我从该研究组了解到，最近该研究组的作者在对病人进行EGFR突变检测并进行分析，结果发现TARCVA 化疗组在有EGFR突变的患者中的有效率为53%，而在那些没有EGFR突变的患者中有效率则仅为18%。而无EGFR突变者则结果相似。这一结果显示对于EGFR突变的患者可以通过联合化疗提高疗效。
这一研究结果与目前我们在EGFR突变方面与IRE A的研究结果是呼应的。目前仍不知有关IRE A 化疗的INTACT研究的结果。研究者显然也要考虑这种情况的可能性。但不知INTACT研究在收集患者标本方面是否完整，如果不完整，INTACT研究将无法深入，IRE A将无法证明其在EGFR突变者中联合化疗的价值。
在《循证医学》杂志新一期的杂志中，多位世界著名的肿瘤专家在讨论时对于IRE A和TARCEVA的选择时认为应选择便宜的。然而，在进行这次讨论时，ISEL研究的结果尚未发表。目前，由于IRE A在ISEL研究中未能获得对病人总体有益的结果，而其竞争对手罗氏公司的TARCEVA在BR21研究中显示对病人总体生存有益，这导致在美国/北美目前更多的肿瘤内科医师推荐TARCEVA。
有鉴于在东亚人中EGFR的突变更高，在东亚进行研究获得更快的结果和更多的资料的可能性更大，以上两种药物的产商均在加快向亚洲开展研究的步伐。这对于东亚的患者也许是个福音。
TRIBUTE - A phase III trial of erlotinib HCl (OSI-774) combined with carboplatin and paclitaxel (CP) chemotherapy in advanced non-small cell lung cancer ( CLC).
Journal of Clinical Oncology, 2004 ASCO A ual Meeting Proceedings (Post-Meeting Edition). Vol 22, No 14S (July 15 Su lement), 2004: 7011
R. S. Her t, D. Prager, R. Herma , V. Miller, L. Fehre acher, P. Hoffman, B. Joh on, A. B. Sandler, R. Ma , D. H. Joh o U Texas M. D. Anderson Cancer Ctr, Houston, TX; UCLA Medical Center, Los Angeles, CA; NW Georgia Oncology Centers, Marietta, GA; Memorial Sloan-Kettering Cancer Center, New York, NY; Kaiser Permanente Medical Center, Vallejo, CA; University of Chicago Ho ital, Chicago, IL; Dana Farber Cancer I titute, Boston, MA; Vanderbilt-Ingram Cancer Center, Nashville, T Genentech, South San Francisco, CA
Background: Tarceva™ (erlotinib) is a potent reversible HER1/EGFR tyrosine kinase inhibitor with single-agent antitumor activity. TRIBUTE was a pro ective, placebo-controlled study randomizing patients (pts) with previously untreated advanced (Stage IIIB / IV) CLC to receive erlotinib at 150 mg/d or placebo ( O) with a course of 6 cycles of CP followed by maintenance monotherapy. Methods: Pts with performance status ( ) of 0 or 1 were eligible. Randomization was stratified by stage, >5% weight lo prior 6 months, measurable disease, and study site. The primary endpoint was overall survival (OS). Secondary endpoints included time to progre ion (TTP), objective re o e (OR), duration of re o e and time to symptomatic progre ion (TT as determined by the Lung Cancer Symptom Scale). Sample size of 1050 was based on 80% power to detect a 25% benefit in OS, α=0.05. Results: 1059 pts were randomized / treated (526 erlotini 533 O). As shown in the table below, there was no difference in median OS for patients treated with erlotinib with CP over CP alone, and no difference in OR or in median TTP. TT results to be presented. O and erlotinib were equivalent in terms of overall adverse (99.5% erlotinib, 99.5% O) and serious adverse events (excepting rash and diarrhea; 47.7% erlotinib, 43.2% O). There was an imbalance in the SAEs attributed by the reporting investigator as leading to death (53 erlotini 27 O). Only 5 of the 80 fatal SAEs were partially rela