scholarly journals Taxane therapy in the adjuvant treatment of breast cancer in Italy: economic evaluation

2006 ◽  
Vol 7 (1) ◽  
pp. 63-69
Author(s):  
Simona Ravera ◽  
Lorenzo G. Mantovani

Breast cancer (BC) is one of the leading cause of death in developed Countries and every year more than a million new cases are diagnosed worldwide. In Italy the prevalence of BC was estimated to be 1,070 per 100,000 at 31 December 1992. Nevertheless, despite the increase in incidence, mortality rate for BC are decreased in the last decades probably due to several factors such as implementation of screening programs, early diagnosis and new adjuvant therapies. Important types of adjuvant chemotherapy include anthracyclines and taxanes and these treatments continue to be evaluated to determine optimal combinations and dosing regimens. The efficacy of paclitaxel and docetaxel in adjuvant setting for the treatment of early BC has been assessed in different trials where the two taxanes showed a significant increase in both Disease Free Survival (DFS) and Overall Survival (OS) in comparison with nontaxane therapy. In particular results from one of the last studies comparing paclitaxel and docetaxel show equivalent efficacy for both drugs. At the light of the recent findings, the objective of this work is to perform a cost minimization analysis of paclitaxel vs docetaxel in the adjuvant setting for treatment of early BC in Italy. The analysis was conducted from the National Health Service’s point of view, assuming equivalent efficacy in terms of DFS and OS for both taxanes. Costs were evaluated on the basis of therapeutic schemes used in the analyzed trials. Results show that paclitaxel, administered every 3 weeks for 4 cycles after doxorubicin and cyclophosphamide, represents the less costly therapy. This is a conservative costs estimate based on data from literature that does not take into account possible additional costs associated to the treatment of febrile neutropenia (FN) as adverse event related to chemotherapy. Since, on the basis of scientific literature data, FN seems to be more related with docetaxel than with paclitaxel administration, it is likely that in clinical practice the Growth–Colony Stimulating Factor is often prescribed as a preventive therapy when Docetaxel is administred, giving rise to treatment costs.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 3088-3088 ◽  
Author(s):  
Kaitlin M. Peace ◽  
Elizabeth Ann Mittendorf ◽  
Sonia A. Perez ◽  
Panagiotis Tzonis ◽  
Nikolaos Fragkiskos Pistamaltzian ◽  
...  

3088 Background: AE37 is a Ii-Key hybrid of the HER2 peptide AE36 (HER2776-790), which stimulates peptide-specific T cells. We have completed the active phase of a prospective, randomized, multi-center, phase II trial of the AE37 vaccine in the adjuvant setting. The primary analysis, performed after a median follow up (f/u) of 25 months (mo), did not show a significant difference in disease free survival (DFS) between vaccinated and control patients (pts). However, demonstrating the efficacy of cancer vaccines may require more time than other therapies, especially in malignancies with relatively late recurrences like breast cancer. Here, we present updated efficacy data after extended f/u in subgroups of pts stratified by clinicopathologic characteristics. Methods: Clinically disease-free, node positive or high-risk node negative pts with any level of HER2 expression were randomized to receive AE37 + GM-CSF (VG) or GM-CSF alone (CG) following standard of care therapy. Pts received 6 monthly intradermal inoculations during the primary vaccine series (PVS) followed by 4 boosters administered every 6 mo. Kaplan Meier and log rank analyses were performed from the time of the first inoculation in pts who completed at least the PVS, according to stage, node status, tumor size, HER2 expression and ER/PR status. Results: There were no clinicopathologic differences between groups in the 298 enrolled pts (VG = 153, CG = 145). The vaccine is safe and well tolerated. After a median f/u of 55 mo, there was a trend toward improved DFS in the VG among stage IIB/III pts (VG, n = 73, DFS 82% vs CG, n = 61, 67%, HR = 0.48, p = 0.06) and those with low HER2 expression (HER2 LE, VG, n = 68, 89% vs CG, n = 66, 51%, HR = 0.47, p = 0.1). Improved DFS in the VG was documented in patients with both stage IIB/III disease and HER2 LE (VG, n = 39, 90% vs CG, n = 38, 32%, HR 0.3, p = 0.02) and triple negative (TNBC) pts (VG, n = 21, 89% vs CG, n = 21, 0%, HR 0.26, p = 0.05). Conclusions: The AE37 vaccine is safe and well tolerated and has statistically significant efficacy in stage IIB/III pts with HER2 LE and in TNBC pts. This justifies further evaluation in a phase III study enrolling stage IIb/III pts not eligible for trastuzumab treatment and the very high risk TNBC group. Clinical trial information: NCT00524277.


2020 ◽  
Author(s):  
Rodrigo Goncalves ◽  
Maria Carolina Formigoni ◽  
José Maria Soares ◽  
Edmund Chada Baracat ◽  
José Roberto Filassi

The incidence and mortality of breast cancer are rising in the whole world in the past few decades, adding up to a total of around two million new cases and 620,000 deaths in 2018. Unlike what occurs in developed countries, most of the cases diagnosed in the developing world are already in advanced stages and also in women younger than 50 years old. As most screening programs suggest annual mammograms starting at the age of 50, we can infer that a considerable portion of the new breast cancer cases is missed with this strategy. Here, we will propose the adoption of an alternative hierarchical patient flow, with the creation of a diagnostic fast track with referral to timely treatment, promoting better resources reallocation favoring the least advantaged strata of the population, which is not only ethically acceptable but also a way of promoting social justice.


PeerJ ◽  
2018 ◽  
Vol 6 ◽  
pp. e4567
Author(s):  
Qi Zhang ◽  
Lanjun Ding ◽  
Xuan Liang ◽  
Yuan Wang ◽  
Jiao Jiao ◽  
...  

Background In China, there is insufficient evidence to support that screening programs can detect breast cancer earlier and improve outcomes compared with patient self-reporting. Therefore, we compared the pathological characteristics at diagnosis between self-detected and screen-detected cases of invasive breast cancer at our institution and determined whether these characteristics were different after the program’s introduction (vs. prior to). Methods Three databases were selected (breast cancer diagnosed in 1995–2000, 2010, and 2015), which provided a total of 3,014 female patients with invasive breast cancer. The cases were divided into self-detected and screen-detected groups. The pathological characteristics were compared between the two groups and multiple imputation and complete randomized imputation were used to deal with missing data. Results Compared with patient self-reporting, screening was associated with the following factors: a higher percentage of stage T1 tumors (75.0% vs 17.1%, P = 0.109 in 1995–2000; 66.7% vs 40.4%, P < 0.001 in 2010; 67.8% vs 35.7%, P < 0.001 in 2015); a higher percentage of tumors with stage N0 lymph node status (67.3% vs. 48.4%, P = 0.007 in 2010); and a higher percentage of histologic grade I tumors (22.9% vs 13.9%, P = 0.017 in 2010). Conclusion Screen-detected breast cancer was associated with a greater number of favorable pathological characteristics. However, although screening had a beneficial role in early detection in China, we found fewer patients were detected by screening in this study compared with those in Western and Asian developed countries.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 522-522 ◽  
Author(s):  
Keith L. Knutson ◽  
Edith A. Perez ◽  
Karla V. Ballman ◽  
Courtney L. Erskine ◽  
Nicholas Fox ◽  
...  

522 Background: In the adjuvant setting, patients with HER2 breast cancer treated with trastuzumab and chemotherapy have superior survival compared to patients treated with chemotherapy alone. We previously showed that trastuzumab and chemotherapy induces HER2-specific antibodies which correlate with response to therapy in patients with HER2+ metastatic breast cancer. It remained unclear from those studies, however, whether the HER2-specific immunity played a role and if antibody immunity was associated with improved disease free survival in the adjuvant setting. In the present study, we addressed these questions by analyzing sera samples from a subset of patients enrolled in the NCCTG adjuvant trial, N9831, which includes an arm (Arm A) in which trastuzumab was not used. Arms B and C received trastuzumab sequentially or concurrently to chemotherapy, respectively. Methods: Pre-and post-treatment initiation sera were obtained from 50 women enrolled in N9831 (22 Arm A; 14 Arm B, and 14 Arm C). Lambda IgG antibodies (to avoid detection of trastuzumab) to HER2 were measured and presented as an index (>0.2 was considered a positive response). Results: Prior to therapy, across all three arms, N9831 patients had similar mean HER2 IgG levels (0.19 units in Arm A, 0.14 in Arm B, and 0.23 in Arm C, P=0.85). Following treatment, the mean levels of antibodies increased in Arm B to 0.35 units and in Arm C to 0.56 units and were higher (p<0.001) than in Arm A where levels did not increase. The proportion of patients who demonstrated antibody immunity increased by 9% in Arm A, 50% in Arm B and 28% in Arm C (P=0.026). Although the event rate was low in this cohort, Cox modeling suggested that larger increases in antibodies were associated with improved disease free survival (HR=0.23; p=0.04). Conclusions: These results show that the increased antibody immunity observed in adjuvant patients treated with combination trastuzumab and chemotherapy is clinically significant and results from the inclusion of trastuzumab. The findings may have important implications for improving treatment outcomes in patients treated with trastuzumab.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12028-e12028
Author(s):  
Silvina Malvasio ◽  
Natalia Camejo ◽  
Cecilia Castillo ◽  
Nora Artagaveytia ◽  
Carina Di Matteo ◽  
...  

e12028 Background: BRCA1 is one of the main susceptibility genes for breast cancer (BC). While BRCA1 mutations are rare in sporadic tumors, loss or reduction of gene expression have been reported in approximately 30-50% of sporadic BCs in the general population. From the molecular point of view, there is no clear characterization of these tumors in young women and we have found no studies reporting the rate of under-expression of BRCA1 in women with sporadic BC under 40 years of age. Objective: to assess the tumor expression of BRCA1 using immunohistochemistry (IHC) and its prognostic value in Uruguayan women diagnosed with BC before the age of 40 years. Methods: IHQ was used to analyze the tumor expression of BRCA1 in paraffin-embedded tumor samples of 40 BC patients diagnosed before the age of 40 between 01/01/2006 and 12/31/2012. The optimization and determination of the BRCA1 protein by IHC was centralized. The antibodies used were anti BRCA1 MS110 monoclonal antibodies against the N-terminal end and GLK-2 against the C-terminal end (amino acids 1839-1863). Expression was considered positive when >10% of the cells had nuclear and/or cytoplasmic labeling. Overall survival (OS) and disease free survival (DFS) were calculated; the curves were developed using the Kaplan-Meier method and the difference in survival was evaluated through the log rank test. Results: the average age of the 40 patients included was 36 years; 8 patients (20%) had significant family history of BC or ovarian cancer. The distribution by stage (S) was as follows: SI: 9 patients (22.5%); SII: 20 patients (50%); SIII: 10 patients (25%), and SIV: 1 patient. Regarding the biological profile: 17 patients (42.5%) were HER2- and ER/PR+, 13 (32.5%) were HER2+ and the remaining 10 patients (25%) were classified as triple negative. The 5-year OS and DFS were 73% and 60% respectively. The expression of BRCA1 with GLK-2 was ≤10% in 16 of the 40 patients included (40%). The 5-year OS and DFS for patients with ≤10% expression was 56% vs. 85% for patients with >10% (p = 0.015) and 40% vs. 72% (p = 0.034) respectively. The expression of BRCA1 by MS110 was ≤10% in 11 of the 40 patients included (27.5%). No statistically significant differences were found in the 5-year OS or DFS based on the expression of this marker. Conclusions: Decreased BRCA1 tumor expression as assessed by IHC using GLK-2 was found in 40% of young patients included and was associated with unfavorable prognosis.


2005 ◽  
Vol 23 (16) ◽  
pp. 3686-3696 ◽  
Author(s):  
Eleftherios P. Mamounas ◽  
John Bryant ◽  
Barry Lembersky ◽  
Louis Fehrenbacher ◽  
Scot M. Sedlacek ◽  
...  

Purpose The primary aim of National Surgical Adjuvant Breast and Bowel Project (NSABP) B-28 was to determine whether four cycles of adjuvant paclitaxel (PTX) after four cycles of adjuvant doxorubicin/cyclophosphamide (AC) will prolong disease-free survival (DFS) and overall survival (OS) compared with four cycles of AC alone in patients with resected operable breast cancer and histologically positive axillary nodes. Patients and Methods Between August 1995 and May 1998, 3,060 patients were randomly assigned (AC, 1,529; AC followed by PTX [AC → PTX], 1,531). Patients ≥ 50 years and those younger than 50 years with estrogen receptor (ER) or progesterone receptor (PR) -positive tumors also received tamoxifen for 5 years, starting with the first dose of AC. Postlumpectomy radiotherapy was mandated. Postmastectomy or regional radiotherapy was prohibited. Median follow-up is 64.6 months. Results The addition of PTX to AC significantly reduced the hazard for DFS event by 17% (relative risk [RR], 0.83; 95% CI, 0.72 to 0.95; P = .006). Five-year DFS was 76% ± 2% for patients randomly assigned to AC → PTX compared with 72% ± 2% for those randomly assigned to AC. Improvement in OS was small and not statistically significant (RR, 0.93; 95% CI, 0.78 to 1.12; P = .46). Five-year OS was 85% ± 2% for both groups. Subset analysis of the effect of paclitaxel according to hormone receptors or tamoxifen administration did not reveal statistically significant interaction (for DFS, P = .30 and P = .44, respectively). Toxicity with the AC → PTX regimen was acceptable for the adjuvant setting. Conclusion The addition of PTX to AC resulted in significant improvement in DFS but no significant improvement in OS with acceptable toxicity. No significant interaction between treatment effect and receptor status or tamoxifen administration was observed.


2018 ◽  
Vol 143 (04) ◽  
pp. 267-278
Author(s):  
Ulrich Hamann ◽  
Christine Ankel

Abstract Learning Objectives After reviewing this article, the participant should be able to: 1. Understand the epidemiology of breast cancer, its incidence and impact. 2. Appreciate the importance of early diagnosis and treatment. 3. Understand the concept of comprehensive breast cancer management and its multidisciplinarity. 4. Be knowledgeable about the entire process required to manage breast cancer, since the early diagnosis until the management of non breast related conditions derived from the treatment. 5. Position their specialty and knowledge in the process and know clearly their role and involvement in the management of the patients with breast cancer. Summary Breast carcinoma accounts for the majority of the malignant diseases in women. In Germany has an estimated incidence of 70 000 new cases per year, which is 30 % of all the malignancies in women, predominantly between 45 and 83 years old, although it can affect as well younger women and men, the latter, in a very low rate. It is accountable for 17.4 % mortality in the country.The high frequency and impact of the mammary carcinoma had lead to the establishment and standardization of screening programs, encompassing self examination, early and regular consultation, sonography and mammography, aimed to the early detection not only of primary disease but also in recurrent or relapsing disease, and continued following up after treatment. Several treatment strategies and tools have been developed and are being chosen in accordance to the histology and biology of the tumor, the patient condition, the social and familiar status, with the increase of conservation of the mammary gland either by adjuvant or neoadjuvant therapies, with radiotherapy or by breast conserving surgery, improving therefore the quality of living without compromising the disease free survival. Next step in the process is the follow up, intended to maintain the patients the healthiest possible, not only from the malignancy but also minimizing the effects of the treatment strategies, incorporating lifestyle improving measures e.g. sports and nutrition, and alternative medicine resources like acupuncture, hence improving the disease free survival rate, the overall survival and diminishing the disease related impact yet personal, familiar, social and economical.The aim of this CME is to give a thorough review of this multifactorial entity, helping the healthcare professional understand the scientific aspects of it and, through comprehensive reading, provide a clear understanding of their role and degree of involvement in the breast cancer management process.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12011-e12011
Author(s):  
Mark D. Danese ◽  
Marc Halperin ◽  
Deepa Lalla ◽  
Bin Yao ◽  
John Crown ◽  
...  

e12011 Background: Long-term efficacy in the extended adjuvant setting requires a long follow-up. In the ExteNET trial, neratinib was given for a year and invasive disease-free survival (iDFS) assessed at 2 and 5 years. In women with HER2+ hormone receptor positive (HR+) cancer who initiated neratinib, the observed difference in iDFS between neratinib and placebo at 5 years (4.5%) was greater than at 2 years (3.7%). The objective of these analyses was to extrapolate the effect of neratinib on iDFS beyond 5 years in patients with HER2+/HR+ early stage breast cancer who initiated treatment after receiving adjuvant trastuzumab. Methods: We analyzed the 5-year follow-up of the ExteNET trial using flexible spline-based parametric survival models to project iDFS risk at 10 years. Analyses included only HR+ patients. Several model specifications were explored including various combinations of the following variables: treatment as a time varying covariate, nodal status (0, 1-3, ≥4 nodes), and months from last trastuzumab treatment to randomization. The regression models included different combinations of interaction terms, either a proportional hazards or a proportional odds (PO) link function, and either 2 or 6 knots. The model fit was compared using Akaike Information Criterion (AIC). Results: In general, the fit statistics among the 16 models were comparable; however, the model with the lowest AIC included no interaction terms, 2 knots, and the PO link function. The mean iDFS event rate at 10 years was estimated to be 12.2% for neratinib and 18.9% for placebo for a difference of 6.8% (range across 16 models: 6.8%-7.8%). The recurrence rate and the difference between treatment groups were largest in women with ≥4 positive nodes. Conclusions: Based on these analyses, the projected 10-year difference in iDFS between placebo and neratinib patients seems likely to persist. However, because the data was limited to 5 years, we could not include the effect of hormonal therapy cessation. Also, low event rates in the node negative group may require longer follow-up to evaluate. In absence of longer-term data for neratinib, flexible parametric survival modeling of the iDFS suggests that the effect of neratinib therapy may remain stable.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 1074-1074
Author(s):  
Isabel Chirivella ◽  
Begona Bermejo ◽  
Amelia Insa ◽  
Jose Alejandro Perez-Fidalgo ◽  
Ana Magro ◽  
...  

1074 Background: A dose-response effect has previously been observed with CMF and anthracycline-based schedules. The objective of this post-hoc analysis was to give additional information on the impact of chemotherapy delivery on patients’ outcome. Methods: Selection criteria were to have early breast cancer (stage I-IIIA) from Jan 1980 to Dec 2000, to undergo surgery as primary treatment and to receive an anthracycline-based non-taxane schedule in the adjuvant setting. G-CSF support was not given to any patient. Chemotherapy delivery was assessed based on ≥ 2 vs. < 2 delayed cycles, ≥ 15 vs. <15 delayed days and < 85% vs. ≥ 85% of the relative dose intensity (RDI) given. Patients’ outcomes were assessed based on 5- and 10-year disease-free survival (DFS) and overall survival (OS) rates. Results: 793 breast cancer patients with a median age of 51 years (21-79) were analyzed of whom 27% had stage IIIA and 23% had stage I disease. As shown in the table, 5- and 10-year rates of DFS and OS significantly improved when adjuvant chemotherapy was optimally delivered. Conclusions: The dose-response effect is a key factor that should be taken into account when an anthracycline-based non-taxane chemotherapy is administered in the adjuvant setting. Delays and/or reductions of chemotherapy should be avoided in order to achieve the maximal benefit for the patient. This study was partially funded by Amgen SA. [Table: see text]


2021 ◽  
Vol 18 (4) ◽  
pp. 667-671
Author(s):  
Anamika Jha ◽  
Ranjit Kumar Chaudhary

Background: Mammography is an established screening tool for early detection of breast cancer, with several protocols used worldwide. Such screening programs and related data are lacking in less developed countries. We documented and analyzed the mammographic trends at Tribhuvan University Teaching Hospital, a tertiary care referral center, in Kathmandu, Nepal, to develop baseline data which may be helpful in further researches.Methods: In this descriptive study, imaging findings of consecutive patients who had undergone mammography between July 2016 and March 2018 were reviewed after obtaining ethical clearance from the Institutional Review Committee. Ultrasonography and histopathological examination were done as needed. Demographics, presenting complaints, breast density, Breast Imaging, Reporting, Assessment and Data System category and final diagnosis were recorded and analyzed using appropriate statistical methods.Results: There were more diagnostic mammograms (62%) than screening with mastalgia the most common presenting complaint. Breast density was less in screening group. Overall, there were more benign lesions with incidence of breast cancer being 4.4% more in the diagnostic group. The age range varied from 22 to 86 years, with 15% (n=219) below 40 years age accounting for one-third of the cases of extremely dense breast and one-fourth of the suspicious lesions. Nearly 50% of breast cancers were seen in patients less than 50 years of age.Conclusions: The study showed greater number of diagnostic than screening mammograms, with malignancies detected more often in the diagnostic group and younger age. Fewer screening studies suggest a lack of breast cancer awareness in our population who seek medical help only when symptomatic. Keywords: BIRADS; Breast Cancer; Mammography


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