scholarly journals Association of remdesivir with poor clinical outcomes in Covid-19

2021 ◽  
Author(s):  
Rajat Ranka ◽  
Arjun ◽  
Prasan Kumar Panda ◽  
Yogesh Arvind Bahurupi ◽  
Gaurav Chikara ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Clinical Trials ◽  
Clinical Outcomes ◽  
Cox Regression ◽  
Statistical Significance ◽  
Real Life ◽  
North India ◽  
P Value ◽  
Clinical Recovery ◽  
The World

Abstract Introduction: Need of an antiviral against Covid-19 prompted clinical trials all over the world and based on initial promising trends, remdesivir was widely used all over the world, including India (compassionate use). Subsequent trials have been conflicting in their results and the utility of the drug has been widely debated. Methods: This is a record-based retrospective cohort study carried out in a 1000-bedded government teaching hospital in North India. The medical e-records of the Covid-19 positive patients who were admitted between June and November 2020 were reviewed for eligibility. After making the necessary exclusions, 112 patients were included in the remdesivir cohort and 85 in the standard care cohort. All the baseline characteristics of relevance and details of hospital admission were collected. The following outcomes in relation to remdesivir administration were assessed: all-cause mortality until discharge – stratified as per baseline oxygen support, age, gender and comorbidities; proportion of severe and non-severe patients progressing to mechanical ventilation later on; and time to clinical recovery in survivors. Results: There was a statistically significant association of higher mortality with the administration of remdesivir (odds ratio, OR 2.3, p-value 0.008) with a Cox regression hazard ratio of 1.590 (CI 0.944–2.679). The trend towards poorer outcomes in the remdesivir cohort persisted even after sub-stratification for age, gender, baseline severity (oxygen need) and comorbidities but failed to reach statistical significance in most of the strata. Similarly, remdesivir administration was associated with higher rates of progression to mechanical ventilation amongst those severe and non-severe patients who were not on mechanical ventilation at admission (49 % versus 15 %, p-value < 0.001, OR 5.2). This association was significant overall as well as for severe category patients when assessed separately (56% versus 26 %, p-value 0.04, OR 3.1). There was, however, no difference in the days taken for clinical recovery between the two groups (13.23 days versus 12.8 days, p-value 0.77). Conclusion: Remdesivir administration was associated with overall worse clinical outcomes. This study contradicts the benefits shown with remdesivir in previous clinical trials done in controlled settings and highlights the challenges that newer therapies face in real life hospital settings. There is a need to include diverse ethnic groups in the future clinical trials of the drug if to be used.

Impact of Hybrid Operating Rooms on Long-Term Clinical Outcomes Following Fenestrated and Branched Endovascular Aortic Repair

2021 ◽  
pp. 152660282199672
Author(s):  
Giovanni Tinelli ◽  
Marie Bonnet ◽  
Adrien Hertault ◽  
Simona Sica ◽  
Gian Luca Di Tanna ◽  
...  
Keyword(s):  
Operating Room ◽  
Clinical Outcomes ◽  
Cox Regression ◽  
Statistical Significance ◽  
Aortic Aneurysms ◽  
Study Patient ◽  
Cox Regression Analysis ◽  
Significant Difference ◽  
The Impact

Purpose: Evaluate the impact of hybrid operating room (HOR) guidance on the long-term clinical outcomes following fenestrated and branched endovascular repair (F-BEVAR) for complex aortic aneurysms. Materials and Methods: Prospectively collected registry data were retrospectively analyzed to compare the procedural, short- and long-term outcomes of consecutive F-BEVAR performed from January 2010 to December 2014 under standard mobile C-arm versus hybrid room guidance in a high-volume aortic center. Results: A total of 262 consecutive patients, including 133 patients treated with a mobile C-arm equipped operating room and 129 with a HOR guidance, were enrolled in this study. Patient radiation exposure and contrast media volume were significantly reduced in the HOR group. Short-term clinical outcomes were improved despite higher case complexity in the HOR group, with no statistical significance. At a median follow-up of 63.3 months (Q1 33.4, Q3 75.9) in the C-arm group, and 44.9 months (Q1 25.1, Q3 53.5, p=0.53) in the HOR group, there was no statistically significant difference in terms of target vessel occlusion and limb occlusion. When the endograft involved 3 or more fenestrations and/or branches (complex F-BEVAR), graft instability (36% vs 25%, p=0.035), reintervention on target vessels (20% vs 11%, p=0.019) and total reintervention rates (24% vs 15%, p=0.032) were significantly reduced in the HOR group. The multivariable Cox regression analysis did not show statistically significant differences for long-term death and aortic-related death between the 2 groups. Conclusion: Our study suggests that better long-term clinical outcomes could be observed when performing complex F-BEVAR in the latest generation HOR.

MO368THE INCIDENCE AND RISK FACTORS FOR ACUTE KIDNEY INJURY IN PATIENTS TREATED WITH IMMUNE CHECKPOINT INHIBITORS: A REAL-LIFE STUDY

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Deniz Can Güven ◽  
Deniz Aral Ozbek ◽  
Taha Koray Sahin ◽  
Melek Seren Aksun ◽  
Gozde Kavgaci ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Clinical Trials ◽  
Kidney Disease ◽  
Immune Checkpoint Inhibitors ◽  
Multivariate Analyses ◽  
Checkpoint Inhibitors ◽  
Statistical Significance ◽  
Real Life ◽  
Kidney Injury

Abstract Background and Aims The immune checkpoint inhibitors (ICIs) became a vital part of cancer treatment. The ICIs seem to be safer than chemotherapy for kidneys in clinical trials. However, recent observational studies from high-resource settings pointed out the possible underreporting of renal adverse events like acute kidney injury (AKI) in the clinical trials due to focusing only to the renal immune-related adverse events. Additionally, clinical trials generally enroll a fitter population with lesser comorbidities and include mostly treatment-naive patients making studies in real-life cohorts imperative for evaluating the AKI rates during ICI treatment. From these points, we aimed to evaluate the AKI rates and predisposing factors in ICI-treated patients. Method This retrospective study has evaluated the data of adult metastatic cancer patients treated with ICIs in Hacettepe University Cancer Center from 01.2014 to 12.2019. All patients other than the ones treated within the context of clinical trials or followed in other institutions after the first dose of ICIs were included. Baseline demographics, cancer types, patient weight and heights, ICI type and the number of cycles, serum creatinine and the estimated GFR values under treatment, regular medications, and comorbidities were recorded. AKI was defined by Kidney Disease Improving Global Outcomes criteria. The predisposing factors to AKI development were evaluated with the univariate and multivariate analyses. Results A total of 147 patients were included in the analyses. Median age was 61 [interquartile range (IQR) 51-67], and 69.4% of the patients were male. Patients were given a median of 8 (IQR 5-17) ICI cycles. Patients with melanoma (24.5%), non-small cell lung cancer (15%), and renal cell carcinoma (25.9%) comprised almost 2/3 of the cohort and 72.8% of the patients were treated with nivolumab. Hypertension was the most common comorbidity (38.1%), followed by chronic kidney disease (21.2%) and type 2 diabetes (19.7%). Median Charlson Comorbidity Index (CCI) was 8 (7-9). Median follow-up was 10.3 (IQR 6.3-19.4) months, and patients had median 9 (IQR 5-18) serum creatinine measurements. During the follow-up, 28 patients (19%) had at least one AKI episode with multiple AKI episodes in 3 patients (10.7%). The median time to AKI development was 2.53 (IQR 1.39-6.19) months. Almost all AKI events were mild (grade 1 or 2 in 27/28) and reversible (25/28). In univariate analyses, coronary artery disease (CAD) (p=&lt;0.001), chronic kidney disease (CKD) (p=0.002), previous nephrectomy (p=0.015), iodinated contrast exposure in the week before immunotherapy (p=0.035), the use of renin-angiotensin-aldosterone system inhibitors (p=0.046) or proton pump inhibitors (PPI) (p=0.041) was associated with an increased AKI risk. The association between diabetes (p=0.067), higher CCI (9 vs. ≥9, p=0.107), baseline lactate dehydrogenase levels (p=0.177), and performance status (ECOG 0 vs. ≥1, p=0.235) and AKI risk did not reach statistical significance. In multivariate analyses, patients with CKD (OR: 3.719, 95% CI: 1.375- 10.057, p=0.010) or CAD (OR: 4.774, 95% CI: 1.803- 12.641, p=0.002) had increased AKI risk. Additionally, regular PPI use (OR: 2.734, 95% CI: .991- 7.542, p=0.052) had borderline statistical significance for AKI development. The development of AKI was not associated with decreased survival (HR: 0.726, 95% CI: 0.409-1.291, p=0.276). Conclusion In this study, we observed AKI development under ICIs in almost one in five cancer patients. The increased AKI rates in patients with CAD, CKD, or regular PPI use pointed out the need for better onco-nephrology collaboration in all ICI-treated patients, with a particular emphasis in these high-risk patients.

scholarly journals Clinical evaluation of pregnant women with SARS-COV2 pneumonia: a real-life study from Egypt

2021 ◽  
Vol 96 (1) ◽  
Author(s):  
Samy Zaky ◽  
Hossam Hosny ◽  
Gehan Elassal ◽  
Noha Asem ◽  
Amin Abdel Baki ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Cohort Study ◽  
Pregnant Women ◽  
Clinical Outcomes ◽  
Clinical Evaluation ◽  
Real Life ◽  
Life Study ◽  
Significant Difference ◽  
Real Life Study ◽  
Special Category

Abstract Background Knowledge about the outcome of COVID-19 on pregnant women is so important. The published literature on the outcomes of pregnant women with COVID-19 is confusing. The aim of this study was to report our clinical experience about the effect of COVID-19 on pregnant women and to determine whether it was associated with increased mortality or an increase in the need for mechanical ventilation in this special category of patients. Methods This was a cohort study from some isolation hospitals of the Ministry of Health and Population, in eleven governorates, Egypt. The clinical data from the first 64 pregnant women with COVID-19 whose care was managed at some of the Egyptian hospitals from 14 March to 14 June 2020 as well as 114 non-pregnant women with COVID-19 was reviewed. Results The two groups did not show any significant difference regarding the main outcomes of the disease. Two cases in each group needed mechanical ventilation (p 0.617). Three cases (4.7%) died among the pregnant women and two (1.8%) died among the non-pregnant women (p 0.352). Conclusions The main clinical outcomes of COVID-19 were not different between pregnant and non-pregnant women with COVID-19. Based on our findings, pregnancy did not exacerbate the course or mortality of COVID-19 pneumonia.

Role of ctDNA to predict risk of recurrence following potentially curative resection of biliary tract and pancreatic malignancies.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 336-336
Author(s):  
Angela Lamarca ◽  
Mairead Geraldine McNamara ◽  
Richard Hubner ◽  
Juan W. Valle
Keyword(s):  
Relapse Rate ◽  
Curative Resection ◽  
Cox Regression ◽  
Statistical Significance ◽  
Molecular Profiling ◽  
P Value ◽  
Relapse Risk ◽  
Baseline Characteristics

336 Background: The potential role of ctDNA to identify residual disease after potentially curative resection has been suggested in some malignancies; its role in resected pancreatico(P)-biliary(B) malignancies is unknown. Methods: Patients diagnosed with PB malignancies underwent molecular profiling (ctDNA) using FoundationMedicine Liquid (72 cancer-related genes) following potentially curative resection. Baseline patient characteristics and molecular profiling outcomes, including mutant allele frequency (MAF) for pathological alterations were extracted. Primary objective: prevalence of ctDNA identification and its correlation with recurrence (relapse-free survival (RFS) and relapse rate). Results: Total of 11 individuals had ctDNA analysed following potentially curative resection for PB malignancies: 8 B (4 extra-hepatic cholangiocarcinoma (eCCA), 2 ampulla, 1 intrahepatic cholangiocarcinoma (iCCA), 1 gallbladder cancer (GBC)) and 3 P. Baseline characteristics: 6 female (54.55%), median age 71.59 years (range 39.98-81.19). Most were pT2 (45.45%), pN0 (54.55%) and R0 (63.64%). Following surgery, 6 patients were started on adjuvant chemotherapy; at the end of follow-up (data cut-off 25/6/2020; median follow-up 11.15 months (range 5.45-13.52); 5 relapsed (45.45%) and 2 died (18.18%). Estimated median RFS was 11.43 months (95% CI 2.28-not reached); median overall survival was not reached. No sample failed ctDNA analysis; presence of ctDNA was identified in 3/11 (27.27%) of the samples; 2 and 1 samples had 2 and 1 pathological alterations identified, respectively: ALK fusion (1 sample; GBC), TP53 mutation (2 samples; eCCA and GBC), CHEK2 mutation (1 sample; pancreas), IDH2 mutation (1 sample; eCCA). Mean maximum MAF was 1.47 (2 in biliary; 0.43 in pancreas). Variants of unknown significance were identified in 72.73% of the samples (87.5% in B; 33.33% in P; p-value 0.152). None of the baseline characteristics explored correlated with presence of ctDNA. There was a trend towards increased relapse risk in the patients with ctDNA present following potentially curative surgery; Cox regression for RFS [HR 2.64 (95% CI 0.36-19.31); median RFS 11.44 months (95% CI 2.28-not reached) vs 10.87 (95% CI 2.21-not reached)]; relapse rate 37.5% (ctDNA absent) vs 66.67% (ctDNA present); statistical significance was not reached (p-value 0.340 and p-value 0.545, respectively). Conclusions: This pilot study demonstrates the feasibility of testing for ctDNA following potentially curative resection in PB malignancies. Presence of ctDNA may be associated with increased relapse risk; further studies are required to increase sample size and assess clinical implications.

Clinical Outcome of Patients with Venous Thromboembolism and Recent Major Bleeding: Findings from a Prospective Registry (RIETE).

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 708-708
Author(s):  
Manuel Monreal ◽  
José Nieto ◽  
Ana de Tuesta ◽  
Pablo Marchena ◽  
Gregorio Tiberio ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Venous Thromboembolism ◽  
Clinical Outcome ◽  
Clinical Outcomes ◽  
Major Bleeding ◽  
Bleeding Complications ◽  
P Value ◽  
Minor Bleeding ◽  
Fatal Bleeding ◽  
Overall Mortality

Abstract Introduction Patients who have experienced a recent major bleeding episode are usually excluded from clinical trials of venous thromboembolism (VTE) treatment. Therefore, recommendations based on evidence from clinical trials of VTE treatment may not be optimal for these patients. The Registro Informatizado de la Enfermedad TromboEmbólica (RIETE), initiated in March 2001, is a multicenter, observational registry gathering data on VTE treatment practices and clinical outcomes in patients with objectively confirmed, symptomatic, acute VTE. The aim of this analysis was to study outcomes in patients with VTE who had experienced major bleeding <30 days prior to VTE diagnosis. Methods Patients with objectively confirmed symptomatic acute VTE are consecutively enrolled into the RIETE registry. Patients are excluded if they are participating in a therapeutic clinical trial or not available for 3-months follow-up. Patient characteristics, details of antithrombotic therapy, and clinical outcomes at 3-months are recorded. Results Of 6361 patients enrolled up to January 2004, 170 (2.7%) had experienced recent major bleeding prior to VTE diagnosis: 69 (40.6%) gastrointestinal tract; 60 (35.3%) intracranial; 41 (24.1%) other. More patients with recent major bleeding had cancer compared with those without recent major bleeding (26.4% vs 20.4%, respectively; p=0.05). More patients who experienced recent major bleeding had undergone surgery <2 months prior to enrollment or had immobility ≥4 days. The incidences of recurrent PE and minor, major, and fatal bleeding complications were also higher in patients who had experienced recent major bleeding (table 1). Patients with recent major bleeding and cancer had an increased incidence of major bleeding compared to those without cancer (20.0% vs. 2.4%, respectively; OR 10.0; 95% CI 2.3–50.0; p<0.001); 11.0% of patients who had recent major bleeding prior to VTE diagnosis and cancer experienced fatal PE compared with none in patients who had recent major bleeding but without cancer (OR 4.1; 95% CI 4.98–17; p<0.05). Conclusion Patients with VTE and recent major bleeding prior to VTE diagnosis (2.7% of total enrolled patients) had poorer clinical outcomes, in terms of bleeding complications, fatal PE and overall mortality compared with those who had not experienced recent major bleeding. In patients who had recent major bleeding prior to VTE diagnosis, those with cancer had a poorer clinical outcome than those without cancer. Table 1. Clinical outcome of enrolled patients 3-month outcome Recent major bleeding No recent major bleeding OR (95% CI) p value n (%) n=170 n=6191 Fatal bleeding 7 (4.1) 41 (0.6) 6.4 (2.6-15) <0.001 Major bleeding 12 (7.1) 146 (2.3) 3.1 (1.6-5.9) 0.001 Minor bleeding 12 (7.1) 172 (2.8) 2.6 (1.4-5.0) <0.005 Fatal (initial) PE 1 (0.6) 14 (0.2) 2.6 (0.2-19) NS Fatal (recurrent) PE 4 (2.4) 33 (0.5) 4.5 (1.3-14) <0.05 Recurrent VTE 8 (4.7) 184 (2.9) 1.6 (0.7-3.4) NS Overall mortality 25 (15.0) 479 (7.7) 2.1 (1.3-3.2) <0.005

Medical oncologists’ skill and understanding of epidemiology and statistical principles need to be strengthened to maximize their use of clinical trial results

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6139-6139
Author(s):  
K. R. Hoffman
Keyword(s):  
Clinical Trials ◽  
Absolute Risk ◽  
Statistical Significance ◽  
Current Treatment ◽  
Forest Plot ◽  
P Value ◽  
Medical Oncologists ◽  
Treatment Data ◽  
Survival Plot ◽  
Sensitivity Specificity

6139 Background: Clinical oncologic practice is based on evaluating data from studies whose results are statistically defined, increasingly from interim analyses. How well the practicing oncologist understands the correct use of these statistical and epidemiologic methods is unknown. Methods: Twenty (20) board-certified community based medical oncologists agreed to take a ninety minute, twenty-five question exam on epidemiology and statistics to test their competence in evaluating current treatment data. This test was based on abstracts and articles presented within the last three years and basic statistical and epidemiology concepts taught to second-year medical students Results: Only 11/20 oncologists had a passing grade of 70% (range 92–24%, mean 72%). The recognition of different phased clinical trials was correctly identified by 17/20 doctors. While the identification between a retrospective vs. prospective study was perfect, only 7/20 respondents correctly identified what information can be obtained from a retrospective study. 11/20 respondents correctly explained a ‘p‘ value. Correct calculations and explanations of the sensitivity, specificity, positive and negative predictive value of screening test ranged between 8/20 and 13/20. The importance of a study’s sample size in defining statistical ‘significance‘ was recognized by 9/20 respondents. Only 5/20 oncologists could explain a ‘hazard ratio‘ while14/20 correctly found survival information off of a Kaplan-Meier survival plot. Only10/20 correctly explained a ‘forest plot.‘ Most doctors knew ‘incidence‘ and ‘prevalence‘ but not ‘lead time bias.‘ The identification of ‘absolute risk‘ vs. ‘relative risk‘ (6/20) and understanding the concept of a ‘Type I‘and ‘Type 2‘ error was poor (8/20). After completion of the exam all respondents agreed that CME opportunities in this field would be very helpful. Conclusions: A confirmatory study should be done. In the meantime, there seems to be a need to improve the competence of the practicing oncologist in evaluating data and clinical trials. ASCO should include this topic in future free (not ticketed) educational symposiums at our national meetings and as part of their regional programs. No significant financial relationships to disclose.

Hand–foot skin reaction, an anticipated dermatologic toxicity to pazopanib, with an unexpected low incidence: A systematic review of literature and meta-analysis.

2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 365-365 ◽  
Author(s):  
Y. Balagula ◽  
S. Wu ◽  
X. Su ◽  
M. E. Lacouture
Keyword(s):  
Clinical Trials ◽  
Tyrosine Kinases ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Statistical Significance ◽  
P Value ◽  
High Grade ◽  
Multikinase Inhibitor ◽  
Systematic Analysis ◽  
Dermatologic Toxicity

365 Background: Pazopanib is a novel multikinase inhibitor that has been approved for the treatment of advanced renal cell carcinoma (RCC). It shares a similar spectrum of target receptors with sorafenib and sunitinib, including VEGFR, PDGFR, and c-kit tyrosine kinases. We have performed a systematic analysis to investigate the risk of HFSR to pazopanib. Exploring the differences in the incidence of HFSR between sorafenib, sunitinib, and pazopanib may offer additional insights into underlying mechanisms of this toxicity. Methods: Relevant studies were identified from PubMed (1998-2010) and abstracts presented at the American Society of Clinical Oncology Conferences between 2004 and 2010. Eligible studies were limited to prospective phase II-III clinical trials in which cancer patients were treated with pazopanib 800 mg orally once daily. Incidence, relative risk (RR), and 95% confidence intervals were calculated using random-effects or fixed-effects models based on the heterogeneity of included studies. Results: A total of 942 patients from 10 prospective clinical trials were included in the analysis. The overall incidence of all-grade and high-grade HFSR was 4.5% (95% CI: 2.5-7.9%) and 1.5% (95% CI: 0.7-3.1 %), respectively. The relative risks of all-grade and high-grade HFSR to pazopanib monotherapy in comparison with controls were increased, reaching statistical significance for all-grade (RR=6.05, 95% CI: 1.11-33.12, p=0.038), but not for high-grade (RR=2.51, 95% CI: 0.12-51.9, p=0.55). The incidence of all-grade HFSR was significantly higher in patients with RCC as compared to patients with non-RCC malignancies (7.8% vs. 2.4%, p value=0.015). Conclusions: Despite sharing the same spectrum of target receptors with sorafenib and sunitinib, pazopanib is associated with an unexpectedly low risk of HFSR. Further investigations are needed to elucidate HFSR pathogenesis. [Table: see text]

Nab-paclitaxel (Nab-P) and gemcitabine (G) as first-line chemotherapy (CT) in advanced pancreatic cancer (APDAC) elderly patients (pts): A “real-life” study.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 424-424 ◽  
Author(s):  
Guido Giordano ◽  
Vanja Vaccaro ◽  
Eleonora Lucchini ◽  
Gianna Musettini ◽  
Paola Bertocchi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cox Regression ◽  
Performance Status ◽  
Advanced Pancreatic Cancer ◽  
Real Life ◽  
Median Number ◽  
World Population ◽  
Toxicity Profile ◽  
First Line ◽  
Clinical Records

424 Background: Nab-P and G represents a standard of care in first line APDAC treatment. Neverthless, activity, efficacy and safety of Nab-P + G have not been established in elderly pts and clinical trials on APDAC treatment contain fewer elderly pts compared with everyday clinical practice. Aim of this analysis is to evaluate outcomes and toxicities of elderly pts treated with first line Nab-P + G in a “real world” population. Methods: Clinical records of APDAC pts receiving Nab-P 125 mg/m2 and G 1000 mg/m2on days 1,8 and 15 of a 28 day cycle as first line CT were retrospectively reviewed, investigating activity (Disease Control Rate, DCR: Stable Disease + Partial Response + Complete Response, SD+PR+CR), efficacy (Progression Free Survival, PFS and Overall Survival, OS) and safety. Analysis was then performed in ≥ 70 years group of pts. OS and PFS were estimated with Kaplan-Meyer method with 95% CI. Cox-regression model was applied to the data with univariate and multivariate approach. Results: 105 pts (M/F:58/47), median age 64 (range 37-77) ECOG Performance Status of 0/1/2: 46/41/17 respectively were included in our analysis. 37 pts (35%) were ≥ 70 years old. In overall population Nab-P+G was administered for a median number of 6 cycles (range 1-12). 4 CR, 24 PR and 28 SD were observed (DCR: 53%), median PFS was 7 months (95% C.I. 5.93 - 8.08) and median OS was 11 months (95% C.I. 9.58 – 12.41). Pts aged ≥ 70 received a median number of 5 cycles (range 1 - 10). DCR was 48% (9 PR + 9 SD) with no differences in PFS (6.5 months, 95%C.I. 5.36 – 7.64, p=0.49) and OS (10 months, 95% C.I. 8.53 – 11.47 p=0.67) with < 70 years old pts. Treatment was mildly tolerated and toxicity profile appeared to be different in elderly pts than younger ones with more G3-4 non-haematological (27% vs 15% p=0.03) and fewer haematological (12% vs 29% p=0.004) events respectively. Conclusions: These data, evaluated under daily practice conditions, in absence of clinical trials on APDAC elderly pts, show that pts aged ≥ 70 may benefit of first-line Nab-P and G combination, as well as younger ones, both in terms of response and survival experiencing a tolerable, but significantly different toxicity profile.

Clinical outcomes of elderly patients with esophageal cancer treated with chemoradiotherapy in the modern era.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 174-174
Author(s):  
Cai Xu ◽  
Mian Xi ◽  
Amy Moreno ◽  
Yutaka Shraishi ◽  
Ritsuko Komaki ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Elderly Patients ◽  
Clinical Outcomes ◽  
Concurrent Chemoradiotherapy ◽  
Statistical Significance ◽  
Concurrent Chemotherapy ◽  
P Value ◽  
Thoracic Esophageal Cancer ◽  
Grade 3 ◽  
Modern Era

174 Background: The optimal treatment approach is not clearly defined for elderly patients with esophageal cancer. We retrospectively analyzed the clinical outcomes of elderly patients ≥ 80 years old treated at a single institution in the modern era. Methods: Patients 80 years or greater with thoracic esophageal cancer who were treated consecutively with conventional modern radiotherapy (intensity-modulated radiation therapy or proton beam therapy) and concurrent chemotherapy between 2004 and 2016 were identified and included in this study. The one patient who had surgery was excluded. Toxicity was assessed using the CTCAE v.4.0. The rates of overall survival (OS) and recurrence free survival (RFS) were calculated with the Kaplan-Meier method. A p-value less than 0.05 indicated statistical significance. Results: Of the 1617 patients, 47 patients met the eligibility criteria. The median age was 81 years (range, 80-92 years). Most patients had some comorbid illnesses, with 81%, 9%, and 11% of patients having some cardiac, pulmonary, or diabetic related diseases, respectively. Twelve of 47 patients (26%) were given induction chemotherapy. The median dose was 50.4 Gy (range, 45 Gy-50.4 Gy). The clinical complete rate was 86%. With a median follow-up of 18 months (ranges, 1.9-117.6 months), the 2-year and 5-year OS was 54.5% and 27.7%, respectively, and the 2-year RFS was 63.6%. Three patients (6.4%) developed grade 3-5 radiation pneumonitis, with 2 (4.2%) being grade 5. Eighteen patients (38%) developed grade 1 pleural effusion, and 1 was grade 3. Three patients had grade 2 arrhythmia. Six patients had grades 1-2 pericardial effusion. One patient died from myocardial infarction. Four (9%) patients developed ≥ grade 3 esophagitis, with 7 patients having grade 3 esophageal stricture. Conclusions: The treatment of esophageal cancer patients 80 years or older with concurrent chemoradiotherapy was associated with an acceptable disease outcome, but the acute and late toxicities were higher than expected, which may be due to accompanying comorbidities. More research is needed to validate our observations and to better select patients who can optimally benefit from concurrent chemoradiotherapy.

scholarly journals Treatment Burden in Patients with Multiple Myeloma According to Comorbidity

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4775-4775
Author(s):  
Ernesto Pérez Persona ◽  
Ariane Unamunzaga Cilaurren ◽  
Ana Vega Gonzalez de Viñaspre ◽  
Itziar Oiartzabal Ormategui ◽  
Ana Santamaría Lopez ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Conflicts Of Interest ◽  
Real Life ◽  
Progression Free Survival ◽  
P Value ◽  
Treatment Burden ◽  
Newly Diagnosed ◽  
Free Survival ◽  
Time To Death

Abstract Introduction: Over the last few years, novel agents-based combinations have been incorporated into the treatment of MM patients, particularly in relapse setting. However, these novel combinations have been evaluated in clinical trials and patients included represent a selected population. Patients in real life are usually older with comorbidities and disabilities and not allowed to be included in the trials, so, in real setting, is expected worse outcomes and shorter survival. The information about treatment burden in real life is scarce. The aim of our study was to analyze the outcome of MM patients in the real life outside clinical trials, in terms of treatment lines in a single institution setting, and to analyze the influence of comorbidities on the treatment burden. Material and methods: Medical records of MM patients treated at Txagorritxu hospital (Spain) between 2009 and January 2017 were retrospectively evaluated with the aim of mapping the course of patients as well as to investigate the factors that influence treatment-decisions at different stages of the disease. Results: 176 patients with MM were diagnosed from jan-2009 to jan-2017. Baseline patient's characteristics are presented in Table 1. The median age at diagnosis was 71 years (range 33.2-93), main of the patients where non-transplant eligible newly diagnosed MM (NTENDMM): 114 (65%). With a median follow-up of 25 months, 90.6% of newly diagnosed MM patients transplant-eligible (TENDMM) remain alive versus 65% NTENDMM patients (p value: 0.000)(figure 1). Overall, patients received a median of 2 lines of treatment, it should be noted that 86% of patients had received 3 or less lines of treatment and only 14% of the patients could receive more than 3 lines of therapy. To better evaluate treatment burden, we focused on deceased patients. At the time of analysis, 19% of TENDMM (12 patients) and 51.4% of in NTENDMM (57 patients) has died with a median time to death of 29.6 months and 18 months to death, respectively. Median lines of therapy for death patients TENDMM was 3.5 (range 1-8), with a 75 percentile of 5 lines of therapy, by contrast, death NTENDMM patients received a median of 2 lines of therapy (range: 1-6), with an 80 percentile of 3 lines of therapy (figure 2). In order to evaluate the influence of comorbidities in treatment burden for NTENDMM patients, CIRS score was estimated retrospectively. Median CIRS score was 5.5 (1-19). CIRS scale did not predict progression free survival (PFS) among the different groups: CIRS <4: 23.4 months; CIRS4-8: 25.1 months and CIRS> 8: 30.6 months (p: 0.819), however, interestingly CIRS scale predicted overall survival (OS): CIRS <4: 48 moths; CIRS4-8: 50.8 months and CIRS> 8: 12.3 months, (p: 0.012) (figure 2). Analyzing treatment burden for each CIRS score group 63% of patients with CIRS> 8 received only one line of treatment before death, compared to 39.5% and 37.5% of patients with CIRS4-8 and CIRS <4, respectively. Conclusion: Although the impressive progress in the management of relapse/refractory MM patients in recent years, half of the patients, particularly those not suitable to received an autologous transplant, will be able to received only 2 lines of treatment before dying. In fact, an adequate comorbidity assessment could select patients that will only need only one line of treatment. To the best of our known, this is the first study that correlate treatment burden according to comorbidities at diagnostic. This study could guide strategies adapted according to the comorbidity of the patients. Disclosures No relevant conflicts of interest to declare.

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