1550PD - Aprepitant is active in the management of biological therapies-related severe pruritus: a phase-ii study

Date 30 September 2012
Event ESMO Congress 2012
Session Supportive and palliative care: Controlling disease and treatment side-effects
Topics Complications of Treatment
Translational Research
Presenter Daniele Santini
Authors D. Santini1, F.M. Guida1, G. Schiavon2, O. Venditti1, A.M. Frezza1, M. Imperatori1, C. Spoto1, P. Berti1, B. Vincenzi3, G. Tonini1
  • 1Medical Oncology, university campus bio-medico, 00128 - rome/IT
  • 2Breast Unit, Erasmus MCDaniel den Hoed Cancer Center, NL-3075 EA - Rotterdam/NL
  • 3university campus bio-medico, 00128 - rome/IT

 

Abstract

Introduction

Itching is a common dermatologic side effect of anti-epidermal growth factor receptor antibodies and tyrosine kinase inhibitors and may have a dramatic impact on patients' quality of life. Aprepitant, a neurokinin receptor inhibitor, showed efficacy in treating refractory pruritus. We designed a pilot single-center phase-II study evaluating the effects of aprepitant in managing biological therapy-induced pruritus.

Methods

Forty-five cancer patients treated with biological therapies were enrolled and divided in: 1) patients affected by itch refractory to standard treatment (“refractory-group”) and 2) patients who did not receive any treatment for pruritus (“naïve-group”). The intensity of itch was evaluated with Visual Analogue Scale (VAS)-score. All included patients had severe pruritus (VAS-score ≥ 7). In the refractory group aprepitant (125 mg on day 1; 80 mg on day 3 and on day 5) was administered after at least 1-week of standard systemic treatment (steroid and/or antihistaminics). In the naïve-group aprepitant was administered, with the same schedule, after first severe pruritus onset.

Results

Forty-five (25 males and 20 females) patients were enrolled, 24 in the refractory group and 21 in the naïve-group. The median age was 64 years. Among the enrolled patients, 38% (n = 17) were affected by lung cancer, 44% (n = 20) by colorectal cancer, and 18% (n = 8) by other tumors. Severe itching occurred in 16 patients treated with erlotinib, 23 with cetuximab, 1 with lapatinib, 3 with sunitinib, 1 with imatinib and 1 with gefitinib. The median decrease in pruritus intensity at 1-week after aprepitant introduction was 93% (p < 0.0001) in the refractory group and 100% (p < 0.0001) in the naïve-group. Aprepitant was active in the majority of patients regardless of the type of biological therapy. Only 6 patients developed pruritus recurrence, with a median interval of 7-weeks from first aprepitant administration. No potentially aprepitant-related toxic effects were registered.

Conclusions

This single-center phase-II study showed a new therapeutic activity of aprepitant in treating biological therapy-induced pruritus, both after standard antipruritic-medication failure and as a first-line therapy.

Disclosure

All authors have declared no conflicts of interest.