Active combination with aprepitant, palonosetron, and dexamethasone for preventing emesis of anthracycline-containing regimens in patients with breast cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19512-e19512
Author(s):  
Yoshie Nakayama ◽  
Yoshinori Ito ◽  
Shunji Takahashi ◽  
Kiyohiko Hatake
Keyword(s):  
Breast Cancer ◽  
Acute Phase ◽  
Medical Records ◽  
Complete Response ◽  
Highly Emetogenic Chemotherapy ◽  
Complete Control ◽  
Antiemetic Drugs ◽  
Number Of Patients ◽  
Phase 0 ◽  
Delayed Phase

e19512 Background: Anthracycline and cyclophoshamaide containing regimens for breast cancer are classified as highly emetogenic chemotherapy. Aprepitant (A), palonosetron (P), granisetron (G) or dexamethasone(D) are recommended as antiemetic drugs. However, it is uncertain which combination would be best effective. We have retrospectively examined the efficacy of these antiemetic drugs. Methods: We reviewed the medical records of 501 patients with breast cancer treated with anthracycline and cyclophoshamaide containing regimens between August, 2009 and September, 2010. The combination of GD were G: 3 mg on day1 (i.v.), 2 mg on days 2-6 (p.o.) and D: 16.5 mg on day1 (i.v.), 8mg on days 2-4 (p.o.). The AGD were A: 125 mg on day1 (i.v.), 80 mg on days 2-3 (p.o.), G: 3 mg on day1 (i.v.), 2 mg on days 2-6 (p.o.), and D: 13.2 mg on day1 (i.v.), 4 mg on days 2-4 (p.o.). The APD were A: 125 mg on day1 (i.v.), 80 mg on days 2-3 (p.o.), P: 0.75 mg on day1 ( i.v.), and D: 13.2 mg on day1 (i.v.), 4 mg on days 2-4 (p.o.). Results: The number of patients who were treated with GD, AGD, and APD were 170, 159, and 172, respectively. Complete response (CR) rate in acute phase (0-24h) or delayed phase (24-120h) and complete control (CC) rate in acute or delayed phase in each regimens were summarized in the table. AGD or APD was significantly superior to GD in CR rate of acute or delayed phase (P<0.01). Of note, CC rate of APD in acute phase was significantly superior to AGD (P<0.01). AGD or APD was significantly superior to GD in CC rate in delayed phase. Conclusions: The combination with APD was the most effective antiemetic therapy in patients who were treated with anthracycline and cyclophosphamide containing regimens. [Table: see text]

scholarly journals Comparative study of fosaprepitant and aprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric cancer patients

2021 ◽  
Author(s):  
Li Ting Yu ◽  
zhuo wang ◽  
fen zhou ◽  
Shuangshuang Shen ◽  
Shunguo Zhang ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Acute Phase ◽  
Pediatric Cancer ◽  
Rescue Medication ◽  
Emetogenic Chemotherapy ◽  
Highly Emetogenic Chemotherapy ◽  
Phase 0 ◽  
Pediatric Cancer Patients ◽  
To Receive ◽  
Delayed Phase

Abstract Children aged 2-12 years scheduled to receive moderately or highly emetogenic chemotherapy were randomly assigned to arm-A (fosaprepitant) or arm-B (aprepitant). Children recruited to arm-A received intravenous ondansetron plus dexamethasone followed by fosaprepitant infusion. Children recruited to arm-B received the same drugs as those given to children in arm-A, except that fosaprepitant was substituted with aprepitant. The primary end point of the study was to determine the proportion of patients who achieved a CR, defined as no vomiting, no retching, and no use of rescue medication, the proportion of patients who achieved a CR during the acute phase (0-24 hours) after administration of the last dose of chemotherapy. Secondary end points were the proportion of patients who achieved a CR during the 24-120 hours (delayed phase) and overall after administration of the last dose of chemotherapy. Results: One hundred and eight patients were analyzed (55 in the fosaprepitant arm and 53 in the aprepitant arm). CR rates were higher in the fosaprepitant arm compared with the aprepitant arm during the acute phase (95 % vs 79 %, P =0.01< 0.05), delayed phase (71 % vs 66 %, P =0.89 ), and overall phase (69 % vs 57 %, P =0.18). Furthermore, the demand of rescue anti-emetics observed in fosaprepitant arm (7 %) has no difference with aprepitant arm (11 %). Conclusion: Addition of fosaprepitant to ondansetron and dexamethasone is more effective than aprepitant for the prevention of acute vomiting.

Phase III study of APF530 versus ondansetron with a neurokinin 1 antagonist + corticosteroid in preventing highly emetogenic chemotherapy-induced nausea and vomiting: MAGIC trial.

2015 ◽  
Vol 33 (28_suppl) ◽  
pp. 68-68
Author(s):  
Ian D. Schnadig ◽  
Richy Agajanian ◽  
Shaker R. Dakhil ◽  
Nashat Y. Gabrail ◽  
Robert E. Smith ◽  
...  
Keyword(s):  
Unmet Need ◽  
Complete Response ◽  
Drug Regimen ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Highly Emetogenic Chemotherapy ◽  
Double Blind ◽  
Complete Control ◽  
Delayed Phase

68 Background: Managing chemotherapy-induced nausea and vomiting (CINV) associated with delayed ( > 24-120 h) highly emetogenic chemotherapy (HEC) is an unmet need. APF530, extended-release granisetron, provides sustained release over ≥ 5 days to prevent acute (0-24 h) and delayed CINV. This trial compared the efficacy and safety of APF530 in preventing CINV after HEC in a 3-drug regimen vs a standard 3-drug regimen with ondansetron (Ond). Methods: In this double-blind, multicenter study (NCT02106494), patients (pts) receiving single-day HEC (2011 ASCO guidelines) were randomized 1:1 to APF530 500 mg SC (10 mg granisetron) or Ond 0.15 mg/kg IV and stratified by cisplatin ( ≥ 50 mg/m2, yes/no). Pts were scheduled to receive concomitant dexamethasone (Dex) 12 mg IV + fosaprepitant (Fos) 150 mg IV on day 1 + PO Dex on days 2-4. The primary end point was delayed-phase complete response (CR) (no emesis, no rescue medication). Secondary end points included CR in acute and overall phases and complete control (CC; CR and no more than mild nausea) in acute, delayed, and overall phases. Treatment (tx) comparisons used chi-square test controlling for cisplatin. Adverse events (AEs) and injection-site reactions (ISRs) were assessed. Results: Modified intent-to-treat analysis included 902 pts (APF530, n = 450; Ond, n = 452) with baseline demographics balanced between tx groups. A significantly higher % of APF530 (65%) vs Ond (57%) pts had delayed-phase CR (P= .014). A significantly higher % of APF530 (61%) vs Ond (53%) pts had delayed-phase CC (P= .022, Table). CR and CC rates in acute and overall phases were numerically higher with APF530 vs Ond, but not statistically significant. APF530 was well tolerated. Most common AEs were ISRs, mostly mild or moderate. Conclusions: APF530 with Fos+Dex led to statistically higher CR and CC rates in delayed-phase CINV with HEC vs a standard 3-drug regimen of Ond with Fos+Dex. Clinical trial information: NCT02106494. [Table: see text]

scholarly journals How shall we treat locally advanced triple negative breast cancer?

F1000Research ◽  
2020 ◽  
Vol 8 ◽  
pp. 1649
Author(s):  
Paulo Luz ◽  
David Dias ◽  
Ana Fortuna ◽  
Luis Bretes ◽  
Beatriz Gosalbez
Keyword(s):  
Breast Cancer ◽  
Triple Negative Breast Cancer ◽  
Triple Negative ◽  
Locally Advanced ◽  
Surrogate Marker ◽  
Metastatic Breast ◽  
Complete Response ◽  
Number Of Patients ◽  
Her 2 ◽  
Near Future

Triple negative breast cancer (TNBC) has been shown to respond to neoadjuvant chemotherapy (NACT). It has been established that achieving pathological complete response (pCR) for certain aggressive subtypes of breast cancer, including HER-2 (over-expressed) and TNBC, provides an important surrogate marker for predicting long-term clinical response and survival outcomes. How to increase the number of patients that achieve pCR remains challenging. Platinum-based NACT seems to be part of the solution and capecitabine, an active drug in metastatic breast cancer, but not a standard one in earlier stages may have found its place in the adjuvant setting. In the near future immunotherapy can play a role in early TNBC

Meta-analysis of trials comparing standard antiemetic treatment (SAT) with aprepitant containing antiemetic regimens (ACAR) for prevention of chemotherapy-induced nausea and vomiting (CINV).

2014 ◽  
Vol 32 (31_suppl) ◽  
pp. 171-171
Author(s):  
Neha Gupta ◽  
Hassan Hatoum ◽  
Omar Al Ustwani ◽  
Pongwut Danchaivijitr ◽  
Katy Wang ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Response To Treatment ◽  
Highly Emetogenic Chemotherapy ◽  
Antiemetic Treatment ◽  
Improved Outcomes ◽  
Score Method ◽  
American Society ◽  
Delayed Phase

171 Background: Various randomized controlled trials (RCTs) have shown improved outcomes with addition of aprepitant to standard antiemetic treatment (SAT) in preventing CINV. We conducted a meta-analysis to study the overall impact of ACAR in CINV prevention in adults. Methods: We searched Pubmed and Ovid databases, and American Society of Clinical Oncology meetings abstracts for RCTs using ACAR with SAT for CINV prevention in adult cancer patients (pts). Major study end points were complete response to treatment (CR; defined as no emesis and no use of rescue medications) in overall phase (OP; 0-120 hours of chemotherapy), acute phase (AP; 0-24 hours) and delayed phase (DP; 24-120 hours). Additionally, we assessed the control of nausea and toxicity profile (TP). Stouffer's Z-score method was used to calculate the overall effect. Results: 16 RCTs (5,547 pts) were included. 11 trials (3,314 pts) involved highly emetogenic chemotherapy (HEC) and 5 trials (2,233 pts) involved moderately emetogenic chemotherapy (MEC). ACAR increased CR in OP from 47% to 63% (OR=0.52, CI=0.46 to 0.58; p<0.001), in AP from 73% to 81% (p<0.01), and in DP from 51% to 66% (p<0.001). Significant increase in nausea control was seen in DP (p=0.03) but not in OP or AP. Incidence of various toxicities was statistically similar in both groups except slightly higher rate of fatigue (p=0.02) and hiccups (p<0.001), and lower rate of neutropenia (p=0.02) in ACAR. Conclusions: ACAR is effective in CINV due to both HEC and MEC in adult cancer pts. ACAR improves the control of emesis in all phases, and nausea in delayed phase only. With the exception of causing more fatigue & hiccups, and lesser neutropenia, overall TP of ACAR is similar to SAT.

Feasibility of olanzapine at reduced dose in highly emetogenic chemotherapy: A randomised controlled trial against aprepitant in triple therapy (FORESIGHT).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12087-12087
Author(s):  
Michelle Chen ◽  
Isabelle Baron ◽  
Stephanie Beaulieu ◽  
Annick Dufour ◽  
Nathalie Letarte ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Large Scale ◽  
Controlled Trial ◽  
Complete Response ◽  
Research Centre ◽  
Highly Emetogenic Chemotherapy ◽  
Patient Reported ◽  
Delayed Phase ◽  
Drug Prophylaxis

12087 Background: Olanzapine is used as an adjunct antiemetic in oncology as salvage therapy and in four-drug prophylaxis. Growing literature supports its effectiveness in initial three-drug prophylaxis in highly emetogenic chemotherapy (HEC). Methods: This prospective, multi-centre, open-label study evaluated the feasibility of a large-scale randomized controlled trial comparing the effectiveness and tolerability of 5 mg olanzapine once daily for four days (starting the night before chemotherapy) versus standard dose aprepitant (in tritherapy with standard ondansetron and dexamethasone) in treatment-naive patients receiving the first cycle of a HEC. Secondary outcomes included: complete response (no nausea, no emesis, no use of rescue medication), complete remission (no emesis, no rescue medication), intensity of patient-reported nausea and emesis on a visual analog scale, quality of life (scored with the Functional Living Index Emesis [FLIE]), and incidence of adverse events. Results: We randomized 30 patients in an intent-to-treat analysis. The large-scale trial was deemed not feasible without support from a research centre. Complete response rates were significantly higher in the olanzapine group in the delayed phase (24-120h post-chemotherapy) (86,7% v 21,4%, p < 0,001) and overall phase (0-120h post-chemotherapy) (60,0% v 21,4%, p = 0,04). Similar results were observed for complete remission. Intensity of patient-reported nausea was significantly lower in the olanzapine group in the delayed phase (p = 0,001). FLIE scores were significantly lower for the nausea domain (mean 62,3 v 60,9, p = 0,004) and overall score (124,3 v 108,8, p = 0,006). Depression on the ESAS-R was more common in the aprepitant group (0% v 38%, p = 0,01). Other adverse events were not significantly different. Conclusions: Support from a research centre must be ensured for study feasibility. Tritherapy olanzapine significantly improved complete response and remission in the delayed and overall phases post-chemotherapy among patients receiving HEC. It was also associated with higher quality of life and a reassuring safety profile. This feasibility trial, despite its small sample size, is one of the first prospective randomised trials to suggest similar efficacy of 5 mg olanzapine to aprepitant and to measure a difference in patient quality of life with this regimen. Clinical trial information: NCT04075955 .

Real-word incidence and management of durable complete response in de novo metastatic HER2-positive breast cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e13017-e13017
Author(s):  
Claire Elizabeth Powers Smith ◽  
Paul Kelly Marcom ◽  
Zahi Ibrahim Mitri
Keyword(s):  
Breast Cancer ◽  
De Novo ◽  
Metastatic Breast ◽  
Predictive Biomarkers ◽  
Complete Response ◽  
Categorical Variables ◽  
Fisher Exact Test ◽  
Her2 Positive ◽  
Number Of Patients

e13017 Background: HER2-directed therapies enable a small number of patients with de novo HER2+ metastatic breast cancer (MBC) to achieve long term durable responses (DR). However, clinic-pathologic factors that correlate with DRs in de novo HER2+ MBC are unknown. Expert opinion dictates indefinite HER2-directed therapies for patients who achieve DRs, but real-world examples of this practice, especially the effect on cardiotoxicity, are lacking in the literature. Methods: This is a retrospective case control study of patients with de novo HER2+ MBC who received treatment with trastuzumab at two NCI designated cancer centers between the years 2012-2017. Patients were included if ≥2 years of follow up data were available or if patients were deceased. DRs are defined as radiographic complete or partial response without progression or death at any point after diagnosis. Controls are patients with evidence of radiographic progression or death any point after diagnosis. Age at diagnosis, ER/PR status, site of metastasis, and initial treatment were analyzed. An un-paired T test for age and fisher exact test for categorical variables were used. Results: A total of 96 patients with de novo HER2+ MBC, 28 with DRs and 68 with progression, were identified. Average follow up length for patients with DR was 90 months (range 27-224 months). Patients who progressed had a mPFS of 17.5 months and a mOS of 60 months. Results are shown in Table. Additionally, six patients (6.3%) developed reduced ejection fraction, one with DR, five with progression. Nine patients have been receiving trastuzumab for over ten years with no evidence of disease. Only one patient opted to discontinue this therapy a year after complete response and is disease free five years from diagnosis. Conclusions: Nearly a third of patients with de novo metastatic HER2+ MBC in our dataset achieved DR. Factors that predict DRs include single organ involved by metastatic disease and more intensive upfront chemotherapy including trastuzumab and pertuzumab. The majority of patients with DR continued HER2 directed therapy indefinitely with minimal cardiotoxicity. In the absence of predictive biomarkers of DRs, indefinite trastuzumab administration is common practice for these patients. [Table: see text]

scholarly journals Evaluation of General, Pathological, and Radiological Features of Male Breast Cancer

2020 ◽  
Vol 17 (3) ◽  
Author(s):  
Fariba Zarei ◽  
Fereshte Bagheri ◽  
Amin Dehdashtian ◽  
Majid Akrami
Keyword(s):  
Breast Cancer ◽  
Survival Time ◽  
Male Breast Cancer ◽  
Medical Records ◽  
Male Breast ◽  
Treatment Modalities ◽  
Time Interval ◽  
Number Of Patients ◽  
History Of

Background: Male breast cancer (MBC) is an infrequent disease and a scarcely researched topic. Since the incidence of male breast cancer is increasing and so far, management advices have been concluded from results of trials in female patients, there has been a growing interest in this field of research. Objectives: In this study, we aimed to evaluate the general, radiological and pathological features of MBC patients. Patients and Methods: We retrospectively reviewed the medical records of MBC patients who had been referred to breast clinic, Shahid Motahari in Shiraz, Iran, between 2005 and 2018. Data regarding general characteristics of patients such as demographic information, age, and also past history of any cancer, family history of breast cancer, mammogram and ultrasound findings, stage, size and location of tumor, histopathology of tumor, metastasis, treatment modalities and follow-up time were attained by reviewing medical records. Results: Fifty-one patients with MBC were included with the mean age of 58.4 years. Invasive ductal carcinoma was the most prevalent pathologic type. By use of the Kaplan Meier survival estimate, survival probability of patients for each time interval after diagnosis was calculated. There was a decline over time until about 85 months after diagnosis when it reached a plateau state above 50%. Age, human epidermal growth factor receptor 2 (HER2) and metastasis showed to lower the survival time by increasing the hazard ratio. Only 13 patients had mammography and 22 had an ultrasound, which are less than 50% of the total number of patients. Conclusions: This study showed that there is still unfulfilled need to evaluate MBC in order to find the best management guidelines such as screening in high risk populations, diagnosis, treatment, and follow-up. Risk factor evaluation, survival time, and diagnostic radiologic modalities have not been well assessed in MBC so far.

Multicenter, randomized comparative study of two doses of paclitaxel in patients with metastatic breast cancer.

1996 ◽  
Vol 14 (6) ◽  
pp. 1858-1867 ◽  
Author(s):  
J M Nabholtz ◽  
K Gelmon ◽  
M Bontenbal ◽  
M Spielmann ◽  
G Catimel ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Low Frequency ◽  
Metastatic Breast ◽  
Therapeutic Index ◽  
Complete Response ◽  
Dose Effect ◽  
Clinical Activity ◽  
High Dose ◽  
Number Of Patients

PURPOSE AND METHODS The objective of this multicenter study was to compare the therapeutic index of two different doses of paclitaxel given as a 3-hour infusion in patients with metastatic breast cancer (MBC), who had failed to respond to previous chemotherapy. A total of 471 patients with MBC were randomized to receive intravenous paclitaxel at a dose of 175 or 135 mg/m2 every 3 weeks. RESULTS Better treatment results were achieved with high-dose (HD) versus low-dose (LD) paclitaxel: overall response rate, 29% versus 22% (P = .108); complete response (CR) rate, 5% versus 2% (P = .088); median time to disease progression, 4.2 versus 3.0 months (P = .027); and median survival time, 11.7 versus 10.5 months (P = .321). Patients previously exposed or resistant to anthracyclines were as likely to respond as those without such prior exposure. Treatment was well tolerated, as documented by the number of administered treatment courses (median, six v five; range, one 17 v one to 18), the low frequency of dose reductions (14% v 7%, P = .024), and the small number of patients (n = 9 or 4% vn = 5 or 2%) who required treatment discontinuation for adverse reactions. The incidence and severity of neutropenia and peripheral neuropathy were dose-related. After quality-of-life-adjusted time-to-progression analysis, the HD arm (175 mg/m2) retained its advantage over the LD arm (135 mg/m2). CONCLUSION The results of this trial substantiate the activity of paclitaxel in the treatment of MBC. The observed superior efficacy with a dose of 175 mg/m2 over 135 mg/m2 suggests a dose-effect relationship. The clinical activity in anthracycline-resistant patients is particularly noteworthy. Paclitaxel in breast cancer needs further evaluation in large trials that use combination chemotherapy and involve earlier disease stages.

Should Olanzapine be Advocated Over Conventional Anti-Emetics for the Prevention of Chemotherapy-Induced Nausea and Vomiting? An Updated Meta-Analysis of Randomized Control Trials

2019 ◽  
Vol 15 (2) ◽  
pp. 80-90
Author(s):  
Eshak Ibrahim Bahbah ◽  
Ahmed Ramadan Abdalla ◽  
Khalid Abdelshafy ◽  
Ahmed Diaa Almohandes ◽  
Amr Menshawy ◽  
...  
Keyword(s):  
Adverse Events ◽  
Active Control ◽  
Acute Phase ◽  
Meta Analysis ◽  
Final Analysis ◽  
Complete Response ◽  
Fixed Effect Model ◽  
Control Group ◽  
And Control ◽  
Delayed Phase

Objective: The aim of this study is to synthesize the evidence about the efficacy of Olanzapine for the prevention of CINV. Methods: A computer literature search of PubMed, EBSCO, Ovid, and Cochrane CENTRAL databases has been conducted. Studies were screened for eligibility and data were extracted. The proportion of patients with complete response (CR) and those with no nausea were pooled as risk ratio (RR) in a fixed effect model meta-analysis using Review Manager Version 5.3 for windows. Results: Nine randomized controlled trials (n=1572) were pooled in the final analysis. In all studies, olanzapine was given as 10 mg PO. Olanzapine was superior to active control in terms of CR rate in acute phase (RR 1.12, 95% CI [1.02, 1.22], p=0.01]), delayed phase (RR 1.31, 95% CI [[1.10, 1.56], p=0.002), and overall phase (RR 1.30, 95% CI [1.09, 1.55], p=0.004). Rates of no nausea were significantly higher in olanzapine 10 mg group compared to active control group in acute phase (RR 1.20, 95% CI [1.04, 1.38], p=0.01), delayed phase (RR 1.72, 95% CI [1.42, 2.08], p<0.00001), and overall phase (RR 1.57, 95% CI [1.39, 1.77], p <0.00001). The incidence of adverse events was similar in olanzapine and control groups, with the most frequently reported treatment-related emergent adverse events being fatigue, constipation, and headache. Conclusion: Olanzapine is a well-tolerated drug for cancer patients and has shown superiority against conventional antiemetics for the prevention of CINV.

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