P1.16-07 Real World Evidence of the Impact of Immunotherapy in Patients with Advanced Lung Cancer

BackgroundSodium-glucose cotransporter-2 inhibitors (SGLT2i) have been associated with increased occurrence of Fournier’s gangrene (FG), a rare but serious form of necrotizing fasciitis, leading to a warning from the Food and Drug Administration. Real-world evidence on FG is needed to validate this warning.MethodsWe used data from IBM MarketScan (2013–2017) to compare the incidence of FG among adult patients who initiated either SGLT2i, a dipeptidyl peptidase-4 inhibitor (DPP4i), or any non-SGLT2i antihyperglycemic medication. FG was defined using inpatient International Classification of Diseases, Ninth Edition and Tenth Edition diagnosis codes 608.83 and N49.3, respectively, combined with procedure codes for debridement, surgery, or systemic antibiotics. We estimated crude incidence rates (IRs) using Poisson regression, and crude and adjusted HRs (aHR) and 95% CIs using standardized mortality ratio-weighted Cox proportional hazards models. Sensitivity analyses examined the impact of alternative outcome definitions.ResultsWe identified 211 671 initiators of SGLT2i (n=93 197) and DPP4i (n=118 474), and 305 329 initiators of SGLT2i (n=32 868) and non-SGLT2i (n=272 461). Crude FG IR ranged from 3.2 to 3.8 cases per 100 000 person-years during a median follow-up of 0.51–0.58 years. Compared with DPP4i, SGLT2i initiation was not associated with increased risk of FG for any outcome definition, with aHR estimates ranging from 0.25 (0.04–1.74) to 1.14 (0.86–1.51). In the non-SGLT2i comparison, we observed an increased risk of FG for SGLT2i initiators when using FG diagnosis codes alone, using all diagnosis settings (aHR 1.80; 0.53–6.11) and inpatient diagnoses only (aHR 4.58; 0.99–21.21).ConclusionsNo evidence of increased risk of FG associated with SGLT2i was observed compared with DPP4i, arguably the most relevant clinical comparison. However, uncertainty remains based on potentially higher risk in the broader comparison with all non-SGLT2i antihyperglycemic agents and the rarity of FG.Trial registration numberEUPAS Register Number 30018.

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IFCT-1502 CLINIVO: real-world evidence of long-term survival with nivolumab in a nationwide cohort of patients with advanced non-small-cell lung cancer

ESMO Open ◽

10.1016/j.esmoop.2021.100353 ◽

2022 ◽

Vol 7 (1) ◽

pp. 100353

Author(s):

O. Molinier ◽

B. Besse ◽

F. Barlesi ◽

C. Audigier-Valette ◽

S. Friard ◽

...

Keyword(s):

Lung Cancer ◽

Small Cell Lung Cancer ◽

Cell Lung Cancer ◽

Real World ◽

Small Cell ◽

Small Cell Lung ◽

Term Survival ◽

Long Term Survival ◽

Real World Evidence

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Real-world evidence analysis of the impact of steroid-eluting implants on healthcare resource use among chronic rhinosinusitis patients undergoing sinus surgery

Current Medical Research and Opinion ◽

10.1080/03007995.2021.2022874 ◽

2021 ◽

pp. 1-12

Author(s):

Veena Hoffman ◽

Kathleen M. Mortimer ◽

Kyra Mulder ◽

Ia Topuria ◽

Richard Gliklich ◽

...

Keyword(s):

Chronic Rhinosinusitis ◽

Resource Use ◽

Real World ◽

Healthcare Resource ◽

Sinus Surgery ◽

Healthcare Resource Use ◽

Real World Evidence ◽

Evidence Analysis ◽

The Impact

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N15 A ‘real-world’ observational multi-centre study comparing the side effects and patient acceptability of budesonide MMX with prednisolone in patients with mild to moderate ulcerative colitis

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.998 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S664-S665

Author(s):

J Kearns ◽

L Scullion ◽

C Masterson ◽

N Kennedy ◽

C Butcher

Keyword(s):

Ulcerative Colitis ◽

Side Effects ◽

Real World ◽

Additional Data ◽

Patient Acceptability ◽

Multi Centre Study ◽

Real World Evidence ◽

Randomised Controlled ◽

The Impact

Abstract Background Budesonide MMX is indicated for the induction of remission in mild to moderate Ulcerative Colitis (UC) patients when 5-ASA treatment is not sufficient. Unlike traditional first-generation glucocorticoid steroids such as prednisolone, budesonide MMX has demonstrated a robust safety profile, comparable to placebo in several randomised controlled trials1,2,3. There is however limited real-world evidence to substantiate this safety claim in clinical practice. The aim of this observational analysis is to evaluate the tolerability and ease of administration of budesonide MMX in the real-world setting using prednisolone as a benchmark. Methods Patients receiving treatment for mild to moderate UC were identified in 3 treatment centres between April and October 2019. After providing privacy and data consent, patients completed a detailed nurse-led questionnaire regarding their experiences with prednisolone treatment. Following 6 weeks of therapy with budesonide MMX, patients were sent a follow-up questionnaire. Data from both the initial and subsequent questionnaires were entered by the nurse into a database for assimilation and analysis. Results Twenty-eight patients completed initial and follow-up questionnaires. Of these, 78.6% (n = 22) had experienced ≥1 prednisolone-related side effects. In comparison, following treatment with budesonide MMX, 21.4% (n = 6) reported ≥1 side effects. Instances of these side effects are shown in Figure 1. 46.4% of patients (n = 13) reported the impact of prednisolone-related side effects on daily life as moderate or severe vs. 7.1% (n = 2) following treatment with budesonide MMX. By week 2 of treatment with budesonide MMX, rectal bleeding was resolved in 32.1% of patients (n = 9) and stool frequency in 35.7% (n = 10). 93.1% (n = 27) found the instructions to take budesonide MMX given by the health care professional very easy to understand and of those expressing a preference, 71.1% of patients (n = 19) would take budesonide MMX again if prescribed. Additional data will be presented. Conclusion Data from this ‘real-world’ observational study appear to support the safely profile of budesonide MMX reported in clinical trials. The incidence of patients who experienced > 1 side-effect was nearly 4 times lower for budesonide vs. prednisolone. In addition, budesonide MMX therapy was acceptable to the majority of patients and accompanying instructions easy to understand. Additional data will be presented. References

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The impact of HPV multi-cohort vaccination: Real-world evidence of faster control of HPV-related morbidity

Vaccine ◽

10.1016/j.vaccine.2019.12.016 ◽

2020 ◽

Vol 38 (6) ◽

pp. 1345-1351 ◽

Cited By ~ 2

Author(s):

Madleen Orumaa ◽

Susanne K. Kjaer ◽

Christian Dehlendorff ◽

Christian Munk ◽

Anne Olaug Olsen ◽

...

Keyword(s):

Real World ◽

Real World Evidence ◽

The Impact

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Alternative nivolumab duration and scheduling in advanced nonsmall cell lung cancer: A real‐world evidence

International Journal of Cancer ◽

10.1002/ijc.33281 ◽

2020 ◽

Vol 148 (5) ◽

pp. 1183-1191

Author(s):

Elizabeth Dudnik ◽

Mor Moskovitz ◽

Abed Agbarya ◽

Teodor Gottfried ◽

Tzippy Shochat ◽

...

Keyword(s):

Lung Cancer ◽

Cell Lung Cancer ◽

Real World ◽

Nonsmall Cell Lung Cancer ◽

Real World Evidence

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Treatment of Lung Cancer in Medically Compromised Patients

American Society of Clinical Oncology Educational Book ◽

10.1200/edbk_158713 ◽

2016 ◽

pp. e484-e491

Author(s):

Jeffrey Crawford ◽

Paul Wheatley-Price ◽

Josephine Louella Feliciano

Keyword(s):

Lung Cancer ◽

Socioeconomic Status ◽

Clinical Trials ◽

Molecular Mechanisms ◽

Early Stage ◽

Care Delivery ◽

Advanced Lung Cancer ◽

Early Stage Disease ◽

Major Barrier ◽

The Impact

Outcomes for patients with lung cancer have been improved substantially through the integration of surgery, radiation, and systemic therapy for patients with early-stage disease. Meanwhile, advances in our understanding of molecular mechanisms have substantially advanced our treatment of patients with advanced lung cancer through the introduction of targeted therapies, immune approaches, improvements in chemotherapy, and better supportive care. However, the majority of these advances have occurred among patients with good functional status, normal organ function, and with the social and economic support systems to be able to benefit most from these treatments. The aim of this article is to bring greater attention to management of lung cancer in patients who are medically compromised, which remains a major barrier to care delivery. Impaired performance status is associated with poor outcomes and correlates with the high prevalence of cachexia among patients with advanced lung cancer. CT imaging is emerging as a research tool to quantify muscle loss in patients with cancer, and new therapeutics are on the horizon that may provide important adjunctive therapy in the future. The benefits of cancer therapy for patients with organ failure are poorly understood because of their exclusion from clinical trials. The availability of targeted therapy and immunotherapy may provide alternatives that may be easier to deliver in this population, but clinical trials of these new agents in this population are vital. Patients with lower socioeconomic status are disproportionately affected by lung cancer because of higher rates of tobacco addiction and the impact of socioeconomic status on delay in diagnosis, treatment, and outcomes. For all patients who are medically compromised with lung cancer, multidisciplinary approaches are particularly needed to evaluate these patients and to incorporate rapidly changing therapeutics to improve outcomes.

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