Association between genomic recurrence risk and well-being among breast cancer patients

BMC Cancer

Valesca P Retèl¹  Catharina GM Groothuis-Oudshoorn⁴  Neil K Aaronson¹  Noel T Brewer³  Emiel JT Rutgers²  Wim H van Harten⁴ 

[1] Division of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam, CX, 1066, The Netherlands

[2] Department of Surgical Oncology, Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam, CX, 1066, The Netherlands

[3] University of North Carolina, Lineberger Comprehensive Cancer Center, North Carolina, USA

[4] Governance and Management, MB-HTSR, University of TwenteSchool, PO Box 217, Enschede, AE, 7500, The Netherlands

关键词: Chemotherapy;    Breast cancer;    Patient-centered care;    70-gene signature;    Genomic profile;    Personalized medicine;   

Others  :  1079695
DOI  :  10.1186/1471-2407-13-295

 received in 2013-01-25, accepted in 2013-06-11,  发布年份 2013

【 摘 要 】

Background

Gene expression profiling (GEP) is increasingly used in the rapidly evolving field of personalized medicine. We sought to evaluate the association between GEP-assessed of breast cancer recurrence risk and patients’ well-being.

Methods

Participants were Dutch women from 10 hospitals being treated for early stage breast cancer who were enrolled in the MINDACT trial (Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy). As part of the trial, they received a disease recurrence risk estimate based on a 70-gene signature and on standard clinical criteria as scored via a modified version of Adjuvant! Online. \Women completed a questionnaire 6–8 weeks after surgery and after their decision regarding adjuvant chemotherapy. The questionnaire assessed perceived understanding, knowledge, risk perception, satisfaction, distress, cancer worry and health-related quality of life (HRQoL), 6–8 weeks after surgery and decision regarding adjuvant chemotherapy.

Results

Women (n = 347, response rate 62%) reported high satisfaction with and a good understanding of the GEP information they received. Women with low risk estimates from both the standard and genomic tests reported the lowest distress levels. Distress was higher predominately among patients who had received high genomic risk estimates, who did not receive genomic risk estimates, or who received conflicting estimates based on genomic and clinical criteria. Cancer worry was highest for patients with higher risk perceptions and lower satisfaction. Patients with concordant high-risk profiles and those for whom such profiles were not available reported lower quality of life.

Conclusion

Patients were generally satisfied with the information they received about recurrence risk based on genomic testing. Some types of genomic test results were associated with greater distress levels, but not with cancer worry or HRQoL.

Trial registration

ISRCTN: ISRCTN18543567

【 授权许可】

   
2013 Retèl et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

• [1]Goldhirsch A, Ingle JN, Gelber RD, et al.: Threshold for therapies: highlights of the St Gallen international expert consensus on the primary therapy of early breast cancer 2009. Ann Oncol 2009, 20:1319-1329.
• [2]Van’t Veer LJ, Dai H, van de Vijver MJ, et al.: Gene expression profiling predicts clinical outcome of breast cancer. Nature 2002, 415:530-536.
• [3]van de Vijver MJ, He YD, Van’t Veer LJ, et al.: A Gene-Expression Signature as a Predictor of Survival in Breast Cancer. N Engl J Med 2002, 347:1999-2009.
• [4]Buyse M, Loi S, van’t Veer L, et al.: Validation and Clinical Utility of a 70-Gene Prognostic Signature for Women With Node-Negative Breast Cancer. J Natl Cancer Inst 2006, 98:1183-1192.
• [5]Bueno-de-Mesquita JM, Linn SC, Keijzer R, et al.: Validation of 70-gene prognosis signature in node-negative breast cancer. Breast Cancer Res Treat 2009, 117:483-495.
• [6]Paik S, Shak S, Tang G, et al.: A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med 2004, 351:2817-2826.
• [7]Cardoso F, Van’t Veer L, Rutgers E, et al.: Clinical application of the 70-gene profile: the MINDACT trial. J Clin Oncol 2008, 26:729-735.
• [8]Bogaerts J, Cardoso F, Buyse M, et al.: Gene signature evaluation as a prognostic tool: challenges in the design of the MINDACT trial. Nat Clin Pract Oncol 2006, 3:540-551.
• [9]Ravdin PM, Siminoff LA, Davis GJ, et al.: Computer program to assist in making decisions about adjuvant therapy for women with early breast cancer. J Clin Oncol 2001, 19:980-991.
• [10]Rutgers E, Piccart-Gebhart MJ, Bogaerts J, et al.: The EORTC 10041/BIG 03–04 MINDACT trial is feasible: results of the pilot phase. Eur J Cancer 2011, 4:2742-2749.
• [11]O’Neill SC, Brewer NT, Lillie SE, et al.: Women’s interest in gene expression analysis for breast cancer recurrence risk. J Clin Oncol 2007, 25:4628-4634.
• [12]Richman AR, Tzeng JP, Carey LA, et al.: Knowledge of genomic testing among early-stage breast cancer patients. Psychooncology 2010, 20(1):28-35.
• [13]Tzeng JP, Mayer D, Richman AR, et al.: Women’s experiences with genomic testing for breast cancer recurrence risk. Cancer 2010, 116:1992-2000.
• [14]Lo SS, Mumby PB, Norton J, et al.: Prospective multicenter study of the impact of the 21-gene recurrence score assay on medical oncologist and patient adjuvant breast cancer treatment selection. J Clin Oncol 2010, 28:1671-1676.
• [15]Sulayman N, Spellman E, Graves KD, et al.: Psychosocial and Quality of Life in Women Receiving the 21-Gene Recurrence Score Assay: The Impact of Decision Style in Women with Intermediate RS. J Cancer Epidemiol. 2012, 2012:728290.
• [16]Bueno-de-Mesquita JM, Van Harten WH, Retèl VP, et al.: Use of 70-gene signature to predict prognosis of patients with node-negative breast cancer: a prospective community-based feasibility study (RASTER). Lancet Oncol 2007, 8:1079-1087.
• [17]Retèl VP, Bueno-de-Mesquita JM, Hummel MJ, et al.: Constructive Technology Assessment (CTA) as a tool in coverage with evidence development: the case of the 70-gene prognosis signature for breast cancer diagnostics. Int J Technol Assess Health Care 2009, 25:73-83.
• [18]Lynch HT, Lemon SJ, Durham C, et al.: A descriptive study of BRCA1 testing and reactions to disclosure of test results. Cancer 1997, 79:2219-2228.
• [19]Lerman C, Daly M, Masny A, et al.: Attitudes about genetic testing for breast-ovarian cancer susceptibility. J Clin Oncol 1994, 12:843-850.
• [20]Brady MJ, Cella DF, Mo F, et al.: Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol 1997, 15:974-986.
• [21]Harel O: The estimation of R2 and adjusted R2 in incomplete data sets using multiple imputation. J Appl Stat 2009, 36(1):1109-1118.
• [22]Rubin DB, Schenker N: Multiple imputation in health-care databases: an overview and some applications. Stat Med 1991, 10:585-598.
• [23]Curran D, Van Dongen JP, Aaronson NK, et al.: Quality of life of early-stage breast cancer patients treated with radical mastectomy or breast-conserving procedures: results of EORTC trial 10801. The European Organization for Research and Treatment of Cancer (EORTC), Breast Cancer Cooperative Group (BCCG). Eur J Cancer 1998, 34(3):307-314.
• [24]De Haes JCJM, Curran D, Aaronson NK, et al.: Quality of life of breast cancer patients aged over 70 years, participating in the EORTC 10850 randomised clinical trial. Eur J Cancer 2003, 39(7):945-951.
• [25]Vadaparampil ST, Miree CA, Wilson C, Jacobsen PB: Psychosocial and behavioral impact of genetic counseling and testing. Breast Dis 2006, 27:97-108.