scholarly journals Uptake of Trastuzumab Biosimilars for the Treatment of HER2-Positive Breast Cancer: A Real-World Experience from a Cancer Center

Pharmaceutics ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 684
Author(s):  
Michela Piezzo ◽  
Roberta D’Aniello ◽  
Ilaria Avallone ◽  
Bruno Barba ◽  
Daniela Cianniello ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Inventory Management ◽  
Switching Process ◽  
Cancer Center ◽  
Electronic Systems ◽  
Her2 Positive ◽  
Reference Drug ◽  
Treatment Regimens ◽  
Reporting Systems ◽  
Effective Cost

Background: The introduction of trastuzumab biosimilars in clinical practice plays an important role in promoting the sustainability of healthcare systems. By contrast, the switching process can be challenging to the clinics. This survey describes the switching process at a National Cancer Institute over a period of 2 years. Methods: Data regarding all trastuzumab-based regimens for breast cancer (BC) from 1 January 2019 and 31 December 2020 were extracted from both adverse drug reactions (ADRs) reporting systems and electronic systems involved in inventory management, prescribing, dispensing, and administration. Both patients under monotherapy and combination treatment regimens were included. There were no exclusion criteria. Results and Conclusions: Overall 354 patients received at least one trastuzumab-based regimen for a total of 493 lines of treatment and 5769 administrations. Biosimilar were used in 34.3% of trastuzumab-based treatments. No differences between biosimilars and reference drug have been observed in terms of ADRs. The effective cost-saving of the first 2 years is greater than EUR 800,000 and it is estimated to increase over time.

scholarly journals Changes in Overall Survival Over Time for Patients With de Novo Metastatic Breast Cancer

2021 ◽  
Author(s):  
Toshiaki Iwase ◽  
Tushaar Vishal Shrimanker ◽  
Ruben Rodriguez-Bautista ◽  
Onur Sahin ◽  
Anjali James ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Metastatic Breast Cancer ◽  
De Novo ◽  
Metastatic Breast ◽  
Locoregional Therapy ◽  
Cancer Center ◽  
Her2 Positive ◽  
Time Periods ◽  
Over Time

The purpose of this study was to determine the change in overall survival (OS) for patients with de novo metastatic breast cancer (dnMBC) over time. We conducted a retrospective cohort study with 1981 patients with dnMBC diagnosed between January 1995 and December 2017 at The University of Texas MD Anderson Cancer Center. OS was measured from the date of diagnosis of dnMBC. OS was compared between patients diagnosed during different time periods: 5-year periods and periods defined according to when key agents were approved for clinical use. The median OS was 3.4 years. The 5- and 10-year OS rates improved over time across both types of time periods. A subgroup analysis showed that OS improved significantly over time for the estrogen-receptor-positive/HER2-positive (ER+/HER2+) subtype, and exhibited a tendency toward improvement over time for the ER-negative (ER-)/HER2+ subtype. Median OS was significantly longer in patients with non-inflammatory breast cancer (P = .02) and in patients with ER+ disease, progesterone-receptor-positive disease, HER2+ disease, lower nuclear grade, locoregional therapy, and metastasis to a single organ (all P <.0001). These findings showed that OS at 5 and 10 years after diagnosis in patients with dnMBC improved over time. The significant improvements in OS over time for the ER+/HER2+ subtype and the tendency toward improvement for ER-/HER2+ subtype suggest the contribution of HER2-targeted therapy to survival.

Correlation of efficacy between rash and lapatinib/capecitabine therapy in Japanese HER2-positive metastatic breast cancer patients.

2011 ◽  
Vol 29 (27_suppl) ◽  
pp. 62-62 ◽  
Author(s):  
S. E. Nagai ◽  
K. Inoue ◽  
S. Kaneko ◽  
S. Uchida ◽  
T. Higuchi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Targeted Therapy ◽  
Clinical Outcome ◽  
Cancer Patients ◽  
Response Rate ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Cancer Center ◽  
Breast Cancer Patients ◽  
Her2 Positive

62 Background: Lapatinib (L) is an oral dual-tyrosine kinase inhibitor with specificity for both EGFR and HER2. A phase III randomized trial (EGF100151) demonstrated that L+ capecitabine (C) is superior to C alone in patients with HER2-positive advanced breast cancer that progressed following prior therapy including trastuzumab. Although, Japanese phase I/II trial (EGF109749) demonstrated better response rate and higher rate of rash over a previous phase III trial. Recent reports demonstrated the correlation of efficacy between EGFR targeted therapy and rash in colon cancer. In lung cancer EGFR mutation, which are predominantly found in patients of East Asia origin are highly sensitive to EGFR-TKI. Analyzing correlation of efficacy between rash and EGFR targeted therapy is important in breast cancer. Methods: From June 2009 to February 2010, we treated 28 HER2-positive MBC patients who developed progression after anthracyclines, taxanes and trastuzumab based regimens with L 1,250 mg p.o. daily plus C 2,000 mg/m2 p.o. days 1-14 q 21 in Saitama Cancer Center. EGFR status was evaluated by immunohistochemistry. We analyzed the correlation among rash, clinical outcome and EGFR status. Results: Fourteen (50%) patients experienced rash, which were two grade 3, four grade 2 and eight grade 1. Rash experienced group showed superior response rate (77% : 24%, p<0.05) and median survival time (N/A: 259 days, p<0.05) over non-rash group. EGFR status has no correlation between rash and clinical outcome. Conclusions: According to our single institute experience, rash might be predictive factor in Japanese HER2 positive breast cancer patients treated with L+C therapy.

scholarly journals Biosimilar Use in Breast Cancer Treatment: A National Survey of Brazilian Oncologists' Opinions, Practices, and Concerns

2021 ◽  
pp. 1316-1324
Author(s):  
Heloísa M. Resende ◽  
Leandro Ladislau ◽  
Ana Carolina F. Cardoso ◽  
Juliana Dinéia P. Brandão ◽  
Biazi R. Assis ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Treatment ◽  
Breast Cancer Treatment ◽  
Her2 Positive ◽  
Treatment Regimens ◽  
Her2 Positive Breast Cancer ◽  
Level Of Knowledge ◽  
The Cost ◽  
Switching Treatment ◽  
Positive Breast Cancer

PURPOSE Breast cancer is the most common malignancy in Brazilian women, with 66,280 new cases in 2020 (with 20% overexpressing human epidermal growth factor receptor 2 [HER2]). The trastuzumab biosimilar was the first oncology biosimilar approved in Brazil for HER2-positive breast cancer treatment. This study aimed to assess the current level of knowledge of biosimilars, comfort of use, extrapolation indications, and switching of practices among oncologists in Brazil. METHODS A 24-question survey was developed using an online platform that sought information regarding responders' characteristics and use of biosimilars. The survey analyzed the basic knowledge of biosimilars, trastuzumab biosimilars, level of comfort with extrapolation, switching treatment regimens, and opinions concerning the cost of HER2-positive breast cancer therapy. Data were collected between July and September 2019 and included 144 oncologists from five Brazilian regions. RESULTS In total, 95% of respondents could identify the most appropriate definition of biosimilars and 96% felt comfortable prescribing trastuzumab biosimilars. Although 63% of respondents would use the biosimilar in all settings wherein the reference biologic was approved, 35% would use the biosimilar for cases involving metastatic disease. Although 82% of oncologists were in favor of switching from a reference biologic to a biosimilar, 18% would avoid switching regimens. The lack of studies detailing switching to other regimens and the correct timing to switch was the major concern. The cost of HER2 therapy was a significant concern for most oncologists. CONCLUSION Oncologists demonstrated a high level of knowledge of biosimilars and encouraging levels of prescriber use; however, extrapolation and switching treatment regimens are barriers to the effective use of biosimilars in cancer treatment. Efforts should be concentrated on strategies involving medical education programs on biosimilars.

scholarly journals Rate of reclassification of HER2-equivocal breast cancer cases to HER2-negative per the 2018 ASCO/CAP guidelines and response of HER2-equivocal cases to anti-HER2 therapy

PLoS ONE ◽  
2020 ◽  
Vol 15 (11) ◽  
pp. e0241775
Author(s):  
James Crespo ◽  
Hongxia Sun ◽  
Jimin Wu ◽  
Qing-Qing Ding ◽  
Guilin Tang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Disease ◽  
Cancer Center ◽  
Her2 Status ◽  
Breast Cancers ◽  
Breast Cancer Patients ◽  
Her2 Positive ◽  
Her2 Testing ◽  
Primary Disease ◽  
The Impact

Purpose The 2018 American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guideline on HER2 testing in breast cancer permits reclassification of cases with HER2-equivocal results by FISH. The impact of such reclassification is unclear. We sought to determine the proportion of HER2-equivocal cases that are reclassified as HER2-negative and the impact of anti-HER2 therapy on survival in HER2-equivocal cases. Methods We reviewed medical records of breast cancer patients who had HER2 testing by fluorescence in stitu hybridization (FISH) and immunohistochemistry (IHC) performed or verified at The University of Texas MD Anderson Cancer Center during April 2014 through March 2018 and had equivocal results according to the 2013 ASCO/CAP guideline. The population was divided into 2 cohorts according to whether the biopsy specimen analyzed came from primary or from recurrent or metastatic disease. HER2 status was reclassified according to the 2018 ASCO/CAP guideline. Overall survival (OS) and event-free survival (EFS) were calculated using the Kaplan-Meier method, and the relationship between anti-HER2 therapy and clinical outcomes was assessed. Results We identified 139 cases with HER2-equivocal results according to the 2013 ASCO/CAP guideline: 90 cases of primary disease and 49 cases of recurrent/metastatic disease. Per the 2018 ASCO/CAP guideline, these cases were classified as follows: overall, HER2-negative 112 cases (80%), HER2-positive 1 (1%), and unknown 26 (19%); primary cohort, HER2-negative 85 (94%), HER2-positive 1 (1%), unknown 4 (4%); and recurrent/metastatic, HER2-negative 27 (55%) and unknown 22 (45%). Five patients in the primary-disease cohort and 1 patient in the recurrent/metastatic-disease cohort received anti-HER2 therapy. There was no significant association between anti-HER2 therapy and OS or EFS in either cohort (primary disease: OS, p = 0.67; EFS, p = 0.49; recurrent/metastatic-disease, OS, p = 0.61; EFS, p = 0.78. Conclusions The majority of HER2-equivocal breast cancer cases were reclassified as HER2-negative per the 2018 ASCO/CAP guideline. No association between anti-HER2 therapy and OS or EFS was observed. HER2-equivocal cases seem to have clinical behavior similar to that of HER2-negative breast cancers.

The effect of trastuzumab on pCR in locally advanced HER2-positive breast cancer.

2011 ◽  
Vol 29 (27_suppl) ◽  
pp. 286-286
Author(s):  
S. M. Lavasani ◽  
K. I. Pritchard ◽  
A. Kiss ◽  
S. Verma ◽  
F. Wright ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Cancer Center ◽  
P Value ◽  
Her2 Positive ◽  
Primary Tumors ◽  
Her2 Breast Cancer ◽  
Baseline Characteristics

286 Background: Neoadjuvant therapy (NAT) is now standard of care for locally advanced breast cancer (LABC). Evidence shows that pathological complete response (pCR) predicts for disease free and overall survival. The pCR rates for LABC vary widely in the literature but prognosis still remains poor for this group of pts. Increases in pCR have been reported in clinical trials with the addition of trastuzumab (T) but these studies have predominantly included operable pts. The aim of this study was to evaluate whether the addition of T to NAT has improved the rates of pCR in HER2+ LABC pts at our center. Methods: Pts from the LABC prospective database at the Sunnybrook Odette Cancer Center in Toronto were included if they had confirmed HER2+ LABC [primary tumors greater than 5cm (T3) with skin or chest wall involvement (T4) or with matted axillary adenopathy (N2)]. Two cohorts of LABC pts, pre-T and post-T groups were compared for baseline characteristics and pCR. Chi square tests and p values were used for comparing proportions. Results: 43 pts were diagnosed between Jan 2002 to Dec 31, 2006 who had HER2+ breast cancer and received NAT without T (pre-T cohort). 17 HER2+ pts were diagnosed with LABC between Jan 1, 2007 to Dec 31, 2009 who received neoadjuvant T (post-T cohort). Baseline characteristics were similar in two cohorts (Table) except more pts in pre-T cohort received neoadjuvant hormonal therapy. The rate of pCR in the pre-T cohort was 9.3% and in the post-T cohort 29% (p value=0.02). Conclusions: The pCR rate dramatically improved in our LABC patients with the addition of T to NAT. The pCR rates still remain lower than in published clinical trials likely reflecting the more advanced nature of LABC in clinical practice. [Table: see text]

Effect on patient care of repeat pathologic review for breast cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6599-6599
Author(s):  
Andrew Cota Shaw ◽  
Hanna Kelly Sanoff ◽  
Mark E Smolkin
Keyword(s):  
Breast Cancer ◽  
Lymph Node ◽  
Interobserver Agreement ◽  
Treatment Plan ◽  
Patient Treatment ◽  
Cancer Center ◽  
Her2 Status ◽  
Lymph Node Status ◽  
Study Cohort ◽  
Her2 Positive

6599 Background: Many cancer centers routinely re-review outside pathologic specimens. We hypothesized re-review rarely changes patient treatment plans. Methods: Of 1495 patients seen at the University of Virginia with a diagnosis of breast cancer from 2006-2011, the 276 cases with both internal and outside pathology reports comprised the study cohort. Interobserver agreement (kappa coefficient, K) between internal and outside diagnoses were calculated for histopathology, lymph node, margin, ER/PR, and HER2 status. We then evaluated if the change would result in a change in therapy or surveillance per the National Comprehensive Cancer Network (NCCN) guidelines. The effect of region and teaching affiliation of outside institutions was explored. Results: For the 276 cases with re-reviewed pathology at UVA there was absolute agreement for ER/PR and surgical margins, and excellent agreement for lymph node, K= 0.93, and histopathology, K=0.93. Agreement was good for HER2, K=0.83. 3 cases were changed from HER2 positive to negative (2) or intermediate (1). Of 9 changes in histopathology, 2 had a major upgrade: 1 ADH to DCIS; 1 DCIS to carcinoma. 3 had a major downgrade: 2 from DCIS to ADH; 1 from carcinoma to DCIS. 2 cases changed from ALH to LCIS. Lymph node status was changed from positive to negative in one out of 31 reviewed cases. Treatment plan would have changed for all 13, 4.7% of all patients. Changes were made almost exclusively (11/13) if referred from a hospital with no or minor teaching affiliation, including all major histopathology changes and changes in lymph node and HER2 status. Conclusions: Interobserver agreement for breast pathology between pathologists at an NCI designated cancer center and outside institutions was good. However, 4.7% of women had discordant results that would lead to a change in their care. Changes were most common for noninvasive carcinoma and benign atypia. In order to best utilize resources, referral centers may want to consider limiting re-review to the pathology from centers with high risk for discordance.

Comparison of neoadjuvant anti-HER2 therapy for breast cancer in public versus private health care: Time to shorten the distance.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18045-e18045
Author(s):  
Virginia Braga ◽  
Jessica Ribeiro Gomes ◽  
Noelle Suemi Wassano ◽  
Jessica Sayuri Tsukamoto ◽  
Luiza Damian Ribeiro Barbosa ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Health Care ◽  
Clinical Stage ◽  
Locally Advanced ◽  
Surrogate Marker ◽  
Complete Response ◽  
Public Health Care ◽  
Cancer Center ◽  
Her2 Positive ◽  
Metastatic Setting

e18045 Background: In the neoadjuvant setting (NAC) of HER2-positive breast cancer (BC), the addition of pertuzumab (P) to trastuzumab (T) and chemotherapy (chemo) has increased pathological complete response (pCR) from 40-50% to over 70%. Recent data has shown that pCR is a reliable surrogate marker of disease-free (DFS) and overall survival (OS). In Brazil, there is an important gap between cancer drugs approved in the public health care system (PHCS) vs. the private setting. Although P approval for NAC (Aug/2016) and metastatic setting (Sep/2015) in the private health system, it is not approved for any indication in the PHCS. Likewise, T is not approved for use as NAC at the PHCS. We aim to compare private practice experience of T + P + chemo in the NAC vs. HER2-positive advanced BC patients treated at the PHCS. Methods: Retrospective analysis of 95 patients diagnosed with locally advanced HER2-positive BC by immunohistochemistry 3+ or FISH according to ASCO/CAP definition. We evaluated 17 consecutive patients at the COAEM private cancer center in Brazil since Feb/2014 (cohort 1). Neoadjuvant therapy was T and P plus docetaxel-based chemo. A cohort of 78 patients with locally advanced HER2-positive BC treated in a PHCS cancer center was analyzed (cohort 2). They received standard NAC regimen according to PHCS guidance: anthracycline and taxane-based therapy without anti-HER2 therapy. Results: Cohort 1: 17 patients with median age of 50 years (range 34-70); Four patients had clinical stage IIA; 2 patients IIB; 7 patients IIIA; 3 patients IIIB; one patient IIIC. The pCR rate was 70.5% (12 patients). Cohort 2: 78 patients with median age of 48 years (range 26-79). One patient IIB; 33 patients IIIA; 37 patients IIIB; 7 patients IIIC. The pCR rate was 16.7% (13 patients); 29 patients (37.2%) had clinical complete response. Only 26 patients (33.3%) received T in the adjuvant setting. Conclusions: Neoadjuvant P and T combined with chemo has shown pCR rates superior to 70% in clinical trials, which is a surrogate marker for DFS and OS in HER2-positive BC. The absence of anti-HER2 therapy in the PHCS must be urgently reviewed not just in light of double-blockage strategy but also in T monotherapy use.

Trastuzumab biosimilar (Kanjinti) in breast cancer patients: One-center retrospective observational study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13015-e13015
Author(s):  
Agnieszka I. Jagiello-Gruszfeld ◽  
Izabela Lemanska ◽  
Elzbieta Brewczynska ◽  
Katarzyna Pogoda ◽  
Roman Dubianski ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adverse Events ◽  
Real World ◽  
Safety Profile ◽  
Safety Data ◽  
Her2 Positive ◽  
Reference Drug ◽  
Her2 Positive Breast Cancer ◽  
Metastatic Setting ◽  
Positive Breast Cancer

e13015 Background: The switch of anti-HER2 therapy from the reference drug Herceptin to a biosimilar has presented challenges to the clinics. Real world data on trastuzumab biosimilars are very limited or not available. In our clinic we perform observational retrospective study to confirm safety and efficacy Kanjinti. Methods: 195 patients (pts) with HER2-positive breast cancer were treated with Kanjinti from Jul.18. 2018 to Jan.29.2020. Cardiac events (↓LVEF) and other unexpected or serious adverse events were monitored in all pts. 34 pts received carboplatin, docetaxel pertuzumab and trastuzumab biosimilar in neoadjuvant setting, 99 received trastuzumab biosymilar in monotherapy or with other cytostatic drugs in neoadjuvant or adjuvant setting, and 62 received docetaxel, pertuzumab and Kanjinti in metastatic setting. Results: Pertuzumab was used in combination with Kanjinti in 49% of pts (32% in the 1st. line of palliative tretment and 17% in the neoadjuvant settings, respectively).Switching from Herceptin to Kanjinti was observed in 65% of MBC patients and 37% of EBC patients. Switching was done at a median of 4th cycle. 6 patients had a decline in LVEF. No other trastuzumab related adverse events was observed. Conclusions: The management of HER2 positive breast cancer in our clinic follows the international recommendations. This is the first real world safety data of Kanjinti from Poland. The 12-month follow-up treatment with Kanjinti an acceptable cardiac safety profile. In cases where there was a switch from Herceptin to Kanjinti or Kanjinti combined with pertuzumab, the safety profile was similar to that previously reported in other studies.

Risk for SARS-CoV-2 infection in patients with breast cancer treated with chemotherapy, biologic therapy or active surveillance: Patient outcomes from multicenter institution in New York.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1513-1513
Author(s):  
Nibash Budhathoki ◽  
John Kucharczyk ◽  
Nina D'Abreo ◽  
Maryann J. Kwa ◽  
Magdalena Plasilova ◽  
...  
Keyword(s):  
Breast Cancer ◽  
New York ◽  
Cancer Treatment ◽  
Early Stage ◽  
Cancer Center ◽  
Her2 Positive ◽  
Real World Data ◽  
Early Stage Disease ◽  
Treatment Type ◽  
Increased Risk

1513 Background: In high-risk estrogen-receptor positive, HER2 positive, or triple negative breast cancer (BC), chemotherapy can increase cure rates in early-stage disease and prolong survival in setting of advanced disease. Real world data specific to BC is needed to counsel patients (pts) with BC on their risk for SARS-CoV-2 infection and mortality in the context of the SARS-CoV-2 pandemic. Methods: In this retrospective study, we abstracted clinical data including demographics, tumor histology, cancer treatment, and COVID-19 testing results status from the electronic medical record of 3778 BC patients who received cancer care from 02/01/2020 – 05/01/2020 in New York City at our cancer center. The primary endpoint of the study was incidence of SARS-CoV-2 infection by treatment type (cytotoxic chemotherapy (CT) vs non-cytotoxic therapies (endocrine and/or HER2 directed therapy (E/H)) diagnosed by either serology, RT-PCR, or documented clinical diagnosis. Probability of Treatment Weighting (IPTW) and Mann-Whitney Test were used to assess risk of SARS-CoV-2 infection by treatment and assess outcomes based on oncologic and non-oncologic risk factors respectively. Results: 3062 patients met inclusion criteria with 379 pts in CT, 2343 pts in E/H and 340 in NT groups. During study period 641 patients (20.9%) were tested by either PCR or serology with 64 patients (2.1%) diagnosed with COVID-19. All pts who tested positive by PCR and subsequently had serology testing were positive for IgG. The weighted risk of SARS-COV-2 infection was 3.5% in CT vs. 2.7% in E/H (p=0.523). 27 patients (0.9%) expired over follow up, with 10 deaths attributed to SARS-CoV-2 infection. The weighted risk for death was 0.7% with CT vs. 0.1% with E/H, p=0.24 (Table A). Age, BMI,CCI and advanced cancer stage were associated with increased mortality following SARS-CoV-2 infection (Table). Conclusions: CT was not associated with increased risk of infection with SARS-CoV-2 infection or death following infection. BC cancer treatment, including CT, can be safely administered with enhanced infectious precautions and should not be withheld particularly when given for curative intent.[Table: see text]

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