A Real-World Experience of Mycophenolate Mofetil for Systemic Sclerosis: A Retrospective Multicenter Observational Study

Abstract Background This study aimed to evaluate the efficacy, side-effects and resistance mechanisms of first-line afatinib in a real-world setting. Methods This is a multicenter observational study of first-line afatinib in Malaysian patients with epidermal growth factor receptor (EGFR)-mutant advanced non-small cell lung cancer (NSCLC). Patients’ demographic, clinical and treatment data, as well as resistance mechanisms to afatinib were retrospectively captured. The statistical methods included Chi-squared test and independent t-test for variables, Kaplan-Meier curve and log-rank test for survival, and Cox regression model for multivariate analysis. Results Eighty-five patients on first-line afatinib from 1st October 2014 to 30th April 2018 were eligible for the study. EGFR mutations detected in tumors included exon 19 deletion in 80.0%, exon 21 L858R point mutation in 12.9%, and rare or complex EGFR mutations in 7.1% of patients. Among these patients, 18.8% had Eastern Cooperative Oncology Group performance status of 2–4, 29.4% had symptomatic brain metastases and 17.6% had abnormal organ function. Afatinib 40 mg or 30 mg once daily were the most common starting and maintenance doses. Only one-tenth of patients experienced severe side-effects with none having grade 4 toxicities. The objective response rate was 76.5% while the disease control rate was 95.3%. At the time of analysis, 56 (65.9%) patients had progression of disease (PD) with a median progression-free survival (mPFS) of 14.2 months (95% CI, 11.85–16.55 months). Only 12.5% of the progressed patients developed new symptomatic brain metastases. The overall survival (OS) data was not mature. Thirty-three (38.8%) patients had died with a median OS of 28.9 months (95% CI, 19.82–37.99 months). The median follow-up period for the survivors was 20.0 months (95% CI, 17.49–22.51 months). Of patients with PD while on afatinib, 55.3% were investigated for resistance mechanisms with exon 20 T790 M mutation detected in 42.0% of them. Conclusions Afatinib is an effective first-line treatment for patients with EGFR-mutant advanced NSCLC with a good response rate and long survival, even in patients with unfavorable clinical characteristics. The side-effects of afatinib were manageable and T790 M mutation was the most common resistance mechanism causing treatment failure.

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REAL WORLD EFFICACY OF NEVIBOLOL ACCORDING TO VARIOUS PRESCRIPTION PATTERNS IN THE OPEN, NON-CONTROLLED, PROSPECTIVE, MULTICENTER OBSERVATIONAL STUDY IN KOREA (BENEFIT-KOREA)

Journal of Hypertension ◽

10.1097/01.hjh.0000539323.72066.e0 ◽

2018 ◽

Vol 36 (Supplement 1) ◽

pp. e124

Author(s):

J. Shin ◽

B. Cho ◽

Y. Choi ◽

G. Hong ◽

H. Yoon ◽

...

Keyword(s):

Observational Study ◽

Real World ◽

Prescription Patterns ◽

Multicenter Observational Study ◽

Prospective Multicenter Observational Study

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2279. Study of Prescribing patterns and Effectiveness of Ceftolozane–tazobactam (C/T): Real-world Analysis (SPECTRA): a multi-national, multicenter observational study

Open Forum Infectious Diseases ◽

10.1093/ofid/ofz360.1957 ◽

2019 ◽

Vol 6 (Supplement_2) ◽

pp. S780-S781

Author(s):

Alex Soriano ◽

Laura Puzniak ◽

David Paterson ◽

Florian Thalhalmmer ◽

Stefan Kluge ◽

...

Keyword(s):

Clinical Trials ◽

Observational Study ◽

Real World ◽

Randomized Clinical Trials ◽

Prescribing Patterns ◽

National Study ◽

Multicenter Observational Study ◽

E Coli ◽

Source Of Infection ◽

Hospital Acquired

Abstract Background C/T has demonstrated efficacy in randomized clinical trials to treat cIAI and cUTI and recently completed a study in ventilator-associated bacterial and ventilated hospital-acquired bacterial pneumonia. The purpose of this study was to evaluate the real-world clinical use and outcomes of C/T in a multi-national study. Methods SPECTRA is a multi-national, multicenter, retrospective, inpatient, observational study of patients treated with C/T in Australia, Austria, Germany, Italy, Spain and United Kingdom. Patients admitted with greater than 48 hours of C/T treatment were included. Demographics, clinical characteristics, treatment management patterns, microbiological findings and outcomes were analyzed. Results There were 155 patients from 20 participating hospitals in 6 countries. The average age was 58.0 years (±17.8) and most were male 114 (74%). The majority 130 (84%) had at least one comorbidity, with the most common being renal impairment 87 (56%), immunocompromised 62 (40%), and diabetes 52 (34%). The majority, 94 (61%), had previous hospitalizations ≥ 6 months prior to receiving C/T, of which 29 (31%) had an ICU stay and surgeries 64 (42%). Most patients 126 (82%) received antibacterials within 30 days of receiving C/T, 61 (40%) received carbapenems and 47 (31%) received aminoglycoside. The average duration of C/T was 15 (SD12) days. The source of infection was cUTI for 31 (20%), cIAI for 19 (12%) and respiratory for 43 (28%) of C/T treated patients. Most 107 (70%) had an ID consult with an average of 7 (SD 11.3) consults. The top pathogen was Pseudomonas 124 (81%) followed by E. coli 22 (14%), with 56 (37%) having a polymicrobial infection. Over half of the patients were in the ICU 84 (55%), 58 (38%) underwent at least 1 surgery, with 65 (48%) being related to the infection, 60 (39%) had sepsis and 21 (14%) had septic shock. All-cause in hospital mortality was 16%. 30-day all-cause readmission was 12% and 6% were infection related. Conclusion Despite the complexity of the patients in this real-world analysis, most C/T patients had beneficial outcomes that are similar to results of controlled clinical trials. Disclosures All authors: No reported disclosures.

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