以下是引用amei在2008-5-9 12:34:44的发言: 谢谢,具体应该怎么服用呢?是否按照乳腺癌的剂量服用呢?发生间质性肺炎的几率有多少呢? 上文所述5例稳定,药量为500-1600MH/日,下文中为一组1500MG/日,另一组500MG,每日俩次,疗效无差别。都不太好
A phase II multicenter trial comparing two schedules of lapatinib (LAP) as first or second line monotherapy in subjects with advanced or metastatic non-small cell lung cancer (NSCLC) with either bronchioloalveolar carcinoma (BAC) or no smoking history.
Abstract No: |
7611
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Citation: |
Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 7611
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Author(s): |
M. Smylie, G. R. Blumenschein, A. Dowlati, J. Garst, F. A. Shepherd, J. R. Rigas, H. Hassani, M. S. Berger, T. Zaks, H. J. Ross
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Abstract: |
Background: LAP (GW572016) is an oral reversible, dual tyrosine kinase inhibitor of EGFR (ERBB1) and HER2/neu (ERBB2).
This study was designed to test the activity of 2 dose schedules of LAP
in chemotherapy naïve pts with NSCLC; it was amended to target patients
with either BAC or no smoking history in the first or second line and
to evaluate the relationship of mutations in target genes to responses.
Methods: LAP was given orally 1,500 mg once (QD) or 500 mg twice
daily (BID) until progression or intolerance. Safety and efficacy
(RECIST) were assessed every 4 & 8 weeks. The primary endpoint was
response. The target (BAC/no smoking) and non- target populations were
assessed for efficacy, and tumor tissue was analyzed for ERBB1 and ERBB2 mutations and/or amplifications. Results:
The study was stopped for futility after 131 pts were randomized (65
QD, 66 BID). Median age 66 (range 32-86); female 56%; BAC 20%, No BAC
71%; previously untreated 98.5%; current/former smokers 70%, never
smoker 30%. There were no complete responses. Of 56 pts in the target
population, 1 (2%) achieved partial response (PR), 11 (20%) had stable
disease (SD) of >24 wks; in the non-target population, 1 pt had a PR (1.3%) and 12 (16%) had SD of >24 wks. 3 pts had ERBB1 mutations (G719S, S768I, KRAS G12S; L858R and T790M; L858R) but none of them responded. There were no ERBB2 mutations. Three of 77 pts evaluated had ERBB1 gene copy increase (none of whom responded) and 2 had ERBB2
gene copy increase (one had a 51% decrease in tumor size). The most
common adverse events were grade 1/2 diarrhea, nausea, rash, vomiting
and fatigue, and were similar in both groups. Conclusions: LAP
was well-tolerated, with no notable difference in toxicity between the
QD and BID groups. Very few responses were seen, stable disease was
sometimes prolonged. The prevalence of mutations was low even in the
target population. Given the preclinical synergy between LAP and other
agents, further studies will be necessary to determine whether LAP is
active in combination with other agents for the treatment of NSCLC. |
[此贴子已经被作者于2008-5-10 9:36:08编辑过] |