Comparative effectiveness of pazopanib and sunitinib as first-line therapy for patients with advanced/metastatic renal cell carcinoma in a U.S. community oncology setting.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 567-567 ◽  
Author(s):  
Bradford Richard Hirsch ◽  
Xiaolong Jiao ◽  
Thomas Wilson ◽  
Michelle Denise Hackshaw ◽  
Eric Jonasch ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Disease Risk ◽  
Progression Free Survival ◽  
Risk Groups ◽  
Office Visits ◽  
First Line ◽  
Eligibility Criteria ◽  
First Line Therapy ◽  
Community Oncology ◽  
Significant Difference

567 Background: The COMPARZ trial demonstrated that pazopanib was non-inferior to sunitinib regarding their efficacy as first line of therapy (LOT) for advanced/metastatic RCC (aRCC). However, no studies have compared the effectiveness of pazopanib to sunitinib outside the clinical trial setting. The purpose of this study was to compare the clinical outcomes of the two therapies in a US community oncology setting. Methods: A retrospective study was conducted using US Oncology’s (USON) iKnowMed electronic health record (EHR) database, supplemented with chart review. Patient eligibility criteria included: ≥ 18 years of age at first diagnosis of aRCC, treated with pazopanib or sunitinib as the 1st LOT between 11/1/2009 – 8/31/2012 in the USON with ≥ 2 office visits. A propensity score (PS) matching was performed to match patients receiving pazopanib to sunitinib. Clinical outcomes including progression free survival (PFS), overall survival (OS) and adverse events (AEs) were compared. Results: A total of 177 patients on pazopanib and 739 patients on sunitinib were identified from the EHR database. After PS matching, 153 pts were included in pazopanib and sunitinib cohort respectively. The mean age, gender distribution, and the Heng disease risk groups were similar between the two cohorts (p>0.05). No significant difference in PFS was observed with pazopanib (median: 9.3 [95%CI, 7.0 to 11.8] months) compared to sunitinib (median: 8.3 [95%CI, 6.4 to 10.9] months, p = 0.43). Similarly, no significant difference was observed in OS for pazopanib (median: 22.3 [95% CI, 16.2 to 31.7] months) compared to sunitinib (median: 26.3 [95% CI, 16.4 to 38.2, p = 0.76] months). AEs (any grade) including diarrhea, hypertension, nausea, vomiting, fatigue were significantly lower in sunitinib (p<0.05) while anorexia was lower in pazopanib (p<0.05). Conclusions: Consistent with the results of COMPARZ, no significant difference was observed in PFS and OS among aRCC patients treated with pazopanib or sunitinib as the 1st LOT in the real world. AEs seemed to be less common with sunitinib, and this may be partially attributed to the limitation of retrospective data.

BuCy Provides Equivalent Outcomes to VCyTBI as Conditioning Prior to Auto-SCT in Patients with Relapsed/Refractory NHL and Is a Valuable Option in Older (≥60 years) Patients.

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 2176-2176
Author(s):  
Shannon L Smiley ◽  
Theresa Hahn ◽  
Wei Tan ◽  
Gregory Wilding ◽  
Minoo Battiwalla ◽  
...  
Keyword(s):  
Stem Cells ◽  
Total Dose ◽  
Disease Risk ◽  
Standard Dose ◽  
Intensive Therapy ◽  
Conditioning Regimen ◽  
Progression Free Survival ◽  
Eligibility Criteria ◽  
Peripheral Blood Stem Cells ◽  
Significant Difference

Abstract Cyclophosphamide+total body irradiation +/− etoposide (CyTBI+/−V) is a standard conditioning regimen prior to auto-SCT for NHL patients. However, TBI-based dose intensive therapy is often contraindicated in older patients, or those with prior radiation. We performed a single-institution Phase II non-randomized prospective study of VCyTBI vs. Busulfan+Cy (BuCy) to determine if BuCy provides comparable disease control to standard dose intensive therapy with VCyTBI. BuCy was used in patients ≥60 years and when TBI was contraindicated. Seventy-five relapsed or refractory NHL patients underwent auto-SCT at Roswell Park Cancer Institute from 8/92 to 7/05. All patients were treated on a single IRB-approved protocol with standard eligibility criteria including age ≥18 and ≤70, adequate cardiac, pulmonary, hepatic and renal function and KPS ≥70. All patients signed informed consent and were followed prospectively. All data have been de-identified. Survival status for all patients was updated through 8/1/08. VCyTBI (N=47) consisted of V 1800 mg/m2 26-hour continuous iv infusion on day -5, Cy 60 mg/kg day -4 (12 patients received 180 mg/kg total dose), and TBI 200 cGy on days -3, -2, and -1 for total dose of 1000 cGy (8 patients received 1200 cGy). BuCy (N=28) consisted of iv Bu 0.8 mg/kg every 6 hours on days -7, -6, -5, -4 (total 12.8mg, one patient received oral Bu total dose 16 mg/kg) and Cy 60 mg/kg on days -3 and -2 (total 120 mg/kg, one patient received total dose 200 mg/kg). Eight patients received iv Bu without dose adjustment and 19 received iv Bu with dose adjusted to maintain a steady state level between 600– 900 ng/ml. Stem cells were re-infused on day 0. Patients received peripheral blood stem cells (n=53), bone marrow (n=14) or both (n=8). The median age was significantly higher in the BuCy compared to the VCyTBI group (61.5 vs 53 years, p=0.0002), and there were fewer patients with a KPS of 90–100 in the VCyTBI group (75% vs 93%, p=0.07). There were no significant differences on the following patient characteristics by BuCy vs VCyTBI: gender, disease risk, stem cell source, histology (diffuse, follicular, mantle, other), or remission status at SCT. Treatment-related mortality at day+100 post-auto SCT was very low in both groups: 0% in BuCy and 2% in VCyTBI. However, 3 patients in the VCyTBI group and none in the BuCy group developed AML at 1.3, 1.8 and 6.5 years post-auto-SCT. At a median follow-up of 4.6 years, the 5-year progression-free survival for BuCy and VCyTBI was 32% (95% CI 14–50%) and 24% (95% CI, 11–39%, P&gt;0.8), respectively. The 5-year overall survival for BuCy and VCyTBI was 46% (95% CI 25– 64%) and 49% (95% CI 33–64%, P&gt;0.7), respectively. Multivariate analysis controlling for age and KPS at BMT also demonstrated no significant difference between BuCy and VCyTBI for either progression-free (RR=0.9, 95% CI 0.5–1.8) or overall (RR=0.7, 95% CI 0.3–1.6) survival. This is the largest reported study evaluating the efficacy of BuCy as alternative conditioning for auto-SCT in relapsed/refractory NHL. BuCy provides equivalent survival outcomes to VCyTBI as conditioning for auto-SCT in NHL patients. Based on these results, our practice continues to use BuCy for NHL patients ≥60 years.

Quality of life (QOL) with sunitinib versus interferon-alfa (IFN-α) as first-line therapy in patients with metastatic renal cell carcinoma (mRCC): Final results

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6529-6529
Author(s):  
D. Cella ◽  
M. D. Michaelson ◽  
J. C. Cappelleri ◽  
A. G. Bushmakin ◽  
C. Charbonneau ◽  
...  
Keyword(s):  
Objective Response ◽  
Progression Free Survival ◽  
Well Being ◽  
The United States ◽  
The European Union ◽  
First Line ◽  
Symptom Index ◽  
First Line Therapy ◽  
Significant Difference ◽  
Eq Vas

6529 Background: In an international, randomized phase 3 trial (Figlin et al, ASCO. 2008), sunitinib showed superior progression-free survival (the primary endpoint) and objective response rate over IFN-α (11 vs. 5 mo and 47% vs. 12%, respectively; p < 0.000001) as first-line mRCC therapy, with a median overall survival of more than 2 years. Here, we report the final health-related QOL results from this trial. Methods: 750 treatment-naïve mRCC patients were randomized 1:1 to receive sunitinib 50 mg orally once-daily in recurring cycles of 4 weeks on drug and 2 weeks off or IFN-α 9 MU subcutaneously thrice-weekly. QOL was measured by the Functional Assessment of Cancer Therapy-General (FACT-G), which has 4 subscales, the FACT-Kidney Symptom Index-15 item (FKSI-15), which includes a Disease-Related Symptoms (FKSI-DRS) subscale, and the EQ-5D questionnaire's utility index (EQ-5D Index) and visual analog scale (EQ-VAS). The primary QOL endpoint was FKSI-DRS. Higher scores indicated better outcomes. Patients completed questionnaires on days 1 and 28 of each cycle. Data were analyzed for the intent-to-treat population using mixed-effects models (MM), supplemented with pattern-mixture models (PMM). We also compared QOL of patients in the United States (US) with patients in the European Union (EU; France, Germany, Italy, Poland, Spain and United Kingdom). Results: Patients on sunitinib reported better FKSI-15 and FKSI-DRS scores than those on IFN-α, with a significant difference in the overall means across cycles (4.06 and 2.36, respectively; p < 0.0001; MM). Similarly, differences in means for FACT-G (and all subscales), EQ-5D Index, and EQ-VAS all significantly favored sunitinib (p < 0.05). Based on pre-set, required minimum score differences, between-treatment differences in the mean scores were clinically meaningful for FKSI-15, FKSI-DRS, FACT-G, and the FACT-G functional well-being subscale. Between-treatment differences were similar for both the US and EU populations. Across all analyses, results from PMM were similar to those from MM. Conclusions: Sunitinib provides superior QOL over IFN-α, in addition to superior efficacy, as first-line mRCC therapy. [Table: see text]

Randomized, open-label, phase II trial of gemcitabine with or without bavituximab in patients with nonresectable stage IV pancreatic adenocarcinoma.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4054-4054 ◽  
Author(s):  
Shuchi Sumant Pandya ◽  
Lucas Wong ◽  
Andrea J. Bullock ◽  
Stephen A. Grabelsky ◽  
Merrill Kingman Shum ◽  
...  
Keyword(s):  
Treatment Options ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Hepatic Function ◽  
Tumor Burden ◽  
Moderate Activity ◽  
Open Label ◽  
Eligibility Criteria ◽  
First Line Therapy ◽  
Significant Difference

4054 Background: Despite advances in the treatment of metastatic pancreatic cancer (PC), there is critical need to develop novel therapies.Median survival with combination chemotherapy is limited to less than one year and only the optimally conditioned patients can tolerate these therapies. Bavituximab (B) is a monoclonal antibody (mAB) directed againstphosphatidylserine (PS) that causes vascular shutdown and reactivation of the innate and adaptive immunity in animal models. Preclinical data in mouse PC models indicate that gemcitabine (G) increases PS exposure and the addition of a mAb targeting PS reduces tumor burden, visible liver metastases, microvessel density, and increases tumor macrophage infiltration compared to G alone (Beck et al. 2006). The purpose of this trial is to evaluate and compare the efficacy and safety of the combination of G+B vs. G alone as first line therapy in pts. with nonresectable Stage IV PC. Methods: Seventy patients were randomized (1:1) to receive G 1000 mg/m2 on days 1, 8, and 15 every 28Edays with or without weekly B 3mg/kg IV until disease progression or unacceptable toxicities. Key eligibility criteria were Stage IV PC, ECOG ≤2, measurable disease, age≥18 years, total bilirubin ≤1.5xULN, and adequate renal, hematologic, and hepatic function. The primary efficacy endpoint was overall survival (OS) and secondary endpoints included overall response rate (ORR) and progression free survival (PFS). Results: Of the 70 (G/G+B 34/36) patients randomized, 67 (G/G+B 33/34) received study treatment and 63 (G/G+B 31/32) were evaluable. No significant difference was seen in age, gender, race or ECOG. At analysis 87% deaths had been reported in G and 72% in G+B group. Median OS estimate is 5.2 months for G and 5.6 months for G+B. No difference between groups was observed in PFS (median 3.9 months for G and 3.7 months for G+B). ORR was 13% for G and 28% for G+B. Most AEs were grade 1-2 and typical of exposure to G. Conclusions: In this patient population with extensive disease burdens and limited treatment options, G+B was well tolerated and demonstrated moderate activity in tumor response and survival. Clinical trial information: NCT01272791.

Treatment-related deterioration of renal function as a biomarker to predict antitumor efficacy of sunitinib in patients with metastatic renal cell carcinoma.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 502-502
Author(s):  
Hironori Fukuda ◽  
Tsunenori Kondo ◽  
Kenji Omae ◽  
Toshio Takagi ◽  
Kazunari Tanabe
Keyword(s):  
Renal Cell Carcinoma ◽  
Renal Function ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Progression Free Survival ◽  
Risk Groups ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy

502 Background: Some on-target adverse events such as hypertension or thrombocytopenia have been reported as biomarkers predicting the efficacy of sunitinib as first-line therapy for patients with metastatic renal cell carcinoma (mRCC). Decrease of renal function is a major adverse event of sunitinib. However, it remains unclear whether the degree of deterioration of renal function can predict the anti-tumor efficacy of sunitinib. We investigated the relationship between treatment-related deterioration of renal function and anti-tumor efficacy in mRCC patients treated with sunitinib. Methods: We retrospectively reviewed the medical records of mRCC patients who were treated with sunitinib for more than 3 months. Patients receiving hemodialysis before receiving sunitinib as well as those who did not undergo nephrectomy were excluded from our analysis. Renal function was evaluated by the estimated glomerular filtration rate (eGFR) calculated using the MDRD equation modified for Japanese patients. The degree of deterioration in eGFR was compared with progression-free survival (PFS). Results: Sixty-two patients were enrolled, the median age was 65 years, and 44 patients (71%) were male. The median baseline eGFR was 49.1 ml/min/1.73m2, and median decrease of eGFR was 9.9 ml/min/1.73m2. Forty-seven patients (76%) had a decreased eGFR of more than 10% compared to baseline values. The patients showing this decrease had significantly longer PFS than those who did not (PFS: 15.5 months vs. 6.1 months, respectively; p=0.001). On multivariate analysis, a decrease in eGFR of more than 10% was a significant independent factor for predicting longer PFS (hazard ratio, 0.37; 95% confidence interval, 0.17-0.83; p=0.017) as well as MSKCC risk groups and cycles of sunitinib. Conclusions: Treatment-related deterioration of renal function is a biomarker to predict better treatment efficacy for use of sunitinib during first-line therapy for patients with mRCC.

Prospective, Randomized, Multicenter, Phase III Study of Fluorouracil, Leucovorin, and Irinotecan Versus Epirubicin, Cisplatin, and Capecitabine in Advanced Gastric Adenocarcinoma: A French Intergroup (Fédération Francophone de Cancérologie Digestive, Fédération Nationale des Centres de Lutte Contre le Cancer, and Groupe Coopérateur Multidisciplinaire en Oncologie) Study

2014 ◽  
Vol 32 (31) ◽  
pp. 3520-3526 ◽  
Author(s):  
Rosine Guimbaud ◽  
Christophe Louvet ◽  
Pauline Ries ◽  
Marc Ychou ◽  
Emilie Maillard ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Line Treatment ◽  
First Line ◽  
First Line Therapy ◽  
Significant Difference ◽  
Phase Iii Study ◽  
Cancérologie Digestive ◽  
First Line Treatment

Purpose To compare epirubicin, cisplatin, and capecitabine (ECX) with fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first-line treatments in patients with advanced gastric or esophagogastric junction (EGJ) adenocarcinoma. Patients and Methods This open, randomized, phase III study was carried out in 71 centers. Patients with locally advanced or metastatic gastric or EGJ cancer were randomly assigned to receive either ECX as first-line treatment (ECX arm) or FOLFIRI (FOLFIRI arm). Second-line treatment was predefined (FOLFIRI for the ECX arm and ECX for the FOLFIRI arm). The primary criterion was time-to-treatment failure (TTF) of the first-line therapy. Secondary criteria were progression-free survival (PFS), overall survival (OS), toxicity, and quality of life. Results In all, 416 patients were included (median age, 61.4 years; 74% male). After a median follow-up of 31 months, median TTF was significantly longer with FOLFIRI than with ECX (5.1 v 4.2 months; P = .008). There was no significant difference between the two groups in median PFS (5.3 v 5.8 months; P = .96), median OS (9.5 v 9.7 months; P = .95), or response rate (39.2% v 37.8%). First-line FOLFIRI was better tolerated (overall rate of grade 3 to 4 toxicity, 69% v 84%; P < .001; hematologic adverse events [AEs], 38% v 64.5%; P < .001; nonhematologic AEs: 53% v 53.5%; P = .81). Conclusion FOLFIRI as first-line treatment for advanced gastric and EGJ cancer demonstrated significantly better TTF than did ECX. Other outcome results indicate that FOLFIRI is an acceptable first-line regimen in this setting and should be explored as a backbone regimen for targeted agents.

Progression-free survival (PFS) with maintenance treatment with bevacizumab (B) in patients with responding mCRC after first-line chemotherapy (CT) plus B.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 612-612
Author(s):  
Maria Agnese Fabbri ◽  
Fabrizio Nelli ◽  
Luca Moscetti ◽  
Enrico Cortesi ◽  
Teresa Gamucci ◽  
...  
Keyword(s):  
Maintenance Treatment ◽  
Progression Free Survival ◽  
Median Number ◽  
Forward Selection ◽  
First Line ◽  
First Line Therapy ◽  
Significant Difference ◽  
Ras Status ◽  
Few Data ◽  
Line Chemotherapy

612 Background: Maintenance treatment with B is considered an option for mCRC pts in responding pts after a first line CT + B, but few data are available on its real benefit on PFS. Methods: We collected data from a cohort of mCRC pts consecutively treated in five oncologic centers of Lazio. One-hundred-ninety-nine mCRC pts treated with first line CT + B achieving a response [partial (PR) or complete (CR)] or a stable disease (SD) were considered eligible, 117 pts had received B maintenance (BM) whereas 82 did not (noBM). The two groups were homogeneous for main characteristics. First-line therapy in the BM vs noBM group included FOLFIRI regimen (96 vs 59 pts), FOLFOX (18 vs 22 pts) and FUFA (3 vs 1 pts). K-ras status was analyzed in 115 pts with an higher percentage of wild-type (wt) in the BM group (65 vs 50 pts, p= 0.04). A CR or PR have been achieved in 65% of pts in the BM group and 61% of noBM group, while a SD was observed in 35% and 39% of pts respectively for the BM and noBM group. The median number of BM cycles administered was 7 (range 3-25). Effectiveness measures included the PFS duration. A multivariate Cox proportional hazard model was developed using stepwise regression (forward selection) Results: At a median follow-up of 18 months (1-109), the median PFS was 13 months (C.I.95%: 11-15) vs 8 months (C.I.95%: 7-10; p<0.0001, and the 1-year PFS 53% vs 28% for BM and noBM respectively. Pts with CR/PR had a mPFS of 15 months (CI 95% 12-19) vs 10 months (CI 95% 10-12) p=0.004 and a 1-year PFS of 62.6% vs 33.7% for the BM vs noBM group respectively. No difference in the 1-year PFS was observed in pts showing SD to chemotherapy and bevacizumab. The mPFS in these patients was 12 (CI 95% 10-13) vs 8 months (CI 95% 7-10, p=0.11) for the BM and noBM group respectively. The multivariate analysis did not show any difference in PFS comparing age, sex, number and site of metastasis, ECOG PS and k ras status. A significant difference in PFS was observed for response to first-line CT (CR/PR vs SD, p=0.002) and for BM vs noBM (p=0.003). Conclusions: The maintenance strategy with B shows a longer PFS in pts responding to the first line chemotherapy + B whereas for pts who achieving an SD no difference was observed.

Comparative effectiveness and resource utilization of nab-paclitaxel plus gemcitabine (nab-P+G) versus gemcitabine monotherapy (G) in first-line treatment of advanced pancreatic adenocarcinoma (PDAC) in a U.S. community oncology setting.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 429-429
Author(s):  
Fadi S. Braiteh ◽  
Manish Patel ◽  
Monika Parisi ◽  
Quanhong Ni ◽  
Si yeon Park ◽  
...  
Keyword(s):  
Supportive Care ◽  
Real World ◽  
Treatment Options ◽  
Line Treatment ◽  
First Line ◽  
Eligibility Criteria ◽  
First Line Therapy ◽  
Community Oncology ◽  
Nationally Representative ◽  
First Line Treatment

429 Background: Based on a randomized clinical trial (RCT), nab-P+G had superior overall survival (OS) compared to G for the treatment of advanced PDAC, but limited data is available comparing the effectiveness of these treatment options in a real-world setting. The objective of this study is to compare treatment patterns of patients receiving nab-P+G versus G for first-line treatment of PDAC. Methods: A retrospective cohort study was performed using fully de-identified data from a nationally representative electronic medical record platform of 1,300 community oncology physicians. Patients diagnosed with advanced PDAC between September 2013 and October 2014 who received first-line therapy with either nab-P+G or Gm were included in the analysis. We calculated the median time to treatment discontinuation (TTD) and database persistence (DP), a proxy for OS, using the Kaplan Meier method, and assessed supportive care usage with Poisson regression. Results: Out of 851 patients, 168 met eligibility criteria for the analysis (nab-P+G, n=122; G, n=46). Patients in the nab-P+G arm were younger (mean age 67.0 v 72.0; p <0.01) and mostly males (60% v 44%). Other baseline characteristics were comparable. Patients treated with nab-P+G had a statistically significant longer median TTD (3.4 v 2.2 mos; p <0.01) and median DP (8.6 v 5.3 mos; p=0.03). Patients receiving nab-P+G had fewer AEs-related to discontinuation (18% v 26%); but they utilized more doses of granulocyte-colony stimulating factor (2.02 v 0.73 doses, p<0.01), erythropoietin-stimulating agents (0.90 v 0.54, p<0.01) and steroids (7.89 v 0.58 doses, p<0.01) per 100 days compared to patients receiving G. Conclusions: Similar to the RCT comparing nab-P+G with G,patients receiving nab-P+G experienced significantly longer TTD and DP in this real-world analysis compared to patients receiving G. Additionally, patients receiving nab-P+G had fewer AEs leading to discontinuation compared to patients receiving G. More supportive care may have been used in the nab-P+G group due to longer treatment duration.

Nab-paclitaxel plus gemcitabine or plus simplified LV5FU2 as first-line therapy in patients with metastatic pancreatic adenocarcinoma: A GERCOR randomized phase II study (AFUGEM).

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 350-350 ◽  
Author(s):  
Olivier Dubreuil ◽  
Jean Baptiste Bachet ◽  
Pascal Hammel ◽  
Jerome Desrame ◽  
Aurelia Meurisse ◽  
...  
Keyword(s):  
Pancreatic Adenocarcinoma ◽  
Progression Free Survival ◽  
Phase Iii ◽  
First Line ◽  
Eligibility Criteria ◽  
First Line Therapy ◽  
Metastatic Pancreatic Adenocarcinoma ◽  
Third Line ◽  
Metastatic Sites ◽  
Ecog Ps

350 Background: Nab-paclitaxel plus gemcitabine regimen (NABGEM) became a standard in first-line patients (pts) with metastatic pancreatic adenocarcinoma (mPAC). The AFUGEM trial evaluated the efficacy and safety of nab-paclitaxel plus simplified LV5FU2 (NABFU). Methods: Main eligibility criteria were: untreated mPAC, ECOG PS≤2. Pts received nab-paclitaxel (125 mg/m2 on d1, 8 and 15) plus gemcitabine (1000 mg/m2 on d1, 8 and 15) or plus simplified LV5FU2 (leucovorin 400 mg/m2, 5FU bolus 400 mg/m2 followed by 2400 mg/m2 given as a 46-hour continuous infusion on d1 and 15), one cycle every 4 weeks in both arms, ratio 1:2, respectively. The primary end point was observed progression-free survival (PFS) rate at 4 months (m). A Fleming 2-stage design was used with a targeted (H1) 4m-PFS rate of 50% in NABFU arm and an uninteresting 35% rate (H0, unilateral alpha of 5% and power of 80%). Results: 114 pts were included: NABGEM n=39, NABFU n=75. Baseline characteristics were well balanced: median age 66 years (45-86), ≥2 metastatic sites 36.8%, ECOG PS 0-1 84.2% and 2 15.8%, at the exception of pain more frequent in the NABFU arm (38.5% vs 56.0%). In mITT population, the observed 4m-PFS rates were of 55.4% [95% CI, 45-63] in NABFU Vs 53.9% [95% CI, 39.6-67.7] in NABGEM. Disease control rates were 65% (95% CI, 53-76) and 62% (95% CI, 45-77) respectively. After a follow-up of 24.3m, median PFS were 5.9 [95% CI, 3.6-7.4] v 4.9 months [95% CI, 2.1-7.7] [HR=0.79, 95% CI: 0.52-1.20]. Grade 3-4 adverse events were more frequent in NABGEM (77% v 87%). At tumor progression, in the NABFU arm, 50 patients (66%) and then 13 patients (17%) received a second and third line of chemotherapy respectively, versus 22 patients (56%) and 6 patients (15%) in the NABGEM arm. Median OS were 11.4 [95% CI, 8.8-16.5] v 9.2 months [95% CI, 6.0-13.6] [HR=0.61, 95% CI: 0.40-0.95], respectively. The 12 and 18-months OS rates in NABFU vs NABGEM arm were 48% Vs 41% and 34% Vs 13%, respectively. Conclusions: Nab-paclitaxel plus simplified LV5FU2 appears at least as active as gemcitabine plus nab-paclitaxel in mPAC. The toxicity profile is safe and tolerable. This regimen deserves evaluation in a phase III trial. Clinical trial information: NCT01964534.

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

scholarly journals L-Asparaginase, Doxorubicin, Vincristine, and Prednisolone (LHOP) Chemotherapy as a First-Line Treatment for Dogs with Multicentric Lymphoma

Animals ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. 2199
Author(s):  
Jih-Jong Lee ◽  
Albert Taiching Liao ◽  
Shang-Lin Wang
Keyword(s):  
Clinical Stage ◽  
Progression Free Survival ◽  
Cell Phenotype ◽  
Chop Chemotherapy ◽  
First Line ◽  
Canine Lymphoma ◽  
Free Survival ◽  
Significant Difference ◽  
Multicentric Lymphoma ◽  
First Line Treatment

Cyclophosphamide exhibits the weakest therapeutic effect compared with vincristine and doxorubicin in the CHOP (C, cyclophosphamide; H, doxorubicin; O, vincristine; and P, prednisolone) chemotherapeutic protocol for the treatment of canine lymphoma. Twenty dogs with multicentric lymphoma were treated using the LHOP protocol, which used l-asparaginase in place of cyclophosphamide, and the outcomes were historically compared with those of dogs that received CHOP chemotherapy in the same institution. No significant differences were found in age (p = 0.107), body weight (p = 0.051), sex (p = 0.453), clinical stage V (p = 1), substage b (p = 0.573), T-cell phenotype (p = 0.340), overall response (p = 1), and hypercalcaemia status (p = 1) between the LHOP and CHOP groups. The adverse effects of l-asparaginase were well tolerated and self-limiting. The median PFS (progression-free survival) and median ST (survival time) in the LHOP group were 344 days (range: 28–940 days) and 344 days (range: 70–940 days), respectively. The median PFS and median ST in the CHOP group were 234 days (range: 49–1822 days) and 314 days (range: 50–1822 days), respectively. The dogs that received LHOP chemotherapy had a significantly longer PFS than the dogs that received CHOP chemotherapy (p = 0.001). No significant difference was observed in ST between the LHOP and CHOP groups (p = 0.131). Our study findings thus indicate that the LHOP protocol can be used as a first-line chemotherapeutic protocol in canine multicentric lymphoma.

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