Quality of Life From Canadian Cancer Trials Group MA.17R: A Randomized Trial of Extending Adjuvant Letrozole to 10 Years

Lemieux, Julie; Brundage, Michael; Parulekar, Wendy R.; Goss, Paul E.; Ingle, James N.; Pritchard, Kathleen I.; Celano, Paul; Muss, Hyman B.; Gralow, Julie R.; Strasser‐Weippl, Kathrin; Whelan, Kate; Tu, Dongsheng; Whelan, Timothy J.

doi:10.1200/jco.2017.75.7500

Cited by 18 publications

(15 citation statements)

References 12 publications

(8 reference statements)

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“…6 In the MA.17R trial, treatment with letrozole extended to 10 years compared to placebo did not show significant differences in overall QoL, most of the QoL domains and menopause-related health. 23,25 Due to the lack of an established criterion defining clinicallyrelevant changes of the BCPT symptom scales, we used the standard measure of one-half of a standard deviation, which we consider a rather conservative estimate, underestimating the proportion of patients suffering from specific endocrine symptoms. The small positive change of hot flushes at 24 months and the modest difference between the randomised treatments were confirmed by the reference measure for hot flushes (LASA scale).…”

Section: Worseningmentioning

confidence: 99%

Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial

Ribi¹,

Luo²,

Colleoni

et al. 2019

Br J Cancer

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28 on behalf of the SOLE Investigators 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: NCT00553410.

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Section: Worseningmentioning

confidence: 99%

Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial

Ribi¹,

Luo²,

Colleoni

et al. 2019

Br J Cancer

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“…At present, the guidelines for breast cancer therapy recommend that the standard adjuvant endocrine therapy for postmenopausal patients is five years of aromatase inhibitor (AI). And for patients at high risk, a prolonged AI treatment can reduce the risk of relapse ( 25 – 28 ). In elderly patients with HR+ breast cancer, endocrine therapy plays an important role in the adjuvant therapy.…”

Section: Discussionmentioning

confidence: 99%

Association of Axillary Lymph Node Evaluation With Survival in Women Aged 70 Years or Older With Breast Cancer

Luo

Zhang

et al. 2021

Front. Oncol.

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BackgroundSurvival in elderly patients undergoing sentinel lymph node biopsy (SLNB) and axillary lymph node dissection (ALND) has not been specifically analyzed. This study aimed to explore the association between different types of axillary lymph node (ALN) evaluations and survival of elderly breast cancer patients.MethodsA retrospective cohort study was conducted of invasive ductal breast cancer patients 70 years and older in the Surveillance, Epidemiology, and End Results database (2004–2016). Analyses were performed to compare the characteristics and survival outcomes of patients who received surgical lymph node dissection and those who did not. Breast cancer specific survival (BCSS) and overall survival were compared by using Cox proportional hazards regression analysis and propensity score matching (PSM) methods to account for selection bias from covariate imbalance.ResultsOf the 75,950 patients analyzed, patients without ALN evaluation had a significantly worse prognosis, while there was no significant difference for BCSS between using a sentinel lymph node biopsy (SLNB) and an axillary lymph node dissection (ALND) after adjustment for known covariates [adjusted hazard ratio (HR) = 0.991, 95% confidence interval (CI) = 0.925–1.062, p = 0.800]. In the stratification analyses after PSM, the ALND did not show a significant BCSS advantage compared with SLNB in any subgroups except for the pN1 stage or above. Furthermore, after PSM of the pN1 stage patients, SLNB was associated with a significantly worse BCSS in hormone receptor negative (HR−) patients (HR = 1.536, 95%CI = 1.213–1.946, p < 0.001), but not in the hormone receptor positive (HR+) group (HR = 1.150, 95%CI = 0.986–1.340, p = 0.075).ConclusionIn our study, ALND does not yield superior survival compared with SLNB for elderly patients with pN1 stage HR+ breast cancer. Although our findings are limited by the bias associated with retrospective study design, we believe that in the absence of results from randomized clinical trials, our findings should be considered when recommending the omission of ALND for elderly breast cancer patients.

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“…Inability (illiteracy in English or French, loss of sight or other equivalent reason) to complete questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible.’ 94 …”

Section: Methods: Data Collection Management and Analysismentioning

confidence: 99%

“…However, ability but unwillingness to complete the questionnaires will make the patient ineligible.' 94…”

Section: Pro Endpoints: 2°qmentioning

confidence: 99%

SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials

et al. 2021

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Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients’ symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses and health policy. Recent evidence suggests the PRO content of past trial protocols was often incomplete or unclear, leading to research waste. To address this issue, international, consensus-based, PRO-specific guidelines were developed: the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-PRO Extension. The SPIRIT-PRO Extension is a 16-item checklist which aims to improve the content and quality of aspects of clinical trial protocols relating to PRO data collection to minimise research waste, and ultimately better inform patient-centred care. This SPIRIT-PRO explanation and elaboration (E&E) paper provides information to promote understanding and facilitate uptake of the recommended checklist items, including a comprehensive protocol template. For each SPIRIT-PRO item, we provide a detailed description, one or more examples from existing trial protocols and supporting empirical evidence of the item’s importance. We recommend this paper and protocol template be used alongside the SPIRIT 2013 and SPIRIT-PRO Extension paper to optimise the transparent development and review of trial protocols with PROs.

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Quality of Life From Canadian Cancer Trials Group MA.17R: A Randomized Trial of Extending Adjuvant Letrozole to 10 Years

Cited by 18 publications

References 12 publications

Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial

Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial

Association of Axillary Lymph Node Evaluation With Survival in Women Aged 70 Years or Older With Breast Cancer

SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials

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