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发表于 2013-10-12 15:43:37
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来自: 美国
NovaRx Announces Results of Lucanix® Phase III Therapeutic Vaccine Trial for Post-frontline Maintenance Therapy in Non-small Cell Lung Cancer to Be Presented at ESMO.
NovaRx Corporation announced that the detailed results from the randomized Phase III trial of Lucanix® (belagenpumatucel-L) post-frontline maintenance therapy in non-small cell lung cancer will be presented at the European Society for Medical Oncology 2013 annual meeting in Amsterdam. The results will be presented in "Presidential Session I: Best and Late Breaking Abstracts" on 28 September 2013, which starts at 1:45 pm.
The primary endpoint of improving overall survival in 532 patients was not met primarily due to the inclusion of patients more than 12 weeks following the completion of frontline chemotherapy. In this predefined subgroup of 305 stage IIIB/IV patients, a median survival of 20.7 months was observed for Lucanix compared to 13.4 months for the control (HR 0.75). In a the predefined subgroup of these patients with a histology of squamous cell carcinoma a media survival of 20.7 months was observed for Lucanix compared to 12.3 months for the control (HR 0.58). In the predefined subgroup of these patients who received radiation therapy prior to enrollment a media survival of 40.1 months was observed for Lucanix compared to 10.3 months for the control (HR 0.45).
这次临床实验以提高532个病人的总生存期为主要目标,但并没能得以实现,原因是部分被纳入实验的病人是在前期化疗结束超过12个星期后,才加入实验组。在预先设置好的305个IIIB/IV期病人的小组中,Lucanix实验组的中位生存期是20.7个月,而控制组是13.4个月(HR 0.75)。对于鳞癌病人,Lucanix实验组的中位生存期是20.7,而控制组只有12.3个月 (HR 0.58)。而对于入组前,接受过放疗的病人,Lucanix的中位生存期是40.1个月,而控制组只有10.3个月(HR 0.45)。
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