TY - JOUR
T1 - The influence on quality of life of intermittent scheduling in first- and second-line chemotherapy of patients with HER2-negative advanced breast cancer
AU - Claessens, Anouk K. M.
AU - Timman, Reinier
AU - Busschbach, Jan J.
AU - Bouma, Jeanette M.
AU - Rademaker-Lakhai, Jeany M.
AU - Erdkamp, Frans L. G.
AU - Tjan-Heijnen, Vivianne C. G.
AU - Bos, Monique E. M. M.
AU - Dutch Breast Canc Res Grp BOOG
N1 - Funding Information:
The results presented in this paper have been presented in abstract form at the ESMO-Breast Cancer Conference 2019 (Poster 159P) and were mentioned in an official ESMO press release [1 , 2]. The full manuscript has not been deposited to a pre-print server. We thank all patients, physicians, (research)nurses, and local data managers who participated in the Stop&Go trial; the members of the steering committee, the data safety monitoring committee, the central data management from the Comprehensive Cancer Centre the Netherlands, especially Steffen de Groot; and the Breast Cancer Research Group, especially Elise van Leeuwen—Stok. We are thankful to the teams from F. Hoffmann-La Roche Ltd and TEVA Nederland B.V. for their support.
Funding Information:
This work was supported by F. Hoffmann-La Roche Ltd, the Netherlands and TEVA Nederland B.V. These funders had no role in study design, data collection or data analysis. They were entitled to comment on the manuscript prior to publication, with a maximum delay for up to 2 months for important reasons. Disputes on the interpretation of the results were not to lead to an unnecessary delay in publication. Acknowledgements
Publisher Copyright:
© 2019, The Author(s).
PY - 2020/2
Y1 - 2020/2
N2 - 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
AB - 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
KW - Quality of life
KW - Advanced breast cancer
KW - Chemotherapy
KW - Scheduling
KW - PHASE-III
KW - WOMEN
KW - BEVACIZUMAB
KW - DIAGNOSIS
KW - SURVIVAL
KW - DISEASE
KW - TRIAL
U2 - 10.1007/s10549-019-05495-3
DO - 10.1007/s10549-019-05495-3
M3 - Article
C2 - 31782032
SN - 0167-6806
VL - 179
SP - 677
EP - 685
JO - Breast Cancer Research and Treatment
JF - Breast Cancer Research and Treatment
IS - 3
ER -