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TAS-102能提高转移性结肠癌患者的存活率

来源:生物谷 2014-07-01 10:19

2014年6月30日讯 /生物谷BIOON/ --第三期临床试验表明,TAS-102能提高全面提高结肠癌患者的存活率,这些患者的结肠癌已经转移,用普通治疗方法难以治疗。

TAS-102是一种新型的抗癌的核苷类药物,它含有三氟胸苷(trifluridine, FTD)和地匹福林盐酸盐(tipiracil hydrochloride, TPI)。其中,三氟胸苷是TAS-102的活性组成部分,能够直接和癌症的DNA互相作用,使得DNA不能正常行使功能。但是三氟胸苷口服会被大量降解为非活性状态,地匹福林盐酸盐则防止了它的降解。TAS-102的作用机理与氟嘧啶、奥沙利铂和依立替康都不同,在二期临床试验中,结果表明TAS-102对于以上三种药物都不能有效治疗的结肠癌患者有着不同的疗效。

这项研究结果可能会给转移性结肠癌患者带来希望,并且可能会被用于结肠癌患者的早期治疗,治疗可能会配合奥沙利铂或依立替康同时使用。该研究表明TAS-102的前景十分光明。(生物谷 Bioon.com)

详细英文报道:

he new combination agent TAS-102 is able to improve overall survival compared to placebo in patients whose metastatic colorectal cancer is refractory to standard therapies, researchers said at the ESMO 16th World Congress on Gastrointestinal Cancer in Barcelona.

"Around 50% of patients with colorectal cancer develop metastases but eventually many of them do not respond to standard therapies," said Takayuki Yoshino of the National Cancer Centre Hospital East in Chiba, Japan, lead author of the phase III RECOURSE trial. "The RECOURSE study shows that TAS-102 improves overall survival in these patients compared to placebo. I believe that this agent will become one of the standards of care in the refractory setting of metastatic colorectal cancer in Japan and worldwide."

TAS-102 is a novel nucleoside anti-tumour agent consisting of trifluridine (FTD) and tipiracil hydrochloride (TPI). FTD is the active component of TAS-102 and is directly incorporated into cancer DNA, leading to DNA dysfunction. However, when FTD is taken orally it is largely degraded to an inactive form. TPI prevents the degradation of FTD. This mechanism of action is different to that of fluoropyrimidine, oxaliplatin and irinotecan.

The phase II trial of TAS-102 had found an overall survival benefit in Japanese patients with metastatic colorectal cancer refractory to fluoropyrimidine 5-fluorouracil (5-FU), irinotecan and oxaliplatin.[1]

The current RECOURSE study was a global phase III trial conducted in 13 countries at 114 centres. Patients had metastatic colorectal cancer refractory to all standard therapies including fluoropyrimidines, oxaliplatin, irinotecan, bevacizumab, and cetuximab or panitumumab for patients with wild-type KRAS tumours. Patients were randomised 2:1 to TAS-102 (534 patients) or placebo (266 patients). The primary endpoint was overall survival.

The researchers found that TAS-102 prolonged overall survival compared to placebo (hazard ratio 0.68): median overall survival was 7.1 months for TAS-102 and 5.3 months for placebo. TAS-102 also improved progression-free survival compared to placebo (hazard ratio 0.48), which was a secondary endpoint. Yoshino said: "We found a statistically significant difference in overall and progression-free survival, and a clinically meaningful improvement."

"TAS-102 has a mild safety profile and the most common side-effect is hematologic toxicity including neutropenia. Patients with metastatic colorectal cancer refractory to standard therapies now have a strong treatment option."

Commenting on the data, ESMO spokesperson Jean Yves Douillard, professor of medical oncology, Institut de Cancérologie de l'Ouest (ICO) René Gauducheau, Saint-Herblain, France, said: "The phase III trial of TAS-102 is a global study and confirms the results of the phase II study in Japanese patients, whose response to fluoropyrimidine is slightly different to patients in Europe and the US. It is good to know that the magnitude of benefit shown in the smaller phase II trial is confirmed in the larger phase III trial and that the results apply to Asians and Caucasians alike."

TAS-102 is a combination of two components. The tipiracil hydrochloride (TPI) prevents degradation of trifluridine (FTD) and also has angiogenic activity. "This is probably why TAS-102 is effective in classical fluoropyrimidine 5-fluorouracil (5-FU) resistant patients. The drug is very promising, tolerance is good and it is manageable with supportive care."

Douillard concluded: "In RECOURSE, TAS-102 was tested in patients who had received all types of chemotherapy available for colorectal cancer. I would probably move this drug into an earlier line of treatment and I would also combine it with either irinotecan or oxaliplatin."

 

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