scholarly journals Survival Benefit in Early Stage Breast Cancer of Herceptin Plus a Chemotherapy Regimen Lacking Adriamycin

2006 ◽  
Vol 5 (1) ◽  
pp. 9-9
Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Yajie Ji ◽  
Siyu Li ◽  
Xinyue Zhang ◽  
Yu Liu ◽  
Qing Lu ◽  
...  

Abstract Background Traditional Chinese medicine (TCM) has a long history of use in breast cancer, but lacking systematic evidence to support its clinical benefits. In this study, we evaluated the prophylactic and therapeutic effects of moxibustion combined with decoctions for treating chemotherapy-induced myelosuppression (CIM) in early-stage breast cancer patients. Methods This is a randomized controlled clinical trial single-blinded for TCM decoction but not moxibustion. Patients are equally divided into the control group without decoction and moxibustion treatment (control), the decoction+moxibustion group (MD), and the placebo+moxibustion group (MP), according to the following stratification factors: age (below 40s, 40s, 50s, and 60s or above), chemotherapy regimen (anthracyclines, taxanes, anthracyclines+taxane, and others), and chemotherapy strategy (adjuvant and neoadjuvant). The TCM decoction is Wenshen Shengbai Decoction. The anticipated sample size is 462 cases (154 cases in each group). All participants are expected to treat with chemotherapy and recombinant human granulocyte colony-stimulating factor (rhG-CSF). The primary outcomes include the proportion of patients with relief of leukopenia and/or neutropenia, the myelosuppression-associated serious adverse event including grade 3–4 leukopenia and/or neutropenia, and febrile neutropenia, and the dose of rhG-CSF. The secondary outcomes include chemotherapy adherence, stratified analysis, adverse reactions, quality of life by EORTC Breast-Cancer-Specific Quality of Life Questionnaire including EORTC QLQ-C30 (V3.0) and QLQ-BR23, TCM Constitution, and 3-year disease-free survival and overall survival. Baseline information including age, surgical approach, chemotherapy regimen and strategy, pathological stage, and molecular subtype will be recorded. Discussion This will be the first randomized controlled trial to evaluate the efficacy of moxibustion combined with TCM decoction in treating CIM in early-stage breast cancer patients, aiming to standardize the TCM decoction and moxibustion method, thus providing evidence for its clinical benefit. Trial registration chictr.org.cn ChiCTR-INR-16009557. Registered on 23 October 2016.


2020 ◽  
Vol 4 (6) ◽  
Author(s):  
Shlomit S Shachar ◽  
Allison M Deal ◽  
Katherine E Reeder-Hayes ◽  
Kirsten A Nyrop ◽  
Natalia Mitin ◽  
...  

Abstract Background Although chemotherapy saves lives, increasing evidence shows that chemotherapy accelerates aging. We previously demonstrated that mRNA expression of p16INK4a, a biomarker of senescence and molecular aging, increased early and dramatically after beginning adjuvant anthracycline-based regimens in early stage breast cancer patients. Here, we determined if changes in p16INK4a expression vary by chemotherapy regimen among early stage breast cancer patients. Methods We conducted a study of stage I-III breast cancer patients receiving adjuvant or neoadjuvant chemotherapy. p16INK4a expression was analyzed prechemotherapy and postchemotherapy (median 6.2 months after the last chemotherapy) in peripheral blood T lymphocytes. Chemotherapy-induced change in p16INK4a expression was compared among regimens. All statistical tests were 2-sided. Results In 146 women, chemotherapy was associated with a statistically significant increase in p16INK4a expression (accelerated aging of 17 years; P < .001). Anthracycline-based regimens were associated with the largest increases (accelerated aging of 23 to 26 years; P ≤ .008). Nonanthracycline-based regimens demonstrated a much smaller increase (accelerated aging of 9 to 11 years; P ≤ .15). In addition to the type of chemotherapy regimen, baseline p16INK4a levels, but not chronologic age or race, were also associated with the magnitude of increases in p16INK4a. Patients with lower p16INK4a levels at baseline were more likely to experience larger increases. Conclusions Our findings suggest that the aging effects of chemotherapy may be influenced by both chemotherapy type and the patient’s baseline p16INK4a level. Measurement of p16INK4a expression is not currently available in the clinic, but nonanthracycline regimens offering similar efficacy as anthracycline regimens might be favored.


2017 ◽  
Vol 165 (3) ◽  
pp. 771-777 ◽  
Author(s):  
Hikmat Abdel-Razeq ◽  
Lina Marei ◽  
Salwa S. Saadeh ◽  
Hazem Abdulelah ◽  
Mahmoud Abu-Nasser ◽  
...  

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10640-10640
Author(s):  
H. L. McArthur ◽  
J. Barnett ◽  
S. Chia

10640 Background: Given the risk of cardiotoxicity demonstrated with trastuzumab (T) in the MBC literature, adjuvant T trials incorporated stringent cardiac monitoring. In 2005, several of these trials were reported with impressive DFS improvements. As a result of these trials, women in the province of British Columbia with HER-2 positive early stage breast cancer were offered T either concurrently or sequentially with their primary chemotherapy regimen. Given the paucity of data surrounding adjuvant T-mediated cardiotoxicity among the general population, we performed a retrospective review of cardiac toxicity among all patients receiving adjuvant T at the BCCA. Methods: Patients receiving adjuvant T between July 1, 2005 and December 31, 2005 either sequentially or concurrently with their primary chemotherapy regimen were identified by screening the BCCA pharmacy database. A chart review was conducted and the T start date; LVEF values at 0, 3 and 6 months; and patients with symptoms suggestive of congestive heart failure were identified. The mean LVEF values at 0, 3 and 6 months were calculated. Results: 133 patients received adjuvant T alone after completing their primary chemotherapy. The mean baseline LVEF was 60.5%. Of the 101 and 11 patients available for analysis at 3 and 6 months, the mean LVEF was 58.5% and 58.4%, respectively. 5 patients (3.8%) developed symptoms of CHF. 58 patients received adjuvant T concurrently with their primary chemotherapy (four cycles of AC followed by four cycles of concurrent paclitaxel and T). Of these, only 18 patients had an LVEF measured at 0 and 3 months, with a mean LVEF of 64.6% and 63.6%, respectively. Of the 7 patients who also had an LVEF measured at 6 months, the mean was 60.5% for an absolute decrease of 4.1% from baseline. One patient (1.7%) had symptomatic CHF. Conclusions: A clinically meaningful rate of cardiotoxicity is seen with both sequential and concurrent adjuvant T. In particular, we have demonstrated a higher rate of cardiotoxicity with adjuvant T alone than was observed in the HERA trial. These findings support ongoing stringent cardiac monitoring among the general population treated with adjuvant T. [Table: see text]


2018 ◽  
Vol 36 (30) ◽  
pp. 2980-2987 ◽  
Author(s):  
Paaladinesh Thavendiranathan ◽  
Husam Abdel-Qadir ◽  
Hadas D. Fischer ◽  
Ying Liu ◽  
Ximena Camacho ◽  
...  

PurposeTo assess prechemotherapy cardiac imaging practices in relation to patients’ heart failure (HF) risk.MethodsWe performed a population-based retrospective cohort study of women receiving chemotherapy for early-stage breast cancer in Ontario between 2007 and 2012. We surveyed for baseline cardiac imaging 6 months before chemotherapy or within 30 days thereafter. The proportion of patients who underwent imaging and cumulative incidence of major adverse cardiac event (MACE) rates was determined based on chemotherapy regimen and HF risk factors. Logistic regression was used to assess predictors of pretreatment cardiac imaging.ResultsWe studied 18,444 women who had been treated with chemotherapy (median age, 55 years). There was near-universal imaging of women treated with trastuzumab-containing regimens, including those without additional HF risk factors. Women who received anthracyclines without trastuzumab underwent imaging more frequently if they had additional HF risk factors (73.3% v 62.6%; P < .001). The 5-year incidence of MACE was two to six times higher in patients with HF risk factors across all treatment regimens. Patients with HF risk factors who received anthracyclines without trastuzumab had a higher 5-year incidence of MACE (4.5%) than patients without HF risk factors who received trastuzumab without anthracyclines (2.6%). However, cardiac imaging was less frequent in the former group (73.3% v 93.6%; P < .001). Logistic regression indicated that most variation in baseline imaging was related to chemotherapy, followed by physician-level factors. The odds of imaging were doubled with female physicians. Patient-specific factors, including HF risk factors, made minimal contribution to variation in imaging.ConclusionBaseline cardiac imaging was driven by chemotherapy regimen rather than HF risk. This risk-imaging mismatch is an impetus to reconsider current cardiac imaging practices in patients who receive chemotherapy for breast cancer.


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