Impact of adding plinabulin to pegfilgrastim for the prevention of TAC chemotherapy (Chemo) induced neutropenia (CIN), on patient quality of life (QoL).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e24031-e24031
Author(s):  
Ramon Mohanlal ◽  
Yvette Lelorier ◽  
Dominic Mitchell ◽  
Lan Huang ◽  
Douglas W. Blayney
Keyword(s):  
Clinical Trial ◽  
Energy Levels ◽  
Breast Cancer Patients ◽  
Emotional Wellbeing ◽  
Phase 3 ◽  
Tac Chemotherapy ◽  
Physical Wellbeing ◽  
The Impact ◽  
Clinical Trial Information

e24031 Background: Plinabulin is a novel non-G-CSF small molecule being developed for the prevention of chemotherapy in conjunction with pegfilgrastim and is administered via 30 min IV infusion, 30 min after chemo on Day (D) 1. The QoL was analyzed using the Functional Assessment of Cancer Therapy - General questionnaire (FACT-G) as part of a phase 3 (Ph3) clinical trial comparing pegfilgrastim alone versus pegfilgrastim and plinabulin for the prevention of neutropenia in newly diagnosed breast cancer patients being treated with Docetaxel (75 mg/m2), Doxorubicin (50 mg/m2), and Cyclophosphamide (500 mg/m2) (TAC) on D1 for four 21 D cycles and study treatment. Methods: The FACT-G was administered to patients in China and Ukraine using an ePRO app downloaded onto patients' phones as part of the Phase 3 PROTECTIVE-2 trial (NCT0329457) with TAC. Patients completed the FACT-G during each chemo cycle at D-1, D1, D8 and D15. Patients received reminders 1 hour before the required completion time and all entries were time stamped. The FACT-G measured the impact of cancer on four categories: Physical wellbeing, Social wellbeing, Emotional wellbeing and Functional wellbeing. Results: Compared to pegfilgrastim alone, patients on plinabulin + pegfilgrastim performed significantly better for Physical wellbeing on D8 and D15 of Cycle 2 (p < 0.0589 and p < 0.0039 respectively) and Cycle 3 (p < 0.0360 and p < 0.0343 respectively). Further analysis of the sub questions showed that both energy levels “I have a lack of energy” and pain”(I have pain” were significantly better for the plinabulin + pegfilgrastim combination versus pegfilgrastim alone (p < 0.0377 and p < 0.0420 respectively). Overall FACT-G completion compliance for the trial was 91%. Conclusions: The Physical wellbeing (in particular, pain and for energy levels) of patients receiving plinabulin in combination with pegfilgrastim for the prevention of TAC CIN, was significantly less impacted by chemo dosing compared to the pegfilgrastim alone arm. In addition, the results suggest that patients receiving the combination therapy recovered their pre-chemo Physical wellbeing levels more rapidly. Clinical trial information: NCT03531099.

Living with an MPN in Ireland: patients' and caregivers' perspectives

2021 ◽  
Vol 30 (17) ◽  
pp. S24-S30
Author(s):  
Geraldine Walpole ◽  
Mary Kelly ◽  
Joy Lewis ◽  
Avril Gleeson ◽  
Ann-Marie Cullen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Unmet Needs ◽  
Negative Impact ◽  
Peer Group ◽  
Myeloproliferative Neoplasms ◽  
Symptom Burden ◽  
Emotional Wellbeing ◽  
The Republic ◽  
The Impact

Myeloproliferative neoplasms (MPNs) are associated with a high disease burden, reduced quality of life and shortened survival. The aim of this questionnaire was to gain patients' and caregivers' perspectives on the impact of living with an MPN in the Republic of Ireland. An Irish adaptation of the ‘Global MPN Landmark survey’ was conducted. Fifty-one patients and 44 caregivers completed the questionnaire. Patients reported a wide variety of symptoms at the time of questionnaire completion; fatigue, bone pain and pruritus being most frequently reported. Approximately one-third of respondents from each of the groups (patients and caregivers) reported a negative impact of MPNs on their emotional wellbeing and daily lives. The study findings revealed that, despite treatment, symptom burden remains high, and several unmet needs exist, including educational, emotional and peer group support. Interventions that focus on reducing symptom burden and addressing these unmet needs, may improve the quality of life for patients with MPNs and their caregivers.

scholarly journals Effect of different modalities of treatment on the quality of life of breast cancer patients in Egypt

1997 ◽  
Vol 3 (1) ◽  
pp. 68-81
Author(s):  
Fatma M. El Sharkawi ◽  
Mahmoud F. Sakr ◽  
Hoda Y. Atta ◽  
Hafez M. Ghanem
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Cancer Therapy ◽  
Adjuvant Therapy ◽  
Cancer Patients ◽  
Breast Cancer Patients ◽  
Breast Cancer Therapy ◽  
Egyptian Women ◽  
The Impact

The impact of breast cancer therapy on the quality of life [QL] of Egyptian women was studied. Patients were divided into four groups:1:mastectomy alone;2:surgery plus radiotherapy;3:surgery plus chemotherapy;and 4:triple modality. The results revealed that all the four domains of QL of women having adjuvant therapy [groups 2, 3, or 4] were significantly altered compared to those who underwent mastectomy alone. Triple modality adversely affected global QL the most compared to radiotherapy or chemotherapy;radiotherapy had significantly less effect on QL compared to chemotherapy. Triple modality predicted the worst QL. QL measures should be incorporated with the traditional end points for evaluation of treatment and patients given health education on the effects of each therapy

scholarly journals The ‘Vero Cell’ COVID-19 vaccine rollout in Nepal: What we know about the Chinese vaccine development and access?

2021 ◽  
Vol 8 (1) ◽  
pp. 1-8
Author(s):  
Jay Narayan Shah
Keyword(s):  
Clinical Trial ◽  
United Arab Emirates ◽  
Science And Technology ◽  
Modern Science ◽  
Phase Iii ◽  
Phase 3 ◽  
Pharmaceutical Group ◽  
Fda Approval ◽  
The Usa ◽  
The Impact

The world has changed dramatically from the impact of the COVID-19. It has impacted the normality of daily life, highlighting the failure of rich and poor nations alike, which is evident from the high number of human lives lost in rich and powerful countries like the USA with total deaths of 32,735,704 and Europe with 43,708,958 until April 24, 2021, as per Worldometer. The COVID-19 pandemic has shown that all of us ‘have and have-not’, no one can escape from the effects of the lockdowns, disruption of normal life including education, businesses, etc. reminding all of us that equitable access to vaccines is the best possible choice not to further exacerbate the challenges because ‘no country is safe until every country is safe’. It is a remarkable scientific achievement that within a year of the identification of the virus, we have COVID-19 vaccines, albeit available mostly in rich countries. The benefit of research is possible only with solidarity, by sharing the available resources, vaccine included, for the control of the ongoing COVID-19 pandemic. Modern science and technology, including the development and marketing of COVID-19 vaccines, have been focused in the USA and Europe. China joined this club of elites of science following the Chinese FDA approval of Sinopharm (the subsidiary of state-owned China National Pharmaceutical Group- CNPG), first COVID-19 vaccine (inactivated Sars-Cov-2) based on the results of the phase-3 clinical trial in UAE and Bahrain showing up to 86% efficacy of the vaccine in preventing COVID-19. Detail of trials of Sinopharm inactivated COVID-19 vaccines (Vero Cells) available on two early trials in China (Phase I/II ChiCTR2000031809, enrollment 1,456) and later 4 trials outside China (phase III, NCT04510207 Bahrain, Egypt, Jordan, United Arab Emirates- enrollment of 45,000; ChiCTR2000034780 United Arab Emirates, enrollment of 15,000; NCT04612972 Peru, enrollment of 6,000) show the progress of research and approval in China and UAE. Modern science and technology, including the development and marketing of COVID-19 vaccines, have been focused in the USA and Europe. China joined this club of elites of science following the Chinese FDA approval of Sinopharm (the subsidiary of state-owned China National Pharmaceutical Group- CNPG) first COVID-19 vaccine (inactivated Sars-Cov-2) based on the results of the phase-3 clinical trial in UAE and Bahrain showing up to 86% efficacy of the vaccine in preventing COVID-19.3

scholarly journals Impact of Comorbidities on Quality Of Life in Breast Cancer Patients

2016 ◽  
Vol 01 (04) ◽  
pp. 025-028
Author(s):  
Monica Irukulla ◽  
Rama Vaghmare ◽  
Deepa Joseph ◽  
Syed Ahmed ◽  
Jyothi Jonnadula ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Cancer Patients ◽  
Physical Functioning ◽  
Bodily Pain ◽  
Evidence Base ◽  
Breast Cancer Patients ◽  
Co Morbidity ◽  
The Impact

AbstractIntroduction: Comorbidities are common among cancer patients and with an aging population are becoming more prevalent. These can potentially affect the stage at diagnosis, treatment and outcomes of people with cancer. Despite the intimate relationship between comorbidity and cancer, there is limited consensus on how to record, interpret or manage comorbidities in the context of cancer. Addressing the impact of comorbid conditions in cancer patients warrants improvement in the evidence base from which to make treatment decisions for those with comorbidities.Methods: In this prospective study, 64 patients with breast cancer, underwent QOL assessment using FACT –B questionnaire at three time points- pre-radiation and three and six months post radiation.Results: 29(46%) patients had comorbidities of which 23 (35%) had cardiovascular comorbidities and 6 had other comorbidities. The co-morbidities were negatively associated with multiple domains of quality of life, including physical functioning, general health, bodily pain. Patients with diabetes and hypertension had significantly lower scores in physical functioning in comparison to patients without diabetes and hypertension, but improved after treatment. In majority of patients the overall scores were less in patients with co-morbidities compared to patients without any co-morbidity.Conclusion: Comorbidities can significantly affect the quality of life in patients with comorbidities. Hence greater research into the QOL issues for better patient care and symptom management especially during the transitioning phase from active care to follow up will help clinicians improve the quality of care and interdisciplinary co-ordination.

scholarly journals Methodological Characteristics of Clinical Trials: Impact of Mandatory Trial Registration

2019 ◽  
Vol 22 ◽  
pp. 131-141
Author(s):  
Ashish Kumar Kakkar ◽  
Biswa Mohan Padhy ◽  
Sudhir Chandra Sarangi ◽  
Yogendra Kumar Gupta
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Statistical Methods ◽  
Quality Characteristics ◽  
Allocation Concealment ◽  
Trial Registration ◽  
Control Group ◽  
Study Protocols ◽  
The Impact

Purpose: Numerous studies across multiple specialties have evaluated the impact of trial registration on quality of study reports and found significant improvements over several domains. However, the impact of mandatory trial registration on the quality of clinical trial protocols remains hitherto unexplored. Methods: We carried out a retrospective cohort study of clinical trial applications submitted to drug regulatory authority of India for initial review with the objective of comparing methodological characteristics of their protocols. Since trial registration was made mandatory in the country in June 2009, we selected two study periods as between January 2007 to May 2009 (Period I) and July 2009 to December 2011 (Period II). Seventy-five protocols were randomly selected using a computer-generated list for each study period, making a total of 150 protocols. Data on twelve key methodological characteristics were collected including clearly defined primary outcomes, randomization, blinding, use of control group, statistical methods, handling of withdrawals amongst others. Results: More than 3/4th of the trial applications in the two study periods were for new chemical entities and nearly 90% were pharmaceutical industry sponsored studies. Comparing the period before and after implementation of mandatory trial registration, description of clearly defined trial outcomes improved from nearly 42% to 80% (p<0.001), sample size justifications increased from 38% to 70% (p<0.001) and use of allocation concealment improved from 24% to 49% (p=0.001). Marked improvement was also noted for blinding, description of statistical methods and handling of withdrawals and dropouts. Remaining characteristics did not change significantly between the two study periods. The mean cumulative scores for the study protocols improved significantly from 7± 0.296 in the first period to 8.93± 0.346 (p<0.001) in the second period. Conclusions: Our study found a significant improvement in the methodological quality characteristics of the protocols particularly in elements related to minimization of bias and statistical methods, which could be attributed to mandatory trial registration. Overall, the significant improvement was limited to global clinical trials, and room for improvement was noted for two quality characteristics – proportion of randomized studies and trials adequately describing the generation of allocation sequence.

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