A prospective study to validate the functional assessment of cancer therapy (FACT) for epidermal growth factor receptor inhibitor (EGFRI)-induced dermatologic toxicities FACT-EGFRI 18 questionnaire: SWOG S1013

Journal of Patient-Reported Outcomes - Tập 4 Số 1 - 2020
Siu-Fun Wong1, Joseph M. Unger2, James L. Wade3, Lynne I. Wagner4, Mario E. Lacouture5, Keisha C. Humphries3, Anna Moseley2, Kathryn B. Arnold2, M Velasco3, Justin D. Floyd6, Benjamin Esparaz3, Afsaneh Barzi7, Heinz Josef Lenz7, Marianna Koczywas8, Shaker R. Dakhil9, Gary V. Burton10, Michael Fisch11, Norah Lynn Henry12, Dawn L. Hershman13, Carol M. Moinpour14
1Chapman University School of Pharmacy, Rinker Health Science Campus, 9401 Jeronimo Road, Irvine, CA, USA
2SWOG Statistics and Data Management Center/Fred Hutchinson Cancer Research Center, Seattle, WA, USA
3Heartland Cancer Research NCORP/Cancer Care Specialists of Central Illinois, Decatur, IL, USA
4Wake Forest School of Medicine, Winston Salem, NC, USA
5Memorial Sloan-Kettering Cancer Center, New York, NY, USA
6Wichita NCORP, Wichita, KS, USA
7University of Southern California, Los Angeles, CA, USA
8City of Hope, Duarte, CA, USA
9Wichita NCORP/ Cancer Center of Kansas, Wichita, Wichita, KS, USA
10Gulf South MU NCORP/Louisiana State University HSC-Shreveport, Shreveport, LA, USA
11Aim Specialty Health, Chicago, IL, USA
12University of Michigan Medical School, Ann Arbor, MI USA
13Columbia University Medical Center, New York, NY, USA
14Fred Hutchinson Cancer Research Center, Public Health Sciences Division (Emerita), Seattle, WA, USA

Tóm tắt

Abstract Background Papulopustular rash is a common class effect of epidermal growth factor receptor inhibitors (EGFRI) that can affect patients’ health-related quality of life and cause disruptions to treatment. SWOG S1013 (NCT01416688) is a multi-center study designed to validate the Functional Assessment of Cancer Therapy EGFRI 18 (FACT-EGFRI 18) using 7-items from the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 to assess EGFRI-induced skin-related toxicities and their impact on functional status. Methods Patients with a diagnosis of colorectal or lung cancer to receive EGFRI therapies for at least 6 weeks were enrolled. Patient self-assessments using the FACT-EGFRI 18 were completed prior to undergoing CTCAE assessment by trained clinicians at baseline, weekly × 6, and then monthly × 3. The psychometric properties of the FACT-EGFRI 14 (skin toxicity items only) and 18 (plus 2 nail and 2 hair items) were established based on criterion validity, known groups validity, internal consistency reliability, and responsiveness to change. Results Of the 146 registered patients, 124 were evaluable. High Cronbach’s alpha (> 0.70) for both FACT-EGFRI 14 and FACT-EGFRI 18 scores across assessment times were observed. Although agreement (i.e. criterion validity) between individual and summary scales of the FACT-EGFRI 18 for assessing skin toxicity was good, agreement with the clinician-reported CTCAE was only fair. The minimal important difference was determined to be 3 points. The results also demonstrated responsiveness to symptom change. Discussion Based on the results of this multi-center validation study, the FACT-EGFRI 18 patient-reported outcome instrument provided data from the patient’s perspective yielding unique information as well as complementing clinician-rated CTCAE grades, especially for the symptoms of pain, pruritus, and paronychia. Conclusions Good to excellent psychometric properties for the FACT-EGFRI 18 were demonstrated, supporting further use of this patient-reported outcomes measure. Additional validation with a more diverse group of patients should be conducted.

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Tài liệu tham khảo

Busam, K. J., Capodieci, P., Motzer, R., Kiehn, T., Phelan, D., & Halpern, A. C. (2001). Cutaneous side-effects in cancer patients treated with the antiepidermal growth factor receptor antibody C225. The British Journal of Dermatology, 144(6), 1169–1176.

Soulieres, D., Senzer, N. N., Vokes, E. E., Hidalgo, M., Agarwala, S. S., & Siu, L. L. (2004). Multicenter phase II study of erlotinib, an oral epidermal growth factor receptor tyrosine kinase inhibitor, in patients with recurrent or metastatic squamous cell cancer of the head and neck. Journal of Clinical Oncology, 22(1), 77–85.

Baselga, J., Pfister, D., Cooper, M. R., et al. (2000). Phase I studies of anti-epidermal growth factor receptor chimeric antibody C225 alone and in combination with cisplatin. Journal of Clinical Oncology, 18(4), 904–914.

Tarceva Package Insert. (2008). OSI pharmaceuticals, Inc and Genentech, Inc.

Sobrero, A. F., Maurel, J., Fehrenbacher, L., et al. (2008). EPIC: Phase III trial of cetuximab plus irinotecan after fluoropyrimidine and oxaliplatin failure in patients with metastatic colorectal cancer. Journal of Clinical Oncology, 26(14), 2311–2319.

Wheatley-Price, P., Ding, K., Seymour, L., Clark, G. M., & Shepherd, F. A. (2008). Erlotinib for advanced non-small-cell lung cancer in the elderly: An analysis of the National Cancer Institute of Canada clinical trials group study BR.21. Journal of Clinical Oncology, 26(14), 2350–2357.

Molinari, E., De Quatrebarbes, J., Andre, T., & Aractingi, S. (2005). Cetuximab-induced acne. Dermatology., 211(4), 330–333.

Perez-Soler, R., & Saltz, L. (2005). Cutaneous adverse effects with HER1/EGFR-targeted agents: Is there a silver lining? Journal of Clinical Oncology, 23(22), 5235–5246.

Wagner, L. I., & Lacouture, M. E. (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), 21(11 Suppl 5), 34–36.

Perez-Soler, R. (2006). Rash as a surrogate marker for efficacy of epidermal growth factor receptor inhibitors in lung cancer. Clinical Lung Cancer, 8(Suppl 1), S7–S14.

Perez-Soler, R., & Van Cutsem, E. (2007). Clinical research of EGFR inhibitors and related dermatologic toxicities. Oncology (Williston Park), 21(11 Suppl 5), 10–16.

Racca, P., Fanchini, L., Caliendo, V., et al. (2008). Efficacy and skin toxicity management with cetuximab in metastatic colorectal cancer: Outcomes from an oncologic/dermatologic cooperation. Clinical Colorectal Cancer, 7(1), 48–54.

Saltz, L., Kies, M., Abbruzzese, J. L., Azarnia, N., & Needle, M. (2003). The presence and intensity of the cetuximab-induced acne-like rash predicts increased survival in studies across multiple malignanciesPaper presented at: 2003 ASCO Annual Meeting.

National Cancer Institute NIH, US Department of Health Human Services. (2006). Common terminology criteria for adverse events (CTCAE) version 3.0 http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf.

National Cancer Institute NIH, US Department of Health and Human Services. (2009). Common terminology criteria for adverse events, version 4.0 https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf.

National Cancer Institute NIH, US Department of Health and Human Services. (2017). Common terminology criteria for adverse events (CTCAE) version 5.0 https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf.

Lacouture, M. E., Maitland, M. L., Segaert, S., et al. (2010). A proposed EGFR inhibitor dermatologic adverse event-specific grading scale from the MASCC skin toxicity study group. Support Care Cancer, 18(4), 509–522.

Lisi, P., Bellini, V., & Bianchi, L. (2014). The epidermal growth factor receptor inhibitor-related skin toxicity index (EGFRISTI): A new tool for grading and managing skin adverse reactions to epidermal growth factor receptor inhibitors. Oncology., 87(5), 311–319.

De Tursi, M., Zilli, M., Carella, C., et al. (2017). Skin toxicity evaluation in patients treated with cetuximab for metastatic colorectal cancer: A new tool for more accurate comprehension of quality of life impacts. Oncology Targets of Theraphy, 10, 3007–3015.

Basch, E., Reeve, B. B., Mitchell, S. A., et al. (2014). Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). Journal of the National Cancer Institute, 106(9), dju244.

Basch, E., Deal, A. M., Kris, M. G., et al. (2016). Symptom monitoring with patient-reported outcomes during routine cancer treatment: A randomized controlled trial. Journal of Clinical Oncology, 34(6), 557–565.

Dueck, A. C., Mendoza, T. R., Mitchell, S. A., et al. (2015). Validity and reliability of the US National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). JAMA Oncology, 1(8), 1051–1059.

Bennett, A. V., Dueck, A. C., Mitchell, S. A., et al. (2016). Mode equivalence and acceptability of tablet computer-, interactive voice response system-, and paper-based administration of the U.S. National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). Health and Quality of Life Outcomes, 14, 24.

Arnold, B., Mitchell, S. A., Lent, L., et al. (2016). Linguistic validation of the Spanish version of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). Support Care Cancer, 24(7), 2843–2851.

Wagner, L. I., Berg, S. R., Gandhi, M., et al. (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, 21(4), 1033–1041.

Zubrod, C. G. S. M., Frei, E., Brindley, C., Gold, G. L., Shnider, B., Oviedo, R., Gorman, J., Jones, R., Jonsson, U., Colsky, J., Chalmers, T., Ferguson, B., Dederick, M., Holland, J., Selawry, O., Regelson, W., Lasagna, L., & Owens, A. H. (1960). Appraisal of methods for the study of chemotherapy of cancer in man: Comparative therapeutic trial of nitrogen mustard and triethylene thiophosphoramide. Journal of Chronic Diseases, 11(1), 7–33.

Cella, D. F., Tulsky, D. S., Gray, G., et al. (1993). The functional assessment of cancer therapy scale: Development and validation of the general measure. Journal of Clinical Oncology, 11(3), 570–579.

Hays, R. D., Farivar, S. S., & Liu, H. (2005). Approaches and recommendations for estimating minimally important differences for health-related quality of life measures. COPD., 2(1), 63–67.

Oken, M. M., Creech, R. H., Tormey, D. C., et al. (1982). Toxicity and response criteria of the eastern cooperative oncology group. American Journal of Clinical Oncology, 5(6), 649–655.

Cohen, J. (1960). A coefficient of agreement for nominal scales. Educational and Psychological Measurement, 20, 37–46.

Cohen, J. (1988). Statistical power analysis for the behavioral sciences. Hillsdale: Lawrence Erlbaum Associates.

Norman, G. R., Sloan, J. A., & Wyrwich, K. W. (2003). Interpretation of changes in health-related quality of life: The remarkable universality of half a standard deviation. Medical Care, 41(5), 582–592.

Reeve, B. B., Wyrwich, K. W., Wu, A. W., et al. (2013). ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Quality of Life Research, 22(8), 1889–1905.

Cronbach, L. (1951). Coefficient alpha and the internal structure of tests. Psychometrika., 16(3), 297–334.

Nunnally, J. (1978). Psychometric theory (2nd ed.). New York: McGaw-Hill Book Company.

Cohen, J. (1968). Weighted kappa: Nominal scale agreement with provision for scaled disagreement or partial credit. Psychological Bulletin, 70(4), 213–220.

Chren, M. M. (2012). The Skindex instruments to measure the effects of skin disease on quality of life. Dermatologic Clinics, 30(2), 231–236 xiii.

Finlay, A. Y., & Khan, G. K. (1994). Dermatology life quality index (DLQI)--a simple practical measure for routine clinical use. Clinical and Experimental Dermatology, 19(3), 210–216.

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Journal of Patient-Reported Outcomes

Tập 4 Số 1

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