Abstract
Purpose
The development of the adjuvant therapy requires that clinicians and patients should discuss the magnitude of benefit of treatment for individual patient, estimating the pros and cons and the personal preferences. The aim of the present study was to determine the preferences of women treated with adjuvant hormonal therapy (HT) for breast cancer.
Methods
The analyses were conducted into three different groups of early breast cancer patients to evaluate the survival benefit needed to make treatment worthwhile before starting HT (A), after a few months from the beginning (B) and after several years of HT (C). The questionnaires, showing hypothetical scenarios based on potential survival times and rates without HT, were used to determine the lowest gains women judged necessary to make the treatment worthwhile.
Results
A total of 452 patients were included in the study: 149 in group A, 150 in group B and 153 in group C. In group C, 65% of patients were receiving HT with aromatase inhibitors (with or without a LHRH analogue). In the groups A, B, C 8%, 20% and 26%, respectively, received adjuvant chemotherapy. Overall, 355 women (79%) had children. The responses were quite similar between the three groups. A median gain of 10 years was judged necessary to make adjuvant HT worthwhile based on the hypothetical scenario of untreated mean survival time of 5 and 15 years. Median gain of 20% more women surviving was judged necessary to make adjuvant HT worthwhile based on an untreated 5-year survival rate expectation of 60%. Cognitive dysfunction was considered the side effect least compatible with the continuation of treatment in all three groups.
Conclusions
This is a large study of patient preferences on HT. Compared with other studies with similar design, the patients included in the present study required larger benefits to make adjuvant therapy worthwhile.
Similar content being viewed by others
References
Early Breast Cancer Trialists’ Collaborative Group (2005) Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet 365:1687–1717
The Early Breast Cancer Trialists’ Collaborative Group (2011) Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: patient-level meta-analysis of randomised trials. Lancet 378:771–784
The Early Breast Cancer Trialists’ Collaborative Group (2015) Aromatase inhibitors versus tamoxifen in early breast cancer: patient-level meta-analysis of the randomised trials. Lancet 386:1341–1352
Burstein HJ, Curigliano G, Loibl S et al (2019) Estimating the benefits of therapy for early stage breast cancer The St Gallen International Consensus Guidelines for the primary therapy of early breast cancer 2019. Ann Oncol 30(10):1541–1557
Burstein HJ, Lacchetti C, Anderson H et al (2019) Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: ASCO Clinical Practice Guideline focused update. J Clin Oncol 37(5):423–438. https://doi.org/10.1200/JCO.18.01160
Cardoso F, Kyriakides S, Ohno S et al (2019) Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 30(8):1194–1220
Ruhstaller T, Giobbie-Hurder A, Colleoni M et al (2019) Adjuvant letrozole and tamoxifen alone or sequentially for postmenopausal women with hormone receptor-positive breast cancer: long-term follow-up of the BIG 1-98 trial. J Clin Oncol 37(2):105–114. https://doi.org/10.1200/JCO.18.00440
Pagani O, Regan MM, Walley BA et al (2014) Adjuvant exemestane with ovarian suppression in premenopausal breast cancer. N Engl J Med 371:107–108. https://doi.org/10.1056/NEJMoa1404037
Francis PA, Pagani O, Fleming GF et al (2018) Tailoring adjuvant endocrine therapy for premenopausal breast cancer. N Engl J Med 379(2):122–137
Metzger Filho O, Giobbie-Hurder A, Mallon E et al (2015) Relative effectiveness of letrozole compared with tamoxifen for patients with lobular carcinoma in the BIG 1–98 trial. J Clin Oncol 33(25):2772–2779
Pan H, Gray R, Braybrooke J, Davies C et al (2017) 20-year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years. N Engl J Med 377(19):1836–1846. https://doi.org/10.1056/NEJMoa1701830
Davies C, Pan H, Godwin J et al (2013) Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. Lancet 381:805–816
Goss PE, Ingle JN, Martino S et al (2005) Randomized trial of letrozole following tamoxifen as extended adjuvant therapy in receptor-positive breast cancer: updated findings from NCIC CTG MA.17. J Natl Cancer Inst 97:1262–1271
Goss PE, Ingle JN, Pritchard KI et al (2016) Extending aromatase-inhibitor adjuvant therapy to 10 years. N Engl J Med 375:209–219
Colleoni M, Luo W, Karlsson P et al (2018) Extended adjuvant intermittent letrozole versus continuous letrozole in postmenopausal women with breast cancer (SOLE): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol 19:127–138
Blok EJ, Kroep JR, Meershoek-Klein Kranenbarg E et al (2018) Optimal duration of extended adjuvant endocrine therapy for early breast cancer; results of the IDEAL trial (BOOG 2006–05). J Natl Cancer Inst 110:40–48
Ravdin PM, Siminoff IA, Harvey JA (1998) Survey of breast cancer patients concerning their knowledge and expectations of adjuvant therapy. J Clin Oncol 16(2):515–521
Blinman P, Duric V, Nowak AK et al (2010) Adjuvant chemotherapy for early colon cancer: what survival benefits make it worthwhile? Eur J Cancer 46(10):1800–1807
Blinman PL, Davis ID, Martin A, Troon S, Sengupta S (2018) Patients’ preferences for adjuvant sorafenib after resection of renal cell carcinoma in the SORCE trial: what makes it worthwhile? Ann Oncol 29(2):370–376. https://doi.org/10.1093/annonc/mdx715
Blinman P, Hughes B, Crombie C et al (2015) Patients’ and doctors’ preferences for adjuvant chemotherapy in resected non-small-cell lung cancer: what makes it worthwhile? Eur J Cancer 51(12):1529–1537
Blinman P, Mileshkin L, Khaw P et al (2016) Patients’ and clinicians’ preferences for adjuvant chemotherapy in endometrial cancer: an ANZGOG substudy of the PORTEC-3 intergroup randomised trial. Br J Cancer 115(10):1179–1185
Berger AM, Buzalko RJ, Kupzyk KA, Gardner BJ, Djalilova DM, Otte JL (2017) Preferences and actual chemotherapy decision-making in the greater plains collaborative breast cancer study. Acta Oncol 56(12):1690–1697. https://doi.org/10.1080/0284186X.2017.1374555
Duric VM, Stockler MR, Heritier S et al (2005) Patients’ preferences for adjuvant chemotherapy in early breast cancer: what makes AC and CMF worthwhile now? Ann Oncol 16(11):1786–1794
Duric VM, Fallowfield LJ, Saunders C et al (2005) Patients/’ preferences for adjuvant endocrine therapy in early breast cancer: what makes it worthwhile? Br J Cancer 93(12):1319–1323
Regan MM, Viale G, Mastropasqua MG et al (2006) Re-evaluating adjuvant breast cancer trials: assessing hormone receptor status by immunohistochemical versus extraction assays. J Natl Cancer Inst 98:1571–1581
Regan MM, Pagani O, Francis PA, SOFT, and TEXT Investigators, and International Breast Cancer Study Group et al (2015) Predictive value and clinical utility of centrally assessed ER, PgR, and Ki-67 to select adjuvant endocrine therapy for premenopausal women with hormone receptor-positive, HER2-negative early breast cancer: TEXT and SOFT trials. Breast Cancer Res Treat 154:275–286
Salsman JM, Schalet BD, Andrykowski MA, Cella D (2015) The impact of events scale: a comparison of frequency versus severity approaches to measuring cancer-specific distress. Psycho-Oncol 24(12):1738–1745
Ha BY, Jung EJ, Choi SY (2014) Effects of resilience, post-traumatic stress disorder on the quality of life in patients with breast cancer. Korean J Women Health Nurs 20(1):83–91
Craparo G, Faraci P, Rotondo G, Gori A (2013) The Impact of Event Scale–Revised: psychometric properties of the Italian version in a sample of flood victims. Neuropsychiatr Dis Treat 9:1427
Connor KM, Davidson JR (2003) Development of a new resilience scale: the Connor-Davidson resilience scale (CD-RISC). Depress Anxiety 18(2):76–82
Loprinzi CE, Prasad K, Schroeder DR, Sood A (2011) Stress Management and Resilience Training (SMART) program to decrease stress and enhance resilience among breast cancer survivors: a pilot randomized clinical trial. Clin Breast Cancer 11(6):364–368
Simes R, Coates A (2001) Patient preferences for adjuvant chemotherapy of early breast cancer: how much benefit is needed? Monogr Natl Cancer Instit 30:146–152
Lindley C, Vasa S, Sawyer W, Winer E (1998) Quality of life and preferences for treatment following adjuvant therapy for early-stage breast cancer. J Clin Oncol 16:1380–1387
Thewes B, Meiser V, Duric VM, Stockler MR, Taylor A, Stuart-Harris R (2005) What survival benefits do premenopausal patients with early breast cancer need to make endocrine therapy worthwhile? Lancet Oncol 6(8):581–588
Fallowfield LJ, Leaity S, Howell A et al (1999) Assessment of quality of life in women undergoing hormonal therapy for breast cancer: validation of an endocrine symptom subscale for the FACT B. Breast Cancer Res Treat 55:189–199
Berglund G, Nystedt M, Bolund C et al (2001) Effect of endocrine treatment on sexuality in pre-menopausal breast cancer patients: a prospective randomised study. J Clin Oncol 19:2788–2796
Ganz P, Rowland J, Desmond K et al (1998) Life after breast cancer: understanding women’s health-related quality of life and sexual functioning. J Clin Oncol 16:501–514
Bakoyiannis I, Tsigka EA, Perrea D et al (2016) The impact of endocrine therapy on cognitive functions of breast cancer patients: a systematic review. Clin Drug Investig 36(2):109–118
Lee PE, Tierney MC, Wu W, Pritchard KI, Rochon PA (2016) Endocrine treatment-associated cognitive impairment in breast cancer survivors: evidence from published studies. Breast Cancer Res Treat 158(3):407–420. https://doi.org/10.1007/s10549-016-3906-9
Chlebowski RT, Kim J, Haque R (2014) Adherence to endocrine therapy in breast cancer adjuvant and prevention settings. Cancer Prev Res 7(4):378–387
Murphy CC et al (2012) Adherence to adjuvant hormonal therapy among breast cancer survivors in clinical practice: a systematic review. Breast Cancer Res Treat 134(2):459–478
McCowan C et al (2008) Cohort study examining tamoxifen adherence and its relationship to mortality in women with breast cancer. Br J Cancer 99(11):1763–1768
Makubate B et al (2013) Cohort study of adherence to adjuvant endocrine therapy, breast cancer recurrence and mortality. Br J Cancer 108(7):1515–1524
Hershman DL et al (2011) Early discontinuation and non-adherence to adjuvant hormonal therapy are associated with increased mortality in women with breast cancer. Breast Cancer Res Treat 126(2):529–537
Wheeler SB, Spencer J, Pinheiro LC et al (2019) Endocrine therapy non-adherence and discontinuation in black and white women. J Natl Cancer Inst 111(5):498–508
Cluze C, Rey D, Huiart L et al (2012) Adjuvant endocrine therapy with tamoxifen in young women with breast cancer: determinants of interruptions vary over time. Ann Oncol 23:882–890
Liu Y, Malin JL, Diamant AL, Thind A, Maly RC (2013) Adherence to adjuvant hormone therapy in low-income women with breast cancer: the role of provider-patient communication. Breast Cancer Res Treat 137:829–836
Kimmick G, Edmond SN, Bosworth HB et al (2015) Medication taking behaviors among breast cancer patients on adjuvant endocrine therapy. Breast 24:630–636
Vromans R, Tenfelde K, Pauws S, van Eenbergen M, Mares-Engelberts I (2019) Assessing the quality and communicative aspects of patient decision aids for early-stage breast cancer treatment: a systematic review. Breast Cancer Res Treat 178(1):1–15. https://doi.org/10.1007/s10549-019-05351-4
Singh JA, Sloan JA, Atherton PJ, Smith T, Hack TF (2010) Preferred roles in treatment decision making among patients with cancer: a pooled analysis of studies using the Control Preferences Scale. Am J Manag Care 16(9):688–696
Liao MN, Chen MF, Chen SC, Chen PL (2008) Uncertainty and anxiety during the diagnostic period for women with suspected breast cancer. Cancer Nurs 31(4):274–283. https://doi.org/10.1097/01.NCC.0000305744.64452.fe
McCormick KM (2002) A concept analysis of uncertainty in illness. J Nurs Scholarsh 32(2):27–131
Acknowledgements
We thank prof Fallowfield for the support in the plan of the study.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interest
E Montagna, G. Cancello and E. Munzone had consulting or Advisory Role from Pierre Fabre. M. Mazza received honoraria from Novartis, Pfizer, Istituto Gentili, Celgene, Astrazeneca. M. Colleoni received honoraria from Novartis and had consulting or Advisory Role from Pierre Fabre Pfizer OBI Pharma Puma Biotechnology Celldex AstraZeneca. The other authors declared no conflict of interest.
Ethical approval
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent
Informed consent was obtained from all individual participants included in the study.
Research involving human and/or animal participants
This article does not contain any studies with animals performed by any of the authors.
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Electronic supplementary material
Below is the link to the electronic supplementary material.
Rights and permissions
About this article
Cite this article
Montagna, E., Pagan, E., Bagnardi, V. et al. Evaluation of endocrine therapy and patients preferences in early breast cancer: results of Elena study. Breast Cancer Res Treat 184, 783–795 (2020). https://doi.org/10.1007/s10549-020-05900-2
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10549-020-05900-2