Metformin monotherapy in melanoma: a pilot, open-label, prospective, and multicentric study indicates no benefit

2017 ◽  
Vol 30 (3) ◽  
pp. 378-380 ◽  
Author(s):  
Henri Montaudié ◽  
Michael Cerezo ◽  
Philippe Bahadoran ◽  
Coralie Roger ◽  
Thierry Passeron ◽  
...  
Keyword(s):  
Open Label ◽  
Multicentric Study ◽  
Metformin Monotherapy

Clinical Efficacy of Ayurvedic formulations, Kanakasava and Trivrit Churna, in the Management of Bronchial Asthma: A Prospective, Open-label, Multicentric Study

2020 ◽  
Vol 4 (1) ◽  
pp. 1-9
Author(s):  
Narayanam Srikanth ◽  
Shruti Khanduri ◽  
Sobaran Singh ◽  
Thugutla Maheswar ◽  
Rakesh Rana ◽  
...  
Keyword(s):  
Bronchial Asthma ◽  
Clinical Efficacy ◽  
Open Label ◽  
Multicentric Study

Combined treatment with reboxetine in depressed patients with no response to venlafaxine: a 6-week follow-up study

2007 ◽  
Vol 19 (5) ◽  
pp. 291-296 ◽  
Author(s):  
Cecilio Álamo ◽  
Francisco López-Muñoz ◽  
Gabriel Rubio ◽  
Pilar García-García ◽  
Antonio Pardo
Keyword(s):  
Adverse Events ◽  
Rating Scale ◽  
Combined Treatment ◽  
Open Label ◽  
Serious Adverse Events ◽  
Multicentric Study ◽  
Intent To Treat ◽  
Events Data ◽  
Clinical Global Impression Improvement

Objective:The purpose of present study was to evaluate the efficacy of the addition of reboxetine in patients that had not previously responded, or had done so only partially, over 6 weeks of conventional pharmacological treatment with venlafaxine.Methods:This open-label, prospective and multicentric study included 40 outpatients diagnosed with major depressive disorder according to the DSM-IV criteria. Efficacy was assessed using the 21-item Hamilton Depression Rating Scale (HAMD) and the Clinical Global Impression-Improvement (CGI-I). Safety was evaluated by recording spontaneously reported adverse events. Data were analysed on an intent-to-treat basis, using the last-observation-carried-forward method.Results:Mean HAMD reduction was 34.9% (P < 0.0001). The percentages of responders (≥50% reduction in HAMD) and patients considered as benefiting from complete remission (HAMD ≤ 10 points) at week 6 were 27.5 and 12.5%, respectively. By the end of the treatment, the score of CGI-I decreased 24.8% (P < 0.0001). Percentage of patient improving (CGI < 4 points) was 47.5%. The most common non-serious adverse events were constipation, nervousness, anxiety and insomnia.Conclusion:These findings suggest that the combined treatment of reboxetine and venlafaxine, in venlafaxine-resistant patients, may be an effective and well-tolerated strategy.

Phase II randomized trial of neoadjuvant (NA) chemotherapy (CT) with or without bevacizumab (Bev) in advanced epithelial ovarian cancer (EOC)‏ (GEICO 1205/NOVA TRIAL).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 5508-5508 ◽  
Author(s):  
Yolanda Garcia Garcia ◽  
Ana De Juan ◽  
Cesar Mendiola ◽  
Maria Pilar Barretina-Ginesta ◽  
Aleix Prat ◽  
...  
Keyword(s):  
Phase Ii ◽  
Stage Iv ◽  
Figo Stage ◽  
Ca 125 ◽  
Sample Collection ◽  
Debulking Surgery ◽  
Open Label ◽  
Serious Adverse Events ◽  
Multicentric Study ◽  
Primary Debulking Surgery

5508 Background: First line carboplatin(C)-paclitaxel(P) and Bev has proved to be an active combination after primary debulking surgery and improve overall survival in sub-optimal resected advanced EOC patients (pts). However, the role of Bev in the NA setting has not been well defined yet. Methods: We performed a phase II randomized open label multicentric study in pts with high grade serous or endometrioid EOC, FIGO stage III-IV, ECOG 0-2, considered unresectable in whom NA CT and interval debulking surgery (IDS) were planned. Main exclusion criteria were intestinal occlusion and contraindication for Bev. Pts were randomized to 4 courses of triweekly C AUC 6 and P 175 mg/m2 iv alone or with at least 3 courses of Bev 15 mg/kg i.v. every 3w in experimental arm. The primary endpoint was complete macroscopic response (CMR) rate at IDS. Secondary objectives were safety, surgical feasibility, optimal surgery rate (OSR), RECIST 1.1 and CA-125 GCIG response rate. Sample collection for translational research was taken at diagnosis and IDS. After surgery pts in both arms completed 3 additional cycles of CT and Bev, followed by maintenance Bev up to 15 mo. Results: Sixty-eight out of seventy-one evaluable pts. Clinical pts characteristics were well balanced, median age 60.0 y.o and a 33.8% stage IV. No differences in CMR were found at IDS (2/33 Control and 2/35 Bev). Bev arm was favoured in rate of surgical feasibility (66.7 vs 88.6%, p = 0.029), while no differences were found in OSR (63.6 vs 65.7%, p = 0.858) and in number of pts considered unresectable at time of IDS (2 vs 0). Median time from IDS to restarting Bev was 7.1 w. Median PFS was 20.3 mo in both arms, 20.13 mo in control arm and 20.36 mo in Bev arm, HR: 1.14 (IC 95%, 0.656 - 1.994). There were lower rates of serious adverse events (grade 3-4) in Bev arm (69.7 vs 42.9%, p = 0.026). 8 pts presented AE of special interest in Bev arm (3G2 proteinuria, 1G2/1G3 hypertension, 1G3 entero-vaginal fistulae, 1G3 entero-cutaneous fistulae, 1G3 deep venous thrombosis, 1G2 bleeding, 1G1 surgical dehiscence). Conclusions: NACT with Bevacizumab was feasible and improved the surgical outcomes at IDS in pts initially considered unresectable. Clinical trial information: 2012-003883-31.

Benefits of pembrolizumab in progressive radioactive iodine refractory thyroid cancer: Results of the AcSé Pembrolizumab Study from Unicancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6082-6082
Author(s):  
Sophie Leboulleux ◽  
Yann Godbert ◽  
Nicolas Penel ◽  
Segolene Hescot ◽  
Christelle De La Fouchardiere ◽  
...  
Keyword(s):  
Thyroid Cancer ◽  
Median Duration ◽  
Radioactive Iodine ◽  
Tumor Response ◽  
Objective Response ◽  
Progression Free Survival ◽  
Median Number ◽  
Open Label ◽  
Multicentric Study ◽  
Duration Of Response

6082 Background: AcSé Pembrolizumab is a Phase II, non-randomized parallel arm, open-label, multicentric study from Unicancer investigating the efficacy and safety of pembrolizumab monotherapy in different cohorts of patients with rare cancers (NCT03012620). Here we report the first results of pembrolizumab in the radioactive iodine refractory thyroid cancer cohort. Methods: Main inclusion criteria were progressive radioactive iodine refractory (RAIR) thyroid cancer (TC) resistant to standard treatment, age > 18, ECOG PS≤1. Patients received pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of every 21-day cycle for a maximum of 2 years. The primary endpoint was the confirmed objective response (OR) rate according to RECIST v1.1 by investigator. Secondary endpoints included duration of response, progression-free survival (PFS), overall survival (OS), and safety. Results: 43 patients (21 female, mean age 64.8 years; range 40-86) with TC (27 patients with differentiated TC (DTC) [papillary: 7; follicular: 14: oncocytic: 5 poorly differentiated: 1] and 16 patients with anaplastic TC (ATC)) were included from September 2017 to December 2020. The median number of previous systemic treatment lines was 2 (range, 0-7) in DTC and 2.5 (range, 1-4) in ATC. The median number of pembrolizumab cycles was 4 (range, 1-35). The median follow-up was 5.9 months (range: 22 days-22.9 months) for DTC and 2.7 months (range: 3 days- 24.4 months) for anaplastic TC. For DTC the best tumor response was partial response (PR) in 3 (11.1%) patients and stable disease (SD) in 5 (18.5%). Median duration of response was 2.5 months (range: 5 days-7.2 months). The median PFS was 2.6 months, the 6-month PFS was 16.9 %. The median OS was 12.7 months with a 6-month OS of 73.3%. For ATC the best tumor response was PR in 3 cases (18.8 %) and SD in 1 case (6.2 %). Median duration of response was 1.6 months (range: 2 days-7.2 months). The median PFS was 2.3 months, the 6-month PFS was 33.8 %. The median OS was 3.6 months with a 6-month OS of 32.9%. Treatment emergent adverse event included 9 Grade 1-2, 20 Grade 3 (3 being considered as related and 17 as not related) and 1 Grade 4 (sepsis, unrelated). Overall, the toxicity profile was similar to that observed in other cancers. Conclusions: The response rates observed under pembrolizumab is low in DTC and not negligible in ATC, but with a short duration of response. Clinical trial information: NCT03012620.

scholarly journals Radiofrequency Ablation for Treatment of Refractory Gastric Antral Vascular Ectasia: A Systematic Review of the Literature

2017 ◽  
Vol 2017 ◽  
pp. 1-5 ◽  
Author(s):  
M. Maida ◽  
S. Camilleri ◽  
M. Manganaro ◽  
S. Garufi ◽  
G. Scarpulla
Keyword(s):  
Systematic Review ◽  
Radiofrequency Ablation ◽  
Case Reports ◽  
Standard Of Care ◽  
Current Evidence ◽  
Open Label ◽  
Multicentric Study ◽  
Chronic Anemia ◽  
Occult Bleeding

Background and Study Aims. GAVE is an uncommon cause of upper nonvariceal bleeding and often manifests itself as occult bleeding with chronic anemia. To date, the standard of care for GAVE is endoscopic treatment with thermoablative techniques. Despite good technical results, approximately two thirds of patients remain dependent on transfusions after the therapy. One of the emerging and more promising endoscopic treatments for GAVE is radiofrequency ablation (RFA). The aim of this study is to perform a systematic review of literature in order to assess current evidence supporting the effectiveness of this technique for treatment of refractory GAVE.Materials and Methods. Through electronic search, we identified 14 records, and after removal of duplicates and irrelevant studies, we selected 10 studies on radiofrequency ablation of GAVE: 4 prospective open-label single-center studies, 1 retrospective multicentric study, and 5 case reports.Results. Among all 72 treated patients reported in literature, 74.3% achieved a clinical response, while nonfatal AEs have been reported in 4.2% of cases.Conclusions. Despite some qualitative limitations, all literature data support effectiveness of RFA for treatment of refractory GAVE. In the future, large prospective controlled trials with adequate follow-up are needed to better assess the effectiveness and safety of this procedure.

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