Evaluation of Fulvestrant in Clinical Practice: Use of an Electronic Data Registry

Lower, Elyse E.; Esparaz, Benjamin; Garnett, Sally; Wade, James L.

doi:10.3816/cbc.2007.n.013

Cited by 5 publications

(3 citation statements)

References 19 publications

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“…Academic MS centers, national networks of MS centers, and patient communities have developed tools for patient-centered web-based research 8–10. Web-based studies can collect “real-world” information on the therapeutic use of drugs from the patient’s perspective using appropriate PROs 18,19. In patients who start a treatment, the intensive online monitoring of predefined outcomes may facilitate the collection of data on the short-term effects 20…”

Section: Discussionmentioning

confidence: 99%

Adherence to monthly online self-assessments for short-term monitoring: a 1-year study in relapsing-remitting multiple sclerosis patients after start of disease modifying treatment

Jongen¹,

Sanders²,

Zwanikken³

et al. 2013

PPA

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BackgroundThe participation of neurologists and patients in studies on the effectiveness and safety of newly authorized drugs in multiple sclerosis (MS) is insufficient. Monthly online self-assessments using patient-reported outcomes may help in short-term monitoring of neurological changes and side effects.ObjectiveInvestigate in relapsing-remitting (RR) MS patients the adherence to monthly online self-assessments after the start of disease modifying treatment.MethodsObservational study in 39 neurological departments in The Netherlands. Patients starting glatiramer acetate treatment were instructed to complete online the Modified Fatigue Impact Scale 5-item version and the 8-item Leeds Multiple Sclerosis Quality of Life scale every month during 1 year (T0 toT12).ResultsSixty-three investigators included 163 analyzable patients. At T3, 148 (90.8%) patients had completed all questionnaires; at T6, 142 (87.1%); at T9, 133 (81.6%); and at T12, 123 (75.5%). Eight (4.9%) patients did not complete any questionnaire. Median values for inter-assessment intervals ranged from 32 to 34 days (first quartile [Q1] 30 days, third quartile [Q3] 41 days), and the final assessment was at 417 days (median: Q1 385 days, Q3 480 days). Forty-three (26.3%) patients completed the questionnaires at all time points (completion adherent) with their final assessment within 30 days after the scheduled T12 (interval adherent). Eighty (49.1%) patients were completion adherent, but not interval adherent. Forty (24.5%) patients were not completion adherent, as they discontinued assessments prematurely. Men were more interval adherent than women (47.5% vs 20.0%; P = 0.001).ConclusionThe observation that three out of four (75.5%) RRMS patients completed two short questionnaires at all monthly time points during 1 year after the start of disease modifying treatment suggests that intensive online monitoring in this patient group is feasible. As only one in five (19.6%) patients adhered to the time intervals between self-assessments, measures are needed that improve the timely completion of questionnaires.

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Section: Discussionmentioning

confidence: 99%

Adherence to monthly online self-assessments for short-term monitoring: a 1-year study in relapsing-remitting multiple sclerosis patients after start of disease modifying treatment

Jongen¹,

Sanders²,

Zwanikken³

et al. 2013

PPA

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“…In phase III clinical trials, treatment with fulvestrant has been observed to result in a clinical benefit rate (i.e., complete response, partial response, and stable disease C24 weeks) of 54.3% in the first-line metastatic setting [6], and between 32.2 and 44.6% for subsequent lines of therapy [7][8][9]. Additionally, phase IV studies involving the review of compassionate use databases and including over 1,100 patients have observed clinical benefit rates of approximately 37% [10][11][12][13][14][15][16]. In these trials, the study population was quite heterogeneous, and complete clinical information was not available for all patients.…”

Section: Introductionmentioning

confidence: 95%

Predicting benefit from fulvestrant in pretreated metastatic breast cancer patients

Freedman

Amir

Dranitsaris

et al. 2009

Breast Cancer Res Treat

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Fulvestrant use in pretreated metastatic breast cancer patients is associated with variable response rates. This study aimed to characterize these responses and to develop a prediction model to identify those patients who could potentially derive the most clinical benefit. A nationwide review of patients enrolled in a Canadian compassionate use program from 1999 to 2006 was performed. Prior therapy with tamoxifen, steroidal, and nonsteroidal aromatase inhibitors was mandatory. The dependent variable in the analysis was the proportion of patients requiring chemotherapy at 3 months following the start of fulvestrant. General Linear Mixed modeling was used to identify factors significantly associated with this dependant variable and to subsequently develop the prediction model. Three hundred and five women received at least one dose of fulvestrant; 207 went on to receive chemotherapy (68%). Median duration of fulvestrant treatment was 4.1 months (range 0.8-63.1). Factors predictive of being chemotherapy free at 3 months included older age, no prior adjuvant hormonal therapy, and the absence of lung or brain metastases at the start of therapy. A receiver operating characteristic (ROC) curve analysis had an area under the curve of 0.70 (95% CI 0.60-0.80). This model was able to identify risk information that could be helpful in assessing which patients would most likely benefit from fulvestrant as an intervention with the objective being a delay in chemotherapy.

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“…The only ERD that is currently marketed in the US is fulvestrant (trade name Faslodex) (Fig. 2E, compound 25), that has been recently reviewed in the literature [175][176]. Fulvestrant exhibits high ER-binding affinity and mediates multiple effects on ER signaling, thus it blocks dimerization and nuclear localization of the ER, reduces cellular levels of ER and blocks ER-mediated gene transcription.…”

Section: Estrogen-receptor Downregulators (Erd)mentioning

confidence: 98%

Pharmacotherapies to Manage Bone Loss-Associated Diseases: A Quest for the Perfect Benefit-to-Risk Ratio

Valverde¹

2008

CMC

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In this review, benefits and side-effects of current and emerging therapies to treat and prevent pathological bone loss are described. Bisphosphonates are the antiresorptive compounds most widely used in the treatment of bone-loss associated diseases. They are generally well-tolerated although have recently been associated with osteonecrosis of the jaw and other complications. Therapies modulating estrogen receptor activation are indicated in the prevention and treatment of either breast cancer or osteoporosis in postmenopausal women. Thus, hormone replacement therapy is effective in prevention of osteoporosis, but its long-term use can increase the risk of breast cancer, stroke and embolism. Tamoxifen benefits all stages of breast cancer, but its use may lead to uterine cancer and thromboembolism. Raloxifene is approved in prevention of breast cancer and treatment of postmenopausal osteoporosis, but its use can increase the risk of fatal stroke. Aromatase inhibitors are superior to tamoxifen at advanced stages of disease and as adjuvants, but their use increase fracture incidence. Fulvestrant is as effective as aromatase inhibitors in the treatment of advanced breast cancer and does not cause bone fractures. Another antiresorptive available for the treatment of postmenopausal osteoporosis, Paget's disease and hypercalcemia is calcitonin, which also exhibits analgesic effects. A promising antiresorptive agent currently in clinical trials is denosumab. Aditional therapies for osteoporosis that decrease fracture risk consist of PTH-like anabolic agents and the dual action bone agent strontium ranelate. Antiseptics and antibiotics are used extensively in periodontal disease intervention to target bacterial biofilm, although host-directed therapies are also being developed.

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Evaluation of Fulvestrant in Clinical Practice: Use of an Electronic Data Registry

Cited by 5 publications

References 19 publications

Adherence to monthly online self-assessments for short-term monitoring: a 1-year study in relapsing-remitting multiple sclerosis patients after start of disease modifying treatment

Adherence to monthly online self-assessments for short-term monitoring: a 1-year study in relapsing-remitting multiple sclerosis patients after start of disease modifying treatment

Predicting benefit from fulvestrant in pretreated metastatic breast cancer patients

Pharmacotherapies to Manage Bone Loss-Associated Diseases: A Quest for the Perfect Benefit-to-Risk Ratio

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