Trastuzumab use and CNS metastasis in Medicare patients diagnosed with metastatic breast cancer (MBC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 1123-1123
Author(s):  
R. Griffiths ◽  
D. Lalla ◽  
M. Brammer ◽  
R. Herbert ◽  
J. Doan ◽  
...  

1123 Background: While trastuzumab was approved in 1998 for treating patients with HER-2-positive MBC, there is little information on its use in the Medicare setting. Methods: We used SEER-Medicare data to examine patterns of trastuzumab use in women diagnosed with MBC . An index date was defined as either the date of diagnosis (stage IV) or of first distant recurrence (stage 0-III). Included patients were diagnosed in 2000–2002, and had their first claim for trastuzumab between their index date and December 31, 2005, the end of the observation period. Patients were divided into those who received trastuzumab as part of their first treatment following their index date (Group A), and those who began trastuzumab after at least one course of chemotherapy (Group B). Chemotherapy agents were grouped into antimicrotubule (vinorelbine, docetaxel, paclitaxel, vincristine), anthracycline (doxorubicin, epirubicin), cyclophosphamide, other, and unknown. Results: 281 patients met the inclusion criteria. Overall, the median (mean) time from the index date to initial chemotherapy and/or trastuzumab treatment was 35 (94) days (range 1–1,587 days). The average duration of trastuzumab use (first to last administration) was 371 days (median 239), during which patients averaged 2.3 trastuzumab claims per month. There were 192 (68%) patients in Group A. The median (mean) time from diagnosis to initial treatment in Group A was 34 (94) days. 64 (33%) received trastuzumab alone, and 121 (63%) received trastuzumab with an antimicrotubule. In Group B (89 patients), the median (mean) time to initial chemotherapy was 41 (92) days. 36 (40%) received anthracycline and/or cyclophosphamide based therapy, 22 (25%) received an antimicrotubule without either an anthracycline or cyclophosphamide. The median (mean) time from initial chemotherapy to initial trastuzumab therapy was 233 (368) days. At that time, 29 (33%) received trastuzumab alone, and 54 (61%) received trastuzumab plus an antimicrotubule. Conclusions: To our knowledge, this is the first study to describe patterns of trastuzumab use in Medicare. When used for metastatic breast cancer, trastuzumab was most often provided soon after diagnosis as part of initial treatment, and usually with an antimicrotubule agent. [Table: see text]

Breast Care ◽  
2021 ◽  
pp. 1-8
Author(s):  
Shouko Hayama ◽  
Rikiya Nakamura ◽  
Toshiko Miyaki ◽  
Makiko Itami ◽  
Naohito Yamamoto

<b><i>Background/Aims:</i></b> The study aim was to evaluate if mTOR inhibitors can be considered as a treatment option for HR+ HER2− metastatic breast cancer (MBC) after progression on CDK4/6 inhibitors in clinical practice. <b><i>Methods:</i></b> We retrospectively collected the clinicopathological data of patients with HR+ HER2− MBC treated with CDK4/6 inhibitors and subsequent therapies at our institution between 2014 and 2020. The patients were divided into 3 groups according to the type of subsequent treatment: (A) exemestane plus everolimus, (B) endocrine monotherapy, and (C) chemotherapy. Overall survival (OS) was estimated by using the Kaplan-Meier method and compared by using the log-rank test. The efficacy and adverse events (AEs) of each subsequent treatment were assessed by using Fisher’s exact tests. <b><i>Results:</i></b> Eighty-six patients (34 in group A, 20 in group B, 32 in group C) were included. The most common endocrine therapy in group B was fulvestrant (40%). The major chemotherapy regimen in group C was eribulin (25%). The median OS times after stopping CDK4/6 inhibitors were 34.5 months (95% confidence interval, 17.2 to NA), 13.6 months (3.9 to NA), and 19.5 months (18.8 to NA) in group A, group B, and group C, respectively. The only significant difference in OS was observed between group A and group B (20.9 months; <i>p</i> = 0.003). There was no difference in the incidence of grade 3 AEs between groups A and C or in the frequency of treatment discontinuation because of AEs among the 3 groups. <b><i>Conclusion:</i></b> Our study shows that mTOR inhibitors might be an effective treatment option for patients with HR+ HER2− MBC previously treated with CDK4/6 inhibitors.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10771-10771
Author(s):  
Z. Jiang ◽  
S. Zhang ◽  
X. Xie ◽  
J. Liu ◽  
J. Ren ◽  
...  

10771 Background: Capecitabine in combination with docetaxel given every 3 weeks has shown a high degree of activity in anthracycline-pretreated metastatic breast cancer (MBC), but with high toxicities. To improve the therapeutic index, we performed a clinical pilot trial to evaluate the efficacy and safety of weekly or 3-week docetaxel in combination with capecitabine given for 14 days every 21 days. Methods: Patients with at least one measurable lesion were randomized to receive the treatment arms: docetaxel 75mg/m2 on days 1, oral capecitabine 950 mg/m2 twice daily on days 1–14 (Arm A); docetaxel 37.5mg/m2 on days 1 and 8, oral capecitabine 950 mg/m2 twice daily on days 1–14 (arm B). Each cycle was repeated every 3 weeks. Patients remained on study for a maximum 6 cycles or until tumor progression or unacceptable toxicity occurred, response assessments were scheduled every two cycles. Results: 64 pts were enrolled, 62 eligible for safety and tumor assessment. Key baseline variables were well balanced. Dominant site of disease was visceral in 66.1%; 24.2% had ≥3 organ sites of disease; all patients had previously received anthracyclines, 24.2% for MBC. 43. 6% were ER negative and 46.8% were HER-2 overexpress. The overall clinical response rate of all groups was 59.7% (37/62). There was no progressive disease (PD) after two cycles. Efficacy outcomes were similar in the two arms. The response rate of group A and B were 60% (18/30) and 59.4% (19/32) respectively. There were no drug-related deaths observed. Neutropenia was the most common toxicity. In all, the frequence of Grade 3/4 neutropenia were similar in two arm, but Grade 4 neutropenia of Group A 66.7% (20/30) was higher than Group B 34.4% (11/32), P = 0.021. Conclusions: The study confirmed the superior activity of docetaxe-capecitabine combination therapy in anthracycline resistant MBC, and comparing with 3-week schedule, weekly docetaxel plus capecitabine has same high efficacy with a favourable safety profile. No significant financial relationships to disclose.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e11611-e11611
Author(s):  
M. Almubarak ◽  
V. Gadiyaram ◽  
S. Osman ◽  
G. Hobbs ◽  
A. Saad ◽  
...  

e11611 Background: Fluorine-18-FDG positron emission tomography (FDG-PET) role in the follow up care of non-metastatic breast cancer is not defined. Methods: We retrospectively analyzed 177 patients with stage I-III breast cancer between November 2004 and June 2006. IRB approval was obtained for this study. Patients were divided into two groups. Group A consisted of patients who had one or more FDG-PET scans as part of their clinical follow up (N=68), and Group B consisted of patients who did not (N=109). Clinical, radiological and pathology data were obtained from patients’ records. Results: Median follow-up is 35 months. Mean age 53 years for group A and 57 years for group B. Group A patients were more likely to have had higher stages (29% stage I, 53% stage II, and 18% stage III) compared with group B (64 % stage I, 31% stage II and 4% stage III). The two groups did not differ significantly in ER+ status (69% vs. 78% p=0.21), or Her2neu status (19% vs. 17%; p=0.6). Group A patients had more clinic visits (18 vs. 11; p=0.009), their tumor marker was checked more often (13 vs. 9 times; p=0.0001), had more radiological studies (10 studies vs. 5; p=0.0001), and had more biopsies (0.88 vs. 0.48 biopsy per patient; p=0.05). These differences were significant even after controlling for stage and chemotherapy. 9/68 patients in group A had tumor recurrence compared to 1/109 in group B (p=0.0003). PET scan indications were as follows: 29 (43%) for asymptomatic follow up evaluation [2 recurred]; 18 (26%) concerning symptoms [0 recurred]; 10 (15%) elevated tumor marker [2 recurred]; 7 (10%) other abnormal imaging studies [1 recurred]; 4 (6%) metastatic workup. Conclusions: While FDG-PET might aid in detecting recurrence in some patients with non-metastatic breast cancer, its use was associated with more clinic visits, blood tests, biopsies, and radiological tests. No significant financial relationships to disclose.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18566-e18566
Author(s):  
Diana Saravia ◽  
Leah Elson ◽  
Hong Liang ◽  
Nadeem Bilani ◽  
Elizabeth Blessing Elimimian ◽  
...  

e18566 Background: We previously elucidated sociodemographic factors associated with risk-of-death, in a subgroup of patients with Stage IV human epidermal growth factor 2 (HER)+ breast cancer. To further understand determinants of disparities in all subgroups of stage IV breast cancer, this study sought to evaluate factors which are predictive of overall survival (OS) in a cohort of patients with metastatic breast cancer (MBC), according to the following subtypes: 1) estrogen receptor (ER)+ or progesterone receptor (PR)+ and (HER)-, (2) (ER+ or PR+) and HER+, (3) (ER- and PR-) and HER-, or (4) (ER- and PR-) and HER+. Methods: Study population included patients with MBC, extracted from the National Cancer Database, treated between 2010 and 2016. Descriptive statistics were used to summarize patient characteristics, and chi-square tests were performed to compare patient characteristics, by ethnic group (white, black, Hispanic, Asian, and other). Multivariate Cox regression models with backward elimination (using significance level of p<0.05) were utilized to compare overall survival among patient cohorts. In addition, Kaplan-Meier survival curves of patient cohort were also produced. Statistics were performed using SAS. Results: Records from n= 47,032 patients were included, the majority were 50 years or older, white, and treated with hormonal therapy. With a median follow-up time of 2.3 years, disparities in OS were observed; black patients were more likely to suffer death (HR=1.12 (1.08-1.16), p<0.0001), compared to white patients. Additional factors contributing to risk of death in MBC included: being male (HR=1.12, (1.02-1.23), p=0.019), having visceral involvement compared to bone only (HR=1.52, (1.05-1.28), p<0.0001), income < $38,000 (HR=1.13 (1.09-1.17), p<0.0001), being on government insurance (HR=1.24, (1.20-1.27), p<0.0001, and having Triple Negative Breast Cancer (ER- and PR-) and HER- status (HR=1.68 (1.60-1.75) p<0.0001). Patients who receive chemotherapy, not hormonal therapy (HR=1.25 (1.2 – 1.3), p<0.0001), were found to have worse prognosis possibly reflecting biology of disease at presentation and lack of specific targeted therapy. Conclusions: This study confirms that sociodemographic disparities exist in OS among patients within the same stage of MBC, and regardless of receptor status subtypes. Clinical practice should focus on closing disparities gaps for those with advanced and MBC, especially among Black, impoverished, and male patients. Better treatment approaches should be sought for patients with visceral metastasis and those diagnosed with triple negative receptor status, who continue to suffer from worse outcomes.


2002 ◽  
Vol 20 (3) ◽  
pp. 743-750 ◽  
Author(s):  
Donald A. Berry ◽  
Gloria Broadwater ◽  
John P. Klein ◽  
Karen Antman ◽  
Joseph Aisner ◽  
...  

PURPOSE: To assess survival of patients with metastatic breast cancer treated with high-dose chemotherapy (HDC) versus standard-dose chemotherapy (SDC). PATIENTS AND METHODS: SDC in four Cancer and Leukemia Group B (CALGB) trials was compared with hematopoietic stem-cell support in patients from the Autologous Blood and Marrow Transplant Registry. Cox proportional hazard regression incorporated potentially confounding effects. A total of 1,509 women were enrolled onto CALGB trials, and 1,188 women received HDC. No significant survival differences existed by CALGB trial or HDC regimen. Consideration was restricted to candidates for both SDC and HDC. The resulting sample included 635 SDC and 441 HDC patients. The outcome of interest was overall survival. RESULTS: The HDC group displayed better performance status. The SDC group had slightly better survival in first year after treatment. The HDC group had lower hazard of death from years 1 to 4 and had somewhat higher probability of 5-year survival (adjusted probabilities [95% confidence intervals], 23% [17% to 29%] v 15% [11% to 19%], P = .03). CONCLUSION: After controlling for known prognostic factors in this nonrandomized analysis of two large independent data sets, women receiving HDC versus SDC for metastatic breast cancer have a similar short-term probability of survival, and might have a modestly higher long-term probability of survival.


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