A multicenter, open-label study to determine the effect of intravenous zoledronic acid (ZOL) on pain and quality of life in patients with bone metastases with or without skeletal-related events (SREs) resulting from breast cancer (BC) and prostate cancer (PC).

2011 ◽  
Vol 29 (15_suppl) ◽  
pp. e19558-e19558
Author(s):  
Y. B. Al Farhat ◽  
J. Cseh ◽  
K. Boer ◽  
M. Csepreghy ◽  
L. Pajor ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Prostate Cancer ◽  
Zoledronic Acid ◽  
Bone Metastases ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Skeletal Related Events

Randomized phase III trial to evaluate radiopharmaceuticals and zoledronic acid in the palliation of osteoblastic metastases from lung, breast, and prostate cancer: Report of RTOG 0517.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS9150-TPS9150 ◽  
Author(s):  
Michael J. Seider ◽  
Stephanie Shook ◽  
Corey J. Langer ◽  
Gwen Wyatt ◽  
William F. Demas ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Zoledronic Acid ◽  
Bone Metastases ◽  
Median Time ◽  
Standard Dose ◽  
Cox Proportional Hazards ◽  
Phase Iii ◽  
Relative Reduction

TPS9150 Background: Skeletal related events (SREs) diminish quality of life (QOL) as well as overall survival (OS) in patients with bone metastases, a common event in breast, lung and prostate cancer. SREs can be reduced or delayed by the use of bisphosphonates. It is postulated that the radiopharmaceuticals, Strontium-89 (Sr89) and Samarium-153 (Sm153), when added to a bisphosphonate can decrease the incidence of SREs. Methods: RTOG 0517 randomized patients with breast, lung and prostate cancer and blastic bone metastases to either Zoledronic acid (ZA) alone or ZA plus a single standard dose of either Sr89 or Sm153. No limitations were placed on additional therapy such as chemotherapy or hormonal treatment. The projected median time to SRE [pathological bone fracture, spinal cord compression, surgery to bone, or radiation to bone] for the ZA arm was 10.4 months requiring 257 SRE events to detect a 33% relative reduction for the radiopharmaceutical arm in the time to development of an SRE with 90% power. Other study objectives included quality of life, pain control, OS and toxicity. Results: 261 patients (median age 68; 62% male; 55% prostate, 35% breast, 10% lung) were accrued from July 2006 through February 2011 (4.6 patients/month). Due to a lower than expected rate of SREs in the control (ZA) arm, the study was closed early and therefore did not reach the targeted accrual. 28 (17.4%) patients in the ZA arm and 27 (16.8%) in the radiopharmaceutical arm experienced an SRE. Median time to development of an SRE in the ZA and radiopharmaceutical arms was 11.60 and 16.74 months, respectively (p=.47). Median OS in the ZA arm and radiopharmaceutical arm was 15.95 and 11.18 months, respectively (p=0.12). Cox proportional hazards regression model showed that baseline characteristics, including gender, race, ethnicity, primary disease site or number of bone metastases, had no significant impact on OS. There was no difference in QOL parameters or toxicities between the two arms. Conclusion: Patients receiving ZA only experienced a much lower SRE rate than was hypothesized. The addition of Sr89 or Sm153 did not result in a difference in SREs, OS, or QOL

scholarly journals Functional impairment and disability among patients with migraine: evaluation of galcanezumab in a long-term, open-label study

2020 ◽  
Author(s):  
Janet H. Ford ◽  
Virginia L. Stauffer ◽  
Peter McAllister ◽  
Sreelatha Akkala ◽  
Matthew Sexson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Treatment Phase ◽  
Phase Iii ◽  
Life Questionnaire ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Patient Reported ◽  
Domain Scores

Abstract Purpose Migraine can negatively impact patient functioning and quality of life. Here, we report the effects of galcanezumab (GMB), a humanized monoclonal antibody that binds to calcitonin gene-related peptide, on patient-reported outcome (PRO) measures in migraine. Methods CGAJ was a Phase III, randomized, open-label study (12-month open-label and 4-month post-treatment follow-up) in patients with episodic or chronic migraine. Patients aged 18–65 years with diagnosis of migraine (≥ 4 migraine headache days per month) as defined by International Classification of Headache Disorders (ICHD)-3 beta guidelines were included in the study. Patients were randomized 1:1 with subcutaneous GMB 120 mg (with a loading dose of 240 mg) or GMB 240 mg given once monthly for 12 months. Changes from baseline in PRO measures such as Migraine-Specific Quality of Life Questionnaire v2.1 (MSQ) and Migraine Disability Assessment (MIDAS) were assessed. Results A total of 135 patients were randomized to each galcanezumab dose group. Mean (SD) baseline MSQ total scores were 53.85 (20.34) [GMB 120 mg] and 53.69 (18.79) [GMB 240 mg]. For MIDAS, mean (SD) total scores were 45.77 (42.06) [GMB 120 mg] and 53.96 (61.24) [GMB 240 mg]. Within-group mean improvement from baseline on MSQ and MIDAS total scores and all individual item/domain scores were statistically significant for both GMB dose groups, at all-time points during the treatment phase (p < 0.001). For MSQ domain scores, greatest improvement was observed in the Role function-restrictive (RF-R) domain (overall least squares (LS) mean change ± SE: 31.55 ± 1.20 [GMB 120 mg] and 33.40 ± 1.16 [GMB 240 mg]). For MIDAS, the overall LS mean change ± SE from baseline across the entire 12-month treatment phase in total scores were: −33.58 ± 2.11 (GMB 120 mg) and −32.67 ± 2.04 (GMB 240 mg). Conclusion Galcanezumab was associated with statistically significant changes from baseline in the PRO measures across the entire 12-month treatment period. These results indicate improved health-related quality of life and decreased disability among patients treated with galcanezumab.

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