• We randomly assigned participants (1:1) to receive either trastuzumab emtansine plus pertuzumab or docetaxel, carboplatin, and trastuzumab plus pertuzumab. (nih.gov)
  • Between June 25, 2014, and June 15, 2015, we randomly assigned 444 patients to neoadjuvant treatment with trastuzumab emtansine plus pertuzumab (n=223) or docetaxel, carboplatin, and trastuzumab plus pertuzumab (n=221). (nih.gov)
  • Trastuzumab emtansine (T-DM1), an antibody-drug conjugate of trastuzumab and the cytotoxic agent emtansine (DM1), a maytansine derivative and microtubule inhibitor, provides benefit in patients with metastatic breast cancer that was previously treated with chemotherapy plus HER2-targeted therapy. (nih.gov)
  • In order to prevent medication errors, it is important to check the vial labels to ensure that the medicinal product being prepared and administered is [BT-ON013 trade name] and not trastuzumab emtansine. (who.int)
  • Trastuzumab emtansine is an antibody-drug conjugate (ADC) comprised of the antibody trastuzumab and the chemotherapy DM1 attached together using a stable linker. (empr.com)
  • Then, pertuzumab in 2012 and ado-trastuzumab emtansine in 2013 were approved in the US and elsewhere based on evidence showing an improvement in survival outcomes in patients with mostly trastuzumab naïve or trastuzumab-exposed metastatic disease. (carcinogenesis.com)
  • The US Food and Drug Administration (FDA) today approved ado-trastuzumab emtansine ( Kadcyla , Genentech), also known as T-DM1, for the treatment of patients with HER2 -positive metastatic breast cancer. (medscape.com)
  • The most common prior treatments were trastuzumab (89.3% and 86.4% in the [vic]-trastuzumab duocarmazine and physician's choice arms, respectively), ado-tarstuzumab emtansine (87.6% and 87.5%, respectively), and pertuzumab (Perjeta) (60.8% and 57.5%, respectively). (cancernetwork.com)
  • The ToGA trial must be characterized as a landmark in the treatment of gastric cancer and it has paved the way for a number of new HER2 targeted compounds such as pertuzumab, ado-trastuzumab emtansine, lapatinib, afatinib, and dacomitinib, which are currently undergoing phase II and III clinical testing. (wjgnet.com)
  • We did a phase 3 trial to assess a neoadjuvant regimen for HER2-positive breast cancer that replaces traditional systemic chemotherapy with targeted treatment. (nih.gov)
  • Patients who have residual invasive breast cancer after receiving neoadjuvant chemotherapy plus human epidermal growth factor receptor 2 (HER2)-targeted therapy have a worse prognosis than those who have no residual cancer. (nih.gov)
  • We conducted a phase 3, open-label trial involving patients with HER2-positive early breast cancer who were found to have residual invasive disease in the breast or axilla at surgery after receiving neoadjuvant therapy containing a taxane (with or without anthracycline) and trastuzumab. (nih.gov)
  • Among patients with HER2-positive early breast cancer who had residual invasive disease after completion of neoadjuvant therapy, the risk of recurrence of invasive breast cancer or death was 50% lower with adjuvant T-DM1 than with trastuzumab alone. (nih.gov)
  • The best candidates for neoadjuvant chemotherapy are patients with ER-negative and/or Her2Neu-positive expressing tumors, whose pathologically complete response (pCR) rates can approach 65% (in Her2Neu-positive cancers) and predict long-term survival. (medscape.com)
  • 2 cm in diameter, as adjuvant therapy following neoadjuvant chemotherapy and surgery (see sections 4.4 and 5.1). (who.int)
  • The clinical benefit demonstrated by those drugs in advanced disease has triggered several adjuvant and neoadjuvant trials testing them in combination with chemotherapy, but also without conventional chemotherapy, using single or dual HER2-targeting drugs. (carcinogenesis.com)
  • Patients were randomly assigned to receive neoadjuvant chemotherapy with concurrent administration of either the triplet combination or intravenous pertuzumab and intravenous trastuzumab during the neoadjuvant and adjuvant therapies. (ascopost.com)
  • For medically fit patients, perioperative neoadjuvant chemotherapy or chemoradiotherapy followed by surgery is appropriate. (medscape.com)
  • Virginia G. Kaklamani, MD, DSc, and Melinda L. Telli, MD, review the various adjuvant therapy options available for patients with HER2+ early breast cancer based on stage, risk status, and whether or not they had received neoadjuvant therapy, and then touch on clinical data supporting the use of fixed-dose pertuzumab/trastuzumab (PH) in this setting. (onclive.com)
  • Assuming a patient hasn't received neoadjuvant therapy and they're coming in after surgery, the NCCN Guidelines are relatively vague as to whether to give trastuzumab-based chemotherapy in small tumors. (onclive.com)
  • A combinatorial biomarker predicts pathologic complete response to neoadjuvant lapatinib and trastuzumab without chemotherapy in patients with HER2+ breast cancer. (cdc.gov)
  • The goal of these response through neoadjuvant chemotherapy, policies is to establish collective guidelines to particularly usinga nthracyclines and taxanes-based increase health and quality of life through combination, surgery, radiotherapy and hormone- prevention, treatment of disease and health based therapy5. (bvsalud.org)
  • Trastuzumab extends survival of women with HER2-overexpressing metastatic breast cancer, and the HERA trial is one of several trials that were initiated to determine whether this treatment would benefit patients with early-stage disease as well. (cancer.gov)
  • The use of trastuzumab, chemotherapy and surgery among women with HER2-positive metastatic breast cancer significantly improved survival from the time central nervous system metastases were diagnosed. (medicalxpress.com)
  • The safety and efficacy of trastuzumab-containing combination therapies (with chemotherapy, hormone blockers, or lapatinib) for the treatment of metastatic breast cancer. (wikipedia.org)
  • Trastuzumab has had a "major impact in the treatment of HER2-positive metastatic breast cancer. (wikipedia.org)
  • Systemic adjuvant chemotherapy with anthracycline- and taxane-containing regimens has become the standard first line treatment for early and metastatic breast cancer [ 5 ], with large phase III randomized trials showing extremely high long-term disease-free survival and overall survival rates (resp. (hindawi.com)
  • In fact, reducing the planned dose intensity of systemic adjuvant chemotherapy regimens by as little as 15% has been shown to significantly reduce time to progression and overall survival rates in women with metastatic breast cancer [ 5 ]. (hindawi.com)
  • Trastuzumab is indicated for the treatment of certain HER2-positive early stage and metastatic breast cancer as well as HER2-positive metastatic gastric cancer. (prnewswire.com)
  • Eligible patients had centrally confirmed, measurable HER2-positive metastatic breast cancer without prior chemotherapy or trastuzumab for metastatic disease. (prnewswire.com)
  • Use in combination with docetaxel for treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. (ascopost.com)
  • Hope S. Rugo, MD , of the University of California San Francisco Comprehensive Cancer Center, discusses trial data on margetuximab plus chemotherapy, which improved progression-free survival in patients with previously treated HER2-positive metastatic breast cancer when compared with trastuzumab plus chemotherapy. (ascopost.com)
  • The international open-label EMILIA study involved 991 patients with HER2 -positive locally advanced breast cancer or metastatic breast cancer who had previously been treated with trastuzumab and a taxane chemotherapy. (medscape.com)
  • Trastuzumab deruxtecan is already approved by the U.S. Food and Drug Administration (FDA) for the treatment of HER2-positive metastatic breast cancer . (cancer.net)
  • LBA15 - Primary outcome of the phase III SYD985.002/TULIP trial comparing [vic-]trastuzumab duocarmazine to physician's choice treatment in patients with pre-treated HER-positive locally advanced or metastatic breast cancer. (cancernetwork.com)
  • Evidence-based recommendations on trastuzumab deruxtecan (Enhertu) for treating HER2-positive unresectable or metastatic breast cancer after 1 or more anti-HER2 treatments in adults. (bvsalud.org)
  • Docetaxel-based chemotherapy regimens have substantially improved survival and recurrence rates for cancer patients. (hindawi.com)
  • The low incidence of adverse effects and chemotherapy dose changes, delays, and withdrawals supports the use of lenograstim as effective primary prophylaxis in South African patients being treated with a docetaxel-based regimen. (hindawi.com)
  • G-CSFs have been shown to reduce overall mortality risk [ 8 , 11 ], reduce the incidence of other adverse events (grade 2 or greater anaemia, asthenia, anorexia, myalgia, nail disorders, and oral mucositis) associated with docetaxel-based chemotherapy regimens, and increase health related quality of life and consequently treatment compliance [ 8 , 12 ]. (hindawi.com)
  • If your doctor recommends you stop docetaxel due to side effects, you may still be able to continue treatment with pertuzumab and trastuzumab. (lbbc.org)
  • Biocon Biologics Ltd), BT-ON013 - following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel - in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. (who.int)
  • We knew from research that the combining pertuzumab, trastuzumab and docetaxel helps people with HER2 positive advanced breast cancer. (cancerresearchuk.org)
  • There were] nearly 5000 patients, and they had the choice of an anthracycline-taxane-based chemotherapy backbone with trastuzumab or the docetaxel-carboplatin regimen with trastuzumab. (onclive.com)
  • It requires only a short infusion every 3 weeks, lacks cumulative toxicity, and has a response rate as first-line chemotherapy that is about the same as that of docetaxel and trastuzumab, with apparently longer remissions," he wrote. (medscape.com)
  • Patients were randomly assigned (1:1) to receive six cycles of either P013 (CinnaGen, Iran) or the originator product (Perjeta, Roche, Switzerland) along with trastuzumab, carboplatin, and docetaxel every 3 weeks. (bvsalud.org)
  • Patients in the observation group who were disease free and did not have heart problems (a possible side effect of trastuzumab) were given the option of crossing over to receive trastuzumab because initial results of the HERA trial had shown a clear benefit in terms of reducing recurrence risk with 1 year of trastuzumab. (cancer.gov)
  • The FDA also approved 1 year of extended adjuvant neratinib after chemotherapy and a year of trastuzumab for HER2-positive breast cancer on the basis of the ExteNET trial. (carcinogenesis.com)
  • Most of us will use the APT [adjuvant paclitaxel-trastuzumab] regimen with weekly paclitaxel and a year of trastuzumab. (onclive.com)
  • [7] This showed that this regimen had efficacy that was numerically similar to the 1 year of trastuzumab, but the study was not powered to demonstrate statistical significance. (scielo.org.za)
  • The latest analysis "provides further assurance" that giving trastuzumab after standard chemotherapy is effective for treatment of early HER2-positive breast cancer and that such treatment "continues to show a generally favorable safety profile with a low rate of congestive heart failure," Dr. Joensuu wrote. (cancer.gov)
  • Trastuzumab after Chemotherapy Is Effective in HER2-Positive Breast Cancer was originally published by the National Cancer Institute. (cancer.gov)
  • medical citation needed] In early-stage HER2-positive breast cancer, trastuzumab-containing regimens improved overall survival (Hazard ratio (HR) = 0.66) and disease-free survival (HR = 0.60). (wikipedia.org)
  • The original studies of trastuzumab showed that it improved overall survival in late-stage (metastatic) HER2-positive breast cancer from 20.3 to 25.1 months. (wikipedia.org)
  • The FDA approved margetuximab (Margenza) in combination with chemotherapy for third-line use in patients with metastatic HER2-positive breast cancer, although the National Comprehensive Cancer Network (NCCN) guidelines recommended it in the fourth-line or later. (medpagetoday.com)
  • The trial team found that the combination of pertuzumab, trastuzumab and a taxane helped people with HER2 positive breast cancer that had spread. (cancerresearchuk.org)
  • The regulatory submission for proposed biosimilar Trastuzumab in Europe takes us a step closer towards enabling affordable access to this critical biologic therapy for the treatment of HER2-positive breast cancer. (prnewswire.com)
  • Currently, most patients with HER2-positive breast cancer receive trastuzumab and pertuzumab at infusion centers. (ascopost.com)
  • One is called trastuzumab (Herceptin ) and it is commonly given to women with early HER2 positive breast cancer or with advanced HER2 positive breast cancer that has spread to other parts of the body. (her2support.org)
  • Despite the significant clinical benefit associated with adjuvant trastuzumab, ~90% of patients in South Africa (SA) with HER2-positive breast cancer do not currently have access to adjuvant trastuzumab. (scielo.org.za)
  • Treatment [vic]-trastuzumab duocarmazine improved progression-free survival for patients with pretreated, metastatic HER2-positive breast cancer when compared with physician's choice chemotherapy. (cancernetwork.com)
  • vic]-trastuzumab duocarmazine) can provide a new treatment option for patients with pretreated, locally advanced or metastatic HER2-positive breast cancer," said study author Cristina Saura Manich, MD, PhD, head of the Breast Cancer Unit of the Service of Medical Oncology at Vall d'Hebron University Hospital in Barcelona, Spain, while presenting the findings. (cancernetwork.com)
  • METHODS: This randomized, phase III, multicenter, equivalency clinical trial was conducted on chemotherapy-naive women with HER2-positive breast cancer. (bvsalud.org)
  • clarification needed] It was difficult to accurately ascertain the true impact of trastuzumab on survival, as in three of the seven trials, over half of the patients in the control arm were allowed to cross-over and receive trastuzumab after their cancer began to progress. (wikipedia.org)
  • After surgery, you will receive trastuzumab either weekly or once every 3 weeks for a total of a year. (lbbc.org)
  • With a new administration route, [this triplet] offers an outpatient option for patients to receive trastuzumab and pertuzumab," said Richard Pazdur, MD , Director of the FDA's Oncology Center of Excellence and Acting Director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research. (ascopost.com)
  • The first was trastuzumab, which was followed by lapatinib ( Tykerb ) and pertuzumab ( Perjeta ). (medscape.com)
  • Treatment with trastuzumab (Herceptin®) for 1 year following standard chemotherapy improved disease-free survival in women with HER2-positive early breast cancer. (cancer.gov)
  • It is surprising that chemotherapy/trastuzumab adds to these women's survival," Brufsky said. (medicalxpress.com)
  • Thus, this analysis likely underestimates the true survival benefit associated with trastuzumab treatment in this population. (wikipedia.org)
  • The combination of trastuzumab with chemotherapy has been shown to increase both survival and response rate, in comparison to trastuzumab alone. (wikipedia.org)
  • FOLFOX-trastuzumab was superior to ToGA schemes in terms of overall survival (OS), with a greater magnitude of effect in IHC 2+/FISH+ tumors (HR 0.47, 0.24-0.92) compared with IHC 3+ (HR 0.69, 0.49-0.96), and in diffuse (HR 0.37, 0.20-0.69) versus intestinal-type tumors (HR 0.76, 0.54-1.06). (gencat.cat)
  • Major Cancer and Leukemia Group B (CALGB) chemotherapy clinical trials have consistently shown that chemotherapy produces significantly better disease-free and overall survival, particularly in patients with ER-negative disease. (medscape.com)
  • Furthermore, lenograstim may increase the patient's exposure to chemotherapy allowing patients to receive optimal dosing and duration of treatment, benefitting survival. (hindawi.com)
  • With the addition of trastuzumab, a monoclonal antibody targeting the human epidermal growth factor receptor-2 (HER2), improvements in overall survival have been observed among patients with advanced HER2-positive disease. (carcinogenesis.com)
  • This subtype accounts for approximately 20%-30% of invasive breast cancers, and until the discovery of effective anti-HER2 therapies ( first of which is trastuzumab), was associated with reduced disease-free survival (DFS), increased risk of metastases, and shorter overall survival (OS). (carcinogenesis.com)
  • When used alone, chemotherapy is not an effective treatment for esophageal cancer or long-term survival. (epnet.com)
  • Javier Cortes, MD, PhD , of the IOB Institute of Oncology, discusses study findings that suggested pembrolizumab offered a prolonged survival benefit compared to chemotherapy for a subset of patients with previously treated metastatic triple-negative breast cancer. (ascopost.com)
  • Trastuzumab is an antibody that blocks the HER2 receptor, and adjuvant trastuzumab has been shown to increase overall survival (OS) and disease-free survival (DFS) in HER2-positive patients, but is associated with a risk of adverse cardiac events. (scielo.org.za)
  • However, a new study confirms that it is probable that a much shorter course, given for 9 weeks, will increase the survival and DFS rates in patients compared with no trastuzumab, as there is no major loss of effectiveness. (scielo.org.za)
  • [4] It is estimated that the 9-week course of trastuzumab has a hazard ratio (HR) of 0.7 compared with no trastuzumab, and results in a 30% increase in patient survival. (scielo.org.za)
  • A Cochrane systematic review and meta-analysis of adjuvant trastuzumab has shown a clinically significant improvement in survival. (scielo.org.za)
  • The 10-year survival rates for regimens with no adjuvant trastuzumab and for the 1-year trastuzumab regimens were 63% and 69%, respectively. (scielo.org.za)
  • A statically significant gain in overall survival was seen in patients who received the combined treatment of trastuzumab and chemotherapy. (wjgnet.com)
  • The finding comes from the third analysis of the Herceptin Adjuvant (HERA) trial , a large multicenter study that compared outcomes in patients randomly assigned to receive standard chemotherapy followed by trastuzumab with those in patients randomly assigned to receive chemotherapy alone (the observation group). (cancer.gov)
  • They may work when standard chemotherapy drugs have not worked. (epnet.com)
  • 2008). Patients receiving chemotherapy with a goal of cure must receive full doses of standard chemotherapy on schedule to achieve optimal outcomes (Bonadonna et al. (medscape.com)
  • This study looked at pertuzumab (Perjeta) and trastuzumab (Herceptin) with a taxane chemotherapy drug. (cancerresearchuk.org)
  • Genentech) and a taxane chemotherapy. (empr.com)
  • T-DM1 is indicated for patients who were previously treated with the anti- HER2 therapy trastuzumab ( Herceptin , Genentech) and a taxane chemotherapy. (medscape.com)
  • OS was best in patients who were treated with a trastuzumab-containing regimen, at 11.9 months, and was worse for those who received monotherapy, they add. (medscape.com)
  • The authors recommend that best supportive care be offered to patients who cannot tolerate a dual chemotherapy regimen. (medscape.com)
  • Seven of these patients were treated with a triplet, five were treated with a doublet, two with monotherapy, and three with a trastuzumab-containing regimen. (medscape.com)
  • If someone has brain metastases, I would recommend the HER2CLIMB regimen of tucatinib [Tukysa] with trastuzumab and capecitabine," McCann said. (medpagetoday.com)
  • On January 15, 2021, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. (ecancer.org)
  • The 12-month adjuvant trastuzumab regimen was chosen empirically, and was supported by the HERceptin Adjuvant (HERA) trial. (scielo.org.za)
  • [5] In 5 102 patients, a regimen of adjuvant chemotherapy with no adjuvant trastuzumab was compared with regimens of either 1 or 2 years of adjuvant trastuzumab. (scielo.org.za)
  • In the PHARE trial, [6] 6 months of adjuvant trastuzumab was shown to be marginally less effective than the 12-month regimen in terms of DFS in a non-inferiority study. (scielo.org.za)
  • The standard second treatment for people with this type of cancer is the chemotherapy paclitaxel (available as a generic drug) with ramucirumab (Cyramza). (cancer.net)
  • A total of 188 patients were randomised (2:1) to receive fam-trastuzumab deruxtecan-nxki 6.4 mg/kg intravenously every 3 weeks or physician's choice of either irinotecan or paclitaxel monotherapy. (ecancer.org)
  • Confirmed ORR was 40.5% (95% CI: 31.8, 49.6) in the fam-trastuzumab deruxtecan-nxki arm compared with 11.3% (95% CI: 4.7, 21.9) for those receiving irinotecan or paclitaxel. (ecancer.org)
  • Median PFS was 5.6 months (95% CI: 4.3, 6.9) in the fam-trastuzumab deruxtecan-nxki arm compared to median PFS of 3.5 months (95% CI: 2.0, 4.3) in the irinotecan or paclitaxel arm. (ecancer.org)
  • Datopotamab deruxtecan is central to the future we envision where antibody drug conjugates improve upon and ultimately displace entrenched standards of care, like chemotherapy, in multiple cancer types. (businesswire.com)
  • This is particularly noteworthy considering datopotamab deruxtecan was also associated with a lower burden of treatment-related severe adverse events than chemotherapy. (businesswire.com)
  • Now, 2 studies have shown promise for a new drug called trastuzumab deruxtecan (Enhertu) in treating people with advanced stomach or esophageal cancer or metastatic colorectal cancer when the first or second treatments do not work. (cancer.net)
  • Trastuzumab deruxtecan is a combination of a drug that is similar to trastuzumab, called a biosimilar , linked to a small amount of a strong chemotherapy. (cancer.net)
  • The first study involving trastuzumab deruxtecan, called DESTINY Gastric-01 , was a phase II clinical trial of people with locally advanced or metastatic HER2-positive stomach cancer or esophageal cancer that was not stopped by treatment with trastuzumab. (cancer.net)
  • In the study, patients were randomly assigned to groups receiving either trastuzumab deruxtecan (125 patients) or the doctor's choice of chemotherapy (62 patients). (cancer.net)
  • The cancer shrunk in a little more than half (51%) of the patients who received trastuzumab deruxtecan compared with about 14% of patients who received chemotherapy. (cancer.net)
  • The recommended fam-trastuzumab deruxtecan-nxki dose for gastric cancer is 6.4 mg/kg administered as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. (ecancer.org)
  • The side effects that caused people to stop pertuzumab and trastuzumab were heart-related problems. (cancerresearchuk.org)
  • Pertuzumab/trastuzumab/hyaluronidase-zzxf showed noninferior pertuzumab and trastuzumab serum trough concentrations compared to intravenous pertuzumab and trastuzumab. (ascopost.com)
  • The safety profile of pertuzumab/trastuzumab/hyaluronidase-zzxf is comparable to intravenous pertuzumab and trastuzumab, except for increased administration-related reactions. (ascopost.com)
  • Background: Trastuzumab combined with cisplatin and fluoropyrimidines, either capecitabine or 5-fluorouracile (XP/FP), is the standard first-line treatment for advanced, HER2-positive, gastric cancer patients based on the ToGA trial. (gencat.cat)
  • The usefulness of HER2 targeted therapy in gastric cancer was demonstrated in the ToGA trial, where HER2-positive patients with advanced gastric and gastroesophageal junction adenocarcinoma were randomized to receive 5-FU/capecitabine and cisplatin, either alone or in combination with trastuzumab. (wjgnet.com)
  • Trastuzumab is a monoclonal antibody that targets tumor cells that overproduce a protein called HER2 and interferes with their growth. (cancer.gov)
  • Trastuzumab, sold under the brand name Herceptin among others, is a monoclonal antibody used to treat breast cancer and stomach cancer. (wikipedia.org)
  • HERZUMA (trastuzumab-pkrb) is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2 . (rxlist.com)
  • Trastuzumab is a type of targeted therapy called a monoclonal antibody that works by targeting HER2 proteins on cancer cells to stop cancer growth. (cancer.net)
  • Secondary endpoints included cycle 7 trastuzumab serum trough concentration, pathologic complete response, and safety. (ascopost.com)
  • The pathologic complete response rate was 59.7% (95% confidence interval [CI] = 53.3%-65.8%) in the pertuzumab/trastuzumab/hyaluronidase-zzxf arm and 59.5% (95% CI = 53.2%-65.6%) in the intravenous pertuzumab and intravenous trastuzumab arm. (ascopost.com)
  • It was an accelerated approval based on phase 2 trials showing increase in the rate of pCR [pathologic complete response] with the addition of pertuzumab to chemotherapy and trastuzumab. (onclive.com)
  • The optimal duration of add-on trastuzumab treatment after surgery for early breast cancer is unknown. (wikipedia.org)
  • Herzuma (trastuzumab-pkrb) is a HER2 /neu receptor antagonist indicated for the treatment of HER2-overexpressing breast cancer . (rxlist.com)
  • Neratinib: A tyrosine kinase inhibitor approved for the extended adjuvant treatment of patients with early-stage Her2Neu-positive breast cancer, following adjuvant trastuzumab-based therapy. (medscape.com)
  • Patients with ER-positive, Her2Neu-negative locally advanced breast cancer (LABC) are unlikely to achieve a pCR from currently available chemotherapy. (medscape.com)
  • BENGALURU, India and HERTFORDSHIRE, England and PITTSBURGH , Aug. 25, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) announced today that the European Medicines Agency (EMA) has accepted for review Mylan's Marketing Authorization Application (MAA) for a proposed biosimilar Trastuzumab, which is used to treat certain HER2-positive breast and gastric cancers. (prnewswire.com)
  • The antibody homes in on HER2 breast cancer cells, delivering the chemotherapy directly to the tumor, which reduces the risk for toxicity. (medscape.com)
  • This study is looking at how well the drug elimusertib (a type of targeted therapy known as an ATR inhibitor) works when combined with chemotherapy for treating people with advanced cancers, including urothelial, ovarian, gastric, endometrial, triple-negative breast cancer and others. (facingourrisk.org)
  • Conclusion: We have updated the external validity of clinical trials with trastuzumab in first-line treatment of gastric cancer. (gencat.cat)
  • Trastuzumab resistance accounts for chemotherapy failure in gastric cancer patients in clinical practice. (techscience.com)
  • This study aimed to identify the specific role of lncRNA-ATB in gastric cancer progression and trastuzumab resistance. (techscience.com)
  • The standard first treatment for people with HER2-positive stomach or esophageal cancer is the targeted therapy trastuzumab (Herceptin, Herceptin Hylecta, Herzuma, Ogivri, Ontruzant) given with chemotherapy. (cancer.net)
  • Trastuzumab is given with chemotherapy every three weeks through a drip into a vein. (cancercouncil.com.au)
  • Patients in the trastuzumab group had a roughly 24 percent lower risk of disease [than those in the observation group], and the difference between groups was highly statistically significant . (cancer.gov)
  • In May 2021, the FDA approved pembrolizumab in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of people with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. (wikipedia.org)
  • Both trastuzumab- and targeted therapy-containing regimens showed significantly better OS and TTF than fluoropyrimidine doublets," the authors observe. (medscape.com)
  • Chemotherapy based around a doublet or triplet platinum/fluoropyrimidine combination is given for metastatic disease. (medscape.com)
  • Efficacy was evaluated in a multicenter, open-label, randomised trial (DESTINY-Gastric01, NCT03329690) in patients with HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma who had progressed on at least two prior regimens, including trastuzumab, a fluoropyrimidine- and a platinum-containing chemotherapy. (ecancer.org)
  • Since then, chemotherapy has been one of the main therapeutic strategies in cancer treatment, but, to paraphrase Paul Ehrlich, resistance has followed as a faithful shadow. (nature.com)
  • Two trials involving shorter term treatment with trastuzumab did not differ in efficacy from longer trials, but produced less cardiac toxicity. (wikipedia.org)
  • It is possible to determine the "erbB2 status" of a tumor, which can be used to predict efficacy of treatment with trastuzumab. (wikipedia.org)
  • If it is determined that a tumor is overexpressing the erbB2 oncogene and the patient has no significant pre-existing heart disease, then a patient is eligible for treatment with trastuzumab. (wikipedia.org)
  • It is surprising that although trastuzumab has great affinity for HER2 and high doses can be administered (because of its low toxicity), 70% of HER2+ patients do not respond to treatment. (wikipedia.org)
  • Debate about treatment duration has become a relevant issue for many public health policy makers because administering trastuzumab for a year is very expensive. (wikipedia.org)
  • The length of treatment depends upon the cancer type and how responsive it is to the chemotherapy. (curesearch.org)
  • Furthermore, they can lead to delays and dose reductions in chemotherapy treatment, thereby potentially compromising the efficacy of chemotherapy and, consequently, patient outcome [ 10 ]. (hindawi.com)
  • There is strong and consistent clinical evidence to show that granulocyte-colony stimulating factors (G-CSFs) reduce the risk of chemotherapy-induced neutropenia and therefore complicated neutropenia and can be used to maintain chemotherapy at the desired dose intensity or density and minimize delays in treatment [ 11 ]. (hindawi.com)
  • You and your doctor will discuss the best chemotherapy treatment for your situation. (lbbc.org)
  • Tell your doctor about any medicines you are taking, including vitamins, herbal supplements, and over-the counter-medicines, to make sure they will not interfere with your chemotherapy treatment. (lbbc.org)
  • An analysis of real-world use of first-line palliative treatment for metastatic esophagogastric cancer supports the use of doublet regimens over triplet chemotherapy protocols. (medscape.com)
  • For the study, the team identified 2204 patients with synchronous metastatic esophgogastric cancer who underwent treatment with some form of systemic chemotherapy from 2010 to 2016 from the Netherlands Cancer Registry. (medscape.com)
  • Systemic treatment strategies were divided into monotherapy, doublet and triplet chemotherapy," van Laarhoven and colleagues note. (medscape.com)
  • Regimens containing trastuzumab (multiple brands) were singled out as a singular treatment strategy. (medscape.com)
  • as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. (who.int)
  • BT-ON013 trade name] treatment should only be initiated by a health care provider experienced in the administration of cytotoxic chemotherapy (see section 4.4), and should be administered by a health care provider only. (who.int)
  • The main treatment option in the frontline setting remains the combination of chemotherapy, typically taxanes, with HER2-targeting agents, most often trastuzumab and pertuzumab [Perjeta]," Ganesan said. (medpagetoday.com)
  • Generally, any positive effects from chemotherapy treatment alone are short-lived. (epnet.com)
  • TDM-1 does not provide a "major change in prognosis" for women with metastatic disease who have progressed on trastuzumab treatment, he wrote, adding that it is likely to be "very expensive. (medscape.com)
  • The treatment of BC is very complex, and include the combination of surgery, chemotherapy, radiotherapy, hormonetherapy and immunotherapy. (isciii.es)
  • The present paper reviews the potential therapeutic value of such mAbs in the treatment of recurrent malignancies, especially those having failed chemotherapy in established clinical trials. (jcancer.org)
  • This column reviews the history and pathophysiology of treatments for CINV, as well as patient- and chemotherapy-specific risk factors that should be considered to optimize treatment outcomes in patients with CINV. (medscape.com)
  • Patients with cancer often approach chemotherapy treatment with preconceived ideas about what their experience will entail. (medscape.com)
  • The cumulative doses of trastuzumab and pertuzumab [Time Frame: After end of treatment, an average of 1 year after inclusion. (who.int)
  • If you have HER2 positive advanced stomach or gastro-oesophageal junction cancer, you may be given a targeted therapy drug called trastuzumab. (cancercouncil.com.au)
  • INCHEON, Korea--( BUSINESS WIRE )-- Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved a 420 mg multi-dose vial of ONTRUZANT ® (trastuzumab-dttb), a biosimilar referencing HERCEPTIN ® i (trastuzumab). (biospace.com)
  • Herzuma (trastuzumab-pkrb) is biosimilar to Herceptin (trastuzumab). (rxlist.com)
  • Mylan and Biocon, which have co-developed this proposed biosimilar, anticipate that this may be the first MAA for a Trastuzumab biosimilar accepted by the EMA for review. (prnewswire.com)
  • The PK study had demonstrated measured bioequivalence of Mylan's and Biocon's proposed Trastuzumab biosimilar relative to that of the reference drug. (prnewswire.com)
  • The second study, the 'HERITAGE Study', evaluated the efficacy, safety and immunogenicity of the proposed biosimilar Trastuzumab in comparison to branded Trastuzumab. (prnewswire.com)
  • The acceptance of our regulatory submission of our proposed biosimilar Trastuzumab in Europe is another example of the strong progress we continue to make across our broad biosimilars portfolio. (prnewswire.com)
  • The proposed biosimilar Trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace. (prnewswire.com)
  • Mylan has exclusive commercialization rights for the proposed biosimilar Trastuzumab in the U.S., Canada , Japan , Australia , New Zealand , the European Union and European Free Trade Association countries. (prnewswire.com)
  • The Phase III study, HERITAGE, is a double-blind, randomized clinical trial designed to evaluate comparative efficacy and safety of the proposed trastuzumab biosimilar, MYL-1401O, versus branded trastuzumab. (prnewswire.com)
  • The biosimilar finds the HER2-positive cancer cells and then releases the chemotherapy to destroy them. (cancer.net)
  • In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab products in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. (biospace.com)
  • Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. (medscape.com)
  • Combination chemotherapy regimens are standard recommendations in the adjuvant setting. (medscape.com)
  • Trastuzumab [Herceptin] was the first, but we now have a wealth of effective therapeutics that in combination can change the natural history of this disease. (medpagetoday.com)
  • Chemotherapy for esophageal cancer is most often used in combination with radiation therapy (called chemoradiation). (epnet.com)
  • A medical oncologist will determine how many cycles of chemotherapy are needed and what combination of drugs will work best. (epnet.com)
  • Varubi indicated for use in combination with other antiemetic agents to treat delayed chemotherapy-induced nausea and vomiting in adults. (pharmacytimes.com)
  • The FDA has approved intravenous (IV) rolapitant (Varubi) for use in combination with other antiemetic agents to treat delayed chemotherapy-induced nausea and vomiting (CINV) in adults, according to Tesaro, the manufacturer of the agent. (pharmacytimes.com)
  • Trastuzumab in combination with adjuvant chemotherapy has changed the natural history of early Her-2 positive BC. (isciii.es)
  • As such we plan to eventually employ the therapeutic mAbs in combination with chemotherapy as a means of enhancing the immunogenicity of the tumor system being treated and to possibly weaken the malignant growth for easier destruction by the mAb. (jcancer.org)
  • it is an antibody-drug conjugate in which the HER2 -targeted antibody trastuzumab is chemically linked to the cytotoxin mertansine (DM1). (medscape.com)
  • Some 45% of patients received doublet chemotherapy, and another 34% received triplet chemotherapy, the authors note. (medscape.com)
  • We also review the data the efficacy and safety of anthracycline-based and nonanthracycline-based adjuvant chemotherapy regimens combined with trastuzumab, and optimum chemotherapy regimens in small HER2-positive tumors. (carcinogenesis.com)
  • Administration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. (rxlist.com)
  • New evidence of the activity and lower toxicity of the short course of trastuzumab has now come from the Italian Short HER study, [4] presented at the prestigious meeting of the American Society of Clinical Oncology recently but not yet fully published. (scielo.org.za)
  • Our data confirm the comparable outcomes of ToGA regimens and CAPOX-trastuzumab in clinical practice and point toward a possible benefit of FOLFOX-trastuzumab, contingent on the subtypes typically less sensitive to trastuzumab, to be confirmed in clinical trials. (gencat.cat)
  • [1] Although chemotherapy has improved outcomes for patients, the marginal benefits achieved with cytotoxic agents seem to have reached a plateau. (carcinogenesis.com)
  • This is based on data coming from the Netherlands looking at a prospective cohort of patients, [where the] T1b patients receiving trastuzumab have better outcomes. (onclive.com)
  • Prevention of chemotherapy-induced nausea and vomiting (CINV) is crucial in maximizing patients' quality of life and optimizing outcomes of cancer therapy, and can be done more effectively than ever before. (medscape.com)
  • Based on these study results, lead researcher Adam Brufsky, M.D., Ph.D., said, "We clearly now know that these women should get trastuzumab and potentially chemotherapy, even if cancer spreads to the brain. (medicalxpress.com)
  • These newer treatments may be used outside of or along with more conventional cancer treatments, like chemotherapy and radiation therapy . (healthline.com)
  • Chemotherapy is a general term for medications used to destroy or stop the growth of cancer cells. (curesearch.org)
  • This Children's Cancer and Chemotherapy video explains how cancer treatments are developed and administered. (curesearch.org)
  • Chemotherapy works by interfering with the ability of cancer cells to divide and duplicate themselves. (curesearch.org)
  • Chemotherapy can be given through the bloodstream to reach cancer cells all over the body, or it can be delivered directly to specific cancer sites. (curesearch.org)
  • Chemotherapy is given in different ways depending on the cancer type and the medicines used. (curesearch.org)
  • The TROPION-Lung01 results demonstrate for the first time that an antibody drug conjugate can delay disease progression or death for longer than conventional chemotherapy in patients with advanced non-small cell lung cancer. (businesswire.com)
  • Trastuzumab attaches to HER2 proteins on the surface of HER2-positive cancer cells and blocks the signals that cause cancer cells to multiply. (lbbc.org)
  • It is designed to target and inhibit HER2 signaling and deliver the chemotherapy directly inside HER2-positive cancer cells. (empr.com)
  • Chemotherapy and targeted therapy are used to treat esophageal cancer. (epnet.com)
  • Chemotherapy uses drugs to kill cancer cells. (epnet.com)
  • Chemotherapy for esophageal cancer may given before or after surgery . (epnet.com)
  • Chemotherapy regimens for esophageal cancer have been found to work better when drugs are combined. (epnet.com)
  • Unlike chemotherapy, targeted therapy drugs attack cancer cells without harming healthy cells. (epnet.com)
  • Current targeted therapy options for esophageal cancer include trastuzumab and ramucirumab. (epnet.com)
  • It has been approved to treat advanced stomach or gastro-oesophageal junction cancer that has not responded to chemotherapy. (cancercouncil.com.au)
  • The objective was to evaluate the external validity of clinical trials with chemotherapy and trastuzumab. (gencat.cat)
  • This filing includes analytical, functional and pre-clinical data, as well as results from the pharmacokinetics (PK) and confirmatory efficacy/safety global clinical trials for Trastuzumab. (prnewswire.com)
  • The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens. (rxlist.com)
  • Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. (who.int)
  • It attaches to the HER2 protein in a different way from trastuzumab, so the two medicines work together well. (lbbc.org)
  • vic]-trastuzumab duocarmazine is an antibody drug conjugate that targets the HER2 protein and is composed of trastuzumab that is bound to duocarmycin, a linker drug. (cancernetwork.com)
  • Luca Gianni, M.D., of the San Raffaele Institute in Milan, Italy, and his colleagues randomly assigned 1,703 women to receive 1 year of adjuvant therapy with trastuzumab and 1,698 women to the observation group. (cancer.gov)
  • Patients were randomly assigned to receive adjuvant T-DM1 or trastuzumab for 14 cycles. (nih.gov)
  • Many healthcare providers tend to believe that CINV is no longer an unmet need but the reality is that more than half of patients treated with emetogenic chemotherapy experience delayed CINV, even when prescribed standard preventative therapies, such as a 5-HT3 receptor antagonist and dexamethasone," Lee Schwartzberg, MD, professor of Medicine at University of Tennessee Health Science Center, said in a statement. (pharmacytimes.com)
  • Our Herzuma (trastuzumab-pkrb) for Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. (rxlist.com)
  • HERZUMA (trastuzumab-pkrb) is a sterile, white to pale yellow, preservative-free lyophilized powder for injection, for intravenous administration. (rxlist.com)
  • Each multiple-dose vial of HERZUMA delivers 420 mg trastuzumab-pkrb, 839 mg α,α-trehalose dihydrate, 9.5 mg L-histidine HCl, 6.1 mg L-histidine, and 1.7 mg polysorbate 20. (rxlist.com)
  • [ 3 ] . For patients who received preoperative chemotherapy, the addition of postoperative radiotherapy has not demonstrated additional benefit. (medscape.com)
  • Trastuzumab, when used with chemotherapy, may help stop tumor growth in cancers with an excess amount of HER2. (epnet.com)
  • Delayed nausea and vomiting occurs between 25 and 120 hours after chemotherapy. (pharmacytimes.com)
  • We will continue our efforts to expand awareness of delayed chemotherapy-induced nausea and vomiting, and plan to make this important medicine available next month. (pharmacytimes.com)
  • Similar to realtors' mantra of "location, location, location," oncology nurses should have the mantra "prevention, prevention, prevention" foremost on their minds when assessing and developing a plan of care for controlling chemotherapy-induced nausea and vomiting (CINV). (medscape.com)
  • Poorly controlled nausea or vomiting associated with chemotherapy increases risk of developing anticipatory nausea and vomiting, which ranges from 18%-57% in incidence (NCCN, 2012a). (medscape.com)