(Gastric Cancer) Is TAS-118 + Oxaliplatin Effective?
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
- September 16, 2019
- Read time: 2 minutes
From July 3–6, 2019, at the ESMO World Congress on Gastrointestinal Cancer held in Barcelona, Spain, Yoon-Koo Kang presented "Comparative efficacy and safety results of TAS-118 (Tegafur, Gimeracil, Oteracil, Leucovorin) + oxaliplatin as first-line treatment in HER2-negative gastric cancer patients in the SOLAR Phase 3 clinical trial."
The SOLAR trial was an open-label Phase 3 clinical trial enrolling HER2-negative gastric cancer patients (N=711). The primary endpoint was overall survival, and secondary endpoints included progression-free survival, duration of response, objective response rate, disease control rate, and safety.
TAS-118 group (2-week cycle, Days 1–7, twice-daily TAS-118 40–60 mg + Day 1 oxaliplatin 85 mg/m², N=356).
S-1 group (5-week cycle, Days 1–21, twice-daily S-1 40–60 mg + Day 1 or 8 cisplatin 60 mg/m², N=355).
Results of this trial showed that the primary endpoint median overall survival was: TAS-118 group 16.0 months / S-1 group 15.1 months. The TAS-118 group showed a 17% reduction in disease progression risk, with significant improvement and a hazard ratio of 0.83.
Secondary endpoint median progression-free survival was: TAS-118 group 7.1 months / S-1 group 6.4 months. TAS-118 showed a 21% reduction in disease progression risk, with significant improvement and a hazard ratio of 0.79. Objective response rates were: TAS-118 group 73.5% / S-1 group 50.0%. Disease control rates were: TAS-118 group 93.4% / S-1 group 88.2%.
Regarding safety, compared to the S-1 group, the most common Grade 3 or higher adverse events in the TAS-118 group were: stomatitis 3.7%, diarrhea 9.4%, peripheral neuropathy 8.5%, and weight loss 5.4%. Treatment discontinuation due to adverse events was: TAS-118 group 5.8% / S-1 group 4.9%.
[Important Note] Medical Supporter's translations of overseas clinical trial data and pharmaceutical information are not intended to encourage participation in clinical trials or use of new drugs. The translated information is for reference only and not intended as medication guidelines. Please discuss with healthcare professionals and refer to the original text below the article for accurate information.
Source: A phase III study of TAS-118 plus oxaliplatin versus S-1 plus cisplatin as first-line chemotherapy in patients with advanced gastric cancer (SOLAR study) (World Congress on Gastrointestinal Cancer 2019 Abstract #LBA-003)
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