Choosing relevant endpoints for older breast cancer patients in clinical trials: an overview of all current clinical trials on breast cancer treatment

2014 ◽  
Vol 146 (3) ◽  
pp. 591-597 ◽  
Author(s):  
N. A. de Glas ◽  
M. E. Hamaker ◽  
M. Kiderlen ◽  
A. J. M. de Craen ◽  
S. P. Mooijaart ◽  
...  
2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18198-e18198
Author(s):  
Omolara A. Fatiregun ◽  
Olufunmilayo I. Olopade ◽  
Abiodun Popoola

e18198 Background: Clinical trials has continued to sharpen the treatment guidelines in managing breast cancer in the United States. The trends in breast cancer management in developed countries and the shifts in treatment paradigms have impacted on breast cancer diagnosis from an incurable entity in the early 1900s’ to the situation today where most women are diagnosed in early stage and cured while advanced staged women are living with the disease for several years. Clinical research in breast cancer is in its infancy stage in Nigeria. There is an urgent need for more clinical trials in Nigeria geared towards developing treatment algorithms in a bid to increase survival in Breast cancer patients. Methods: A systematic review of all research published on breast cancer since 1963 till 2017 in Nigeria .We reviewed all articles found on PubMed and Google scholar search engines by searching “ Breast cancer in Nigeria”. Using the PRISMA and NIH guidelines, we reviewed classified them based on their study designs into different levels of evidence. Information extracted from studies include, year of publications, study designs and level of evidence. Studies selected were group into seven levels of evidence .Meta-analysis was not considered in the review due to vary study designs and difficulty n pooling then together. Results: Out of 430 published articles cited relating to Breast cancer, only 282 articles where eligible for the systematic review. 56.4%(159) of studies done on breast were cross sectional studies, followed by case – control studies 11.7% (33), then case reports & series 10.4%(29) ,2.8%(8) , only 1.1% (3)of studies cited were clinical trials registered on Clinical Trials.gov on breast cancer treatment. On Levels of Evidence, Level 6 accounted for 54.9 %( 155) followed by Level 7, 18.1 %( 51), level 1, 2, 3 were 0%, 1.1%, 8.9%.Conclusions: A vast majority of research done on Breast Cancer done in the Country are still at the Levels 4, 6 and 7 of Evidence. Clinical trials in Breast cancer treatment are rare in Nigeria, they however provide Level 1, 2 or 3 evidence which helps to develop treatment protocols for Breast cancer Treatment in Nigeria. , it is pertinent to develop more clinical trials so as to improve quality of care and life in breast cancer patients.


2021 ◽  
Vol 8 ◽  
Author(s):  
Zhang Juan ◽  
Zhang Qing ◽  
Liang Yongping ◽  
Liyuan Qian ◽  
Wei Wu ◽  
...  

Background: Docetaxel is an important chemotherapy-agent for breast cancer treatment. One of its side-effects is weight gain, which increases the all-cause mortality rate. Considering gut microbiota is one important factor for weight regulation, we hypothesized that probiotics could be potentially used to reduce the docetaxel-related weight gain in breast cancer patients.Methods: From 10/8/2018 to 10/17/2019, 100 breast cancer (Stage I-III) patients underwent four cycles of docetaxel-based chemotherapy were enrolled and randomly assigned to receive probiotics (Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis) or placebo (supplementary material of the probiotics capsule) treatment for 84 days with three capsules per time, twice/day. The primary outcome: the changes in body weight and body-fat percentage of the patients were measured by a designated physician using a fat analyzer, and the secondary outcomes: the fasting insulin, plasma glucose, and lipids were directly obtained from the Hospital Information System (HIS); The metabolites were measured using liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS); The fecal microbiome was analyzed using bacterial 16S ribosomal RNA (rRNA) gene sequence. All indicators were measured 1 day before the first cycle of docetaxel-based chemotherapy and 21 days after the last cycle of docetaxel-based chemotherapy.Results: Compared with the placebo group, the probiotic group showed significantly smaller changes in body weight (Mean [SD] 0.77 [2.58] vs. 2.70 [3.08], P = 0.03), body-fat percentage (Mean [SD] 0.04 [1.14] vs. 3.86 [11.09], P = 0.02), and low density lipoprotein (LDL) (Mean [SD]−0.05[0.68] vs. 0.39 [0.58], P = 0.002). Moreover, five of the 340 detected plasma metabolites showed significant differences between the two groups. The change of biliverdin dihydrochloride (B = −0.724, P = 0.02) was inverse correlated with weight gain. One strain of the phylum and three strains of the genus were detected to be significantly different between the two groups. Also, the changes of Bacteroides (B = −0.917, P < 0.001) and Anaerostipes (B = −0.894, P < 0.001) were inverse correlated with the change of LDL.Conclusions: Probiotics supplement during docetaxel-based chemotherapy for breast cancer treatment may help to reduce the increase in body weight, body-fat percentage, plasma LDL, and minimize the metabolic changes and gut dysbacteriosis.Clinical Trial Registration:http://www.chictr.org.cn/showproj.aspx?proj=24294, ChiCTR-INQ-17014181.


1987 ◽  
Vol 5 (1) ◽  
pp. 68-74 ◽  
Author(s):  
W H Wolberg ◽  
M A Tanner ◽  
E P Romsaas ◽  
D L Trump ◽  
J F Malec

Primary breast cancer treatment is determined by tumor factors and by patient preference. Breast cancer treatments that preserve the cosmetic appearance of the breast are appealing and effective for appropriately selected patients; long-term survival following tumor excision and breast irradiation appears to be comparable to that for mastectomy. Since April 1981, when a protocol was developed and treatment options were offered, factors influencing treatment selection have been analyzed in 206 consecutive primary breast cancer patients. Mastectomy was dictated by tumor-related factors in 96 patients (47%); 110 patients (53%) had the option of mastectomy or conservation--tumor excision plus radiotherapy to the breast. Among these 110 eligible patients, 54 chose conservation (49%) and 56 chose mastectomy (51%). Intraoperative findings for ten patients electing conservation necessitated mastectomy, so conservation was accomplished for 44 (21%) of those treated for breast cancer. Beginning in July 1982, breast cancer patients took a battery of psychosexual assessments before any operation (Profile of Mood States [POMS], Health Locus of Control Scale [HLCS] Locke-Wallace Marital Adjustment Test [MAT], Psychosocial Adjustment to Illness Scale [PAIS], Derogatis Sexual Function Inventory [DSFI], Millon Clinical Multiaxial Inventory [MCMI], and a Breast Cancer Information Test [BCIT]). Comparisons of psychologic and demographic variables were made between patients who chose mastectomy and those who chose conservation. No demographic variable was statistically significantly related to choice, although older women tended to select mastectomy more than younger women. Compared with those who elected conservation, women who elected mastectomy were more tense and anxious (P less than .01), more introverted (P less than .01), felt more depressed and dejected (P less than .05), and reported more sexual problems (P less than .05). Those who elected conservation valued their physical appearance more highly (P less than .01) and were generally more self-interested (P less than .05). Mastectomy was dictated by medical considerations for approximately half of patients with breast cancer. Among candidates for breast conservation, the importance of retaining the breast appeared to be determined to a significant degree by measurable psychological factors.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e23043-e23043
Author(s):  
Guro Fanneløb Giskeødegård ◽  
Torfinn Støve Madssen ◽  
Riyas Vettukattil ◽  
Vidar Gordon Flote ◽  
Anders Husøy ◽  
...  

e23043 Serum metabolism during breast cancer treatment Background: Breast cancer treatment may include surgery, systemic therapy and radiation, often involving side-effects. Many patients experience weight gain during treatment, which is associated with decreased survival rates1. The purpose of this study was to describe serum metabolic alterations in breast cancer patients undergoing treatment, and relate these alterations to weight gain during treatment. Methods: This pilot study includes 60 breast cancer patients, aged 35-75 years, with histologically verified stage I/II disease. All patients underwent tumor surgery, and were treated according to national guidelines. Samples were collected before and 6 months after surgery, and analyzed by MR spectroscopy (MRS) and mass spectrometry (MS). 170 metabolites and 105 lipoprotein subfractions were quantified by combined MRS and MS analyses. Results: Multilevel PLS-DA showed significant alterations in serum metabolite profiles post-treatment, both in patients receiving (n = 35) and not receiving (n = 25) chemotherapy (classification accuracy: 86.7% and 77.0%, resp., p < 0.001). Lipoprotein profiles were also significantly altered in both groups (p < 0.001). Chemotherapy recipients had decreased levels of citrate, ornithine, and methionine after treatment, while non-recipients had increased levels of glutamate, alanine, proline and two biogenic amines, and decreased levels of acylcarnitines. 17/52 patients (32.7%) gained weight (≥ 1.5 kg) during treatment. Weight gain was predicted from pre-treatment samples with accuracy 67.0% (p = 0.020). Weight gain patients had lower levels of three acylcarnitines and 20 phosphocholines, and higher levels of lysine and isoleucine, suggesting aberrant lipid and amino acid metabolism. Weight gain was also reflected in the post-treatment samples (accuracy 66.8%, p = 0.015), with weight gain patients having higher levels of five acylcarnitines, and lower levels of glycine, isoleucine and valine. Conclusions: This study indicates that treatment induces changes in serum metabolite levels. Patients gaining weight had significantly different metabolite profiles than those not gaining weight both before and after treatment. 1. Chan et al, Ann Oncol 25: 1901-14, 2014.


2018 ◽  
Vol 92 ◽  
pp. S32
Author(s):  
M. Gregorowitsch ◽  
A. Swart ◽  
D. Young Afat ◽  
D. Van den Bongard ◽  
H. Verkooijen

2018 ◽  
Vol 36 (7_suppl) ◽  
pp. 78-78
Author(s):  
Lauren P. Wallner ◽  
Yun Li ◽  
Chandler McLeod ◽  
Archana Radhakrishnan ◽  
Sarah T. Hawley ◽  
...  

78 Background: Surgical treatment decisions for early-stage breast cancer patients are complex and often involve discussions with multiple oncology providers. However, with the increasing adoption of team-based cancer care models, it remains unknown to what extent primary care providers (PCPs) are participating in breast cancer treatment decisions and whether they feel they have enough knowledge to participate in these decisions effectively. Methods: A stratified random sample of PCPs identified by newly diagnosed early-stage breast cancer patients who participated in iCanCare Study (Georgia and Los Angeles SEER registries) were surveyed about their experiences caring for cancer patients (N = 519, 58% current response rate). PCPs were asked how frequently they discussed which surgery a patient should have, how comfortable they were with these discussions, whether they had the necessary knowledge to participate in treatment decision making and their confidence in their ability to help with treatment decision making (5-item likert-type scales). The individual items were then categorized as somewhat/often/always vs. never/rarely for analyses. Results: In this preliminary sample, 62% of PCPs were not comfortable having a discussion about surgery options with a patient newly diagnosed with breast cancer, 41% did not feel that they had the necessary knowledge to participate in treatment decision-making, and 34% were not confident in the ability to help with treatment decision-making. One third (32%) of PCPs reported discussing surgical treatment options with their newly diagnosed breast cancer patients, but 22% of these PCPs also reported that they were not comfortable having these discussions and 16% reported they did not have necessary knowledge to participate in decision-making. Conclusions: A minority of PCPs participate in breast cancer treatment decision-making and there are notable gaps in their self-reported knowledge about decision-making and confidence in their ability to help with these decisions. Efforts to increase PCP knowledge about the specifics of cancer treatments may be warranted, but further research is needed to assess the impact of PCP participation on treatment decision-making outcomes.


2019 ◽  
Vol 39 (3) ◽  
Author(s):  
Wei-xian Chen ◽  
Lin Cheng ◽  
Ling-yun Xu ◽  
Qi Qian ◽  
Yu-lan Zhu

Abstract Background: Tripartite motif 13 (TRIM13) plays a significant role in various biological processes including cell growth, apoptosis, transcriptional regulation, and carcinogenesis. However, the prognostic significance of TRIM13 gene in breast cancer treatment remains largely unclear. Methods: We performed a bioinformatics analysis of the clinical parameters and survival data as it relates to TRIM13 in breast cancer patients using several online databases including Oncomine, bcGenExMiner, PrognoScan, and UCSC Xena. Results: We found that TRIM13 was lower-expressed in different subtypes of breast cancer with respect to normal tissues. Estrogen receptor and progesterone receptor status were positively correlated with TRIM13 level; whereas, the Scarff–Bloom–Richardson grade, Nottingham prognostic index, nodal status, basal-like status, and triple-negative status were negatively related to TRIM13 expression in breast cancer patients with respect to normal individuals. Lower TRIM13 expression correlated with worse distant metastasis free survival, relapse free survival, disease specific survival, and metastatic relapse free survival. We also confirmed a positive correlation between TRIM13 and RAB11FIP2 gene expression. Conclusion: Bioinformatics analysis revealed that TRIM13 may be adopted as a promising predictive biomarker for prognosis of breast cancer. More in-depth experiments and clinical trials are needed to validate the value of TRIM13 in breast cancer treatment.


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