scholarly journals P298 Budesonide MMX versus Prednisolone for Ulcerative Colitis: Comparative outcomes from a British retrospective multi-centre study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S327-S327
Author(s):  
K Rosiou ◽  
E Ong Ming San ◽  
A Kumar ◽  
K Esquivel ◽  
S Almas ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Rectal Bleeding ◽  
Global Assessment ◽  
Hospital Admissions ◽  
Physician Global Assessment ◽  
First Line ◽  
Multi Centre Study ◽  
End Of Treatment ◽  
Significant Difference ◽  
Baseline Characteristics

Abstract Background Budesonide MMX (Cortiment) is superior to placebo for mild to moderate UC flares and has a favourable side effect profile. However, no head-to-head data with Prednisolone exist. During the COVID-19 pandemic many IBD units chose Cortiment as first line treatment for outpatients’ flares of UC. The aim of this retrospective study was to compare outcomes of Cortiment vs Prednisolone treatment for UC. Methods Hospital based prescriptions from of 3 UK IBD units were extracted from computerized pharmacy records for the time periods between 1/3/2019 – 30/6/2019 and 1/3/2020 – 30/6/2020. All adult outpatients treated with oral steroids for a flare of UC were included. Baseline data included age, sex, phenotype, IBD medications, symptoms and changes to medication at time of steroid prescription. Follow up data included need for hospital admission for acute severe ulcerative colitis, symptoms at 4 weeks and end of treatment, need for rescue Prednisolone (Cortiment group only). Primary outcome was symptomatic improvement at 4 weeks. Results The 2019 (94 patients) and 2020 (127 patients) cohorts did not differ significantly with regards to age, sex, phenotype and baseline characteristics. The proportion of Cortiment prescriptions rose significantly from 24.5% in 2019 to 70.1% in 2020 (p<0.001). At week 4 of treatment there were statistically significant differences in mean bowel frequency (3.49 in 2019 vs 5.85 in 2020, p=0.001), rectal bleeding <50% (89.7% of patients in 2019 vs 73.1% in 2020, p=0.039) and physician global assessment (39.2% of patients in remission in 2019 compared to 19.8% in 2020, p=0.045).There was no significant difference in hospital admissions, rectal bleeding and physician global assessment at end of treatment. Patients prescribed Cortiment in 2019 had similar baseline characteristics to those prescribed Cortiment in 2020. Mean bowel frequency at four weeks was significantly higher in 2020 (6.18) compared to 2019 (3.69, p=0.034), but rectal bleeding (p=0.388) and physician global assessment at week four did not differ between 2019 and 2020 (p=0.422). Rescue Prednisolone was required in 10% of Cortiment patients in 2019 vs 31.3% in 2020 (p=0.058). Conclusion Cortiment was used as the main first line steroid for UC during the pandemic to reduce the risk of adverse COVID-19 outcomes. This change in treatment was, however, associated with worse UC outcomes at 4 weeks and 31% needed rescue Prednisolone. As active IBD is associated with worse COVID-19 outcomes clinicians should carefully evaluate the choice of steroid to achieve optimal disease control and COVID-19 risk minimization.

scholarly journals Comparative Outcomes of Budesonide MMX versus Prednisolone for Ulcerative Colitis: Results from a British Retrospective Multi-Centre Real-World Study

2021 ◽  
Vol 10 (19) ◽  
pp. 4329
Author(s):  
Konstantina Rosiou ◽  
Elaine Ong Ming San ◽  
Aditi Kumar ◽  
Kim Esquivel ◽  
Saima Almas ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Rectal Bleeding ◽  
Hospital Admissions ◽  
Physician Global Assessment ◽  
Careful Evaluation ◽  
First Line ◽  
End Of Treatment ◽  
Significant Difference ◽  
Favourable Side Effect Profile ◽  
Oral Steroids

During the COVID-19 pandemic many IBD units chose Budesonide MMX (Cortiment) as the first-line treatment for flares of ulcerative colitis (UC) in outpatients for its favourable side effect profile. This retrospective study of all UC patients treated with oral steroids between 1 March 2019–30 June 2019 and 1 March 2020–30 June 2020 aimed to compare Cortiment with Prednisolone in routine clinical practice. Outcomes included the need for hospitalisation for acute severe ulcerative colitis, symptoms at four weeks and end of treatment, and the need for rescue Prednisolone. The 2019 and 2020 cohorts did not differ at the baseline. Cortiment prescriptions rose from 24.5% in 2019 to 70.1% in 2020 (p < 0.001). At week four there were significant differences between 2019 and 2020 in mean bowel frequency (3.49 vs. 5.85, p = 0.001), rectal bleeding <50% (89.7% vs. 73.1% of patients, p = 0.039), and physician global assessment (PGA) (39.2% vs. 19.8% in remission, p = 0.045). There was no significant difference in hospital admissions, rectal bleeding, and PGA at week eight. Rescue Prednisolone was required in 10% of Cortiment patients in 2019 vs. 31.3% in 2020 (p = 0.058). Active IBD is associated with worse COVID-19 outcomes prompting the careful evaluation of the choice of first-line steroid for UC, as Cortiment was associated with worse outcomes at four weeks.

scholarly journals OP0163 COMPARATIVE ANALYSIS OF ETANERCEPT BIOSIMILAR AND ORIGINATOR USE IN CLINICAL PRACTICE: DATA FROM THE GERMAN BIKER-REGISTRY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 98.1-98
Author(s):  
G. Horneff ◽  
D. Windschall ◽  
T. Hospach ◽  
S. Mrusek ◽  
M. Rühlmann ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Adverse Events ◽  
Disease Activity ◽  
Special Interest ◽  
Global Assessment ◽  
Drug Exposure ◽  
Disease Onset ◽  
Injection Site Reaction ◽  
Physician Global Assessment ◽  
First Line

Background:In 2017, 2 Etanercept biosimilars became approved. Comparative studies performed in adult patients with rheumatoid arthritis, ankylosing spondylitis or psoriasis by extrapolation led to approval for juvenile idiopathic arthritis (JIA).Objectives:So far there is limited experience with Etanercept biosimilars in JIA: The large national data base of the BIKER-registry was used to describe experience with Etanercept biosimilars in clinical practice.Methods:In this retrospective analysis patients exposed to ETA were identified in the German BIKER-registry and grouped into cohorts according to initiation of treatment after 2017, use of the originator and of biosimilars. The course of JADAS10, Physician global assessment VAS 0–100-mm, Parent/patient global assessment VAS 0–100-cm, Active joint count 0-71, truncated at 10, ESR and CHAQ-DI was analyzed. Descriptive statistics was used for demographic, clinical data, drug exposure, adverse events (AEs) and events of special interest (ESI).Results:Until 31.10.2020, 2917 JIA patients were reported to have received Etanercept. Since January 1 2017, in 39 centres treatment with Etanercept was started in 439 patients (377 (85.9%) started with the originator and 62 (14.1%) started a Biosimilar). Biosimilars were prescribed n 17 centres (44%). In 12 centres (31%), Etanercept biosimilars were used first line in 62 patients. In 17 centres (44%), 63 patients switched for the originator to a biosimilar. 3 patients reswitched from the biosimilar to the originator. 4 patient switched from a biosimilar to the originator). 22 centres (56%) had not prescribed a biosimilars so far.In not a single centre, initiation of a biosimilar was more frequent than of the originator.The patients’ characteristics and disease activity parameters were widely comparanble. Patients receiving biosimilar first line were slightly older at disease onset and had a longer disease duration. Patients receiving biosimilar first line had more often rheumatoid factor (RF) negative polyarthritis while extended oligoarthritis was more frequent in the originator cohort. In the switching cohort, more patients had extended oligoarthritis and fewer had RF negative polyarthritis and ERA JIA.No difference in disease activity parameters was noted, neither at baseline, during the course of treatment nor at last observation upon treatment. A decrease of the JADAS10 indicates improvement in both groups (Figure 1). At the time of switching, 68% had JADAS minimal disease activity (MDA) and 43% were in JASDAS remission. At month 6 and 12 these numbers increased to 74%/65% and 62%/50%.In total, 66 adverse events (AE) were reported in 45 patients upon biosimilar treatment.33 patients had 1, 5 patients 2, 5 patients had 3 and 2 reported 4 events. Adverse event of special interest were hypersensitivity n=1, injection site reaction n=1, new onset of psoriasis n=1, celiac disease n=1, Crohn‘s diesease n=1, elevated transaminases n=2, depression n=1 and disease deterioration (arthritis flare) in n=21. In 20 patients, the etanercept biosimilar was discontinued.Conclusion:This analysis is the first attempt to present a large data sample on JIA patients exposed to Etanercept biosimilars. Biosimilar were used in a minority of patients and by a minority of centers although no difference in efficacy or safety was noted from our analysis. Until today, the use of the originator is by far exceeding the use of biosimilars. The prescription of a biosimilar either first line or by switching from the originator is limited to a part of centres. Differences in efficacy between first line biosimilar users and originator users could not be observed. Also, after switching, no loss of efficacy was observed.Disclosure of Interests:Gerd Horneff Speakers bureau: Pfizer, Daniel Windschall: None declared, Toni Hospach: None declared, Sonja Mrusek: None declared, Michael Rühlmann: None declared, Ariane Klein: None declared

Effect of first-line molecular targeted agents on the efficacy of second-line bevacizumab-containing regimen for metastatic colorectal cancer.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 748-748
Author(s):  
Hiroko Hasegawa ◽  
Hiroya Taniguchi ◽  
Seiichiro Mitani ◽  
Azusa Komori ◽  
Toshiki Masuishi ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Multivariate Analyses ◽  
Second Line ◽  
Targeted Agents ◽  
First Line ◽  
Significant Difference ◽  
Prior Use ◽  
Baseline Characteristics ◽  
Molecular Targeted Agents

748 Background: Bevacizumab (BV)-containing regimen is a standard second-line chemotherapy(CTX) for patients (pts) with metastatic colorectal cancer (mCRC) regardless of the prior use of BV in the first-line CTX. However, little is known about the efficacy of the second-line BV-containing regimen after first-line CTX with anti-EGFR agents. Methods: We retrospectively evaluated the efficacy of a BV-containing regimen as the second-line CTX for mCRC. The eligibility criteria for the pts included in the study were as follows: ECOG PS 0–2, KRAS wild-type tumors, and refractory to first-line CTX with fluoropyrimidine and oxaliplatin or irinotecan from March 2007 to March 2015. The Kaplan–Meier method with a log-rank test and Cox regression analysis were performed to evaluate the progression-free survival (PFS) of the pts. Results: A total of 123 pts were eligible. The pts’ characteristics were as follows: males/females 73/50, median age 59 years, PS 0-1/2 118/5, LDH levels < 400IU/l / ≥ 400IU/l 91/32, second-line CTX regimen FOLFIRI+BV/FOLFOX+BV 111/12. The patients were categorized into the following 3 cohorts according to the prior use of molecular targeted agents: anti EGFR agents (cohort E, 35 pts), BV (cohort B, 58 pts), no molecular targeted agents (cohort C, 30 pts). There was hardly any difference in the baseline characteristics of the 3 cohorts; however, LDH levels in cohort E were higher than those in the other cohorts. Treatment efficacies were as follows (cohort E/B/C): response rate, 30%/10%/20%, with a significant difference between cohort E and B (OR = 1.50, p = 0.035) and median PFS, 8.6/5.9/6.9 months, with a significant difference between cohort E and B (p = 0.025). Multivariate analyses for PFS were adjusted for baseline characteristics such as histology, PS, chemotherapy regimen, presence of peritoneal metastasis, LDH levels, and duration of PFS in the first-line CTX. The PFS of cohort E was better than that of cohort B (HR = 2.180, p = 0.0025) and was not much different from that of cohort C (HR = 1.682, p = 0.64)in multivariate analyses. Conclusions: The second-line BV-containing regimen is effective regardless of the prior use of anti-EGFR agents.

scholarly journals P627 Change in urgency among ulcerative colitis patients: Analyses from the SPARC IBD

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S564-S566
Author(s):  
J Lewis ◽  
M Shan ◽  
X Xhou ◽  
A Naegeli ◽  
T Hunter
Keyword(s):  
Ulcerative Colitis ◽  
Well Being ◽  
Stool Frequency ◽  
Common Symptom ◽  
Physician Global Assessment ◽  
Chi Square ◽  
Bowel Movements ◽  
Urgency Symptoms ◽  
Baseline Characteristics ◽  
Fecal Urgency

Abstract Background The objective of this study was to assess the changes in prevalence and severity of fecal urgency in Ulcerative Colitis (UC) patients at 6-months from their enrollment visit. Methods Data from patients in the Study of a Prospective Adult Research Cohort with Inflammatory Bowel Disease (SPARC IBD) were analyzed. UC patients that had an enrollment visit and 6-month visit were included in these analyses. Fecal urgency at each visit was assessed on a scale ranging from 0 (none) to 4 (severe). The change in urgency status from enrollment visit to 6-months is categorized as Improvement (decrease of 1–3 points), No Change, or Worsening (increase of 1–3 points). Descriptive statistics and contingency tables were created to summarize baseline characteristics by fecal urgency group. Chi-square tests, Fisher’s exact tests, ANOVA and Wilcoxon rank sum tests were conducted to compare the distribution of baseline characteristics between change in urgency groups, with Bonferroni corrections used for multiple comparisons. Results Data from 272 UC patients were included in this analysis. 25% of UC patients had an improvement in urgency, 54.4% had no change, 20.6% had a worsening of urgency at 6-months from their enrollment visit. When compared to patients that had no change in urgency at 6-months, UC patients that had improvement in urgency were more likely to have a higher baseline UCDAI (p&lt;0.0001), mean daily bowel movements (p&lt;0.0001), mean daily liquid bowel movements (P&lt;0.0001), elevated stool frequency relative to their normal when well (p&lt;0.0001), liquid stool consistency (p=0.0418), blood in stools (p=0.0001), abdominal pain (p=0.0065), moderate/severe fecal urgency (p&lt;0.0001), worse general well-being (p&lt;0.0001), moderate/severe Physician Global Assessment (PGA) (p=0.0013), and steroid use (p=0.0287) (Table 1). When compared to patients with worsening urgency at 6-months, UC patients that had an improvement in urgency at 6-months were more likely to have a higher baseline UCDAI (p&lt;0.0001), mean daily bowel movements (p&lt;0.0001), mean daily liquid bowel movement (P&lt;0.0001), more stool frequency relative to their normal when well (p&lt;0.0001), moderate/severe fecal urgency (p&lt;0.0001), worse general well-being (p=0.0053), and moderate/severe PGA (p=0.0022). There were no statistically significant differences in baseline characteristics between UC patients that had a worsening or no change in urgency at 6-months. Conclusion Fecal urgency is a common symptom among UC patients. Urgency is not a stable symptom, with nearly 50% experiencing either worsening or improvement over 6-months. Worse disease activity at enrollment in the cohort was associated with improved fecal urgency symptoms over 6-months.

scholarly journals POS1303 EXPERIENCE WITH ADALIMUMAB BIOSIMILAR USE IN CLINICAL PRACTICE: DATA FROM THE GERMAN BIKER-REGISTRY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 933.2-934
Author(s):  
G. Horneff ◽  
F. Dressler ◽  
M. Rühlmann ◽  
T. Geikowski ◽  
S. Mrusek ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Psoriatic Arthritis ◽  
Adverse Events ◽  
Disease Activity ◽  
Special Interest ◽  
Global Assessment ◽  
Female Adolescent ◽  
Physician Global Assessment ◽  
First Line ◽  
Limited Experience

Background:In 2017, Adalimumab Biosimilars became approved. Comparative studies to the originator have been performed in adult patients with rheumatoid arthritis, ankylosing spondylitis and psoriasis and extrapolation led to approval for juvenile idiopathic arthritis (JIA).Objectives:So far there is limited experience with biosimilars in JIA: The large national data base of the BIKER-registry was used to describe experience with Adalimumab biosimilars in clinical practiceMethods:This retrospective analysis used data of the German BIKER-registry. The data basis war screened for patients exposed to Adalimumab. Subcohorts with initiation of treatment after 2017, use of the originator and of biosimilars were built. The course of JADAS10, Physician global assessment VAS 0–100-mm, Parent/patient global assessment VAS 0–100-cm, Active joint count 0-71, truncated at 10, ESR and CHAQ-DI was analyzed. Descriptive statistics was used for demographic, clinical data, drug exposure, adverse events (AEs) and events of special interest (ESI).Results:Until 31.10.2020, 1173 JIA patients were reported to have received Adalimumab. 352 treatments have been started after January 1, 2017. A biosimilar was used first line in 44 patients. Further 55 patients switched for the originator to a biosimilar. 2 patient switched from a biosimilar to the originator. 3 patients switched to a second biosimilar while 5 patients who switched from the originator to a biosimilar reswitched back to the originator.After 2017, 33 pediatric rheumatology centres reported initiation of Adalimumab treatment. 17 have used a biosimilar. 15 centres have swichted at least 1 patient from the originator to a biosimilar and 14 have used first line a biosimilar in at least 1 patient. In a single centre, initiation of a biosimilar was used more frequently (8 versus 7).The patients’ characteristics and disease activity parameters were brightly comparable. The JIA category rheumatoid factor (RF) negative polyarthritis was less frequent in the biosimilar first cohort while RF positive polyarthritis and psoriatic arthritis was more frequent. In patients with idiopathic uveitis the originator was used more often. In the switching cohort, more patients had RF negative polyarthritis, persistent oligoarthritis but less had psoriatic arthritis and no had RF positive polyarthritis.No difference in disease activity parameters between patients receiving the originator or biosimilars were noted, neither at baseline, during the course of treatment nor at last observation upon treatment (Figure 1). At the time of switching, 46 (92%) had JADAS minimal disease activity (MDA) and 30 (69%) were in JASDAS remission. At last observation, those numbers were comparable with 42 (86%) with JADAS MDA and 28 (57%) with JADAS remission.In total, 45 adverse events (AE) were reported in 45 patients upon biosimilar treatment. 26 patients had 1, 12 patients had 2 and 6 patients reported 3 and 1 reported 4 events. Adverse event of special interest were Infection associated leukopenia (n=1), COVID 19 infection (n=1), Uveitis flare (n=8), other disease deterioration (arthritis flare) (n=20), injection site reaction n=2. A single serious AE was reported. A 16 year old female adolescent was admitted for unexpected CK elevation. In 10 patients, Adalimumab was discontinued, in 2 it was temporarily paused.Conclusion:This article is the first attempt to present a large sample of data on JIA patients exposed to Adalimumab biosimilars. Since approval of Adalimumab-Biosimilars, limited experience from clinical practice is available. Biosimilars are used in a minority of patients and by a minority of centers although no difference in efficacy or safety was noted from our analysis.Disclosure of Interests:Gerd Horneff Speakers bureau: Novartis, MSD, Sobi, Grant/research support from: MSD, Roche, Frank Dressler: None declared, Michael Rühlmann: None declared, Tilmann Geikowski: None declared, Sonja Mrusek: None declared, Ariane Klein: None declared

Cisplatin-based combination chemotherapy in elderly patients with metastatic urothelial cancer.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 269-269
Author(s):  
Aristotelis Bamias ◽  
Susanne Krege ◽  
Chia-Chi Lin ◽  
Noah M. Hahn ◽  
Thorsten Ecke ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Urothelial Carcinoma ◽  
Combination Chemotherapy ◽  
Age Groups ◽  
First Line ◽  
Significant Difference ◽  
Visceral Metastases ◽  
Metastatic Urothelial Carcinoma ◽  
Baseline Characteristics ◽  
Two Age Groups

269 Background: Cisplatin-based combination chemotherapy is considered standard first-line treatment for patients with metastatic urothelial carcinoma. However, cisplatin-based chemotherapy is frequently avoided in elderly patients due to concerns regarding treatment-related toxicities. We analyzed the efficacy, and tolerability, of cisplatin-based chemotherapy in two age groups (< 70 versus ≥ 70 years old). Methods: Individual patient data was pooled from eight phase II and III trials evaluating cisplatin-based first-line chemotherapy in patients with metastatic urothelial carcinoma. Toxicities, treatment delivery, response proportions, and survival outcomes were compared between patients < 70 versus ≥ 70 years old. Results: Of the 543 patients included in the analysis, 162 patients (30%) were ≥ 70 years old. Patients ≥ 70 years old had a significantly lower baseline calculated creatinine clearance (57 vs. 73 ml/min, p<0.0001). All other baseline characteristics, including PS and visceral metastases were well balanced between the two age groups. Patients ≥ 70 years received a median of 1 cycle less of chemotherapy compared with younger patients (median cycles 5 versus 6; p = 0.004). There was no significant difference in the proportions of patients experiencing Grade 3-4 renal failure, febrile neutropenia, or treatment-related death. Response rate among patients ≥ 70 years old was 50% compared to 52% for patients < 70 years old (p=0.65). There was no significant difference in survival between the age groups (p=0.91). The median survival of the patients ≥ 70 years old was 12.1 months compared to 12.8 months for patients < 70 years old. There was no significant difference in survival between age groups when controlling for baseline performance status and/or the presence of visceral metastases. Conclusions: Elderly patients, with adequate renal function and other baseline characteristics suitable for clinical trial enrollment, tolerate cisplatin-based chemotherapy similarly, and achieve comparable clinical outcomes, compared with their younger counterparts. Cisplatin-based therapy need not be withheld from such patients.

scholarly journals Drug retention of biological DMARD in rheumatoid arthritis patients: the role of baseline characteristics and disease evolution

Rheumatology ◽  
2019 ◽  
Vol 58 (12) ◽  
pp. 2221-2229 ◽  
Author(s):  
Kim Lauper ◽  
Denis Mongin ◽  
Deshire Alpizar-Rodriguez ◽  
Catalin Codreanu ◽  
Florenzo Iannone ◽  
...  
Keyword(s):  
Global Assessment ◽  
Cox Regression ◽  
Drug Discontinuation ◽  
Physician Global Assessment ◽  
Tnf Inhibitor ◽  
Disease Evolution ◽  
Patient Reported ◽  
Discontinue Therapy ◽  
Baseline Characteristics ◽  
The Individual

Abstract Objective To examine the association of the evolution in physician-reported and patient-reported outcomes with decision to stop biological DMARDs (bDMARDs) in RA. The contribution of baseline characteristics is well established, but little is known about how the disease evolution influences the decision to discontinue therapy. Methods RA patients who initiated a bDMARD treatment from 2009 and with information on date of visit were pooled from seven European RA registers. Each outcome was divided into baseline assessments (capturing the inter-individual differences at drug initiation) and changes from baseline at subsequent visits (capturing the individual evolution). Cox regression models were used to examine their association with drug discontinuation, adjusting for baseline patient and co-therapy characteristics and stratifying by register and calendar year of drug initiation. Results A total of 25 077 patients initiated a bDMARDs (18 507 a TNF-inhibitor, 3863 tocilizumab and 2707 abatacept) contributing an amount of 46 456.8 patient-years. Overall, drug discontinuation was most strongly associated with a poor evolution of the DAS28, with a hazard ratio of 1.34 (95% CI 1.29, 1.40), followed by its baseline value. A change of Physician Global Assessment was the next strongest predictor of discontinuation, then the Patient Global Assessment. Conclusions The decision to discontinue treatments appears to be mostly influenced by DAS28 and particularly its evolution over time, followed by Physician Global Assessment evolution, suggesting that the decision to stop bDMARDs relies more on the physician’s than on the patient’s global assessment.

Efficacy and Toxicity of Addition of Bevacizumab to Chemotherapy in Patients with Metastatic Colorectal Cancer

2019 ◽  
Vol 21 (10) ◽  
pp. 718-724 ◽  
Author(s):  
Wen-Cong Ruan ◽  
Yue-Ping Che ◽  
Li Ding ◽  
Hai-Feng Li
Keyword(s):  
Colorectal Cancer ◽  
Adverse Event ◽  
Metastatic Colorectal Cancer ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Second Line Therapy ◽  
Clinical Prognosis ◽  
Line Therapy ◽  
Significant Difference

Background: Pre-treated patients with first-line treatment can be offered a second treatment with the aim of improving their poor clinical prognosis. The therapy of metastatic colorectal cancer (CRC) patients who did not respond to first-line therapy has limited treatment options. Recently, many studies have paid much attention to the efficacy of bevacizumab as an adjuvant treatment for metastatic colorectal cancer. Objectives: We aimed to evaluate the efficacy and toxicity of bevacizumab plus chemotherapy compared with bevacizumab-naive based chemotherapy as second-line treatment in people with metastatic CRC. Methods: Electronic databases were searched for eligible studies updated to March 2018. Randomized-controlled trials comparing addition of bevacizumab to chemotherapy without bevacizumab in MCRC patients were included, of which, the main interesting results were the efficacy and safety profiles of the addition of bevacizumab in patients with MCRC as second-line therapy. Result: Five trials were eligible in the meta-analysis. Patients who received the combined bevacizumab and chemotherapy treatment in MCRC as second-line therapy showed a longer overall survival (OS) (OR=0.80,95%CI=0.72-0.89, P<0.0001) and progression-free survival (PFS) (OR=0.69,95%CI=0.61-0.77, P<0.00001). In addition, there was no significant difference in objective response rate (ORR) (RR=1.36,95%CI=0.82-2.24, P=0.23) or severe adverse event (SAE) (RR=1.02,95%CI=0.88-1.19, P=0.78) between bevacizumab-based chemotherapy and bevacizumabnaive based chemotherapy. Conclusion: Our results suggest that the addition of bevacizumab to the chemotherapy therapy could be an efficient and safe treatment option for patients with metastatic colorectal cancer as second-line therapy and without increasing the risk of an adverse event.

scholarly journals The impact of COVID-19 infection on hip fracture 30-day mortality

Trauma ◽  
2021 ◽  
pp. 146040862094972
Author(s):  
Ahmed Fadulelmola ◽  
Rob Gregory ◽  
Gavin Gordon ◽  
Fiona Smith ◽  
Andrew Jennings
Keyword(s):  
Hip Fracture ◽  
Hip Fractures ◽  
Hospital Admissions ◽  
The Elderly ◽  
Primary Outcome Measure ◽  
Time To Death ◽  
Significant Difference ◽  
The Mean ◽  
The Impact ◽  
Mean Time

Introduction: A novel virus, SARS-CoV-2, has caused a fatal global pandemic which particularly affects the elderly and those with comorbidities. Hip fractures affect elderly populations, necessitate hospital admissions and place this group at particular risk from COVID-19 infection. This study investigates the effect of COVID-19 infection on 30-day hip fracture mortality. Method: Data related to 75 adult hip fractures admitted to two units during March and April 2020 were reviewed. The mean age was 83.5 years (range 65–98 years), and most (53, 70.7%) were women. The primary outcome measure was 30-day mortality associated with COVID-19 infection. Results: The COVID-19 infection rate was 26.7% (20 patients), with a significant difference in the 30-day mortality rate in the COVID-19-positive group (10/20, 50%) compared to the COVID-19-negative group (4/55, 7.3%), with mean time to death of 19.8 days (95% confidence interval: 17.0–22.5). The mean time from admission to surgery was 43.1 h and 38.3 h, in COVID-19-positive and COVID-19-negative groups, respectively. All COVID-19-positive patients had shown symptoms of fever and cough, and all 10 cases who died were hypoxic. Seven (35%) cases had radiological lung findings consistent of viral pneumonitis which resulted in mortality (70% of mortality). 30% ( n = 6) contracted the COVID-19 infection in the community, and 70% ( n = 14) developed symptoms after hospital admission. Conclusion: Hip fractures associated with COVID-19 infection have a high 30-day mortality. COVID-19 testing and chest X-ray for patients presenting with hip fractures help in early planning of high-risk surgeries and allow counselling of the patients and family using realistic prognosis.

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