produced a disease control rate of
63.2% in elderly patients with previously
untreated 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 phase II data (abstract
7080) at the 40th annual
meeting of the American Society of
"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 at least
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 of the patients had
adenocarcinomas; 14% had squamous
cell carcinomas; 11% had adenocarcinomas
with BAC features; 11% had
BAC; 11% had unclassified NSCLC 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
FDG-PET 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 at least 70 years of
age with previously untreated advanced
NSCLC. Accrual is continuing to 60
patients," Dr. Johnson said.