Jatoi, A., Dakhil, S.R., Sloan, J.A., Kugler, J.W., Rowland, K.M., Jr., Schaefer, P.L., . . . Loprinzi, C.L. (2011). Prophylactic tetracycline does not diminish the severity of epidermal growth factor receptor (EGFR) inhibitor-induced rash: Results from the North Central Cancer Treatment Group (Supplementary N03CB). Supportive Care in Cancer, 19, 1601–1607.

DOI Link

Study Purpose

To attempt to confirm the benefit of the antibiotic tetracycline in decreasing the severity of epidermal growth factor receptor (EGFR)–inhibitor-induced rash.

Intervention Characteristics/Basic Study Process

Eligible patients who were starting an EGFR inhibitor and were rash free were randomly assigned to tetracycline 500 mg orally BID for 28 days, versus placebo. Rash development and severity, quality of life, and adverse events were monitored during the four-week intervention and for an additional four weeks. The primary objective was to compare the incidence of grade 2 or worse rash between the study arms.

Sample Characteristics

  • The study reported on a sample of 65 patients aged 18 years or older.
  • The sample was 63% male and 36% female.
  • All patients had a cancer diagnosis and were starting an EGFR inhibitor.

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

This was a randomized, double-blind, placebo-controlled clinical trial.

Measurement Instruments/Methods

  • Patients were monitored for rash severity by physician report using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.   
  • Patient-reported questionnaire regarding rash
  • Patient-reported quality of life as per the Skindex-16 questionnaire
  • Patient-reported series of linear analogue self-assessment (LASA) scales
  • Adverse events reported by the patient and physician
  • Patient diary regarding compliance with EGFR inhibitor consumption

Results

  • The cumulative incidence of grade 2 or worse rash was comparable across study arms.
  • Quality of life also was not significantly different between study arms.

Conclusions

This randomized, double-blinded, placebo-controlled study did not find that tetracycline decreased rash incidence or severity in patients who were taking EGFR inhibitors.

Limitations

The sample size was small (fewer than 100 patients).

Nursing Implications

Quality of life was comparable and tetracycline was well tolerated, but the current results did not support what prior studies had suggested.