A phase II study of dovitinib in patients with recurrent or metastatic adenoid cystic carcinoma (ACC).

Dillon, Patrick M.; Petroni, Gina R.; Moskaluk, Chris; Fracasso, Paula M.; Douvas, Michael G.; Perez, Jose Ricardo; Varhegyi, Nikole; Zaja‐Milatovic, Snjezana; Thomas, Christopher Y.

doi:10.1200/jco.2015.33.15_suppl.e17092

Cited by 5 publications

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“…In our study, 98.5% of patients achieved disease control, and tumor shrinkage within the PR criteria was observed in 46.2% of patients. The response rate was much higher than that reported in several phase II trials (0-11%) of other multitargeted TKIs tested for ACC, including sunitinib, 16 sorafenib, 15 dovitinib, 17 and lenvatinib. 18 There have been few objective responses in previous trials, but several studies have demonstrated high rates and prolonged disease stabilization.…”

Section: Discussionmentioning

confidence: 55%

Apatinib in patients with recurrent or metastatic adenoid cystic carcinoma of the head and neck: a single-arm, phase II prospective study

et al. 2021

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Background: Apatinib, a vascular endothelial growth factor receptor (VEGFR) blocker, has demonstrated encouraging antitumor activities and tolerable toxicities in various cancer types. Recurrent or metastatic adenoid cystic carcinoma of the head and neck (R/MACCHN) carries a poor prognosis, and treatment options are currently limited. This study was conducted to explore the antitumor activity and safety of apatinib in patients with R/MACCHN. Methods: In this phase II single-arm, prospective study, patients aged 15–75 years with incurable R/MACCHN received apatinib at a 500 mg dose once daily until intolerance or progression occurred. The primary endpoint was the 6-month progression-free survival (PFS) rate based on RECIST version 1.1. The secondary endpoints included response rate, overall survival (OS), and safety. Efficacy was assessed in all dosed patients with at least one post-baseline tumor assessment. Results: Among 68 patients treated with apatinib, 65 were evaluable for efficacy analysis, with a median follow-up time of 25.8 months. The 6-month, 12-month, and 24-month PFS rates were 92.3% [95% confidence interval (CI): 83–97.5%], 75.2% (95% CI: 61.5–84.0%) and 44.7% (95% CI: 32.3–57.5%), respectively. The objective response rate (ORR) and disease control rate (DCR), as assessed by investigators, were 46.2% (95% CI: 33.7–59.0%) and 98.5% (95% CI: 91.7–100.0%), respectively. The median duration of response was 17.7 months [interquartile range (IQR) 14.0–20.9]. The 12-month and 24-month OS rates were 92.3% (95% CI: 83.0–97.5%) and 82.3% (95% CI: 70–90.4%), respectively. The most common adverse events of grades 3–4 were hypertension (5.9%), proteinuria (9.2%), and hemorrhage (5.9%). One patient developed a fatal hemorrhage. Conclusion: An encouraging PFS, a high ORR, and a manageable safety profile were observed in this study. It seems that the administration of apatinib in R/MACCHN is likely to have a clinically meaningful therapeutic benefit and warrants further investigation. This study was prospectively registered in ClinicalTrials.gov (NCT02775370; date of registration: 17 May 2016; date of first patient enrollment: 25 May 2016)

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Section: Discussionmentioning

confidence: 55%

Apatinib in patients with recurrent or metastatic adenoid cystic carcinoma of the head and neck: a single-arm, phase II prospective study

et al. 2021

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“…Axitinib - a small molecule inhibitor of vascular endothelial growth factor (VEGF), c-kit, and platelet derived growth factor receptor (PDGFR) - produced three partial responses (9 % ORR) in a single center trial for ACC [30]. Dovitinib -an oral tyrosine-kinase inhibitor that inhibits VEGF and fibroblast growth factor receptors (FGFR) - showed minimal activity in two trials (ORR 3 % and 6 %) and poor tolerability with grade 3/4 asthenia reported in >50 % of patients [31, 32]. Genetic analysis of tumors of patients with ACC showed that a significant number of tumors had mutations involving the FGF-PI3K-AKT pathway [33], however the AKT-inhibitor MK-2206 and the mTOR inhibitor everolimus showed no responses in ACC patients [34, 35].…”

Section: Biologic Agentsmentioning

confidence: 99%

Systemic therapy for recurrent or metastatic salivary gland malignancies

2016

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Salivary gland carcinomas are notoriously resistant to therapy and no standard of care exists. Due to the rarity of these malignancies, various histologies, and wide ranging clinical behavior it has been difficult to standardize systemic therapy. We have reviewed clinical prospective studies in the last 15 years with salivary gland malignancies involving cytotoxic chemotherapy and biologic agents including targeted therapies such as anti-HER-2, anti-EGFR therapies, and therapies directed at c-kit. Although the results of most trials are modest at best, there has been an increase in studies for salivary cancer in recent years and there are several promising treatment approaches in evolution. Every effort should be made to treat salivary gland malignancies under a clinical protocol and/or at a large multidisciplinary practice with clinicians experienced in treating these malignancies.

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Systemic therapy in metastatic salivary gland carcinomas: A pathology-driven paradigm?

et al. 2017

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A phase II study of dovitinib in patients with recurrent or metastatic adenoid cystic carcinoma (ACC).

Cited by 5 publications

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Apatinib in patients with recurrent or metastatic adenoid cystic carcinoma of the head and neck: a single-arm, phase II prospective study

Apatinib in patients with recurrent or metastatic adenoid cystic carcinoma of the head and neck: a single-arm, phase II prospective study

Systemic therapy for recurrent or metastatic salivary gland malignancies

Systemic therapy in metastatic salivary gland carcinomas: A pathology-driven paradigm?

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