scholarly journals Health-related Quality of Life in Intermediate- or High-risk Patients Treated With Radical External Radiotherapy and Adjuvant Docetaxel for Localized Prostate Cancer: A Randomized, Phase III SPCG-13 Study

2021 ◽  
Vol 42 (1) ◽  
pp. 87-92
Author(s):  
MIIKKA LEHTONEN ◽  
JORMA SORMUNEN ◽  
MARIE HJÄLM-ERIKSSON ◽  
CAMILLA THELLENBERG-KARLSSON ◽  
TEPPO HUTTUNEN ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
High Risk ◽  
Phase Iii ◽  
External Radiotherapy ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related ◽  
Risk Patients

Association of health-related quality of life (HRQOL) variations with biological biomarkers for patients with metastatic castrate-resistant prostate cancer (MCRPC) treated by abiraterone/prednisone combination or prednisone.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 54-54
Author(s):  
Morgan Goujon ◽  
Amelie Anota ◽  
Alexandre Frontczak ◽  
Emilie Charton ◽  
Tristan Maurina ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Phase Iii ◽  
Health Related Quality ◽  
Meaningful Improvement ◽  
Related Quality ◽  
Health Related ◽  
Castrate Resistant Prostate Cancer ◽  
Castrate Resistant

54 Background: A potential link between Health-Related Quality of life (HRQoL) and oncologic outcomes such as overall survival or progression-free survival has been underlined for endocrine therapies in patients with metastatic castrate resistant prostate cancer (mCRPC). Other surrogates such as circulating tumor cells (CTCs) or PSA can be used to evaluate disease control. This study explored the associations between HRQoL and biological biomarkers for patients with mCRPC treated by abiraterone / prednisone or prednisone within registration phase III trial COU-AA-301. Methods: Baseline differences of HRQoL evaluated with FACT-P total score (FACT-P TS) according to biological parameters (including CTCs and PSA) and links between HRQoL's change and variations of these parameters were assessed. The primary objective was to estimate the association between improvement or deterioration in FACT-P TS and the variations of CTCs and PSA. All analyses were conducted using clinically meaningful improvement and deterioration in FACT-P TS and subscales. Results: Among 1130 patients enrolled, 1111 (98.3%) had a baseline FACT-P TS available. At baseline, a favorable CTCs count was associated with higher FACT-P TS compared to unfavorable CTCs (difference in means 8 points, [95% CI, 4 to 12] p < 0.001). At 3 months, there were differences in mean change from baseline FACT-P TS favoring patients with biomarkers response, with clinically meaningful difference for CTCs (12.7 points, [95% CI, 6 to 19.5%] p < 0.001) and PSA (11.64 points, [95% CI, 9.3 to 14] p < 0.0001). Biological progression was associated with higher risk of FACT-P TS worsening for PSA (Odds Ratio (OR) 2.8 [95% CI, 1.9 to 4.2]) with more frequent FACT-P TS improvement in case of response for CTCs (OR 3.14 [95% CI, 1.3 to 7.7]) and PSA (OR 2.9 [95% CI 2.1 to 4]). Significantly longer time until definitive deterioration was observed for patients with CTCs or PSA response (p < 0.001) and shorter time in case of progression (p < 0.001). Conclusions: QUA-lify is the first study to show an association between HRQoL and biomarkers outcomes in patients with mCRPC treated with endocrine therapy in a post-taxane setting. This concept is reinforced by the consistency of the association for all analyses carried out.

Health-related quality of life outcomes in a phase I/II study of stereotactic hypofractionated once-weekly radiation therapy (SHORT) for nonmetastatic prostate cancer.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 126-126 ◽  
Author(s):  
Indranil Mallick ◽  
Moses Arunsingh ◽  
Sujoy Gupta ◽  
Satyadip Mukherjee ◽  
Sanjoy Chatterjee ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
High Risk ◽  
Symptom Score ◽  
Urinary Symptom ◽  
End Of Treatment ◽  
Related Quality ◽  
Health Related ◽  
Risk Patients

126 Background: Stereotactic Radiation Therapy (SRT) for prostate cancer offers an opportunity to exploit the low alpha/beta ratio of prostate cancer. We present patient reported health-related Quality-of-life (HR-QoL) outcomes of an SRT schedule with once-weekly fractionation in an unselected cohort of non-metastatic prostate cancer. Methods: In a Phase I/II study 30 patients with non-metastatic prostate cancer (multiparametric MRI cT1-4N0, M0, Gleason 6-10, PSA < = 60 ng/ml) were treated to a dose of 35Gy in 5 fractions delivered once a week (along with simultaneous elective nodal radiotherapy at 25Gy/5Fr to patients high-risk by NCCN criteria). Androgen deprivation therapy given to intermediate and high-risk patients. Treatments were planned using volumetric intensity modulated arc therapy. Quality of life was assessed using the EORTC QLQ C30 and PR25 questionnaires. HR-QoL parameters at baseline (before start of SRT) was compared to those at treatment completion and 3 months post-SRT. The raw QoL scores were converted to a scale of 0-100 by convention. A scale difference of 10 or higher was considered clinically meaningful. Results: All of the 30 recruited patients completed treatment and HR-QoL data were available at 3 time points for all patients. The ratio of low, intermediate and high risk patients was 1:9:20. SRT was well tolerated with no acute Grade 3 GI or GU symptoms by NCI CTC v4 (separately reported). Twenty one parameters were studies within the QLQ C30 and PR25 framework. At the end of treatment, only the urinary symptom score showed a clinically meaningful worsening (mean of 20/100 at baseline vs 34/100 at end of treatment, p < 0.001). At 3 months, the urinary symptom score had returned close to baseline (26/100, p = 0.08). There was no clinically meaningful deterioration in the remaining HR-QoL parameters. Conclusions: Patient perception of function and symptoms with once-weekly SRT was good, with only a temporary worsening of the urinary symptom score, and subsequent recovery by 3 months. Compared to baseline scores, other QoL parameters did not show a clinically meaningful difference at end of treatment or at 3 months. Clinical trial information: CTRI/2016/02/006671.

Phase III Study Comparing a Reduced Dose of Cabazitaxel (20 mg/m2) and the Currently Approved Dose (25 mg/m2) in Postdocetaxel Patients With Metastatic Castration-Resistant Prostate Cancer—PROSELICA

2017 ◽  
Vol 35 (28) ◽  
pp. 3198-3206 ◽  
Author(s):  
Mario Eisenberger ◽  
Anne-Claire Hardy-Bessard ◽  
Choung Soo Kim ◽  
Lajos Géczi ◽  
Daniel Ford ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Phase Iii ◽  
Health Related Quality ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Related Quality ◽  
Health Related ◽  
Upper Boundary

Purpose Cabazitaxel 25 mg/m2 (C25) significantly improved overall survival (OS) versus mitoxantrone ( P < .001) in postdocetaxel patients with metastatic castration-resistant prostate cancer (mCRPC) in the phase III TROPIC study. The phase III PROSELICA study ( ClinicalTrials.gov identifier: NCT01308580) assessed the noninferiority of cabazitaxel 20 mg/m2 (C20) versus C25 in postdocetaxel patients with mCRPC. Methods Patients were stratified by Eastern Cooperative Oncology Group performance status, measurability of disease per Response Evaluation Criteria in Solid Tumors (RECIST), and region, and randomly assigned to receive C20 or C25. To claim noninferiority of C20 (maintenance of ≥ 50% of the OS benefit of C25 v mitoxantrone in TROPIC) with 95% confidence level, the upper boundary of the CI of the hazard ratio (HR) for C20 versus C25 could not exceed 1.214 under a one-sided 98.89% CI after interim analyses. Secondary end points included progression-free survival, prostate-specific antigen (PSA), tumor and pain responses and progression, health-related quality of life, and safety. Results Overall, 1,200 patients were randomly assigned (C20, n = 598; C25, n = 602). Baseline characteristics were similar in both arms. Median OS was 13.4 months for C20 and 14.5 months for C25 (HR, 1.024). The upper boundary of the HR CI was 1.184 (less than the 1.214 noninferiority margin). Significant differences were observed in favor of C25 for PSA response (C20, 29.5%; C25, 42.9%; nominal P < .001) and time to PSA progression (median: C20, 5.7 months; C25, 6.8 months; HR for C20 v C25, 1.195; 95% CI, 1.025 to 1.393). Health-related quality of life did not differ between cohorts. Rates of grade 3 or 4 treatment-emergent adverse events were 39.7% for C20 and 54.5% for C25. Conclusion The efficacy of cabazitaxel in postdocetaxel patients with mCRPC was confirmed. The noninferiority end point was met; C20 maintained ≥ 50% of the OS benefit of C25 versus mitoxantrone in TROPIC. Secondary efficacy end points favored C25. Fewer adverse events were observed with C20.

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