Efficacy and safety of trifluridine/tipiracil (FTD/TPI) in patients (pts) with metastatic gastric cancer (mGC) with or without prior gastrectomy: Results from a phase III study (TAGS).

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 3-3 ◽  
Author(s):  
David H. Ilson ◽  
Aliaksandr Prokharau ◽  
Hendrik-Tobias Arkenau ◽  
Michele Ghidini ◽  
Kazumasa Fujitani ◽  
...  
Keyword(s):  
Effective Treatment ◽  
Treatment Option ◽  
Safety Profile ◽  
Metastatic Gastric Cancer ◽  
Best Supportive Care ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Effective Treatment Option ◽  
Phase 3 ◽  
Heavily Pretreated

3 Background: The phase 3 study TAGS demonstrated that the novel oral therapy FTD/TPI (TAS-102) represents an effective treatment option with a manageable safety profile for pts with heavily pretreated mGC. In an earlier single-arm Japanese phase 2 trial in mGC, no differences were found in the pharmacokinetics of either FTD or TPI in pts with or without prior gastrectomy. We evaluated the efficacy and safety of FTD/TPI in pts with or without prior gastrectomy within the TAGS study. Methods: In this global phase 3 study of adult pts with mGC who had received ≥ 2 prior regimens of chemotherapy, pts were randomized 2:1 to receive FTD/TPI (35 mg/m2 BID on days 1–5 and 8–12 of each 28-day cycle) or placebo, plus best supportive care. We performed a preplanned analysis of efficacy and safety endpoints in pt subgroups with or without prior gastrectomy. Results: Of 507 randomized pts, 221 (44%) had a prior gastrectomy (FTD/TPI, 147/337; placebo, 74/170). Baseline pt characteristics were balanced across pt subgroups. FTD/TPI prolonged survival versus placebo regardless of gastrectomy (table). The frequency of neutropenia/leukopenia appeared to be higher among FTD/TPI-treated pts with vs without gastrectomy, but this did not result in more treatment discontinuations (table). Conclusions: In the TAGS study, subgroup analysis demonstrated that FTD/TPI is an effective treatment option with a manageable safety profile for pts with heavily pretreated mGC, regardless of prior gastrectomy. Clinical trial information: NCT02500043. [Table: see text]

Intralesional Vitamin D Injection May Be an Effective Treatment Option for Warts

2015 ◽  
Vol 20 (2) ◽  
pp. 118-122 ◽  
Author(s):  
Habibullah Aktaş ◽  
Can Ergin ◽  
Betül Demir ◽  
Özlem Ekiz
Keyword(s):  
Vitamin D ◽  
Candida Albicans ◽  
Adverse Effects ◽  
Effective Treatment ◽  
Treatment Option ◽  
Complete Resolution ◽  
Efficacy And Safety ◽  
Effective Treatment Option ◽  
Rubella Vaccine ◽  
Plantar Warts

Background: Plantar warts are typically resistant to treatment. In recent years, treatments have included administration of intralesional tuberculin; measles, mumps, rubella vaccine; and Candida albicans antigen immunotherapy. To the best of our knowledge, there are no reports of intralesional vitamin D administration for the treatment of warts. Aim: To evaluate the efficacy and safety of intralesional vitamin D treatment for plantar warts. Methods: Twenty patients with single or multiple plantar warts were included in this study. Vitamin D3 (0.2 mL, 7.5 mg/mL) was injected into the base of the warts after prilocaine (0.1 mL, 20 mg/mL) injection. A maximum of 5 warts were treated in 1 session, with at maximum 2 injections performed at 4-week intervals. Results: In total, 16 of 20 patients (80%) showed complete resolution of warts, and 1 patient showed partial resolution. Three patients failed to show any response. No recurrence or serious adverse effects were observed. Conclusion: Intralesional vitamin D3 may be an effective treatment option for warts.

scholarly journals Effectiveness of omalizumab in patients with chronic spontaneous and inducible urticaria

2019 ◽  
Vol 2 (21) ◽  
pp. 5-8
Author(s):  
D. M. Skander ◽  
A. S. Allenova ◽  
M. L. Samsonyan ◽  
P. V. Kolkhir
Keyword(s):  
Effective Treatment ◽  
Treatment Option ◽  
Response To Treatment ◽  
Control Test ◽  
Efficacy And Safety ◽  
Effective Treatment Option ◽  
Chronic Inducible Urticaria ◽  
Inducible Urticaria ◽  
Provocation Testing ◽  
Urticaria Activity Score

Background. Omalizumab, a recombinant humanized anti-IgE antibody, is an effective treatment option for patients with antihistamine-resistant chronic spontaneous urticaria (CSU). 14–36 % of CSU patients have concomitant chronic inducible urticaria (CIndU). However, it is unclear whether CSU patients with comorbid CIndU can benefit from this treatment.Aim of the study. To assess the efficacy and safety of omalizumab in two patients with CSU and several of types of concomitant CIndU.Materials and methods. CSU and CIndU were diagnosed as recommended by the international urticaria guideline. Both female patients were treated with omalizumab 300 mg by subcutaneous injection every 4 weeks. Response to treatment was assessed by a carefully determined history, the urticaria activity score, urticaria control test, and results of provocation testing.Results. Symptoms of both CSU and CIndU decreased dramatically during the first week of treatment. No adverse events were documented.Conclusions. Omalizumab may be an effective treatment option for patients with combination of antihistamine-resistant CSU and concomitant CIndU. Our findings should be confirmed in larger prospective studies.

Trifluridine/tipiracil (FTD/TPI) in patients (pts) with metastatic gastroesophageal junction cancer (mGEJC): Subgroup analysis from TAGS.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4038-4038 ◽  
Author(s):  
Wasat Mansoor ◽  
Hendrik-Tobias Arkenau ◽  
MARIA ALSINA ◽  
Kohei Shitara ◽  
Mohamedtaki Abdulaziz Tejani ◽  
...  
Keyword(s):  
Placebo Group ◽  
Safety Profile ◽  
Early Stage ◽  
Gastroesophageal Junction ◽  
Metastatic Gastric Cancer ◽  
Best Supportive Care ◽  
Efficacy And Safety ◽  
Early Stage Disease ◽  
Gastroesophageal Junction Cancer ◽  
Disease Site

4038 Background: The incidence of GEJC is increasing in North America and Europe, especially among white men. Many pts present with metastatic disease or relapse locally or systemically after resection of early-stage disease. The global phase 3 study TAGS (NCT02500043) demonstrated the efficacy and safety of FTD/TPI in previously treated pts with metastatic gastric cancer (mGC)/mGEJC. Here we report results in the mGEJC subgroup from TAGS. Methods: Pts with mGC/mGEJC treated with ≥2 prior chemotherapy regimens were randomized (2:1) to receive FTD/TPI (35 mg/m2 BID on days 1–5 and 8–12 of each 28-day cycle) or placebo, plus best supportive care. A preplanned efficacy and safety analysis was performed in pts with mGEJC. Results: Of 507 randomized pts, 145 (29%) had GEJC as the sole primary disease site (FTD/TPI, 98/337; placebo, 47/170). Of pts with mGEJC, 85% were male and 83% were white (overall population, 73% and 70%). Baseline characteristics were generally balanced for pts with mGEJC across treatment groups, except for fewer pts having prior gastrectomy (40% vs 55%) and more pts having received ≥3 prior regimens (74% vs 66%) in the FTD/TPI group than in the placebo group. FTD/TPI had an efficacy benefit in pts with mGEJC, and the FTD/TPI safety profile was similar in this subgroup and the overall population (table). Conclusions: FTD/TPI showed a manageable safety profile and efficacy benefit in pts with mGEJC in the TAGS trial, despite heavier pretreatment of the FTD/TPI than the placebo group. Clinical trial information: NCT02500043. [Table: see text]

scholarly journals COVID-19 convalescent plasma clears SARS-CoV-2 refractory to remdesivir in an infant with congenital heart disease

2020 ◽  
Vol 4 (18) ◽  
pp. 4278-4281 ◽  
Author(s):  
Zahidee Rodriguez ◽  
Andi L. Shane ◽  
Hans Verkerke ◽  
Christopher Lough ◽  
Matthew G. Zimmerman ◽  
...  
Keyword(s):  
Congenital Heart Disease ◽  
Heart Disease ◽  
Effective Treatment ◽  
Treatment Option ◽  
Congenital Heart ◽  
Effective Treatment Option ◽  
Immune Systems ◽  
Key Points ◽  
Donor Variability

Key Points COVID-19 convalescent plasma (CP) may be a safe and effective treatment option in SARS-CoV-2 infection refractory to remdesivir. Infants may benefit from CP despite developing immune systems and donor variability emphasizes the need for characterization prior to use.

scholarly journals POS0928 NETAKIMAB EFFICACY IN ANTI-TNF-NAIVE AND ANTI-TNF-EXPERIENCED PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS: RESULTS OF SUBANALYSIS OF PHASE 3 ASTERA TRIAL

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 726.2-727
Author(s):  
S. Erdes ◽  
V. Mazurov ◽  
T. Dubinina ◽  
I. Gaydukova ◽  
A. Kundzer ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Phase Iii ◽  
P Value ◽  
Interleukin 17 ◽  
Inadequate Response ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Two Phase ◽  
Double Blind ◽  
Asas Criteria

Background:According to previous studies, the effectiveness of interleukin-17 (IL-17) inhibitors was higher in anti-TNF-naïve patients with ankylosing spondylitis (AS) [1,2]. Netakimab (NTK) is a humanized anti-IL-17A antibody approved for the treatment of AS, psoriatic arthritis, moderate-to-severe plaque psoriasis in Russia and Belarus.Objectives:To compare the efficacy of NTK in anti-TNF-naïve patients with anti-TNF-experienced patients with active AS at week 16 of therapy.Methods:ASTERA (NCT03447704) is an ongoing phase 3 placebo (PBO)-controlled clinical study, aimed at evaluating NTK efficacy in AS [3]. 228 adult patients with active AS (BASDAI ≥ 4) were randomly assigned (1:1) to receive 120 mg NTK or PBO subcutaneously at week 0,1,2 and then q2w. This analysis includes 112 patients in NTK group. Efficacy endpoints included ASAS20/40, ASAS5/6 and ASAS partial remission (PR) at week 16 of therapy.Results:28 (25.0%) of 112 patients in NTK group had previous inadequate response/intolerance to anti-TNF (anti-TNF-IR): 24 (21.4%) – one anti-TNF, and 4 (3.6%) – two anti-TNF. 84 (75.0%) patients were TNF-naive. Achievement of ASAS criteria response at week 16 was similar in both groups (Table 1).Table 1.Efficacy of NTK at week 16ParameterTNF-naïve (n = 84)anti-TNF-IR (n = 28)p-value*ASAS20, n (%)52 (61.9%)17 (60.7%)0.91ASAS40, n (%)35 (41.7%)11 (39.3%)0.82ASAS5/6, n (%)39 (46.4%)11 (39.3%)0.51ASAS(PR), n (%)15 (17.9%) 4 (14.3%)0.78*- Fisher’s exact testConclusion:NTK 120 mg provided sustained improvements in signs and symptoms of AS in anti-TNF-naive and anti-TNF-IR patients at 16 weeks of therapy.References:[1]Blair HA, Dhillon S. Secukinumab: A Review in Ankylosing Spondylitis. Drugs. 2016;76(10):1023-30.[2]Dougados M, et al. Efficacy and safety of ixekizumab through 52 weeks in two phase 3, randomised, controlled clinical trials in patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W). Ann Rheum Dis. 2020;79(2):176-185.[3]Mazurov VI, et al. Efficacy and safety of Netakimab, anti-IL-17A monoclonal antibody, in patients with ankylosing spondylitis. Results of phase III international, multicenter, randomized double-blind clinical trial BCD-085-5/ASTERA. Nauchno-Practicheskaya Revmatologia=Rheumatology Science and Practice. 2020;58 (4):376–386 (In Russ).Acknowledgements:This study was sponsored by JSC BIOCAD.Disclosure of Interests:Shandor Erdes: None declared, V Mazurov: None declared, Tatiana Dubinina: None declared, Inna Gaydukova Speakers bureau: Abbvie, Biocad, Eli Lilly, MSD, Novartis, Pfizer, Sandoz, Alena Kundzer: None declared, Nikolaj Soroka: None declared, Anna Eremeeva Employee of: Biocad

scholarly journals Gentamicin susceptibility among a sample of multi-drug resistantNeisseria gonorrhoeaeisolates in India

2016 ◽  
pp. AAC.01907-16 ◽  
Author(s):  
Manju Bala ◽  
Vikram Singh ◽  
Aradhana Bhargava ◽  
Monika Kakran ◽  
Naveen Chandra Joshi ◽  
...  
Keyword(s):  
Effective Treatment ◽  
Treatment Outcomes ◽  
Treatment Option ◽  
Antimicrobial Susceptibility ◽  
Susceptibility Testing ◽  
Dual Therapy ◽  
Clinical Treatment ◽  
Antimicrobial Susceptibility Testing ◽  
Effective Treatment Option

Antimicrobial susceptibility testing of 258N. gonorrhoeaeisolates by Etest determined that 60.1% were MDR while 5% strains had decreased susceptibility to currently recommended extended-spectrum cephalosporins (ESCs). Among these, 84.5% MDR and 76.9% strains having decreased susceptibility to ESCs were susceptible to gentamicin. No MDR isolate was resistant to gentamicin. Thesein vitroresults suggest that gentamicin might be an effective treatment option for the MDR strains and in dual therapy for gonorrhea. However, further research regarding the clinical treatment outcomes is essential.

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