Barriers to Clinical Trial Participation by Older Women With Breast Cancer

2003 ◽  
Vol 21 (12) ◽  
pp. 2268-2275 ◽  
Author(s):  
M. Margaret Kemeny ◽  
Bercedis L. Peterson ◽  
Alice B. Kornblith ◽  
Hyman B. Muss ◽  
Judith Wheeler ◽  
...  

Purpose: Although 48% of breast cancer patients are 65 years old or older, these older patients are severely underrepresented in breast cancer clinical trials. This study tested whether older patients were offered trials significantly less often than younger patients and whether older patients who were offered trials were more likely to refuse participation than younger patients. Patients and Methods: In 10 Cancer and Leukemia Group B institutions, using a retrospective case-control design, breast cancer patients eligible for an open treatment trial were paired: less than 65 years old and ≥ 65 years old. Each of the 77 pairs were matched by disease stage and treating physician. Patients were interviewed as to their reasons for participating or refusing to participate in a trial. The treating physicians were also given questionnaires about their reasons for offering or not offering a trial. Results: Sixty-eight percent of younger stage II patients were offered a trial compared with 34% of the older patients (P = .0004). In multivariate analyses, disease stage and age remained highly significant in predicting trial offering (P = .0008), when controlling for physical functioning and comorbidity. Of those offered a trial, there was no significant difference in participation between younger (56%) and older (50%) patients (P = .67). Conclusion: In a multivariate analysis including comorbid conditions, age and stage were the only predictors of whether a patient was offered a trial. The greatest impediment to enrolling older women onto trials in the setting of this study was the physicians’ perceptions about age and tolerance of toxicity.

2010 ◽  
Vol 76 (12) ◽  
pp. 1397-1400 ◽  
Author(s):  
Jack Sariego

Patients under 40 years of age comprise about 5 per cent of the overall breast cancer population. These patients are often considered to have a more aggressive disease and are often treated differently as well. A review was performed of all breast cancer patients reported in the American College of Surgeons Cancer Database from 1998 to 2005. The study cohort included all patients less than 40 years of age. Data collected included stage at time of diagnosis, histologic type, and initial treatment performed. These data were then compared with those of patients age 40 or older. The 70,437 cohort patients identified comprised 5.0 per cent of all breast cancer patients reported. There was a statistically significant difference in stage at the time of presentation: 20 per cent of younger patients presented with advanced disease (stage III or IV) versus 13.5 per cent of older patients. A significantly greater percentage of younger patients also presented with infiltrating ductal carcinoma as opposed to the older population (76.9% vs 67.9%). A significantly greater percentage of young patients was treated with mastectomy when compared with the older population (47.7% vs 36.7%, respectively). This difference persisted even when data were controlled for stage. The younger breast cancer patient presents with more advanced disease, suggesting either a more aggressive disease or a greater delay in diagnosis. Also, at all stages, the young patient tends to be treated more “aggressively” surgically, suggesting that the prevailing concept that breast cancer is a “worse” disease in the young may be directing treatment options and patient choices.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Hikmat Abdel-Razeq ◽  
Sereen Iweir ◽  
Rashid Abdel-Razeq ◽  
Fadwa Abdel Rahman ◽  
Hanan Almasri ◽  
...  

AbstractIn developing countries, breast cancer is diagnosed at a much younger age. In this study we investigate the dichotomies between older and young breast cancer patients in our region. The study involved two cohorts; older patients (≥ 65 years, n = 553) and younger ones (≤ 40 years, n = 417). Statistical models were used to investigate the associations between age groups, clinical characteristics and treatment outcomes. Compared to younger patients, older patients were more likely to present with advanced-stage disease (20.6% vs. 15.1%, p = .028). However, among those with non-metastatic disease, younger patients tended to have more aggressive pathological features, including positive axillary lymph nodes (73.2% vs. 55.6%, p < .001), T-3/4 (28.2% vs. 13.8%, p < .001) and HER2-positive disease (29.3% vs. 16.3%, p < .001). The 5-year overall survival (OS) rate was significantly better for the younger (72.1%) compared to the older (67.6%), p = .035. However, no significant difference was observed in disease-free survival (DFS) between the two groups.In conclusion, younger patients with breast cancer present with worse clinical and pathological features, albeit a better OS rate. The difference in DFS between the two groups was not insignificant, suggesting that older women were more likely to die from non-cancer related causes.


2019 ◽  
Vol 14 (1) ◽  
Author(s):  
Rohini K. Bhatia ◽  
Mohan Narasimhamurthy ◽  
Yehoda M. Martei ◽  
Pooja Prabhakar ◽  
Jeré Hutson ◽  
...  

Abstract Background To characterize the clinico-pathological features including estrogen receptor (ER), progesterone receptor (PR) and Her-2/neu (HER2) expression in breast cancers in Botswana, and to compare them by HIV status. Methods This was a retrospective study using data from the National Health Laboratory and Diagnofirm Medical Laboratory in Gaborone from January 1, 2011 to December 31, 2015. Clinico-pathological details of patients were abstracted from electronic medical records. Results A total of 384 unique breast cancer reports met our inclusion criteria. Of the patients with known HIV status, 42.7% (50/117) were HIV-infected. Median age at the time of breast cancer diagnosis was 54 years (IQR 44–66 years). HIV-infected individuals were more likely to be diagnosed before age 50 years compared to HIV-uninfected individuals (68.2% vs 23.8%, p < 0.001). The majority of patients (68.6%, 35/51) presented with stage III at diagnosis. Stage IV disease was not presented because of the lack of data in pathology records surveyed, and additionally these patients may not present to clinic if the disease is advanced. Overall, 68.9% (151/219) of tumors were ER+ or PR+ and 16.0% (35/219) were HER2+. ER+ or PR+ or both, and HER2- was the most prevalent profile (62.6%, 132/211), followed by triple negative (ER−/PR−/HER2-, 21.3%, 45/211), ER+ or PR+ or both, and HER2+, (9.0%, 19/211) and ER−/PR−/HER2+ (7.1%, 15/211). There was no significant difference in receptor status noted between HIV-infected and HIV-uninfected individuals. Conclusions Majority of breast cancer patients in Botswana present with advanced disease (stage III) at diagnosis and hormone receptor positive disease. HIV-infected breast cancer patients tended to present at a younger age compared to HIV-uninfected patients. HIV status does not appear to be associated with the distribution of receptor status in breast cancers in Botswana.


2016 ◽  
Vol 11 (1) ◽  
Author(s):  
Mushahida Batool ◽  
Afsar Ali Bhatti ◽  
Maryam Gul ◽  
Ghulam Mustafa Arain ◽  
Abul Fadal Ali Khan

Introduction: Breast cancer is the commonest malignancy in women in the world. About 5% of all breast cancer patients are 35 years old or younger. Current literature suggests that breast cancer in these younger women may be different in etiology, clinical features and outcome from the disease seen in older women. Patients and methods: We included all breast cancer patients who underwent surgical treatment at Surgical Unit IV, Jinnah hospital, Lahore from December, 1998 to December, 2003. All patients who left against medical advice or were lost to follow up before completing treatment at our hospital wee excluded. The patients were divided into two groups by age. Those who were 35 years old or younger were placed in group 1 (88 patients) and those older than 35 years were placed in group 11(54 patients), which served as the control group. We compared the clinical presentation, the risk factor profile, and the grade and the stage of the tumor at presentation in younger women and their older controls. Results: The mean age in group I was 29.38 years 3.68 years. While the mean age in group II was 44.41 years 7.64 years. The commonest mode of presentation in both groups was a painless lump. (93.2% in group I and 66.67% in group II; p value < 0.001). The distribution of classical risk factors was similar in the two groups. These included family history (12.5% in group I and 11.1% in group II), nulliparity (7.95% in group I and 7.4% in group II), and oral contraceptives use(14.77% in group I and 12.96% in group II). Younger patients presented with a greater number of poorly differentiated (Grade III) tumors compared to the older patients. (73.76% vs.24.07%; p value <0.001). They also presented more frequently with hormone insensitive tumors (79.55% in group I vs. 24.52% in group II ; p value < 0.001). Mammography was positive more often in older women compared to the younger ones (97.44% vs.41.38% ; p value < 0.001). Ultrasound was done in 67.05% of the younger women and 27.78% in the older women. It was suggestive of malignancy in 89.83% of the younger women and 86.67% of the older ones. Modified radical mastectomy was done in 75% of the younger patients (Group I) and 61.11% of the older patients (Group II). Radical mastectomy was done in 19.32% of group I patients and 27.78% of group II patients. Older women underwent breast conservation treatment more often than the younger women (11.11% vs. 5.68%; p value < 0.05) Adjuvant chemotherapy was given more often to younger women (73.86% in group I vs. 9.26% in group II; p value < 0.0001). On the other hand, older patients received hormonal therapy more often that the younger ones (74.07% vs. 20.45%; p value < 0.001). Younger patients also received adjuvant radiotherapy more frequently than their older counterparts (84.32% vs. 49.26; p value <0.05). Conclusion: We conclude that women with breast cancer who are 35 years old or younger have more aggressive tumors than the older patients i.e. they present at a higher stage with poorly differentiated tumors that are frequently hormone insensitive.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18604-e18604
Author(s):  
Hikmat Abdel-Razeq ◽  
Sereen Iweir ◽  
Rashid Abdel-Razeq ◽  
Fadwa Abdel Rahman ◽  
Hanan Almasri ◽  
...  

e18604 Background: In developing countries, breast cancer treatment outcomes may be uniquely affected by the tendency of breast cancer patients to develop the disease at a much younger age than the worldwide average. Contrarily, older patients tend to present with multiple comorbidities that complicate their outcomes and influence their treatment options and decisions. This study will be the first to investigate the dichotomies between older and young breast cancer patients in our region. Methods: The study was based on data collected from the cancer registry of our institution for breast cancer patients 65 years or older (n = 553), and patients 40 years or younger (n = 417) at time of diagnosis. Statistical models were used to investigate the associations between age groups, clinical characteristics and treatment outcomes. Results: A total of 970 patients were included in the final analysis. Compared to younger patients, older ones were more frequently diagnosed with distal metastasis; 20.6% compared to 15.1%, p =0.028. However, among patients with non-metastatic disease, younger ones tended to have more aggressive pathological features, including positive axillary lymph nodes (73.2% vs. 55.6%, p< 0.001), T-3/4 (28.2% vs. 13.8%, p< 0.001) and HER2-positive disease (29.3% vs. 16.3%, p< 0.001). A higher percentage of patients from the young cohort underwent surgery (85.4%) when compared to the older group (74.9%), p< 0.001. More patients in the older group had mastectomy than did younger patients (67.5% versus 40.2%, p< 0.001), while breast conserving surgery (BCS) was performed on almost a third in each cohort, p= 0.245. Skin-sparing, with or without, nipple-sparing mastectomies (SSMs) along with breast reconstruction surgery were more frequently performed on younger patients than they were on the older patients. After a median follow-up of 59 months for the younger patients and 45 months for the older ones, the 5-year OS rate of the older patients was 67.6% compared to 72.1% for the younger patients, p= 0.035. However, the 5-year DFS rates of the two cohorts were not statistically different at 63.9% for the older group and 60.7% for the young patients, p= 0.31. The survival of patients with non-metastatic disease was also compared among both groups; the 5-year OS among the younger patients was significantly higher (83.6% compared to 78.8% among the older patients, p= 0.046). Survival was better among the younger patients across many clinical and pathological characteristics. Conclusions: Younger patients with breast cancer present with worse clinical and pathological features, albeit a better OS rate. The difference in DFS between the two groups was insignificant, suggesting that older women were more likely to die from non-cancer related causes.


BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Safa Najafi ◽  
Maryam Ansari ◽  
Vahid Kaveh ◽  
Shahpar Haghighat

Abstract Background The objective of this study was to compare the efficacy and side effects of a single dose (Pegfilgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non-inferiority clinical trial. Methods In this randomized clinical trial, 80 patients were recruited and allocated randomly to two equal arms. In one group, a single subcutaneous dose of PDL was injected the day after receiving the chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of PDG for six consecutive days in each cycle of treatment. The side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight cycles of chemotherapy. Results Hematologic parameters showed no significant differences in any of the treatment courses between the two study groups. The comparison of WBC (p = 0.527), Hgb (p = 0.075), Platelet (p = 0.819), Neutrophil (p = 0.575), Lymphocyte (p = 705) and ANC (p = 0.675) changes during the eight courses of treatment also revealed no statistically significant difference between the two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs. Conclusion It seems that PDL is non-inferior in efficacy and also less toxic than PDG. Since PDL can be administered in a single dose and is also less costly, it can be regarded as a cost-effective drug for the treatment of chemotherapy-induced neutropenia. Trial registration IRCT20190504043465N1, May 2019.


2008 ◽  
Vol 26 (25) ◽  
pp. 4072-4077 ◽  
Author(s):  
Jennifer K. Litton ◽  
Ana M. Gonzalez-Angulo ◽  
Carla L. Warneke ◽  
Aman U. Buzdar ◽  
Shu-Wan Kau ◽  
...  

Purpose To understand the mechanism through which obesity in breast cancer patients is associated with poorer outcome, we evaluated body mass index (BMI) and response to neoadjuvant chemotherapy (NC) in women with operable breast cancer. Patients and Methods From May 1990 to July 2004, 1,169 patients were diagnosed with invasive breast cancer at M. D. Anderson Cancer Center and received NC before surgery. Patients were categorized as obese (BMI ≥ 30 kg/m2), overweight (BMI of 25 to < 30 kg/m2), or normal/underweight (BMI < 25 kg/m2). Logistic regression was used to examine associations between BMI and pathologic complete response (pCR). Breast cancer–specific, progression-free, and overall survival times were examined using the Kaplan-Meier method and Cox proportional hazards regression analysis. All statistical tests were two-sided. Results Median age was 50 years; 30% of patients were obese, 32% were overweight, and 38% were normal or underweight. In multivariate analysis, there was no significant difference in pCR for obese compared with normal weight patients (odds ratio [OR] = 0.78; 95% CI, 0.49 to 1.26). Overweight and the combination of overweight and obese patients were significantly less likely to have a pCR (OR = 0.59; 95% CI, 0.37 to 0.95; and OR = 0.67; 95% CI, 0.45 to 0.99, respectively). Obese patients were more likely to have hormone-negative tumors (P < .01), stage III tumors (P < .01), and worse overall survival (P = .006) at a median follow-up time of 4.1 years. Conclusion Higher BMI was associated with worse pCR to NC. In addition, its association with worse overall survival suggests that greater attention should be focused on this risk factor to optimize the care of breast cancer patients.


QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Abeer I Abd Elmagid ◽  
Hala Abdel Al ◽  
Wessam El Sayed Saad ◽  
Seham Kamal Mohamed

Abstract Background Breast cancer is the most common cancer among women and one of the most important causes of death among them.Angiogenesis is an important step for primary tumor growth, invasiveness, and metastases. Angiopoietins are well-recognized endothelial growth factors that are involved in angiogenesis associated with tumors. Aim To explore the diagnostic significance of serum angiopoietin-2 (Ang-2) in breast cancer and to evaluate its prognostic efficacy through studying the degree of its association with the TNM staging of the disease. Patients and Methods This study was conducted on (35) Egyptian female patients who were diagnosed as breast cancer according to histopathological examination of breast biopsy (Group 1, Breast Cancer Patients) and (25) female patients with benign breast diseases (Group II, Pathological Control Patients), in addition to (20) age - matched apparently healthy, free mammogram, females serving as healthy controls (Group III, Healthy Controls). For all participants, measurement of serum Ang-2 was done using enzyme linked immunosorbent assay (ELISA) technique. Results A highly significant increased levels of Ang-2 was observed in breast cancer patients when compared to healthy control group (Z = 4.95, p &lt; 0.01). However, no significant difference was observed in Ang-2 levels between breast cancer patients group and pathological control group (Z = 3.37, p &gt; 0.05). No significant difference was detected in Ang-2 levels in relation to TNM stage and histological grade. No significant correlation was found between Ang-2 levels and serum levels of CA15-3, hormone receptors, HER2/new receptor status (p &gt; 0.05, respectively). Conclusion This study revealed that Ang-2 serum levels were significantly increased in patient with breast cancer compared with healthy controls, indicating that high Ang-2 level is a promising non invasive biomarker for breast cancer diagnosis. However, no significant difference of Ang-2 levels was detected in relation of breast TNM staging in the population studied.


2021 ◽  
Vol 12 ◽  
Author(s):  
Mengdi Chen ◽  
Deyue Liu ◽  
Weilin Chen ◽  
Weiguo Chen ◽  
Kunwei Shen ◽  
...  

BackgroundThe 21-gene assay recurrence score (RS) provides additional information on recurrence risk of breast cancer patients and prediction of chemotherapy benefit. Previous studies that examined the contribution of the individual genes and gene modules of RS were conducted mostly in postmenopausal patients. We aimed to evaluate the gene modules of RS in patients of different ages.MethodsA total of 1,078 estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer patients diagnosed between January 2009 and March 2017 from Shanghai Jiao Tong University Breast Cancer Data Base were included. All patients were divided into three subgroups: Group A, ≤40 years and premenopausal (n = 97); Group B, &gt;40 years and premenopausal (n = 284); Group C, postmenopausal (n = 697). The estrogen, proliferation, invasion, and HER2 module scores from RS were used to characterize the respective molecular features. Spearman correlation and analysis of the variance tests were conducted for RS and its constituent modules.ResultsIn patients &gt;40 years, RS had a strong negative correlation with its estrogen module (ρ = −0.76 and −0.79 in Groups B and C) and a weak positive correlation with its invasion module (ρ = 0.29 and 0.25 in Groups B and C). The proliferation module mostly contributed to the variance in young patients (37.3%) while the ER module contributed most in old patients (54.1% and 53.4% in Groups B and C). In the genetic high-risk (RS &gt;25) group, the proliferation module was the leading driver in all patients (ρ = 0.38, 0.53, and 0.52 in Groups A, B, and C) while the estrogen module had a weaker correlation with RS. The impact of ER module on RS was stronger in clinical low-risk patients while the effect of the proliferation module was stronger in clinical high-risk patients. The association between the RS and estrogen module was weaker among younger patients, especially in genetic low-risk patients.ConclusionsRS was primarily driven by the estrogen module regardless of age, but the proliferation module had a stronger impact on RS in younger patients. The impact of modules varied in patients with different genetic and clinical risks.


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