Addition of drug/s to a chemotherapy regimen for metastatic breast cancer

Butters, Daria J; Ghersi, Davina; Wilcken, Nicholas

doi:10.1002/14651858.cd003368.pub2

Cited by 4 publications

(3 citation statements)

References 30 publications

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“…However, systematic reviews are guided by a priori reasoning to avoid post hoc rationalization and frequently highlight lack of evidence or uncertainty . Of the five most recent medical systematic reviews published by the Cochrane collaboration (see URL http://www.cochrane.org, accessed 1 Oct 2006), all retrieved and meta-analysed fewer studies than the current review and the conclusions of four were negative, highlighting no clear evidence (Wu et al 2006, Millet et al 2006, considerable uncertainty (Trinh et al 2006) or no significant differences (Jones et al 2006). One review was akin to the current work, synthesizing few studies (six) but identifying statistically significant patterns in the data (Briel et al 2006).…”

Section: Data Setmentioning

confidence: 69%

Poor evidence-base for assessment of windfarm impacts on birds

2007

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Concerns about anthropogenic climate change have resulted in promotion of renewable energy sources, especially wind energy. A concern raised against widespread windfarm development is that it may negatively impact bird populations as a result of bird collision with turbines, habitat loss and disturbance. Using systematic review methodology bird abundance data were synthesized from 19 globally-distributed windfarms using meta-analysis. The effects of bird taxon, turbine number, power, location, latitude, habitat type, size of area, time since operation, migratory status of the species and quality of evidence were analysed using meta-regression. Although the synthesized data suggest a significant negative impact of windfarms on bird abundance, there is considerable variation in the impact of individual windfarm sites on individual bird species, and it is unclear if the negative impact is a decline in population abundance or a decline in use owing to avoidance. Anseriformes experienced greater declines in abundance than other taxa, followed by Charadriiformes, Falconiformes and Accipitriformes, and Passeriformes. Time since windfarms commenced operation also had a significant impact on bird abundance, with longer operating times resulting in greater declines in abundance than short operating times. Other variables, including turbine number and turbine power either had very weak but statistically significant effects or did not have a significant effect on bird abundance. Windfarms may have significant biological impacts, especially over longer time scales, but the evidence-base is poor, with many studies being methodologically weak, and more long-term impact assessments are required. There is clear evidence that Anseriformes (wildfowl) and Charadriiformes (waders) experience declines in abundance, suggesting that a precautionary approach should be adopted to windfarm development near aggregations of these taxa in offshore and coastal locations. The impact of windfarm developments on bird populations must also be viewed in the context of the possible impact of climate change in the absence of windfarms.

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Section: Data Setmentioning

confidence: 69%

Poor evidence-base for assessment of windfarm impacts on birds

2007

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“…Improving response and prolonging the duration of response to endocrine-based therapy while maintaining or improving quality of life (QOL) is an important treatment goal. The addition of agents targeted to pathways contributing to resistance may improve response and delay progression, but it is critical to understand both the safety profile and the impact of these therapies on QOL [ 1 , 2 ]. As such, patient-reported outcomes (PROs) are an integral component of benefit–risk assessments in the evaluation of new treatment regimens.…”

Section: Introductionmentioning

confidence: 99%

Impact of palbociclib plus letrozole on patient-reported health-related quality of life: results from the PALOMA-2 trial

et al. 2018

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BackgroundPatient-reported outcomes are integral in benefit–risk assessments of new treatment regimens. The PALOMA-2 study provides the largest body of evidence for patient-reported health-related quality of life (QOL) for patients with metastatic breast cancer (MBC) receiving first-line endocrine-based therapy (palbociclib plus letrozole and letrozole alone).Patients and methodsTreatment-naïve postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) MBC were randomized 2 : 1 to palbociclib plus letrozole (n = 444) or placebo plus letrozole (n = 222). Patient-reported outcomes were assessed at baseline, day 1 of cycles 2 and 3, and day 1 of every other cycle from cycle 5 using the Functional Assessment of Cancer Therapy (FACT)-Breast and EuroQOL 5 dimensions (EQ-5D) questionnaires.ResultsAs of 26 February 2016, the median duration of follow-up was 23 months. Baseline scores were comparable between the two treatment arms. No significant between-arm differences were observed in change from baseline in FACT-Breast Total, FACT-General Total, or EQ-5D scores. Significantly greater improvement in pain scores was observed in the palbociclib plus letrozole arm (−0.256 versus −0.098; P = 0.0183). In both arms, deterioration of FACT-Breast Total score was significantly delayed in patients without progression versus those with progression and patients with partial or complete response versus those without. No significant difference was observed in FACT-Breast and EQ-5D index scores in patients with and without neutropenia.ConclusionsOverall, women with MBC receiving first-line endocrine therapy have a good QOL. The addition of palbociclib to letrozole maintains health-related QOL and improves pain scores in treatment-naïve postmenopausal patients with ER+/HER2− MBC compared with letrozole alone. Significantly greater delay in deterioration of health-related QOL was observed in patients without progression versus those who progressed and in patients with an objective response versus non-responders.ClinicalTrials.gov: NCT01740427 (https://clinicaltrials.gov/ct2/show/NCT01740427)

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“…Although the majority of patients are diagnosed with localized tumors, more than half will be exposed to chemotherapy at some time during the course of their disease, usually with regimens that combine anthracyclines and taxanes [2]. The addition of other chemotherapy drugs to an established regimen increases tumor response, although this positive effect is offset by greater toxicity [3].…”

Section: Introductionmentioning

confidence: 99%

A Prospective, Controlled Study of the Botanical Compound Mixture LCS101 for Chemotherapy-Induced Hematological Complications in Breast Cancer

et al. 2011

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Background. This prospective, controlled study evaluated the safety, tolerability, and efficacy of the mixture of botanical compounds known as LCS101 in preventing chemotherapy-induced hematological toxicity in breast cancer patients.Methods. Female patients diagnosed with localized breast cancer were randomly allocated to receive treatment with either LCS101 or placebo capsules, in addition to conventional chemotherapy. The study intervention was initiated 2 weeks prior to the initiation of chemotherapy and continued until chemotherapy was completed, with participants receiving 2 g of LCS101 capsules thrice daily. Subjects were assessed for the development of hematological and nonhematological toxicities, as well as the tolerability and safety of the study intervention.Results. Sixty-five breast cancer patients were recruited, with 34 allocated to LCS101 and 31 allocated to

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Addition of drug/s to a chemotherapy regimen for metastatic breast cancer

Cited by 4 publications

References 30 publications

Poor evidence-base for assessment of windfarm impacts on birds

Poor evidence-base for assessment of windfarm impacts on birds

Impact of palbociclib plus letrozole on patient-reported health-related quality of life: results from the PALOMA-2 trial

A Prospective, Controlled Study of the Botanical Compound Mixture LCS101 for Chemotherapy-Induced Hematological Complications in Breast Cancer

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