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IFCT-0401 trial: A phase II study of gefitinib administered as first-line treatment in advanced adenocarcinoma with bronchioloalveolar carcinoma subtype
Journal of Thoracic Oncology, 09/03/09

Cadranel J et al. – Gefitinib combines efficacy with low toxicity and is suitable as a first-line treatment of advanced ADC-BAC, particularly in patients with non-mucinous BAC subtype.

Methods

Chemotherapy-naive patients (n = 88) with advanced ADC-BAC were treated with 250 mg/d of gefitinib
Clinical and disease characteristics that conferred a favorable prognosis under gefitinib were also analyzed

Results

Disease control was achieved in 25 patients (29.4%); 11 patients (12.9%) had partial response and 14 (16.4%) had stable disease.
Median PFS was 2.9 mos and median OS was 13.2 mos
Never smokers, patients with low respiratory symptoms score, occurrence of cutaneous rash, and nonmucinous ADC-BAC subtype were associated with increased probability of disease control
Nonmucinous ADC-BAC was associated with increased PFS and OS at 3 years
Patients with non-mucinous BAC had longer OS and PFS compared with patients with other ADC-BAC variants; median PFS for non-mucinous BAC was 11.3 mos, whereas it was 2.6 mos for mucinous BAC
Toxicity was low, with dermatologic problems, diarrhea, and nausea being the most common adverse events

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