Southwest oncology group phase II trial (S0341) of erlotinib (OSI-774) in patients with advanced non-small cell lung cancer and a performance status of 2

Paul J. Hesketh, Kari Chansky, Antoinette J. Wozniak, Fred R. Hirsch, Anna Spreafico, James Moon, Philip Mack, Benjamin T. Marchello, Wilbur A. Franklin, John J. Crowley, David R Gandara

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Abstract

Purpose: This phase II study (S0341) evaluated the efficacy and tolerability of single-agent erlotinib in unselected chemotherapy-naive patients with advanced non-small cell lung cancer (NSCLC) and a performance status (PS) of 2. Exploratory analyses of a number of biomarkers relating to epidermal growth factor receptor pathway activation were also performed. PATIENTS AND METHODS: Patients with stage IIIB (pleural effusion) or stage IV NSCLC with a PS of 2 and no prior chemotherapy or biologic treatment for NSCLC received erlotinib 150 mg daily. RESULTS: A total of 81 patients entered the study; 76 were assessable. One complete and 5 partial responses were noted for an overall response rate of 8% (95% CI 3%-16%). Stable disease (SD) was seen in 26 patients (34%) resulting in a disease control rate (DCR = CR/PR/SD) of 42%. Progression free and median survival were 2.1 months (95% CI 1.5-3.1) and 5 months (95% CI 3.6-7.2), respectively. One-year survival was 24% (95% CI 15%-34%). Although treatment was generally well tolerated, grade 3 to 4 toxicity was reported in 30 patients (40%), including fatigue (16%), rash (9%), diarrhea (7%), and anorexia (7%). There was one possible treatment related death (pneumonitis). CONCLUSIONS: In chemotherapy-naive patients with advanced NSCLC and a PS of 2, single agent erlotinib resulted in an acceptable but significant level of treatment-related side effects. With an overall DCR of 42% and median survival of 5 months, results are comparable to those achieved with chemotherapy in this population. Development of an epidermal growth factor receptor-directed biomarker selection strategy may optimize use of erlotinib in PS 2 patients.

Original languageEnglish (US)
Pages (from-to)1026-1031
Number of pages6
JournalJournal of Thoracic Oncology
Volume3
Issue number9
DOIs
StatePublished - Sep 2008

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Non-Small Cell Lung Carcinoma
Drug Therapy
Epidermal Growth Factor Receptor
Biomarkers
Survival
Anorexia
Pleural Effusion
Therapeutics
Erlotinib Hydrochloride
Exanthema
Disease-Free Survival
Fatigue
Diarrhea
Pneumonia
Population

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Medicine(all)

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Southwest oncology group phase II trial (S0341) of erlotinib (OSI-774) in patients with advanced non-small cell lung cancer and a performance status of 2. / Hesketh, Paul J.; Chansky, Kari; Wozniak, Antoinette J.; Hirsch, Fred R.; Spreafico, Anna; Moon, James; Mack, Philip; Marchello, Benjamin T.; Franklin, Wilbur A.; Crowley, John J.; Gandara, David R.

In: Journal of Thoracic Oncology, Vol. 3, No. 9, 09.2008, p. 1026-1031.

Research output: Contribution to journalArticle

Hesketh, Paul J. ; Chansky, Kari ; Wozniak, Antoinette J. ; Hirsch, Fred R. ; Spreafico, Anna ; Moon, James ; Mack, Philip ; Marchello, Benjamin T. ; Franklin, Wilbur A. ; Crowley, John J. ; Gandara, David R. / Southwest oncology group phase II trial (S0341) of erlotinib (OSI-774) in patients with advanced non-small cell lung cancer and a performance status of 2. In: Journal of Thoracic Oncology. 2008 ; Vol. 3, No. 9. pp. 1026-1031.
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abstract = "Purpose: This phase II study (S0341) evaluated the efficacy and tolerability of single-agent erlotinib in unselected chemotherapy-naive patients with advanced non-small cell lung cancer (NSCLC) and a performance status (PS) of 2. Exploratory analyses of a number of biomarkers relating to epidermal growth factor receptor pathway activation were also performed. PATIENTS AND METHODS: Patients with stage IIIB (pleural effusion) or stage IV NSCLC with a PS of 2 and no prior chemotherapy or biologic treatment for NSCLC received erlotinib 150 mg daily. RESULTS: A total of 81 patients entered the study; 76 were assessable. One complete and 5 partial responses were noted for an overall response rate of 8{\%} (95{\%} CI 3{\%}-16{\%}). Stable disease (SD) was seen in 26 patients (34{\%}) resulting in a disease control rate (DCR = CR/PR/SD) of 42{\%}. Progression free and median survival were 2.1 months (95{\%} CI 1.5-3.1) and 5 months (95{\%} CI 3.6-7.2), respectively. One-year survival was 24{\%} (95{\%} CI 15{\%}-34{\%}). Although treatment was generally well tolerated, grade 3 to 4 toxicity was reported in 30 patients (40{\%}), including fatigue (16{\%}), rash (9{\%}), diarrhea (7{\%}), and anorexia (7{\%}). There was one possible treatment related death (pneumonitis). CONCLUSIONS: In chemotherapy-naive patients with advanced NSCLC and a PS of 2, single agent erlotinib resulted in an acceptable but significant level of treatment-related side effects. With an overall DCR of 42{\%} and median survival of 5 months, results are comparable to those achieved with chemotherapy in this population. Development of an epidermal growth factor receptor-directed biomarker selection strategy may optimize use of erlotinib in PS 2 patients.",
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AU - Chansky, Kari

AU - Wozniak, Antoinette J.

AU - Hirsch, Fred R.

AU - Spreafico, Anna

AU - Moon, James

AU - Mack, Philip

AU - Marchello, Benjamin T.

AU - Franklin, Wilbur A.

AU - Crowley, John J.

AU - Gandara, David R

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N2 - Purpose: This phase II study (S0341) evaluated the efficacy and tolerability of single-agent erlotinib in unselected chemotherapy-naive patients with advanced non-small cell lung cancer (NSCLC) and a performance status (PS) of 2. Exploratory analyses of a number of biomarkers relating to epidermal growth factor receptor pathway activation were also performed. PATIENTS AND METHODS: Patients with stage IIIB (pleural effusion) or stage IV NSCLC with a PS of 2 and no prior chemotherapy or biologic treatment for NSCLC received erlotinib 150 mg daily. RESULTS: A total of 81 patients entered the study; 76 were assessable. One complete and 5 partial responses were noted for an overall response rate of 8% (95% CI 3%-16%). Stable disease (SD) was seen in 26 patients (34%) resulting in a disease control rate (DCR = CR/PR/SD) of 42%. Progression free and median survival were 2.1 months (95% CI 1.5-3.1) and 5 months (95% CI 3.6-7.2), respectively. One-year survival was 24% (95% CI 15%-34%). Although treatment was generally well tolerated, grade 3 to 4 toxicity was reported in 30 patients (40%), including fatigue (16%), rash (9%), diarrhea (7%), and anorexia (7%). There was one possible treatment related death (pneumonitis). CONCLUSIONS: In chemotherapy-naive patients with advanced NSCLC and a PS of 2, single agent erlotinib resulted in an acceptable but significant level of treatment-related side effects. With an overall DCR of 42% and median survival of 5 months, results are comparable to those achieved with chemotherapy in this population. Development of an epidermal growth factor receptor-directed biomarker selection strategy may optimize use of erlotinib in PS 2 patients.

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