Multigene assays such as the 21-gene recurrence score (RS) quantify risk for recurrence and potential benefit from chemotherapy in early-stage, ER+ breast cancers. Few studies have assessed the impact of testing on patient-reported outcomes such as cancer-related distress or quality of life. The few studies that have assessed these outcomes do not consider potential modifiers, such as the patients’ level of involvement in the treatment decision-making process. In the current study, 81 breast cancer patients who received the RS assay completed cross-sectional surveys. We used linear multiple regression to assess whether test result, decision-making role (passive versus shared/active), and their interaction contributed to current levels of distress, quality of life, and decisional conflict. There were no associations between these variables and test result or decision-making role. However, women who received an intermediate RS and took a passive role in their care reported higher-cancer-related distress and cancer worry and lower quality of life than those who took a shared or active role. These data should be confirmed in prospective samples, as these poorer outcomes could be amenable to intervention. 1. Introduction Improvements in our understanding of the molecular mechanisms of breast cancer progression, diagnosis, and treatment represent a major advance [1]. Genomic profiling of breast tumors increasingly is being used clinically to refine recurrence estimates and guide adjuvant treatment decisions in early-stage, hormone-receptor positive breast cancer [2] and has been integrated into clinical guidelines for this group of patients [3, 4]. The 21-gene recurrence score (RS) assay (Oncotype DX; Genomic Health Inc., Redwood City, CA) quantifies risk of recurrence in patients with early stage, estrogen-receptor- (ER-) positive breast cancer treated with tamoxifen. While data have accumulated to support treatment recommendations for the 25% of women who receive high RS and 50% who receive low RS, [5, 6] recommendations for the remaining quarter of patients with intermediate RS remain less clear pending additional trials, presenting a clinical challenge [7]. Like other cancer treatment decisions which involve more than one appropriate treatment option [8, 9], the uncertainty related to this clinical equipoise could require patients to take more active roles in their treatment decision-making than those who receive a high or low RS. Several studies demonstrate that the RS impacts treatment decisions for physicians and patients [10–14]. Specifically, RS
References
[1]
O. I. Olopade, T. A. Grushko, R. Nanda, and D. Huo, “Advances in breast cancer: pathways to personalized medicine,” Clinical Cancer Research, vol. 14, no. 24, pp. 7988–7999, 2008.
[2]
L. Harris, H. Fritsche, R. Mennel et al., “American society of clinical oncology 2007 update of recommendations for the use of tumor markers in breast cancer,” Journal of Clinical Oncology, vol. 25, no. 33, pp. 5287–5312, 2007.
[3]
N. Ben-Baruch, A. Hammerman, S. Klang, and N. Liebermann, “A prospective study of the impact of the 21-gene recurrence score assay on treatment decisions in N-, ER+ early stage breast cancer patients,” Journal of Clinical Oncology, vol. 25, no. 18, abstract 1108, 2007.
[4]
National Comprehensive Cancer Network, NCCN Clinical Practice Guidelines in Oncology. Breast Cancer. Version 1, 2012, http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf.
[5]
E. P. Mamounas, G. Tang, B. Fisher et al., “Association between the 21-gene recurrence score assay and risk of locoregional recurrence in node-negative, estrogen receptor-positive breast cancer: results from NSABP B-14 and NSABP B-20,” Journal of Clinical Oncology, vol. 28, no. 10, pp. 1677–1683, 2010.
[6]
S. Paik, G. Tang, S. Shak et al., “Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer,” Journal of Clinical Oncology, vol. 24, no. 23, pp. 3726–3734, 2006.
[7]
J. A. Sparano and S. Paik, “Development of the 21-gene assay and its application in clinical practice and clinical trials,” Journal of Clinical Oncology, vol. 26, no. 5, pp. 721–728, 2008.
[8]
A. H. Pieterse, I. Henselmans, H. C. J. M. de Haes, C. C. E. Koning, E. D. Geijsen, and E. M. A. Smets, “Shared decision making: prostate cancer patients' appraisal of treatment alternatives and oncologists' eliciting and responding behavior, an explorative study,” Patient Education and Counseling, vol. 85, no. 3, pp. e251–e259, 2011.
[9]
A. Sidana, D. J. Hernandez, Z. Feng et al., “Treatment decision-making for localized prostate cancer: what younger men choose and why,” Prostate, vol. 72, no. 1, pp. 58–64, 2012.
[10]
J. Albanell, A. Gonzalez, M. Ruiz-Borrego, et al., “Prospective transGEICAM study of the impact of the 21-gene Recurrence Score assay and traditional clinicopathological factors on adjuvant clinical decision making in women with estrogen receptor-positive (ER+) node-negative breast cancer,” Annals of Oncology, vol. 23, no. 3, pp. 625–631, 2012.
[11]
J. Asad, A. F. Jacobson, A. Estabrook et al., “Does oncotype DX recurrence score affect the management of patients with early-stage breast cancer?” American Journal of Surgery, vol. 196, no. 4, pp. 527–529, 2008.
[12]
D. B. Geffen, S. Abu-Ghanem, N. Sion-Vardy, et al., “The impact of the 21-gene recurrence score assay on decision making about adjuvant chemotherapy in early-stage estrogen-receptor-positive breast cancer in an oncology practice with a unified treatment policy,” Annals of Oncology, vol. 22, no. 11, pp. 2381–2386, 2011.
[13]
L. R. Henry, A. Stojadinovic, S. M. Swain, S. Prindiville, R. Cordes, and P. W. Soballe, “The influence of a gene expression profile on breast cancer decisions,” Journal of Surgical Oncology, vol. 99, no. 6, pp. 319–323, 2009.
[14]
J. F. Partin and E. P. Mamounas, “Impact of the 21-gene recurrence score assay compared with standard clinicopathologic guidelines in adjuvant therapy selection for node-negative, estrogen receptor-positive breast cancer,” Annals of Surgical Oncology, vol. 18, no. 12, pp. 3399–3406, 2011.
[15]
R. Oratz, D. Paul, A. L. Cohn, and S. M. Sedlacek, “Impact of a commercial reference laboratory test recurrence score on decision making in early-stage breast cancer,” Journal of Oncology Practice, vol. 3, no. 4, pp. 182–186, 2007.
[16]
J. A. Rayhanabad, L. A. Difronzo, P. I. Haigh, and L. Romero, “Changing paradigms in breast cancer management: introducing molecular genetics into the treatment algorithm,” American Surgeon, vol. 74, no. 10, pp. 887–890, 2008.
[17]
S. S. Lo, P. B. Mumby, J. Norton 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,” Journal of Clinical Oncology, vol. 28, no. 10, pp. 1671–1676, 2010.
[18]
N. T. Brewer, A. R. Richman, J. T. Defrank, V. F. Reyna, and L. A. Carey, “Improving communication of breast cancer recurrence risk,” Breast Cancer Research and Treatment, vol. 133, no. 2, pp. 553–561, 2012.
[19]
J. P. Tzeng, D. Mayer, A. R. Richman et al., “Women's experiences with genomic testing for breast cancer recurrence risk,” Cancer, vol. 116, no. 8, pp. 1992–2000, 2010.
[20]
R. Brown, P. Butow, M. Wilson-Genderson, J. Bernhard, K. Ribi, and I. Juraskova, “Meeting the decision-making preferences of patients with breast cancer in oncology consultations: impact on decision-related outcomes,” Journal of Clinical Oncology, vol. 30, no. 8, pp. 857–862, 2012.
[21]
M. Gattellari, P. N. Butow, and M. H. N. Tattersall, “Sharing decisions in cancer care,” Social Science and Medicine, vol. 52, no. 12, pp. 1865–1878, 2001.
[22]
M. R. Andersen, D. J. Bowen, J. Morea, K. D. Stein, and F. Baker, “Involvement in Decision-Making and Breast Cancer Survivor Quality of Life,” Health Psychology, vol. 28, no. 1, pp. 29–37, 2009.
[23]
T. F. Hack, L. F. Degner, P. Watson, and L. Sinha, “Do patients benefit from participating in medical decision making? Longitudinal follow-up of women with breast cancer,” Psycho-Oncology, vol. 15, no. 1, pp. 9–19, 2006.
[24]
T. F. Hack, T. Pickles, J. D. Ruether et al., “Predictors of distress and quality of life in patients undergoing cancer therapy: impact of treatment type and decisional role,” Psycho-Oncology, vol. 19, no. 6, pp. 606–616, 2010.
[25]
“Taking shared decision making more seriously,” Lancet, vol. 377, no. 9768, p. 784, 2011.
[26]
A. Barratt, “Evidence based medicine and shared decision making: the challenge of getting both evidence and preferences into health care,” Patient Education and Counseling, vol. 73, no. 3, pp. 407–412, 2008.
[27]
P. M. Ravdin, L. A. Siminoff, G. J. Davis et al., “Computer program to assist in making decisions about adjuvant therapy for women with early breast cancer,” Journal of Clinical Oncology, vol. 19, no. 4, pp. 980–991, 2001.
[28]
L. A. Siminoff, N. H. Gordon, P. Silverman, T. Budd, and P. A. Ravdin, “A decision aid to assist in adjuvant therapy choices for breast cancer,” Psycho-Oncology, vol. 15, no. 11, pp. 1001–1013, 2006.
[29]
L. F. Degner and C. A. Russell, “Preferences for treatment control among adults with cancer,” Research in Nursing & Health, vol. 11, no. 6, pp. 367–374, 1988.
[30]
L. F. Degner, L. J. Kristjanson, D. Bowman et al., “Information needs and decisional preferences in women with breast cancer,” Journal of the American Medical Association, vol. 277, no. 18, pp. 1485–1492, 1997.
[31]
M. Horowitz, N. Wilner, and W. Alvarez, “Impact of event scale: a measure of subjective stress,” Psychosomatic Medicine, vol. 41, no. 3, pp. 209–218, 1979.
[32]
C. Lerman, B. Trock, B. K. Rimer, C. Jepson, D. Brody, and A. Boyce, “Psychological side effects of breast cancer screening,” Health Psychology, vol. 10, no. 4, pp. 259–267, 1991.
[33]
M. J. Brady, D. F. Cella, F. Mo et al., “Reliability and validity of the functional assessment of cancer therapy- breast quality-of-life instrument,” Journal of Clinical Oncology, vol. 15, no. 3, pp. 974–986, 1997.
[34]
A. M. O'Connor, “Validation of a decisional conflict scale,” Medical Decision Making, vol. 15, no. 1, pp. 25–30, 1995.
[35]
M. Horowitz, “Stress response syndromes and their treatment,” in Handbook of Stress: Theoretical and Clinical Aspects, L. Goldberger and S. Breznitz, Eds., pp. 209–218, Free Press, New York, NY, USA, 1982.
[36]
N. E. Avis, S. Crawford, and J. Manuel, “Quality of life among younger women with breast cancer,” Journal of Clinical Oncology, vol. 23, no. 15, pp. 3322–3330, 2005.
[37]
S. C. O'Neill, C. Rini, R. E. Goldsmith, H. Valdimarsdottir, L. H. Cohen, and M. D. Schwartz, “Distress among women receiving uninformative BRCA1/2 results: 12-month outcomes,” Psycho-Oncology, vol. 18, no. 10, pp. 1088–1096, 2009.
[38]
D. Braithwaite, J. Emery, F. Walter, A. T. Prevost, and S. Sutton, “Psychological impact of genetic counseling for familial cancer: a systematic review and meta-analysis,” Journal of the National Cancer Institute, vol. 96, no. 2, pp. 122–133, 2004.
[39]
J. G. Hamilton, M. Lobel, and A. Moyer, “Emotional distress following genetic testing for hereditary breast and ovarian cancer: a meta-analytic review,” Health Psychology, vol. 28, no. 4, pp. 510–518, 2009.
[40]
J. S. Hilgart, B. Coles, and R. Iredale, “Cancer genetic risk assessment for individuals at risk of familial breast cancer,” Cochrane Database of Systematic Reviews, no. 2, Article ID CD003721, 2007.
[41]
C. Rini, S. C. O'Neill, H. Valdimarsdottir et al., “Cognitive and emotional factors predicting decisional conflict among high-risk breast cancer survivors who receive uninformative BRCA1/2 results,” Health Psychology, vol. 28, no. 5, pp. 569–578, 2009.
[42]
S. Brownlee, J. E. Wennberg, M. J. Barry, E. S. Fisher, D. C. Goodman, and J. P. W. Bynum, “Improving patient decision-making in health care: a 2011 Dartmouth Atlas report highlighting Minnesota,” http://www.dartmouthatlas.org/downloads/reports/Decision_making_report_022411.pdf.
[43]
S. J. Katz, P. M. Lantz, N. K. Janz et al., “Patient involvement in surgery treatment decisions for breast cancer,” Journal of Clinical Oncology, vol. 23, no. 24, pp. 5526–5533, 2005.
[44]
P. M. Lantz, N. K. Janz, A. Fagerlin et al., “Satisfaction with surgery outcomes and the decision process in a population-based sample of women with breast cancer,” Health Services Research, vol. 40, no. 3, pp. 745–767, 2005.
[45]
D. H. Lea, K. A. Kaphingst, D. Bowen, I. Lipkus, and D. W. Hadley, “Communicating genetic and genomic information: health literacy and numeracy considerations,” Public Health Genomics, vol. 14, no. 4-5, pp. 279–289, 2011.
[46]
S. T. Hawley, P. M. Lantz, N. K. Janz et al., “Factors associated with patient involvement in surgical treatment decision making for breast cancer,” Patient Education and Counseling, vol. 65, no. 3, pp. 387–395, 2007.
[47]
J. F. Waljee, M. A. M. Rogers, and A. K. Alderman, “Decision aids and breast cancer: do they influence choice for surgery and knowledge of treatment options?” Journal of Clinical Oncology, vol. 25, no. 9, pp. 1067–1073, 2007.
[48]
H. S. Gong, J. K. Huh, J. H. Lee, M. B. Kim, M. S. Chung, and G. H. Baek, “Patients' preferred and retrospectively perceived levels of involvement during decision-making regarding carpal tunnel release,” Journal of Bone and Joint Surgery Series A, vol. 93, no. 16, pp. 1527–1533, 2011.
[49]
S. T. Hawley, J. J. Griggs, A. S. Hamilton et al., “Decision involvement and receipt of mastectomy among racially and ethnically diverse breast cancer patients,” Journal of the National Cancer Institute, vol. 101, no. 19, pp. 1337–1347, 2009.
[50]
C. N. Lee, Y. Chang, N. Adimorah et al., “Decision making about surgery for early-stage breast cancer,” Journal of the American College of Surgeons, vol. 214, no. 1, pp. 1–10, 2012.
[51]
M. Dowsett, J. Cuzick, C. Wale et al., “Prediction of risk of distant recurrence using the 21-gene recurrence score in node-negative and node-positive postmenopausal patients with breast cancer treated with anastrozole or tamoxifen: a TransATAC study,” Journal of Clinical Oncology, vol. 28, no. 11, pp. 1829–1834, 2010.
[52]
R. Oratz, B. Kim, C. Chao et al., “Physician survey of the effect of the 21-gene recurrence score assay results on treatment recommendations for patients with lymph node-positive, estrogen receptor-positive breast cancer,” Journal of Oncology Practice, vol. 7, no. 2, pp. 94–99, 2011.
