Burden of out-of-pocket spending among high-deductible health plan members with metastatic breast cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 1029-1029
Author(s):  
Christine Leopold ◽  
Anita K. Wagner ◽  
Fang Zhang ◽  
Christine Lu ◽  
Craig Earle ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Health Plan ◽  
Statistical Significance ◽  
Metastatic Breast ◽  
Health Plans ◽  
Region Of Residence ◽  
Monthly Total ◽  
High Deductible Health Plan ◽  
Enrollment Data

1029 Background: 50% of workers have high-deductible health plans (HDHP) that require major outofpocket (OOP) spending for cancerrelated care. The OOP burden among patients with advanced cancer in HDHPs is unknown. Our objective was to estimate OOP spending for women with metastatic breast cancer (mbc) stratified by health plan type. Methods: Our data source was administrative health insurance claims and enrollment data of members insured though a large national health plan. We included 7142 women age 25-64 with mbc who had at least 6 months enrollment before the diagnosis and at least 12 months followup. We used a time series design and plotted OOP spending stratified by HDHP vs low-deductible plan. Primary outcome measures included: (1) 20042012 calendar trends in total annual OOP spending, (2) monthly total OOP spending in the 6 months before and 24 months after women were diagnosed with mbc, and (3) monthly total OOP spending in the last 6 months of life. Plots were adjusted for age, socioeconomic status, race/ethnicity, and US region of residence, and we then conducted linear regression to assess for statistical significance of trends. Results: In 2004, average annual OOP spending for women with mbc cancer in low-deductible health plans was $1196.2 and increased to $2570 in 2012, a yearly increase of $159.2 (113.2205.2). For women in HDHP average OOP spending in 2004 amounted to $2648 and increased to $3736.4 in 2012, representing an annual increase of $160.4 per year (105.4215.4) Average OOP spending per person month peaked in the month of diagnosis to $1633.8 for women in HDHPs and to $643 among low-deductible plan members. Average OOP spending in the last 6 months of life were $285.7 per person month among low-plan ($1714.2 per 6 months) and $607.3 among HDHP ($3644 per 6 months). Conclusions: To our knowledge, this is the first analysis to estimate OOP spending for women with mbc accounting for enrollment in HDHPs versus low-deductible plans. We found that OOP spending is increasing over time and is high in the last 6 months of life. HDHP members with mbc faced much higher OOP spending than women in traditional plans across all analyses. Findings raise concerns that HDHPs could worsen access to mbc treatments.

scholarly journals Rucaparib in patients presenting a metastatic breast cancer with Homologous Recombination Deficiency, without germline BRCA1/2 mutation

2020 ◽  
Author(s):  
Anne Patsouris ◽  
M'boyba Khadija DIOP ◽  
Olivier Tredan ◽  
Daniel Nenciu ◽  
Anthony Goncalves ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Homologous Recombination ◽  
Statistical Significance ◽  
Objective Response ◽  
Metastatic Breast ◽  
Parp Inhibitors ◽  
Small Subset ◽  
Durable Response ◽  
Homologous Recombination Deficiency

Abstract Breast cancer may present genomic alterations leading to homologous recombination deficiency. PARP inhibitors have proved their efficacy in patients with HER2-negative metastatic breast cancer (mBC) harboring germline (g) BRCA1/2 mutations. We conducted the phase 2 RUBY trial to assess the efficacy of rucaparib in HER2-negative mBC with high genomic loss of heterozygosity (LOH) score or somatic, without gBRCA1/2 mutation. 220 of 711 patients with mBC screened for LOH presented high LOH score which was associated with a higher likelihood of death (HR = 1.39, 95% CI: 1.11-1.75, p = 0.005). The primary objective was not reached with a clinical benefit rate (objective response or SD>16 weeks) of 13.5%. Two LOH-high patients, without somatic BRCA1/2 mutation, presented a complete and durable response (14 and 32 months). HRDetect tended to be associated with response to rucaparib, whithout reaching statistical significance (median HRDetect responders versus non responders: 0.465 versus, 0.040, p = 0.2135). Our data suggests that a small subset of patients with high LOH score could derive benefit from PARP inhibitors.

Randomized clinical trial of tamoxifen alone or combined with fluoxymesterone in postmenopausal women with metastatic breast cancer.

1988 ◽  
Vol 6 (5) ◽  
pp. 825-831 ◽  
Author(s):  
J N Ingle ◽  
D I Twito ◽  
D J Schaid ◽  
S A Cullinan ◽  
J E Krook ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Metastatic Breast Cancer ◽  
Side Effects ◽  
Postmenopausal Women ◽  
Randomized Clinical Trial ◽  
Statistical Significance ◽  
Metastatic Breast ◽  
Rank Test ◽  
Breast Cancer Patients

A randomized clinical trial was performed to determine if combination hormonal therapy with tamoxifen (TAM) and fluoxymesterone (FLU) was more efficacious than TAM alone for the treatment of postmenopausal women with metastatic breast cancer. Patients failing TAM could subsequently receive FLU. The dose of both drugs was 10 mg orally twice daily. Objective responses were seen in 50 of 119 TAM patients (42%) and 63 of 119 TAM plus FLU patients (53%) (one-sided P = .05). Time to disease progression distributions were better for TAM plus FLU (median, 350 days v 199 days), but the log rank test only approached statistical significance (one-sided P = .07). Duration of response and survival distributions were similar between the two treatment arms. Toxicities, in terms of androgenic side effects, were greater on the TAM plus FLU regimen. Fifty-two patients are evaluable for response with FLU following TAM and 21 (40%) have achieved a response. We conclude that the advantages in terms of response rate and time to progression observed with TAM plus FLU probably represent a biological effect, but are not of sufficient magnitude to justify the routine clinical use of this combination given the lack of survival advantage and side effects encountered.

Impact of PIK3CA mutations and p95HER2 expression on the outcome of HER2-positive metastatic breast cancer patients treated with a trastuzumab-based therapy.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 629-629
Author(s):  
Andrea Fontana ◽  
Giacomo Allegrini ◽  
Mazhar al Zoubi ◽  
Paola Collecchi ◽  
Chiara Mazzanti ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Statistical Significance ◽  
Metastatic Breast ◽  
Rank Test ◽  
Her2 Positive ◽  
Pik3ca Mutations ◽  
Mutational Status ◽  
Clinical Resistance ◽  
The Impact

629 Background: Currently, no biomarkers of trastuzumab (T) clinical resistance have been validated. The aim of this pilot study was to evaluate the impact of PIK3CA mutations and p95HER2 (pHER2 truncated form) expression on the efficacy of a T based-therapy in a HER2-positive metastatic breast cancer (MBC) patients (pts). Methods: 107 HER2-positive MBC pts, treated in the last 10 years, were evaluated. Median age was 54 years (25-79); ECOG performance status was 0 in 56% of pts; all pts received several lines of treatment including T; biomarkers molecular analysis was performed in 70 tumor specimens. The IHC expression of p95HER2 was evaluated by a monoclonal antibody that specifically recognizes only the HER2 external domain; the HER2 integrity was defined by the presence of a homogeneous membrane staining (moderate or intense) in at least 30% of the cells, otherwise the HER2 was defined as p95HER2 positive. PIK3CA mutations in exons 9 and 20 were detected by automated sequencing. The molecular data were correlated to Time to progression (TTP) of the first line treatment including T and the Overall Survival (OS) by using the Kaplan-Meir method and the log-rank-test. Results: p95HER2 positive pts and PIK3CA mutations in exon 9 or 20 were detected in 42% and 22% of tumor specimens, respectively. p95HER2 positive tumors showed a shorter TTP and OS that did not reach statistical significance; PIK3CA mutations correlated with a worse TTP (median 7,6 vs 11,3 months) and OS (median 20,1 vs 41,0 months, p= 0,046). Conclusions: These preliminary results suggest a possible role of PIK3CA mutational status in predicting the outcome of MBC pts treated with T.

Concordance of study objectives with efficacy findings in metastatic breast cancer (MBC) treatment trials

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6600-6600
Author(s):  
D. Frame ◽  
S. D. Ross
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Primary Endpoint ◽  
Statistical Significance ◽  
Metastatic Breast ◽  
Geographic Location ◽  
Group Differences ◽  
English Studies ◽  
Research Activity ◽  
Antineoplastic Treatment

6600 Background: Despite ongoing development of new agents, overall survival in MBC remains discouraging. We reviewed large randomized controlled trials (RCTs) published since 2000 to compare stated objectives with efficacy endpoints. Methods: Systematic review of RCTs of systemic antineoplastic treatment in advanced / metastatic breast cancer, published 2000–2006 in English. Studies enrolling fewer than 100 patients or performed only at sites outside North America and Europe were excluded. Study success was characterized with regard to the primary endpoint as described in prospective power calculations. Results: 68 RCTs, enrolling 24,956 patients, met inclusion criteria. The 68 RCTs comprised 83 efficacy comparisons due to multiple arms and/or more than one primary endpoint. Frequency of success was similar by geographic location and presence of industry sponsorship, but higher for noninferiority comparisons ( Table 1 ). 5 of 13 non-inferiority studies reported unplanned superiority findings for the experimental arm, while 11 of 39 studies failing to meet planned superiority endpoints made statements regarding equivalence or superiority to control treatments. For 10 of 20 successful superiority studies, reported results did not match/exceed planned between-group differences, though the comparisons reached statistical significance: 4 such studies substantially exceeded planned enrollment (2 of which recalculated sample size after reviewing interim data), while reasons for attaining superiority in 6 cases were unclear. Of the remaining 10 superiority comparisons, 4 reached significance due to underperforming control arms (enabling PFS/TTP differences of <2 months to establish superiority), 2 exceeded point estimates, and 4 exceeded estimated between- group ratios. Conclusions: Slippage from prospective study goals, even in large randomized trials, may contribute to a disconnect between the profusion of research activity and disappointing efficacy gains in MBC. No significant financial relationships to disclose. [Table: see text]

Evaluation of Ile655Val HER2 polymorphism associated with cardiac toxicity following the administration of trastuzumab in women with breast cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 634-634
Author(s):  
Caroline Diorio ◽  
Julie Lemieux ◽  
Marc-Andre Cote ◽  
Louise Provencher ◽  
Corinne Nadeau-Larochelle ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Cancer Patients ◽  
Cardiac Toxicity ◽  
Statistical Significance ◽  
Metastatic Breast ◽  
Fisher Exact Test ◽  
Breast Cancer Patients ◽  
Her2 Positive ◽  
Genotype Frequencies

634 Background: Trastuzumab is well tolerated without major side effects except for cardiac toxicity. Although a number of clinical parameters have been associated with trastuzumab-associated cardiac toxicity (TACT), there is some indication that genetic variation of the HER2 gene may play a toxic role in a population of metastatic breast cancer patients. However, this finding needs confirmation and we looked at a population of non-metastatic breast cancer. This study aimed to evaluate the association between cardiac toxicity and HER2 [Ile655Val] polymorphism in non-metastatic breast cancer patients treated with trastuzumab. Methods: The Ile655Val HER2 polymorphism was assessed in 73 women using TaqMan technology. For this study, the genotyping was performed using DNA extracted from normal breast tissue located at more than 1 cm of any other lesions. Charts review was used to collect information on TACT which was defined as any decline in LVEF > 10 % from the baseline to < 55 % or a decline in LVEF > 5 % to < 50 % (lower limit of normal). The Fisher exact test was used to evaluate the association between cardiac toxicity and HER2 polymorphism. Results: No deviation from the Hardy-Weinberg equilibrium has been observed for the allele and genotype frequencies. The distribution of HER2 polymorphism was 3 Val/Val (4%), 18 Ile/Val (25%) and 52 Ile/Ile (71%). In this population, 19% (14/73) developed a cardiac toxicity. We found that 29% (6/21) of Ile/Val or Val/Val carriers compared to 15% (8/52) of Ile/Ile carriers showed TACT, but this association did not reach statistical significance (P = 0.21). Conclusions: HER2 Ile655Val polymorphism may be an efficient marker of TACT considering this tendency with this small cohort of patients. Larger sample is needed to strengthen this conclusion, since this result may influence on prescribing decision for adjuvant chemotherapy and anti-HER2 therapy in HER2 positive patients.

The cost of adverse events in metastatic breast cancer in taxane- and capecitabine-based regimens.

2013 ◽  
Vol 31 (31_suppl) ◽  
pp. 261-261
Author(s):  
Anthony Masaquel ◽  
Ryan N. Hansen ◽  
Scott David Ramsey ◽  
Deepa Lalla ◽  
Melissa Brammer ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Adverse Events ◽  
Metastatic Breast ◽  
Payer Perspective ◽  
The Us ◽  
Monthly Total ◽  
The Mean ◽  
Nationally Representative ◽  
The Cost

261 Background: Over 155,000 women are living with metastatic breast cancer (mBC) in the US. Chemotherapies can prolong survival for women with mBC, but adverse events (AEs) stemming from their use are common and costly to manage. We compared the healthcare costs for taxane- (TAX) and capecitabine-based (CAP) treatments for mBCpatients as either first- or second-line (FL or SL) therapy in the US. Methods: Using the Marketscan Commercial Database, a nationally representative database of over 52 million people, we selected mBC patients diagnosed from 2008-2011. Patients were categorized into FL and SL chemotherapy including either a TAX (paclitaxel or docetaxel) or CAP using an algorithm based on pharmacy and medical claims data. Chemotherapy-related AEs were identified by ICD-9 codes. Costs were tabulated from a payer perspective. Average monthly costs were stratified by treatment and the presence/absence of AEs. Results: Among 15,535 mBCpatients we identified 15,472 FL and 6,809 SL cases treated with TAX or CAP. The mean age of patients was 51 years (SD 8). At least one AE was experienced during FL treatment by 74% (SD 44%) and 68% (SD 46%) of TAX and CAP users and during SL treatment 60% (SD 49%) and 59% (SD 49%), respectively. Average monthly total costs during the FL period were $2,385 higher (p <0.0001) and $1,679 higher (p=0.28) for TAX- and CAP-treated patients who experienced at least one AE. In SL, costs for patients with at least one AE had were $2,995 (p<0.0001) higher for TAX-treated patients and $4,870 (p=0.0026) higher for CAP-treated patients. Conclusions: Among community-treated patients, AEs are common in women with mBC receiving TAX- and CAP-based chemotherapy regimens. These AEs are associated with higher costs in FL and SL. When possible, prevention or earlier management of AEs may represent an opportunity to reduce costs and improve outcomes for women with mBC. [Table: see text]

A phase III, multicenter, randomized trial of maintenance versus observation after achieving clinical response in patients with metastatic breast cancer who received six cycles of gemcitabine plus paclitaxel as first-line chemotherapy (KCSG-BR 0702, NCT00561119).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 1003-1003
Author(s):  
Young-Hyuck Im ◽  
Yeon Hee Park ◽  
Kyung Hae Jung ◽  
Seock-Ah Im ◽  
Joo Hyuk Sohn ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Randomized Trial ◽  
Statistical Significance ◽  
Metastatic Breast ◽  
Hazard Ratio ◽  
Phase Iii ◽  
Maintenance Chemotherapy ◽  
First Line ◽  
Significant Difference

1003 Background: Chemotherapy provides a survival benefit in patients with metastatic breast cancer (MBC), but the optimal duration of chemotherapy remains controversial. Primary purpose of the study was to evaluate whether the maintenance chemotherapy with gemcitabine/paclitaxel (GP), which is one of the two regimens which showed a survival gain from a randomized trial, is superior to observation in terms of progression free survival (PFS) in responding patients with MBC after 6 cycles of GP as first-line treatment. Methods: This study is a prospective, randomized, multi-center, phase III study. Patients who achieved response (CR+PR+SD) following 6 cycles of GP chemotherapy (gemcitabine 1250 mg/m2 on day 1 and 8 plus paclitaxel 175 mg/m2 on day 1 every 3 weeks) randomized to maintenance till progression or observation arm. The trial was conducted by the Korean Cancer Study Group (KCSG). Results: Among total 324 patients enrolled between 2007 and 2010 from 10 centers, 231 responding patients to were randomly assigned to maintenance chemotherapy (n=116) or observation (n=115). Median age was 49 (range 28-76). The numbers of hormone receptor (HR)+ve and HR-ve patients were 172 (74.5%) and 59 (25.5%), respectively. The median No. of chemotherapy cycles in maintenance group was 12 (range 6-32). During median 33 months of follow-up, median PFS was superior in maintenance than in observation (12.0 vs. 8.3 months, p=0.030). Patients < age 50 years (hazard ratio 0.50, p=0.001) and HR-ve patients (hazard ratio 0.52, p=0.019) received more benefit from maintenance chemotherapy in terms of PFS. Median OS was superior in maintenance than in observation (36.8 vs 28.0 months, p=0.047). Neurotoxicity (≥ grade 2) was more common in maintenance than in observation without statistical significance (41.7% vs 33.3%, p=0.210). Serial assessment of Quality of Life (QoL) did not show any significant difference between two groups. Conclusions: Maintenance GP chemotherapy for responding patients with MBC showed clinical benefit in terms of PFS and OS without impairment of QoL.

Comparison of the cell-free DNA genomics in patients with metastatic breast cancer (MBC) who develop brain metastases versus those without brain metastases.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 1094-1094
Author(s):  
Neelima Vidula ◽  
Andrzej Niemierko ◽  
Katherine Hesler ◽  
Steven J. Isakoff ◽  
Dejan Juric ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Brain Metastases ◽  
De Novo ◽  
Statistical Significance ◽  
Metastatic Breast ◽  
Common Mutation ◽  
Cell Free Dna ◽  
Free Dna ◽  
Gene Assay

1094 Background: The genomics of patients with metastatic breast cancer (MBC) who develop brain metastases (BM) is not well understood given the difficulty in obtaining brain tumor for genotyping. We compared tumor genotyping results via cell-free DNA (cfDNA) collected at MBC diagnosis in patients who developed BM after MBC diagnosis with those who did not develop BM (non-BM). Methods: Patients at an academic institution who had cfDNA testing (Guardant 360/Next generation sequencing, 73 gene assay) at MBC diagnosis between 1/2016-12/2017, with ≥ 6 months of follow-up post testing, were identified. A chart review was done to identify tumor subtype, demographics, cfDNA results, and development of BM at or after MBC diagnosis. Pearson’s chi-squared and Wilcoxon rank sum tests were used to determine differences in clinical and cfDNA characteristics in BM vs. non-BM (p<0.05 for statistical significance). Results: CfDNA results were available for 49 patients, of whom 13 (27%) developed BM (4 with BM at MBC diagnosis). The median time to BM development was 11 months. While patients with BM were younger at MBC diagnosis than non-BM (median age BM 53 vs. non-BM 61, p=0.05), they had similar subtype (BM vs. non-BM: HR+/HER2- 62% vs. 69%, HER2+ 8% vs. 14%, TNBC 23% vs. 17%, unknown 8% vs. 0%, p=0.3), de-novo vs. recurrent disease (BM vs. non-BM: de-novo 8% vs. 14%, recurrent 92% vs. 86%, p=0.6), and visceral disease (BM vs. non-BM: 77% vs. 56%, p=0.2) distributions. All patients with BM had ≥1 detectable cfDNA mutation vs. 88% of non-BM. While the median mutant allele frequency of the most common mutation was similar in BM vs. non-BM (2.4% vs. 3.7%, p=0.5), the mutation pattern varied. Patients with BM more often had mutations in BRCA1 (15% vs. 3%, p=0.1), APC (15% vs. 0%, p=0.02), and CDKN2A (15% vs. 0%, p=0.02), compared to non-BM. In 4 patients with BM at MBC diagnosis, mutations in APC (50%), CDKN2A (50%), and BRCA 1/2 (25%) were noted; 1 had coexisting APC and BRCA1/2 mutations and another had coexisting APC and CDKN2A mutations. Conclusions: Patients with MBC who develop BM may have different cfDNA genomics, particularly BRCA1, APC, and CDKN2A mutations. Further research is needed to determine the predictive value of cfDNA at MBC diagnosis in the identification of patients at higher risk of developing BM. [Table: see text]

scholarly journals Phase II randomized trial of a non-steroidal mouth wash for prevention and treatment of stomatitis in women with hormone receptor positive breast cancer treated with everolimus

2020 ◽  
Vol 12 ◽  
pp. 175883592096725
Author(s):  
Parvin F. Peddi ◽  
Merry Tetef ◽  
Paul Coluzzi ◽  
Karo K. Arzoo ◽  
Eddie H. Hu ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Randomized Trial ◽  
Phase Ii ◽  
Statistical Significance ◽  
Metastatic Breast ◽  
Average Score ◽  
Prophylactic Measure ◽  
The Difference ◽  
Mouth Wash

Background: Stomatitis is a frequent dose limiting toxicity of everolimus, an approved therapy for patients with metastatic breast cancer. No randomized trials of a prophylactic measure to prevent mucositis have been reported. Methods: We conducted a phase II, open-label trial in which patients with metastatic breast cancer starting everolimus were randomized to best supportive care (BSC) versus prophylactic use of an oral mucoadhesive, non-steroid containing mouth wash. The primary endpoint was rate of any grade stomatitis as reported by the treating physicians. Secondary endpoints were severity of stomatitis according to the Oral Mucositis Assessment Scale (OMAS) and rates of everolimus dose reduction or discontinuation due to mucositis. Results: Of 61 evaluable patients, 32 were randomized to and treated with oral mucoadhesive and 29 with BSC. Any grade stomatitis developed in 46.9% (15/32) of study arm and 65.5% (19/29) of BSC arm patients ( p = 0.14). The difference between the two arms was significantly in favor of the mucoadhesive arm when mucositis was scored according to the OMAS with average score of 0.3 in study arm versus 0.5 in the control arm ( p = 0.03). There were fewer dose adjustments or therapy discontinuations in the study arm compared with BSC (16% versus 31%, respectively) but the difference did not reach statistical significance. Conclusion: Here we provide early evidence from the first randomized trial supporting the use of oral prophylactic mucoadhesive for everolimus-associated stomatitis. A trial comparing prophylactic oral mucoadhesive to steroid mouth wash may be warranted.

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