Trends in Adjuvant Chemotherapy Use in Endocrine-Sensitive,  HER-2 Negative Breast Cancer, With 1 to 3 Positive Nodes:  A Single-Centre Study

José Manuel Baena Cañada; Carlos de la Torre Hita; Marta Bernal Gómez; Alicia Campini Bermejo; Salvador Gámez Casado; Lourdes Rodríguez Pérez; Alicia Quílez Cutillas; Julio Calvete Candenas; Sara Estalella Mendoza; Encarnación Benítez Rodríguez

doi:10.32768/abc.202183233-242

José Manuel Baena Cañada ⁽¹⁾, Carlos de la Torre Hita ⁽²⁾, Marta Bernal Gómez ⁽³⁾, Alicia Campini Bermejo ⁽⁴⁾, Salvador Gámez Casado ⁽⁵⁾, Lourdes Rodríguez Pérez ⁽⁶⁾, Alicia Quílez Cutillas ⁽⁷⁾, Julio Calvete Candenas ⁽⁸⁾, Sara Estalella Mendoza ⁽⁹⁾, Encarnación Benítez Rodríguez ⁽¹⁰⁾

(1) Medical Oncology Department, Hospital Universitario Puerta del Mar, Cádiz, Spain b Instituto de Investigación e Innovación Biomédica de Cádiz (INiBICA), Spain, Spain,

(2) Medical Oncology Department, Hospital Universitario Puerta del Mar, Cádiz, Spain AND Instituto de Investigación e Innovación Biomédica de Cádiz (INiBICA), Spain, Spain,

(3) Medical Oncology Department, Hospital Universitario Puerta del Mar, Cádiz, Spain AND Instituto de Investigación e Innovación Biomédica de Cádiz (INiBICA), Spain, Spain,

(4) Medical Oncology Department, Hospital Universitario Puerta del Mar, Cádiz, Spain AND Instituto de Investigación e Innovación Biomédica de Cádiz (INiBICA), Spain, Spain,

(5) Medical Oncology Department, Hospital Universitario Puerta del Mar, Cádiz, Spain AND Instituto de Investigación e Innovación Biomédica de Cádiz (INiBICA), Spain, Spain,

(6) Medical Oncology Department, Hospital Universitario Puerta del Mar, Cádiz, Spain AND Instituto de Investigación e Innovación Biomédica de Cádiz (INiBICA), Spain, Spain,

(7) Medical Oncology Department, Hospital Universitario Puerta del Mar, Cádiz, Spain AND Instituto de Investigación e Innovación Biomédica de Cádiz (INiBICA), Spain, Spain,

(8) Medical Oncology Department, Hospital Universitario Puerta del Mar, Cádiz, Spain AND Instituto de Investigación e Innovación Biomédica de Cádiz (INiBICA), Spain, Spain,

(9) Medical Oncology Department, Hospital Universitario Puerta del Mar, Cádiz, Spain AND Instituto de Investigación e Innovación Biomédica de Cádiz (INiBICA), Spain, Spain,

(10) Instituto de Investigación e Innovación Biomédica de Cádiz (INiBICA), Spain AND Provincial Cancer Register, Regional Health Authority, Cádiz, Spain, Spain

https://doi.org/10.32768/abc.202183233-242

Issue
Vol 8, No 3: August 2021

Submitted
April 9, 2021

Published
July 27, 2021

Keywords:

Breast neoplasm, Hormonal Antineoplastic Agents, Adjuvant Chemotherapy, Survival, Systemic adjuvant therapies

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Abstract

Background: There is a tendency to decrease the intensity of breast cancer treatments, e.g. omitting adjuvant chemotherapy in endocrine-sensitive and HER-2 negative patients. The purpose of this study was to analyse changes in the frequency of the indication of adjuvant chemotherapy and the differences in survival over time for this subtype of breast cancer, with 1–3 positive nodes.
Methods: The study was based on descriptive, observational, retrospective, single-institution research between 2004–10 and 2011–18, on endocrine-sensitive, HER-2 negative breast cancer, stage pN1 (1–3 nodes). The analytical tests carried out for a comparison of the frequency of chemotherapy use the chi-square test with Fisher's exact test. Survival data in both periods are presented.
Results: A total of 236 patients were included, 66 for the period 2004–10, and 170 for 2011–18. More patients were treated with hormone therapy alone in 2011–18: hormone therapy alone 10/66 (15.20%) for 2004–10, and 83/169 (49.10%) for 2011–18; chemotherapy-hormone therapy 56/66 (84.80%) for 2004–10, and 86/169 (50.90%) for 2011–18 (P = 0.0001). For 2004–10, the 5-year overall survival probability was 100%. For 2011–18 it was 98.20% (95% CI 95.65–100). For 2004-10, 5-year disease free survival (DFS) was 96.9% (95% CI 92.7–101). For 2011–18 it was 87.7% (95% CI 81.8–93.5) (P=0,040). For 2004–10 the 5 year distant relapse free interval was 96.9% (95% CI 92.5–101.2). For 2011–18 it was 93% (95% CI 88.1–97.9) (P=0.312).
Conclusion: A decrease in the indication of adjuvant chemotherapy according to the clinical risk is confirmed in endocrine-sensitive, HER-2 negative breast cancer, with 1-3 positive nodes, over the period 2011–18 compared to 2004–10. Based on the results, 5-year DFS is slightly worse in the 2011–18 period.

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References

Curigliano G, Burstein HJ, Winer EP, Gnant M, Dubsky P, Loibl S, et al. De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017. Ann Oncol. 2017;28(8):1700-12.

Burstein HJ, Curigliano G, Loibl S, Dubsky P, Gnant M, Poortmans P, et al. 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. 2019;30(10):1541-57.

Group EBCTC. Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100 000 women in 123 randomised trials. The Lancet. 2012;379(9814):432-44.

Ravdin PM, Siminoff LA, Davis GJ, Mercer MB, Hewlett J, Gerson N, et al. Computer program to assist in making decisions about adjuvant therapy for women with early breast cancer. Journal of clinical oncology. 2001;19(4):980-91.

Wishart GC, Azzato EM, Greenberg DC, Rashbass J, Kearins O, Lawrence G, et al. PREDICT: a new UK prognostic model that predicts survival following surgery for invasive breast cancer. Breast Cancer Research. 2010; 12(1):1-10.

Matikas A, Foukakis T, Swain S, Bergh J. Avoiding over-and undertreatment in patients with resected node-positive breast cancer with the use of gene expression signatures: are we there yet? Annals of Oncology. 2019;30(7):1044-50.

Cardoso F, van’t Veer LJ, Bogaerts J, Slaets L, Viale G, Delaloge S, et al. 70-gene signature as an aid to treatment decisions in early-stage breast cancer. New England Journal of Medicine. 2016;375(8):717-29.

Albain KS, Barlow WE, Shak S, Hortobagyi GN, Livingston RB, Yeh IT, et al. Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. Lancet Oncol. 2010;11(1):55-65.

Roberts MC, Miller DP, Shak S, Petkov VI. Breast cancer-specific survival in patients with lymph node-positive hormone receptor-positive invasive breast cancer and Oncotype DX Recurrence Score results in the SEER database. Breast Cancer Res Treat. 2017;163(2):303-10.

Dowsett M, Cuzick J, Wale C, Forbes J, Mallon EA, Salter J, 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. J Clin Oncol. 2010;28(11):1829-34.

Nitz U, Gluz O, Christgen M, Kates RE, Clemens M, Malter W, et al. Reducing chemotherapy use in clinically high-risk, genomically low-risk pN0 and pN1 early breast cancer patients: five-year data from the prospective, randomised phase 3 West German Study Group (WSG) PlanB trial. Breast cancer research and treatment. 2017;165(3):573-83.

Gnant M, Sestak I, Filipits M, Dowsett M, Balic M, Lopez-Knowles E, et al. Identifying clinically relevant prognostic subgroups of postmenopausal women with node-positive hormone receptor-positive early-stage breast cancer treated with endocrine therapy: a combined analysis of ABCSG-8 and ATAC using the PAM50 risk of recurrence score and intrinsic subtype. Ann Oncol. 2015;26(8):1685-91.

Lænkholm AV, Jensen M-B, Eriksen JO, Rasmussen BB, Knoop A, Buckingham W, et al. PAM50 risk of recurrence score predicts 10-year distant recurrence in a comprehensive Danish cohort of postmenopausal women allocated to 5 years of endocrine therapy for hormone receptor–positive early breast cancer. Journal of Clinical Oncology. 2018;36(8):735-40.

Martin M, Brase JC, Calvo L, Krappmann K, Ruiz-Borrego M, Fisch K, et al. Clinical validation of the EndoPredict test in node-positive, chemotherapy-treated ER+/HER2- breast cancer patients: results from the GEICAM 9906 trial. Breast Cancer Res. 2014;16(2):R38.

Kurian AW, Bondarenko I, Jagsi R, Friese CR, McLeod MC, Hawley ST, et al. Recent trends in chemotherapy use and oncologists’ treatment recommendations for early-stage breast cancer. JNCI: Journal of the National Cancer Institute. 2018;110(5):493-500.

Jasem J, Fisher CM, Amini A, Shagisultanova E, Rabinovitch R, Borges VF, et al. The 21-gene recurrence score assay for node-positive, early-stage breast cancer and impact of RxPONDER Trial on chemotherapy decision-making: have clinicians already decided? Journal of the National Comprehensive Cancer Network. 2017;15(4):494-503.

Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-55.

Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83.

Hudis CA, Barlow WE, Costantino JP, Gray RJ, Pritchard KI, Chapman JA, et al. Proposal for standardized definitions for efficacy end points in adjuvant breast cancer trials: the STEEP system. J Clin Oncol. 2007;25(15):2127-32.

Haque W, Verma V, Hatch S, Klimberg VS, Butler EB, Teh BS. Omission of chemotherapy for low-grade, luminal A N1 breast cancer: Patterns of care and clinical outcomes. Breast. 2018;41:67-73.

Benot López S, Noriega Barreda C, Martínez Ferez I, Bayo Lozano E, Márquez Peláez S, Abu Omar N, et al. Estudio observacional post-introducción de las pruebas predictivo/pronósticas en cáncer de mama: AETSA Evaluación de Tecnologías Sanitarias de Andalucía2019.

Parsons BM, Landercasper J, Smith AL, Go RS, Borgert AJ, Dietrich LL. 21-Gene recurrence score decreases receipt of chemotherapy in ER+ early-stage breast cancer: an analysis of the NCDB 2010–2013. Breast cancer research and treatment. 2016;159(2):315-26.

Feinstein AR, Sosin DM, Wells CK. The Will Rogers phenomenon: stage migration and new diagnostic techniques as a source of misleading statistics for survival in cancer. New England Journal of Medicine. 1985;312(25):1604-8.

Ramsey SD, Barlow WE, Gonzalez-Angulo AM, Tunis S, Baker L, Crowley J, et al. Integrating comparative effectiveness design elements and endpoints into a phase III, randomized clinical trial (SWOG S1007) evaluating oncotypeDX-guided management for women with breast cancer involving lymph nodes. Contemporary clinical trials. 2013;34(1):1-9.

Stein RC, Dunn JA, Bartlett JM, Campbell AF, Marshall A, Hall P, et al. OPTIMA prelim: a randomised feasibility study of personalised care in the treatment of women with early breast cancer. Health Technology Assessment (Winchester, England). 2016;20(10):1.

Mamounas EP, Russell CA, Lau A, Turner MP, Albain KS. Clinical relevance of the 21-gene Recurrence Score® assay in treatment decisions for patients with node-positive breast cancer in the genomic era. NPJ breast cancer. 2018;4(1):1-6.

Ho PJ, Ow SGW, Sim Y, Liu J, Lim SH, Tan EY, et al. Impact of deviation from guideline recommended treatment on breast cancer survival in Asia. Sci Rep. 2020;10(1):1330.

Authors

José Manuel Baena Cañada

Medical Oncology Department, Hospital Universitario Puerta del Mar, Cádiz, Spain b Instituto de Investigación e Innovación Biomédica de Cádiz (INiBICA), Spain

josem.baena.sspa@juntadeandalucia.es (Primary Contact)

Carlos de la Torre Hita