Evaluation of high-dose versus standard FAC chemotherapy for advanced breast cancer in protected environment units: a prospective randomized study.

Fifty-nine evaluable patients under 65 years of age with measurable metastatic breast cancer and without prior chemotherapy were randomly assigned to treatment with fluorouracil, Adriamycin (Adria Laboratories, Columbus, OH), and cyclophosphamide (FAC) at standard or high doses (100% to 260% higher than standard FAC) following a dose escalation schedule. Patients randomized to the high-dose FAC received the first three cycles of therapy within a protected environment. Subsequent cycles for this group were administered at standard doses of FAC in an ambulatory setting, the same as for the control group. After reaching 450 mg/m2 of Adriamycin, patients in both groups continued treatment with cyclophosphamide, methotrexate, and fluorouracil until there was disease progression. Analysis of pretreatment patient characteristics showed an even distribution for most known pretreatment factors, although the control group had slightly (but nonsignificantly) more favorable prognostic characteristics. Fourteen patients (24%) achieved a complete remission (CR) and 32 (54%) achieved a partial remission (PR), for an overall major response rate of 78%. There were no differences in overall, CR, or PR rates between the high-dose FAC and control groups. The median response durations were 11 and 10 months for the protected environment and control groups, respectively, and the median survival was 20 months for both groups. Hematologic, gastrointestinal (GI), and infection-related complications were significantly more frequent and severe in the group treated with high-dose chemotherapy. Stomatitis, diarrhea, and skin toxicity were dose-limiting. However, there were no treatment-related deaths. High-dose induction combination chemotherapy with the agents used in this study failed to increase the response rate or survival duration, and resulted in a substantial increase in toxicity.

Download Full-text

Prophylactic Effect of Memantine in Docetaxel Induced Neuropathy in Patients With Breast Cancer

10.21203/rs.3.rs-692391/v1 ◽

2021 ◽

Author(s):

Pegah Mohammadzadeh ◽

Elnaz Shaseb ◽

Zohreh Sanaat ◽

Parvin Sarbakhsh ◽

Nasrin Gholami ◽

...

Keyword(s):

Breast Cancer ◽

Peripheral Neuropathy ◽

Intervention Group ◽

Metastatic Breast ◽

Control Group ◽

P Value ◽

Control Groups ◽

Significant Difference ◽

And Control

Abstract Purpose Peripheral neuropathy is a complication of taxane that in severe cases can limit the optimal treatment. The aim of this study was to evaluate the efficacy of memantine in prevention of docetaxel induced peripheral neuropathy in patients with breast cancer. Methods In this randomized clinical trial, 40 women between the ages of 18 and 64 years with non-metastatic breast cancer (stages I to III) were included (registry number: IRCT20160310026998N9 and registry date: 26 March 2019). All patients were treated with the AC-T regimen (with docetaxel). Patients in intervention group received memantine at a dose of 20 mg for 8 weeks at the beginning of the first cycle of docetaxel. Patients in control group did not take any medication for neuropathy prevention. To assess the neuropathy, DN4 and CTCAE questionnaires were used at baseline, one months, three months and six months after the intervention. Results The DN4 questionnaire score was remarkably less in memantine group in follow up one (p-value: 0.033) and three (p < 00.1). The CTCAE follow up score did not change during study. The Neuropathy duration and Neuropathy onset, were shown significant difference between the intervention and control groups, p = 0.050 and p = 0.001, respectively. From 40 patients, 8 (40%) in memantine group and 2 (10%) in control group, did not experience any kind of neuropathy. Conclusion Data showed that prophylactic administration of memantine 20 mg/day has been effective in prevention of severity and incidence of docetaxel induced neuropathy in patients with breast cancer.

Download Full-text

Effects of Cancer, Chemotherapy and Cytokines on Subjective and Objective Cognitive Functioning Among Patients with Breast Cancer

Cancers ◽

10.3390/cancers13112576 ◽

2021 ◽

Vol 13 (11) ◽

pp. 2576

Author(s):

Vincent Chin-Hung Chen ◽

Chin-Kuo Lin ◽

Han-Pin Hsiao ◽

Bor-Show Tzang ◽

Yen-Hsuan Hsu ◽

...

Keyword(s):

Breast Cancer ◽

Cognitive Function ◽

Cognitive Abilities ◽

Verbal Fluency ◽

Control Group ◽

Control Groups ◽

Semantic Verbal Fluency ◽

Cytokine Levels ◽

Chemotherapy Patients ◽

And Control

Background: We aimed to investigate the associations of breast cancer (BC) and cancer-related chemotherapies with cytokine levels, and cognitive function. Methods: We evaluated subjective and objective cognitive function in BC patients before chemotherapy and 3~9 months after the completion of chemotherapy. Healthy volunteers without cancer were also compared as control group. Interleukins (IL) 2, 4, 5, 6, 10, 12p70, 13, 17A, 1β, IFNγ, and TNFα were measured. Associations of cancer status, chemotherapy and cytokine levels with subjective and objective cognitive impairments were analyzed using a regression model, adjusting for covariates, including IQ and psychological distress. Results: After adjustment, poorer performance in semantic verbal fluency was found in the post-chemotherapy subgroup compared to controls (p = 0.011, η2 = 0.070); whereas pre-chemotherapy patients scored higher in subjective cognitive perception. Higher IL-13 was associated with lower semantic verbal fluency in the post-chemotherapy subgroup. Higher IL-10 was associated with better perceived cognitive abilities in the pre-chemotherapy and control groups; while IL-5 and IL-13 were associated with lower perceived cognitive abilities in pre-chemotherapy and control groups. Our findings from mediation analysis further suggest that verbal fluency might be affected by cancer status, although mediated by anxiety. Conclusions: Our findings suggest that verbal fluency might be affected by cancer status, although mediated by anxiety. Different cytokines and their interactions may have different roles of neuroinflammation or neuroprotection that need further research.

Download Full-text

Impact of selection process on response rate and long-term survival of potential high-dose chemotherapy candidates treated with standard-dose doxorubicin-containing chemotherapy in patients with metastatic breast cancer.

Journal of Clinical Oncology ◽

10.1200/jco.1997.15.10.3171 ◽

1997 ◽

Vol 15 (10) ◽

pp. 3171-3177 ◽

Cited By ~ 116

Author(s):

Z U Rahman ◽

D K Frye ◽

A U Buzdar ◽

T L Smith ◽

L Asmar ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Response Rate ◽

Standard Dose ◽

Metastatic Breast ◽

High Dose Chemotherapy ◽

Long Term Results ◽

High Dose ◽

Term Survival

PURPOSE Most of the data about high-dose chemotherapy (HDCT) for metastatic breast cancer are derived from phase II studies. The interpretation of these data depends on comparisons with data from properly selected historical control patients treated with standard therapy under similar circumstances. We report the long-term results of patients with metastatic breast cancer who were eligible for HDCT but were treated with doxorubicin-containing standard-dose chemotherapy. PATIENTS AND METHODS Prospectively collected data from 18 successive doxorubicin-containing protocols for the treatment of metastatic breast cancer were evaluated. Using common eligibility criteria for HDCT, we identified patients who would have been candidates for HDCT. We analyzed response rates, progression-free survival (PFS), and overall survival (OS) for all patients, potential HDCT candidates, and noncandidates. RESULTS A total of 1,581 patients was enrolled onto the 18 studies. Six hundred forty-five were HDCT candidates, and 936 were noncandidates. The complete response rate was 27% for HDCT candidates and 7% for noncandidates; median PFS was 16 and 8 months and median OS was 30 and 17 months, respectively. Survival rates for HDCT candidates and noncandidates, respectively, were 21% and 6% at 5 years and 7% and 2% at 10 years. CONCLUSION This study suggests that encouraging results of single-arm trials of HDCT could partially be due to selection of patients with better prognoses and further stresses the importance of completing ongoing randomized trials of HDCT to assess the relative efficacy of HDCT in patients with metastatic breast cancer.

Download Full-text

Phase II trial of docetaxel in advanced anthracycline-resistant or anthracenedione-resistant breast cancer.

Journal of Clinical Oncology ◽

10.1200/jco.1995.13.12.2879 ◽

1995 ◽

Vol 13 (12) ◽

pp. 2879-2885 ◽

Cited By ~ 233

Author(s):

P M Ravdin ◽

H A Burris ◽

G Cook ◽

P Eisenberg ◽

M Kane ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Response Rate ◽

Objective Response ◽

Metastatic Breast ◽

Response Duration ◽

Fluid Retention ◽

Skin Reactions ◽

Median Response ◽

High Level

PURPOSE The purpose of this study was to evaluate the clinical efficacy and safety of docetaxel in patients with metastatic breast cancer (MBC) resistant to doxorubicin or mitoxantrone. PATIENTS AND METHODS Docetaxel 100 mg/m2 was administered as a 1-hour intravenous (IV) infusion every 3 weeks to 42 patients registered at four centers. Patients must have received at least one but no more than two prior chemotherapy regimens for MBC (in addition to any prior adjuvant therapy). One of the regimens for metastatic breast cancer must have included an anthracycline or anthracenedione and the cancer must have progressed on that regimen. RESULTS Objective responses were seen in 20 of 35 assessable patients (three complete responses [CRs] and 17 partial responses [PRs]), for an objective response rate of 57% (95% confidence interval [CI], 39% to 74%) and in 21 of 42 registered patients (50% response rate [RR]; 95% CI, 34% to 66%) entered onto the trial. The median response duration was 28 weeks. The most common toxicity in this study was grade 4 neutropenia, which occurred in 95% of patients. Other clinically significant nonhematologic side effects included stomatitis, skin reactions, neurosensory changes, asthenia, and fluid retention. Patients who received dexamethasone premedication had a later onset of fluid retention than those who did not receive dexamethasone (onset at a median cumulative docetaxel dose of 503 mg/m2 and 291 mg/m2, respectively). CONCLUSION Docetaxel at this dose and schedule has a high level of antitumor activity in patients with treatment-refractory advanced breast cancer, and appears to be one of the most active agents for the treatment of this patient population.

Download Full-text

The effect of reflexology on quality of life in Iranian patients with breast cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.26_suppl.90 ◽

2016 ◽

Vol 34 (26_suppl) ◽

pp. 90-90

Author(s):

Shadan Pedramrazi

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Placebo Group ◽

Test Group ◽

Control Group ◽

Relaxation Techniques ◽

Control Groups ◽

Significant Difference ◽

And Control

90 Background: Breast cancer is one the most prevalent cancers among Iranian women. One of the complementary therapies is reflexology. The extant paper has been provided with the objective of determining the effect of reflexology on quality of life of patients with breast cancer undergoing chemotherapy in the breast disease center. Methods: This study is a randomized clinical trial which has been applied to 60 patients suffering from breast cancer under chemotherapy in breast diseases center, in 2012. The patients were selected randomly in three test, control and placebo groups. In test group, reflexology was implemented for 3 weeks and each session lasted half an hour. In placebo group, only relaxation techniques were implemented for 3 weeks, each session lasted 20-30 minutes. Control group received the routine therapies of breast cancer center. Results: Data were collected by standard questionnaires of EORTIC QLQ-C30.V.3 and EORTIC QLQ-BR23.V.3. The questionnaires were filled before intervention and two weeks after applying study. There was no significant difference in demographic characteristics or quality of life score of three groups, before intervention. Total score of quality of life was higher in interventional group compared to placebo group before and two weeks after intervention (p < 0.001) Results also indicated a significant difference in total score of quality of life between three test, placebo, and control groups after intervention (p < 0.001). A considerable improvement was noticed in the different aspects of quality of life in the test group compared to two other placebo and control groups. Conclusions: Reduction of pain, anxiety, nausea, and other symptoms related to cancer in patients suffering from cancer are assumed as the important cases of nursing cares focus, and precise nursing may diminish these symptoms considerably. Using reflexology in patients suffering from breast cancer may improve the quality of life as an effective method, and can be recommended for use in patients with breast cancer if it is supervised by health system personnel.

Download Full-text

An Overview of the Swedish Randomised Mammography Trials: Total Mortality Pattern and the Representivity of the Study Cohorts

Journal of Medical Screening ◽

10.1177/096914139600300208 ◽

1996 ◽

Vol 3 (2) ◽

pp. 85-87 ◽

Cited By ~ 40

Author(s):

Lennarth Nyström ◽

Lars-Gunnar Larsson ◽

Stig Wall ◽

Lars Erik Rutqvist ◽

Ingvar Andersson ◽

...

Keyword(s):

Breast Cancer ◽

Cause Of Death ◽

Mammography Screening ◽

Breast Cancer Mortality ◽

Total Mortality ◽

Control Group ◽

Control Groups ◽

Mortality Pattern ◽

And Control ◽

Screening Trials

Objectives –To analyse the cause of death pattern in the cohorts of women included in the Swedish randomised mammography screening trials by comparing the groups of invited and control women both with each other and with the general population of Swedish women. Setting –Since 1977 four randomised trials of mammography screening have been performed in Sweden: Malmö, Kopparberg and ÖOstergötland (the two county trial), Stockholm, and Gothenburg. Design –Overview of four randomised mammography screening trials. Results –The total numbers of deaths in the invited and control groups respectively were 15 695 and 11 887 corresponding to a relative risk (RR) of 1.00. There were no significant differences between the invited and control groups for cause-specific mortality, except for breast cancer. When the total mortality in the invited and the control groups was compared with that for Swedish women in general the standardised mortality ratio was close to 100. Conclusions –The cause of death pattern in the invited group was, except for breast cancer, very similar to that in the control group, showing that the groups were comparable. Similarly, the total mortality including breast cancer mortality in the control group was almost identical to that in Swedish women in general. The same was true, with the exception of breast cancer, for the invited group. These observations confirm that the trial cohorts are representative of Swedish women and indicate that the quantitative results from these trials may safely be generalised to the Swedish population.

Download Full-text

Prognostic effect of professional oral care in estrogen receptor-positive metastatic breast cancer patients treated with everolimus and exemestane enrolled in Oral Care-BC: a randomized controlled trial

10.21203/rs.2.20270/v1 ◽

2020 ◽

Author(s):

katsuhiko nakatsukasa ◽

Naoki Niikura ◽

Kosuke Kashiwabara ◽

Takeshi Amemiya ◽

Kenichi Watanabe ◽

...

Keyword(s):

Breast Cancer ◽

Estrogen Receptor ◽

Metastatic Breast Cancer ◽

Cancer Patients ◽

Oral Care ◽

Metastatic Breast ◽

Breast Cancer Patients ◽

Control Groups ◽

Estrogen Receptor Positive ◽

And Control

Abstract Background: The Oral Care BC-trial reported that professional oral care (POC) reduces the incidence and severity of oral mucositis in patients receiving everolimus (EVE) and exemestane (EXE). However, the effect of POC on clinical response among patients receiving EVE and EXE was not established. We compared outcomes for estrogen receptor-positive metastatic breast cancer patients that received POC to those that had not and evaluated clinical prognostic factors. All patients simultaneously received EVE and EXE. Methods: Between May 2015 and Dec 2017, 174 eligible patients were enrolled in the Oral Care-BC trial. The primary endpoint was the comparative incidence of grade 1 or worse oral mucositis, as evaluated by an oncologist over 8 weeks between groups. The secondary endpoints were progression-free survival (PFS) and overall survival (OS). Data were collected after a follow-up period of 13.9 months. Results: There were no significant differences in PFS between the POC and Control Groups ( P = 0.801). A BMI < 25 mg/m 2 and non-visceral metastasis were associated with longer PFS ( P = 0.018 and P = 0.003, respectively) and the use of bone modifying agents (BMA) was associated with shorter PFS ( P = 0.028). The PFS and OS between the POC and control groups were not significantly different in the Oral-Care BC trial. Conclusions: POC did not influence the prognosis of estrogen receptor-positive metastatic breast cancer patients. Patients with non-visceral metastasis, a BMI < 25 mg/m 2 , and who did not receive BMA while receiving EVE and EXE may have better prognoses. Trial registration: The study protocol was registered online at the University Hospital Medical Information Network (UMIN), Japan (protocol ID 000016109), on January 5, 2015 and at ClinicalTrials.gov (NCT02376985).

Download Full-text

Impact of preoperative breast MRI on 10-year survival of patients included in the Swedish randomized multicentre POMB trial

BJS Open ◽

10.1093/bjsopen/zrab088 ◽

2021 ◽

Vol 5 (5) ◽

Author(s):

V Gonzalez ◽

B Arver ◽

L Löfgren ◽

L Bergkvist ◽

K Sandelin ◽

...

Keyword(s):

Breast Cancer ◽

Breast Mri ◽

Control Group ◽

Conventional Imaging ◽

Newly Diagnosed ◽

Control Groups ◽

Risk Of Death ◽

Preoperative Breast Mri ◽

And Control

Abstract Background The value of preoperative breast MRI as an adjunct technique regarding its effect on re-excision rates has been a subject of discussion. No survival data regarding preoperative breast MRI are available from randomized studies. Methods Ten-year follow-up of the POMB randomized multicentre study was analysed, evaluating MRI and its effect on disease-free survival (DFS) and overall survival (OS). Patients with newly diagnosed breast cancer were randomized to either preoperative MRI or conventional imaging. Kaplan–Meier plots were used to analyse DFS and OS, and Cox regression to estimate hazard ratios (HRs). Results A total of 440 patients, aged 56 years or less, with newly diagnosed breast cancer were randomized to either preoperative MRI (220) or conventional imaging (220; control). Median follow-up for each group was 10 years. DFS rates were 85.5 and 80.0 per cent for the MRI and control groups respectively (P = 0.099). The risk of relapse or death was 46 per cent higher in the control group (HR 1.46, 95 per cent c.i. 0.93 to 2.29). OS rates after 10 years were 90.9 and 88.6 per cent in the MRI and control groups respectively (P = 0.427). The risk of death was 27 per cent higher in the control group (HR 1.27, 0.71 to 2.29). Locoregional, distant, and contralateral recurrence outcomes combined were increased in the control group (P = 0.048). A subgroup analysis of patients with breast cancer stages I–III showed that preoperative MRI improved DFS compared with conventional imaging, but this did not reach statistical significance (P = 0.057). Conclusion After 10 years of follow-up, preoperative breast MRI as an adjunct to conventional imaging resulted in slightly, but non-significantly, improved DFS and OS. Registration number: NCT01859936 (http://www.clinicaltrials.gov).

Download Full-text

EFFECTIVENESS OF AN EDUCATIONAL PROGRAM ABOUT BREAST CANCER AND BREAST CANCER SELF-EXAMINATION ON PERCEPTION AND PRACTICE AMONG WOMEN IN ALJEERAIF WEST ADMINISTRATIVE UNIT (2)

10.36106/ijsr/4646294 ◽

2021 ◽

pp. 38-42

Author(s):

Amel Eltaib Elagib ◽

Ibrahim Ismail Mohammed ◽

SamiaYousif Idris ◽

Jaafar Abdelrahman Omar ◽

Somia Bilal Babiker ◽

...

Keyword(s):

Breast Cancer ◽

Educational Program ◽

Intervention Group ◽

T Test ◽

Control Group ◽

P Value ◽

Control Groups ◽

Administrative Unit ◽

Self Examination ◽

And Control

In Sudan, cancer incidence has been growing considerably in recent years and is likely to continue to grow creating a big burden on the health system resources. The aim of this study is to assess the baseline Perception and Practice about breast cancer and breast self-examination (BSE) and to nd out the effectiveness of an educational program about breast cancer and BSE on Perception and Practice among women in AlJeeraif West Administrative Unit. Community based intervention study with pre-post and control was carried out among 200 women who were recruited by means of multistage sampling. The sample size was divided equally into intervention and control groups. Baseline data was collected from both groups through direct interview, using structured close ended questionnaire. Educational program was implemented for the intervention group. Four months after the intervention, women in the study and control groups were exposed to the same questionnaire. Chi-square, paired t-test and independent t-test (difference of difference) were conducted in the course of the data analyses. There was statistically signicant difference in the intervention group pre-post program in all of the HBM components in the intervention group (p value0.000), while in the control group statistically signicant difference existed only in perceived barrier (p value.004) and perceived benet (p value.000) and over all perception (p value .016) with no signicant difference in other (HBM) components. In the intervention group practice and performance scores were highly signicant pre-post program (p value 0.000), where as in the control group only practice was signicant (p value 0.001). There were statistically signicant differences in the mean difference of performance, practice and perceptions between the intervention and control groups (p-value .000). The results of this study have conrmed the effectiveness of educational program based on the health belief model on improving perceptions and practice of breast cancer and breast self-examination.

Download Full-text

A Case-Control Study on the p73 G4A Gene Polymorphism and Susceptibility to Breast Cancer in an Iranian Population

Iranian Journal of Public Health ◽

10.18502/ijph.v48i10.3493 ◽

2020 ◽

Author(s):

Zeinab TAVAKKOL AFSHARI ◽

Zahra GHOLIZADEH ◽

Amin Reza NIKPOOR ◽

Jalil TAVAKKOL AFSHARI ◽

Rashin GANJALI ◽

...

Keyword(s):

Breast Cancer ◽

Case Control Study ◽

Case Control ◽

Iranian Population ◽

Control Group ◽

Case Group ◽

Medical Sciences ◽

Control Groups ◽

And Control ◽

Control Study

Background: The tumor protein p73 (TP73) is a homolog of TP53 family. Ectopic p73 overexpression largely mimics p53 activities as a tumor suppressor and activates the transcription of p53-responsive genes and as a result induce apoptosis. This study aimed to investigate the association between p73 G4A polymorphism and the risk of breast cancer in a northeastern Iranian population. Methods: This case-control study was performed on 105 patients who admitted in educational hospitals of Mashhad University of Medical Sciences, Iran during 2013-2015, with breast cancer as case group and 120 healthy women as the control group. PCR-CTPP method was used to investigate the relationship between the p73 G4A polymorphism and the risk of breast cancer. Results: There was no significant association between the AA genotype of the p73 G4A polymorphism and breast cancer in case and control groups. Although G allele frequency was higher in the case group, the abundance of this allele between case and control groups was not statistically meaningful and, as a result, not associated with the risk of breast cancer in this study group. Conclusion: There was no association between G4A p73 polymorphism and the risk of breast cancer in a northeastern Iranian population.

Download Full-text