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Randomized Phase II Trial of Erlotinib or Standard Chemotherapy in Patients With Advanced Non–Small-Cell Lung Cancer and a Performance Status of 2

Rogerio Lilenbaum, Rita Axelrod, Sachdev Thomas, Afshin Dowlati, Leonard Seigel, Donald Albert, Karsten Witt, David Botkin

From the Mount Sinai Cancer Center, Miami Beach, FL; Thomas Jefferson University Hospital, Philadelphia, PA; Oncology/Hematology Associates of Central Illinois, IL; University Hospitals of Cleveland, Cleveland, OH; Holy Cross Hospital, Ft. Lauderdale, FL; OSI Pharmaceuticals, Boulder, CO; and Sharp Clinical Oncology Research, San Diego, CA

Corresponding author: Rogerio Lilenbaum, MD, Mount Sinai Cancer Center; 4306 Alton Road; Miami Beach, FL 33140; e-mail: rlilenbaum{at}aptiumoncology.com

Purpose: A multicenter randomized phase II trial to evaluate two treatment strategies in the first-line management of advanced non–small-cell lung cancer (NSCLC) patients with a performance status (PS) of 2.

Patients and Methods: Patients were assigned to erlotinib 150 mg orally daily until progression or to carboplatin (area under the curve [AUC] 6) and paclitaxel (200 mg/m² day 1 every 3 weeks) for up to four cycles. Patients who experienced progression or did not tolerate or refused further chemotherapy were allowed to cross over to erlotinib. The primary end point was progression-free survival (PFS). Secondary end points were response, survival, quality of life (QOL), and a retrospective molecular correlation.

Results: Fifty-two patients were randomly assigned to erlotinib and 51 to chemotherapy. Partial responses were 2% and 12%, respectively. Median PFS was 1.9 months in the erlotinib arm and 3.5 months in the chemotherapy arm (hazard ratio [HR] = 1.45; 95% CI, 0.98 to 2.15; P = .06). Median survival times were 6.5 and 9.7 months, respectively (HR = 1.73; 95% CI, 1.09 to 2.73; P = .018). Patients who crossed over to erlotinib had a median survival of 14.9 months. Sex, histology, skin rash, and smoking history predicted outcome with erlotinib. Rash and diarrhea were more common with erlotinib; emesis, alopecia, peripheral neuropathy, and fatigue were more common with chemotherapy. QOL was similar between the two arms. Molecular correlation was limited by available samples.

Conclusion: Unselected patients with advanced NSCLC and PS 2 are best treated with combination chemotherapy as first-line therapy. Erlotinib may be considered in patients selected by clinical or molecular markers.

Supported by OSI Pharmaceuticals Inc, Melville, NY.

Presented in part at the 42nd Annual Meeting of the American Society of Clinical Oncology, June 2-6, 2006, Atlanta, GA.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.