Racca, P., Fanchini, L., Caliendo, V., Ritorto, G., Evangelista, W., Volpatto, R., . . . Ciuffreda, L. (2008). Efficacy and skin toxicity management with cetuximab in metastatic colorectal cancer: Outcomes from an oncologic/dermatologic cooperation. Clinical Colorectal Cancer, 7, 48–54.

DOI Link

Study Purpose

To evaluate the effectiveness of treatments for several cutaneous reactions.

Intervention Characteristics/Basic Study Process

Rash was treated with erythromycin 4% gel, phosphate clindamycin 1.2 g and oil 100 g in cream BID, and oral doxycycline 100 mg daily for two months. Patients with grade 2 or 3 pruritus were treated with antihistamines (e.g., cetirizine). Finally, xerosis was treated with topical antibiotic ointments, soap substitutes, bath oil, and moisturizing emollients.

Sample Characteristics

The study reported on a sample of 34 patients with metastatic colorectal cancer who were receiving cetuximab and irinotecan.

Setting

The trial was conducted at two sites in Italy.

Study Design

This was an open-label, uncontrolled phase 2 trial. A series of cases with significant dermatologic events (DEs) was described, and management of DEs was discussed.

Measurement Instruments/Methods

  • Skin toxicity was evaluated with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
  • Efficacy was evaluated locally according to the Response Evaluation Criteria in Solid Tumors (RECIST) system.

Results

Rash:

  • Twenty of 32 patients (63%) developed a rash characterized by a pustular papular erythematous eruption.
  • Onset of eruptions was one to three weeks after therapy initiated.
  • In some cases, the investigators observed diffuse erythema with follicular papules and pustules.
  • A degree of hyperpigmentation was noted in some patients.
  • Bacterial cultures were performed when infection was possible, and no secondary infection appeared concomitantly in the patients.
  • Topical antibiotic therapy was performed until resolution of skin toxicity.
  • Seven patients required oral doxycycline 100 mg daily for two months.

Pruritus:

  • Antihistamines provided relief for patients with grade 2 or 3 pruritus.

Xerosis:

  • Xerosis was observed in 16 patients (50%).
  • After six to eight weeks of treatment, some patients developed scaly, dry, itchy skin in areas previously affected by the acneform eruptions.
  • Topical antibiotic ointments, soap substitutes, bath oil, and treatment with moisturizing emollients controlled the symptoms well.

Conclusions

Interventions were effective in resolving the dermatologic effects of cetuximab and irinotecan.

Limitations

  • This was an uncontrolled, nonrandomized trial.
  • A combination of interventions was used; therefore, determining the effectiveness of the individual interventions is difficult.
  • The authors stated that no established guidelines exist for the treatment of skin toxicities associated with epidermal growth factor receptor–inhibitor (EGFRI) therapy. Interventions were based on expert opinion.