produced a disease control rate of
63.2% in elderly patients with advanced
non-small-cell lung cancer
(NSCLC), and at a median follow up
of 6 months, 33 of the 38 study patients
were still alive. Bruce E. Johnson,
MD, of Dana-Farber Cancer Institute
in Boston presented preliminary data
from the phase II study (abstract 7080).
"Erlotinib demonstrated encouraging
antitumor activity in patients
over age 70 who had previously untreated,
advanced NSCLC. Responses
were observed in advanced disease and
in bronchoalveolar carcinoma
(BAC)," Dr. Johnson said.
Elderly patients are more vulnerable
to chemotherapy-related toxicity
than younger patients. Dr. Johnson
explained that erlotinib was an attractive
candidate in this setting because
of its activity and generally low sideeffect
profile in the treatment of
patients who have failed prior chemotherapy.
Nearly All Were Smokers
This ongoing single center phase II
study is enrolling patients ≥ 70 years
of age who are chemotherapy-naive
and have stage IIIB (with malignant
effusion) or stage IV NSCLC and performance
status (PS) of 0 to 2. Patients
are treated with oral erlotinib
150 mg/d until evidence of disease
progression or toxicity.
The primary study endpoint is median
survival. Secondary endpoints include
response rate, quality of life,
changes in fluorodeoxyglucosepositron
emission tomography (FDGPET)
imaging, and analysis of the
EGFR signaling pathway from pretreatment
Dr. Johnson reported data for 38
patients who were evaluable for toxicity
and response at the time of this
presentation. Median age was 76 years,
with a range of 70 to 86. Most patients
(28/38) were PS 1. Nearly all (30/38)
were former smokers, and two were
Fifty-six percent had adenocarcinomas;
14% had squamous cell carcinomas;
11% had adenocarcinomas with
BAC features; 11% had BAC; 11% had
unclassified NSCLC unclassified; and
2% had large cell carcinomas.
Five patients (13.1%) had partial
responses with a median duration of
8.0 months, and 19 (50%) had disease
stabilization with a median duration
of 3.5 months. "Survival and FDGPET
imaging outcomes are too early
to evaluate," Dr. Johnson said.
Rash affected 77% of patients but
was grade 1 or 2 in 92% of those affected.
"All of the responding patients
developed rash," Dr. Johnson noted.
Grade 1 or 2 diarrhea developed in
61% of patients. Grade 3 or worse
toxicities included pneumonitis
(6.5%) and lacrimation (3.2%). Dr.
Johnson reported that one patient died
from drug toxicity (pneumonitis).
Three patients (8.5%) were dose reduced
owing to toxicity, and three
patients discontinued treatment.
"Erlotinib appears to be well tolerated
and demonstrates encouraging
activity in patients ≥ 70 years of age
with previously untreated advanced
NSCLC. Accrual is continuing to 60
patients," Dr. Johnson said.