American Association for Cancer Research
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Table S2 from A Phase II Trial of Rivoceranib, an Oral Vascular Endothelial Growth Factor Receptor 2 Inhibitor, for Recurrent or Metastatic Adenoid Cystic Carcinoma

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posted on 2023-11-14, 08:20 authored by Glenn J. Hanna, Myung-Ju Ahn, Jameel Muzaffar, Bhumsuk Keam, Daniel W. Bowles, Deborah J. Wong, Alan L. Ho, Sung-Bae Kim, Francis Worden, Tak Yun, Xianzhang Meng, Jan M. Van Tornout, Maureen G. Conlan, Hyunseok Kang

Table S2. Adverse Events of Any Grade that Occurred in ≥10% of Patients [n (%)]


NIH/NCI Cancer Center



This open-label, single-arm, phase II study evaluated the vascular endothelial growth factor receptor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) rivoceranib in patients with recurrent or metastatic (R/M) adenoid cystic carcinoma (ACC). Eligible patients had confirmed disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) with ≥20% increase in radiologically or clinically measurable lesions or appearance of new lesions within the preceding 6 months. Patients received oral rivoceranib 700 mg once daily. Primary outcomes were objective response rate (ORR) by investigator review and by blinded independent review committee (BIRC). Eighty patients were enrolled and 72 were efficacy evaluable. Seventy-four patients had distant metastases and 49 received prior systemic treatment (14 received VEGFR TKIs). Per investigator and BIRC, respectively, ORR was 15.3% [95% confidence interval (95% CI), 7.9–25.7] and 9.7% (95% CI, 4.0–19.0); median duration of response was 14.9 months (95% CI, 4.9–17.3) and 7.2 months (95% CI, 3.5–8.4); and median progression-free survival was 9.0 months (95% CI, 7.3–11.5) and 9.0 months (95% CI, 7.7–11.5). Grade ≥3 treatment-related adverse events occurred in 56 patients (70.0%); the most common were hypertension (34, 42.5%) and stomatitis (6, 7.5%). Four grade 5 events occurred with one attributed to rivoceranib (epistaxis). Sixty-eight patients (85.0%) had ≥1 dose modifications and 16 patients (20.0%) discontinued rivoceranib for toxicity. In patients with progressing R/M ACC, rivoceranib demonstrated antitumor activity and a manageable safety profile consistent with other VEGFR TKIs.

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