Erlotinib ‘dosing-to-rash’: a phase II intrapatient dose escalation and pharmacologic study of erlotinib in previously treated advanced non-small cell lung cancer
2011

Erlotinib Dosing to Rash in Lung Cancer

Sample size: 42 publication Evidence: moderate

Author Information

Author(s): Mita A C, Papadopoulos K, de Jonge M J A, Schwartz G, Verweij J, Mita M M, Ricart A, Chu Q S-C, Tolcher A W, Wood L, McCarthy S, Hamilton M, Iwata K, Wacker B, Witt K, Rowinsky E K

Primary Institution: Institute for Drug Development, Cancer Therapy and Research Center, University of Texas Health Science Center

Hypothesis

Can increasing the dose of erlotinib to the level associated with maximal skin toxicity improve anticancer activity in patients with advanced non-small cell lung cancer?

Conclusion

Increasing the dose of erlotinib does not significantly enhance its anticancer activity in patients with advanced non-small cell lung cancer.

Supporting Evidence

  • Erlotinib dose escalation was feasible in 90% of patients.
  • 57% of patients developed a target rash.
  • 12% of patients had a partial response.
  • Median progression-free survival was 2.3 months.
  • Patients who developed a target rash had a median PFS of 3.5 months.

Takeaway

This study looked at whether giving a higher dose of a cancer drug called erlotinib, until patients developed a skin rash, would help fight lung cancer better. It found that this approach didn't really make a difference.

Methodology

Patients started with 150 mg of erlotinib daily, with doses increased based on the development of a target rash.

Potential Biases

Potential bias due to the small sample size and lack of randomization.

Limitations

The study was not designed to demonstrate statistically significant increases in antitumor activity compared to previous studies.

Participant Demographics

{"age":{"median":63,"range":"41-78"},"gender":{"male":14,"female":28},"race":{"caucasian":34,"hispanic":5,"african_american":2,"asian":1},"smoking_status":{"never_smokers":2,"former_smokers":35,"current_smokers":5}}

Statistical Information

P-Value

0.051

Confidence Interval

95% CI: 1.61–4.14

Statistical Significance

p=0.051

Digital Object Identifier (DOI)

10.1038/bjc.2011.332

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