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Aromatase inhibitors and calcium absorption in early stage breast cancer.

ABSTRACT: To investigate the effect of aromatase inhibitors (AI) on intestinal calcium absorption, measured using the gold-standard dual stable calcium isotope method. In this pilot study, we recruited 10 postmenopausal women with hormone receptor-positive breast cancer who planned to initiate AI therapy; women receiving chemotherapy were excluded. Women completed two 24 h inpatient calcium absorption study visits, the first prior to AI therapy and the second at least 6 weeks following onset of AI therapy. We calculated total fractional calcium absorption (TFCA) using the dose-corrected fractional recovery of two stable isotopes from 24 h urine collections. Ten postmenopausal women (mean±SD age, 66±7 years; 25(OH)D 40±7 ng/mL, and total calcium intake of 1,714±640 mg/day) exhibited no change in TFCA related to AI therapy (0.155±0.042 prior to and 0.160±0.064 following AI therapy, p=1.0). Subjects exhibited a surprisingly small decline in serum estradiol levels with AI therapy that was not statistically significant. However, there was a significant correlation between duration of AI therapy and the decline in serum estradiol levels (r=-0.65, p=0.040). In this pilot study, AI therapy did not decrease TFCA. Women with early stage breast cancer exhibited an unexpectedly low TFCA, most likely due to their high calcium intake. The null effect of AI therapy on TFCA might relate to the brief duration of AI therapy, the minimal effect of AI therapy on estradiol levels, subjects' high calcium intake or excellent vitamin D status.

SUBMITTER: Tevaarwerk A

PROVIDER: S-EPMC3376688 | biostudies-literature | 2012 Jul

REPOSITORIES: biostudies-literature

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Aromatase inhibitors and calcium absorption in early stage breast cancer.

Tevaarwerk Amye A Burkard Mark E ME Wisinski Kari B KB Shafer Martin M MM Davis Lisa A LA Gogineni Jyothi J Crone Elizabeth E Hansen Karen E KE

Breast cancer research and treatment 20120218 1

To investigate the effect of aromatase inhibitors (AI) on intestinal calcium absorption, measured using the gold-standard dual stable calcium isotope method. In this pilot study, we recruited 10 postmenopausal women with hormone receptor-positive breast cancer who planned to initiate AI therapy; women receiving chemotherapy were excluded. Women completed two 24 h inpatient calcium absorption study visits, the first prior to AI therapy and the second at least 6 weeks following onset of AI therapy ...[more]

PMID: 22350731

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Project description:BackgroundA key priority in developing policies for providing affordable cancer care is measuring the value for money of new therapies using cost-effectiveness analyses (CEAs). For CEA to be useful it should focus on relevant outcomes and include thorough investigation of uncertainty. Randomized controlled trials (RCTs) of five years of aromatase inhibitors (AI) versus five years of tamoxifen in the treatment of post-menopausal women with early stage breast cancer, show benefit of AI in terms of disease free survival (DFS) but not overall survival (OS) and indicate higher risk of fracture with AI. Policy-relevant CEA of AI versus tamoxifen should focus on OS and include analysis of uncertainty over key assumptions.MethodsWe conducted a systematic review of published CEAs comparing an AI to tamoxifen. We searched Ovid MEDLINE, EMBASE, PsychINFO, and the Cochrane Database of Systematic Reviews without language restrictions. We selected CEAs with outcomes expressed as cost per life year or cost per quality adjusted life year (QALY). We assessed quality using the Neumann checklist. Using structured forms two abstractors collected descriptive information, sources of data, baseline assumptions on effectiveness and adverse events, and recorded approaches to assessing parameter uncertainty, methodological uncertainty, and structural uncertainty.ResultsWe identified 1,622 citations and 18 studies met inclusion criteria. All CE estimates assumed a survival benefit for aromatase inhibitors. Twelve studies performed sensitivity analysis on the risk of adverse events and 7 assumed no additional mortality risk with any adverse event. Sub-group analysis was limited; 6 studies examined older women, 2 examined women with low recurrence risk, and 1 examined women with multiple comorbidities.ConclusionPublished CEAs comparing AIs to tamoxifen assumed an OS benefit though none has been shown in RCTs, leading to an overestimate of the cost-effectiveness of AIs. Results of these CEA analyses may be suboptimal for guiding policy.

Project description:Early discontinuation of aromatase inhibitors (AIs) is common and leads to poor outcomes but is challenging to predict. In the Exemestane and Letrozole Pharmacogenetics trial, a high rate of early discontinuation due to intolerance was observed. We hypothesized that early changes in patient-reported outcomes (PROs) predict AI discontinuation and that biochemical factors are associated with changes in PROs.Postmenopausal women with early-stage breast cancer enrolled in a prospective randomized trial of exemestane versus letrozole completed questionnaires at baseline and serially over 24 months to assess overall quality of life (EuroQOL Visual Analog Scale [VAS]); mood; and multiple symptoms, including a musculoskeletal symptom cluster. A joint mixed-effects/survival model was used to estimate the effect of the change in PROs on AI discontinuation. Associations between biochemical factors and change in PROs were examined.A total of 490 patients were analyzed. Worsening of EuroQOL VAS and the musculoskeletal cluster were associated with the highest risk for early discontinuation (hazard ratio [HR], 2.77 [95% confidence interval (CI), 2.72-2.81; p = .015]; HR, 4.39 [95% CI, 2.40-8.02; p < .0001], respectively). Pharmacokinetics and estrogen metabolism were not consistently associated with change in PRO measures. No clinically significant differences in any PRO between AIs were observed.Changes in PROs early during AI therapy were associated with treatment discontinuation. Identification of these changes could be used to target interventions in patients at high risk for early discontinuation.Early changes in patient-reported outcomes (PROs) can predict nonpersistence to aromatase inhibitor therapy. If used in clinical practice, PROs might identify women at highest risk for early discontinuation and allow for interventions to improve tolerance before significant toxicities develop. Further research is needed to improve capturing PROs in routine clinical practice.

Dataset Information

Aromatase inhibitors and calcium absorption in early stage breast cancer.

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Aromatase inhibitors and calcium absorption in early stage breast cancer.

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