In a nutshell
This study evaluated the long-term outcomes of patients with ALK-positive non-small-cell lung cancer (NSCLC) treated with alectinib (Alecensa). This study concluded that this treatment improved survival without cancer worsening in these patients.
Some background
ALK-positive non-small-cell lung cancer (NSCLC) remains a difficult to treat cancer. New targeted drugs are being developed such as alectinib to treat NSCLC. When compared to existing treatments such as crizotinib (Xalkori), alectinib showed improvement in both progression-free survival (PFS) and overall survival (OS) in the treatment of ALK-positive NSCLC. However, longer-term data are lacking.
Methods & findings
There were 303 patients with previously untreated stage III-IV ALK-positive NSCLC who entered this study. 152 patients randomly received alectinib 600 mg twice a day. 151 patients randomly received 250 mg crizotinib. Patients were followed up for an average of 23 months to 48.2 months.
Alectinib had, on average, a significantly longer survival without cancer worsening (progression-free survival; PFS) of 34.8 months versus 10.9 months with crizotinib. Alectinib was associated with a 57% improvement in PFS compared to crizotinib.
The benefit of alectinib was the same for patients who had or did not have cancer spread to the brain (brain metastasis). In patients with brain metastasis at the beginning of the study, alectinib had a PFS of 25.4 months compared to 7.4 months in the crizotinib group. In patients without brain metastasis at the beginning of the study, PFS was 38.6 months with alectinib and 14.8 months with crizotinib.
The 5-year OS rate was 62.5% for alectinib. The 5 year OS was 45.5% with patients on crizotinib. The OS benefit was seen in patients with or without brain metastases at the beginning of the study.
Treatment duration was longer on average with alectinib at 28.1 months compared to 10.8 months on crizotinib. Similar amounts of patients experienced serious side effects with 52% of the alectinib group and 56.3% of the crizotinib g group. This led to dose reductions in 20.4% of alectinib patients and 19.9% of crizotinib patients. The most common side effects experienced were anemia, increased liver enzymes, and low white blood cells.
The bottom line
The authors concluded that alectinib was associated with significant improvement in PFS and OS when compared to crizotinib in the treatment of ALK-positive NSCLC.
The fine print
The OS data remains short and further work needs to be carried out. This study was sponsored by Roche Holding AG, the manufacturer of alectinib.
Published By :
Annals of oncology: official journal of the European Society for Medical Oncology
Date :
May 11, 2020
