A new study on maintenance treatment for patients with advanced non-small cell lung cancer (NSCLC) has found that Gefitinib prolongs cancer progression-free survival after first-line chemotherapy. The INFORM study is an ongoing research, a randomised, double blind, placebo-controlled study, with the aim to assess and investigate the safety, efficacy, and tolerability of EGFR-tyrosine kinase inhibitor Gefitinib for maintenance therapy.
Study in Brief
- Participants were 18 years and older and of Asian ethnic origin
- They had a life expectancy of 12 weeks and more
- All had diagnosis of confirmed stage IIIb or IV NSCLC
- Had completed 4 first-line platinum-based chemotherapy cycles
- Had no disease progression or toxic effects
- Patients were randomly assigned 1:1 to receive Gefitinib 250mg/day or placebo within 3 to 6 weeks of completing chemotherapy
- Primary end point was progression free survival
Results and Interpretation
Adverse events were more frequent in the Gefitinib group and these included, rashes, diarrhea, and increase in alanine aminotransferase.
Progression free survival was longer with Gefitinib when compared with the placebo.
The study titled, ‘Gefitinib versus placebo as maintenance therapy in patients with locally advanced or metastatic non-small-cell lung cancer (INFORM; C-TONG 0804): a multicentre, double-blind randomised phase 3 trial’ has been published in the journal, The Lancet.
About Maintenance Therapy
Maintenance therapy is treatment used with advanced NSCLC patients to improve survival, but not to ‘cure’. In other words, the cancer is treated so that it does not spread or worsen. Maintenance therapy is used in patients who are diagnosed with advanced stage IIIB and Stage IV lung cancer and who have been treated with first line chemotherapy.
Currently, there are only two medication approved by the FDA for maintenance therapy, Alimta (permetrexed) and Tarceva (Erlotinib). Several medications are being studied in clinical trials. Gefitinib is an EGFR inhibitor similar to Erlotinib. The drug interrupts signaling pathways of epidermal growth factor receptor (EGFR) in cancer cells.
- Clinical Trials of Erlotinib (Tarceva) in Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) – 1
- Clinical Trials of Erlotinib (Tarceva) in Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) – 2
- Small Cell Lung Cancer (SCLC) Vs Non-Small Cell Lung Cancer (NSCLC): Quick Fact Sheet
- Non-Small Cell Lung Cancer Therapy Enhanced – Combination Of RNAi With Tyrosine Kinase Inhibitors
- AACR: Lung Cancer Vaccine Prolongs Survival