TY - JOUR
T1 - Single agent gefitinib as first line therapy in patients with advanced non-small cell lung cancer
T2 - Washington University Experience
AU - Kommareddy, Aruna
AU - Coplin, Margaret A.
AU - Gao, Feng
AU - Behnken, Danelle
AU - Romvari, Edie
AU - Read, William
AU - Govindan, Ramaswamy
N1 - Funding Information:
We retrospectively analyzed safety and efficacy data from patients with previously untreated metastatic NSCLC who received gefitinib monotherapy. This patient population was selected from a larger database of patients with advanced NSCLC who were enrolled under the expanded access program as described below. The nonrandomized, open-label, expanded access clinical program was initiated in May 2001 at the Washington University School of Medicine. A total of 171 patients had been enrolled as of 30 August 2002. Under this program, sponsored by Astra Zeneca Pharmaceuticals and administered by the National Organization of Rare Diseases, patients with advanced NSCLC received gefitinib of 250 mg orally once daily. A complete history and physical examination was required before enrollment. Patients underwent baseline radiologic evaluation within 28 days before initiating therapy and a follow up was performed at 2–3 monthly intervals. Most of the patients were followed with serial computerized tomography (CT) scans and one patient was followed by chest X-ray (CXR). Treatment was continued so long as the treating physician determined that there was clinical benefit without unacceptable toxicity. Toxicity was assessed using the National Cancer Institute (NCI) toxicity criteria and response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST). Initial response evaluation was based on radiologic and clinical evaluation performed after 2–3 months of treatment initiation. Patients who had stable disease or patients with progressive disease who were alive as of that date were followed for outcomes subsequently. Dates of last clinical contact in patients with stable disease and dates of death or dates of last contact in patients with progressive disease were documented.
PY - 2004/8
Y1 - 2004/8
N2 - Gefitinib has modest activity with an overall response rate of 11-18% in patients with metastatic non-small cell lung cancer (NSCLC) who have had progressive disease following platinum containing chemotherapy. However, the efficacy of gefitinib in previously untreated metastatic NSCLC is not known. We retrospectively analyzed the efficacy of gefitinib as a first line therapy in 26 patients with advanced NSCLC enrolled in the expanded access program. Patients received gefitinib 250 mg a day orally if they had a poor performance status (PS) or if they refused cytotoxic chemotherapy. Treatment was continued as long as there was no evidence of disease progression or unacceptable treatment related toxicities. The characteristics of 25 evaluable patients enrolled between the period of May 2001 and August 2002 include: 15 women, 10 men; median age 73 years (range 56-86), 81% had an ECOG performance status of two. Only one patient had a partial response and 32% had stable disease as their best response for a disease control rate of 36%; 32% of patients had disease control lasting 5 months or longer. The median overall survival and progression-free survival (PFS) were 14.1 and 2.9 months, respectively. Toxicities were minimal and included rash and diarrhea. Gefitinib was well tolerated and had interesting activity in previously untreated patients with advanced NSCLC.
AB - Gefitinib has modest activity with an overall response rate of 11-18% in patients with metastatic non-small cell lung cancer (NSCLC) who have had progressive disease following platinum containing chemotherapy. However, the efficacy of gefitinib in previously untreated metastatic NSCLC is not known. We retrospectively analyzed the efficacy of gefitinib as a first line therapy in 26 patients with advanced NSCLC enrolled in the expanded access program. Patients received gefitinib 250 mg a day orally if they had a poor performance status (PS) or if they refused cytotoxic chemotherapy. Treatment was continued as long as there was no evidence of disease progression or unacceptable treatment related toxicities. The characteristics of 25 evaluable patients enrolled between the period of May 2001 and August 2002 include: 15 women, 10 men; median age 73 years (range 56-86), 81% had an ECOG performance status of two. Only one patient had a partial response and 32% had stable disease as their best response for a disease control rate of 36%; 32% of patients had disease control lasting 5 months or longer. The median overall survival and progression-free survival (PFS) were 14.1 and 2.9 months, respectively. Toxicities were minimal and included rash and diarrhea. Gefitinib was well tolerated and had interesting activity in previously untreated patients with advanced NSCLC.
KW - First line treatment
KW - Gefitinib
KW - Non-small cell lung cancer
UR - http://www.scopus.com/inward/record.url?scp=3042747669&partnerID=8YFLogxK
U2 - 10.1016/j.lungcan.2004.01.022
DO - 10.1016/j.lungcan.2004.01.022
M3 - Article
C2 - 15246194
AN - SCOPUS:3042747669
SN - 0169-5002
VL - 45
SP - 221
EP - 225
JO - Lung Cancer
JF - Lung Cancer
IS - 2
ER -