Ziv-aflibercept (Z) in combination with FOLFIRI for second-line treatment of patients (pts) with metastatic colorectal cancer (mCRC): Interim safety data from the global aflibercept safety and quality-of-life program in pts pretreated with bevacizumab (B).

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 556-556 ◽  
Author(s):  
David Raymond Ferry ◽  
Alberto F. Sobrero ◽  
Roberto Bordonaro ◽  
Salvatore Siena ◽  
Filippo Pietrantonio ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Safety Data ◽  
Real Life ◽  
The United States ◽  
Open Label ◽  
Real Life Setting ◽  
Safety Population ◽  
Previously Treated ◽  
Initial Starting

556 Background: In the VELOUR study, adding Z (known as aflibercept outside the United States) to FOLFIRI resulted in improved OS, PFS, and RR in mCRC pts who had received prior oxaliplatin. Prior treatment with B (~30% of the ITT population) did not appear to impact the safety profile of Z. Results from VELOUR supported initiation of the global Aflibercept Safety and Quality-of-Life (QoL) Program composed of two clinical studies (ASQoP [NCT01571284]; AFEQT [NCT01670721]) to capture QoL and safety data from a population similar to that of VELOUR in a real-life setting. We report early safety data from this interim analysis in pts pretreated with B. Methods: ASQoP and AFEQT are single-arm, open-label trials evaluating safety and QoL of Z in mCRC pts previously treated with an oxaliplatin-containing regimen. Eligible pts receive Z (4 mg/kg) q2wks on day 1 of each cycle followed by FOLFIRI until disease progression, unacceptable toxicity, death, or investigator/pt decision. Initial starting doses and subsequent modifications are at treating physicians’ discretion. The percentage of pts with grade (G) 3/4 adverse events (AEs) in the combined safety population of ASQoP and AFEQT in B-pretreated pts is compared with that of B-pretreated pts in VELOUR. Results: At data cut-off, the safety population comprised 116 pts with ≥1 completed treatment cycle; 67 (57.8%) were pretreated with B. At least 1 G3/4 AE was experienced by 49.3% of pts vs 82.5% in VELOUR. Most G3/4 AEs were G3. There were no reports of G4 hypertension or proteinuria. Conclusions: Thisinterim safety analysis from ASQoP/AFEQT in pts pretreated with B has identified no new safety signals for Z and a trend toward decreased incidence of G3/4 events. The early analysis provides additional safety data and suggests an acceptable toxicity profile in this real-life setting. Clinical trial information: NCT01571284. [Table: see text]

Ziv-aflibercept in combination with FOLFIRI for second-line treatment of patients with metastatic colorectal cancer (mCRC): Interim safety data from the global aflibercept safety and quality-of-life program (ASQoP and AFEQT studies) in patients ≥65.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 545-545 ◽  
Author(s):  
Roberto Bordonaro ◽  
Alberto F. Sobrero ◽  
Luca Frassineti ◽  
Libero Ciuffreda ◽  
Giuseppe Aprile ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Interim Analysis ◽  
Safety Data ◽  
Real Life ◽  
The United States ◽  
Real Life Setting ◽  
Safety Population ◽  
Study Results ◽  
Initial Starting

545 Background: The prespecified analysis of patients ≥65 years of age in the VELOUR study demonstrated a safety profile similar to that of ziv-aflibercept (Z) (known as aflibercept outside the United States) plus FOLFIRI in the overall VELOUR study. Results from VELOUR supported the initiation of the global Aflibercept Safety and Quality-of-Life (QoL) Program composed of two clinical studies (ASQoP [NCT01571284]; AFEQT [NCT01670721]) to capture QoL and safety data from a target population similar to that of VELOUR in a real-life setting. We report early safety data from this interim analysis for patients ≥65 y. Methods: ASQoP and AFEQT are single-arm, open-label trials evaluating safety and QoL of Z in mCRC patients previously treated with an oxaliplatin-containing regimen. Eligible patients received Z (4 mg/kg) q2wks on day 1 of each cycle followed by FOLFIRI until disease progression, unacceptable toxicity, death, or investigator/patient decision. Initial starting doses and subsequent dose modifications are at the treating physician’s discretion. The percentage of patients ≥65 y with grade (G) 3/4 adverse events (AEs) in the combined safety population of ASQoP and AFEQT are compared with that of the prespecified analysis in patients ≥65 y from VELOUR. Results: At data cut-off, the safety population comprised 116 patients with at least 1 completed cycle of treatment; 53 (45.7%) were ≥65 y. At least 1 G3/4 AE was experienced by 64.2% of patients vs 89.3% in VELOUR. Most reported G3/4 AEs were G3. There were no reports of G4 hypertension, diarrhea, stomatitis, or proteinuria. Conclusions: Thisinterim safety analysis from ASQoP and AFEQT in patients ≥65 y has identified no new safety signals. The early interim analysis provides additional safety data and suggests an acceptable toxicity profile in this real-life setting. Clinical trial information: NCT01571284. [Table: see text]

Ziv-aflibercept (Z) in combination with FOLFIRI for second-line treatment of patients with metastatic colorectal cancer (mCRC): Interim safety data from the global Aflibercept Safety and Quality-of-Life Program (ASQoP and AFEQT) in patients age 65 or older.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 588-588 ◽  
Author(s):  
Roberto Bordonaro ◽  
Giovanni Luca Frassineti ◽  
Libero Ciuffreda ◽  
Giuseppe Aprile ◽  
Anne Thomas ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Interim Analysis ◽  
Safety Data ◽  
Real Life ◽  
The United States ◽  
Open Label ◽  
Real Life Setting ◽  
Safety Population ◽  
Initial Starting

588 Background: The prespecified analysis of patients (pts) ≥65 y in the VELOUR study demonstrated a safety profile similar to that of ziv-aflibercept (Z) (known as aflibercept outside the United States) plus FOLFIRI in the overall VELOUR population. The global ASQoP/AFEQT Program comprises 2 clinical studies (ASQoP [NCT01571284]; AFEQT [NCT01670721]) designed to capture QoL and safety data from a population similar to VELOUR but treated in a real-life setting. We report safety data from the fourth interim analysis of pts ≥65 y. Methods: ASQoP/AFEQT are single-arm, open-label trials evaluating Z in metastatic colorectal cancer pts previously treated with an oxaliplatin-containing regimen. Eligible pts received Z (4 mg/kg) q2w on day 1 of each cycle followed by FOLFIRI until disease progression, unacceptable toxicity, death, or investigator/pt decision. Initial starting doses of FOLFIRI and dose modifications are at treating physician’s discretion. The % of pts ≥65 y with grade (G) 3 or 4 AEs in the combined safety population of ASQoP/AFEQT are compared with the prespecified analysis in pts ≥65 y from the Z + FOLFIRI arm of VELOUR. Results: At data cutoff, the overall safety population comprised 688 pts with ≥1 completed treatment cycle; 303 (44.1%) were ≥65 y. In the overall safety population ≥1 G3/4 AE was reported in 72.2% of pts vs. 83.5% in overall VELOUR. Most G3/4 AEs were G3. There were no reports of G4 hypertension, diarrhea, or fatigue. Median number of cycles was 6 in ASQoP/AFEQT and 9 in the Z + FOLFIRI arm of VELOUR. Table shows summary of AEs in pts ≥65 y. Conclusions: This interim analysis from ASQoP/AFEQT in pts ≥65 y has identified no new safety signals and provides additional safety data suggesting an acceptable toxicity profile in this real-life setting. Clinical trial information: NCT01571284. [Table: see text]

Ziv-aflibercept (Z) in combination with FOLFIRI for second-line treatment of patients (pts) with metastatic colorectal cancer (mCRC): Interim safety data from the global Aflibercept Safety and Quality-of-Life Program in pts pretreated with bevacizumab (B).

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 528-528 ◽  
Author(s):  
Alberto F. Sobrero ◽  
Roberto Bordonaro ◽  
Katia Bencardino ◽  
Filippo Pietrantonio ◽  
Stefan Bauer ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Safety Data ◽  
Real Life ◽  
The United States ◽  
Median Number ◽  
Open Label ◽  
Real Life Setting ◽  
Safety Population ◽  
Initial Starting

528 Background: In the VELOUR study, adding ziv-aflibercept (Z) (known as aflibercept outside the United States) to FOLFIRI resulted in improved OS, PFS, and RR in metastatic colorectal cancer (mCRC) patients (pts) who had received prior oxaliplatin. Prior treatment with bevacizumab (B) did not appear to impact safety profile of Z. The global ASQoP/AFEQT studies are 2 clinical studies (ASQoP [NCT01571284]; AFEQT [NCT01670721]) designed to capture QoL and safety data from a population similar to VELOUR but treated in a real-life setting. We report safety data from the 4th interim analysis in B-pretreated pts. Methods: ASQoP/AFEQT are single-arm, open-label trials of Z in mCRC pts previously treated with an oxaliplatin-containing regimen. Eligible pts receive Z (4 mg/kg) q2w on day 1 of each cycle followed by FOLFIRI until disease progression, unacceptable toxicity, death, or investigator/pt decision. Initial starting doses of FOLFIRI and subsequent modifications are at treating physician’s discretion. % of pts with grade (G) 3 or 4 AEs in the combined B-pretreated safety population of ASQoP/AFEQT is compared with B-pretreated pts in the Z + FOLFIRI arm of VELOUR. Results: At data cutoff, overall safety population comprised 688 pts with ≥1 completed treatment cycle; 343 (49.9%) were B-pretreated. Currently, median number of cycles administered to ASQoP/AFEQT pts is 6; in VELOUR, pts in Z + FOLFIRI arm had a median of 9. Table shows summary of TEAEs in B-pretreated pts. Conclusions: Thisinterim safety analysis of ASQoP/AFEQT in B-pretreated pts identified no new safety signals for Z and a trend toward decreased G3/4 events. The analysis provides additional safety data suggesting an acceptable toxicity profile in a real-life setting. Clinical trial information: NCT01571284. [Table: see text]

Aflibercept (Z) in combination with FOLFIRI for second-line treatment of patients (pts) with metastatic colorectal cancer (mCRC): Safety and quality of life (QoL) data from the Spanish subgroup of the Aflibercept Safety and Quality-of-Life Program (ASQoP).

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 751-751
Author(s):  
Fernando Rivera ◽  
Eduardo Polo Marques ◽  
Enrique Aranda ◽  
Carlos Fernandez-Martos ◽  
Adelaida La Casta Munoa ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Real Life ◽  
Open Label ◽  
Utility Index ◽  
Real Life Setting ◽  
Safety Population ◽  
Eortc Qlq C30 ◽  
Report Data ◽  
Eortc Qlq

751 Background: In the VELOUR trial, adding Z to FOLFIRI improves OS, PFS and RR in mCRC pts progressing after oxaliplatin ±biologic agents. The ASQoP trial (NCT01571284) was designed to gather safety and QoL data from mCRC in real-life setting. We report data collected by the Spanish investigators. Methods: ASQoP is single-arm, open-label trial evaluating safety and QoL of Z in mCRC pts as 2nd line. Eligible pts received Z (4mg/kg) q2wks on day 1/cycle, followed by FOLFIRI (dosing was at physician’s discretion) until disease progression, unacceptable toxicity, death, or investigator/pt decision. The EQ-5D was used for utility index (UI) measure and the EORTC QLQ-C30 as generic cancer instrument. QoL population consisted of pts completing the questionnaire at baseline and ≥1 assessment post-baseline and received ≥1 part of 1 dose of study treatment. Results: The safety population comprised 77 pts with ≥1 completed cycle of treatment. Grade (G)3/4 AEs were reported in 72.7% of pts (vs 83.5% in VELOUR), being G3 most commonly reported. There was no G4 hypertension, stomatitis, or proteinuria. G4 Diarrhea was found in 1.3% of pts. Mean baseline UI was 0.7 (95% CI, 0.63-0.78) in 51 pts, and remained relatively stable at cycles 3 (n=39) and 7 (n=24), with a mean (±SD) change from baseline of 0.03 (±0.26) and -0.06 (±0.35), respectively. Mean baseline global health status score was 63.1 (95% CI, 55.8-70.4) in 54 pts, and remained stable up to cycle 9 with a mean (±SD) change from baseline of 4.17 (±38). Conclusions: Thisanalysis has identified no new safety signals and suggests an acceptable toxicity profile with a relatively stable UI and QoL in Spanish mCRC pts in the real-life setting. [Table: see text]

Weekly (QW) epoetin alfa (EPO) in prostate cancer (PC) patients (pts) with anemia not receiving chemotherapy (CT) or radiation therapy (RT)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14634-14634
Author(s):  
D. Shasha
Keyword(s):  
Quality Of Life ◽  
Healthcare Providers ◽  
Open Label ◽  
Vascular Events ◽  
Cancer Data ◽  
Early Withdrawal ◽  
Safety Population ◽  
Study Results ◽  
The Many

14634 Background: While EPO is widely used in the management of CT-related anemia, anemia in cancer pts may stem from causes other than CT. Tumor invasion of the bone marrow and cytokine-mediated inhibition of erythropoiesis are among the many disease-related causes of anemia in cancer. Data evaluating the use of EPO in pts not receiving CT or RT, particularly in specific tumor types, would be important information to healthcare providers. Methods: An open-label, prospective, non-randomized, multicenter pilot study was conducted to evaluate the efficacy and safety of EPO 40,000 U QW in anemic (hemoglobin [Hb] ≤ 11 g/dL) cancer pts not receiving CT or RT1. (Blood 2004;104:abstract 4223.) Treatment duration was up to 12 wks with a 4-wk post-treatment observation period. Primary efficacy endpoint was hematopoietic response during the treatment period (% of pts achieving a ≥ 1 or ≥ 2 g/dL Hb increase from baseline [BL]). Secondary endpoints included change from BL in quality of life as measured by the Linear Analog Scale Assessment (LASA). This is a retrospective subset analysis of PC pts (n = 24) enrolled in the prospective study. Results: For the safety population (all pts who received ≥ 1 EPO dose, n = 23), mean age was 71.4 ± 6.8 yrs; 21 (91.3%) had ECOG status of 0 or 1; and mean BL Hb was 10.4 ± 0.8 g/dL. Of 21 pts evaluated for efficacy, 17 (81.0%) achieved Hb increase from BL ≥ 2 g/dL, while 19 (90.5%) achieved ≥ 1 g/dL by wk 17/early withdrawal. EPO dose was increased in 5 (23.8%) pts (to 60,000 U for Hb increase < 1 g/dL after 4 wks) and held in 16 (76.2%) pts (due to Hb > 13 g/dL, with dosing resumed when Hb was ≤12 g/dL, at 30,000 U from 40,000 U or at 40,000 U from 60,000 U). Both Wk 9 and 17 LASA scores increased significantly from BL in all categories (Energy Level, Daily Activities, and Quality of Life; P < 0.001). 15 of 23 pts (65.2%) had at least one adverse event (AE); 4 (17.4%) pts had at least one serious AE. No clinically relevant thrombotic vascular events were noted. No pt received transfusion. 5 pts discontinued: 2 for AEs, 1 at pt request, and 2 at study sponsor request. Conclusions: This retrospective analysis suggests that EPO 40,000 U QW is safe and effective for treating anemia in PC pts not receiving CT or RT. [Table: see text]

scholarly journals Acoustic Coordinated Reset Neuromodulation in a Real Life Patient Population with Chronic Tonal Tinnitus

2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Christian Hauptmann ◽  
Armin Ströbel ◽  
Mark Williams ◽  
Nitesh Patel ◽  
Hannes Wurzer ◽  
...  
Keyword(s):  
Real Life ◽  
Negative Influence ◽  
Tinnitus Questionnaire ◽  
Open Label ◽  
Safety And Efficacy ◽  
Life Conditions ◽  
Real Life Setting ◽  
Clinically Significant ◽  
Coordinated Reset

Purpose. Primary tinnitus has a severe negative influence on the quality of life of a significant portion of the general population. Acoustic coordinated reset neuromodulation is designed to induce a long-lasting reduction of tinnitus symptoms. To test acoustic coordinated reset neuromodulation as a treatment for chronic, tonal tinnitus under real life conditions, an outpatient study “RESET Real Life” was commissioned by ANM GmbH. Herein we present the results of this study.Methods. In a prospective, open-label, nonrandomized, noncontrolled multicenter clinical study with 200 chronic tinnitus patients, tinnitus questionnaire TBF-12 and Global Clinical Improvement-Impression Scale (CGI-I7) are used to study the safety and efficacy of acoustic coordinated reset neuromodulation. 189 patients completed the last 12-month visit, 11 patients dropped out (8 because of nontreatment related reasons; 2 because tinnitus did not change; and 1 because tinnitus got louder).Results. Acoustic coordinated reset neuromodulation caused a statistically and clinically significant decrease in TBF-12 scores as well as in CGI-I7 after 12 months of therapy under real life conditions. There were no persistent adverse events reported that were related to the therapy.Conclusion. The field study “RESET Real Life” provides evidence for safety and efficacy of acoustic coordinated reset neuromodulation in a prospective, open-label, real life setting.

Long-term treatment of chronic migraine with OnabotulinumtoxinA: efficacy, quality of life and tolerability in a real-life setting

2016 ◽  
Vol 123 (5) ◽  
pp. 533-540 ◽  
Author(s):  
Katja Kollewe ◽  
Claus M. Escher ◽  
Dirk U. Wulff ◽  
Davood Fathi ◽  
Lejla Paracka ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Migraine ◽  
Real Life ◽  
Term Treatment ◽  
Real Life Setting ◽  
Long Term Treatment

scholarly journals Efficacy and safety of dolutegravir plus emtricitabine versus standard ART for the maintenance of HIV-1 suppression: 48-week results of the factorial, randomized, non-inferiority SIMPL’HIV trial

PLoS Medicine ◽  
2020 ◽  
Vol 17 (11) ◽  
pp. e1003421
Author(s):  
Delphine Sculier ◽  
Gilles Wandeler ◽  
Sabine Yerly ◽  
Annalisa Marinosci ◽  
Marcel Stoeckle ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Viral Suppression ◽  
Safety Data ◽  
Risk Difference ◽  
Hiv Treatment ◽  
Efficacy And Safety ◽  
Open Label ◽  
Hiv 1

Background Dolutegravir (DTG)–based dual therapy is becoming a new paradigm for both the initiation and maintenance of HIV treatment. The SIMPL’HIV study investigated the outcomes of virologically suppressed patients on standard combination antiretroviral therapy (cART) switching to DTG + emtricitabine (FTC). We present the 48-week efficacy and safety data on DTG + FTC versus cART. Methods and findings SIMPL’HIV was a multicenter, open-label, non-inferiority randomized trial with a factorial design among treatment-experienced people with HIV in Switzerland. Participants were enrolled between 12 May 2017 and 30 May 2018. Patients virologically suppressed for at least 24 weeks on standard cART were randomized 1:1 to switching to DTG + FTC or to continuing cART, and 1:1 to simplified patient-centered monitoring versus standard monitoring. The primary endpoint was the proportion of patients virologically suppressed with <100 copies/ml through 48 weeks. The secondary endpoints included virological suppression at 48 weeks according to the US Food and Drug Administration (FDA) snapshot analysis. Non-inferiority of DTG + FTC versus cART for viral suppression was assessed using a stratified Mantel–Haenszel risk difference, with non-inferiority declared if the lower bound of the 95% confidence interval was greater than −12%. Adverse events were monitored to assess safety. Quality of life was evaluated using the PROQOL-HIV questionnaire. Ninety-three participants were randomized to DTG + FTC, and 94 individuals to cART. Median nadir CD4 count was 246 cells/mm3; median age was 48 years; 17% of participants were female. DTG + FTC was non-inferior to cART. The proportion of patients with viral suppression (<100 copies/ml) through 48 weeks was 93.5% in the DTG + FTC arm and 94.7% in the cART arm in the intention-to-treat population (risk difference −1.2%; 95% CI −7.8% to 5.6%). Per-protocol analysis showed similar results, with viral suppression in 96.5% of patients in both arms (risk difference 0.0%; 95% CI −5.6% to 5.5%). There was no relevant interaction between the type of treatment and monitoring (interaction ratio 0.98; 95% CI 0.85 to 1.13; p = 0.81). Using the FDA snapshot algorithm, 84/93 (90.3%) participants in the DTG + FTC arm had an HIV-1 RNA viral load of <50 copies/ml compared to 86/94 (91.5%) participants on standard cART (risk difference −1.1%; 95% CI −9.3% to 7.1%; p = 0.791). The overall proportion of patients with adverse events and discontinuations did not differ by randomization arm. The proportion of patients with serious adverse events was higher in the cART arm (16%) compared to the DTG + FTC arm (6.5%) (p = 0.041), but none was considered to be related to the study medication. Quality of life improved more between baseline and week 48 in the DTG + FTC compared to the cART arm (adjusted difference +2.6; 95% CI +0.4 to +4.7). The study’s main limitations included a rather small proportion of women included, the open label design, and its short duration. Conclusions In this study, DTG + FTC as maintenance therapy was non-inferior to cART in terms of efficacy, with a similar safety profile and a greater improvement in quality of life, thus expanding the offer of 2-drug simplification options among virologically suppressed individuals. Trial registration ClinicalTrials.gov NCT03160105.

Malignant gastrointestinal stromal tumors treated with imatinib in France: Results in unselected patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e22177-e22177
Author(s):  
A. Mathieu-Boue ◽  
O. Bouché ◽  
A. Cioffi ◽  
M. Rios ◽  
F. Duffaud ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Disease Onset ◽  
Initial Dosage ◽  
Real Life ◽  
Published Data ◽  
Case Report Form ◽  
Primary Tumors ◽  
Real Life Setting

e22177 Background: GISTs are rare tumors of the GI tract. In France, their incidence is estimated to be 9- 12/106 inhabitants/year. Imatinib (IM) has been approved to treat unresectable and/or metastatic Kit-positive GISTs since 2002 but information on routine use, safety and efficacy in unselected “real life” setting is lacking. An observational cohort (EPIGIST) in France was designed to provide data on survival, safety and treatment patterns and quality of life. Methods: EPIGIST is a nationwide multi-center, observational study on GIST patients (pts) treated with IM for the first time between the availability on the French Market and the end of the 2008. Centers were randomly selected in national files of oncologists, gastrointestinal surgeons and gastrointestinal specialists. The planned follow-up duration was three years. A case report form (CRF) had to be completed at inclusion and during each follow-up visits. Quality of life was assessed using QLQ-C30 and SF36 questionnaires. Results: 29 on 51 selected centers enrolled at least one pt and 127 pts were included (as of 12/2008), The median age of disease onset was 59 years (range 29 - 85) with 48% pts>50 years. 63% were symptomatic at diagnosis; 69% were fully active (grade 0 on the ECOG index). Primary tumors were most often gastric (34%), or from jejunum/ileum (24%). At diagnosis 84% of pts had a tumor size over 5cm. 64% of patients had surgery of the primary tumor before starting IM. For 86% of the pts, IM was given at an in initial dosage of 400 mg, 8% at 300 mg and 6% at 800mg. Compliance was superior to 90% for all pts. With a median follow-up of 1.72 years (CI95%: [1.08;1.95]), two-years overall survival from first treatment with IM was 88.1% (CI95%: [65.3%-96.3%]). Conclusions: EPIGIST is still an ongoing survey. Current results confirm previous published data on survival in GIST treated with IM in an unselected cohort of patients outside of a clinical trial. [Table: see text]

Sign in / Sign up

Export Citation Format

Share Document