最新抑制新血管抗癌新藥:AVASTIN
Genetech公司原始的 說明:
The original Avastin FDA approval was based on data from a large, placebo controlled, randomized study demonstrating prolongation in the median survival of patients treated with Avastin plus the IFL (5-FU/Leucovorin/CPT-11) chemotherapy regimen by approximately five months, compared to patients treated with the IFL chemotherapy regimen alone (20.3 months versus 15.6 months). This is one of the largest improvements in survival ever reported in a randomized, Phase III study of patients with metastatic colorectal cancer. (化療加上avastin可以讓病人延長5個月壽命!人生最後5個月是去環遊世界?還是在加護病房或安寧病房? 花了幾個月忍受化療的 痛苦甚至自費幾十萬,結果多活痛苦的 5個月,有意義嗎?)
The second approval was based on results of a randomized, controlled, multicenter Phase III trial (E3200) of 829 patients with advanced or metastatic colorectal cancer who had received previous treatment with irinotecan and 5-FU as initial therapy for metastatic disease or as adjuvant therapy. The study showed that patients who received Avastin plus the 5-FU-based chemotherapy regimen known as FOLFOX4 (oxaliplatin/5-FU/leucovorin) had a 25 percent reduction in the risk of death (based on a hazard ratio of 0.75), the primary endpoint, which is equivalent to a 33 percent improvement in overall survival, compared to patients who received FOLFOX4 alone. Median survival for patients receiving Avastin plus FOLFOX4 was 13.0 months, compared to 10.8 months for those receiving FOLFOX4 alone. (死亡危險機率降低25%,平均存活時間從10.8月延長到13個月? 更短?)
The third approval was based on results from E4599, a randomized, controlled, multicenter trial that enrolled 878 patients with unresectable, locally advanced, recurrent or metastatic non-squamous NSCLC. The most common Grade 3-5 (severe) adverse events in Study E4599 seen in Avastin-treated patients, were neutropenia (low white blood cell count), fatigue, hypertension (high blood pressure), infection and hemorrhage. Results showed that patients receiving Avastin plus paclitaxel and carboplatin chemotherapies had a 25 percent improvement in overall survival, the trial's primary endpoint, compared to patients who received chemotherapy alone (based on a hazard ratio of 0.80). One-year survival was 51 percent in the Avastin arm versus 44 percent in the chemotherapy-alone arm. Median survival of patients treated with Avastin plus chemotherapy was 12.3 months, compared to 10.3 months for patients treated with chemotherapy alone. (這個研究平均存活率從10.3個月增加到12.3個月?您不覺科學家很辛苦嗎?花這麼多時間經費,結果只讓病人多活一些些?)
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使用抗肺癌標榜新藥Irexxx,竟然只有9.1%患者腫瘤有縮小 |
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