This report is part of a 12-month Clinical
Context series. By Michael Smith, North
American Correspondent, MedPage Today Published: June 04, 2012 Reviewed by Robert Jasmer, MD; Associate
Clinical Professor of Medicine, University of California, San Francisco and
Dorothy Caputo, MA, BSN, RN, Nurse Planner
Take PosttestAction Points This study was published as an abstract and
presented at a conference. These data and conclusions should be considered to
be preliminary until published in a peer-reviewed journal. An investigational
oral drug (afatinib) delayed disease relapse for nearly a year in patients with
advanced NSCLC and mutations in the gene for the epidermal growth factor
receptor (EGFR). Note that patients receiving afatinib also had improved
quality of life and had less cough and shortness of breath. CHICAGO
-- An investigational oral drug delayed disease relapse for nearly a year in
some patients with advanced non-small cell lung cancer (NSCLC), a researcher
said here. In lung adenocarcinomas that
harbor mutations in a key receptor, the tyrosine kinase inhibitor (TKI)
afatinib outperformed standard chemotherapy with cisplatin and pemetrexed
(Alimta), according to James Yang, MD, of the National
Taiwan University
in Taipei . Patients receiving the study drug also had
improved quality of life and less cough and shortness of breath, Yang told reporters
at the annual meeting of the American Society of Clinical Oncology (ASCO). The findings come from a large phase III
trial involving 354 patients with stage IIIB or IV NSCLC that had mutations in
the gene for the epidermal growth factor receptor (EGFR), Yang said. Currently, two TKIs are approved to target
EGFR mutations: gefitinib (Iressa) and erlotinib (Tarceva). But Yang said afatinib differs from those to
TKIs in that it is irreversible. "When it binds to EGFR, it doesn't bail
out," he said. He added that the
drug also targets other receptors in the same family as EGFR, which might give
it broader anti-cancer activity. The
trial's primary endpoint was difference in progression-free survival (PFS),
Yang said, and after a median follow-up of 8 months, the median time to relapse
was 11.1 months among patients getting the drug. In contrast, the median PFS for those
receiving chemotherapy was 6.9 months, yielding a hazard ratio for relapse of
0.58, which was significant at P=0.004. Among
patients with the two most common EGFR mutations -- deletion 19 or L858R -- the
benefit was even greater: 13.6 months before relapse versus 6.9. Adverse events were similar to those seen
with other EGFR inhibitors, Yang said, and 7.9% of afatinib patients dropped out
because of toxicity, compared with 11.7% of those in the chemotherapy arm. He added that patients reported better
quality of life in the afatinib arm, mainly because of better control of such
symptoms as cough and shortness of breath.
The study is "exciting" for two reasons, commented Sylvia
Adams, MD, of New York
University Langone
Medical Center ,
who was not part of the study but who moderated the ASCO press conference. Afatinib represents a new generation of
tyrosine kinase inhibitors" and blocks the entire family receptor that
includes EGFR, she told MedPage Today. The
drug will probably be approved as first-line therapy for disease with
EGFR-mutated NSCLC, she said, but the broader activity might lead to wider use. The results are also exciting because there
was a clear clinical benefit for patients in terms of better PFS and quality of
life, she said.
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