Dataset Information

Complementary and alternative medicine and musculoskeletal pain in the first year of adjuvant aromatase inhibitor treatment in early breast cancer patients.

ABSTRACT:

Background

Patients with breast cancer (BC) show strong interest in complementary and alternative medicine (CAM), particularly for adverse effects of adjuvant endocrine treatment - e.g., with letrozole. Letrozole often induces myalgia/limb pain and arthralgia, with potential noncompliance and treatment termination. This analysis investigated whether CAM before aromatase inhibitor (AI) therapy is associated with pain development and the intensity of AI-induced musculoskeletal syndrome (AIMSS) during the first year of treatment.

Patients and methods

The multicenter phase IV PreFace study evaluated letrozole therapy in postmenopausal, hormone receptor-positive patients with early BC. Patients were asked about CAM use before, 6 months after, and 12 months after treatment started. They recorded pain every month for 1 year in a diary including questions about pain and numeric pain rating scales. Data were analyzed for patients who provided pain information for all time points.

Results

Of 1396 patients included, 901 (64.5%) had used CAM before AI treatment. Throughout the observation period, patients with CAM before AI treatment had higher pain values, for both myalgia/limb pain and arthralgia, than non-users. Pain increased significantly in both groups over time, with the largest increase during the first 6 months. No significant difference of pain increase was noted regarding CAM use.

Conclusions

CAM use does not prevent or improve the development of AIMSS. Pain intensity was generally greater in the CAM group. Therefore, because of the risk of non-compliance and treatment discontinuation due to the development of higher pain levels, special attention must be paid to patient education and aftercare in these patients.

SUBMITTER: Hack CC

PROVIDER: S-EPMC7377331 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Publications

Complementary and alternative medicine and musculoskeletal pain in the first year of adjuvant aromatase inhibitor treatment in early breast cancer patients.

Hack C C CC Häberle L L Brucker S Y SY Janni W W Volz B B Loehberg C R CR Hartkopf A D AD Walter C-B CB Baake G G Fridman A A Malter W W Wuerstlein R R Harbeck N N Hoffmann O O Kuemmel S S Martin B B Thomssen C C Graf H H Wolf C C Lux M P MP Bayer C M CM Rauh C C Almstedt K K Gass P P Heindl F F Brodkorb T T Willer L L Lindner C C Kolberg H-C HC Krabisch P P Weigel M M Steinfeld-Birg D D Kohls A A Brucker C C Schulz V V Fischer G G Pelzer V V Rack B B Beckmann M W MW Fehm T T Rody A A Maass N N Hein A A Fasching P A PA Nabieva N N

Breast (Edinburgh, Scotland) 20200108

<h4>Background</h4>Patients with breast cancer (BC) show strong interest in complementary and alternative medicine (CAM), particularly for adverse effects of adjuvant endocrine treatment - e.g., with letrozole. Letrozole often induces myalgia/limb pain and arthralgia, with potential noncompliance and treatment termination. This analysis investigated whether CAM before aromatase inhibitor (AI) therapy is associated with pain development and the intensity of AI-induced musculoskeletal syndrome (AI ...[more]

PMID: 31958661

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Project description:Almost one-half of aromatase inhibitor (AI)-treated breast cancer patients experience AI-associated musculoskeletal symptoms (AIMSS); 20%-30% discontinue treatment because of severe symptoms. We hypothesized that we could identify predictors of pain reduction in AIMSS intervention trials by combining data from previously conducted trials. We pooled patient-level data from 3 randomized trials testing interventions (omega-3 fatty acids, acupuncture, and duloxetine) for AIMSS that had similar eligibility criteria and the same patient-reported outcome measures. Only patients with a baseline Brief Pain Inventory average pain score of at least 4 of 10 were included. The primary outcome examined was 2-point reduction in average pain from baseline to week 12. Variable cut-point selection and logistic regression were used. Risk models were built by summing the number of factors statistically significantly associated with pain reduction. Analyses were stratified by study and adjusted for treatment arm. For the 583 analyzed patients, the 4 factors statistically significantly associated with pain reduction were Functional Assessment of Cancer Therapy Functional Well-Being greater than 24 and Physical Well-Being greater than 14 (higher scores reflect better function), and Western Ontario and McMaster Universities Osteoarthritis Index less than 50 and Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands less than 33 (lower scores reflect less pain). Patients with all 4 factors were greater than 6 times more likely to experience at least a 2-point pain reduction (odds ratio = 6.37, 95% confidence interval = 2.31 to 17.53, 2-sided P < .001); similar results were found for secondary 30% and 50% pain reduction endpoints. Patients with AIMSS who have lower symptom and functional distress at study entry on AIMSS intervention trials are more likely to experience meaningful pain reduction. Baseline symptom and functional status should be considered as stratification factors in future interventional trials.

Project description:BackgroundComplementary and alternative medicine (CAM) is very popular with patients frequently combining it with orthodox health care. The high prevalence of CAM use and satisfaction with CAM reported by patients directly challenges an orthodox system that can only approve such use if it results from the application of biomedical concepts and science. Studies highlighting this as a cultural, sociological and historical phenomenon emphasise the value of choice for consumers of health care. Musculoskeletal conditions typify common problems for which the effectiveness of orthodox care is often unclear. We postulated that the reasons people give for using or not using CAM for musculoskeletal conditions, would therefore indicate the full range of expectations that people have of health care. Furthermore, these reasons would indicate how much people feel orthodox health care is or is not meeting their expectations. Therefore, this study aims to investigate people's reasons for choosing or avoiding CAM for non-traumatic musculoskeletal conditions.MethodsA systematic search and narrative synthesis was conducted of published qualitative and quantitative studies related to CAM and non-traumatic musculoskeletal conditions.ResultsWe identified 169 relevant papers detailing 152 separate studies, from which 1486 justifications were extracted concerning CAM use. Content analysis resulted in 11 distinct categories across four themes: practical aspects of care, clinical effectiveness, non-clinical outcomes of care, and a person's philosophy of illness and care. People provided similar rationales for both using and avoiding CAM, emphasising that, whilst CAM is perceived by many patients with musculoskeletal conditions to fill gaps in care (such as practitioner time or quality of the therapeutic relationship), orthodox care also seeks to deliver these aspects of care. However, people who used CAM also highlighted its alignment with their general philosophy and ideas about illness and health care, and often emphasised CAM's capacity to give them control over their condition and its treatment.ConclusionCurrently, CAM appears to have a significant role for patients with common painful long-term conditions in providing choices to enable individual needs to be met.

Project description:BackgroundTreatment with an aromatase inhibitor for 5 years as up-front monotherapy or after tamoxifen therapy is the treatment of choice for hormone-receptor-positive early breast cancer in postmenopausal women. Extending treatment with an aromatase inhibitor to 10 years may further reduce the risk of breast-cancer recurrence.MethodsWe conducted a double-blind, placebo-controlled trial to assess the effect of the extended use of letrozole for an additional 5 years. Our primary end point was disease-free survival.ResultsWe enrolled 1918 women. After a median follow-up of 6.3 years, there were 165 events involving disease recurrence or the occurrence of contralateral breast cancer (67 with letrozole and 98 with placebo) and 200 deaths (100 in each group). The 5-year disease-free survival rate was 95% (95% confidence interval [CI], 93 to 96) with letrozole and 91% (95% CI; 89 to 93) with placebo (hazard ratio for disease recurrence or the occurrence of contralateral breast cancer, 0.66; P=0.01 by a two-sided log-rank test stratified according to nodal status, prior adjuvant chemotherapy, the interval from the last dose of aromatase-inhibitor therapy, and the duration of treatment with tamoxifen). The rate of 5-year overall survival was 93% (95% CI, 92 to 95) with letrozole and 94% (95% CI, 92 to 95) with placebo (hazard ratio, 0.97; P=0.83). The annual incidence rate of contralateral breast cancer in the letrozole group was 0.21% (95% CI, 0.10 to 0.32), and the rate in the placebo group was 0.49% (95% CI, 0.32 to 0.67) (hazard ratio, 0.42; P=0.007). Bone-related toxic effects occurred more frequently among patients receiving letrozole than among those receiving placebo, including a higher incidence of bone pain, bone fractures, and new-onset osteoporosis. No significant differences between letrozole and placebo were observed in scores on most subscales measuring quality of life.ConclusionsThe extension of treatment with an adjuvant aromatase inhibitor to 10 years resulted in significantly higher rates of disease-free survival and a lower incidence of contralateral breast cancer than those with placebo, but the rate of overall survival was not higher with the aromatase inhibitor than with placebo. (Funded by the Canadian Cancer Society and others; ClinicalTrials.gov numbers, NCT00003140 and NCT00754845.).

Dataset Information

Complementary and alternative medicine and musculoskeletal pain in the first year of adjuvant aromatase inhibitor treatment in early breast cancer patients.

Background

Patients and methods

Results

Conclusions

Publications

Complementary and alternative medicine and musculoskeletal pain in the first year of adjuvant aromatase inhibitor treatment in early breast cancer patients.

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