Single-agent gefitinib in patients with untreated advanced non-small-cell lung cancer and poor performance status: a Minnie Pearl Cancer Research Network Phase II Trial.
Clin Lung Cancer
; 7(2): 127-32, 2005 Sep.
Article
in En
| MEDLINE
| ID: mdl-16179100
ABSTRACT
BACKGROUND:
Patients with advanced non-small-cell lung cancer (NSCLC) and poor performance status (PS) are often excluded from trials. Gefitinib is a safe oral agent that may benefit these patients. PATIENTS ANDMETHODS:
Seventy-two patients with poor PS and advanced NSCLC were enrolled onto this study of gefitinib 250 mg per day given orally until disease progression, with evaluation at 8 weeks. Eligible patients had no previous chemotherapy, an Eastern Cooperative Oncology Group PS of 2/3, and stage IIIB/IV NSCLC. Quality of life (QOL) and symptom response (SR) scores were calculated using the Functional Assessment of Cancer-Lung questionnaire. Patient characteristics included a median age of 75 years; PS of 2/3; and bronchoalveolar (n=3), adenocarcinoma (n=29), squamous cell (n=21), large-cell (n=11), and unspecified histology (n=6). Mean treatment duration was 4 months (range, 3 days to 18 months), and median duration of follow-up was 12 months. Grade 3/4 toxicities included rash and diarrhea.RESULTS:
Among 70 patients assessed for response, there were 3 partial responses (4%), 32 patients with stable disease (46%), and 18 with progressive disease (26%). Median progression-free survival (PFS) and overall survival (OS) were 3.7 months and 6.3 months, respectively. Six-month and 1-year PFS and OS rates were 35% and 21% and 50% and 24%, respectively. Eighty-two percent and 48% of patients reported improvements or no change in QOL and SR, respectively.CONCLUSION:
Gefitinib demonstrates modest efficacy and is well tolerated as initial therapy in advanced NSCLC for patients with poor PS.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Psychomotor Performance
/
Quinazolines
/
Carcinoma, Non-Small-Cell Lung
/
Lung Neoplasms
/
Antineoplastic Agents
Type of study:
Clinical_trials
Aspects:
Patient_preference
Limits:
Aged
/
Aged80
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Clin Lung Cancer
Journal subject:
NEOPLASIAS
Year:
2005
Document type:
Article
Affiliation country:
United States