TORONTO, Canada-Erlotinib
(Tarceva) not only extended survival
in patients with advanced non-smallcell
lung cancer (NSCLC) but it also
improved their quality of life (QOL),
according to data from BR.21, a double-
blind randomized placebo-controlled
trial in 731 patients. Pain, cough,
and dyspnea got worse at a slower rate
among patients who took erlotinib
than among those who took placebo
on the trial, which was conducted by
the National Cancer Institute of Canada
(NCIC).
The primary findings of BR.21, reported
last year, showed that erlotinib
significantly improved median overall
survival time and 1-year survival, compared
with placebo, in patients with
previously treated stage IIIb or IV
NSCLC. The QOL data from BR.21
were reported by Andrea Bezjak, MD,
who led the QOL analysis (abstract
7018). Dr. Bezjak is associate professor
in the departments of radiation oncology
and health policy, management
and evaluation at the University of
Toronto, and is a staff radiation oncologist
at Princess Margaret Hospital,
Toronto.
"Patients on erlotinib had slower
deterioration of their disease-related
symptoms and quality of life improved
in more patients on the erlotinib arm
than on the placebo arm," Dr. Bezjak
said. "These differences were clinically
as well as statistically significant."
To collect the data, Dr. Bezjak and
her colleagues used the QOL core questionnaire
and lung cancer module of
the European Organization for Research
and Treatment of Cancer
(EORTC); the questionnaire was administered
monthly. Compliance wasexcellent, Dr. Bezjak noted, with 85%
of patients completing questionnaires
in the first year.
The results showed that the median
time to deterioration of cough was
4.9 months for patients on the erlo-tinib arm of the study vs 3.7 months
for those on the placebo arm. For dyspnea,
the median time to deterioration
was 4.7 months vs 2.9 months;
and for pain, it was 2.8 months vs 1.9
months, respectively.
The researchers also analyzed global
QOL by determining how many
patients had an improvement of at
least 10 points during the study. Theyfound that 35% of the patients on
erlotinib fell into this category vs 26%
of those on placebo. The favorable
impact of erlotinib included less fatigue,
which is usually difficult to
achieve, Dr. Bezjak noted.
Erlotinib is one of several agents
that have been tested as second-line
therapy in "this burgeoning population"
of patients with advanced
NSCLC, said discussant Vincent Miller,
MD, associate attending physician
in the Thoracic Oncology Service at
Memorial Sloan-Kettering Cancer
Center, New York. Dr. Miller reviewed
trials with docetaxel (Taxotere), topotecan
(Hycamtin), pemetrexed (Alimta),
and erlotinib. He concluded
that docetaxel, pemetrexed, and erlotinib
are all reasonable choices as second-
line therapy but further study is
needed, including trials of combination
therapies. In addition, he said,
"erlotinib, though having a favorable
quality-of-life profile, has not yet been
compared with a cytotoxic agent in
this population, and I do think that
would be a very appropriate study to
undertake."
