Get 20M+ Full-Text Papers For Less Than $1.50/day. Start a 14-Day Trial for You or Your Team.

Learn More →

Compassionate Use Programs or Phase IV Trials of Innovative Molecular Targeted Drugs in Lung Cancer Deal or No Deal?

Compassionate Use Programs or Phase IV Trials of Innovative Molecular Targeted Drugs in Lung... EDITORIAL Compassionate Use Programs or Phase IV Trials of Innovative Molecular Targeted Drugs in Lung Cancer Deal or No Deal? Wilfried Eberhardt, MD PHASE IV OPEN-LABELED STUDY WITH ERLOTINIB IN SOUTH-EAST ASIANS WITH NON-SMALL CELL LUNG CANCER In this month’s issue of the journal, we are faced with yet another large compassionate use program (expanded access program [EAP/phase IV trial]) with a molecular targeted drug 1 1 in patients with non-small cell lung cancer (NSCLC). This time, Mok et al. present the results of a large South-East Asian patient cohort treated within an expanded access program of erlotinib for NSCLC in multiple-line situations after chemotherapy and/or radiotherapy or upfront in patients unsuitable for standard combination chemotherapy. Interestingly, 1242 patients were investigated for safety and efficacy of the treatment with the EGF-R tyrosine kinase inhibitor erlotinib in this mature analysis of the clinical trials results. The median overall survival with more than 14 months and the median progres- sion-free survival (PFS) of nearly 6 months seen with erlotinib in South-East Asian patients were found to be significantly better than the results observed in the parallel TRUST program with erlotinib in white/non-Asian patients reported in the same issue of this journal. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Thoracic Oncology Wolters Kluwer Health

Compassionate Use Programs or Phase IV Trials of Innovative Molecular Targeted Drugs in Lung Cancer Deal or No Deal?

Eberhardt, Wilfried
Journal of Thoracic Oncology , Volume 5 (10) – Oct 1, 2010
Download PDF
3 pages

Loading next page...
 
/lp/wolters-kluwer-health/compassionate-use-programs-or-phase-iv-trials-of-innovative-molecular-TV80jI51Or

References (14)

ISSN
1556-0864
DOI
10.1097/JTO.0b013e3181f41b1c
pmid
20871257
Publisher site
See Article on Publisher Site

Abstract

EDITORIAL Compassionate Use Programs or Phase IV Trials of Innovative Molecular Targeted Drugs in Lung Cancer Deal or No Deal? Wilfried Eberhardt, MD PHASE IV OPEN-LABELED STUDY WITH ERLOTINIB IN SOUTH-EAST ASIANS WITH NON-SMALL CELL LUNG CANCER In this month’s issue of the journal, we are faced with yet another large compassionate use program (expanded access program [EAP/phase IV trial]) with a molecular targeted drug 1 1 in patients with non-small cell lung cancer (NSCLC). This time, Mok et al. present the results of a large South-East Asian patient cohort treated within an expanded access program of erlotinib for NSCLC in multiple-line situations after chemotherapy and/or radiotherapy or upfront in patients unsuitable for standard combination chemotherapy. Interestingly, 1242 patients were investigated for safety and efficacy of the treatment with the EGF-R tyrosine kinase inhibitor erlotinib in this mature analysis of the clinical trials results. The median overall survival with more than 14 months and the median progres- sion-free survival (PFS) of nearly 6 months seen with erlotinib in South-East Asian patients were found to be significantly better than the results observed in the parallel TRUST program with erlotinib in white/non-Asian patients reported in the same issue of this journal.

Journal

Journal of Thoracic Oncology – Wolters Kluwer Health

Published: Oct 1, 2010

There are no references for this article.