Early Data Indicate Erlotinib Controls Advanced NSCLC in Elderly Patients, Phase II Trial Shows

BOSTON-Erlotinib (Tarceva) 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 Clinical Oncology. "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 tumor specimens. 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 current smokers. 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.