Original Title: Alectinib en primera línea de tratamiento en pacientes adultos con carcinoma de pulmón no microcítico avanzado ALK positivo

Authors' objectives: The objective is to assess the relative effectiveness and safety of alectinib as first-line monotherapy for adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC) in comparison with crizotinib and ceritinib.

Authors' results and conclusions: From direct comparison, based on high quality of evidence, alectinib demonstrated a substantial and statistically significant increase in PFS. It is also associated with a statistically significant longer time to CNS progression compared to crizotinib. This is of high clinical relevance as CNS metastasis and progression affects both the symptoms and the quality of life, as well as the prognosis of the patients. The OS data are immature and therefore preclude firm conclusions. From an indirect comparison, an advantage of alectinib versus ceritinib is indicated for PFS, but because of uncertainties regarding the adequacy of the comparison, this observed result has to be regarded as unsure. From direct comparison, the serious adverse events and adverse events leading to treatment discontinuation occurred at similar frequencies for both alectinib and crizotinib. Alectinib appears to have a more favourable safety profile compared with crizotinib with regard to non-serious adverse events that tend to affect quality of life, as well as severe (grade ≥3) events. This notion is supported by the lower frequencies of treatment interruptions and dose reductions observed for alectinib in the direct comparison to crizotinib. Thus markedly lower frequencies for alectinib were reported for diarrhoea, vomiting and nausea. For any grade adverse event, myalgia and anaemia were reported more frequently for alectinib than crizotinib. While conclusions on relative safety compared with ceritinib should be made with caution, both the NMA and the comparison of the established AE profiles in the SmPCs indicate an overall superior safety profile of alectinib. Patients receiving alectinib had clinically meaningful improvement in HRQoL for a longer duration compared with patients receiving crizotinib. Overall a trend favouring alectinib was observed in HRQoL, but the difference was not statistically significant. As only one patient was interviewed, no general conclusions can be drawn.

Project Status: Completed

Year Published: 2018

URL for published report: https://www.aetsa.org/publicacion/alectinib-en-primera-linea-de-tratamiento-en-pacientes-adultos-con-carcinoma-de-pulmon-no-microcitico-avanzado-alk-positivo/

Requestor: Consejería de Salud. Junta de Andalucía

English language abstract: An English language summary is available

Publication Type: Other

Country: Spain

Organisation Name: Andalusian Health Technology Assessment Area

Contact Address: Area de Evaluacion de Tecnologias Sanitarias Sanitarias de Andalucia (AETSA) Avda. Innovación, s/n Edificio Arena 1. Sevilla (Spain) Tel. +34 955 006 309

Contact Name: aetsa.csalud@juntadeandalucia.es

Contact Email: aetsa.csalud@juntadeandalucia.es

Copyright: <p>Andalusian Agency for Health Technology Assessment (AETSA)</p>