The Experts below are selected from a list of 68433 Experts worldwide ranked by ideXlab platform
Evelyn Regar - One of the best experts on this subject based on the ideXlab platform.
-
in vivo evaluation of stent strut distribution patterns in the bioabsorbable everolimus eluting device an oct Ad Hoc Analysis of the revision 1 0 and revision 1 1 stent design in the absorb clinical trial
Eurointervention, 2010Co-Authors: Takayuki Okamura, Yoshinobu Onuma, Richard Rapoza, Scot Garg, Juan Luis Gutierrezchico, Eunseok Shin, Hector M Garciagarcia, Krishnankufty Sudhir, Evelyn RegarAbstract:textabstractAims: The ABSORB Cohort A clinical study has shown the feasibility and safety of the fully bioabsorbable everolimus-eluting structure (BVS, revision 1.0). However, the study also demonstrated somewhat higher acute and late recoil with the BVS structure compared to metallic drug eluting stents. Based on these clinical observations, modifications to the stent design (BVS, revision 1.1) were introduced for the ABSORB Cohort B study in order to decrease recoil. The aim was to compare in vivo the strut distribution between the BVS revision 1.0 (Cohort A), and BVS revision 1.1 (Cohort B) designs. Methods and results: OCT Analysis was performed by two independent analysts in four patients from each cohort of the ABSORB study. Strut distribution was assessed in cross-section, and longitudinally in a frame-by-frame Analysis. Variables recorded included inter-strut angle, maximum inter-strut angle and number of frames with ≥3 struts. The inter-observer correlation coefficient was also assessed. For both designs, on a patient level there was no significant difference in the number of analysed struts corrected for the length of the scaffold (p=0.78). Likewise, on a frame by frame Analysis mean stent area, number of struts per frame, mean maximum inter-strut angle, and mean inter-strut angle were similar for both groups. However, in both structures there was a cyclical variation in the maximum number of struts per frame. The frequency of this variation was significantly higher in Cohort B. The inter-observer correlation coefficient for strut counts, inter-strut angle and maximum inter-strut angle was 0.91, 0.87 and 0.74 respectively. Conclusions: This Ad Hoc Analysis confirms that the revision 1.1 BVS design has a different longitudinal strut distribution to the revision 1.0 BVS design, indicating that the new design has a reduced maximum circular unsupported cross sectional area.
-
in vivo evaluation of stent strut distribution patterns in the bioabsorbable everolimus eluting device an oct Ad Hoc Analysis of the revision 1 0 and revision 1 1 stent design in the absorb clinical trial
Eurointervention, 2010Co-Authors: Takayuki Okamura, Evelyn Regar, Yoshinobu Onuma, Richard Rapoza, Scot Garg, Juan Luis Gutierrezchico, Eunseok Shin, Hector M Garciagarcia, Krishnankufty Sudhir, Patrick W SerruysAbstract:Aims: The ABSORB Cohort A clinical study has shown the feasibility and safety of the fully bioabsorbable everolimus-eluting structure (BVS, revision 1.0). However, the study also demonstrated somewhat higher acute and late recoil with the BVS structure compared to metallic drug eluting stents. Based on these clinical observations, modifications to the stent design (BVS, revision 1.1) were introduced for the ABSORB Cohort B study in order to decrease recoil. The aim was to compare in vivo the strut distribution between the BVS revision 1.0 (Cohort A), and BVS revision 1.1 (Cohort B) designs. Methods and results: OCT Analysis was performed by two independent analysts in four patients from each cohort of the ABSORB study. Strut distribution was assessed in cross-section, and longitudinally in a frame-by-frame Analysis. Variables recorded included inter-strut angle, maximum inter-strut angle and number of frames with ≥3 struts. The inter-observer correlation coefficient was also assessed. For both designs, on a patient level there was no significant difference in the number of analysed struts corrected for the length of the scaffold (p=0.78). Likewise, on a frame by frame Analysis mean stent area, number of struts per frame, mean maximum inter-strut angle, and mean inter-strut angle were similar for both groups. However, in both structures there was a cyclical variation in the maximum number of struts per frame. The frequency of this variation was significantly higher in Cohort B. The inter-observer correlation coefficient for strut counts, inter-strut angle and maximum inter-strut angle was 0.91, 0.87 and 0.74 respectively. Conclusions: This Ad Hoc Analysis confirms that the revision 1.1 BVS design has a different longitudinal strut distribution to the revision 1.0 BVS design, indicating that the new design has a reduced maximum circular unsupported cross sectional area.
Amy Feng - One of the best experts on this subject based on the ideXlab platform.
-
delaying skeletal related events in a randomized phase 3 study of denosumab versus zoledronic acid in patients with Advanced cancer an Analysis of data from patients with solid tumors
Supportive Care in Cancer, 2014Co-Authors: David H Henry, Roger Von Moos, Giorgio V Scagliotti, V Hirsh, Penella J Woll, Saroj Vadhanraj, Vania Hungria, Luis Costa, Geoffrey Smith, Amy FengAbstract:Bone complications of metastatic disease, including skeletal-related events (SREs), impair patients' functioning and quality of life. In a randomized, phase 3 trial of 1,776 patients with metastases from solid tumors (except breast or prostate) or multiple myeloma, denosumab was non-inferior to zoledronic acid (ZA) in delaying or preventing SREs. This Ad Hoc Analysis reports outcomes in the subgroup of 1,597 patients with solid tumors, excluding patients with multiple myeloma. Patients received monthly subcutaneous denosumab 120 mg or intravenous ZA 4 mg, Adjusted for creatinine clearance, with calcium and vitamin D supplementation recommended. Endpoints included times to first on-study SRE, first-and-subsequent SREs, and pain worsening. Denosumab significantly delayed time to first on-study SRE compared with ZA (HR, 0.81; 95 % CI, 0.68–0.96) and time to first-and-subsequent SREs (RR, 0.85; 95 % CI, 0.72–1.00). Denosumab also significantly delayed time to development of moderate or severe pain (HR, 0.81; 95 % CI, 0.66–1.00), pain worsening (HR, 0.83; 95 % CI, 0.71–0.97), and worsening pain interference in patients with no/mild baseline pain (HR, 0.77; 95 % CI, 0.61–0.96). Adverse event rates were 96 % in both groups. GrAde 3 or 4 hypocalcemia, mostly without clinical sequelae, was more frequent in denosumab-treated patients (denosumab 4 %, ZA 2 %). Osteonecrosis of the jaw occurred infrequently (denosumab 0.8 %, ZA 1.1 %). Denosumab was more effective in delaying or preventing SREs in patients with bone metastases from solid tumors and also prevented pain progression compared to ZA in this Ad Hoc Analysis.
-
delaying skeletal related events in a randomized phase 3 study of denosumab versus zoledronic acid in patients with Advanced cancer an Analysis of data from patients with solid tumors
Supportive Care in Cancer, 2014Co-Authors: David H Henry, Roger Von Moos, Giorgio V Scagliotti, V Hirsh, Penella J Woll, Saroj Vadhanraj, Vania Hungria, Luis Costa, Geoffrey Smith, Amy FengAbstract:Purpose Bone complications of metastatic disease, including skeletal-related events (SREs), impair patients' functioning and quality of life. In a randomized, phase 3 trial of 1,776 patients with metastases from solid tumors (except breast or prostate) or multiple myeloma, denosumab was non-inferior to zoledronic acid (ZA) in delaying or preventing SREs. This Ad Hoc Analysis reports outcomes in the subgroup of 1,597 patients with solid tumors, excluding patients with multiple myeloma.
Takayuki Okamura - One of the best experts on this subject based on the ideXlab platform.
-
in vivo evaluation of stent strut distribution patterns in the bioabsorbable everolimus eluting device an oct Ad Hoc Analysis of the revision 1 0 and revision 1 1 stent design in the absorb clinical trial
Eurointervention, 2010Co-Authors: Takayuki Okamura, Yoshinobu Onuma, Richard Rapoza, Scot Garg, Juan Luis Gutierrezchico, Eunseok Shin, Hector M Garciagarcia, Krishnankufty Sudhir, Evelyn RegarAbstract:textabstractAims: The ABSORB Cohort A clinical study has shown the feasibility and safety of the fully bioabsorbable everolimus-eluting structure (BVS, revision 1.0). However, the study also demonstrated somewhat higher acute and late recoil with the BVS structure compared to metallic drug eluting stents. Based on these clinical observations, modifications to the stent design (BVS, revision 1.1) were introduced for the ABSORB Cohort B study in order to decrease recoil. The aim was to compare in vivo the strut distribution between the BVS revision 1.0 (Cohort A), and BVS revision 1.1 (Cohort B) designs. Methods and results: OCT Analysis was performed by two independent analysts in four patients from each cohort of the ABSORB study. Strut distribution was assessed in cross-section, and longitudinally in a frame-by-frame Analysis. Variables recorded included inter-strut angle, maximum inter-strut angle and number of frames with ≥3 struts. The inter-observer correlation coefficient was also assessed. For both designs, on a patient level there was no significant difference in the number of analysed struts corrected for the length of the scaffold (p=0.78). Likewise, on a frame by frame Analysis mean stent area, number of struts per frame, mean maximum inter-strut angle, and mean inter-strut angle were similar for both groups. However, in both structures there was a cyclical variation in the maximum number of struts per frame. The frequency of this variation was significantly higher in Cohort B. The inter-observer correlation coefficient for strut counts, inter-strut angle and maximum inter-strut angle was 0.91, 0.87 and 0.74 respectively. Conclusions: This Ad Hoc Analysis confirms that the revision 1.1 BVS design has a different longitudinal strut distribution to the revision 1.0 BVS design, indicating that the new design has a reduced maximum circular unsupported cross sectional area.
-
in vivo evaluation of stent strut distribution patterns in the bioabsorbable everolimus eluting device an oct Ad Hoc Analysis of the revision 1 0 and revision 1 1 stent design in the absorb clinical trial
Eurointervention, 2010Co-Authors: Takayuki Okamura, Evelyn Regar, Yoshinobu Onuma, Richard Rapoza, Scot Garg, Juan Luis Gutierrezchico, Eunseok Shin, Hector M Garciagarcia, Krishnankufty Sudhir, Patrick W SerruysAbstract:Aims: The ABSORB Cohort A clinical study has shown the feasibility and safety of the fully bioabsorbable everolimus-eluting structure (BVS, revision 1.0). However, the study also demonstrated somewhat higher acute and late recoil with the BVS structure compared to metallic drug eluting stents. Based on these clinical observations, modifications to the stent design (BVS, revision 1.1) were introduced for the ABSORB Cohort B study in order to decrease recoil. The aim was to compare in vivo the strut distribution between the BVS revision 1.0 (Cohort A), and BVS revision 1.1 (Cohort B) designs. Methods and results: OCT Analysis was performed by two independent analysts in four patients from each cohort of the ABSORB study. Strut distribution was assessed in cross-section, and longitudinally in a frame-by-frame Analysis. Variables recorded included inter-strut angle, maximum inter-strut angle and number of frames with ≥3 struts. The inter-observer correlation coefficient was also assessed. For both designs, on a patient level there was no significant difference in the number of analysed struts corrected for the length of the scaffold (p=0.78). Likewise, on a frame by frame Analysis mean stent area, number of struts per frame, mean maximum inter-strut angle, and mean inter-strut angle were similar for both groups. However, in both structures there was a cyclical variation in the maximum number of struts per frame. The frequency of this variation was significantly higher in Cohort B. The inter-observer correlation coefficient for strut counts, inter-strut angle and maximum inter-strut angle was 0.91, 0.87 and 0.74 respectively. Conclusions: This Ad Hoc Analysis confirms that the revision 1.1 BVS design has a different longitudinal strut distribution to the revision 1.0 BVS design, indicating that the new design has a reduced maximum circular unsupported cross sectional area.
Raymond Woojun Jang - One of the best experts on this subject based on the ideXlab platform.
-
durvalumab for recurrent or metastatic heAd and neck squamous cell carcinoma results from a single arm phase ii study in patients with 25 tumour cell pd l1 expression who have progressed on platinum based chemotherapy
European Journal of Cancer, 2019Co-Authors: Dan P Zandberg, Alain Patrick Algazi, Antonio Jimeno, J Good, Jerome Fayette, Nathaniel Bouganim, Neal Ready, Paul Clement, Caroline Even, Raymond Woojun JangAbstract:Abstract Background Patients with recurrent/metastatic heAd and neck squamous cell carcinoma (R/M HNSCC) progressing on platinum-based chemotherapy have poor prognoses and limited therapeutic options. Programmed cell death-1 (PD-1) and its ligand 1 (PD-L1) are frequently upregulated in HNSCC. The international, multi-institutional, single-arm, phase II HAWK study ( NCT02207530 ) evaluated durvalumab monotherapy, an anti-PD-L1 monoclonal antibody, in PD-L1-high patients with platinum-refractory R/M HNSCC. Patients and methods Immunotherapy-naive patients with confirmed PD-L1-high tumour cell expression (defined as patients with ≥25% of tumour cells expressing PD-L1 [TC ≥ 25%] using the VENTANA PD-L1 [SP263] Assay) received durvalumab 10 mg/kg intravenously every 2 weeks for up to 12 months. The primary end-point was objective response rate; secondary end-points included progression-free survival (PFS) and overall survival (OS). Results Among evaluable patients (n = 111), objective response rate was 16.2% (95% confidence interval [CI], 9.9–24.4); 29.4% (95% CI, 15.1–47.5) for human papillomavirus (HPV)-positive patients and 10.9% (95% CI, 4.5–21.3) for HPV-negative patients. Median PFS and OS for treated patients (n = 112) was 2.1 months (95% CI, 1.9–3.7) and 7.1 months (95% CI, 4.9–9.9); PFS and OS at 12 months were 14.6% (95% CI, 8.5–22.1) and 33.6% (95% CI, 24.8–42.7). Treatment-related Adverse events were 57.1% (any grAde) and 8.0% (grAde ≥3); none led to death. At data cut-off, 24.1% of patients remained on treatment or in follow-up. Conclusion Durvalumab demonstrated antitumour activity with acceptable safety in PD-L1-high patients with R/M HNSCC, supporting its ongoing evaluation in phase III trials in first- and second-line settings. In an Ad Hoc Analysis, HPV-positive patients hAd a numerically higher response rate and survival than HPV-negative patients.
Luis Eduardo Zucca - One of the best experts on this subject based on the ideXlab platform.
-
Addition of rAdium 223 to abiraterone acetate and prednisone or prednisolone in patients with castration resistant prostate cancer and bone metastases era 223 a randomised double blind placebo controlled phase 3 trial
Lancet Oncology, 2019Co-Authors: Matthew R. Smith, Quan Sing Ng, Martin Boegemann, Vsevolod Matveev, Josep M Piulats, C Parker, Kurt Miller, Bertrand Tombal, Fred Saad, Luis Eduardo ZuccaAbstract:Summary Background Abiraterone acetate plus prednisone or prednisolone improves progression-free survival and overall survival in patients with metastatic castration-resistant prostate cancer. RAdium-223 improves overall survival and delays the onset of symptomatic skeletal events in patients with castration-resistant prostate cancer and bone metastases. We assessed concurrent treatment with abiraterone acetate plus prednisone or prednisolone and rAdium-223 in such patients. Methods We did a randomised, double-blind, placebo-controlled, phase 3 trial at 165 oncology and urology centres in 19 countries. Eligible patients were aged 18 years or older, and hAd histologically confirmed, progressive, chemotherapy-naive, asymptomatic or mildly symptomatic castration-resistant prostate cancer and bone metastases, Eastern Cooperative Oncology Group performance status of 0 or 1, life expectancy of at least 6 months, and Adequate haematological, renal, and liver function. Participants were randomly assigned (1:1) according to a permuted block design (block size 4) via interactive response technology to receive up to six intravenous injections of rAdium-223 (55 kBq/kg) or matching placebo once every 4 weeks. All patients were also scheduled to receive oral abiraterone acetate 1000 mg once daily plus oral prednisone or prednisolone 5 mg twice daily during and after rAdium-223 or placebo treatment. The primary endpoint was symptomatic skeletal event-free survival, which was assessed in the intention-to-treat population. Safety analyses were done in all patients who received at least one dose of any study drug. This trial is registered with ClinicalTrials.gov, number NCT02043678. Enrolment has been completed, and follow-up is ongoing. Findings Between March 30, 2014, and Aug 12, 2016, 806 patients were randomly assigned to receive rAdium-223 (n=401) or placebo (n=405) in Addition to abiraterone acetate plus prednisone or prednisolone. The study was unblinded prematurely, on Nov 17, 2017, after more fractures and deaths were noted in the rAdium-223 group than in the placebo group (in an unplanned Ad-Hoc Analysis), but all patients hAd completed rAdium-223 or placebo before this date. At the primary Analysis (data cutoff Feb 15, 2018), 196 (49%) of 401 patients in rAdium-223 group hAd hAd at least one symptomatic skeletal event or died, compared with 190 (47%) of 405 patients in the placebo group (median follow-up 21·2 months [IQR 17·0–25·8]). Median symptomatic skeletal event-free survival was 22·3 months (95% CI 20·4–24·8) in the rAdium-223 group and 26·0 months (21·8–28·3) in the placebo group (hazard ratio 1·122 [95% CI 0·917–1·374]; p=0·2636). Fractures (any grAde) occurred in 112 (29%) of 392 patients in the rAdium-223 group and 45 (11%) of 394 patients in the placebo group. The most common grAde 3–4 treatment-emergent Adverse events were hypertension (43 [11%] patients in the rAdium-223 group vs 52 [13%] patients in the placebo group), fractures (36 [9%] vs 12 [3%]) and increased alanine aminotransferase concentrations (34 [9%] vs 28 [7%]). Serious treatment-emergent Adverse events occurred in 160 (41%) patients in the rAdium-223 group and 155 (39%) in the placebo group. Treatment-related deaths occurred in two (1%) patients in the rAdium-223 group (acute myocardial infarction and interstitial lung disease) and one ( Interpretation The Addition of rAdium-223 to abiraterone acetate plus prednisone or prednisolone did not improve symptomatic skeletal event-free survival in patients with castration-resistant prostate cancer and bone metastases, and was associated with an increased frequency of bone fractures compared with placebo. Thus, we do not recommend use of this combination. Funding Bayer.