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01-08-2015 | Original Article

A systematic review of patient-reported outcome instruments of dermatologic adverse events associated with targeted cancer therapies

Authors: Alexandre Chan, Michael C. Cameron, Benjamin Garden, Christine B. Boers-Doets, Katja Schindler, Joel B. Epstein, Jennifer Choi, Laura Beamer, Eric Roeland, Elvio G. Russi, René-Jean Bensadoun, Yi Ling Teo, Raymond J. Chan, Vivianne Shih, Jane Bryce, Judith Raber-Durlacher, Peter Arne Gerber, César O. Freytes, Bernardo Rapoport, Nicole LeBoeuf, Vincent Sibaud, Mario E. Lacouture

Published in: Supportive Care in Cancer | Issue 8/2015

Abstract

Purpose

Dermatologic adverse events (dAEs) in cancer treatment are frequent with the use of targeted therapies. These dAEs have been shown to have significant impact on health-related quality of life (HRQoL). While standardized assessment tools have been developed for physicians to assess severity of dAEs, there is a discord between objective and subjective measures. The identification of patient-reported outcome (PRO) instruments useful in the context of targeted cancer therapies is therefore important in both the clinical and research settings for the overall evaluation of dAEs and their impact on HRQoL.

Methods

A comprehensive, systematic literature search of published articles was conducted by two independent reviewers in order to identify PRO instruments previously utilized in patient populations with dAEs from targeted cancer therapies. The identified PRO instruments were studied to determine which HRQoL issues relevant to dAEs were addressed, as well as the process of development and validation of these instruments.

Results

Thirteen articles identifying six PRO instruments met the inclusion criteria. Four instruments were general dermatology (Skindex-16©, Skindex-29©, Dermatology Life Quality Index (DLQI), and DIELH-24) and two were symptom-specific (functional assessment of cancer therapy-epidermal growth factor receptor inhibitor-18 (FACT-EGFRI-18) and hand-foot syndrome 14 (HFS-14)).

Conclusions

While there are several PRO instruments that have been tested in the context of targeted cancer therapy, additional work is needed to develop new instruments and to further validate the instruments identified in this study in patients receiving targeted therapies.

Available only for authorised users

Agha R, Kinahan K, Bennett CL, Lacouture ME (2007) Dermatologic challenges in cancer patients and survivors. Oncology (Williston Park, NY) 21(12):1462–1472, discussion 1473, 1476, 1481 passim

Joshi SS, Ortiz S, Witherspoon JN, Rademaker A, West DP, Anderson R, Rosenbaum SE, Lacouture ME (2010) Effects of epidermal growth factor receptor inhibitor-induced dermatologic toxicities on quality of life. Cancer 116(16):3916–3923. doi:10.1002/cncr.25090 PubMedCrossRef

Chen A, Acharya A, Setser A (2013) Grading dermatologic adverse events in clinical trials using CTCAE v4.0. In: dermatologic principles and practice in oncology. Wiley, New Jersey, pp 47–59. doi:10.1002/9781118590638.ch5 CrossRef

Basch E, Iasonos A, McDonough T, Barz A, Culkin A, Kris MG, Scher HI, Schrag D (2006) Patient versus clinician symptom reporting using the national cancer institute common terminology criteria for adverse events: results of a questionnaire-based study. Lancet Oncol 7(11):903–909. doi:10.1016/s1470-2045(06)70910-x PubMedCrossRef

Basch E (2012) Beyond the FDA PRO guidance: steps toward integrating meaningful patient-reported outcomes into regulatory trials and US drug labels. Value Health: J Int Soc Pharmacoeconomics Outcomes Res 15(3):401–403. doi:10.1016/j.jval.2012.03.1385 CrossRef

Lacouture ME, Mitchell EP, Piperdi B, Pillai MV, Shearer H, Iannotti N, Xu F, Yassine M (2010) Skin toxicity evaluation protocol with panitumumab (STEPP), a phase II, open-label, randomized trial evaluating the impact of a pre-emptive skin treatment regimen on skin toxicities and quality of life in patients with metastatic colorectal cancer. J Clin Oncol: Off J Am Soc Clin Oncol 28(8):1351–1357. doi:10.1200/jco.2008.21.7828 CrossRef

Cano SJ, Klassen A, Pusic AL (2009) The science behind quality-of-life measurement: a primer for plastic surgeons. Plast Reconstr Surg 123(3):98e–106e. doi:10.1097/PRS.0b013e31819565c1 PubMedCrossRef

Aaronson N, Alonso J, Burnam A, Lohr KN, Patrick DL, Perrin E, Stein RE (2002) Assessing health status and quality-of-life instruments: attributes and review criteria. Qual Life Res Int J Qual Life Asp Treat Care Rehab 11(3):193–205CrossRef

Nardone B, Hensley JR, Kulik L, West DP, Mulcahy M, Rademaker A, Lacouture ME (2012) The effect of hand-foot skin reaction associated with the multikinase inhibitors sorafenib and sunitinib on health-related quality of life. J Drugs Dermatol: JDD 11(11):e61–65PubMed

10.

Rosen AC, Case EC, Dusza SW, Balagula Y, Gordon J, West DP, Lacouture ME (2013) Impact of dermatologic adverse events on quality of life in 283 cancer patients: a questionnaire study in a dermatology referral clinic. Am J Clin Dermatol 14(4):327–333. doi:10.1007/s40257-013-0021-0 PubMedCrossRef

11.

Jatoi A, Rowland K, Sloan JA, Gross HM, Fishkin PA, Kahanic SP, Novotny PJ, Schaefer PL, Johnson DB, Tschetter LK, Loprinzi CL (2008) Tetracycline to prevent epidermal growth factor receptor inhibitor-induced skin rashes: results of a placebo-controlled trial from the north central cancer treatment group (N03CB). Cancer 113(4):847–853. doi:10.1002/cncr.23621 PubMedCentralPubMedCrossRef

12.

Andreis F, Rizzi A, Mosconi P, Braun C, Rota L, Meriggi F, Mazzocchi M, Zaniboni A (2010) Quality of life in colon cancer patients with skin side effects: preliminary results from a monocentric cross sectional study. Health Qual Life Outcomes 8:40. doi:10.1186/1477-7525-8-40 PubMedCentralPubMedCrossRef

13.

Osio A, Mateus C, Soria JC, Massard C, Malka D, Boige V, Besse B, Robert C (2009) Cutaneous side-effects in patients on long-term treatment with epidermal growth factor receptor inhibitors. Br J Dermatol 161(3):515–521. doi:10.1111/j.1365-2133.2009.09214.x PubMedCrossRef

14.

Unger K, Niehammer U, Hahn A, Goerdt S, Schumann M, Thum S, Schepp W (2013) Treatment of metastatic colorectal cancer with cetuximab: influence on the quality of life. Z Gastroenterol 51(8):733–739. doi:10.1055/s-0033-1335064 PubMedCrossRef

15.

Wagner LI, Berg SR, Gandhi M, Hlubocky FJ, Webster K, Aneja M, Cella D, Lacouture ME (2013) The development of a functional assessment of cancer therapy (FACT) questionnaire to assess dermatologic symptoms associated with epidermal growth factor receptor inhibitors (FACT-EGFRI-18). Support Care Cancer: Off J Multinatl Assoc Support Care in Cancer 21(4):1033–1041. doi:10.1007/s00520-012-1623-4 CrossRef

16.

Boers-Doets CB, Gelderblom H, Lacouture ME, Epstein JB, Nortier JW, Kaptein AA (2013) Experiences with the FACT-EGFRI-18 instrument in EGFRI-associated mucocutaneous adverse events. Support Care Cancer: Off J Multinatl Assoc Support Care Cancer 21(7):1919–1926. doi:10.1007/s00520-013-1752-4 CrossRef

17.

Sibaud V, Dalenc F, Chevreau C, Roche H, Delord JP, Mourey L, Lacaze JL, Rahhali N, Taieb C (2011) HFS-14, a specific quality of life scale developed for patients suffering from hand-foot syndrome. Oncologist 16(10):1469–1478. doi:10.1634/theoncologist. 2011-0033 PubMedCentralPubMedCrossRef

18.

Taieb C, Sibaud V (2009) PCN82 HFS 14: a specific quality of life instrument for patients with hand-foot syndrome. Value Health 12(3):A52CrossRef

19.

Teo YL, Chong XJ, Chue XP, Chau NM, Tan MH, Kanesvaran R, Wee HL, Ho HK, Chan A (2014) Role of sunitinib and SU12662 on dermatological toxicities in metastatic renal cell carcinoma patients: in vitro, in vivo, and outcomes investigation. Cancer Chemother Pharmacol 73(2):381–388. doi:10.1007/s00280-013-2360-1 PubMedCrossRef

20.

Chren MM (2012) The Skindex instruments to measure the effects of skin disease on quality of life. Dermatol Clin 30(2):231–236. doi:10.1016/j.det.2011.11.003, xiiiPubMedCentralPubMedCrossRef

21.

Chren MM, Lasek RJ, Sahay AP, Sands LP (2001) Measurement properties of Skindex-16: a brief quality-of-life measure for patients with skin diseases. J Cutan Med Surg 5(2):105–110. doi:10.1007/s102270000010 PubMedCrossRef

22.

Finlay AY, Khan GK (1994) Dermatology Life Quality Index (DLQI)—a simple practical measure for routine clinical use. Clin Exp Dermatol 19(3):210–216PubMedCrossRef

23.

Lewis V, Finlay AY (2004) 10 years experience of the Dermatology Life Quality Index (DLQI). The journal of investigative dermatology Symposium proceedings / the Society for Investigative Dermatology, Inc [and] European Society for Dermatological Research 9 (2):169–180. doi:10.1111/j.1087-0024.2004.09113.x

24.

Finlay AY, Basra MK, Piguet V, Salek MS (2012) Dermatology life quality index (DLQI): a paradigm shift to patient-centered outcomes. J Invest Dermatol 132(10):2464–2465. doi:10.1038/jid.2012.147 PubMedCrossRef

25.

Schafer T, Staudt A, Ring J (2001) German instrument for the assessment of quality of life in skin diseases (DIELH). Internal consistency, reliability, convergent and discriminant validity and responsiveness. Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete 52(7):624–628PubMedCrossRef

26.

Chen AP, Setser A, Anadkat MJ, Cotliar J, Olsen EA, Garden BC, Lacouture ME (2012) Grading dermatologic adverse events of cancer treatments: the common terminology criteria for adverse events version 4.0. J Am Acad Dermatol 67(5):1025–1039. doi:10.1016/j.jaad.2012.02.010 PubMedCrossRef

27.

Boone SL, Rademaker A, Liu D, Pfeiffer C, Mauro DJ, Lacouture ME (2007) Impact and management of skin toxicity associated with anti-epidermal growth factor receptor therapy: survey results. Oncology 72(3–4):152–159. doi:10.1159/000112795 PubMedCrossRef

28.

Wagner LI, Lacouture ME (2007) Dermatologic toxicities associated with EGFR inhibitors: the clinical psychologist’s perspective. Impact on health-related quality of life and implications for clinical management of psychological sequelae. Oncology (Williston Park, NY) 21(11):34–36

29.

Velikova G, Booth L, Smith AB, Brown PM, Lynch P, Brown JM, Selby PJ (2004) Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol Off J Am Soc Clin Oncol 22(4):714–724. doi:10.1200/jco.2004.06.078 CrossRef

30.

Wagner LI, Cella D (2013) Psychosocial issues in oncology: clinical management of psychosocial distress, health-related quality of life, and special considerations in dermatologic oncology. In: dermatologic principles and practice in oncology. Wiley, Hoboken, pp 60–68. doi:10.1002/9781118590638.ch6

Title: A systematic review of patient-reported outcome instruments of dermatologic adverse events associated with targeted cancer therapies
Authors: Alexandre Chan
Michael C. Cameron
Benjamin Garden
Christine B. Boers-Doets
Katja Schindler
Joel B. Epstein
Jennifer Choi
Laura Beamer
Eric Roeland
Elvio G. Russi
René-Jean Bensadoun
Yi Ling Teo
Raymond J. Chan
Vivianne Shih
Jane Bryce
Judith Raber-Durlacher
Peter Arne Gerber
César O. Freytes
Bernardo Rapoport
Nicole LeBoeuf
Vincent Sibaud
Mario E. Lacouture
Publication date: 01-08-2015
Publisher: Springer Berlin Heidelberg
Published in: Supportive Care in Cancer / Issue 8/2015
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI: https://doi.org/10.1007/s00520-014-2564-x

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Abstract

Purpose

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