Evaluating the safety and effectiveness of nimotuzumab combined with chemoradiotherapy for patients with squamous cell lung cancer.

This study investigated the effectiveness and safety outcomes of nimotuzumab (Theraloc) combined with chemoradiotherapy (CRT) for the treatment of patients with locally advanced squamous non-small cell lung cancer (SqNSCLC). The data showed that nimotuzumab plus CRT had similar survival outcomes compared to CRT alone, but with a lower risk of brain metastases (cancer spread to the brain). 

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer. NSCLC is categorized as squamous or non-squamous. SqNSCLC is responsible for around 30% of all lung cancer diagnoses. In SqNSCLC, the cancer forms in the thin, flat cells lining the inside of the lungs. Standard treatment for SqNSCLC involves surgical removal of solid tumors and chemoradiotherapy (CRT). CRT involves administering both chemotherapy (CT) and performing radiation therapy (RT).

In advanced cancer, cCRT has a limited effect. New drug targets are needed to improve survival. The epidermal growth factor receptor (EGFR) protein plays a role in the creation, spread, and survival of cancer cells. Nimotuzumab is a drug the blocks EGFR and slows the growth and spread of cancer cells. It is approved for the treatment of a type of brain cancer called glioma. 

However, the effectiveness and safety outcomes of combining nimotuzumab with CRT for the treatment of patients with locally advanced SqNSCLC are still under investigation.

This study involved 122 patients with SqNSCLC. Patients were randomly assigned into 2 groups. Group 1 included 57 patients who received CRT plus nimotuzumab. Group 2 included 65 patients who received CRT alone. The average follow-up was 23.3 months.

The average overall survival was 24.9 months in group 1 compared to 23.5 months in group 2. After 2 years, 52.7% of patients in group 1 were alive compared to 49.8% of patients in group 2.

The average survival without cancer worsening was 12.1 months in group 1 compared to 13.7 months in group 2. The overall response rate (ORR; partial or complete disappearance of cancer) was 70.2% in group 1 and 67.7% in group 2.

After 3 years, 60.2% of patients in group 1 were alive without cancer spread compared to 54.3% of patients in group 2. Patients who received CRT plus nimotuzumab had a significantly lower risk of brain metastasis (by 99%). 1.8% of the patients in group 1 developed brain metastasis during the study compared to 12.3% in group 2.

Side effects were similar between the 2 groups. The most common side effects were inflammation of the lungs and esophagus lining.

This study concluded that nimotuzumab combined with CRT had similar survival outcomes compared to CRT alone but a lower risk of developing brain metastasis in patients with SqNSCLC. 

The sample size was very small. The CRT regimen used in this study was different from the standard CRT regimen. Further studies are needed before drawing any conclusions.