Article
First experiences with oral tyrosine kinase inhibitor Erlotinib in patients with advanced Non small cell lung cancer within an Expanded Access Program (EAP Germany)
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Authors
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Claus-Peter Schneider
- Zentralklinik Bad Berka GmbH, Klinik für Pneumologie, Onkologische Pneumologie, Deutschland
| Published: | March 20, 2006 |
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Outline
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Background: Erlotinib (Tarceva®) was recently approved within the European Community as the first oral tyrosine kinase inhibitor for the treatment of advanced NSCLC after failure of chemotherapy. That was a major progress in the treatment of this disease.
From November 2004 till September 2005 Erlotinib was supplied to suitable patients in selected centres within an EAP in more than 50 countries and in Germany.
Patients: We treated 76 patients with Erlotinib inside the EAP. The biometric data were as follows: median age: 64 years, women:men = 30:46, non- or never smokers:active/former smokers= 32:44, pretreatment lines: 0:1:2 = 24:33:19, WHO-performance status: 0:1:2:3 = 44:22:8:2, histologic subtypes: adeno:squamous:other = 36:24:16.
Results: Data are preliminary: 23 out of 76 included patients are still under treatment. The mean survival time up to the last contact was 111 days. The observed clinical remissions were as follows: (57 patients truly evaluable): CR:PR:SD:PD = 0:8:40:9.
In one female patient a complete remission of a central nervous metastasis could be observed. two other patients with preexisting CNS-metastases were clinically stable under Erlotinib therapy.
Discussion: Treatment with Erlotinib offers a very good option for patients with advanced Non small cell lung cancer (NSCLC) with a favorable safety profile and enduring remissions. The response to subsequent treatments seems not to be influenced by Erlotinib since constantly remissions after Erlotinib failure could be demonstrated, an action in CNS is apparent.
Demonstrative examples will be provided.
