The impact of kidney function on the efficacy and safety of pazopanib in metastatic renal cell carcinoma (mRCC) patients: CORE-URO-01 study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e16063-e16063
Author(s):  
Maria Giuseppa Vitale ◽  
Cristina Masini ◽  
Giuseppe Procopio ◽  
Ugo De Giorgi ◽  
Sebastiano Buti ◽  
...  
Keyword(s):  
Renal Function ◽  
Side Effects ◽  
Progression Free Survival ◽  
Efficacy And Safety ◽  
Therapy Initiation ◽  
Frequent Monitoring ◽  
Group 2 ◽  
Grade 3 ◽  
The Impact ◽  
Group 1

e16063 Background: Pazopanibhas been approved for treatment of patients (pts) with mRCC based on the prospective randomized trial that enrolled only pts with adequate renal parameters. There are no data on the toxicity profile and efficacy of pazopanib in pts with renal insufficiency (RI).The aim of this study is to investigate the effect of renal function on treatment outcomes in pts treated with pazopanib for mRCC. Methods: We retrospectively analyzed the data of the mRCC pts treated with pazopanib with respect to renal function in eleven Italian institutions from January 2010 to June 2016. Baseline glomerular filtration rate (GFR) was calculated using the Modification of Diet in Renal Disease (MDRD) formula at the time of therapy initiation. Pts with MDRD < 60 mL/min/1.73 m2 (group 1) were compared with pts with MDRD ≥60 mL/min/1.73 m2(group 2) in terms of response rates, progression free survival (PFS), overall survival (OS) and side effects. Results: One hundred and twenty-ninepts with mRCC were included in this study: 70 pts in group 1 and 59 pts in group 2. 67% of pts were male, median age was 66 years (34-83) and median CrCl was 49 ml/min (6.3-59.5) in group 1. In group 2, 64% of pts were male, median age was 65 years (38-80), and median CrCl was 64 ml/min (58.1-137.1) Pts with MDRD < 60 were more likely to have had a previous nephrectomy (84.3% vs 79.7%). No difference between the 2 groups was observed in terms of outcomes: PFS was 9.6 months (0.6–56.9) and 9.0 months (0.4–60.1), OS was 16.1 months (1.3–56.9) and 17.0 months (1.2–60.1), for MDRD < 60 group and MDRD ≥60 respectively. The disease control rate was 85.8% in group 1, and 72.9% in group 2. About grade 1-2 toxicity, no difference between the 2 groups was reported (67.1% vs 67.8%) while a higher incidence of grade 3-4 toxicity was evident in the group 1 (25.7% vs 18.6%). Conclusions: RI was commonly observed in pts with mRCC. Renal function at therapy initiation does not adversely affect the efficacy and safety of pazopanib. More frequent monitoring of side-effects in patients with RI is recommended.

scholarly journals Comparison between use of combination of mifepristone and misoprostol versus misoprostol alone in the management of intrauterine fetal death

2018 ◽  
Vol 7 (7) ◽  
pp. 2778
Author(s):  
Sreeveena Talasani ◽  
Pran Hitha Venkamolla ◽  
Kalpana Betha
Keyword(s):  
Side Effects ◽  
Fetal Death ◽  
Intrauterine Fetal Death ◽  
P Value ◽  
Ultrasound Scan ◽  
Efficacy And Safety ◽  
Medical Sciences ◽  
The Mean ◽  
Group 2 ◽  
Group 1

Background: Intrauterine fetal death (IUFD) is estimated to occur in 1% of all pregnancies. The advent of prostaglandins has revolutionized the management of IUFD. There are limited studies using a combined regimen of mifepristone and misoprost for induction of labor in IUFD. Hence this study was undertaken to assess the efficacy and safety of combined regimen with misoprostol alone, in the management of IUFD.Methods: This hospital based prospective study included 60 pregnant women with IUFD admitted at Mediciti Institute of Medical Sciences, during the period January 2015 to July 2016. An ultrasound scan was performed to confirm IUFD and localize the placenta. Women were divided alternatively into 2 groups with 30 in each group (group 1- women received 200 mg mifepristone orally followed by misoprostol after 24 hours & in group 2, 100 µg misoprostol  every 6 hourly for a maximum of 4 doses between gestational age  24-26 weeks, 25-50 µg 4 hourly for a maximum of 6 doses beyond 26 weeks).Results: The mean induction to delivery interval was 10 hours in group 1 and 16.3 hours in group 2 (p value 0.007). Mean dose of misoprostol required in group 1 was 1.87 and 2.67 in group 2 (p value 0.008). With respect to side effects, the two groups did not differ significantly.Conclusions: The combined regimen was more effective than misoprostol for the induction of labour in IUFD, in terms of higher rate of successful delivery and shorter induction to delivery interval. 

Granulocyte-Colony Stimulating Factor Use in Young Fit CLL Patients Receiving Fludarabine-Cyclophosphamide-Rituximab Frontline: Impact on Outcomes, Relative Dose Intensity and Toxicities

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 1798-1798
Author(s):  
Emmanuelle Bouvet ◽  
Lucie Oberic ◽  
Christian Recher ◽  
Françoise Huguet ◽  
Xavier Carles ◽  
...  
Keyword(s):  
Creatinine Clearance ◽  
Residual Disease ◽  
Dose Intensity ◽  
Phase Iii ◽  
Relative Dose Intensity ◽  
Color Flow ◽  
Group 2 ◽  
Grade 3 ◽  
The Impact ◽  
Group 1

Abstract Abstract 1798 INTRODUCTION: fludarabine-cyclophosphamide-rituximab (FCR) is the standard upfront immunochemotherapy for young fit CLL patients. The clinical benefit of growth factors support is yet unclear, despite recently published possible impact on outcomes in a series of 32 patients [Grüber M, 2011]. The use of G-CSF is not recommended in the CLL8 trial, outside febrile neutropenia, but often applied outside clinical trials to prevent toxicities and achieve good relative dose-intensity (RDI). We retrospectively assessed, in an Hematology healthcare network, the impact of G-CSF on survivals (PFS, TTNT, OS), outcomes (RDI, minimal residual disease (MRD), overall response rates (CR/CRi), and toxicities (grade 3–4 neutropenia, fever, hospitalizations). PATIENTS AND METHODS: among 101 patients treated with FCR frontline, three groups of patients are considered: group 1 (no G-CSF), group 2 (primary prophylaxis with pegfilgrastim after each course of FCR), and group 3 (patients of group 1 initially, but who were treated with G-CSF due to at least one episode of grade 4 neutropenia (at the discretion of the physician)). Respectively, toxicities have been assessed in 24/28/13 patients, and outcomes in 45/23/23 patients. Pretreatment characteristics were well balanced between G-CSF-naïve and -treated patients (IgVH, Binet stage, del11q). No del17p patient was included in this series. Planned RDI for F and C were calculated before 1st cycle of FCR according to age (-20% if >65y), and creatinine clearance (-25% if <60ml/mn). Average RDI (ARDI) actually prescribed to patients were assessed at the last cycle, in mg/m2/week (6xFCR=24 wks) to include dose delays in the calculation of RDI. RESULTS: median age in the cohort of 101 FCR treated pts was 60y (21–83y), 68% were males. 20% had >65y, 13% had creatinine clearance <60ml/mn, CIRS-G comorbidity scores were: 0 (25.5%), 1 (26.5%), 2 (19%), 3 (10%), 4 (8%), 5 (5%), 6 (2%), ≥7 (4%). Planned RDI was ≤75% standard FCR doses (due to age, CrCL, or physician's choice) in 12% of cases, and ARDI was further decreased ≥20% of initial planned RDI in 25% of patients. Peripheral blood 4-color flow MRD wad undetectable in 49% of patients. Impact of G-CSF use on outcomes: results are summarized in Table 1. The use of G-CSF on curative intent for grade 4 neutropenia induced an increase in rates of CRi and prolonged neutropenia at the end of therapy. When used at the time of neutropenia (d15-d21 after FCR cycle), stimulation with G-CSF may be deleterious due to the prescription of the next FCR at d28. Median PFS, TTNT, OS were not significantly improved by the use of G-CSF (prophylactic or curative). G-CSF did not impact on MRD levels neither. MRD eradication was the strongest parameter linked to PFS/TTNT. Impact of G-CSF use on toxicities and RDI: results are summarized in Table 2. The use of prophylactic G-CSF (group 2) significantly reduced the rate of neutropenia grade 3–4, and tended to decrease the need for antibiotics given for fever. A dose modification (>10%) was observed in 26% vs 33.3% in patients receiving prophylactic G-CSF or not, respectively. A planned RDI <75% standard FCR doses was linked to reduced PFS and TTNT, but not OS. Prophylactic G-CSF did not prevent a decrease >20% of planned RDI at the end of therapy. CONCLUSIONS: Our data suggest that prophylactic G-CSF use after FCR decreases toxicities but does not impact on outcomes. We plan to study G-CSF impact on FCR results in an older, less fit population (FORTIS phase III trial). Disclosures: Ysebaert: Roche: Membership on an entity's Board of Directors or advisory committees, Research Funding.

Efficacy and Safety of Bortezomib Based Regimens Retreatment in Relapsed Multiple Myeloma Patients: Results from a Retrospective Study.

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 5387-5387
Author(s):  
Wenjun Wu ◽  
Gaofeng Zheng ◽  
Xiaoyan Han ◽  
Yi Zhao ◽  
Donghua He ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Partial Response ◽  
Confidence Interval ◽  
Incidence Rate ◽  
Conflicts Of Interest ◽  
Progression Free Survival ◽  
Initial Therapy ◽  
Efficacy And Safety ◽  
Grade 3 ◽  
Group 1

Abstract Objective: To evaluate the efficacy and safety of bortezomib retreatment in relapsed multiple myeloma (MM) patients, who previously responded to bortezomib. Methods: This retrospective observational study included data from 45 patients and evaluated the efficacy and safety of bortezomib based retreatment in these patients, who had achieved at least a partial response (PR) on initial bortezomib therapy in our hospital from May 2006 to May 2013. Results: The overall response rate (ORR) was 71.2%, among them 9% patients achieved CR, 11.1% patients achieved very good partial response (VGPR), 51.1% patients achieved PR. All patients were divided into 3 groups according to the response of initial bortezomib therapy, including CR group, VGPR group and PR group. After bortezomib retreatment, the ORR of the 3 groups was 76.9%, 75% and 62.5%, respectively. According to the response of bortezomib retreatment, the patients were divided into 2 groups: group 1 who at least achieved PR, group 2 who showed no response. The median progression-free survival (PFS) after bortezomib retreatment for group 1 and 2 was 9( 95% confidence interval 7.947~10.051) and 10 (95% confidence interval 8.381∼11.619) months, respectively (P>0.05), while the median overall survival (OS) after bortezomib retreatment was 71 (95% confidence interval 66.694∼75.306)) and 37 (95% confidence interval 1-28) months, respectively (P<0.05). In patients with bortezomib retreatment had different degrees of adverse events (AE) , the most AE for grade 1~2. The most common grade ≥3 AE was thrombocytopenia, neutropenia and anemia. The incidence rate of grade ≥3 AE peripheral neuropathy bortezomib was 15%. Conclusion: Bortezomib based regimens retreatment was effective and tolerable in relapsed MM patients, who had achieved at least a partial response (PR) on initial therapy. The incidence rate of AE was not significantly increased. Disclosures No relevant conflicts of interest to declare.

The influence of renal function on gemcitabine-based chemotherapy for advanced biliary tract cancer: An exploratory subgroup analysis of JCOG1113.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 368-368
Author(s):  
Makoto Ueno ◽  
Chigusa Morizane ◽  
Takuji Okusaka ◽  
Gakuto Ogawa ◽  
Yuya Sato ◽  
...  
Keyword(s):  
Renal Function ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Cox Regression ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Eligibility Criteria ◽  
Tract Cancer ◽  
Grade 3 ◽  
The Impact

368 Background: JCOG1113 is a randomized phase III trial to evaluate gemcitabine (GEM) plus S-1 (GS) versus GEM plus cisplatin (GC) regarding overall survival (OS) for advanced biliary tract cancer (BTC) (UMIN000001685) and the non-inferiority of GS was demonstrated. It is necessary to consider renal function using cisplatin or S-1 because cisplatin has renal toxicity, and the toxicity of S-1 is affected by renal function. Therefore, we evaluated the influence of renal function on the efficacy and safety of GC and GS in JCOG1113. Methods: All enrolled patients (pts) in JCOG1113 (n = 354) were analyzed. Eligibility criteria included chemotherapy-naïve pts with recurrent or unresectable biliary tract adenocarcinoma, ECOG-PS of 0–1, CCr > 50 ml/min, and adequate organ function. Renal function was classified into two groups by creatinine clearance (CCr) as calculated by the Cockcroft-Gault formula; high CCr (CCr ≥ 80 ml/min) or low CCr (80 > CCr ≥ 50 ml/min). The impact of renal function on OS and progression-free survival (PFS) were compared using the Cox regression model. The adverse events (AEs) were compared using Fisher’s exact test. Results: Eighty-eight pts on GC and 88 pts on GS were included in the high CCr group, and 87 pts on GC and 91 pts on GS were included in the low CCr group. There were no differences between the groups regarding, sex, PS, primary site, biliary drainage, operation, or recurrence, except for age. The hazard ratio (HR) of GS to GC for OS was 1.12 (95% CI 0.81–1.56) in the high CCr group and 0.80 (95% CI 0.58–1.11) in the low CCr group. The HR of GS to GC for PFS was 1.06 (95% CI 0.78–1.44) in the high CCr group and 0.69 (95% CI 0.50–0.94) in the low CCr group. Grade 3-4 AEs of white blood cell count decreased (35.3%/23.6%), anemia (29.4%/7.9%) and platelet count decreased (18.8%/10.1%) were more common in GC than GS in the low CCr group. In contrast, the incidence of all grade 3-4 non-hematological AEs was higher (36.0%/11.8%) in GS than GC in the low CCr group ( p = 0.0002). Conclusions: GS was better in terms of OS, PFS, and hematological toxicities than GC in the low CCr group. GS might be recommended for the population with lower renal function in the treatment for advanced BTC.

scholarly journals Impact of Renal Function on Long-Term Clinical Outcomes in Patients With Coronary Chronic Total Occlusions: Results From an Observational Single-Center Cohort Study During the Last 12 Years

2020 ◽  
Vol 7 ◽  
Author(s):  
Lei Guo ◽  
Huaiyu Ding ◽  
Haichen Lv ◽  
Xiaoyan Zhang ◽  
Lei Zhong ◽  
...  
Keyword(s):  
Renal Function ◽  
Renal Insufficiency ◽  
Clinical Outcomes ◽  
Group 4 ◽  
Significant Difference ◽  
Group 3 ◽  
Group 2 ◽  
The Impact ◽  
Group 1

Background: The number of coronary chronic total occlusion (CTO) patients with renal insufficiency is huge, and limited data are available on the impact of renal insufficiency on long-term clinical outcomes in CTO patients. We aimed to investigate clinical outcomes of CTO percutaneous coronary intervention (PCI) vs. medical therapy (MT) in CTO patients according to baseline renal function.Methods: In the study population of 2,497, 1,220 patients underwent CTO PCI and 1,277 patients received MT. Patients were divided into four groups based on renal function: group 1 [estimated glomerular filtration rate (eGFR) ≥ 90 ml/min/1.73 m2], group 2 (60 ≤ eGFR &lt;90 ml/min/1.73 m2), group 3 (30 ≤ eGFR &lt;60 ml/min/1.73 m2), and group 4 (eGFR &lt;30 ml/min/1.73 m2). Major adverse cardiac event (MACE) was the primary end point.Results: Median follow-up was 2.6 years. With the decline in renal function, MACE (p &lt; 0.001) and cardiac death (p &lt; 0.001) were increased. In group 1 and group 2, MACE occurred less frequently in patients with CTO PCI, as compared to patients in the MT group (15.6% vs. 22.8%, p &lt; 0.001; 15.6% vs. 26.5%, p &lt; 0.001; respectively). However, there was no significant difference in terms of MACE between CTO PCI and MT in group 3 (21.1% vs. 28.7%, p = 0.211) and group 4 (28.6% vs. 50.0%, p = 0.289). MACE was significantly reduced for patients who received successful CTO PCI compared to patients with MT (16.7% vs. 22.8%, p = 0.006; 16.3% vs. 26.5%, p = 0.003, respectively) in group 1 and group 2. eGFR &lt; 30 ml/min/1.73 m2, age, male gender, diabetes mellitus, heart failure, multivessel disease, and MT were identified as independent predictors for MACE in patients with CTOs.Conclusions: Renal impairment is associated with MACE in patients with CTOs. For treatment of CTO, compared with MT alone, CTO PCI may reduce the risk of MACE in patients without chronic kidney disease (CKD). However, reduced MACE from CTO PCI among patients with CKD was not observed. Similar beneficial effects were observed in patients without CKD who underwent successful CTO procedures.

scholarly journals Long-term efficacy and safety of hydroquinidine in patients with Brugada syndrome

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
F Angelini ◽  
S Pourshayesteh ◽  
E Gastino ◽  
M.M Cingolani ◽  
D Castagno ◽  
...  
Keyword(s):  
Side Effects ◽  
Secondary Prevention ◽  
Brugada Syndrome ◽  
Treatment Discontinuation ◽  
Efficacy And Safety ◽  
Elevated Liver Enzymes ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Abstract Background Brugada syndrome (BrS) is an inherited channelopathy with an increased risk of supraventricular, ventricular arrhythmias (VAs) and sudden cardiac death (SCD). Implantable cardioverter-defibrillator (ICD) is a cornerstone of SCD prevention, but it does not reduce the incidence of life-threatening VAs and it can carry substantial complications. Hydroquinidine (HQ) is a class IA antiarrhythmic drug used for electrical storms, to reduce ICD's appropriate discharges and as an alternative to ICD in children with BrS or in patients with a contraindication to ICD. Nevertheless, HQ's side effects may undermine treatment compliance. Purpose The aim of this study was to evaluate the efficacy and safety of HQ in reducing VAs (ventricular fibrillation, sustained and non-sustained ventricular tachycardia) inducibility at electrophysiology study (EPS) and atrial fibrillation/flutter (AF/AFL) or VAs recurrence in patients with BrS. Methods From the prospective Piedmont Brugada Registry, patients treated with HQ were selected and divided into three groups according to the indication for HQ initiation: index EPS positive for VAs induction (group 1), secondary prevention of AF/AFl (group 2), secondary prevention of VAs (group 3). In group 3 recurrence of VAs was monitored by implantable devices or by periodic 24-hour ECG Holter monitoring. In 5 patients HQ was started for reasons different from the above mentioned, so they were considered only for safety outcomes. Safety was assessed considering the occurrence of HQ side effects and their impact on treatment discontinuation. Results A total of 98 patients (79 males, 80,6%) were included. Median follow-up was 61 months (IQR 31–89 months). None of the baseline clinical characteristics was associated with arrhythmic recurrences. Among 46 patients in group 1 HQ was effective in reducing EPS inducibility in 91.9% of patients (p&lt;0.0001); in group 2 (31 patients) HQ reduced palpitations [before HQ 83,8%, with HQ 27,6%, RRR 67.1%, NNT 1.8; p&lt;0.0001] and no AF/AFL recurrence was recorded during follow-up (p&lt;0.0001); in group 3 (17 patients; 70.6% with ICD/LR implanted) VAs recurrences were significantly reduced in patients with HQ (5.9% recurrence rate, p&lt;0.0001). Overall, no cardiac arrest occurred during follow-up. At ECG, HQ determined a significant increase in QTc duration (V5-lead mean QTc duration pre-HQ 406 ms vs with HQ 428 ms; p=0.001). Overall, 28.6% of patients presented HQ-related side effects, mainly due to gastrointestinal intolerance (18.3%). Treatment discontinuation rate was 25% but only about half of these patients discontinued HQ for adverse events (29.2% for GI intolerance, 16.7% for drug-induced QTc prolongation, 8.3% for elevated liver enzymes; 45.8% self-discontinuation). Conclusions In patients with BrS, HQ was effective in reducing VAs inducibility at EPS, AF/AFL and VAs recurrences; moreover, it was effective in reducing symptoms. Overall, HQ proved to be safe and well-tolerated. Funding Acknowledgement Type of funding source: None

Abstract 278: Phenomapping of Worsening Renal Function During Hospitalization for Acute Heart Failure

2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
Ryuichiro Yagi ◽  
Shun Kosaka ◽  
Makoto Takei ◽  
Ayaka Endo ◽  
Naoki Hirata ◽  
...  
Keyword(s):  
Heart Failure ◽  
Renal Function ◽  
Acute Heart Failure ◽  
Clustering Analysis ◽  
Distinct Population ◽  
Worsening Renal Function ◽  
Significant Difference ◽  
Group 2 ◽  
The Impact ◽  
Group 1

Background: Worsening renal function (WRF) during the hospitalization has been recognized as a predictor for worse outcomes in patients with acute heart failure (AHF). However, in recent years, elevation of serum creatinine during the acute phase of the treatment is accepted as a sign of efficient decongestion. Herein, we aimed to evaluate the phenotypic difference in this heterogeneous phenomenon by using clustering analysis. Methods: A total of 4000 patient data from the West-Tokyo Heart Failure Registry, a multicenter, prospective registry for consecutive AHF hospitalization were analyzed. Within 632 patients identified to have WRF (17%; defined as elevation of eGFR over 20 percent during the hospitalization), we applied two-step clustering analysis of phenotypic data (37 variables) to define and characterize phenotypically distinct population. After identification of phenotypically distinct subgroups, survival analysis with Cox proportional hazard was conducted to elucidate the impact of the classification on composite outcomes of heart failure re-hospitalization and all cause death. Results: The analysis identified four distinct populations (group 1-4) that distinctly differed in terms of clinical characteristics: Group1 composed of patients with reduced ejection fraction (EF), while group 2 to 4 were composed of patients with mid-range and preserved EF. Group 1 patients also had lowest eGFR and blood pressure at the time of admission. Group 1 and 2 patients were younger, but had higher plasma BNP compared to 3 and 4. Among these subgroups, group 1 had the worst, and group 2 had the most favorable prognosis. The difference in prognosis between these two groups was significant after adjustments with known prognostic factors (hazard ratio, 0.58; 95 percent confidence interval, 0.35-0.97). Conclusion: WRF represents heterogeneous condition; our clustering analysis revealed four phenotypically distinct population with significant difference in their prognosis. Further investigation is needed to assess its therapeutic implication.

Sequential (ST) versus combination (CT) chemotherapy in older patients (pts) with advanced colorectal cancer (aCRC): A retrospective analysis of the CAIRO study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9542-9542
Author(s):  
J. Doornebal ◽  
A. Wymenga ◽  
N. Antonini ◽  
W. T. van der Graaf ◽  
M. Koopman ◽  
...  
Keyword(s):  
Age Groups ◽  
Progression Free Survival ◽  
Median Number ◽  
Phase Iii ◽  
Appetite Loss ◽  
Comparable Group ◽  
Group 2 ◽  
Grade 3 ◽  
Eortc Qlq ◽  
Group 1

9542 Background: Although older pts have been underrepresented in clinical trials, studies support the efficacy of chemotherapy in older pts with aCRC. We retrospectively evaluated efficacy, tolerability, and quality of life (QoL, EORTC QLQ C30) of older (group 1: ≥ 70 yrs) vs younger pts (group 2: < 70 yrs) who participated in a randomized phase III trial of ST vs CT in CRC (Koopman et al, Lancet 2007). Moreover, differences between ST vs CT were analyzed in both age groups. Methods: All 803 eligible pts were randomized between ST - 1st line capecitabine (Ca) 1250 mg/m2 bid d1–14 (group 1: n = 104/group 2: n = 297), 2nd line irinotecan (Ir) 350 mg/m2 d1 (1:63/2:189) and 3rd line Ca 1000 mg/m2 bid d1–14 + oxaliplatin 130 mg/m2 d1 ([CAPOX], 1:34/2:119) - and CT - 1stline Ca 1000 mg/m2 bid d1–14 + Ir 250 mg/m2 d1 (1:95/2:307), 2nd line CAPOX (1:33/2:165). Cycles were given q 3 weeks. Results: Baseline characteristics, median number of administered cycles and median relative dose intensities were comparable. Group 1 vs 2: Overall survival (OS) and progression free survival (PFS) were comparable (OS: ST: 17.6 vs 16.0 months, HR 1.127 [0.883 - 1.437], CT: 19.8 vs 16.8 months, HR 0.913 [0.708 - 1.178]). A better RR was observed in 1st line ST for group 1 (30% vs 17%). Grade 3–4 toxicity was more common in 1st and 2nd line ST in group 1 (overall grade 3–4 toxicity 54/59% vs 40/43%). However, significant decreases in overall QoL, fatigue, appetite loss, and diarrhea were only reported in CT for group 1. ST vs CT: OS was comparable (1: 17.6 vs 19.8 months; 2: 16.0 vs 16.8 months). A better RR (17% vs 40%) and longer PFS (5.4 vs 7.8 months) were only observed in CT for group 2. Cumulative overall toxicity over all subsequent lines of treatment was worse for ST in group 1 (85% vs 69%). However, significant decreases in overall QoL, symptomatic appetite loss, nausea and vomiting and diarrhea were only reported in group 1 for CT. Conclusions: Older pts derived comparable benefit from both chemotherapeutic strategies compared to younger pts. CT did not result in any benefit in terms of efficacy in older pts. Despite the higher incidence of grade 3–4 toxicities, both efficacy and QoL results support the preference of ST in fit older aCRC patients. No significant financial relationships to disclose.

Evaluating Contemporary Radiotherapy Approaches in the Primary Treatment of Cervical Cancer

2010 ◽  
Vol 20 (6) ◽  
pp. 1087-1091 ◽  
Author(s):  
Rajiv Samant ◽  
Sofya Kobeleva ◽  
Choan E ◽  
Khalid Balaraj ◽  
Tien Le ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Statistical Significance ◽  
Progression Free Survival ◽  
Primary Treatment ◽  
Rank Test ◽  
Curative Intent ◽  
The Difference ◽  
Group 2 ◽  
The Impact ◽  
Group 1

Purpose:Radiotherapy with concurrent cisplatinum-based chemotherapy became a standard recommendation for the management of advanced cervical cancer in 1999. We reviewed our experience with this approach to determine the impact on patient outcomes.Methods:A retrospective review of all cervical cancer patients treated with curative intent using radical radiotherapy ± chemotherapy from 1992 to 2005 was performed. Survival and relapse rates were analyzed using the Kaplan-Meier method and were compared using the log-rank test.Results:During this period, 224 treated patients were identified: 153 (68%) were treated between 1992 and 1999 (group 1) and 71 (32%) were treated after 1999 (group 2). The median age was 53 and 55 years with a median follow-up of 49 and 34 months for groups 1 and 2, respectively. Stage classification and histological diagnosis were similar for both groups. Treatment usually consisted of external beam pelvic radiotherapy (40-45 Gy in 20-25 fractions) followed by low-dose rate brachytherapy (35-40 Gy to point A). Chemotherapy consisted of weekly intravenous cisplatinum (40 mg/m2) given concurrently with pelvic radiation. The proportion of patients receiving chemotherapy increased significantly after 1999, 12% in group 1 compared with 79% in group 2 (P < 0.01). The 5-year overall survival (OS) and progression-free survival (PFS) rates were 53% and 54% for group 1 and 64% and 67% for group 2. The improvement in PFS for group 2 approached statistical significance (P = 0.06), but the difference in OS did not.Conclusions:There has been a significant increase in the use of concurrent chemoradiation for cervical cancer treatment after 1999, and this seems to have led to higher rates of PFS and OS, although these have yet to achieve statistical significance.

Efficacy and safety of Entecavir for Hepatitis B virus-associated Glomerulonephritis with renal function insufficient

2021 ◽  
Author(s):  
Yu Yani ◽  
Xu Lingyu ◽  
Xu Ting ◽  
Yang Chengyu ◽  
Quandong Bu ◽  
...  
Keyword(s):  
Renal Function ◽  
Serum Creatinine ◽  
Elevated Serum ◽  
Efficacy And Safety ◽  
Renal Function Impairment ◽  
B Virus ◽  
Function Impairment ◽  
Group 2 ◽  
Group 1

Abstract Background HBV-GN is one of the most common secondary kidney diseases in China. Entecavir is one of the first-line antiviral nucleoside drugs at present, which can also effectively apply to antiviral therapy for HBV-GN.Objective The retrospective study to explore whether the entecavir is efficacy and safety for the treatment of Hepatitis B virus-associated glomerulonephritis(HBV-GN) with renal function insufficient.Methods We screened patients diagnosed with HBV-GN in The Affiliated Hospital of Qingdao University, elevated serum creatinine at 130umol/l ~ 250umol/l. Group 1 (30 patients) was given entecavir as antiviral treatment. Group 2 (28 patients) was treated with angiotensin II receptor blocker (ARB). The changes of renal function and the possible influencing factors were observed, with a mean follow-up time of 36 months.Results Baseline demographic and clinical parameters were not different between the 2 groups. For both cohorts, serum creatinine levels were increased gradually and the levels of eGFR declined progressively during the follow-up. At the end of the follow-up, serum creatinine levels in group 1 (t = 1.64, P = 0.1) and in group 2 ( t = 4.35, P = 0.001) were considered statistically significant compared to baseline creatinine. The levels of eGFR in group 1 (t = 2.37, P = 0.0018) and in group 2 ( t = 4.35, P = 0.001) were considered statistically significant compared to baseline eGFR. Comparison between the two groups showed that the elevated serum creatinine level and reduction in the level of eGFR were significantly lower in group 1 (t = 2.67, P = 0.008) than in group 2 (t = 2.76, P = 0.006), which were considered statistically significant. At the same time, cumulative renal survival, using end-stage renal disease (ESRD, eGFR < 15ml/min) as the primary renal endpoint, was 96.7% in group 1 and 67.9% in group 2 respectively (P = 0.005). Meanwhile, urine protein excretion was significantly decreased in both groups compared with baseline values, group 1 (t = 5.74, P = 0.001) and group 2 (t = 4.27, P = 0.001), while no significant difference was found(P = 0.370)in both groups. We performed a multivariate Cox regression analysis required eGFR < 15ml/min as the primary end point, then we found that the entecavir treatment and remission of proteinuria were the protective factors of renal function impairment, while the lower baseline eGFR was the risk factor of the progression of ESRD.Conclusion Entecavir treatment slows the progression of renal function impairment in HBV-GN, meanwhile, entecavir shows a significantly renal protective effect.

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