scholarly journals Does zafirlukast reduce future risk of asthma exacerbations in adults? Systematic review and meta-analysis

2014 ◽  
Vol 9 ◽  
Author(s):  
Chao Feng Chen ◽  
Yan Lv ◽  
Hong Ping Zhang ◽  
Gang Wang
Keyword(s):  
Current Control ◽  
Small Sample ◽  
First Line ◽  
Emergency Visits ◽  
First Line Therapy ◽  
Asthma Exacerbations ◽  
Line Therapy ◽  
Systemic Corticosteroids ◽  
Significant Difference ◽  
Future Risk

Background and objective: The purpose of asthma management is to achieve a total asthma control that involves current control and future risk. It has proven efficacy in reducing asthma exacerbations, but the effect size of zafirlukast for asthma exacerbations of various severity is not systematically explored. Methods: Randomized controlled trials were searched in PubMed Central, Web of Science, and Embase, where zafirlukast prevented asthma exacerbations in adults. The primary outcome was asthma exacerbations, the secondary outcomes were asthma exacerbations requiring systemic corticosteroids and emergency visits, respectively. Odds ratio (OR) with 95% confidence intervals (CI) were pooled. Results: Twelve trials were identified. As first-line therapy, compared to those having placebo, the patients with chronic asthma receiving zafirlukast experienced statistically lower asthma exacerbations (OR = 0.68, 95% CI = [0.45, 1.00]), but it was not found that zafirlukast was superior to placebo in asthma exacerbations requiring systemic corticosteroids (OR = 0.76, 95% CI = [0.45, 1.29]). Furthermore, zafirlukast was inferior to ICs in asthma exacerbations (OR = 2.11, 95% CI = [1.35, 3.30]) and requiring systemic corticosteroids (OR = 3.71, 95% CI = [1.82, 7.59]). As add-on therapy, zafirlukast was not superior to placebo in asthma exacerbations (OR =0.99, 95% CI = [0.54, 1.81] and requiring emergency visits (OR = 0.72, 95% CI = [0.18, 2.99]). Intriguingly, there was not a significant difference in asthma exacerbations between zafirlukast and ICs (OR = 1.12, 95% CI = [0.53, 2.34]). Conclusions: Our study suggests that zafirlukast, as the first-line therapy, significantly reduces mild to moderate but not severe asthma exacerbations. In the add-on regimen, zafirlukast could not reduce asthma exacerbations, which would perhaps result from small sample size and needs to be further studied.

scholarly journals 1338. Analysis of Prescription Guideline Adherence in Pediatric Outpatient Pneumonia Treatment

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S680-S681
Author(s):  
Carly Heck ◽  
Judith Martin ◽  
Marcia Kurs-Lasky
Keyword(s):  
Drug Allergy ◽  
Health Concern ◽  
Second Line ◽  
First Line ◽  
Second Line Therapy ◽  
First Line Therapy ◽  
Line Therapy ◽  
Comparison Results ◽  
Significant Difference ◽  
Recommended Therapy

Abstract Background Background: Antibiotic resistance is a major public health concern. A modifiable intervention is outpatient antibiotic stewardship. The goal of this study was to review the electronic health records (EHR) of children diagnosed with community acquired pneumonia (CAP) to compare patients who received non-guideline concordant therapy with those prescribed recommended therapy. Methods Methods: This was a retrospective chart review of 300 children (6 months to 6 years old) with an outpatient diagnosis of CAP between July 2017 and June 2019. 45 Children’s Hospital of Pittsburgh (CHP) and UPMC Children’s Community Pediatrics (CCP) practices were included. CHP practices are academic-based with trainees involved in visits, while CCP practices do not include trainees. First-line recommended therapy was defined as amoxicillin, second-line therapy as azithromycin or amoxicillin-clavulanate, and all other prescriptions were defined as other. Patients prescribed first-line therapy were compared to patients with second-line therapy or other. If first-line therapy was not prescribed, the EHR was manually reviewed for justification. If drug allergy was listed, the medication allergy and type of reaction were recorded. Results Results: In this study the minority of children (43%) were prescribed first-line therapy. This group was younger (57 vs. 63 months of age), more likely to be Non-white (80%), and seen at the CHP locations than those prescribed non-guideline concordant therapy. The average symptom duration was shorter, heart rate and respiratory rate were higher and the presence of fever was more common in the first-line therapy group. Justification for non-guideline therapy was most often reported as to provide coverage for atypical organisms. The most common drug allergy recorded was amoxicillin, and urticaria with unknown timing was the most common type of reaction. Demographics Comparison Results Justification for Second-line / Other Therapy and Drug Allergy Results Conclusion This project observed a high proportion of children being prescribed non-guideline concordant therapy for a diagnosis of CAP. Age, race, practice location, and severity of illness measures showed a statistically significant difference between groups. This study highlights the importance of education which reviews the current guidelines and the most likely pathogens for children with CAP. Disclosures All Authors: No reported disclosures

Comparison of First-line Pazopanib and Sunitinib in Metastatic Renal Cell Carcinoma: Experiences of the Urologic Cancer Centre for Research and Innovation

2019 ◽  
Author(s):  
Emily C.L. Wong ◽  
Camilla Tajzler ◽  
Gaurav Vasisth ◽  
Amanda Zhu ◽  
Mathilda Chow ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Side Effects ◽  
Cell Carcinoma ◽  
Disease Progression ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Significant Difference

Abstract Background: Sunitinib and pazopanib are orally-administered tyrosine kinase receptor inhibitors (TKIs) approved as first-line therapy for the treatment of metastatic renal cell carcinoma (mRCC). The IMDC criteria are a predictive prognostic model for patients with mRCC when stratified into three prognosis groups: favourable, intermediate and poor. We retrospectively compared the efficacy and safety of sunitinib and pazopanib as first-line therapy for patients with mRCC in our single institution database. Methods: Retrospective analysis was done to compare progression-free survival (PFS) and side effects of sunitinib and pazopanib as first-line therapy in patients with mRCC. Patients were stratified into prognosis groups according to IMDC criteria. Disease assessment was performed on measurable aspects of disease based on computed tomography or magnetic resonance imaging reports. Survival analysis was performed using the Kaplan-Meier method and Cox regression, with disease progression as the endpoint.Results: Data was obtained from 228 patients with mRCC who were treated with either pazopanib (n=57) or sunitinib (n=171). No significant difference in PFS was found between sunitinib and pazopanib (HR for disease progression or all-cause death, 1.10; 95%CI: 0.76-1.57, p=0.62). Median PFS time for patients receiving sunitinib was 9.4 months and for pazopanib, 8.5 months. Median PFS for patients with intermediate-risk disease was similar between groups (9.4 months vs. 9.2 months, respectively, p=0.93). However, patients treated with sunitinib experienced a greater number of side effects compared to pazopanib. Conclusions: Sunitinib and pazopanib are similarly efficacious as first-line therapy for mRCC. However, adverse events are lower with pazopanib.

Health related quality of life (HRQOL) evaluated with the EORTC C30 questionnaire in first line therapy of elderly patients with chronic lymphocytic leukemia (CLL): Results of a phase III trial of the German CLL Study Group (GCLLSG)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7572-7572 ◽  
Author(s):  
B. F. Eichhorst ◽  
R. Busch ◽  
M. Hallek
Keyword(s):  
Social Functioning ◽  
Age Groups ◽  
Lymphocytic Leukemia ◽  
Phase Iii ◽  
Response To Treatment ◽  
First Line ◽  
Elderly Age ◽  
First Line Therapy ◽  
Line Therapy ◽  
Significant Difference

7572 Background: The GCLLSG evaluated the efficacy of fludarabine (F) versus (vs.) chlorambucil (Clb) in first line therapy of older patients with advanced CLL. HRQOL was evluated by using the EORTC C30 questionnaire. Methods: Pts were randomized to receive 6 courses of F (25 mg/m²/day (d) IV for 5d; 92 pts) or 12 months (mo) of Clb (0.4–0.8 mg/kg/d PO, every 15d; 99 pts). All pts were previously untreated, aged between 65 and 79 years and in advanced stage Binet C or symptomatic Binet B or A. Primary endpoints were overall survival (OS) and progression free survival (PFS), secondary endpoint was HRQOL. The EORTC C30 questionnaire (version 2.0) was sent to all patients at baseline and after 6, 12 and 24 mo. Scores (0–100) for 15 different measures (1 global HRQOL, 5 functional, 3 symptom and 6 single item scales) were evaluated at each time point. Results: F induced significantly higher response rates and prolonged the PFS, while no significant difference in OS was observed. At baseline 130 of 191 pts (68%) completed the questionnaires followed by more than 80% at mo 6 to 24. Compliance rates were similar in both treatment arms. Between pts completing questionnaires or not no statistically significant differences in perfomance status, age, stage or response to treatment were observed. HRQOL differences in comparison to baseline values were significantly improved after F treatment in global HRQOL, role and social functioning after 12 months as shown by the table. Responders had a significantly better global HRQOL and social functioning as well. Except for an impaired physical functioning no differences in HRQOL were observed between different age groups (65–69, 70–74, 75–79). Conclusion: Elderly F treated patients with CLL showed improvement inglobal HRQOL. Elderly age groups had a similar HRQOL as younger age groups. [Table: see text] [Table: see text]

Whether mCRC patients with other RAS mutations benefit from the addition of bevacizumab as first-line therapy.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 579-579
Author(s):  
Mingyi Zhou ◽  
Ping Yu ◽  
Kezuo Hou ◽  
Xiujuan Qu ◽  
Yunpeng Liu ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Large Sample Size ◽  
First Line ◽  
Exon 2 ◽  
Ras Mutations ◽  
First Line Therapy ◽  
Line Therapy ◽  
Significant Difference ◽  
Ras Status ◽  
Kras Exon

579 Background: It is not clear whether Bevacizumab plus chemotherapy could improve the prognosis of mCRC patients with other RAS mutations beyond KRAS exon 2. Methods: The MEDLINE, EMBASE, Cochrane databases, and Clinical Trials databases were reviewed to September 2015. The data of patients with KRAS exon 2 mutations was only available in FIRE3 study. So we could not perform the meta-analysis by KRAS exon 2 mutations. The data of patients with other RAS mutations beyond KRAS exon 2 were available in PEAK and FIRE3 studies. Hazard ratio (HR) was used to analyze the progressive-free survival (PFS) and overall survival (OS). Relative risk (RR) was used to analyze overall response rate (ORR). Results: Patients with other RAS mutations beyond KRAS exon 2 benefited from the addition of Bevacizumab. Bevacizumab + chemotherapy significantly improved the PFS compared with anti-EGFR moAb + chemotherapy (HR: 1.82, CI: 1.20–2.77, P =.005). The addition of Bevacizumab tended to improve ORR, though there is no significant difference (RR: 0.83, CI: 0.58–1.18, P =.288). But the OS tended to be shorter in Bevacizumab + chemotherapy arm than anti-EGFR moAb + chemotherapy arm without significant difference (HR: 0.72, CI: 0.25–2.05, P =.534). Conclusions: Patients with other RAS mutations beyond KRAS exon 2 could choose Bevacizumab plus chemotherapy as first-line therapy. But there is still no adequate evidence to reject or support the predictive value of RAS status in the effect of the addition of Bevacizumab. Moreover, which is the better primary endpoint, PFS or OS? Which is the better consequence of strategy, anti-EGFR moAb followed by Bevacizumab or Bevacizumab followed by anti-EGFR moAb? RCTs with large sample size comparing the efficacy of anti-VEGF moAb + chemotherapy and chemotherapy alone by RAS status as the first-line therapy in mCRC patients are required in the future.

Comparison of clinical outcome between gefitinib and erlotinib treatment in patients with non-small cell lung cancer harboring an epidermal growth factor receptor exon 19 or exon 21 mutations.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e19051-e19051
Author(s):  
Sung Hee Lim ◽  
Ji Yoon Lee ◽  
Jong-Mu Sun ◽  
Jin Seok Ahn ◽  
Keunchil Park ◽  
...  
Keyword(s):  
Egfr Mutation ◽  
Performance Status ◽  
Small Cell ◽  
Small Cell Lung ◽  
First Line ◽  
Ecog Performance Status ◽  
First Line Therapy ◽  
Line Therapy ◽  
Significant Difference ◽  
Egfr Tki

e19051 Background: Gefitinib and erlotinib are small-molecule kinase inhibitors that inhibit signaling via EGFR and both agents showed dramatic response rate and prolonged PFS in patients harboring activating EGFR mutation. We investigated the clinical outcomes between gefitinib- and erlotinib-treated patients with recurrent or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutations. Methods: A total 375 patients with recurrent or metastatic NSCLC who had either an exon 19 deletion or L858R mutation on exon 21 and received gefitinib (n=228) or erlotinib (n=147) therapy between August 2007 and December 2011 were retrospectively reviewed. By using a matched-pair case-control study design, 121 pairs of gefitinib-treated and erlotinib-treated patients were matched according to sex, smoking history, ECOG performance status, and types of EGFR mutation. Results: The median age of all patients was 58 years (range, 30-84) and more than half of patients were never smokers (63.6%). Most patients had adenocarcinoma (98.3%) and good ECOG performance status (0, 1) (90.9%). Of 242 patients, 64 (26.4%) received an EGFR TKI as first line therapy. The overall response rates and disease control rates in the gefitinib-treated and erlotinib-treated groups were 85.5% versus 79.8 % (p=.375) and 94.0% versus 89.1%, respectively (p=.242). There was no statistically significant difference noted with regard to OS (median, 38.9 vs 37.5; p=.642) and PFS (median, 12.9 vs 10.1; p=.135) between the gefitinib-treated and erlotinib-treated groups. For a subgroup which patients were treated with TKI as first line therapy, the overall response rates were higher than those of patients who had progressed on prior chemotherapy (90.3% vs 79.9%; p=.063). However, there was no significant difference in PFS (median, 13.3 vs 10.3; p=.134) between subjects with first line TKI therapy and more than second line treatment. Conclusions: Both gefitinib and erlotinib showed similar effective activity in selected population of NSCLC that harbored an EGFR mutation and further studies are needed to evaluate the efficacy of EGFR TKI as first line treatment.

Efficacy of platinum-based regimens as the first-line therapy in Chinese patients with advanced TNBC and deleterious BRCA1/2 mutations.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12565-e12565
Author(s):  
Nan Wang ◽  
Kun Li ◽  
Wei-Yao Kong ◽  
Xiao-Ran Liu ◽  
Meng-Yao Tan ◽  
...  
Keyword(s):  
Chinese Patients ◽  
Line Treatment ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Platinum Based Chemotherapy ◽  
Significant Difference ◽  
Peking University ◽  
Grade 3 ◽  
First Line Treatment

e12565 Background: Platinum-based therapy remains an effective treatment for triple-negative breast cancer (TNBC), however, the usage is largely limited due to its side effect and rapidly developed drug resistance. High prevalence of BRCA1/2 mutations are reported in TNBC. Here we explored efficacy of platinum-based regimens as the first-line treatment for Chinese patients (pts) with advanced TNBC, and analyzed its association with mutations of germline BRCA1/2 (gBRCA). Methods: We retrospectively analyze 220 patients diagnosed as advanced TNBC who were treated at the Dept. of Breast Oncology, Peking University Cancer Hospital in 2013-2018, and routinely evaluated by RECIST 1.1. Statistical analysis is performed in R 3.5.1. Cox proportional-hazard models are used for survival analysis. Results: 129 pts received non-platinum chemotherapy (NPCT) as the first-line therapy, and 91 pts received platinum-based chemotherapy (PBCT). The clinical benefit rate (CBR) and median PFS were not statistically different between NPCT and PBCT groups The median OS was 30.0 and 22.5 months for PBCT and NPCT group respectively (P = 0.09, HR = 0.70). Among them, 114 pts had BRCA gene tested, of which 14 had deleterious gBRCA mutations, 7 in each group. In PBCT group, the CBR was 85.7% and 35.1% for pts with and without deleterious gBRCA mutations respectively (P = 0.04). The median PFS, OS were 14.9 months and 5.3months (P = 0.001), 26.5 and 15.5 months (P = 0.16) for pts with and without the gBRCA mutations. No significant difference was observed between NPCT pts with and without gBRCA mutations as regards the CBR, PFS and OS. PBCT Pts had significantly more grade 3-4 anaemia (5.5% vs 0%) and thrombocytopenia (8.8% vs 0%) while higher percentage of palmar-plantar erythrodysesthesia (PPE) (12.4% vs 0%) and peripheral neuropathy (8.6% vs 1.1%) were observed in NPCT pts. Conclusions: The efficacy of platinum-based regimens as the first-line treatment of advanced TNBC insignificantly differs from that of non-platinum therapy. However, they are more effective for patients with deleterious gBRCA mutations, suggesting a BRCA1/2 genetic testing may be warranted for such patients.

Health-related quality of life (HRQoL) of pembrolizumab plus chemotherapy versus chemotherapy as first-line therapy in patients with advanced esophageal cancer: The phase III KEYNOTE-590 study.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 168-168
Author(s):  
Wasat Mansoor ◽  
Amit S. Kulkarni ◽  
Ken Kato ◽  
Jong-Mu Sun ◽  
Manish A. Shah ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Phase Iii ◽  
Advanced Esophageal Cancer ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Pain Subscale ◽  
Significant Difference ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

168 Background: In the randomized, international, double-blind, placebo-controlled KEYNOTE-590 (NCT03189719) study, pembrolizumab (pembro) + chemotherapy (chemo) provided statistically significant and clinically meaningful improvement in OS, PFS, and ORR vs placebo + chemo as first-line therapy for patients (pts) with locally advanced/unresectable or metastatic adenocarcinoma or esophageal squamous cell carcinoma (ESCC) or Siewert type 1 esophagogastric junction adenocarcinoma (EGJ). Here we report HRQoL outcomes in KEYNOTE-590. Methods: 749 pts were randomized 1:1 to pembro 200 mg or placebo Q3W for up to 2y + chemo (cisplatin 80 mg/m2 Q3W [d1; 6 doses] + 5-FU 800 mg/m2 on d1-5 Q3W). EORTC QLQ-C30, EORTC QLQ-OES18, and EQ-5D-5L questionnaires were administered at baseline, every 3 weeks (Q3W) up to week 24, and then Q9W up to 1 year or end of treatment, and at the 30-d safety follow-up visit. HRQoL was assessed in all treated patients who completed ≥1 HRQoL assessment (N = 711: 356 for pembro + chemo; 355 for chemo). Change from baseline to week 18 in EORTC-QLQ-C30 global health status (GHS)/QoL and physical functioning, and in QLQ-OES18 scores were prespecified secondary endpoints. Change from baseline to week 18 in EQ-5D scores was an exploratory endpoint. Time to deterioration (TTD) was evaluated for all endpoints. Least square mean (LSM) change from baseline (95% CI) was compared using a constrained longitudinal data analysis model. TTD was compared using a stratified log rank test and Cox proportional hazards model. P-values are nominal and two-sided. Results: QLQ-C30, QLQ-OES18 and EQ-5D-5L compliance was ≥90% in both arms at baseline and at week 18. There was no significant difference in least squares mean (LSM) change from baseline to week 18 in GHS/QoL status between arms (LSM difference [95% CI] -0.10 [-3.40-3.20]; P = 0.9530). Median TTD in GHS/QoL was similar between arms (HR, 0.86 [95% CI, 0.66-1.13]; P = 0.2864). Outcomes were similar in ESCC PD-L1 CPS ≥10, ESCC, and PD-L1 CPS ≥10 patient populations. LSM change from baseline to week 18 for QLQ-OES18 pain subscale was better for pembro + chemo (-4.78) vs chemo (-1.85 ) (-2.94, -5.86 to -0.02; P = 0.0487). There was no significant difference in LSM change from baseline to week 18 between arms for reflux (-1.19; -4.49-2.10; P = 0.4781) or dysphagia (-2.35; -7.78-3.07; P = 0.3945). VAS LSM change from baseline to week 18 was similar between arms (1.20, -1.61-4.01; P = 0.4016). Conclusions: HRQoL was stable and similar over 18 weeks in the pembro + chemo and chemo arms. Together with superior OS, PFS, and ORR and a manageable safety profile with pembro + chemo, these results support the clinically meaningful benefit of pembro + chemo in patients with advanced esophageal cancer including EGJ adenocarcinoma. Clinical trial information: NCT03189719.

Fludarabine, Cyclophosphamide and Rituximab (FCR) Related Prolonged Cytopenia Is Frequent and Adverse Factor Affecting Survival of Patients with Chronic Lymphocytic Leukemia (CLL)

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 1790-1790
Author(s):  
Petra Obrtlikova ◽  
Anna Jonasova ◽  
Magda Siskova ◽  
Eduard Cmunt ◽  
Adela Berkova ◽  
...  
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Lymphocytic Leukemia ◽  
High Dose ◽  
Second Line ◽  
First Line ◽  
Second Line Therapy ◽  
First Line Therapy ◽  
Line Therapy ◽  
Significant Difference

Abstract Abstract 1790 Background: The immunochemotherapy regimen composed of fludarabine, cyclophosphamide and rituximab (FCR) has emerged as highly effective frontline or second line therapy for chronic lymphocytic leukemia (CLL). This regimen may be however associated with prolonged cytopenia and the risk of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Aims and methods: In our retrospective single center analysis, we evaluated the efficacy and the toxicity of FC or FCR regimen in unselected population of CLL patients with treatment indication. The overall survival (OS) and progression free survival (PFS) was calculated for all patients as intent to treat analysis. The prolonged cytopenia was defined as cytopenia (grade 2–4 according to CTCAE v.4 ) developing during of after the last cycle of FC/FCR and persisting two or more months. Cytopenia was evaluated in patients with follow-up at least 6 months after this treatment. Patients were excluded from analysis of cytopenia if they underwent immediate other treatment (antibody maintenance, high dose therapy with autologous stem cell transplantation (ASCT) consolidation, or they received other therapy due to unsatisfactory response to FCR). Patients with missing laboratory data after FC(R) were also excluded. Kaplan Maier curves for PFS and OS were calculated and log rank test was used for survival comparison. Results: Altogether, 252 patients started the treatment with FC or FCR in the years 2000–2012 at our institution. There were 86 (34%) women and 166 (66%) men with a median age of 62 years (31–87) at the time of FC(R) therapy. 52 (21%) pts received FC regimen, including 40 pts treated in first line therapy and 12 pts in second line therapy. FCR therapy was administered in 200 pts (79%): 153 pts received FCR as first line therapy, 38 pts as second line therapy and 8 pts as third or fouth line therapy. The median number of FC cycles was 5 (1–8) with or without R. The estimated OS for the first line therapy was 87,5% in FCR group vs 80% at 3y in FC group (p ns) (Hallek,CLL8: 87% vs 83%) and PFS was 70% in FCR group vs 50% in FC group (p=0,004) with the median of follow-up 45 months. Altogether 184 pts fulfill the criteria for cytopenia analysis. The most frequent immediate subsequent therapy considered as exclusion for this analysis was ASCT consolidation (n 20). Out of 184 pts, 146 recieved FC(R) as 1st line treatment and 38 subsequent therapy. The prolonged cytopenia was observed in 54 pts (29%), 42 (29%) in 1st line group and 12 (32%) in subsequent line group. Median duration of cytopenia was 8 m (2–65), 29 out of 54 patients have had persistent cytopenia at the time of last follow up. The cumulative probability to develop cytopenia was 30.3% at 2y among all pts and 29.7% among first line FCR treated pts. There was no significant difference between FC and FCR treated pts. Eleven pts developed MDS/AML, 7 cases were observed in the followed group of 184 pts (with probability 6.1% at 6y), in all cases the cytopenia preceded the MDS onset, 6y probability to develop MDS was 25.2% for patients who develop prolonged cytopenia after FC(R). Moreover 2 MDS and 1 AML were observed among 20 pts treated with ASCT (6y probability 5.6%, 8y probability 22.5%). The OS probability from 1stcycle of FC(R) was significantly better for pts without cytopenia (75.5% vs 57.5% at 5y, p<0.005), nonsigificant trend was observed if only first line FCR pts were analyzed (88% vs 85%). The median survival for the MDS pts from the time of MDS dg was 6 months only. Conclusions: Although the FCR is the best available standard treatment option for CLL pts, it is associated with prolonged cytopenia in 30% of cases. These patients with prolonged cytopenia afte FC(R) have considerably high probability (25.2%) to develop MDS and they have worse OS compared to pts without cytopenia. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Xeloda as first-line therapy of metastatic colorectal cancer-our experience

2002 ◽  
Vol 10 (4) ◽  
pp. 249-252
Author(s):  
Vladimir Kovcin ◽  
Rada Jesic ◽  
Zoran Krivokapic ◽  
Zoran Andric ◽  
Aleksandra Pavlovic
Keyword(s):  
Liver Function ◽  
Adverse Events ◽  
Liver Dysfunction ◽  
Primary Tumor ◽  
Response Rate ◽  
Phase Iii ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Significant Difference

BACKGROUND: Results of phase III clinical studies comparing efficacy of Xeloda vs. standard 5-FU/FA protocols as first line therapy of metastatic colorectal carcinoma (MCRC), have shown better efficacy of Xeloda, with less toxic adverse effects, apart from handfoot syndrome. METHODS: From January 2000 to May 2001 the study enrolled 54 patients with MCRC, 38 males and 16 females, aged 30-78 years. All patients had metastatic diseases. In 33 the primary tumor was in colon, in 21 in rectum. All patients received Xeloda 2500 mg/m2/day in two daily doses, during 14 days followed by 7 days of pause. Dose intensity was 88,79% +/- 9,2. For efficacy evaluation the WHO criteria and tumor markers CEA and CA 19-9 were used. RESULTS: Overall response rate was 47%, with 13% complete responses, 34% partial responses 38% stable disease and 15% disease progression. No significant difference was found between patients with regard to localization of primary tumor (colon or rectum). There was no significant difference in response rate when compared 27 patients with adverse events of capecitabine ('hand and foot' syndrome and diarrhea) and those without them. Response rate in a subgroup of 21 evaluable (out of 29) patients with initial signs of liver dysfunction was worse (p<0.005) in comparison with patients with normal liver function. Most frequent adverse events were 'hand and foot' syndrome (52%) and diarrhea (24%), or both (14%). Other adverse events, up to grade 2 toxicity, were sporadically reported; however, hematological toxicity was significantly more common in a subgroup of patients with compromised liver function (p<0.007). CONCLUSION: This study has shown that Xeloda is a good monotherapy choice, with high response rate as first line therapy of metastatic CRC. Adverse events do not influence response. Liver dysfunction is a poor prognostic parameter. Therapy with Xeloda is convenient and relatively safe in patients with liver dysfunction, where administration of other cytotoxic agents is not possible.

Outcome of Risk Adapted Therapy for Relapsed/Refractory Acute Lymphoblastic Leukemia in Children: Results From a Single Institution

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4237-4237
Author(s):  
Asim F Belgaumi ◽  
Asem Bukhari ◽  
Mohammed Al-Mahr ◽  
Amal Al-Seraihy ◽  
Hazem Mahmoud ◽  
...  
Keyword(s):  
Overall Survival ◽  
Induction Therapy ◽  
Late Relapse ◽  
Second Line ◽  
First Line ◽  
Second Line Therapy ◽  
Hematopoietic Stem ◽  
First Line Therapy ◽  
Line Therapy ◽  
Significant Difference

Abstract Abstract 4237 Although the outcome of first line therapy for childhood ALL has improved significantly, the results of second line therapy remains suboptimal. The most important predictive factors identified for second line therapy are timing and site of relapse; early relapse and bone marrow (BM) involvement invoking poorer outcomes. At our institution we have utilized a risk stratified therapeutic strategy for relapsed/refractory ALL which includes these factors. Re-induction for patients with first remission (CR1) duration of <18 months or those with remission failure was with high dose cytarabine (HDAraC) containing regimens, most often with idarubicin (Ida). For patients with CR1 >18 months, we utilized a standard 4-drug (prednisone, vincristine, daunomycin, asparaginase [PVDA]) induction regimen. Patients who relapsed in the BM while on chemotherapy or within 1 year of being off therapy were eligible for hematopoietic stem cell transplantation (SCT) after achieving CR, as were patients with isolated extra-medullary relapse with CR1 <18 months. Patients with late relapse were treated with post consolidation maintenance chemotherapy alone. Data collected prospectively in our database were reviewed. ALL patients who relapsed after receiving first line therapy at our institution and those who were referred to us at first relapse were included in this analysis. Only overall survival (OS) is presented as all patients who failed to achieve a CR or relapsed after achieving CR eventually died regardless of further therapeutic interventions. Fifty-nine patients with ALL failed their first line therapy between January 1, 2005 and May 31, 2011. There were four induction failures and 55 relapses. These 59 patients included 39 males; 53 of the patients had B-cell ALL and 6 had T-cell ALL. The age at original diagnosis ranged from 0.55 to 13.8 years (mean 6; median 4.8; SEM 0.50) whereas the age at first failure ranged from 0.68 to 16.4 years (mean 8.0; median 7.8; SEM 0.50). 36/55 (65.5%) relapses occurred on first line chemotherapy, 17 (30.9%) after completion of therapy and 2 (3.6%) following SCT. For the relapsed patients, the duration of CR1 ranged from 0.09 to 9 years (mean 2.0; median 1.7; SEM 0.22); 24 (44.4%) patients relapsed less than 18 months from CR1. 36 (61%) patients had isolated BM relapse, 13 (22.1%) had isolated extra-medullary (7 CNS; 6 testicular) and the remaining 10 had BM with other sites. Twenty four patients (40.7%) were re-induced with HDAraC/Ida (HIda), 28 (47.5%) with PVDA, 4 (6.8%) Fludarabine/AraC (FA) and 3 did not receive any second line therapy. For those who were treated 37 (62.7%) achieved a CR; 13 of the 19 patients who did not achieve CR with second-line therapy received third-line induction therapy (9 FA; 1 HIda; 1 VM26/AraC; 1 PVDA; 1 VP/CTX) and 7 (53.8%) achieved CR. The overall survival for all 59 patients at 2 years is 45.3%; for those who achieved CR the overall survival at 2 years is 64.7%. When we compared those patients who had CR1 durations >18 months with those who were induction failures or had CR1 duration <18 months, we found no significant difference in CR2 induction rates (76.7% v. 80%; p=1.0), nor in OS (56.9% v. 34.5% at 2 years; p=0.14). CR induction rates did not change when we further categorized CR1 duration into 18 months, 18–36 months and >36 months (80% v. 72.2% v. 80%; p=0.74). However, the OS was significantly higher for the >36 month group (83.3%; p=0.023) when compared to the other 2 groups (38.7% and 38.4%, respectively). In patients with <36 months of CR1, HSCT resulted in a significantly improved OS as compared to chemotherapy alone (51.4% v. 30.9 at 2 years; p=0.05). For those patients who achieved a CR2 there was no difference in the OS between those who underwent HSCT v. those who continued on chemotherapy (68% v. 58.5% at 2 years; p=0.33). Patients who achieved a CR after 2nd line therapy fared much better than those who achieved a CR after 3rd line therapy (25/36 [69.4%] alive v. 2/7 [28.6%] alive; OS at 2 years 68.3% v. 29.2%; p=0.06). In conclusion, we believe that this risk stratified approach to the treatment of relapsed/refractory ALL in children is effective. While the majority of the patients can be re-induced into remission, maintenance of the remission is dependent on the duration of CR1; patients with late relapse do as well as treatment naïve patients. Increased intensity induction therapy for early relapses and SCT for patients with <36 months of CR1 may be beneficial. Disclosures: No relevant conflicts of interest to declare.

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