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
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Skin toxicity was evaluated with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
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Efficacy was evaluated locally according to the Response Evaluation Criteria in Solid Tumors (RECIST) system.
Results
Rash:
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Twenty of 32 patients (63%) developed a rash characterized by a pustular papular erythematous eruption.
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Onset of eruptions was one to three weeks after therapy initiated.
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In some cases, the investigators observed diffuse erythema with follicular papules and pustules.
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A degree of hyperpigmentation was noted in some patients.
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Bacterial cultures were performed when infection was possible, and no secondary infection appeared concomitantly in the patients.
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Topical antibiotic therapy was performed until resolution of skin toxicity.
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Seven patients required oral doxycycline 100 mg daily for two months.
Pruritus:
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Antihistamines provided relief for patients with grade 2 or 3 pruritus.
Xerosis:
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Xerosis was observed in 16 patients (50%).
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After six to eight weeks of treatment, some patients developed scaly, dry, itchy skin in areas previously affected by the acneform eruptions.
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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
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This was an uncontrolled, nonrandomized trial.
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A combination of interventions was used; therefore, determining the effectiveness of the individual interventions is difficult.
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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.