Pyrotinib as neoadjuvant therapy for HER2+ breast cancer: A multicenter, randomized, controlled, phase II trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 574-574
Author(s):  
Xiaowen Ding ◽  
Wenju Mo ◽  
Xiaohong Xie ◽  
Ouchen Wang ◽  
Yuqin Ding ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Treatment Group ◽  
Neoadjuvant Therapy ◽  
Randomized Controlled ◽  
Her2 Breast Cancer ◽  
Significant Difference ◽  
Multicenter Randomized Controlled Trial ◽  
Group 3 ◽  
Grade 3 ◽  
Carboplatin Auc

574 Background: Pyrotinib is a new irreversible tyrosine kinase inhibitor (TKI) which significantly improved the progression-free survival (PFS) of patients with HER2+ metastatic breast cancer (MBC). In this study we aim to investigate the efficacy and safety of pyrotinib in neoadjuvant therapy. Methods: This is an open-label, multicenter, randomized controlled trial. Eligible patients (pts) aged 18–70 years with invasive carcinoma, cT2-3N0-3M0 stage, HER2-positive breast cancer were included. We randomized 34 pts into the treatment group and 33 into the controlled group from 2019-2021. Pts in the treatment group received 6 cycles of pyrotinib 400mg + trastuzumab 6mg/kg (LD 8mg/kg) + docetaxel 75mg/m2 + carboplatin (AUC = 6mg/ml·min) (TCbH+Py) treatment while the controlled group received 6 cycles of trastuzumab 6mg/kg (LD 8mg/kg) + docetaxel 75mg/m2 + carboplatin (AUC = 6mg/ml·min) (TCbH). Total pathologic complete response (tpCR) was defined as no invasive or in situ disease in the breast or axilla (ypT0/Tis, ypN0) and was assigned to be the primary outcome (NCT03756064). Results: 51 cases had completed 6 cycles of neoadjuvant therapy and successfully underwent operation (21 in the treatment group and 30 in the controlled group). In the treatment group, 6 cases have not complete neoadjuvant therapy, 6 cases quitted because of poor compliance and 1 patient has not receive operation yet. For controlled group, 3 patients have not complete neoadjuvant therapy. The tpCR rate in the treatment group is 71.4% (15/21) versus 36.7% (11/30) in the controlled group. A significant difference was determined between the two groups (p < 0.05). All pts achieved an objective response in the treatment group while in the controlled group for about 83.3% (25/30). 4 cases showed stable disease (SD) and 1 case was evaluated as progressive disease (PD) in the controlled group. The most common AE in the treatment group is diarrhoea with grade 3 occurred in 6 cases (28.6%), most of this event limited in the first treatment cycle. In the controlled group 3 pts (10%) occurred grade 3 diarrhoea. Conclusions: In this study TCbH+Py neoadjuvant therapy significantly improved the tpCR rate of HER2+ breast cancer pts for about twice higher than TCbH with a manageable safety. Clinical trial information: NCT03756064.

scholarly journals Effects of adjunctive light-activated disinfection and probiotics on clinical and microbiological parameters in periodontal treatment: a randomized, controlled, clinical pilot study

2021 ◽  
Author(s):  
Michael Patyna ◽  
Vicky Ehlers ◽  
Benjamin Bahlmann ◽  
Adrian Kasaj
Keyword(s):  
Pilot Study ◽  
Treatment Group ◽  
Periodontal Treatment ◽  
Treatment Modalities ◽  
Pocket Depth ◽  
Periodontal Tissues ◽  
Randomized Controlled ◽  
Probiotic Treatment ◽  
Significant Difference ◽  
Group 3

Abstract Objectives The aim of this pilot study was to evaluate the clinical and microbiological outcomes of light-activated disinfection (LAD) alone or combined with probiotics as an adjunct to non-surgical periodontal treatment. Materials and methods In this single-blinded, randomized, controlled clinical pilot study, 48 patients (28 females and 20 males) with untreated periodontitis (stages II and III, grade B) were included. Using a parallel-group design, patients were randomly assigned into 3 groups to receive subgingival debridement (SD) alone (group 1, n = 16), SD with LAD (group 2, n = 16), or SD with LAD plus probiotic treatment (group 3, n = 16). Probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), gingiva-index simplified (GIs), plaque-control record (PCR), and subgingival microbiological samples were analyzed at baseline, 3 months, and 6 months of follow-up. Results All treatment modalities demonstrated clinical improvements in PPD and CAL at 6 months compared to baseline but without a statistical significant difference between the groups. The combination of SD + LAD + probiotic treatment (group 3) demonstrated significantly greater reductions in BOP, GIs, and red complex bacteria P. gingivalis and T. forsythia compared with other groups at 6 months (p < 0.05). Conclusions A single application of LAD as an adjunct to SD provided no additional clinical and microbiological benefits compared to SD alone. The combination of SD + LAD + probiotic treatment in group 3 led to further improvements of the inflammatory parameters. Clinical relevance The additional use of probiotics in periodontal treatment can be a useful approach to support inflammation and infection control of periodontal tissues. Further studies are necessary to determine the extent of added benefit for this treatment approach.

Therapeutic Effect of Changqiang Acupoint Injection on Children with Functional Fecal Incontinence

2021 ◽  
Author(s):  
Changying Yi ◽  
Jie Zhang ◽  
Meili Fan
Keyword(s):  
Treatment Group ◽  
Fecal Incontinence ◽  
Cleveland Clinic ◽  
Control Group ◽  
Incontinence Score ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled ◽  
Stool Incontinence ◽  
Acupoint Injection ◽  
Significant Difference

<B>Objective:</B> Functional fecal incontinence in children (FFIC), also known as functional fecal disorder in children, is a type of childhood diseases characterized by excretory dysfunction. In the study, we observed the clinical effect of Changqiang acupoint injection on functional fecal incontinence in children (FFIC) by randomized controlled clinical trials. <BR><B>Materials and methods:</B> 140 children with functional fecal incontinence who met the screening criteria were respectively assigned into the treatment group (100 cases) and the control group (40 cases) according to the completely randomized controlled design. In the treatment group, Chuankezhi injection was administrated at the Changqiang acupoint once a week for three weeks (one course of treatment). In contrast, the subjects in the control group was instructed to receive sphincter exercise and defecation training, followed by an assessment on the therapeutic efficacy after one course of treatment. <BR><B>Results:</B> The overall response rate of the two groups was 93.00% (93/100) and 57.50% (23/40), respectively, with a statistically significant difference (P<0.01). The treatment group showed a performance superior to the control group based on the Cleveland Clinic Florida Fecal Incontinence Score System (CCF-FI)—dry stool incontinence, liquid incontinence, gas incontinence, lifestyle change, necessity of using pads or antidiarrheals, the ability to delay defecation, and the total score. The inter-group comparison revealed a statistically significant difference (P<0.01). <BR><B>Conclusion:</B>Changqiang acupoint injection has significant curative effect on FFIC as demonstrated by significant relief in the symptoms associated with fecal incontinence, and thus is considered as a useful approach to be widely applied in clinical practice.

scholarly journals Poly(ADP-Ribose) Polymerase Inhibitors (PARPi) for Patients With Advanced Breast Cancer: a Meta-analysis of Randomized Controlled Trials

2020 ◽  
Author(s):  
YongCheng Su ◽  
XiaoGang Zheng
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trials ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Parp Inhibitors ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Grade 3

Abstract BACKGROUND: Poly(ADP–ribose) polymerase (PARP) inhibitors are new class of drugs that are currently being studied in several malignancies. However, datas about the efficacy and safety of the PARP inhibitors are limited. Therefore, we conducted a meta-analysis of randomized controlled trials (RCT) in patients with breast cancer.METHODS: Pubmed/Medline, Embase, Cochrane Library, and abstracts presented at the annual meeting of the American Society of Clinical Oncology (ASCO) were searched for articles published from 2000 to June 2018.Summary incidences and the RR, HR with 95% confidence intervals, were calculated by using a random-effects or fixed-effects model.RESULTS: The summary HR indicated PARPi was not associated with OS (HR=0.83, 95%CI 0.66–1.06, Z=1.49, P=0.14), while it could significantly improve PFS ande time to deterioration (TTD) of global health status/quality of life(GHS/QoL) as compared with traditional standard therapy, the HR was 0.60(95%CI 0.50-0.72; Z=5.52, P＜0.00001) and 0.4 (95%CI 0.29–0.54,z=5.80 ,p=0.000),respectively.The RR of grade 3 or more anemia ,fatigue and headache was 3.02 (95% CI, 0.69–13.17;p = 0.14,,I2=90%),0.77 (95%CI, 0.34–1.73;p=0.52,I2=7%) and 1.13 (95% CI,0.30–4.18;p=0.86,I2=0%),respectively.CONCLUSION: The findings of this meta-analysis showed that PARPi has no significant effect on OS, while it could significantly improve in PFS and TTD of GHS/QoL for patients with advanced or metastatic breast cancer.Furthermore,our findings also demonstrated that the PARPi treatment is connected with an increased risk of grade 3 or more anemia adverse events.

scholarly journals A randomized, controlled study to compare the effects of intravenous labetalol and esmolol on haemodynamic changes during laryngoscopy and intubation

2017 ◽  
Vol 5 (9) ◽  
pp. 4003
Author(s):  
Atit Kumar ◽  
Prashant Kumar Mishra ◽  
Saurabh Shukla
Keyword(s):  
Randomized Controlled Study ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Cardiovascular Stress ◽  
Significant Difference ◽  
Haemodynamic Changes ◽  
Β Blocker ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Background: Direct laryngoscopy and endotracheal intubation frequently induce cardiovascular stress response characterised by hypertension and tachycardia due to reflex sympathetic stimulation. Considering the clinical significance of these changes stress attenuation is needed to blunt these responses. β- blockers are used to reduce the unwanted hemodynamic responses. Esmolol is ultra-short acting cardio selective β blocker. Labetalol is useful in not only attenuating the response to laryngoscopy and intubation but also in preventing perioperative cardiovascular events. Present study compared the efficacy of esmolol and labetalol for attenuation of sympathomimetic response to laryngoscopy and intubation.Methods: It was a prospective, randomized, controlled study carried out in 75 adult patients with ASA 1 and ASA 2 posted for elective surgeries. Patients were allocated randomly into Group-1 (esmolol) and Group-2 (labetalol) and Group-3 (placebo) of 25 patients each. Inj. esmolol (1mg/kg) or Inj. labetalol (0.4 mg/kg) or placebo (0.9NS) dissolved up to 5 ml in distilled water was injected intravenously 5 minutes prior to intubation. All patients premeditated with Inj. glycopyrrolate (4µg/kg). Patient were then induced with Inj. propofol (2mg/kg), Inj. scoline (2mg/kg) given followed by laryngoscopy and intubation. Haemodynamic readings were noted at T0 (baseline before injecting the drug), T1 (1 minute after injecting the drug), T2 (after intubation), T3 (2 minutes after intubation), T4 (4 minutes after intubation), T5 (6 minutes after intubation), T6 (8 minutes after injection), T7 (10 minutes after injection).Results: Gr-1, Gr-2 and Gr-3, when compared with each other for systolic BP, diastolic BP, mean BP, and HR, showed a statistically significant difference at different intervals.Conclusions: Both the drugs are found to be effective in attenuation of hemodynamic reflex without any side effects. Further studies are recommended to substantiate the findings in present study.

scholarly journals Adverse reactions to docetaxel: an active survey

2015 ◽  
Vol 51 (3) ◽  
pp. 551-559
Author(s):  
Leandro Cabral Pereira ◽  
Thaísa Amorim Nogueira ◽  
Leandro Augusto de Oliveira Barbosa ◽  
Sabrina Calil-Elias ◽  
Selma Rodrigues de Castilho
Keyword(s):  
Breast Cancer ◽  
Adverse Reactions ◽  
Breast Cancer Mortality ◽  
World Health ◽  
Healthcare Team ◽  
The Third ◽  
Naranjo Algorithm ◽  
Significant Difference ◽  
Grade 3 ◽  
Health Organization

The rates of breast cancer mortality remain high in Brazil. Docetaxel is a semi-synthetic taxane used to treat various tumors, particularly tumors of the breast, lung and prostate. In this study ADR that occurred in 45 docetaxel users with breast cancer were surveyed. They were identified by type, causality (Naranjo algorithm and World Health Organization categories) and, if considered probable or defined, rated for severity according to SOBRAFO proposal (2007). A total of 325 ADR were observed: 165 in the first, 137 in the second and 23 in the third cycle. Fifty seven ADR were immediate and the others, late. Fatigue and exhaustion for more than five days, classified as Grade 3 by SOBRAFO (2007), were reported as the primary late RAM. There was no significant difference in the occurrence of immediate and late ADR between cycles (p=1 and p=0.3577, respectively). The presence of a pharmacist gave the patients a better understanding of the occurrence of RAM, especially those that occur outside the hospital, between chemotherapy cycles and are often not reported to the healthcare team, creating institutional demands and reaching the goal to track, observe and correlate the RAM for each user.

Tamoxifen for the Prevention of Breast Cancer: Psychosocial Impact on Women Participating in Two Randomized Controlled Trials

2001 ◽  
Vol 19 (7) ◽  
pp. 1885-1892 ◽  
Author(s):  
Lesley Fallowfield ◽  
Anne Fleissig ◽  
Rob Edwards ◽  
Andrea West ◽  
Trevor J. Powles ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Treatment Group ◽  
Randomized Controlled Trials ◽  
Sexual Functioning ◽  
Self Report ◽  
Controlled Trials ◽  
Double Blind ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Prevention Of Breast Cancer

PURPOSE: The purpose of this study was to evaluate the psychosocial implications of tamoxifen versus placebo in women who are at increased risk of breast cancer. PATIENTS AND METHODS: The 488 women in the psychosocial study were recruited from participants in two placebo-controlled, double-blind, randomized, controlled trials that investigated the efficacy of tamoxifen in the prevention of breast cancer in women who are at high familial risk. During a 5-year period, repeated assessments were made of anxiety, psychological distress, and sexual functioning using standardized questionnaires before treatment at baseline and at 6-month intervals during the trial. RESULTS: Questionnaire completion over 5 years was good, with 71.1% of women returning at least 8 of 10 follow-up assessments. Although scores from individuals showed considerable fluctuation and variation over time, changes in anxiety, mood, and sexual functioning were not associated with treatment group. The number of symptoms reported at 48 months via a self-report cheklist were not associated with treatment group, but vasomotor symptoms were more frequent among tamoxifen-treated women. Symptoms of low energy, breast sensitivity, and visual blurring were reported most frequently in the placebo group. CONCLUSION: In general, these results are comparable to those from the National Surgical Adjuvant Breast and Bowel Project psychosocial study despite differences in study populations, methodology, and instruments. The long-term use of tamoxifen and other selective estrogen response modulators as preventive agents in high-risk groups has been questioned, but we found no evidence of treatment-related side effects that affect women’s psychosocial and sexual functioning.

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