drugset / Trial / NCT02646020
Aprepitant vs. Desloratadine in EGFR-TKIs Related Pruritus Treatment
RandomizedParallel-groupTriple-blindTreatment
Summary
Study hypothesis is that aprepitant is more effective than desloratadine in relieving pruritus caused by EGFR TKIs. Primary endpoint is the effective rate of pruritus, effective treatment defined as visual analogue scale (VAS) decrease ≥ 50% after treatment compared to baseline score. 130 NSCLC patients undertaken EGFR-TKI and suffer from moderate or severe pruritus (VAS score ≥ 4) will be enrolled in this study, and stratified (gender, VAS 4-6 or 7-10, and 2nd generation TKI or non 2nd generation) randomized (1:1) into aprepitant or desloratadine treatment. VAS investigation will be taken once a week to treatment end (4 weeks).
Timeline
- Start
- 2015-12
- Primary completion
- 2020-10-01
- Completion
- 2020-12-01
Outcome
Met primary endpoint
paper 33 (53.2%) patients responded to aprepitant, which was significantly higher than that of 14 (23.7%) patients responded to desloratadine (p = .001). PMID 36197287 ↗
paper aprepitant elicited a better and faster response and mild toxicity for managing EGFR-TKI induced pruritus than desloratadine. PMID 36197287 ↗
Publications
- Results Mok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, Sunpaweravong P, Han B, Margono B, Ichinose Y, Nishiwaki Y, Ohe Y, Yang JJ, Chewaskulyong B, Jiang H, Duffield EL, Watkins CL, Armour AA, Fukuoka M. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009 Sep 3;361(10):947-57. doi: 10.1056/NEJMoa0810699. Epub 2009 Aug 19.
- Results Zhou C, Wu YL, Chen G, Feng J, Liu XQ, Wang C, Zhang S, Wang J, Zhou S, Ren S, Lu S, Zhang L, Hu C, Hu C, Luo Y, Chen L, Ye M, Huang J, Zhi X, Zhang Y, Xiu Q, Ma J, Zhang L, You C. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2011 Aug;12(8):735-42. doi: 10.1016/S1470-2045(11)70184-X. Epub 2011 Jul 23.
- Results Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005 Jul 14;353(2):123-32. doi: 10.1056/NEJMoa050753.
- Results Cappuzzo F, Ciuleanu T, Stelmakh L, Cicenas S, Szczesna A, Juhasz E, Esteban E, Molinier O, Brugger W, Melezinek I, Klingelschmitt G, Klughammer B, Giaccone G; SATURN investigators. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol. 2010 Jun;11(6):521-9. doi: 10.1016/S1470-2045(10)70112-1. Epub 2010 May 20.
- Results Zhang L, Ma S, Song X, Han B, Cheng Y, Huang C, Yang S, Liu X, Liu Y, Lu S, Wang J, Zhang S, Zhou C, Zhang X, Hayashi N, Wang M; INFORM investigators. Gefitinib versus placebo as maintenance therapy in patients with locally advanced or metastatic non-small-cell lung cancer (INFORM; C-TONG 0804): a multicentre, double-blind randomised phase 3 trial. Lancet Oncol. 2012 May;13(5):466-75. doi: 10.1016/S1470-2045(12)70117-1. Epub 2012 Apr 17.
- Results Lynch TJ Jr, Kim ES, Eaby B, Garey J, West DP, Lacouture ME. Epidermal growth factor receptor inhibitor-associated cutaneous toxicities: an evolving paradigm in clinical management. Oncologist. 2007 May;12(5):610-21. doi: 10.1634/theoncologist.12-5-610.
- Results Lacouture ME, Anadkat MJ, Bensadoun RJ, Bryce J, Chan A, Epstein JB, Eaby-Sandy B, Murphy BA; MASCC Skin Toxicity Study Group. Clinical practice guidelines for the prevention and treatment of EGFR inhibitor-associated dermatologic toxicities. Support Care Cancer. 2011 Aug;19(8):1079-95. doi: 10.1007/s00520-011-1197-6. Epub 2011 Jun 1.
- Results Chan A, Tan EH. How well does the MESTT correlate with CTCAE scale for the grading of dermatological toxicities associated with oral tyrosine kinase inhibitors? Support Care Cancer. 2011 Oct;19(10):1667-74. doi: 10.1007/s00520-010-0999-2. Epub 2010 Sep 5.
- Results Ocvirk J, Cencelj S. Management of cutaneous side-effects of cetuximab therapy in patients with metastatic colorectal cancer. J Eur Acad Dermatol Venereol. 2010 Apr;24(4):453-9. doi: 10.1111/j.1468-3083.2009.03446.x. Epub 2009 Sep 27.
- Results Scope A, Agero AL, Dusza SW, Myskowski PL, Lieb JA, Saltz L, Kemeny NE, Halpern AC. Randomized double-blind trial of prophylactic oral minocycline and topical tazarotene for cetuximab-associated acne-like eruption. J Clin Oncol. 2007 Dec 1;25(34):5390-6. doi: 10.1200/JCO.2007.12.6987.
- Results Porzio G, Aielli F, Verna L, Porto C, Tudini M, Cannita K, Ficorella C. Efficacy of pregabalin in the management of cetuximab-related itch. J Pain Symptom Manage. 2006 Nov;32(5):397-8. doi: 10.1016/j.jpainsymman.2006.07.006. No abstract available.
- Results Stander S, Siepmann D, Herrgott I, Sunderkotter C, Luger TA. Targeting the neurokinin receptor 1 with aprepitant: a novel antipruritic strategy. PLoS One. 2010 Jun 4;5(6):e10968. doi: 10.1371/journal.pone.0010968.
- Results Stander S, Weisshaar E. Medical treatment of pruritus. Expert Opin Emerg Drugs. 2012 Sep;17(3):335-45. doi: 10.1517/14728214.2012.711316. Epub 2012 Aug 7.
- Results Chang SE, Han SS, Jung HJ, Choi JH. Neuropeptides and their receptors in psoriatic skin in relation to pruritus. Br J Dermatol. 2007 Jun;156(6):1272-7. doi: 10.1111/j.1365-2133.2007.07935.x.
- Results Quartara L, Altamura M. Tachykinin receptors antagonists: from research to clinic. Curr Drug Targets. 2006 Aug;7(8):975-92. doi: 10.2174/138945006778019381.
- Results Booken N, Heck M, Nicolay JP, Klemke CD, Goerdt S, Utikal J. Oral aprepitant in the therapy of refractory pruritus in erythrodermic cutaneous T-cell lymphoma. Br J Dermatol. 2011 Mar;164(3):665-7. doi: 10.1111/j.1365-2133.2010.10108.x. Epub 2011 Jan 28. No abstract available.
- Results Vincenzi B, Fratto ME, Santini D, Tonini G. Aprepitant against pruritus in patients with solid tumours. Support Care Cancer. 2010 Sep;18(9):1229-30. doi: 10.1007/s00520-010-0895-9. Epub 2010 Jun 11. No abstract available.
- Results Jimenez Gallo D, Albarran Planelles C, Linares Barrios M, Fernandez Anguita MJ, Marquez Enriquez J, Rodriguez Mateos ME. Treatment of pruritus in early-stage hypopigmented mycosis fungoides with aprepitant. Dermatol Ther. 2014 May-Jun;27(3):178-82. doi: 10.1111/dth.12113. Epub 2013 Dec 2.
- Results Santini D, Vincenzi B, Guida FM, Imperatori M, Schiavon G, Venditti O, Frezza AM, Berti P, Tonini G. Aprepitant for management of severe pruritus related to biological cancer treatments: a pilot study. Lancet Oncol. 2012 Oct;13(10):1020-4. doi: 10.1016/S1470-2045(12)70373-X. Epub 2012 Sep 18.
- Results Marquez D, Ramonda C, Lauxmann JE, Romero CA, Vukelic VL, Martinatto C, Barron B, Novoa PA, Peixoto AJ, Orias M. Uremic pruritus in hemodialysis patients: treatment with desloratidine versus gabapentin. J Bras Nefrol. 2012 Jun;34(2):148-52. doi: 10.1590/s0101-28002012000200007.
- Results Bachert C, Maurer M. Safety and efficacy of desloratadine in subjects with seasonal allergic rhinitis or chronic urticaria: results of four postmarketing surveillance studies. Clin Drug Investig. 2010;30(2):109-22. doi: 10.2165/11530930-000000000-00000.
- Results Grob JJ, Auquier P, Dreyfus I, Ortonne JP. Quality of life in adults with chronic idiopathic urticaria receiving desloratadine: a randomized, double-blind, multicentre, placebo-controlled study. J Eur Acad Dermatol Venereol. 2008 Jan;22(1):87-93. doi: 10.1111/j.1468-3083.2007.02385.x.
- Results Ortonne JP, Grob JJ, Auquier P, Dreyfus I. Efficacy and safety of desloratadine in adults with chronic idiopathic urticaria: a randomized, double-blind, placebo-controlled, multicenter trial. Am J Clin Dermatol. 2007;8(1):37-42. doi: 10.2165/00128071-200708010-00005.
- Zhou T, Zhang Y, Ma Y, Ma W, Wu X, Huang L, Feng W, Zhou H, Liu J, Zhao H, Zhang L, Yang Y, Huang Y. Comparison of aprepitant versus desloratadine for EGFR-TKI-induced pruritus: A randomized phase 2 clinical trial. Cancer. 2022 Nov 15;128(22):3969-3976. doi: 10.1002/cncr.34474. Epub 2022 Oct 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aprepitant | Other / unclassified | 80 mg | Oral |
| Comparator | Desloratadine | Small molecule | 5 mg | Oral |