In a nutshell
This article investigated the safety and effectiveness of durvalumab (Imfinzi) for the treatment of unresectable non-small-cell lung cancer (NSCLC). The authors concluded that durvalumab is safe and can improve survival of these patients.
Non-small cell lung cancer (NSCLC) is the most common kind of lung cancer. Patients with stage 3 NSCLC are usually treated with chemotherapy and radiation therapy (CRT). However, after this treatment, cancer continues to grow in the majority of patients.
An alternative treatment method is immunotherapy. This treatment uses monoclonal antibodies (laboratory-produced molecules engineered to stimulate the immune system to destroy cancer cells). Durvalumab is a type of immunotherapy. A prior analysis showed that durvalumab increased progression-free survival (PFS; the time it took for cancer to start growing again) after CRT in patients with unresectable stage 3 NSCLC. However, the effect on overall survival and safety of durvalumab are still under investigation.
Methods & findings
This study involved 709 patients with NSCLC who had been treated with CRT. They were randomly assigned to two groups. Group 1 received treatment with durvalumab (473 patients). Group 2 was given placebo treatment (236 patients). The average follow-up period was 25.2 months. Overall survival and side effects were the main outcomes measured.
Group 1 had a longer overall survival (66.3%)than group 1 (55.6%). The group that received durvalumab were 32% less likely to die compared with the placebo group. The average PFS was also longer in the durvalumab group (17.2 months) compared to placebo (5.6 months). The group that received durvalumab were 49% less likely to have cancer progression compared with the placebo group. The average time to death or cancer spreading to other organs or tissues (metastasis) was 47% less in the durvalumab group compared with the placebo group.
Serious side effects were reported in 30.5% of patients in group 1 and 26.1% in group 2. 15.4% of patients in the durvalumab group and 9.8% of patients in the placebo group stopped treatment due to side effects such as pneumonitis (inflammation of lung tissue) and pneumonia (infection in the lungs).
The bottom line
The authors concluded that durvalumab therapy resulted in longer survival than placebo in patients with stage 3 NSCLC after CRT.
The fine print
The study was supported by AstraZeneca, the manufacturer of durvalumab.
Durvalumab was recently approved by the FDA for the treatment of patients with locally advanced, unresectable stage 3 NSCLC who have not progressed following CRT.
Published By :
The New England Journal of Medicine
Sep 25, 2018