ALK pozitif akciğer kanserinde yeni tedavi seçeneği

ALK pozitif akciğer kanserinde yeni tedavi seçeneği

Hastalık büyük oranda engellenebilir

 

Akciğer kanseri farklı alt gruplara ayrılmaktadır. Hedefe yönelik mutasyonları araştıran yeni tekniklerle çok sayıda hedeflenebilir mutasyon saptanmaktadır.

Bu mutasyonlar sonucu oluşan akciğer kanseri farklı özelikler göstermekle beraber farklı tedavi seçeneklerine sahip olmaktadır

ALK akciğer kanserinde ortalama %5 oranında görülen bir mutasyon. Bu mutasyona sahip hastalarda hastalığın tekrarını önleyen güçlü bir molekülün sonuçları son Avrupa onkoloji derneği kongresinde yayınlandı

Ameliyat olmuş evre IB-III hastalarda ALK inhibitörü Alectinib alan hastalarda hastalığın tekrar etmesi kemoterapi alanlara göre %80 oranında azalma saptandı.

Bu çok büyük bir başarı ve bu hastaların erken dönem bu tedaviyi alması ile ileriki yaşamlarında hastalığın tekrar oluşmasında büyük oranda engellenmesi sağlandı

 

Kaynak

ESMO 2023

Background

For patients (pts) with resected, stage IB–IIIA, ALK+ NSCLC, the recommended treatment after surgery is platinum-based chemotherapy (CT), which is associated with modest improvements in survival. In advanced ALK+ NSCLC, alectinib is a preferred first-line treatment. Here, we report data from the prespecified interim analysis of ALINA (NCT03456076), a global, phase III, open-label, randomised trial assessing the efficacy and safety of adjuvant alectinib compared with CT in pts with completely resected ALK+ NSCLC.

 

Methods

Eligible pts were ≥18 years old, had an ECOG PS of 0/1 and completely resected, stage IB (≥4 cm)–IIIA, ALK+ NSCLC (per UICC/AJCC 7th edition). Pts were randomised 1:1 to receive either oral alectinib 600 mg twice daily, or up to four 21-day cycles of IV platinum-based CT. Randomisation was stratified by stage (IB vs II vs IIIA) and race (Asian vs non-Asian). Alectinib was given for up to 24 months or until disease recurrence, unacceptable toxicity, or withdrawal of consent. Primary endpoint: investigator-assessed disease-free survival (DFS), tested hierarchically first in the stage II–IIIA and then in the ITT population (stage IB–IIIA). Other endpoints included: CNS-DFS, overall survival (OS), safety.

 

Results

A total of 257 pts were randomised to receive alectinib (n=130) or CT (n=127); baseline characteristics were overall well balanced between arms. At data cutoff (26 June 2023), median follow up was 27.8 months. A significant DFS benefit was observed with alectinib vs CT in both the stage II–IIIA (HR 0.24; 95% CI: 0.13–0.45) and ITT populations (HR 0.24; 95% CI: 0.13–0.43; Table). A clinically meaningful CNS-DFS benefit was observed in the ITT population (HR 0.22; 95% CI 0.08–0.58). OS data were immature. No unexpected safety findings were observed.

 

Conclusions

Alectinib is the first ALK inhibitor to significantly improve DFS compared with CT and provides an effective new treatment strategy for pts with resected ALK+ NSCLC.  Table: LBA2

 

Clinical trial identification

NCT03456076.

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