Medical guidelines for treatment of newly diagnosed non-small cell lung cancer (NSCLC) mandate upfront testing of tumor tissue for mutations in the EGFR gene (as well as ALK and ROS gene translocation). EGFR mutations are found in 10 to 15% of white patients, but in patients of East Asian origin such mutations are in encountered in approximately 48%. However, with new data and drugs entering the playing field, newly diagnosed patients’ treatment decisions could become more complex.
There is a good reason to test for EGFR mutations: the accumulated data show that, compared to first-line chemotherapy, treatment with drugs that inhibit the activity of EGFR in patients with activating EGFR mutations improves patients’ median progression-free survival (PFS) time from 4.6 to 6.9 months to 9.6 to 13.1 months, and has a higher objective response rate (ORR). Moreover, EGFR inhibitors are associated with a significantly lower incidence of adverse effects and better control of disease symptoms. Continue reading…
The gist: Certain Asian patients with non-small cell lung cancer (NSCLC) have better survival results when treated with the drug afatinib (Gilotrif) than with standard chemotherapy. In a clinical trial, these results were true for patients whose tumors had a particular mutation called del19 EGFR. But patients with the Leu858Arg EGFR mutation did just as well on Gilotrif as on standard chemotherapy.
“In an analysis of overall survival in the phase III LUX-Lung 3 and LUX-Lung 6 trials reported in The Lancet Oncology, Yang et al found no significant difference between afatinib (Gilotrif) vs pemetrexed (Alimta)-cisplatin (LUX-Lung 3) or vs gemcitabine-cisplatin (LUX-Lung 6) in previously untreated, predominantly Asian patients with EGFR mutation-positive stage IIIB or IV lung adenocarcinoma. A significant difference favoring afatinib was found among patients with exon 19 deletion (del19) in both trials, with no difference observed among patients with the Leu858Arg mutation…
“The investigators concluded: ‘Although afatinib did not improve overall survival in the whole population of either trial, overall survival was improved with the drug for patients with del19 EGFR mutations. The absence of an effect in patients with Leu858Arg EGFR mutations suggests that EGFR del19-positive disease might be distinct from Leu858Arg-positive disease and that these subgroups should be analysed separately in future trials.’ ”
The gist: Asian people with non-small cell lung cancer (NSCLC) whose tumors have a common mutation in the EGFR gene called del19 might have better survival when treated with the drug afatinib instead of chemotherapy. That was the conclusion of a recent clinical trial that tested afatinib in volunteer patients.
“Boehringer Ingelheim has reported positive data from a pre-specified subgroup-analysis of the pivotal Phase III LUX-Lung 3 trial of afatinib in Asian non-small cell lung cancer (NSCLC) patients.
“The trial showed that these patients with the most common type of EGFR mutation, (exon 19 deletion; del19), lived significantly longer after receiving first-line treatment with afatinib compared to chemotherapy.
“The company noted that overall survival results from this pre-specified Asian subgroup-analysis are consistent with the overall del19 population in LUX-Lung , and with the previously reported Asian Phase III LUX-Lung 6 trial, in which patients with the del19 mutation lived a median of more than one year longer if they started treatment with afatinib rather than standard chemotherapy…
“Guangdong Academy of Medical Sciences and Guangdong General Hospital vice-president and principal investigator of the LUX-Lung 6 trial Yi-Long Wu said: ‘Afatinib is the first treatment to demonstrate a significant overall survival benefit for NSCLC patients with the del19 mutation, the most common EGFR mutation.
” ‘More than half of the world’s lung cancer cases occur in Asia. Therefore, EGFR testing for NSCLC patients is important in order to identify the patients eligible for targeted therapy.’ “
“Boehringer Ingelheim today announced results of the pre-specified individual, as well as the exploratory combined, analyses of two Phase III trials (LUX-Lung 3 and LUX-Lung 6). These data, to be presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO), demonstrated for the first time that patients with NSCLC with the most common epidermal growth factor receptor (EGFR) mutation (exon 19 deletions; del19) lived more than one year longer if treated with first-line afatinib compared to chemotherapy.”
Editor’s note: This article discusses the results of a clinical trial that tested a targeted drug called afatinib (aka Giotrif, or Gilotrif) on volunteer patients with non-small cell lung cancer (NSCLC). The trial found that patients whose tumors had a particular mutation called del19 in the EGFR gene lived more than one year longer if treated with afatinib than if treated with chemotherapy. EGFR mutations and other mutations are detected via molecular testing, and can be used by oncologists to help develop personalized lung cancer treatment plans.