Safety and tolerability of surufatinib in western patients with solid tumours

Hamilton, Erika; Wang, J.S.; Li, D.; Dasari, N.A.; Paulson, Scott; Cohn, Allen Lee; Sauter, Nicholas; Kania, Marek; Kauh, John S.

doi:10.1093/annonc/mdz256.013

Cited by 3 publications

(6 citation statements)

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“…After full text reading, an additional 20 studies were excluded. Finally, seven clinical experimental studies that included 638 participants (8)(9)(10)(17)(18)(19)(20) were retained (Fig. 1).…”

Section: Resultsmentioning

confidence: 99%

“…Treatment regimens. A total of 638 patients were included in the meta-analysis; 510 were assigned to treatment arms, of which 35 patients participated in a dose escalation study (19). These patients were equally divided into five groups and they were then treated with different concentrations of surufatinib (50, 100, 200, 300 and 400 mg) once daily and continuously for every 28-day cycle until disease progression, intolerable toxicity or withdrawal of consent.…”

Section: Resultsmentioning

confidence: 99%

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Efficacy and safety of surufatinib in the treatment of advanced solid tumors: a systematic evaluation and meta‑analysis

Cai

Cheng

et al. 2023

Oncol Lett

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Previous retrospective studies have suggested that surufatinib is effective for treating advanced solid tumors; however, the efficacy and safety of this drug needs to be investigated further via high-quality evidence or randomized controlled trials. In the present study, a meta-analysis was carried out to evaluate the safety and effectiveness of surufatinib for patients with advanced solid tumors. Systematic, electronic literature searches were conducted using PubMed, EMBASE, Cochrane Library and ClinicalTrials.gov. The disease control rate (DCR) of surufatinib in solid tumors was 86% [effect size (ES), 0.86; 95% confidence interval (CI), 0.82-0.90; I 2 =34%; P=0.208] and the objective response rate was 16% (ES, 0.16; 95% CI, 0.12-0.21; I 2 =48%; P=0.103), while the progressive disease rate was only 9% (ES, 0.09; 95% CI, 0.05-0.15; I 2 =68%, P=0.014). Surufatinib showed different degrees of adverse reactions during the treatment of solid tumors. Among these adverse events, the incidence of increased levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were 24% (ES, 0.24; 95% CI, 0.18-0.30; I 2 =45.1%; P=0.141) and 33% (ES, 0.33; 95%CI, 0.28-0.38; I 2 =63.9%; P=0.040), respectively. In the placebo-controlled trial, the relative risks (RRs) of elevated AST and ALT were 1.04 (95% CI, 0.54-2.02; I 2 =73.3%; P=0.053) and 0.84 (95% CI, 0.57-1.23; I 2 =0%; P=0.886), respectively. Overall, surufatinib was characterized by a high DCR and a low disease progression rate, thus indicating that it could exert a good therapeutic effect on solid tumors. Additionally, surufatinib showed a lower RR for adverse effects compared with other treatment modalities.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Efficacy and safety of surufatinib in the treatment of advanced solid tumors: a systematic evaluation and meta‑analysis

Cai

Cheng

et al. 2023

Oncol Lett

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“…NCT02549937 is an ongoing dose‐escalation/expansion study in the US on participants with solid tumors. According to Hamilton et al 27 six patients received 100 mg surufatinib, 11 received 300 mg surufatinib, and 13 received 400 mg surufatinib. A total of 1/6 patients reported fatigue in the 100 mg group, 1/11 patients reported hypertension in the 300 mg group, and 4/13 patients reported proteinuria, thrombocytopenia, and ALT elevation in the 400 mg group.…”

Section: Resultsmentioning

confidence: 99%

“…A total of 73 articles were identified with eight articles from PubMed, 35 articles from Embase, 15 articles from Web of Science, nine articles from Cochrane, and six articles from clinicaltrials.gov. Two RCTs (N = 370) 24,25 and three nonrandomized studies (N = 170) [26][27][28] were included based on inclusion criteria (Figure 1).…”

Section: Discussionmentioning

confidence: 99%

Efficacy and toxicity of surufatinib in neuroendocrine tumors: A systematic review and meta‐analysis

Ali

Shah

Tahir

et al. 2022

J Neuroendocrinology

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The incidence and prevalence of neuroendocrine neoplasms (NENs) has increased in the US in recent decades. These are well-vascularized tumors, but no antiangiogenic drug has been approved for treatment of extra-pancreatic NENs. The aim is to assess efficacy and safety of surufatinib in pancreatic and extra-pancreatic NETs. We searched PubMed, Embase, Cochrane Library, Web of Science and Clinicaltrials.gov.Clinical trials and observational studies that provided safety and efficacy data in clinical terms were included. Characteristics of the study, baseline characteristics of participants, treatment drugs, measures of efficacy, and toxicity (≥grade 3 adverse effects) were extracted. The meta-analysis was performed using the "R" programming language. Risk ratio (RR) of objective response (OR)/partial response (PR) was 8.55 (95% CI: 1.68-43.66, I 2 = 0) in favor of surufatinib. The hazard ratio (HR) of progression-free survival (PFS) was 0.48 (95% CI: 0.25-0.92, I 2 = 77%) in favor of surufatinib. The risk of ≥grade 3 adverse effects: diarrhea, hypertension, hypertriglyceridemia, proteinuria, and vomiting were high with the use of surufatinib. Quality of life (QoL) was similar in surufatinib and placebo groups except for the diarrhea that was high with surufatinib. Lack of randomized clinical trials in non-Chinese population. Surufatinib is well tolerated and is more effective than placebo in both pancreatic and extra-pancreatic NETs. More multicenter randomized, double-blinded clinical trials are needed to confirm these results.

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“…Surufatinib was tested in a randomized phase III study including non-panNETs in China [ 46 ] and showed a median PFS of 9.2 months in the surufatinib arm vs 3.8 months with placebo, HR 0.33 (95% CI 0.22–0.50); p < 0.0011 (IIB). Data in non-Chinese patients are limited, but similar pharmacokinetic and toxicity profile is suggested in a phase I/II study conducted in the USA in heavily pretreated patients [ 47 ]. Currently, a phase II study is being conducted in Europe.…”

Section: Antiproliferativementioning

confidence: 99%

SEOM-GETNE clinical guidelines for the diagnosis and treatment of gastroenteropancreatic and bronchial neuroendocrine neoplasms (NENs) (2022)

et al. 2023

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Neuroendocrine neoplasms (NENs) are a heterogeneous family of tumors of challenging diagnosis and clinical management. Their incidence and prevalence continue to rise mainly due to an improvement on diagnostic techniques and awareness. Earlier detection, along with steadfast improvements in therapy, has led to better prognosis over time for advanced gastrointestinal and pancreatic neuroendocrine tumors. The aim of this guideline is to update evidence-based recommendations for the diagnosis and treatment of gastroenteropancreatic and lung NENs. Diagnostic procedures, histological classification, and therapeutic options, including surgery, liver-directed therapy, peptide receptor radionuclide therapy, and systemic hormonal, cytotoxic or targeted therapy, are reviewed and discussed, and treatment algorithms to guide therapeutic decisions are provided.

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Safety and tolerability of surufatinib in western patients with solid tumours

Cited by 3 publications

References 0 publications

Efficacy and safety of surufatinib in the treatment of advanced solid tumors: a systematic evaluation and meta‑analysis

Efficacy and safety of surufatinib in the treatment of advanced solid tumors: a systematic evaluation and meta‑analysis

Efficacy and toxicity of surufatinib in neuroendocrine tumors: A systematic review and meta‐analysis

SEOM-GETNE clinical guidelines for the diagnosis and treatment of gastroenteropancreatic and bronchial neuroendocrine neoplasms (NENs) (2022)

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