TY - JOUR
T1 - Gefitinib therapy in advanced bronchioloalveolar carcinoma
T2 - Southwest Oncology Group study S0126
AU - West, Howard L.
AU - Franklin, Wilbur A.
AU - McCoy, Jason
AU - Gumerlock, Paul H.
AU - Vance, Ralph
AU - Lau, Derick H M
AU - Chansky, Kari
AU - Crowley, John J.
AU - Gandara, David R.
AU - Granados, Bonnie
PY - 2006/4/20
Y1 - 2006/4/20
N2 - Purpose: Advanced bronchioloalveolar carcinoma (BAC) is a distinct subtype of non-small-cell lung cancer (NSCLC) for which there is currently no optimal therapy. Based on preclinical and clinical data suggesting relevance of the epidermal growth factor receptor (EGFR) axis in BAC, the Southwest Oncology Group initiated a phase II trial (S0126) to evaluate the EGFR tyrosine kinase inhibitor gefitinib in chemotherapy-naive and chemotherapy-pretreated patients with advanced BAC. Methods: A total of 136 eligible and assessable patients (101 untreated, 35 previously treated) received gefitinib 500 mg daily until progression or prohibitive toxicity. Results: The median age was 68.0 years (range, 34.3 to 88.6); 51 % were female; 89% had a performance status (PS) of 0% or 1 % and 11 % had a PS of 2. The Response Evaluation Criteria in Solid Tumors response rate was 17%, with 6% complete responses (CRs) among 69 previously untreated patients with measurable disease, and 9% with no CRs among 22 pretreated patients. Median survival was 13 months for both chemo-naïve (95% CI, 8 to 18) and previously treated patients (95% CI, 6 to 17). Overall survival at 3 years was 23% (95% CI, 14% to 32%). Toxicity consisted mainly of rash and diarrhea, but 2% of patients died of presumed interstitial lung disease. Exploratory subset analyses revealed improved survival among women (P = .031), patients developing a rash (P = .003), never-smokers (P = .061), and patients with a PS of 0 or 1 (P = .015). Conclusion: Gefitinib is an active agent in advanced stage BAC. Several subsets demonstrate significantly improved clinical outcomes.
AB - Purpose: Advanced bronchioloalveolar carcinoma (BAC) is a distinct subtype of non-small-cell lung cancer (NSCLC) for which there is currently no optimal therapy. Based on preclinical and clinical data suggesting relevance of the epidermal growth factor receptor (EGFR) axis in BAC, the Southwest Oncology Group initiated a phase II trial (S0126) to evaluate the EGFR tyrosine kinase inhibitor gefitinib in chemotherapy-naive and chemotherapy-pretreated patients with advanced BAC. Methods: A total of 136 eligible and assessable patients (101 untreated, 35 previously treated) received gefitinib 500 mg daily until progression or prohibitive toxicity. Results: The median age was 68.0 years (range, 34.3 to 88.6); 51 % were female; 89% had a performance status (PS) of 0% or 1 % and 11 % had a PS of 2. The Response Evaluation Criteria in Solid Tumors response rate was 17%, with 6% complete responses (CRs) among 69 previously untreated patients with measurable disease, and 9% with no CRs among 22 pretreated patients. Median survival was 13 months for both chemo-naïve (95% CI, 8 to 18) and previously treated patients (95% CI, 6 to 17). Overall survival at 3 years was 23% (95% CI, 14% to 32%). Toxicity consisted mainly of rash and diarrhea, but 2% of patients died of presumed interstitial lung disease. Exploratory subset analyses revealed improved survival among women (P = .031), patients developing a rash (P = .003), never-smokers (P = .061), and patients with a PS of 0 or 1 (P = .015). Conclusion: Gefitinib is an active agent in advanced stage BAC. Several subsets demonstrate significantly improved clinical outcomes.
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U2 - 10.1200/JCO.2005.04.9890
DO - 10.1200/JCO.2005.04.9890
M3 - Article
C2 - 16622257
AN - SCOPUS:33646381931
VL - 24
SP - 1807
EP - 1813
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 12
ER -