Extended therapy with letrozole as adjuvant treatment of postmenopausal patients with early-stage breast cancer: a multicentre, open-label, randomised, phase 3 trial

Mastro, Lucia Del; Mansutti, M.; Bisagni, Giancarlo; Ponzone, Riccardo; Durando, Antonio; Amaducci, Laura; Campadelli, Enrico; Cognetti, F.; Frassoldati, Antonio; Michelotti, Andrea; Mura, Silvia; Urracci, Ylenia; Sanna, Giovanni; Gori, Stefania; Placido, Sabino De; Garrone, Ornella; Fabi, Alessandra; Barone, C.; Tamberi, Stefano; Bighin, Claudia; Puglisi, Fabio; Moretti, G; Arpino, Grazia; Ballestrero, Alberto; Poggio, F.; Lambertini, Matteo; Montemurro, Filippo; Bruzzi, Paolo; investigators, Gruppo Italiano Mammella

doi:10.1016/s1470-2045(21)00352-1

Cited by 50 publications

(42 citation statements)

References 25 publications

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“…Finally, we analyzed the blood lipid indices and found that the blood lipid indices of the research group receiving sequential therapy with TAM and LTZ were significantly better, suggesting that the sequential treatment had some beneficial effects on improving the blood lipid of patients. Del Mastro et al [ 25 ] also confirmed that sequential therapy with TAM and LTZ was the best standard treatment strategy for postmenopausal hormone-receptor-positive BC patients, which is similar to the results of our study.…”

Section: Discussionsupporting

confidence: 92%

Efficacy, Safety, and Prognosis of Sequential Therapy with Tamoxifen and Letrozole versus Letrozole Monotherapy for Breast Carcinoma

Qian²

2022

Computational and Mathematical Methods in Medicine

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Objective. To explore the efficacy, safety, and patient prognosis of letrozole (LTZ) alone or in sequence with tamoxifen (TAM) for the treatment of breast carcinoma (BC). Methods. In this retrospective study, 150 patients with BC who received treatment in the First People’s Hospital of Ningyang County between January 2012 and January 2017 were selected. According to different treatment methods, 99 cases receiving sequential therapy with TAM and LTZ were included in the research group, and the remaining 51 patients receiving LTZ monotherapy were selected as the control group. The efficacy, safety, survival rate, recurrence rate, and blood lipid indices (total cholesterol, TC; triglyceride, TG; high-density lipoprotein cholesterol, HDL-C; and low-density lipoprotein cholesterol, LDL-C) of the two groups were observed and compared. Results. The overall response rate of the research group was statistically higher than that of the control group, and the incidence of adverse reactions was significantly lower. No evident difference was observed in 1-, 3-, or 5-year survival rates between the two groups, while the 3-5-year recurrence rate was obviously lower, and the improvement of blood lipid indices was significantly better in the research group compared with the control group. Conclusion. LTZ alone or in sequence with TAM is effective and safe for the treatment of BC, which can significantly improve the prognosis and blood lipid indices of BC patients.

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Section: Discussionsupporting

confidence: 92%

Efficacy, Safety, and Prognosis of Sequential Therapy with Tamoxifen and Letrozole versus Letrozole Monotherapy for Breast Carcinoma

Qian²

2022

Computational and Mathematical Methods in Medicine

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“…This is all the more important in consideration of recently implemented strategies to escalate hormonal therapy by adding ovarian function suppression 46 or extending its duration beyond 5 years. [47][48][49] Substantial evidence shows that cancer-related fatigue is underaddressed 3,6,8,50 and that the utilization of strategies to manage this symptom may be suboptimal. 51 In light of the collective research to date, including the present study, we propose a risk-stratified framework of long-term toxicity management, applied to fatigue (Table 4), and an online tool for fatigue risk calculation.…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Development and Validation of a Predictive Model of Severe Fatigue After Breast Cancer Diagnosis: Toward a Personalized Framework in Survivorship Care

Meglio

Havas

Soldato

et al. 2022

JCO

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PURPOSE Fatigue is common and troublesome among breast cancer survivors; however, limited tools exist to predict its risk. PATIENTS AND METHODS Participants with stage I-III breast cancer were prospectively included from CANTO (ClinicalTrials.gov identifier: NCT01993498 ), collecting longitudinal data at diagnosis (before the initiation of any cancer treatment) and 1 (T1), 2 (T2), and 4 (T3) years after diagnosis. The main outcome was severe global fatigue at T2 (score ≥ 40/100, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30). Analyses at T3 were exploratory. Secondary outcomes included physical, emotional, and cognitive fatigue (EORTC Quality of Life Questionnaire-FA12). Multivariable logistic regression models retained associations with severe fatigue by bootstrapped Augmented Backward Elimination. Validation methods included 10-fold internal cross-validation, overoptimism-corrected area under the receiver operating characteristic curves, and external validation. RESULTS Among 5,640, 5,000, and 3,400 patients at T1, T2, and T3, respectively, the prevalence of post-treatment severe global fatigue was 35.6%, 34.0%, and 31.5% in the development cohort. Retained risk factors for severe global fatigue at T2 were severe pretreatment fatigue (adjusted odds ratio v no 3.191 [95% CI, 2.704 to 3.767]); younger age (for 1-year decrement 1.015 [1.009 to 1.022]), higher body mass index (for unit increment 1.025 [1.012 to 1.038]), current smoking behavior ( v never 1.552 [1.291 to 1.866]), worse anxiety ( v noncase 1.265 [1.073 to 1.492]), insomnia (for unit increment 1.005 [1.003 to 1.007]), and pain at diagnosis (for unit increment 1.014 [1.010 to 1.017]), with an area under the receiver operating characteristic curve of 0.73 (95% CI, 0.72 to 0.75). Receipt of hormonal therapy was a risk factor for severe fatigue at T3 ( v no 1.448 [1.165 to 1.799]). Dimension-specific risk factors included body mass index for physical fatigue and emotional distress for emotional and cognitive fatigue. CONCLUSION We propose a predictive model to assess fatigue among breast cancer survivors, within a personalized survivorship care framework. This may help clinicians to provide early management interventions or to correct modifiable risk factors and offer more tailored monitoring and education to patients at risk of severe post-treatment fatigue.

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“…16 Similarly, in a trial of extended letrozole after 2-3 years of tamoxifen, the curves did not separate until 9.5 years of follow-up in a postmenopausal population. 17 This suggests that when the SOFT/TEXT is updated beyond the current 8-year follow-up, we may see further differences emerge between arms.…”

mentioning

confidence: 99%

“…Alternatively, tamoxifen for 2-3 years followed by 5 years of AI is a reasonable strategy as recent data have shown this approach led to a 4% absolute improvement in overall survival for postmenopausal women. 17 Perhaps justice offers the solution? Tools like Regan score 12 and the CTS5 calculator 18 offer accessible tools to better distribute scarce resources-whether an emerging shortage of professionals to care for people in long-term cancer survivorship, 19 cost, or access to agents for ovarian suppression.…”

mentioning

confidence: 99%

Treatment of Premenopausal Women: Finding the Right-Sized Endocrine Therapy

Graff

2022

JCO Oncology Practice

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Extended therapy with letrozole as adjuvant treatment of postmenopausal patients with early-stage breast cancer: a multicentre, open-label, randomised, phase 3 trial

Cited by 50 publications

References 25 publications

Efficacy, Safety, and Prognosis of Sequential Therapy with Tamoxifen and Letrozole versus Letrozole Monotherapy for Breast Carcinoma

Efficacy, Safety, and Prognosis of Sequential Therapy with Tamoxifen and Letrozole versus Letrozole Monotherapy for Breast Carcinoma

Development and Validation of a Predictive Model of Severe Fatigue After Breast Cancer Diagnosis: Toward a Personalized Framework in Survivorship Care

Treatment of Premenopausal Women: Finding the Right-Sized Endocrine Therapy

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