B-TREUH: A single-arm phase II pilot study of euthyroid hypothyroxinemia in metastatic breast carcinoma.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS1115-TPS1115
Author(s):  
Shruti Trehan ◽  
Suzan S. Cheng ◽  
Aleck Hercbergs
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Breast Carcinoma ◽  
Radiation Effects ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Free T4 ◽  
Metastatic Breast Carcinoma ◽  
The Us

TPS1115 Background: It is estimated that there are approximately 155,000 people living with metastatic breast cancer in the US. Studies exploring the connection between hypothyroidism or hyperthyroidism and breast cancer have yielded varying results with up to 33% prevalence of thyroid disease in these patients. L-thyroxine (T4) is the most commonly prescribed agent in the US to manage hypothyroidism. However, there are data suggesting that T4 is a pro-oncogenic agent with proposed mechanisms such as stimulation of mitogenesis, angiogenesis, resistance to apoptosis. In addition, T4 May counter anti-PDL-1 and radiation effects. Triiodothyronine (T3), which is deiodinated form of T4 and also commercially available, is felt to be less oncogenic and less mitogenic. Therefore, exogenous supplementation of T3 would decrease the T4 levels creating the desired state of EUTHYROID HYPOTHYROXINEMIA. The study hypothesizes that replacing L-thyroxine (T4) with Triiodothyronine (T3) in hypothyroid patients with metastatic breast carcinoma, while they simultaneously continue to receive standard systemic therapy, with titrating T3 dose to achieve a state of Euthyroid Hypothyroxinemia would result in improved disease outcomes. Methods: Eligible participants are adults with metastatic breast carcinoma with estimated life expectancy of > 3months, hypothyroidism, and with normal TSH on L-thyroxine (T4). Following consent, participants will discontinue L-thyroixne (T4) and initiate Triiodothyronine (T3) dose based on current T4 dose after an appropriate washout period. Drug titration will be in accordance with thyroid function testing to maintain levels of free T4 at < 50% normal range. The treatment period will continue for 9 months with periodic assessment of disease status, quality of life (FACT-B) and laboratory measures. The primary endpoint is the progression free survival at 12 months while the secondary endpoints are prevalence of hypothyroidism in the cohort, overall survival, quality of life, and duration of time to achieve the Euthyroid Hypothyroxinemia state. Given many uncertainties to calculate power precisely, the sample size is estimated to be approximately 30 patients. Clinical trial information: NCT03787303 .

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

Impact of symptoms and toxicity on quality of life: Exploratory analysis of gemcitabine plus docetaxel vs capecitabine plus docetaxel in metastatic breast cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 682-682 ◽  
Author(s):  
P. Fumoleau ◽  
G. Romieu ◽  
S. Chan ◽  
J. Huober ◽  
M. Tubiana-Hulin ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Metastatic Breast Cancer ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Exploratory Analysis ◽  
Phase Iii ◽  
Serious Adverse Events ◽  
Distress Scale

682 Background: A recent phase III trial comparing gemcitabine-docetaxel (GD) with capecitabine-docetaxel (CD) for metastatic breast cancer (MBC) found comparable progression-free survival but patients (pts) on GD had less toxicity (Chan, ASCO 2005). To better understand how quality of life (QoL) is impacted by toxicity and symptoms, we conducted an exploratory analysis. Methods: The study had 305 pts who relapsed after anthracycline-based treatment either in (neo)adjuvant or first-line MBC. Pts were randomized to GD or CD for 21-day cycles until PD or unacceptable toxicity. QoL was assessed every cycle with Rotterdam Symptom Checklist (RSCL). Only pts with RSCL data were included in the QoL analysis. Comparison between arms of changes from baseline in RSCL dimensions at each cycle were analyzed using analysis of co-variance (ANCOVA). Because the physical symptom distress scale (PSDS) includes symptom- and toxicity-related items, distributions of responses to each item were explored. Results: 302 pts received treatment (GD 152; CD 150); median number of cycles was 6 for both arms. 267 pts (88%) had baseline RSCL data; compliance ranged from 79%-88% for the first 6 cycles. Baseline RSCL scores were comparable between arms. No statistical differences between arms were seen for any of the RSCL dimensions (p>.05 at all cycles). Both arms had worsening in the PSDS (median increases of 3–6.8 on 69-point scale). Numerical differences were seen in some PSDS items rated as “quite a bit” or “very much.” By cycle 3, more GD pts reported tiredness (58% v 47%), lack of energy (45% v 38%), back pain (19% v 9%), and by cycle 2, alopecia (76% v 66%). By cycle 1, more CD pts reported tingling hands/feet (15% v 7%) and burning/sore eyes (14% v 3%). Conclusions: Preliminary analysis indicated no QoL differences between GD and CD; however, further exploration shows that physical distress is explained by different symptoms and toxicities in each arm. Results, particularly at later cycles, should be cautiously interpreted because of pt attrition and different reasons for discontinuation (eg, more CD than GD pts discontinued due to serious adverse events [28% v 13%]). Further analysis incorporating clinical outcomes may better explain QoL outcomes [Table: see text]

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.

Sign in / Sign up

Export Citation Format

Share Document