1:1 to capecitabine plus cisplatin or fluorouracil plus cisplatin every 3 weeks for six cycles, with or without intravenous trastuzumab; block randomisation stratified by ECOG performance status, chemotherapy regimen, extent of disease, primary cancer site and measurability of disease. Primary endpoint: overall survival in all randomised patients who received study medication at least once (584 of 594 randomised).
Primary endpoint
OS
Arms
  • Chemotherapy alone (control, n = 296): Capecitabine plus cisplatin or fluorouracil plus cisplatin every 3 weeks for six cycles
  • Trastuzumab plus chemotherapy (experimental, n = 298): The same chemotherapy with intravenous trastuzumab
People
Bang YJ, ToGA Trial Investigators
OSHR 0.74 (95% CI 0.60–0.91)Δ median OS+2.7 months
Show the numbers
Results reported for ToGA
EndpointAnalysisTrastuzumab plus chemotherapyChemotherapy aloneEffect
OSAll randomised patients who received study medication at least once (584: 294 trastuzumab plus chemotherapy, 290 chemotherapy alone)primaryBang 2010median 13.8 months (12–16)median 11.1 months (10–13)HR 0.74 (95% CI 0.60–0.91)P=0.0046Median follow-up 18.6 months (IQR 11-25) with trastuzumab plus chemotherapy and 17.1 months (9-25) with chemotherapy alone. The 594 randomly assigned patients were 298 and 296; the abstract's primary analysis set is 584.
Results reported for ToGA
EndpointAnalysisTrastuzumab plus chemotherapyChemotherapy aloneEffect
OSAll randomised patients who received study medication at least once (584: 294 trastuzumab plus chemotherapy, 290 chemotherapy alone)primaryBang 2010median 13.8 months (12–16)median 11.1 months (10–13)HR 0.74 (95% CI 0.60–0.91)P=0.0046Median follow-up 18.6 months (IQR 11-25) with trastuzumab plus chemotherapy and 17.1 months (9-25) with chemotherapy alone. The 594 randomly assigned patients were 298 and 296; the abstract's primary analysis set is 584.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.740.6–0.91
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%051015202530Months (modelled)
  • Trastuzumab plus chemotherapy (experimental)
  • Chemotherapy alone (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsTrastuzumab plus chemotherapyChemotherapy alone
0100.0%100.0%
963.6%57.0%
1742.6%34.6%
2627.1%19.7%
3517.2%11.2%
Primary publication: Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010;376(9742):687-97. PubMedDOI

Appears in

Sources

  1. Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010;376(9742):687-97.

    PubMedDOI