Multicenter phase I/II study of cetuximab with paclitaxel and carboplatin in untreated patients with stage IV non-small-cell lung cancer

Christiane D. Thienelt, Paul A. Bunn, Nasser Hanna, Arthur Rosenberg, Michael N. Needle, Michael E. Long, Daniel L. Gustafson, Karen Kelly

Research output: Contribution to journalArticle

177 Citations (Scopus)

Abstract

Purpose: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors have demonstrated antitumor activity in patients with non-small-cell lung cancer (NSCLC). This study examined the safety profile of the monoclonal antibody EGFR inhibitor, cetuximab, when added to paclitaxel and carboplatin in untreated patients with stage IV NSCLC. Secondary objectives included efficacy and paclitaxel and carboplatin pharmacokinetics during cetuximab treatment. Patients and Methods: Patients with tumor evidence of EGFR by immunohistochemistry, performance status of 0 to 2, and measurable disease received paclitaxel 225 mg/m2 with carboplatin area under the curve = 6 on day 1 every 3 weeks. Cetuximab was administered at 400 mg/m2, 1 week before paclitaxel and carboplatin, then weekly at 250 mg/m2. The regimen continued until disease progression or intolerable toxicity. Results: Thirty-one of 32 enrolled patients were treated. The most common cetuximab toxicity was rash in 84% of patients (grade 3 in 13%). Pharmacokinetic sampling did not reveal an interaction between carboplatin, paclitaxel, and cetuximab. An objective response was observed in eight patients (26%). With a median follow-up of 19 months, the median time to progression was 5 months, median survival was 11 months, and the 1- and 2-year survival rates were 40% and 16%, respectively. Conclusion: The combination of cetuximab, paclitaxel, and carboplatin was safe and well tolerated in this population of stage IV patients. The response rate, time to progression, and median survival were slightly superior to historical controls treated with paclitaxel and carboplatin alone. A randomized phase II trial has completed accrual.

Original languageEnglish (US)
Pages (from-to)8786-8793
Number of pages8
JournalJournal of Clinical Oncology
Volume23
Issue number34
DOIs
StatePublished - 2005
Externally publishedYes

Fingerprint

Carboplatin
Paclitaxel
Non-Small Cell Lung Carcinoma
Epidermal Growth Factor Receptor
Pharmacokinetics
Survival
Cetuximab
Exanthema
Protein-Tyrosine Kinases
Area Under Curve
Disease Progression
Survival Rate
Immunohistochemistry
Monoclonal Antibodies
Safety
Population

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Multicenter phase I/II study of cetuximab with paclitaxel and carboplatin in untreated patients with stage IV non-small-cell lung cancer. / Thienelt, Christiane D.; Bunn, Paul A.; Hanna, Nasser; Rosenberg, Arthur; Needle, Michael N.; Long, Michael E.; Gustafson, Daniel L.; Kelly, Karen.

In: Journal of Clinical Oncology, Vol. 23, No. 34, 2005, p. 8786-8793.

Research output: Contribution to journalArticle

Thienelt, Christiane D. ; Bunn, Paul A. ; Hanna, Nasser ; Rosenberg, Arthur ; Needle, Michael N. ; Long, Michael E. ; Gustafson, Daniel L. ; Kelly, Karen. / Multicenter phase I/II study of cetuximab with paclitaxel and carboplatin in untreated patients with stage IV non-small-cell lung cancer. In: Journal of Clinical Oncology. 2005 ; Vol. 23, No. 34. pp. 8786-8793.
@article{ec5cfdd88efe4c4dbf685b4035f26a31,
title = "Multicenter phase I/II study of cetuximab with paclitaxel and carboplatin in untreated patients with stage IV non-small-cell lung cancer",
abstract = "Purpose: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors have demonstrated antitumor activity in patients with non-small-cell lung cancer (NSCLC). This study examined the safety profile of the monoclonal antibody EGFR inhibitor, cetuximab, when added to paclitaxel and carboplatin in untreated patients with stage IV NSCLC. Secondary objectives included efficacy and paclitaxel and carboplatin pharmacokinetics during cetuximab treatment. Patients and Methods: Patients with tumor evidence of EGFR by immunohistochemistry, performance status of 0 to 2, and measurable disease received paclitaxel 225 mg/m2 with carboplatin area under the curve = 6 on day 1 every 3 weeks. Cetuximab was administered at 400 mg/m2, 1 week before paclitaxel and carboplatin, then weekly at 250 mg/m2. The regimen continued until disease progression or intolerable toxicity. Results: Thirty-one of 32 enrolled patients were treated. The most common cetuximab toxicity was rash in 84{\%} of patients (grade 3 in 13{\%}). Pharmacokinetic sampling did not reveal an interaction between carboplatin, paclitaxel, and cetuximab. An objective response was observed in eight patients (26{\%}). With a median follow-up of 19 months, the median time to progression was 5 months, median survival was 11 months, and the 1- and 2-year survival rates were 40{\%} and 16{\%}, respectively. Conclusion: The combination of cetuximab, paclitaxel, and carboplatin was safe and well tolerated in this population of stage IV patients. The response rate, time to progression, and median survival were slightly superior to historical controls treated with paclitaxel and carboplatin alone. A randomized phase II trial has completed accrual.",
author = "Thienelt, {Christiane D.} and Bunn, {Paul A.} and Nasser Hanna and Arthur Rosenberg and Needle, {Michael N.} and Long, {Michael E.} and Gustafson, {Daniel L.} and Karen Kelly",
year = "2005",
doi = "10.1200/JCO.2005.03.1997",
language = "English (US)",
volume = "23",
pages = "8786--8793",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "34",

}

TY - JOUR

T1 - Multicenter phase I/II study of cetuximab with paclitaxel and carboplatin in untreated patients with stage IV non-small-cell lung cancer

AU - Thienelt, Christiane D.

AU - Bunn, Paul A.

AU - Hanna, Nasser

AU - Rosenberg, Arthur

AU - Needle, Michael N.

AU - Long, Michael E.

AU - Gustafson, Daniel L.

AU - Kelly, Karen

PY - 2005

Y1 - 2005

N2 - Purpose: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors have demonstrated antitumor activity in patients with non-small-cell lung cancer (NSCLC). This study examined the safety profile of the monoclonal antibody EGFR inhibitor, cetuximab, when added to paclitaxel and carboplatin in untreated patients with stage IV NSCLC. Secondary objectives included efficacy and paclitaxel and carboplatin pharmacokinetics during cetuximab treatment. Patients and Methods: Patients with tumor evidence of EGFR by immunohistochemistry, performance status of 0 to 2, and measurable disease received paclitaxel 225 mg/m2 with carboplatin area under the curve = 6 on day 1 every 3 weeks. Cetuximab was administered at 400 mg/m2, 1 week before paclitaxel and carboplatin, then weekly at 250 mg/m2. The regimen continued until disease progression or intolerable toxicity. Results: Thirty-one of 32 enrolled patients were treated. The most common cetuximab toxicity was rash in 84% of patients (grade 3 in 13%). Pharmacokinetic sampling did not reveal an interaction between carboplatin, paclitaxel, and cetuximab. An objective response was observed in eight patients (26%). With a median follow-up of 19 months, the median time to progression was 5 months, median survival was 11 months, and the 1- and 2-year survival rates were 40% and 16%, respectively. Conclusion: The combination of cetuximab, paclitaxel, and carboplatin was safe and well tolerated in this population of stage IV patients. The response rate, time to progression, and median survival were slightly superior to historical controls treated with paclitaxel and carboplatin alone. A randomized phase II trial has completed accrual.

AB - Purpose: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors have demonstrated antitumor activity in patients with non-small-cell lung cancer (NSCLC). This study examined the safety profile of the monoclonal antibody EGFR inhibitor, cetuximab, when added to paclitaxel and carboplatin in untreated patients with stage IV NSCLC. Secondary objectives included efficacy and paclitaxel and carboplatin pharmacokinetics during cetuximab treatment. Patients and Methods: Patients with tumor evidence of EGFR by immunohistochemistry, performance status of 0 to 2, and measurable disease received paclitaxel 225 mg/m2 with carboplatin area under the curve = 6 on day 1 every 3 weeks. Cetuximab was administered at 400 mg/m2, 1 week before paclitaxel and carboplatin, then weekly at 250 mg/m2. The regimen continued until disease progression or intolerable toxicity. Results: Thirty-one of 32 enrolled patients were treated. The most common cetuximab toxicity was rash in 84% of patients (grade 3 in 13%). Pharmacokinetic sampling did not reveal an interaction between carboplatin, paclitaxel, and cetuximab. An objective response was observed in eight patients (26%). With a median follow-up of 19 months, the median time to progression was 5 months, median survival was 11 months, and the 1- and 2-year survival rates were 40% and 16%, respectively. Conclusion: The combination of cetuximab, paclitaxel, and carboplatin was safe and well tolerated in this population of stage IV patients. The response rate, time to progression, and median survival were slightly superior to historical controls treated with paclitaxel and carboplatin alone. A randomized phase II trial has completed accrual.

UR - http://www.scopus.com/inward/record.url?scp=33144484457&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33144484457&partnerID=8YFLogxK

U2 - 10.1200/JCO.2005.03.1997

DO - 10.1200/JCO.2005.03.1997

M3 - Article

C2 - 16246975

AN - SCOPUS:33144484457

VL - 23

SP - 8786

EP - 8793

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 34

ER -