Abstract |
In phase I trials in healthy volunteers and patients with refractory cancers, erlotinib ( Tarceva) was well tolerated and showed activity against non-small-cell lung cancer and other tumors. The dose identified for further clinical development was 150 mg/ d; at this dose, erlotinib achieves high exposure, with maximum concentrations greater than 2,000 ng/mL and 24-hour area under the concentration-time cure greater than 35,000 ng.h/L. In a phase II trial in 57 patients with previously treated advanced non-small-cell lung cancer, erlotinib treatment produced an objective response rate of 12.3% and a stable disease rate of 38.6%, with median duration of response of 19.6 weeks; median overall survival was 8.4 months and 1-year survival was 40%, with 9 patients remaining alive over follow-up of greater than 18 months. No grade 4 toxicity was observed, and grade 3 toxicity was minimal. In an ongoing phase II trial in bronchioloalveolar carcinoma, erlotinib treatment has produced objective response in 26% of 50 evaluable patients, with median duration of response not yet having been reached. An ongoing phase II trial is examining the combination of erlotinib with the angiogenesis inhibitor bevacizumab ( Avastin) in previously treated non-small-cell lung cancer; phase I evaluation revealed no dose-limiting toxicities at tested doses and provided evidence of antitumor activity. Two phase III trials are examining erlotinib in combination with carboplatin ( Paraplatin)/ paclitaxel (the TRIBUTE trial) or cisplatin/ gemcitabine ( Gemzar) (the TALENT trial) as first-line treatment in advanced non-small-cell lung cancer. The phase III BR.21 trial is assessing erlotinib monotherapy in advanced refractory non-small-cell lung cancer. Results of these phase II trials will soon be available.
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Authors | Alan Sandler |
Journal | Oncology (Williston Park, N.Y.)
(Oncology (Williston Park))
Vol. 17
Issue 11 Suppl 12
Pg. 17-22
(Nov 2003)
ISSN: 0890-9091 [Print] United States |
PMID | 14682119
(Publication Type: Journal Article, Review)
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Chemical References |
- Angiogenesis Inhibitors
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Quinazolines
- Bevacizumab
- Carboplatin
- Erlotinib Hydrochloride
- ErbB Receptors
- Paclitaxel
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Topics |
- Angiogenesis Inhibitors
(administration & dosage)
- Antibodies, Monoclonal
(administration & dosage)
- Antibodies, Monoclonal, Humanized
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Area Under Curve
- Bevacizumab
- Carboplatin
(administration & dosage)
- Carcinoma, Non-Small-Cell Lung
(drug therapy, physiopathology)
- Clinical Trials, Phase I as Topic
- Clinical Trials, Phase II as Topic
- Clinical Trials, Phase III as Topic
- ErbB Receptors
(antagonists & inhibitors)
- Erlotinib Hydrochloride
- Humans
- Lung Neoplasms
(drug therapy, physiopathology)
- Paclitaxel
(administration & dosage)
- Quinazolines
(adverse effects, pharmacokinetics, pharmacology, therapeutic use)
- Survival Analysis
- Treatment Outcome
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