EVESOR, a model-based, multiparameter, Phase I trial to optimize the benefit/toxicity ratio of everolimus and sorafenib

Madani, Mévidette El; Colomban, Olivier; Tod, Michel; Maillet, Denis; Péron, Julien; Rodriguez-Lafrasse, Claire; Badary, Osama A.; Valette, Pierre-Jean; Lefort, Thibaud; Cassier, Philippe; El‐Shenawy, Siham M.; El‐Demerdash, Ebtehal; Hommel-Fontaine, Juliette; Guitton, Jérôme; Gagnieu, Marie‐Claude; Ibrahim, Bassant M. M.; Barrois, Catherine; You, Benoît

doi:10.2217/fon-2016-0357

Cited by 5 publications

(2 citation statements)

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“…Patient cohorts were subsequently treated at three dose levels of everolimus with docetaxel: 5–60 mg/m 2 , 10–60 mg/m 2 , and 10–70 mg/m 2 . The primary end point was the safety and tolerability of combination therapy.185 (27.7)5 (27.7)Deenen et al462012Phase I and pharmacokinetic study of capecitabine and the oral mTOR inhibitor everolimus in patients with advanced solid malignanciesFixed-dose everolimus 10 mg/day continuously plus capecitabine twice daily for 14 days in 3-weekly cycles189 (50)9 (50)Doi et al472010Multicenter phase II study of everolimus in patients with previously treated metastatic gastric cancerEverolimus 10 mg orally dailyA: 533 (5.7)Elmadani et al482017EVESOR, a model-based, multiparameter, phase I trial to optimize the benefit/toxicity ratio of everolimus and sorafenibEverolimus + sorafenib266 (23.1)6 (23.1)Escudier at al 492016Open-label phase 2 trial of first-line everolimus monotherapy in patients with papillary metastatic renal cell carcinoma: RAPTOR final analysisOral everolimus 10 mg once daily until disease progression or unacceptable toxicity9223 (25)23 (25)Fazio et al502013Everolimus plus octreotide long-acting repeatable in patients with advanced lung neuroendocrine tumors: analysis of the phase 3, randomized, placebo-controlled RADIANT-2 studyEverolimus + octreotide333 (9.1)Ferolla et al512017Efficacy and safety of long-acting pasireotide or everolimus alone or in combination in patients with advanced carcinoids of the lung and thymus (LUNA): an open-label, multicentre, randomised, phase 2 trialA: everolimusB: everolimus + pasireotideA: 42B: 41Total A: 30 (72)Total B: 15 (37)A: 26 (62)B: 13 (32)A: G3 4 (10)<...>…”

Section: Resultsmentioning

confidence: 99%

<p>Stomatitis And Everolimus: A Review Of Current Literature On 8,201 Patients</p>

Arena¹,

Troiano²,

Zhurakivska³

et al. 2019

OTT

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BackgroundOral toxicities, such as mucositis and stomatitis, are some of the most significant and unavoidable side effects associated with anticancer therapies. In past decades, research has focused on newer targeted agents with the aim of decreasing the rates of side effects on healthy cells. Unfortunately, even targeted anticancer therapies show significant rates of toxicity on healthy tissue. mTOR inhibitors display some adverse events, such as hyperglycemia, hyperlipidemia, hypophosphatemia, hematologic toxicities, and mucocutaneous eruption, but the most important are still stomatitis and skin rash, which are often dose-limiting side effects.AimThis review was performed to answer the question “What is the incidence of stomatitis in patients treated with everolimus?”MethodsWe conducted a systematic search on the PubMed and Medline online databases using a combination of MESH terms and free text: “everolimus” (MESH) AND “side effects” OR “toxicities” OR “adverse events”. Only studies fulfilling the following inclusion criteria were considered eligible for inclusion in this study: performed on human subjects, reporting on the use of everolimus (even if in combination with other drugs or ionizing radiation), written in the English language, and reporting the incidence of side effects.ResultsThe analysis of literature revealed that the overall incidence of stomatitis after treatment with everolimus was 42.6% (3,493) and that of stomatitis grade G1/2 84.02% (2,935), while G3/4 was 15.97% (558).ConclusionResults of the analysis showed that the incidence of stomatitis of grade 1 or 2 is higher than grade 3 or 4. However, it must be taken into account that it is not possible to say if side effects are entirely due to everolimus therapy or combinations with other drugs.

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Section: Resultsmentioning

confidence: 99%

<p>Stomatitis And Everolimus: A Review Of Current Literature On 8,201 Patients</p>

Arena¹,

Troiano²,

Zhurakivska³

et al. 2019

OTT

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“…Definition of PTSD was conflictual; Barrois defines this traumatic neurosis as "a group of psychological disorders that arise after a longer or shorter latency, following a very intense emotional shock" [7].…”

Section: Introductionmentioning

confidence: 99%

Double-blind, Randomized, Placebo-Controlled study to evaluate the Efficacy of an early treatment with Herbal Supplement based in the Prevention of Post-Traumatic Stress Disorder in emergency department (PHYTéS Study)

Boukef

Youssef

Yaacoubi

et al. 2022

Preprint

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Introduction: The prevention from Post-traumatic stress disorder (PTSD) is therefore of major public health interest and one of the concerns of any emergency physician. The purpose of our study was to evaluate the efficacy and safety of an herbal supplement to prevent the occurrence of PTSD in high-risk patients. Methods: It is a randomized, double-blind, prospective, interventional study including patients exposed to a potentially traumatic event that meets DSM-V Criterion A and has a Peri-traumatic Distress Inventory score or the Questionnary for traumatic dissociation experiments (PDEQ) and/or L.Crocq score higher than the thresholds between day 1 and day 3. Two hundred patients were included randomly assigned into two groups: Aleozen group and placebo group. Patients included in aleozen group received Aleozen® for 10 days while patients in placebo group received Placebo. A CAPS-5 assessment was performed for all patients at different moments. The main objective was to assess the efficacy of Aleozen after 90 days of an exposition to traumatic events according to PTSD. Secondary objectives were to evaluate the safety of Aleozen® at 10 and 30 days after its administration and PTSD in the study population after one year of inclusion. Results: No statistical differences were noted between the two groups in term of baseline characteristics including age, sex and the ISS score. After 90 days of follow-up, and according to the CAPS-5 scale, 85 patients (42.5%) of the population study showed PTSD. Concerning primary endpoint, less PTSD were seen in intervention group compared to placebo group (38.8% versus 61.2% respectively; p<0.001). During the study, no adverse events were noted. Conclusion: Results of this work suggest the potential preventive effects of an herbal supplement on PTSD for traumatic patient in emergency. Further confirmatory studies are needed.

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Clinical results of the EVESOR trial, a multiparameter phase I trial of everolimus and sorafenib combination in solid tumors

Varnier

Puszkiel

Tod

et al. 2023

Cancer Chemother Pharmacol

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EVESOR, a model-based, multiparameter, Phase I trial to optimize the benefit/toxicity ratio of everolimus and sorafenib

Abstract: Feasibility of EVESOR trial is demonstrated. Intermittent schedules might provide better tolerance and efficacy than continuous schedules.

Cited by 5 publications

References 18 publications

<p>Stomatitis And Everolimus: A Review Of Current Literature On 8,201 Patients</p>

<p>Stomatitis And Everolimus: A Review Of Current Literature On 8,201 Patients</p>

Double-blind, Randomized, Placebo-Controlled study to evaluate the Efficacy of an early treatment with Herbal Supplement based in the Prevention of Post-Traumatic Stress Disorder in emergency department (PHYTéS Study)

Clinical results of the EVESOR trial, a multiparameter phase I trial of everolimus and sorafenib combination in solid tumors

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