Response to Sorafenib at a Low Dose in Patients with Radioiodine-Refractory Pulmonary Metastases from Papillary Thyroid Carcinoma

Chen, Libo; Shen, Yan; Luo, Quan-Yong; Yu, Yongli; Lu, Hankui; Zhu, Ran

doi:10.1089/thy.2010.0199

Cited by 50 publications

(64 citation statements)

References 29 publications

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“…Grade 4: febrile neutropenia and ruptured aortic graft Chen et al (2011) None 0/0 0/0 1/11 0/0 Schneider et al (2012) Grade 3: hypertension (16), HFS (23), rash (16), mucositis (10), weight loss (10), diarrhea (6), and elevated LFTs (7) 18/58 7/23 1/3 13/42…”

Section: Discussionmentioning

confidence: 99%

“…A meta-analysis was also carried out on the proportion of patients in six trials requiring dose reductions due to the toxicity of sorafenib (one trial was excluded because the initial dose used was already 200 mg PO b.i.d. (Chen et al 2011)) and the incidence was 62% (95% CI: 36-89; PZ0.000) (Fig. 2D).…”

Section: Safetymentioning

confidence: 90%

“…Following a more detailed review, six articles were excluded because two combined sorafenib with other agents, two mainly referred to molecular mechanisms, two had a duplicate trial, and one included only anaplastic thyroid carcinoma (ATC) cases. The remaining seven trials involving 211 patients fulfilled our inclusion criteria (GuptaAbramson et al 2008, Ahmed et al 2011, Chen et al 2011, Schneider et al 2012, Marotta et al 2013. The process of study selection is shown as a flow chart in Fig.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…) in all the trials, except in one trial, which used 200 mg PO b.i.d. (Chen et al 2011). The efficacy of each trial is summarized in Table 2, along with the evaluation index including PR, stability of disease, clinical benefits, and PFS and OS rates.…”

Section: Study Characteristicsmentioning

confidence: 99%

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Sorafenib in the treatment of radioiodine-refractory differentiated thyroid cancer: a meta-analysis

Shen¹,

Qiu²,

Luo³

2013

Endocrine-Related Cancer

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The advent of biologically targeted agents and increased understanding of thyroid carcinogenesis have generated much interest in the development of biologically targeted therapeutic agents for thyroid cancer. Among them, sorafenib is the most commonly studied drug. The current meta-analysis was carried out to estimate the efficacy and safety of sorafenib administered in radioiodine-refractory differentiated thyroid cancer patients. An electronic search was conducted using PubMed/MEDLINE and EMBASE. Statistical analyses were carried out using either random-effects or fixed-effects models according to heterogeneity. All the statistical analyses were carried out using the Stata version 12.0 software. Seven eligible studies were identified. The final results indicated that 22% of the patients (95% CI: 15-28) achieved a partial response. Hand-foot syndrome, diarrhea, fatigue, rash, weight loss, and hypertension were the most frequently observed adverse effects (AEs) associated with sorafenib use and the incidence of these AEs (all grades) was 80% (95% CI: 68-91), 68% (95% CI: 59-77), 67% (95% CI: 57-78), 66% (95% CI: 50-82), 52%(95% CI: 33-72), and 31% (95% CI: 21-42) respectively. Sixty-two percent (95% CI: 36-89) patients required dose reductions due to toxicity of sorafenib. As far as PR and AEs are concerned, the results of this meta-analysis indicate that sorafenib has a modest effect in patients with radioiodine-refractory differentiated thyroid cancer and the high incidence of AEs associated with this agent may affect the quality of patients' lives. Though the use of sorafenib in the treatment of radioiodinerefractory differentiated thyroid cancer is considered promising by most physicians working in this field, more effective agents with less toxicity and cost are still needed.

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Section: Discussionmentioning

confidence: 99%

Section: Safetymentioning

confidence: 90%

Section: Study Characteristicsmentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

See 2 more Smart Citations

Sorafenib in the treatment of radioiodine-refractory differentiated thyroid cancer: a meta-analysis

Shen¹,

Qiu²,

Luo³

2013

Endocrine-Related Cancer

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“…The effectiveness of sorafenib was also reported in a Chinese population. Chen et al tried sorafenib in nine Chinese patients with progressive RI-refractory PTC and pulmonary metastasis [54]. They reported three (33%) PRs and four (44%) SDs after 13-week treatment.…”

Section: Molecular Target Therapymentioning

confidence: 99%

Alternative Medical Treatment for Radioiodine-Refractory Thyroid Cancers

Paeng

Kang

Park

et al. 2011

Nucl Med Mol Imaging

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Thyroid cancer is one of the most rapidly increasing cancers in many countries. Although most thyroid cancers are differentiated cancers and easily treated with radioiodine (RI), a portion of differentiated and undifferentiated cancers is refractory not only to RI therapy, but also to radiotherapy and chemotherapy. Thus, various alternative therapies have been tested in RI-refractory thyroid cancers. These alternative therapies include two major categories: redifferentiation therapy and recent molecular target therapy. Several clinical trials have investigated these therapies. They demonstrated potential effects of the therapies, although the results have been somewhat limited so far. Thus, the future strategy for undifferentiated thyroid cancers will involve individualized, lesion-specific, and combined therapy. In this review, the basic mechanism of each redifferentiation and molecular target therapy is discussed, and results of recent clinical trials using these therapeutic agents are summarized.

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Dose‐Finding Studies Among Orphan Drugs Approved in the EU: A Retrospective Analysis

Schuller

Wied

Hollak

et al. 2018

The Journal of Clinical Pharma

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In the development process for new drugs, dose-finding studies are of major importance. Absence of these studies may lead to failed phase 3 trials and delayed marketing authorization. In our study we investigated to what extent dose-finding studies are performed in the case of orphan drugs for metabolic and oncologic indications. We identified all orphan drugs that were authorized until August 1, 2017. European Public Assessment Reports were used to extract the final dose used in the summary of product characteristics, involvement of healthy volunteers, study type, end points used, number of patients, number of doses, studies in special populations, and dose used for phase 3 studies. Each drug was checked for major objections and dose changes postmarketing. We included 49 orphan drugs, of which 28 were indicated for metabolic disorders and 21 for oncologic indications. Dose-finding studies were performed in 32 orphan drugs, and studies in healthy volunteers in 26. The absence of dose-finding studies was mostly due to the rarity of the disease. In this case the dose was determined based on factors such as animal studies or clinical experience. Dose-related major objections were raised for 9 orphan drugs. Postmarketing dose-finding studies were conducted in 18 orphan drugs, but dose changes were applied in only 2 drugs. In conclusion, dose-finding studies in the case of metabolic and oncologic orphan drugs were conducted in the development programs of two thirds of orphan drugs. Dose-finding studies performed postmarketing suggest that registered doses are not always optimal. It is thus important to perform more robust dose-finding studies both pre- and postmarketing.

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Response to Sorafenib at a Low Dose in Patients with Radioiodine-Refractory Pulmonary Metastases from Papillary Thyroid Carcinoma

Abstract: Sorafenib at a dose of 200 mg twice daily has a potential therapeutic effect and is well tolerated in Chinese patients with PTC and radioiodine-refractory pulmonary metastases. Further study is warranted with a larger cohort of patients.

Cited by 50 publications

References 29 publications

Sorafenib in the treatment of radioiodine-refractory differentiated thyroid cancer: a meta-analysis

Sorafenib in the treatment of radioiodine-refractory differentiated thyroid cancer: a meta-analysis

Alternative Medical Treatment for Radioiodine-Refractory Thyroid Cancers

Dose‐Finding Studies Among Orphan Drugs Approved in the EU: A Retrospective Analysis

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