Abstract
Original language | English |
---|---|
Pages (from-to) | 959-967 |
Number of pages | 9 |
Journal | Eur. J. Cancer |
Volume | 120 |
Issue number | 10 |
DOIs | |
Publication status | Published - 2019 |
Keywords
- letrozole
- adjuvant chemotherapy
- adjuvant therapy
- adult
- aged
- arm disease
- Article
- bladder disease
- body weight disorder
- breast cancer
- cancer patient
- cancer survival
- cognitive defect
- continuous infusion
- controlled study
- disease free survival
- drug withdrawal
- early cancer
- fatigue
- female
- follow up
- hot flush
- human
- lymph node
- major clinical study
- middle aged
- mood
- multicenter study
- musculoskeletal pain
- nausea
- open study
- phase 3 clinical trial
- physical well-being
- priority journal
- quality of life
- randomized controlled trial
- sexual arousal disorder
- sexual dysfunction
- sleep disorder
- vagina disease
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Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial : British Journal of Cancer. / Ribi, K.; Luo, W.; Colleoni, M.; Karlsson, P.; Chirgwin, J.; Aebi, S.; Jerusalem, G.; Neven, P.; Di Lauro, V.; Gomez, H.L.; Ruhstaller, T.; Abdi, E.; Biganzoli, L.; Müller, B.; Barbeaux, A.; Graas, M.-P.; Rabaglio, M.; Francis, P.A.; Foukakis, T.; Pagani, O.; Graiff, C.; Vorobiof, D.; Maibach, R.; Di Leo, A.; Gelber, R.D.; Goldhirsch, A.; Coates, A.S.; Regan, M.M.; Bernhard, J.; Investigators, on behalf of the SOLE.
In: Eur. J. Cancer, Vol. 120, No. 10, 2019, p. 959-967.Research output: Contribution to journal › Article › peer-review
}
TY - JOUR
T1 - Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial
T2 - British Journal of Cancer
AU - Ribi, K.
AU - Luo, W.
AU - Colleoni, M.
AU - Karlsson, P.
AU - Chirgwin, J.
AU - Aebi, S.
AU - Jerusalem, G.
AU - Neven, P.
AU - Di Lauro, V.
AU - Gomez, H.L.
AU - Ruhstaller, T.
AU - Abdi, E.
AU - Biganzoli, L.
AU - Müller, B.
AU - Barbeaux, A.
AU - Graas, M.-P.
AU - Rabaglio, M.
AU - Francis, P.A.
AU - Foukakis, T.
AU - Pagani, O.
AU - Graiff, C.
AU - Vorobiof, D.
AU - Maibach, R.
AU - Di Leo, A.
AU - Gelber, R.D.
AU - Goldhirsch, A.
AU - Coates, A.S.
AU - Regan, M.M.
AU - Bernhard, J.
AU - Investigators, on behalf of the SOLE
N1 - Export Date: 28 February 2020 CODEN: BJCAA Correspondence Address: Bernhard, J.; Quality of Life Office, International Breast Cancer Study Group Coordinating Center and Bern University Hospital, InselspitalSwitzerland; email: juerg.bernhard@ibcsg.org Chemicals/CAS: letrozole, 112809-51-5 Funding details: KU Leuven Funding details: Harvard Medical School Funding details: Monash University Funding details: Harvard T.H. Chan School of Public Health Funding details: University of Melbourne Funding details: Institute for Clinical Evaluative Sciences Funding details: Karolinska Institutet Funding details: Dana-Farber Cancer Institute Funding details: Foundation for Research, Science and Technology Funding details: Schweizerische Arbeitsgemeinschaft für Klinische Krebsforschung Funding details: Novartis Funding details: British Microcirculation Society Funding details: Eli Lilly and Company Funding details: Daiichi-Sankyo Funding details: AstraZeneca Schweiz Funding details: Pfizer Funding details: Celgene Funding details: Amgen Funding details: Meso Scale Diagnostics Funding details: Roche Funding text 1: 1Quality of Life Office, International Breast Cancer Study Group Coordinating Center, Bern, Switzerland; 2International Breast Cancer Study Group Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA; 3Division of Medical Senology, IEO, European Institute of Oncology IRCCS, Milan, Italy; 4Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy/Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden; 5Box Hill and Maroondah Hospitals, Monash University, Victoria, Australia; 6Luzerner Kantonsspital, Lucerne, Switzerland; 7CHU Liège, Liège University, Liège, Belgium; 8Multidisciplinary Breast Center, University Hospitals, KU Leuven, Leuven, Belgium; 9Division of Medical Oncology B, CRO-Aviano, Aviano, Italy; 10Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru; 11Breast Center St. Gallen, Swiss Group for Clinical Cancer Research and International Breast Cancer Study Group, Bern, Switzerland; 12The Tweed Hospital, Tweed Heads, NSW & Griffith University Gold Coast, Southport, Australia; 13Hospital of Prato-AUSL Toscana Centro, Istituto Toscano Tumori, Prato, Italy; 14Chilean Cooperative Group for Oncologic Research (GOCCHI), Providencia, Santiago, Chile; 15CHR Verviers, Verviers, Belgium; 16CHC Clinique St. Joseph, Liège, Belgium; 17Bern University Hospital, Inselspital, Bern, Switzerland; 18Peter MacCallum Cancer Center, University of Melbourne, Melbourne and Breast Cancer Trials Australia & New Zealand, University of Newcastle, Newcastle, Australia; 19Department of Oncology, Karolinska Institute and University Hospital, Stockholm, Sweden; 20Institute of Oncology of Southern Switzerland, Bellinzona, Geneva University Hospitals, Geneva, Swiss Group for Clinical Cancer Research (SAKK) and International Breast Cancer Study Group, Bern, Switzerland;21Division of Medical Oncology, Ospedale Centrale di Bolzano, Bolzano, Italy; 22Sandton Oncology Centre, Johannesburg, South Africa; 23International Breast Cancer Study Group Coordinating Center, Bern, Switzerland; 24International Breast Cancer Study Group Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Harvard Medical School, Harvard T.H. Chan School of Public Health and Frontier Science and Technology Research Foundation, Boston, MA, USA; 25International Breast Cancer Study Group and IEO, European Institute of Oncology IRCCS, Milan, Italy; 26International Breast Cancer Study Group and University of Sydney, Sydney, Australia; 27International Breast Cancer Study Group Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA and 28Quality of Life Office, International Breast Cancer Study Group Coordinating Center and Bern University Hospital, Inselspital, Bern, Switzerland Correspondence: Jürg Bernhard (juerg.bernhard@ibcsg.org) Presented: 2017 San Antonio Breast Cancer Symposium, San Antonio, TX, USA. The investigators in the Study of Letrozole Extension (SOLE), the leadership and staff of the International Breast Cancer Study Group, and the trial’s support and acknowledgments are listed in the Supplementary Appendix. Funding text 2: SOLE is a Breast International Group trial (BIG 01-07). We thank the patients, physicians, nurses, and trial coordinators who participated in the SOLE quality of life sub-study. SOLE receives financial support for trial conduct from Novartis and the International Breast Cancer Study Group (IBCSG). Novartis provided the letrozole used in this study. Support for the coordinating group, IBCSG, was provided by the Frontier Science & Technology Research Foundation; the Swiss Group for Clinical Cancer Research; Cancer Research Switzerland, Oncosuisse and the Cancer League Switzerland; and the Foundation for Clinical Cancer Research of Eastern Switzerland. Funding text 3: Competing interests: Dr Colleoni reports advisory board fees from AstraZeneca, Pierre Fabre, Pfizer, OBI Pharma, Puma Biotechnology, Celldex; and honoraria from Novartis. Dr Karlsson reports advisory board fees from Novartis. Dr Jerusalem reports grants from Novartis, Roche, Amgen, BMS, and MSD; personal fees from Novartis, Roche, Lilly, Celgene, Amgen, BMS, Pfizer, Puma, Daiichi-Sankyo, MSD, and AstraZeneca; and non-financial support from Novartis, Roche, Lilly, BMS, and AstraZeneca. Dr Ruhstaller reports travel grants from Roche and Amgen; and advisory board fees from Novartis, Roche, AstraZeneca, and Lilly; and honoraria from Pfizer. Dr Francis reports personal fees from AstraZeneca and Novartis; and nonfinancial support from Pfizer: Dr Foukakis reports an institutional grant from Pfizer; and personal fees from Novartis and UpToDate. Dr Leo reports grants from AstraZeneca, Pierre Fabre, and Pfizer; and personal fees from AstraZeneca, Bayer, Celgene, Daichii-Sankyo, Eisai, Genomic Health, Ipsen, Lilly, Novartis, Pierre Fabre, Pfizer, and Roche. Dr Gelber reports institution fees from Novartis, Pfizer, AstraZeneca, Merck, Celgene, Ferring, Roche, and Ipsen. Dr Goldhirsch reports that the institute received a per-patient fee from the IBCSG for trial conduct. Dr Regan reports grants from International Breast Cancer Study Group, during the conduct of the study; grants from Novartis, grants from Pfizer, grants from Ipsen, outside the submitted work. The remaining authors declare no competing interests. References: Sabnis, G.J., Macedo, L.F., Goloubeva, O., Schayowitz, A., Brodie, A.M., Stopping treatment can reverse acquired resistance to letrozole (2008) Cancer Res., 68, pp. 4518-4524. , COI: 1:CAS:528:DC%2BD1cXnt1aqsbY%3D; Colleoni, M., Luo, W., Karlsson, P., Chirgwin, J., Aebi, S., Jerusalem, G., Extended adjuvant intermittent letrozole versus continuous letrozole in postmenopausal women with breast cancer (SOLE): a multicentre, open-label, randomised, phase 3 trial (2018) Lancet Oncol., 19, pp. 127-138. , COI: 1:CAS:528:DC%2BC2sXhvVequr7N; Cella, D., Fallowfield, L., Barker, P., Cuzick, J., Locker, G., Howell, A., Quality of life of postmenopausal women in the ATAC ("Arimidex", tamoxifen, alone or in combination) trial after completion of 5 years' adjuvant treatment for early breast cancer (2006) Breast Cancer Res. Treat., 100, pp. 273-284; Fallowfield, L.J., Kilburn, L.S., Langridge, C., Snowdon, C.F., Bliss, J.M., Coombes, R.C., Long-term assessment of quality of life in the Intergroup Exemestane Study: 5 years post-randomisation (2012) Br. J. Cancer, 106, pp. 1062-1067. , COI: 1:CAS:528:DC%2BC38XktVait7g%3D; Goss, P.E., Ingle, J.N., Martino, S., Robert, N.J., Muss, H.B., Piccart, M.J., A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer (2003) N. Engl. J. Med., 349, pp. 1793-1802. , COI: 1:CAS:528:DC%2BD3sXosl2gtbc%3D; Whelan, T.J., Goss, P.E., Ingle, J.N., Pater, J.L., Tu, D., Pritchard, K., Assessment of quality of life in MA.17: a randomized, placebo-controlled trial of letrozole after 5 years of tamoxifen in postmenopausal women (2005) J. Clin. Oncol., 23, pp. 6931-6940. , COI: 1:CAS:528:DC%2BD2MXhtFCrsbvJ; Stanton, A.L., Bernaards, C.A., Ganz, P.A., The BCPT symptom scales: a measure of physical symptoms for women diagnosed with or at risk for breast cancer (2005) J. Natl Cancer Inst., 97, pp. 448-456; Ganz, P.A., Rowland, J.H., Desmond, K., Meyerowitz, B.E., Wyatt, G.E., Life after breast cancer: understanding women's health-related quality of life and sexual functioning (1998) J. Clin. Oncol., 16, pp. 501-514. , COI: 1:STN:280:DyaK1c7ivFagtA%3D%3D; Cella, D., Land, S.R., Chang, C.H., Day, R., Costantino, J.P., Wolmark, N., Symptom measurement in the Breast Cancer Prevention Trial (BCPT) (P-1): psychometric properties of a new measure of symptoms for midlife women (2008) Breast Cancer Res. Treat., 109, pp. 515-526; Terhorst, L., Blair-Belansky, H., Moore, P.J., Bender, C., Evaluation of the psychometric properties of the BCPT Symptom Checklist with a sample of breast cancer patients before and after adjuvant therapy (2011) Psychooncology, 20, pp. 961-968. , PID: 20669338; Ganz, P.A., Cecchini, R.S., Julian, T.B., Margolese, R.G., Costantino, J.P., Vallow, L.A., Patient-reported outcomes with anastrozole versus tamoxifen for postmenopausal patients with ductal carcinoma in situ treated with lumpectomy plus radiotherapy (NSABP B-35): a randomised, double-blind, phase 3 clinical trial (2016) Lancet, 387, pp. 857-865. , COI: 1:CAS:528:DC%2BC2MXitVSku7fL; Bernhard, J., Hurny, C., Coates, A.S., Peterson, H.F., Castiglione-Gertsch, M., Gelber, R.D., Quality of life assessment in patients receiving adjuvant therapy for breast cancer: the IBCSG approach. The International Breast Cancer Study Group (1997) Ann. Oncol., 8, pp. 825-835. , COI: 1:STN:280:DyaK1c%2Fitlygug%3D%3D; Bernhard, J., Luo, W., Ribi, K., Colleoni, M., Burstein, H.J., Tondini, C., Patient-reported outcomes with adjuvant exemestane versus tamoxifen in premenopausal women with early breast cancer undergoing ovarian suppression (TEXT and SOFT): a combined analysis of two phase 3 randomised trials (2015) Lancet Oncol., 16, pp. 848-858. , COI: 1:CAS:528:DC%2BC2MXht1agsbbJ; Ribi, K., Luo, W., Bernhard, J., Francis, P.A., Burstein, H.J., Ciruelos, E., Adjuvant tamoxifen plus ovarian function suppression versus tamoxifen alone in premenopausal women with early breast cancer: patient-reported outcomes in the suppression of ovarian function trial (2016) J. Clin. Oncol., 34, pp. 1601-1610. , COI: 1:CAS:528:DC%2BC2sXivFClsb0%3D; Butow, P., Coates, A., Dunn, S., Bernhard, J., Hurny, C., On the receiving end. IV: validation of quality of life indicators (1991) Ann. Oncol., 2, pp. 597-603. , COI: 1:STN:280:DyaK387nt1Ortw%3D%3D; Bernhard, J., Sullivan, M., Hurny, C., Coates, A.S., Rudenstam, C.M., Clinical relevance of single item quality of life indicators in cancer clinical trials (2001) Br. J. Cancer, 84, pp. 1156-1165. , COI: 1:STN:280:DC%2BD3MzktFyhsw%3D%3D; Hurny, C., Bernhard, J., Coates, A., Peterson, H.F., Castiglione-Gertsch, M., Gelber, R.D., Responsiveness of a single-item indicator versus a multi-item scale: assessment of emotional well-being in an international adjuvant breast cancer trial (1996) Med. Care., 34, pp. 234-248. , COI: 1:STN:280:DyaK283itFentA%3D%3D; Hurny, C., Bernhard, J., Bacchi, M., van Wegberg, B., Tomamichel, M., Spek, U., The perceived adjustment to chronic illness scale (PACIS): a global indicator of coping for operable breast cancer patients in clinical trials. Swiss Group for Clinical Cancer Research (SAKK) and the International Breast Cancer Study Group (IBCSG) (1993) Support Care Cancer, 1, pp. 200-208. , COI: 1:STN:280:DyaK2c3ltFGmuw%3D%3D; Bernhard, J., Maibach, R., Thurlimann, B., Sessa, C., Aapro, M.S., Patients' estimation of overall treatment burden: why not ask the obvious? (2002) J. Clin. Oncol., 20, pp. 65-72. , COI: 1:STN:280:DC%2BD38%2FltFSktA%3D%3D, PID: 11773155; Hurny, C., Bernhard, J., Coates, A.S., Castiglione-Gertsch, M., Peterson, H.F., Gelber, R.D., Impact of adjuvant therapy on quality of life in women with node-positive operable breast cancer. International Breast Cancer Study Group (1996) Lancet, 347, pp. 1279-1284. , COI: 1:CAS:528:DyaK28Xjs1eksLY%3D; Bernhard, J., Zahrieh, D., Castiglione-Gertsch, M., Hurny, C., Gelber, R.D., Forbes, J.F., Adjuvant chemotherapy followed by goserelin compared with either modality alone: the impact on amenorrhea, hot flashes, and quality of life in premenopausal patients—the International Breast Cancer Study Group Trial VIII (2007) J. Clin. Oncol., 25, pp. 263-270. , COI: 1:CAS:528:DC%2BD2sXitFSjtbk%3D; Sloan, J.A., Dueck, A., Issues for statisticians in conducting analyses and translating results for quality of life end points in clinical trials (2004) J. Biopharm. Stat., 14, pp. 73-96. , COI: 1:STN:280:DC%2BD2c7jsVKkug%3D%3D; Goss, P.E., Ingle, J.N., Pritchard, K.I., Robert, N.J., Muss, H., Gralow, J., Extending aromatase-inhibitor adjuvant therapy to 10 years (2016) N. Engl. J. Med., 375, pp. 209-219. , COI: 1:CAS:528:DC%2BC28XhvF2ks73N; Curigliano, G., Burstein, H.J., PW, E., Gnant, M., Dubsky, P., Loibl, S., 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 (2017) Ann. Oncol., 28, pp. 1700-1712. , COI: 1:STN:280:DC%2BC1cbhtlOjtw%3D%3D; Lemieux, J., Brundage, M.D., Parulekar, W.R., Goss, P.E., Ingle, J.N., Pritchard, K.I., Quality of Life from Canadian Cancer Trials Group MA.17R: a randomized trial of extending adjuvant letrozole to 10 years (2018) J. Clin. Oncol., 36, pp. 563-571. , COI: 1:CAS:528:DC%2BC1cXitFOqtbzL; Cella, D., Hahn, E.A., Dineen, K., Meaningful change in cancer-specific quality of life scores: differences between improvement and worsening (2002) Qual. Life Res., 11, pp. 207-221
PY - 2019
Y1 - 2019
N2 - Background: In the phase III SOLE trial, the extended use of intermittent versus continuous letrozole for 5 years did not improve disease-free survival in postmenopausal women with hormone receptor-positive breast cancer. Intermittent therapy with 3-month breaks may be beneficial for patients’ quality of life (QoL). Methods: In the SOLE QoL sub-study, 956 patients completed the Breast Cancer Prevention Trial (BCPT) symptom and further QoL scales up to 24 months after randomisation. Differences in change of QoL from baseline between the two administration schedules were tested at 12 and 24 months using repeated measures mixed-models. The primary outcome was change in hot flushes at 12 months. Results: There was no difference in hot flushes at 12 months between the two schedules, but patients receiving intermittent letrozole reported significantly more improvement at 24 months. They also indicated less worsening in vaginal problems, musculoskeletal pain, sleep disturbance, physical well-being and mood at 12 months. Overall, 25–30% of patients reported a clinically relevant worsening in key symptoms and global QoL. Conclusion: Less symptom worsening was observed during the first year of extended treatment with the intermittent administration. For women experiencing an increased symptom burden of extended adjuvant endocrine therapy, an intermittent administration is a safe alternative. Clinical trial information: Clinical trial information: NCT00651456. © 2019, Cancer Research UK.
AB - Background: In the phase III SOLE trial, the extended use of intermittent versus continuous letrozole for 5 years did not improve disease-free survival in postmenopausal women with hormone receptor-positive breast cancer. Intermittent therapy with 3-month breaks may be beneficial for patients’ quality of life (QoL). Methods: In the SOLE QoL sub-study, 956 patients completed the Breast Cancer Prevention Trial (BCPT) symptom and further QoL scales up to 24 months after randomisation. Differences in change of QoL from baseline between the two administration schedules were tested at 12 and 24 months using repeated measures mixed-models. The primary outcome was change in hot flushes at 12 months. Results: There was no difference in hot flushes at 12 months between the two schedules, but patients receiving intermittent letrozole reported significantly more improvement at 24 months. They also indicated less worsening in vaginal problems, musculoskeletal pain, sleep disturbance, physical well-being and mood at 12 months. Overall, 25–30% of patients reported a clinically relevant worsening in key symptoms and global QoL. Conclusion: Less symptom worsening was observed during the first year of extended treatment with the intermittent administration. For women experiencing an increased symptom burden of extended adjuvant endocrine therapy, an intermittent administration is a safe alternative. Clinical trial information: Clinical trial information: NCT00651456. © 2019, Cancer Research UK.
KW - letrozole
KW - adjuvant chemotherapy
KW - adjuvant therapy
KW - adult
KW - aged
KW - arm disease
KW - Article
KW - bladder disease
KW - body weight disorder
KW - breast cancer
KW - cancer patient
KW - cancer survival
KW - cognitive defect
KW - continuous infusion
KW - controlled study
KW - disease free survival
KW - drug withdrawal
KW - early cancer
KW - fatigue
KW - female
KW - follow up
KW - hot flush
KW - human
KW - lymph node
KW - major clinical study
KW - middle aged
KW - mood
KW - multicenter study
KW - musculoskeletal pain
KW - nausea
KW - open study
KW - phase 3 clinical trial
KW - physical well-being
KW - priority journal
KW - quality of life
KW - randomized controlled trial
KW - sexual arousal disorder
KW - sexual dysfunction
KW - sleep disorder
KW - vagina disease
U2 - 10.1038/s41416-019-0435-4
DO - 10.1038/s41416-019-0435-4
M3 - Article
VL - 120
SP - 959
EP - 967
JO - Eur. J. Cancer
JF - Eur. J. Cancer
SN - 0959-8049
IS - 10
ER -