Investigator-initiated pilot study of bicalutamide and raloxifene in hormone-resistant prostate cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e16065-e16065
Author(s):  
Thai Huu Ho ◽  
Donald W. Northfelt ◽  
Rafael Nunez Nateras ◽  
Alan H. Bryce ◽  
Amylou C. Dueck ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Estrogen Receptor ◽  
Adverse Event ◽  
Adverse Events ◽  
Group Performance ◽  
Combined Treatment ◽  
Eastern Cooperative Oncology Group ◽  
Hormone Resistant Prostate Cancer

e16065 Background: Estrogens, in addition to androgen may contribute to the progression of prostate cancer.The combination of bicalutamide, a non-steroidal anti-androgen, and raloxifene, a selective estrogen receptor modulator, has a synergistic effect on cell death of prostate cancer cell lines such as DU145 and PC3. We investigated the safety of combined treatment of bicalutamide and raloxifene on quality of life in patients affected by hormone-resistant prostate cancer. Methods: Eligibility requirements included metastatic hormone-resistant prostate cancer, Eastern Cooperative Oncology Group performance status of 0 or 1. Patients received the combination of bicalutamide, 50 mg, and raloxifene, 60 mg, daily in 28 day cycles for a maximum of 6 cycles. The primary endpoint was to describe the adverse event profile of combined treatment with bicalutamide and raloxifene. The secondary endpoint was to describe the quality of life of patients receiving the combination. Adverse events were graded by the investigator using the NCI Common Terminology Criteria for Adverse Events version 4.0 and the quality of life was assessed by the patient using aLinear Analog Scale Assessment (scale of 0-100). Serum levels of estradiol and testosterone were monitored during treatment. Results: Eighteen evaluable patients were included in the statistical analysis after an initial run-in safety cohort of six patients. Two patients completed 6 cycles per protocol, the remaining sixteen patients were taken off protocol after disease progression. Patients completed a median of 2 cycles. There were no grade 4 events and grade 3 adverse events consisted of hypertension (5.6%) and back pain (5.6%). Erectile dysfunction (grade 1) was the most common adverse event (77.8%). Patient assessment of quality of life (mental, physical, social, emotional, spiritual) did not reveal any statistically different changes after 2 cycles of treatment. An analysis of testosterone and estradiol levels will be reported. Conclusions: We conclude that combination of bicalutamide and raloxifene is well-tolerated. The combination of androgen and estrogen receptor blockade warrants further study for efficacy in hormone-resistant prostate cancer. Clinical trial information: NCT01050842.

Radium-223 (Ra-223) versus novel antihormone therapy (NAH) for progressive metastatic castration-resistant prostate cancer (mCRPC) after 1 line of NAH: RADIANT, an international phase 4, randomized, open-label study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS5093-TPS5093
Author(s):  
Karim Fizazi ◽  
Aránzazu González del Alba ◽  
Özgüroğlu Mustafa ◽  
Iwona Anna Skoneczna ◽  
Heiko Krissel ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Adverse Events ◽  
Bone Metastases ◽  
Disease Progression ◽  
Group Performance ◽  
Short Form ◽  
Cross Resistance ◽  
Hormone Sensitive

TPS5093 Background: Men with mCRPC often receive sequential NAH (abiraterone and enzalutamide) despite reported cross-resistance, indicating a need for further life-prolonging options for progressive disease after prior NAH. Ra-223 is a targeted alpha therapy approved for mCRPC with symptomatic bone metastases based on the phase 3 ALSYMPCA study, in which it demonstrated significantly increased overall survival (OS), reduced symptomatic skeletal event (SSE) risk, improved quality of life, and reduced treatment-emergent adverse event rates vs placebo. As life-prolonging therapy is increasingly used in hormone-sensitive settings, this study has been designed to assess Ra-223 outcomes in patients with mCRPC that progressed after prior treatment with NAH and docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC) or mCRPC. Methods: This study is conducted in accordance with the Declaration of Helsinki, international ethical and good clinical practice guidelines, and local laws and regulations, with institutional review board/ethics committee approval at each site and written informed consent from patients before participation. This trial is registered with EudraCT: 2019-000476-42. Participants must be ≥18 years old, with an Eastern Cooperative Oncology Group performance status of 0/1; they must have mCRPC that progressed on/after ≥3 months of NAH for mHSPC or mCRPC and ≥2 cycles of docetaxel unless they refused or were ineligible, with ≥2 bone metastases on bone scan, no visceral metastases, and a worst pain score ≥1 on the Brief Pain Inventory-Short Form. Patients are randomized 1:1 to Ra-223 or NAH: Ra-223 55 kBq/kg intravenously every 4 weeks for 6 cycles or until disease progression, death, or withdrawal of consent if earlier; or abiraterone 1000 mg + prednisone 10 mg daily (if prior enzalutamide) or enzalutamide 160 mg daily (if prior abiraterone) until disease progression, death, or withdrawal of consent. NAH dosing may be modified to manage adverse events. Patients must use luteinizing hormone-releasing hormone analogs, if not surgically castrated, and bone health agents (bisphosphonates or denosumab) throughout the study. The primary endpoint is OS. Secondary endpoints are time to first SSE, radiologic progression-free survival, time to pain progression, adverse events, fracture incidence, and time to deterioration in quality of life (FACT-P total score). Using a test with a two-sided alpha of 0.05, 90% power, and randomization ratio of 1:1, approximately 508 events are required to detect a 33% increase in OS with Ra-223 vs NAH, assuming a median OS of 10 months with NAH. The expected study duration is 55 months, with a target of 696 patients to be randomized. The first patient was enrolled on November 9, 2020; 5 patients have been randomized and 2 have started treatment to date. Clinical trial information: 2019-000476-42.

The study of the treatment efficacy in metastatic castration-resistant prostate cancer of low dose abiraterone with food.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e17571-e17571
Author(s):  
Kanta Makphanchareonkit ◽  
Thitiya Sirisinha Dejthevaporn ◽  
Dittapol Muntham ◽  
Phichai Chansriwong
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Adverse Events ◽  
Low Dose ◽  
Standard Dose ◽  
Abiraterone Acetate ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Psa Response

e17571 Background: Abiraterone acetate and prednisolone (AAP) + ADT has been approved for treatment metastatic castration-resistant prostate cancer (CRPC) in the standard dose 1,000 mg with fasting state. Data in Ramathibodi hospital showed patients who had treated with standard dose of Abiraterone acetate (AA); had PSA response 47.83%. Previous studies showed using low dose AA of 250 mg with food had the non-inferiority results in efficacy. AA was not be reimbursed in Thailand, so the ability to use a highly effective drug at a quarter of the dose, could help in patient accessibility to cancer treatments. We sought to test the hypothesis that low-dose AA with food would have the comparable activity in Thai CRPC patients in both of the pre-Docetaxel and post Docetaxel treatment groups, and exploring the quality of life (QOL) of these patients. Methods: An observational cohort enrolled newly diagnosed metastasis CRPC at Ramathibodi hospital from 1st Jan 2019 to 31st Dec 2019. Patients were assigned to AA (250mg) with actual daily life meal. We collected the data of serum PSA and the adverse events every 4 weeks for 4 months. The QOL data was collected with the EuroQoL (EQ-5D) questionnaire which were done at baseline and every 4 weeks. The primary end point was PSA response that defined as PSA decreased ≥ 50% from PSA level at baseline. The secondary endpoint were the depth of PSA change, QOL and adverse events by using Fisher's exact test and T-test. Results: 21 patients were enrolled. At 12 weeks, there were 11 patients (52.38%) achieved 50% PSA response and 6 patients (28.57%) achieved 90% PSA response. The adverse events occurred 23.8%, and mostly were mild grade. The adverse events were comparable with the historical data in standard dose of AA. Low dose AA has significantly shown the improvement in quality of life from baseline (p < 0.001), and especially the significant improvement in pre-Docetaxel subgroup. Conclusions: Low-dose AA with food has good efficacy in PSA response, adverse events and QOL. Moreover, low dose AA shows more efficacy especially in pre-Docetaxel mCRPC patients. Low dose AA may be helping in reducing cost of cancer care, enabling in delivering affordable cancer care and increasing value of treatment.

Phase III Comparison of Two Irinotecan Dosing Regimens in Second-Line Therapy of Metastatic Colorectal Cancer

2003 ◽  
Vol 21 (5) ◽  
pp. 807-814 ◽  
Author(s):  
Charles S. Fuchs ◽  
Melvin R. Moore ◽  
Graydon Harker ◽  
Luis Villa ◽  
David Rinaldi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Group Performance ◽  
Eastern Cooperative Oncology Group ◽  
Phase Iii ◽  
Significant Difference ◽  
Global Quality Of Life ◽  
Grade 3

Purpose: Randomized trials in fluorouracil (FU)-refractory colorectal cancer demonstrate significant survival advantages for patients receiving irinotecan. We prospectively compared the efficacy and tolerability of two irinotecan regimens (once a week for 4 weeks followed by a 2-week rest period [weekly] v once every 3 weeks) in such patients. Patients and Methods: This multicenter, open-label, phase III study randomly assigned patients in a 1:2 ratio to irinotecan given either weekly (125 mg/m2) or once every 3 weeks (350 mg/m2, or 300 mg/m2 in patients who were ≥ 70 years of age, who had Eastern Cooperative Oncology Group performance status equal to 2, or who had prior pelvic irradiation). Results: With median follow-up of 15.8 months, there was no significant difference in 1-year survival (46% v 41%, respectively; P = .42), median survival (9.9 v 9.9 months, respectively; P = .43), or median time to progression (4.0 v 3.0 months, respectively; P = .54) between the two regimens. Grade 3/4 diarrhea occurred in 36% of patients treated weekly and in 19% of those treated once every 3 weeks (P = .002). Grade 3/4 neutropenia occurred in 29% of patients treated weekly and 34% of those treated once every 3 weeks (P = .35). Treatment-related mortality occurred in five patients (5.3%) receiving irinotecan weekly and three patients (1.6%) given therapy once every 3 weeks (P = .12). Global quality of life was not statistically different between treatment groups. Conclusion: Irinotecan schedules of weekly and of once every 3 weeks demonstrated similar efficacy and quality of life in patients with FU-refractory, metastatic colorectal cancer. The regimen of once every 3 weeks was associated with a significantly lower incidence of severe diarrhea.

scholarly journals Probiotic and Peanut OIT leads to long-lasting sustained unresponsiveness and quality-of-life improvement in peanut-allergic children

2021 ◽  
Author(s):  
Paxton Loke ◽  
Kuang-Chih Hsiao ◽  
Adriana Lozinsky ◽  
Sarah Ashley ◽  
Melanie Lloyd ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Peanut Allergy ◽  
Combined Treatment ◽  
Post Treatment ◽  
Long Term Effects ◽  
Sustained Unresponsiveness ◽  
End Of Treatment

Background: Combined treatment with probiotic and peanut oral immunotherapy (PPOIT) was shown to induce sustained unresponsiveness (SU) in a proof-of-concept randomized trial. Additional data on safety and long-term outcomes are needed. This study aimed to evaluate the safety and long-term effects of PPOIT in children with peanut allergy. Methods: Open-label study of 20 children aged 1-12 years with challenge-confirmed peanut allergy; all children received 18-months of PPOIT. Efficacy endpoints were desensitization, 8-week SU, and persistence of 8-week SU at 3-years post-treatment, assessed by double-blind placebo-controlled food challenge (cumulative 4950mg peanut protein). Treatment emergent adverse events and relationship to study treatment were recorded. Immunologic measures and health related quality of life (HRQL) were evaluated at screening, end-of-treatment and 3-years post-treatment. Results: Sixteen children (75%) completed treatment. By intention-to-treat analysis, 75% (15/20) achieved desensitization and 60% (12/20) achieved 8-week SU. Ten of 12 participants with SU at end-of-treatment consented to the 3-year SU challenge; 6 (60%) had persistence of SU. PPOIT was associated with significantly reduced peanut skin prick test wheal size and serum peanut specific-IgE levels at end-of-treatment, 12-months and 3-years post-treatment. There were no serious adverse events. HRQL scores improved (exceeding the Minimal Clinically Important Difference of 0.45) at 12-months post-treatment with benefit sustained at 3-years post-treatment. Conclusions: Eighteen months of PPOIT induced high rates of desensitization and SU, and SU persisted to 3-years post-treatment in a majority of initial responders. PPOIT led to long-lasting suppression of peanut sIgE and long-lasting clinically important improvement in HRQL.

scholarly journals Toxicity, Adverse Events, and Quality of Life Associated with the Treatment of Metastatic Castration-Resistant Prostate Cancer

2016 ◽  
Vol 10 (4) ◽  
pp. 169-173 ◽  
Author(s):  
Senol Tonyali ◽  
Hakan Bahadir Haberal ◽  
Emrullah Sogutdelen
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Adverse Events ◽  
Abiraterone Acetate ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Common Cancer ◽  
Health Related Qol ◽  
Health Related

Objectives: Among males, prostate cancer (PCa) is the most common cancer in Europe and the second most common cancer worldwide, especially in those aged > 70 years. With the advent of novel alternative treatments, survival in patients with advanced PCa has increased. PCa is now considered a chronic disease. Survival is an important endpoint in advanced PCa, as is quality of life (QoL). The effects of the disease and its treatment on patient health-related QoL must be taken into account when selecting the most appropriate treatment options. The present literature review aimed to provide an overview of metastatic castration-resistant prostate cancer treatment modalities, with an emphasis on side effect profiles and general health-related QoL. Methods: PubMed was searched using the keywords metastatic castration-resistant prostate cancer, docetaxel, cabazitaxel, enzalutamide, abiraterone acetate, and QoL. Conclusion: Based on the studies reviewed herein, abiraterone acetate and enzalutamide provide favorable outcomes, in terms of hematological adverse events. As enzalutamide and abiraterone acetate can be taken orally, they might have a positive effect on patient QoL.

How Accurate Is Clinician Reporting of Chemotherapy Adverse Effects? A Comparison With Patient-Reported Symptoms From the Quality-of-Life Questionnaire C30

2004 ◽  
Vol 22 (17) ◽  
pp. 3485-3490 ◽  
Author(s):  
Erik K. Fromme ◽  
Kristine M. Eilers ◽  
Motomi Mori ◽  
Yi-Ching Hsieh ◽  
Tomasz M. Beer
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Adverse Event ◽  
Adverse Effects ◽  
Adverse Events ◽  
Life Questionnaire ◽  
European Organization ◽  
Quality Of Life Questionnaire ◽  
Patient Reported

Purpose Adverse events in chemotherapy clinical trials are assessed and reported by clinicians, yet clinician accuracy in assessing symptoms has been questioned. We compared patient reporting of eight symptoms using a validated instrument, the European Organization for the Research and Treatment of Cancer Quality-of-Life Questionnaire C30 (QLQ-C30 or QLQ) with physicians' reporting of the same symptoms in the study's adverse events log. Patients and Methods Thirty-seven men with metastatic, androgen-independent prostate cancer enrolled onto a phase II trial of weekly calcitriol and docetaxel completed the QLQ every 4 weeks for up to 28 weeks. A patient-reported symptom was defined as an increase in a QLQ symptom score by at least 10 points (0 to 100 scale), sustained for at least 4 weeks. A physician-reported symptom was considered present if it was ever documented in the adverse event log. Results Forty-nine (new or worsened) symptoms were detected by both physician and QLQ, 48 symptoms were detected by the physician alone, and 55 symptoms were detected by the QLQ alone. They agreed on the absence of a symptom in 102 instances of 254 possible opportunities. Their uncorrected agreement was 59.4%, but Cohen's κ, a coefficient of agreement that corrects for chance, was 0.15, indicating only slight agreement. Using the QLQ as the standard, overall physician sensitivity and specificity was 47% and 68%, respectively, although it varied considerably among symptoms. Conclusion Even in a tightly controlled clinical trial, physician reporting was neither sensitive nor specific in detecting common chemotherapy adverse effects. Tools for collecting patient-reported adverse event data in chemotherapy clinical trials should be developed.

A pilot study to examine the relationship between boredom and spirituality in cancer patients

2003 ◽  
Vol 1 (2) ◽  
pp. 143-151 ◽  
Author(s):  
ALICE INMAN ◽  
KENNETH L. KIRSH ◽  
STEVEN D. PASSIK
Keyword(s):  
Quality Of Life ◽  
Cancer Patients ◽  
Group Performance ◽  
Eastern Cooperative Oncology Group ◽  
Depression Scale ◽  
Well Being ◽  
Mediating Effect ◽  
The Impact ◽  
The Relationship

Objective: Spirituality has been neglected when assessing the well-being of cancer patients. Traditionally, researchers have focused on areas such as physical, social, and emotional functioning. However, there is a potential for spirituality to have a large impact on quality of life in patients with cancer. The current study was conducted to investigate the relationship between spirituality and boredom, constraint, social contact, and depression.Methods: A total of 100 oncology patients completed several assessment instruments, including the Purposelessness, Under-stimulation, and Boredom (PUB) Scale, Functional Assessment of Cancer Therapy Scale–Anemia, Brief Zung Self-Rating Depression Scale (BZSDS), Cancer Behavior Inventory, Systems of Belief Inventory, and Eastern Cooperative Oncology Group Performance Status Scale.Results: The average age of the sample was 62.37 years (SD = 13.43) and was comprised of 60 women (60%) and 40 men (40%). A regression analysis conducted to explore the impact of the variables on quality of life found only the BZSDS (R2Δ = .650, F = 180.392, p < .001) and the PUB Scale (R2Δ = .077, F = 26.885, p < .001) were significant predictors of quality of life. Another set of regression analyses were conducted to explore whether spirituality had a mediating effect on this relationship, but the mediated model was not supported.Significance of results: We conclude that spirituality and boredom are difficult concepts to define, operationalize, and measure, but crucial to our understanding of quality of life in advanced cancer. More research is needed to clarify the nature of the interrelationships between these important concepts.

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