Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Breast Cancer Research and Treatment
Published in: Breast Cancer Research and Treatment 3/2020

Open Access 01-02-2020 | Breast Cancer | Clinical trial

The influence on quality of life of intermittent scheduling in first- and second-line chemotherapy of patients with HER2-negative advanced breast cancer

Authors: Anouk K. M. Claessens, Reinier Timman, Jan J. Busschbach, Jeanette M. Bouma, Jeany M. Rademaker-Lakhai, Frans L. G. Erdkamp, Vivianne C. G. Tjan-Heijnen, Monique E. M. M. Bos, the Dutch Breast Cancer Research Group (BOOG)

Published in: Breast Cancer Research and Treatment | Issue 3/2020

Login to get access

Abstract

Background

The Stop&Go study randomized patients with advanced breast cancer to intermittent (two times four) or continuous (eight subsequent cycles) first- and second-line chemotherapy.

Methods

QoL was measured with RAND-36 questionnaires every 12 weeks. The primary objective was to estimate differences in changes from baseline between intermittent and continuous treatment. An effect size of 0.5 SD (5 points) was considered clinically meaningful.

Results

A total of 398 patients were included with a median follow-up of 11.4 months (IQR 5.6–22.2). Mean physical QoL baseline scores were 38.0 resp. 38.2, and mental scores 45.0 resp. 42.4 for intermittent and continuous treatment. Physical QoL declined linearly in the intermittent arm causing a clinically meaningful difference of 5.40 points at 24 months (p < 0.001), while scores in the continuous arm stabilized after a small decline of ± 3.4 points at 12 months. Conversely, mental QoL was fairly stable and even improved with 1.58 (p = 0.005) and 2.48 points (p < 0.001) at 12 months for intermittent and continuous treatment, respectively. When comparing arms for both components in changes from baseline, the maximum differences were 2.46 (p = 0.101) and 1.95 points (p = 0.182) for physical and mental scores, both measured at 30 months and in favor of continuous treatment.

Conclusion

Intermittent first- and second-line chemotherapy in patients with HER2-negative advanced breast cancer showed a trend for worse impact on QoL compared to continuous chemotherapy, with neither significant nor meaningful differences in course. We recommend prescribing chemotherapy continuously until progressive disease or unacceptable toxicity.
Trial registration EudraCT 2010-021519-18; BOOG 2010-02
Appendix
Available only for authorised users
Literature
1.
Claessens AKM, Timman R, Busschbach JJ, Bouma JM, Rademaker-Lakhai JM, Erdkamp FLG, Tjan-Heijnen VCG, Bos MMEM (2019) 159P_PRInfluence on quality of life of chemotherapy scheduling for patients with advanced HER2-negative breast cancer. Annal Oncol 30(Supplement_3):100
2.
EBCc (2019) Continuous chemotherapy improves outcomes and quality of life in advanced breast cancer. ESMO Press, Lugano
3.
Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F (2015) Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer 136(5):E359–E386CrossRef
4.
O’Shaughnessy J (2005) Extending survival with chemotherapy in metastatic breast cancer. Oncologist 10(Suppl 3):20–29CrossRef
5.
Sant M, Chirlaque Lopez MD, Agresti R, Sanchez Perez MJ, Holleczek B, Bielska-Lasota M, Dimitrova N, Innos K, Katalinic A, Langseth H et al (2015) Survival of women with cancers of breast and genital organs in Europe 1999–2007: results of the EUROCARE-5 study. Eur J Cancer 51(15):2191–2205CrossRef
6.
Noone A, Howlader N, Krapcho M, Miller D, Brest A, Yu M, Ruhl J, Tatalovich Z, Mariotto A, Lewis D et al: SEER cancer statistics review 1975–2015. In: Based on November 2017 SEER data submission, posted to SEER webiste April 18. Bethesda, MD: National Cancer Insitute; 2018
7.
European School of Oncology PO: Global status of advanced/metastatic breast cancer: 2005-2015 decade report. In: Advanced breast cancer international consensus conference (ABC). March 2016
8.
Claessens AKM, Bos M, Lopez-Yurda M, Bouma JM, Rademaker-Lakhai JM, Honkoop AH, de Graaf H, van Druten E, van Warmerdam LJC, van der Sangen MJC et al (2018) Intermittent versus continuous first-line treatment for HER2-negative metastatic breast cancer: the Stop and Go study of the Dutch Breast Cancer Research Group (BOOG). Breast Cancer Res Treat 172(2):413–423CrossRef
9.
Hays RD, Sherbourne CD, Mazel RM (1993) The RAND 36-Item Health Survey 1.0. Health Econ 2(3):217–227CrossRef
10.
Zee KIvd, Sanderman R: Het meten van de algemene gezondheidstoestand met de RAND-36: een handleiding. In. Edited by SHARE RI, Groningen UR, vol. Noordelijk Centrum voor Gezondheidsvraagstukken, NCG.—(NCG reeks Meetinstrumenten; 3) Groningen: Research Institute SHARE; 2012
11.
Aaronson NK, Müller M, Cohen PDA, Essink-Bot ML, Fekkes M, Sanderman R, Sprangers MAG (1998) Velde tA, Verrips E: translation, validation, and norming of the Dutch language version of the SF-36 health survey in community and chronic disease populations. J Clin Epidemiol 51:1055–1068CrossRef
12.
Ware JE, Kosinski M, Keller SK: SF-36 physical and mental health summary scales: a user’s manual. In. Edited by Institute TH. Boston, Massachusetts: New England Medical Centre; 1994
13.
Ware J, Snoww K, Ma K, Bg G: SF36 Health Survey: Manual and Interpretation Guide, vol. 30; 1993
14.
Verbeke G (2000) Linear mixed models for longitudinal data. Springer, New York
15.
Singer J, Willett J (2003) Applied longitudinal data analysis—modeling change and event occurrence. Oxford University Press, OxfordCrossRef
16.
Norman GR, Sloan JA, Wyrwich KW (2003) Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care 41(5):582–592PubMed
17.
Cohen J (1992) A power primer. Psychol Bull 112:1155–1159
18.
Jones SMW, LaCroix AZ, Li W, Zaslavsky O, Wassertheil-Smoller S, Weitlauf J, Brenes GA, Nassir R, Ockene JK, Caire-Juvera G et al (2015) Depression and quality of life before and after breast cancer diagnosis in older women from the Women’s Health Initiative. J Cancer Survivor 9(4):620–629CrossRef
19.
Leung J, Pachana NF, McLaughlin D (2014) Social support and health-related quality of life in women with breast cancer: a longitudinal study. Psychooncology 23(9):1014–1020CrossRef
20.
Tibben A, Timman R, Bannink EC, Duivenvoorden HJ (1997) Three-year follow-up after presymptomatic testing for Huntington’s disease in tested individuals and partners. Health Psychol 16(1):20–35CrossRef
21.
Wang SY, Hsu SH, Gross CP, Sanft T, Davidoff AJ, Ma X, Yu JB (2016) Association between time since cancer diagnosis and health-related quality of life: a population-level analysis. Value Health 19(5):631–638CrossRef
22.
Park YH, Jung KH, Im SA, Sohn JH, Ro J, Ahn JH, Kim SB, Nam BH, Oh DY, Han SW et al (2015) Quality of life (QoL) in metastatic breast cancer patients with maintenance paclitaxel plus gemcitabine (PG) chemotherapy: results from phase III, multicenter, randomized trial of maintenance chemotherapy versus observation (KCSG-BR07-02). Breast Cancer Res Treat 152:77–85CrossRef
23.
Tredan O, Follana P, Moullet I, Cropet C, Trager-Maury S, Dauba J, Lavau-Denes S, Dieras V, Beal-Ardisson D, Gouttebel M et al (2016) A phase III trial of exemestane plus bevacizumab maintenance therapy in patients with metastatic breast cancer after first-line taxane and bevacizumab: a GINECO group study. Ann Oncol 27(6):1020–1029CrossRef
24.
Nooij MA, de Haes JCJM, Beex LVAM, Wildiers J, Klijn J, Becquart D, Jassem J, Engelsman E, Duchateau L (2003) Continuing chemotherapy or not after the induction treatment in advanced breast cancer patients. Clinical outcomes and oncologists’ preferences. Eur J Cancer 39:614–721CrossRef
25.
Coates A, Gebski V, Bishop JF, Jeal PN, Woods RL, Snyder R, Tattersall MH, Byrne M, Harvey V, Gill G (1987) Improving the quality of life during chemotherapy for advanced breast cancer. A comparison of intermittent and continuous treatment strategies. N Engl J Med 317(24):1490–1495CrossRef
26.
Gligorov J, Doval D, Bines J, Alba E, Cortes P, Pierga JY, Gupta V, Costa R, Srock S, de Ducla S et al (2014) Maintenance capecitabine and bevacizumab versus bevacizumab alone after initial first-line bevacizumab and docetaxel for patients with HER2-negative metastatic breast cancer (IMELDA): a randomised, open-label, phase 3 trial. Lancet Oncol 15(12):1351–1360CrossRef
27.
Becher R, Kloke O, Hayungs J, Hartwich G, Bartels H, Szanto J, Wolf E, Illiger H-J, Halabi S, Rieche K et al (1996) Epirubicin and ifosfamide in metastatic breast cancer. Semin Oncol 23(3; suppl 7):28–33PubMed
28.
Ghislain I, Zikos E, Coens C, Quinten C, Balta V, Tryfonidis K, Piccart M, Zardavas D, Nagele E, Bjelic-Radisic V et al (2016) Health-related quality of life in locally advanced and metastatic breast cancer: methodological and clinical issues in randomised controlled trials. Lancet Oncol 17(7):e294–e304CrossRef
29.
Chari N (2013) Metastatic breast cancer in Canada: the lived experiene of patients and caregivers presented by the Canadian Breast Cancer Network and Rethink Breast Cancer. Breast 22:S28CrossRef
Metadata
Title
The influence on quality of life of intermittent scheduling in first- and second-line chemotherapy of patients with HER2-negative advanced breast cancer
Authors
Anouk K. M. Claessens
Reinier Timman
Jan J. Busschbach
Jeanette M. Bouma
Jeany M. Rademaker-Lakhai
Frans L. G. Erdkamp
Vivianne C. G. Tjan-Heijnen
Monique E. M. M. Bos
the Dutch Breast Cancer Research Group (BOOG)
Publication date
01-02-2020
Publisher
Springer US
Published in
Breast Cancer Research and Treatment / Issue 3/2020
Print ISSN: 0167-6806
Electronic ISSN: 1573-7217
DOI
https://doi.org/10.1007/s10549-019-05495-3

Other articles of this Issue 3/2020

Breast Cancer Research and Treatment 3/2020 Go to the issue

Preclinical study

Clinicopathological significance of lipocalin 2 nuclear expression in invasive breast cancer

Preclinical study

Tumor microenvironment and breast cancer survival: combined effects of breast fat, M2 macrophages and hyaluronan create a dismal prognosis

Clinical trial

Axillary lymph node dissection in node-positive breast cancer: are ten nodes adequate and when is enough, enough?

Preclinical study

Evaluation of the anti-Thomsen–Friedenreich antibodies Nemod-TF1 and Nemod-TF2 as prognostic markers in breast cancer

Preclinical study

Paget’s disease of the nipple in a Her2-positive breast cancer xenograft model

Preclinical Study

The orphan nuclear receptor estrogen-related receptor beta (ERRβ) in triple-negative breast cancer
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Watch now

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine
Image Credits