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Drug Safety Evaluations

Reviewing the safety of erlotinib in non-small cell lung cancer

, MD PhD, , MD FRCPC, , MD, , MD & , MD FACS
Pages 147-157 | Published online: 08 Dec 2010
 

Abstract

Importance of the field: Erlotinib, a potent inhibitor of EGFR activity, is approved as a monotherapy for the treatment of advanced NSCLC and in combination with gemcitabine for advanced pancreatic cancer. The oral administration and manageable toxicity of erlotinib, along with its similar efficacy to chemotherapy, make it an important option as either maintenance therapy or in second-/third-line for patients with NSCLC who have previously received first-line chemotherapy. It is also an emerging option in other treatment settings in NSCLC.

Areas covered in this review: This review summarizes safety data from major clinical trials of erlotinib in patients with advanced NSCLC, as well as post-marketing data obtained in the 5 years since this drug was first approved.

What the reader will gain: An understanding of the common toxicities expected with erlotinib in patients with advanced NSCLC.

Take home message: Erlotinib is a well-tolerated treatment option for patients with advanced NSCLC. The main adverse events of rash and diarrhea are typically mild or moderate in severity, and rarely lead to treatment withdrawal. When necessary, rash and diarrhea can be easily managed prophylactically, by active intervention or through dose reduction.

Acknowledgements

The authors thank B Chopra of F. Hoffmann-La Roche Ltd. for the post-marketing data.

Declaration of interests

Support for third party writing assistance for this manuscript was provided by F. Hoffmann-La Roche Ltd. M Reck has received honoraria for lectures from Eli Lilly, Merck & Co., F. Hoffmann-La Roche and AstraZeneca, and has attended advisory boards for Eli Lillly, Merck & Co., F. Hoffmann-La Roche Ltd., AstraZeneca and Bristol-Myers Squibb.

T Mok has received honoraria from AstraZeneca, F. Hoffmann-La Roche Ltd., Pfizer, Merck Serono, Eli Lilly and Bristol-Myers Squibb. He has also acted as a consultant for AstraZeneca, F. Hoffmann-La Roche Ltd., Pfizer, Taiho, Eisai, Merck Serono and Eli Lilly.

J Wolf has received honoraria for lectures or advisory board participation from F. Hoffmann-La Roche Ltd., AstraZeneca, Merck Darmstadt, Eli Lilly, Amgen and Novartis.

D Heigener has received honoraria for lectures from Eli Lilly, Sanofi-Aventis, Boehringer Ingelheim, Amgen, F. Hoffmann-La Roche Ltd. and AstraZeneca, and has attended advisory boards for Eli Lilly, F. Hoffmann-La Roche Ltd. and AstraZeneca.

Y-l Wu has received honoraria for lectures from Eli Lilly, F. Hoffmann-La Roche Ltd., AstraZeneca and Pfizer.

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