一線藥物Erlotinib延長NSCLC患者免於惡化存活時間


  【24drs.com】根據一項第三期臨床試驗期中分析,新診斷罹患非小細胞肺癌(NSCLC)患者,使用erlotinib(Tarceva)可以顯著延長免於惡化存活時間。
  
  一個獨立數據監測委員會建議Tarceva與化學治療歐洲隨機分派研究提早結束,因為這項研究符合其主要試驗終點;研究數據顯示,相較於以鉑金類藥物為主的療程,erlotinib顯著地延長NSCLC且有表皮生長因子受體(EGFR)活化突變患者免於惡化存活時間。
  
  EURTAC由西班牙肺癌團隊贊助,他們與法國及義大利的研究團隊合作。這是第一項顯示罹患NSCLC且有EGFR突變的西方患者接受第一線治療有免於惡化存活好處的第三期臨床試驗。
  
  根據廠商指出,雖然EURTAC的完整結果目前尚未公開,但這些研究數據將在之後的醫學會議中發表。
  
  Erlotinib是一種酪胺酸磷酸酶抑制劑,作用在EGFR上。該藥物目前適用於局部進展或轉移性NSCLC且過去使用其他治療選擇失敗的患者,或是局部進展、無法切除或轉移性胰臟癌。
  
  【過去的研究結果具有潛力】
  之前的OPTIMAL研究也發現,當erlotinib作為第一線治療時,可以延長進展性NSCLC患者免於惡化存活時間;那項研究在亞洲人身上進行,接受erlotinib治療的EGFR活化突變患者,免於惡化存活時間延長了三倍。
  
  OPTIMAL研究發表在2010年歐洲內科腫瘤醫學會年會,當時,主要作者中國同濟大學上海胸腔醫院Caicun Zhou醫師表示,該項研究顯示erlotinib在EGFR活化突變患者身上表現得比標準療程好。
  
  他指出,使用erlotinib的患者免於惡化存活時間增加三倍;因此應考慮作為罹患這種截然不同疾病患者們的第一線化學治療。
  
  【擴展適應症】
  Erlotinib由OSI藥廠研發與行銷,在美國與Genetech公司、在日本與中外製藥、在世界其他國家與羅氏藥廠合作。
  
  這項新研究比較erlotinib與鉑金類化學治療(cisplatin/gemcitabine、cisplatin/docetaxel或carboplatin/docetaxel)療程。主要試驗終點為免於惡化存活時間;次級試驗終點包括整體存活率、一年存活率、客觀反應率以及安全性。
  
  藥廠宣稱初期安全性分析顯示與過去該藥物研究結果一致。
  
  OSI藥廠CEO Naoki Okamura在一篇聲明中指出,很高興看到EURTAC研究這麼快就顯示erlotinib可能是新診斷NSCLC且有EGFR活化突變患者,除了鉑金類藥物為主化學治療外另一個可行的治療選擇。EURTAC研究的期中分析再次強化erlotinib可能用於除了亞洲人種以外患者的角色,亞洲人種在歷史觀點上有較高EGFR活化突變機率。
  
  2010年6月,羅氏藥廠向歐洲醫療署申請擴展該藥物適應症,包括治療進展性NSCLC且其腫瘤帶有EGFR活化突變患者。根據EURTAC研究數據,OSI與Genetech公司計畫與美國食品藥物管理局討論類似的擴展適應症。羅氏藥廠與OSI藥廠將會聯合呈交給其他衛生主管機關。

First-Line Erlotinib Extends Progression-Free Survival in NSCLC

By Roxanne Nelson
Medscape Medical News

January 28, 2011 — In patients with newly diagnosed nonsmall-cell lung cancer (NSCLC), erlotinib (Tarceva) can significantly extend progression-free survival, according to the interim results of a phase 3 trial.

An independent data-monitoring committee has recommended that the European Randomized Trial of Tarceva vs Chemotherapy be stopped early because it has met its primary end point. The data showed that, compared with a platinum-based chemotherapy regimen, erlotinib significantly extended progression-free survival in patients with NSCLC tumors with epidermal growth-factor receptor (EGFR)-activating mutations.

EURTAC was sponsored by the Spanish Lung Cancer Group, which conducted it in conjunction with researchers in France and Italy. It is the first phase 3 study to show a progression-free survival benefit with first-line treatment in a Western population with advanced NSCLC with EGFR mutations.

Although the full results from EURTAC are not publicly available, the data will be submitted for presentation at a future medical meeting, according to the manufacturer.

Erlotinib is a tyrosine kinase inhibitor, which acts on the EGFR. It is currently indicated as maintenance therapy for patients with locally advanced or metastatic NSCLC who have failed other treatment regimens, and as first-line treatment for patients with locally advanced, unresectable, or metastatic pancreatic cancer.

Previous Results Promising

As previously reported by Medscape Medical News, the OPTIMAL study also found that erlotinib extended progression-free survival when used as first-line therapy in advanced NSCLC. That study was conducted in an Asian population, and progression-free survival tripled in patients with EGFR-activating mutations who were treated with erlotinib.

The results of the OPTIMAL study were presented at the 2010 European Society for Medical Oncology Congress. At that time, lead author Caicun Zhou, MD, from Shanghai Pulmonary Hospital, Tongji University, China, told Medscape Medical News that "the study shows us that erlotinib does much better than standard regimens in patients with EGFR-activating mutations."

"Progression-free survival tripled in patients on erlotinib," he said. "It should therefore be considered in preference to first-line chemotherapy in patients with this distinct disease."

Extending Indication

Erlotinib is being developed and marketed by OSI Pharmaceuticals, in partnership with Genentech in the United States, Chugai in Japan, and Roche in the rest of the world.

The new trial compared erlotinib with a regimen of platinum-based chemotherapy (cisplatin/gemcitabine, cisplatin/docetaxel, carboplatin/gemcitabine, or carboplatin/docetaxel). The primary end point was progression-free survival; secondary end points included overall survival, 1-year survival, objective response rate, and safety profile.

The manufacturer notes that a preliminary safety analysis showed that it was consistent with previous studies of this agent.

"We are pleased that the EURTAC study so quickly revealed [that erlotinib] may be a viable alternative to platinum-based chemotherapy in newly diagnosed NSCLC patients with EGFR-activating mutations," said Naoki Okamura, chief executive officer of OSI Pharmaceuticals, in a statement. "The interim analysis of the EURTAC study reinforces the role that [erlotinib] may have in treating patients beyond the Asian population, which has a historically higher instance of EGFR-activating mutations."

In June 2010, Roche applied to the European Medicines Agency to extend the indication and include first-line treatment for patients with advanced NSCLC whose tumors harbor EGFR-activating mutations. On the basis of the EURTAC data, OSI and Genentech have announced plans to discuss similar extended indications with the US Food and Drug Administration. Roche and OSI will collaborate regarding submissions to other health authorities.

    
相關報導
治療肺癌時最好有高強度運動
2011/10/27 上午 11:47:14
NCCN指引:先NSCLC病理學檢驗而後突變測試
2011/3/25 下午 03:15:00
修改過的放射線治療可能改善肺癌患者預後
2010/5/27 下午 02:28:00

上一頁
   1   2   3   4   5   6   7   8   9   10  




回上一頁