In a nutshell
This study aimed to determine the safety and efficacy of a combination of the anticancer drugs afatinib (Gilotrif) and nimotuzumab (Theraloc) to treat kinase inhibitor resistant EGFR-mutant-NSCLC. The study found that a combination of these drugs had encouraging potential and an acceptable safety profile.
Some background
A mutation in the epidermal growth factor receptor (EGFR) can lead to non-small cell lung cancer (NSCLC). EGFR-mutant-NSCLC responds better to treatments that block EGFR, such as gefitinib (Iressa) and erlotinib (Tarceva), than other chemotherapies. However, patients usually develop resistance to both drugs and disease progresses.
Afatinib has shown good anti-cancer properties when used in combination with other drugs, but toxicity (negative side effects) has been high. Other combinations for afatinib are needed.
Methods & findings
This trial examined the safety and effectiveness of the combination of afatinib with the low toxicity drug nimotuzumab.
The study included 50 patients with stage 3B/4 (spread beyond the lungs) EGFR-mutant-NSCLC cancer that has progressed following gefitinib and erlotinib. Adverse effects, overall response rate (ORR, patients with tumors that decrease by at least 50%), disease control rate (DCR, patients with tumors that shrink or remain the same size), progression free survival (PFS) and overall survival (OS) were measured.
The study was broken up in two phases. Phase 1 was to determine the recommended dose (RD) that should be used in phase 2. There were 13 patients and two doses used in this phase. Phase 2 then included 37 patients who were given this RD (40 mg afatinib and 100 mg nimotuzumab).
44 patients were given this RD. 16% had grade 3 (severe) toxicities including skin rash (7%), diarrhea (5%), acne (2%), and fatigue (2%). The ORR was 23% and the DCR was 84%. Average PFS was 4 months, and the average OS was 11.7 months.
The bottom line
This study concluded that a combination of afatinib and nimotuzumab was safe and effective in EGFR-NSCLC.
The fine print
The sample size for this study was very small and a large scale clinical trial will need to be examined.
What’s next?
Discuss this dual combination of afatinib and nimotuzumab with your doctor if your disease has progressed following gefitinib and erlotinib.
Published By :
Clinical Cancer Research
Date :
Dec 15, 2015
