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1.  Geriatric screening tools are of limited value to predict decline in functional status and quality of life: results of a cohort study 
BMC Family Practice  2015;16:30.
Background
Geriatric screening tools are increasingly implemented in daily practice, especially in the oncology setting, but also in primary care in some countries such as the Netherlands. Nonetheless, validation of these tools regarding their ability to predict relevant outcomes is lacking. In this study we evaluate if geriatric screening tools predict decline in functional status and quality of life after one year, in a population of older cancer patients and an older primary care population without cancer with a life expectancy of at least six months.
Methods
Older cancer patients and a general older primary care population without a history of cancer (≥70 years) were included in an on-going prospective cohort study. Data were collected at baseline and after one-year follow-up. Functional decline was based on the Katz Index and Lawton IADL-scale and was defined as deterioration on one or more domains. Decline in quality of life was measured using the global health related subscale of the EORTC QLQ-C30, and was defined as a decline ≥10 points. The selected geriatric screening tools were the abbreviated Comprehensive Geriatric Assessment, Groningen Frailty Indicator, Vulnerable Elders Survey-13, and G8. We calculated sensitivity, specificity, predictive values, and odds ratios to assess if normal versus abnormal scores predict functional decline and decline in quality of life.
Results
One-year follow-up data were available for 134 older cancer patients and 220 persons without cancer. Abnormal scores of all screening tools were significantly associated with functional decline. However, this was only true for older persons without cancer, and only in univariate analyses. For functional decline, sensitivity ranged from 54% to 71% and specificity from 33% to 66%. For decline in quality of life, sensitivity ranged from 40% to 67% and specificity from 37% to 54%.
Conclusion
In older persons with a relatively good prognosis, geriatric screening tools are of limited use in identifying persons at risk for decline in functional status or quality of life after one year. Hence, a geriatric screening tool cannot be relied on in isolation, but they do provide very valuable information and may prompt physicians to also consider different aspects of functioning.
Electronic supplementary material
The online version of this article (doi:10.1186/s12875-015-0241-x) contains supplementary material, which is available to authorized users.
doi:10.1186/s12875-015-0241-x
PMCID: PMC4358725  PMID: 25888485
Neoplasms; Functional status; Quality of life; Geriatric oncology; Longitudinal study
2.  SUBMIT: Systemic therapy with or without up front surgery of the primary tumor in breast cancer patients with distant metastases at initial presentation 
BMC Surgery  2012;12:5.
Background
Five percent of all patients with breast cancer have distant metastatic disease at initial presentation. Because metastatic breast cancer is considered to be an incurable disease, it is generally treated with a palliative intent. Recent non-randomized studies have demonstrated that (complete) resection of the primary tumor is associated with a significant improvement of the survival of patients with primary metastatic breast cancer. However, other studies have suggested that the claimed survival benefit by surgery may be caused by selection bias. Therefore, a randomized controlled trial will be performed to assess whether breast surgery in patients with primary distant metastatic breast cancer will improve the prognosis.
Design
Randomization will take place after the diagnosis of primary distant metastatic breast cancer. Patients will either be randomized to up front surgery of the breast tumor followed by systemic therapy or to systemic therapy, followed by delayed local treatment of the breast tumor if clinically indicated.
Patients with primary distant metastatic breast cancer, with no prior treatment of the breast cancer, who are 18 years or older and fit enough to undergo surgery and systemic therapy are eligible. Important exclusion criteria are: prior invasive breast cancer, surgical treatment or radiotherapy of this breast tumor before randomization, irresectable T4 tumor and synchronous bilateral breast cancer. The primary endpoint is 2-year survival. Quality of life and local tumor control are among the secondary endpoints.
Based on the results of prior research it was calculated that 258 patients are needed in each treatment arm, assuming a power of 80%. Total accrual time is expected to take 60 months. An interim analysis will be performed to assess any clinically significant safety concerns and to determine whether there is evidence that up front surgery is clinically or statistically inferior to systemic therapy with respect to the primary endpoint.
Discussion
The SUBMIT study is a randomized controlled trial that will provide evidence on whether or not surgery of the primary tumor in breast cancer patients with metastatic disease at initial presentation results in an improved survival.
Trial registration
NCT01392586.
doi:10.1186/1471-2482-12-5
PMCID: PMC3348008  PMID: 22469291
Primary metastatic breast cancer; surgery; randomised controlled trial
3.  Haptoglobin phenotype is not a predictor of recurrence free survival in high-risk primary breast cancer patients 
BMC Cancer  2008;8:389.
Background
Better breast cancer prognostication may improve selection of patients for adjuvant therapy. We conducted a retrospective follow-up study in which we investigated sera of high-risk primary breast cancer patients, to search for proteins predictive of recurrence free survival.
Methods
Two sample sets of high-risk primary breast cancer patients participating in a randomised national trial investigating the effectiveness of high-dose chemotherapy were analysed. Sera in set I (n = 63) were analysed by surface enhanced laser desorption ionisation time-of-flight mass spectrometry (SELDI-TOF MS) for biomarker finding. Initial results were validated by analysis of sample set II (n = 371), using one-dimensional gel-electrophoresis.
Results
In sample set I, the expression of a peak at mass-to-charge ratio 9198 (relative intensity ≤ 20 or > 20), identified as haptoglobin (Hp) alpha-1 chain, was strongly associated with recurrence free survival (global Log-rank test; p = 0.0014). Haptoglobin is present in three distinct phenotypes (Hp 1-1, Hp 2-1, and Hp 2-2), of which only individuals with phenotype Hp 1-1 or Hp 2-1 express the haptoglobin alpha-1 chain. As the expression of the haptoglobin alpha-1 chain, determined by SELDI-TOF MS, corresponds to the phenotype, initial results were validated by haptoglobin phenotyping of the independent sample set II by native one-dimensional gel-electrophoresis. With the Hp 1-1 phenotype as the reference category, the univariate hazard ratio for recurrence was 0.87 (95% CI: 0.56 – 1.34, p = 0.5221) and 1.03 (95% CI: 0.65 – 1.64, p = 0.8966) for the Hp 2-1 and Hp 2-2 phenotypes, respectively, in sample set II.
Conclusion
In contrast to our initial results, the haptoglobin phenotype was not identified as a predictor of recurrence free survival in high-risk primary breast cancer in our validation set. Our initial observation in the discovery set was probably the result of a type I error (i.e. false positive). This study illustrates the importance of validation in obtaining the true clinical applicability of a potential biomarker.
doi:10.1186/1471-2407-8-389
PMCID: PMC2627917  PMID: 19108738

Results 1-3 (3)