155P Surufatinib plus toripalimab for second-line treatment of advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, esophageal squamous cell carcinoma (ESCC) and neuroendocrine carcinoma (NEC): A multicenter, single-arm phase II study

Lu, Ming; Yu, Xianjun; Chen, Z.; Zhang, Y.; Li, Z.; Zhang, X.; Yin, Fei; Ye, F.; Cheng, Ying; Song, Lijie; Xu, Jianming; Zhou, Jin; Shi, Haiyan; Tan, Peng; Fan, ST; Su, Weiguo; Shen, Lin

doi:10.1016/j.annonc.2021.10.174

Cited by 3 publications

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“…Phase III trials of targeted therapy solely encompassed patients with G1/G2 NENs, while the effectiveness and safety of drugs for high-grade (G3 or Ki67 >20%) NENs and poorly-differentiation NECs remain unexplored. Two prospective phase 2 trials tried to verify everolimus and sunitinib activity in advanced G3/NEC patients and found that efficacy was limited with mPFS of 1.2 and 1.4 months ( 38 , 39 ), respectively, whereas surufatinib achieved a 23% ORR and 4.14 months mPFS in NEC ( 40 ). Hence, application of targeted agents needs careful consideration.…”

Section: Discussionmentioning

confidence: 99%

Assessing the effectiveness and safety of surufatinib versus everolimus or sunitinib in advanced neuroendocrine neoplasms: insights from a real-world, retrospective cohort study using propensity score and inverse probability treatment weighting analysis

Zhu,

Ye,

She

et al. 2024

J Gastrointest Oncol

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Background While surufatinib, sunitinib, and everolimus have shown efficacy for advanced neuroendocrine neoplasms (NENs) in randomized controlled trials (RCTs), direct comparisons in a real-world setting remain unexplored. This gap highlights the clinical need to understand their comparative effectiveness and safety within the diverse Chinese population. Addressing this, our study provides insights into the real-world performance of these therapies, aiming to inform treatment selection and improve patient outcomes. Methods A retrospective, observational study was conducted at Fudan University Shanghai Cancer Center, including patients with advanced NENs treated with surufatinib, sunitinib, or everolimus between July 2020 and April 2023. Eligibility criteria focused on histologically confirmed, locally advanced, unresectable, or metastatic NENs, with patients having received at least one month of targeted therapy. We employed inverse probability weighting (IPW) with the propensity score (PS) matching to adjust for the bias of baseline characteristics. The assessment of covariates included age, sex, performance status, primary tumor site, functional status, genetic mutations, tumor differentiation, Ki67 index, tumor grade, metastasis site, and previous therapies. The primary outcome was progression-free survival (PFS), and secondary outcomes included objective response rate (ORR), disease control rate (DCR), and adverse events (AEs). Results The study enrolled 123, 56, and 68 locally advanced or metastatic NEN patients treated with surufatinib, sunitinib, and everolimus, respectively. Before adjusting for confounding factors, surufatinib was used less frequently as a first-line treatment compared to sunitinib and everolimus in pancreatic NENs (pNENs) (11.1% vs. 22.1%, P=0.057). Significant differences were noted in prior treatments and tumor characteristics between surufatinib and everolimus groups in extrapancreatic NENs (epNENs) (P<0.05). Post-IPW, these disparities were resolved (P>0.05). Surufatinib demonstrated superior median PFS (mPFS) in both pancreatic [8.30 vs. 6.33 months, hazard ratio (HR) 0.592, P<0.001] and epNENs (8.73 vs. 3.70 months, HR 0.608, P<0.001) compared to everolimus or sunitinib. Notably, male gender (HR 1.75, P=0.001), functional status (HR 2.09, P=0.01), Ki67 index >20% (HR 12.7, P=0.004), previous somatostatin analogue (SSA) treatment (HR 1.73, P=0.001), germline mutation (HR 5.62, P<0.001), poor differentiation (HR 7.45, P<0.001), liver metastasis (HR 1.72, P=0.001) and multiple treatment lines (HR 1.62 for 2 nd line, P=0.04; HR 1.88 for ≥3 rd line, P=0.01) were identified as negative prognostic factors for PFS. Conversely, dose adjustment (HR 0.63, P=0.009) and treatment with surufatinib (HR 0.58 for pNEN, P<0.001; HR 0.62 for epNEN, P=0.002) were correlated with longer PFS. ...

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Section: Discussionmentioning

confidence: 99%

Assessing the effectiveness and safety of surufatinib versus everolimus or sunitinib in advanced neuroendocrine neoplasms: insights from a real-world, retrospective cohort study using propensity score and inverse probability treatment weighting analysis

Zhu,

Ye,

She

et al. 2024

J Gastrointest Oncol

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“…Everolimus [52] Long-acting octreotide or lanreotide (SSTR-2-positive patients) * Sunitinib [53] Surufatinib [51] PRRT [55,[57][58][59][60] Temozolomide + Capecitabine [61] For patients with favorable tumor biology Nivolumab + Ipilimumab Surufatinib+Toripalimab [65] Other recommendations Belzutifan (for patients with germline VHL alterations) [63] Pembrolizumab (for patients with TMB-H, dMMR, or MSI-H) For patients with unfavorable tumor biology: Nivolumab + Ipilimumab [64] Pembrolizumab * Note: SSAs are recommended second-line approach for patients who have not received in the first-line setting. However, if the disease progressed on first-line SSAs, treatment with SSAs should be discontinued for non-functioning tumors, while continued for functioning tumors.…”

Section: Preferred Regimensmentioning

confidence: 99%

Chinese Medical Association consensus for standardized diagnosis and treatment of pancreatic neuroendocrine neoplasms

Jiao,

Cui,

et al. 2023

Chinese Medical Journal

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Pancreatic neuroendocrine neoplasms (pNENs) are rare and highly heterogeneous tumors originating from pluripotent stem cells with neuroendocrine differentiation in the pancreas, constituting approximately 3% of all pancreatic tumors. [1] The global incidence of pNENs has been increasing recently, and most cases are sporadic and more common in women. [1,2] Feng Jiao and Jiujie Cui contributed equally to this work.

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“…distinct geographical distribution and is particularly common among Asian and African populations [6,7]. The first-line treatment with standard of care (SoC) chemotherapy has a poor prognosis with a mPFS of seven months and a mOS of 22.1 months [8,9].…”

Section: S3mentioning

confidence: 99%

“…Results of an ongoing multicenter phase II trial investigating the efficacy and safety of surufatinib (250 mg per oral (PO) once daily) plus toripalimab (240 mg IV Q3W) in patients with unresectable or metastatic advanced solid tumors was presented at ESMO IO 2021 (NCT04169672) [7]. At the time of data cut-off (August 1, 2021), 62 patients were assigned in this open-label study into three cohorts of patients with advanced neuroendocrine carcinoma (NEC, n=21), gastric or gastroesophageal junction adenocarcinoma (G/GEJ, n=21), or advanced esophageal squamous cell carcinoma (ESCC, n=20) who progressed after 1L systemic chemotherapy.…”

Section: Novel Surufatinib Combined With Toripalimab In Solid Tumorsmentioning

confidence: 99%

A GLOBAL DIGEST ON APPROACHES IN ADVANCED SOLID TUMORS. Report from the ESMO Immuno-Oncology Congress, 8th – 11th December 2021

2022

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155P Surufatinib plus toripalimab for second-line treatment of advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, esophageal squamous cell carcinoma (ESCC) and neuroendocrine carcinoma (NEC): A multicenter, single-arm phase II study

Cited by 3 publications

References 0 publications

Assessing the effectiveness and safety of surufatinib versus everolimus or sunitinib in advanced neuroendocrine neoplasms: insights from a real-world, retrospective cohort study using propensity score and inverse probability treatment weighting analysis

Assessing the effectiveness and safety of surufatinib versus everolimus or sunitinib in advanced neuroendocrine neoplasms: insights from a real-world, retrospective cohort study using propensity score and inverse probability treatment weighting analysis

Chinese Medical Association consensus for standardized diagnosis and treatment of pancreatic neuroendocrine neoplasms

A GLOBAL DIGEST ON APPROACHES IN ADVANCED SOLID TUMORS. Report from the ESMO Immuno-Oncology Congress, 8th – 11th December 2021

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