51LBA Completion of a Phase II study of sorafenib for advanced thyroid cancer

Brose, Marcia S.; Troxel, A.; Harlacker, K.; Redlinger, Maryann; Chalian, Ara A.; Loevner, Laurie A.; O’Dwyer, P. J.; Keefe, Stephen Michael

doi:10.1016/s1359-6349(09)72086-5

Cited by 6 publications

(7 citation statements)

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“…For one of the included prospective observational studies of sorafenib, known as UPCC-03305 [32], the majority of data were extracted from later conference reports of the same study [57–59] which reported baseline characteristics from a greater number of patients [58], efficacy data [59] and safety data [57].…”

Section: Resultsmentioning

confidence: 99%

“…Most of the observational studies were conducted in single countries (and often in single centres) in Europe [28, 31, 34, 35], the US [33, 58], and Asia [30, 36]. However, there was one multi-centre international study of lenvatinib (Study 201) [29].…”

Section: Resultsmentioning

confidence: 99%

“…In total, across all studies, 109 patients were treated with lenvatinib, of whom 83 had RR-DTC; 213 patients were treated with sorafenib, of whom 186 had RR-DTC. Other patients included in four of the studies [28, 33, 36, 58] had anaplastic ( n = 26) or medullary ( n = 27) carcinoma. Participant characteristics were reported for all treated patients in each study and, where reported, median age ranged from 55 years [28] to 64 years [33].…”

Section: Resultsmentioning

confidence: 99%

“…Participant characteristics were reported for all treated patients in each study and, where reported, median age ranged from 55 years [28] to 64 years [33]. Where reported, four studies included a majority of males [28, 29, 33, 35] and three studies included a majority of females [31, 34, 58]. Only two studies explicitly stated that patients could have received a prior TKI [29, 34] and, in these studies, the proportion of patients who did receive a prior TKI ranged from 11.8% [34] to 29.3% [29].…”

Section: Resultsmentioning

confidence: 99%

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A systematic review of lenvatinib and sorafenib for treating progressive, locally advanced or metastatic, differentiated thyroid cancer after treatment with radioactive iodine

et al. 2019

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BackgroundTreatment with radioactive iodine is effective for many patients with progressive, locally advanced or metastatic, differentiated thyroid cancer. However, some patients become refractory to treatment. These types of patients are considered to have radioactive iodine refractory differentiated thyroid cancer (RR-DTC).MethodsWe searched Embase, MEDLINE, PubMed and the Cochrane Library from January 1999 through January 2017. Reference lists of included studies and ongoing trial registries were also searched. Reports of randomized controlled trials (RCTs), prospective observational studies, and systematic reviews/indirect comparisons were eligible for inclusion. In the absence of direct clinical trial evidence comparing lenvatinib versus sorafenib, we assessed the feasibility of conducting an indirect comparison to obtain estimates of the relative efficacy and safety of these two treatments.ResultsOf 2364 citations, in total, 93 papers reporting on 2 RCTs (primary evidence), 9 observational studies and 13 evidence reviews (supporting evidence) were identified. Compared to placebo, RCT evidence demonstrated improvements with lenvatinib or sorafenib in median progression-free survival (PFS) and objective tumour response rate (ORR). Overall survival (OS) was confounded by high treatment crossover (≥75%) in both trials. Adverse events (AEs) were more common with lenvatinib or sorafenib than with placebo but the most common AEs associated with each drug differed. Primarily due to differences in the survival risk profiles of patients in the placebo arms of the RCTs, we considered it inappropriate to indirectly compare the effectiveness of lenvatinib versus sorafenib. ORR and AE findings for lenvatinib and sorafenib from the supporting evidence were broadly in line with RCT evidence. Health-related quality of life (HRQoL) data were limited.ConclusionsLenvatinib and sorafenib are more efficacious than placebo (a proxy for best supportive care) for treating RR-DTC. Uncertainty surrounds the extent of the impact on OS and HRQoL. Lenvatinib could not reliably be compared with sorafenib. Choice of treatment is therefore likely to depend on an individual patient’s circumstances.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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A systematic review of lenvatinib and sorafenib for treating progressive, locally advanced or metastatic, differentiated thyroid cancer after treatment with radioactive iodine

et al. 2019

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“…Большинство нежелательных явлений в этих исследованиях относились к I или II степени тяжести и поддавались коррекции. Шесть наиболее частых проявлений токсичности, свя занных с применением препарата, включают ладонно-подошвенную кожную реакцию, сыпь, анорексию, диарею, гипертензию и усталость [56][57][58][59].…”

Section: Discussionunclassified

Target Therapy of High Differentiated Carcinoma Resistant to Radioiod Therapy (Review of Literature)

Васильков¹,

Исаев²,

Пимонова³

et al. 2017

Opuholi golovy šei

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Высокодифференцированный рак щитовидной железы (ВДРЩЖ) относят к неагрессивным опухолям из-за того, что он долгое время способен не увеличиваться и не метастазировать в окружающие ткани и органы. Современная медицина имеет возможность справиться с этим заболеванием, выявив его на ранних стадиях и начав своевременное лечение, которое включает операцию и последующую радиойодтерапию по показаниям. В то же время резистентность отдаленных метастазов к терапии радиоактивным йодом у больных ВДРЩЖ значительно ухудшает прогноз выживаемости. Результаты применения химиопрепаратов не позволили рекомендовать их в качестве терапии выбора. Сегодня достижения противоопухолевого лекарственного лечения связаны, главным образом, с развитием таргетной терапии, а именно с применением отдельных ингибиторов тирозинкиназ, в частности Сорафениба. Он стал первым зарегистрированным в России препаратом, доказавшим свою терапевтическую эффективность у пациентов с данной патологией, возможности лечения которых в настоящее время крайне ограничены или отсутствуют.

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Sorafenib: a review of its use in patients with radioactive iodine-refractory, metastatic differentiated thyroid carcinoma

Blair

Plosker

2015

Targ Oncol

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Sorafenib (Nexavar®) is the first tyrosine kinase inhibitor to be approved for the treatment of radioactive iodine (RAI)-refractory differentiated thyroid carcinoma (DTC). In the pivotal phase III DECISION trial in patients with RAI-refractory, locally advanced or metastatic DTC, oral sorafenib 400 mg twice daily significantly prolonged median progression-free survival (PFS) relative to placebo. The PFS benefit of sorafenib over placebo was evident in all pre-specified clinical and genetic biomarker subgroups, and neither BRAF nor RAS mutation status was predictive of sorafenib benefit for PFS. The objective response rate was significantly higher in patients receiving sorafenib than in those receiving placebo; all objective responses were partial responses. The overall survival benefit of sorafenib is as yet unclear, with no significant benefit observed at the time of primary analysis or at 9 months following the primary analysis. Overall survival was possibly confounded by the crossover of patients in the placebo group to sorafenib upon disease progression. The adverse events associated with sorafenib in the DECISION trial were consistent with the known tolerability profile of the drug, with hand-foot skin reaction, diarrhea, and alopecia reported most commonly. Most treatment-emergent adverse events were grade 1 or 2 in severity and occurred early in treatment. However, a high proportion of patients discontinued sorafenib therapy or required dose reductions or interruptions because of toxicity. Although final overall survival data are awaited, current evidence suggests that sorafenib is a promising new treatment option for patients with RAI-refractory, metastatic DTC.

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51LBA Completion of a Phase II study of sorafenib for advanced thyroid cancer

Cited by 6 publications

References 0 publications

A systematic review of lenvatinib and sorafenib for treating progressive, locally advanced or metastatic, differentiated thyroid cancer after treatment with radioactive iodine

A systematic review of lenvatinib and sorafenib for treating progressive, locally advanced or metastatic, differentiated thyroid cancer after treatment with radioactive iodine

Target Therapy of High Differentiated Carcinoma Resistant to Radioiod Therapy (Review of Literature)

Sorafenib: a review of its use in patients with radioactive iodine-refractory, metastatic differentiated thyroid carcinoma

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