scholarly journals PRECYCLE: Multicenter, Randomized Phase IV Intergroup Trial to Evaluate the Impact of E Health-Based Patient Reported Outcome (PRO) Assessment on Quality of Life in Patients with Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Treated with Palbociclib and an Aromatase Inhibitor- or Palbociclib and Fulvestrant

2021 ◽  
Author(s):  
Tom Degenhardt ◽  
Peter A. Fasching ◽  
Diana Lüftner ◽  
Volkmar Müller ◽  
Christoph Thomssen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Overall Survival ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Patient Reported Outcome ◽  
Free Survival ◽  
Hormone Receptor Positive ◽  
Patient Reported

Abstract Background: Efficacy and quality of life (QoL) are key when selecting a therapy for metastatic breast cancer (MBC) patients. In hormone receptor positive (HR+) human epidermal growth factor receptor 2 minus (HER2-) MBC, addition of targeted oral agents such as everolimus or a cycline-dependent kinase 4/6 (CDK 4/6) inhibitor (e.g. palbociclib, ribociclib, abemaciclib) to endocrine therapy substantially prolongs progression-free survival and in the case of a CDK 4/6i also overall survival. Prerequiste for obtaining such benefit is adherence to therapy over the whole treatment duration. Adherence, maintaining patients’ satisfaction, early detection and management of side effects have thus become important challenges, in particular with these new oral drugs and new ways of continuous support for oncological patients are needed. An eHealth-based platform can help to support therapy management and physician-patient interaction.Methods: PreCycle is a multicenter, randomized, phase IV trial in HR+ HER2+ MBC. All patients (n=960) receive the CDK 4/6 inhibitor palbociclib either in first (62.5%) or later line (37.5%) together with endocrine therapy (AI, fulvestrant) according to national guidelines. PreCycle evaluates the time to deterioration (TTD) of QoL in patients supported by eHealth systems with substantially different functionality: CANKADO active vs. inform. CANKADO active is the fully functional CANKADO-based eHealth treatment support system. CANKADO inform is a CANKADO-based eHealth service with a personal login, documentation of daily drug intake, but no further functions. To evaluate QoL, the FACT-B questionnaire is completed at every visit. As little is known about relationships between behavior (e.g. adherence), genetic background, and drug efficacy, the trial includes both patient reported outcome and biomarker screening for discovery of forecast models for adherence, symptoms, QoL, progression free survival (PFS), and overall survival (OS).Discussion: The primary objective of PreCycle is to test the hypothesis of superiority for time to deterioration (TTD) in terms of DQoL = “Deterioration of quality of life” (FACT-G scale) in patients supported by an eHealth therapy management system (CANKADO active) versus in patients merely receiving eHealth-based information (CANKADO inform). EudraCT Number: 2016-004191-22

Assessing the value of progression-free survival (AVALPROFS).

2014 ◽  
Vol 32 (31_suppl) ◽  
pp. 187-187
Author(s):  
Lesley Fallowfield ◽  
Lucy Matthews ◽  
Susan L. Catt ◽  
Mairead MacKenzie ◽  
Jacqui Gath ◽  
...  
Keyword(s):  
Pilot Study ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Disease Stabilisation ◽  
Patient Reported Outcome ◽  
Free Survival ◽  
True Value ◽  
Patient Reported ◽  
Clinical Trial Information

187 Background: Controversy exists about progression free survival (PFS) as an endpoint in novel cancer therapy trials. PFS is attractive for practical and methodological reasons but is not always a surrogate for overall survival. It is debatable whether or not PFS has discernable clinical benefit for patients (pts), the main treatment (tmt) goal. Also overlooked are pt perceptions. Few trials directly address if disease stabilisation is worth tmt side effects (SEs) or include relevant patient reported outcome (PRO) measures. AVALPROFS examines longitudinally pts’ understanding of therapeutic intent, PFS and the value placed on drugs that control cancer but have SEs. We report the pilot study here. Methods: The primary pilot aim was to obtain feedback from pts having drugs offering only PFS or modest OS gains, about the acceptability and comprehensibility of PROs for use in a longitudinal study. These included validated quality of life and anxiety measures and 4 study specific interview schedules. In close collaboration with Independent Cancer Patients’ Voices (ICPV) and using an iterative process, draft interviews (pre-tmt, on-tmt, at withdrawal due to toxicity or progression) were developed. Pilot study pts’ clinic consultations were taped prior to home interviews by researchers. Results: 11/19 eligible pts with metastatic breast, lung and head and neck cancers at different treatment phases participated. No pt recalled the phrase PFS being used in consultations. Few knew their latest scan results. Some were confused about the therapeutic aims of further tmt, 4/10 thought it would extend survival. All had experienced or anticipated considerable toxicity. None found the interview schedules too upsetting; all provided comprehensive feedback about these and the trade-off questions. Conclusions: PFS is confusing and questions remain about its true value. Involvement of ICPV in potentially distressing research about study design and PROs at the outset was invaluable. Inclusion of feedback from pilot study pts permitted further refinements to the AVALPROFS study which is currently open and recruiting. Clinical trial information: 16342. [Table: see text]

scholarly journals Patient-Reported Outcomes in Metastatic Breast Cancer: A Review of Industry-Sponsored Clinical Trials

2016 ◽  
Vol 10 ◽  
pp. BCBCR.S39385 ◽  
Author(s):  
Meaghan Krohe ◽  
Yanni Hao ◽  
Roger E. Lamoureux ◽  
Nina Galipeau ◽  
Denise Globe ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trials ◽  
Metastatic Breast Cancer ◽  
Metastatic Breast ◽  
Patient Reported Outcome ◽  
Primary Study ◽  
Successful Implementation ◽  
Patient Reported

Introduction Patient-reported outcome (PRO) measures serve to capture vital patient information not otherwise obtained by primary study endpoints. This paper examines how PROs are utilized as endpoints in industry-sponsored metastatic breast cancer clinical trials. Methods A search was conducted in the clinicaltrials.gov web site for trials involving common treatments for metastatic breast cancer. Thirty-eight clinical trials were identified which included a PRO endpoint in the study, and data were extracted and summarized. Results Overall, 17 unique PRO questionnaires and 14 concepts of measurement were identified as secondary or exploratory endpoints. The Functional Assessment of Cancer Therapy—Breast was the most frequently utilized questionnaire, commonly implemented to assess quality of life. The EORTC QLQ-C30 was also frequently used to measure quality of life or pain. Conclusion This review shares insights into the role of PROs in trials for metastatic breast cancer from which treatment developers and other stakeholders can enhance successful implementation of the patient voice into future trials.

Metronomic chemotherapy with oral Navelbine produces clinical benefit and low toxicity in metastatic breast cancer in K Hospital

2021 ◽  
Author(s):  
Duong Phi Thuy
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Metastatic Breast Cancer ◽  
Cancer Patients ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Breast Cancer Patients ◽  
Oral Vinorelbine ◽  
Free Survival

Background: The metronomic concept emerged more than 20 year sago, however, a significant development in various solidtumors was noticed in the past 10 years. There are potentially several mechanisms of action against tumor cells including inhibition of angiogenesis. This study aims to assess the efficacy and the safety of ametronomic schedule of oral Vinorelbine (Navelbine) in treatment of metastatic breast cancer. Methods: For the duration from January 2020 to June 2021 there were 30 metastatic breast cancer patients at the median age of 53 years (range 34 - 72), were treated with a metronomic schedule of oral Vinorelbine (VNR). Oral VNR was administered 40 mg three times weekly, continuously. Patients took oral VNR continuously on days 1, 3 and 5 of the week until the disease progression or unacceptable side effects. The difference between before and after 9 weeks treatment was conducted via the matched t - tests to discern the quality - of - life indicator (p < 0.05 was considered significant). Progression - free survival analysis was performed using Kaplan Maier. Results: All 30 patients received at least 9 weeks of therapy and were evaluated. 7 achieved partial responses (23.3%) and 13 achieved stable disease responses (43.4%). Median progression - free survival entailed 6.9 months. The quality of life was notified significantly. A good result was found in our metastatic breast cancer patients, who were given with a Metronomic Vinorelbine (mVNR) administration. Conclusions: As a result of our latest study indicated that themetronomic vinorelbine might become a potential treatment for metastatic breast cancer patients via the reduction of adverse effects and improvement of life quality and sets the stage for future extensive clinical trials.

scholarly journals Single arm, phase two study of low-dose metronomic eribulin in metastatic breast cancer

2021 ◽  
Author(s):  
Pavani Chalasani ◽  
Kiah Farr ◽  
Vicky Wu ◽  
Isaac Jenkins ◽  
Alex Liu ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Metastatic Breast Cancer ◽  
Peripheral Neuropathy ◽  
Clinical Benefit ◽  
Low Dose ◽  
Response Rate ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Free Survival

Abstract Background Treatment options for metastatic breast cancer (MBC) refractory to anthracyclines and taxanes are limited. In a phase III trial, eribulin demonstrated a significant improvement in overall survival compared to treatment of physician’s choice, but had limited tolerability because of neutropenia and peripheral neuropathy. Based on prior studies of alternative treatment schedules with other therapies, we hypothesized that a low-dose metronomic schedule of eribulin would permit patients to remain on treatment more consistently without treatment delays, resulting in longer time to progression, and improved toxicity profile. Methods We conducted a multi-site single arm, phase II trial patients with MBC. All patients were treated with metronomic eribulin (0.9 mg/m2 administered intravenously on days 1, 8, and 15 of a 28-day cycle.) Treatment was continued until the patient developed disease progression, unacceptable toxicity, or chose to stop the study. Patients must have had prior taxane exposure. The primary endpoint was progression-free survival. Secondary end points were overall survival, response rate, and clinical benefit rate. Exploratory biomarkers were performed to analyze change in levels of circulating endothelial cells (CECs), circulating endothelial precursors, and carbonic anhydrase IX (CAIX) with response to therapy. Findings We consented 86 patients and 59 were evaluable for final analysis. Median age was 59 years; 78% had HER2 negative tumors. The median progression-free survival (PFS) was 3.5 months with overall survival (OS) of 14.3 months. Objective response rate was 15% with clinical benefit rate of 48%. Reported grade 3 neutropenia and peripheral neuropathy were 18% and 5%, respectively. Treatment discontinuation due to toxicity was seen in 3% of patients. Interpretation Metronomic weekly low-dose eribulin is an active and tolerable regimen with significantly less myelosuppression, alopecia, and peripheral neuropathy than is seen with the approved dose and schedule, allowing longer duration of use and disease control, with similar outcomes compared to the standard dose regimen.

scholarly journals BOMET-QoL-10 questionnaire for breast cancer patients with bone metastasis: the prospective MABOMET GEICAM study

2019 ◽  
Vol 3 (1) ◽  
Author(s):  
A. Barnadas ◽  
◽  
M. Muñoz ◽  
M. Margelí ◽  
J. I. Chacón ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Health Status ◽  
Bone Metastasis ◽  
Assessment Tool ◽  
Metastatic Breast ◽  
Perceived Health ◽  
Perceived Health Status ◽  
Patient Reported

Abstract Background Bone metastasis (BM) is the most common site of disease in metastatic breast cancer (MBC) patients. BM impacts health-related quality of life (HRQoL). We tested prospectively the psychometric properties of the Bone Metastasis Quality of Life (BOMET-QoL-10) measure on MBC patients with BM. Methods Patients completed the BOMET-QoL-10 questionnaire, the Visual Analogue Scale (VAS) for pain, and a self-perceived health status item at baseline and at follow-up visits. We performed psychometric tests and calculated the effect size of specific BM treatment on patients´ HRQoL. Results Almost 70% of the 172 patients reported symptoms, 23.3% experienced irruptive pain, and over half were receiving chemotherapy. BOMET-QoL-10 proved to be a quick assessment tool performing well in readability and completion time (about 10 min) with 0–1.2% of missing/invalid data. Although BOMET-QoL-10 scores remained fairly stable during study visits, differences were observed for patient subgroups (e.g., with or without skeletal-related events or adverse effects). Scores were significantly correlated with physician-reported patient status, patient-reported pain, symptoms, and perceived health status. BOMET-QoL-10 scores also varied prospectively according to changes in pain intensity. Conclusions BOMET-QoL-10 performed well as a brief, easy-to-administer, useful, and sensitive HRQoL measure for potential use for clinical practice with MBC patients. Trial registration NCT03847220. Retrospectively registered on clinicaltrials.gov (February the 20th 2019).

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