Cancer Research and Treatment

Original Articles

General

Phase 1/2a Study of Rivoceranib, a Selective VEGFR-2 Angiogenesis Inhibitor, in Patients with Advanced Solid Tumors: Yoon-Koo Kang, Min-Hee Ryu, Yong Sang Hong, Chang-Min Choi, Tae Won Kim, Baek-Yeol Ryoo, Jeong Eun Kim, John R. Weis, Rachel Kingsford, Cheol Hee Park, Seong Jang, Arlo McGinn, Theresa L. Werner, Sunil Sharma; Cancer Res Treat. 2024;56(3):743-750. Published online January 18, 2024; DOI: https://doi.org/10.4143/crt.2023.980

Abstract PDF Supplementary Material PubReader ePub: Purpose
This study aimed to report the results from an early-phase study of rivoceranib, an oral tyrosine kinase inhibitor highly selective for vascular endothelial growth factor receptor 2, in patients with advanced solid tumors.
Materials and Methods
In this open-label, single-arm, dose-escalating, multicenter three-part phase 1/2a trial, patients had advanced solid tumors refractory to conventional therapy. Part 1 evaluated the safety and pharmacokinetics of five ascending once-daily doses of rivoceranib from 81 mg to 685 mg. Part 2 evaluated the safety and antitumor activity of once-daily rivoceranib 685 mg. Part 3 was conducted later, due to lack of maximum tolerated dose determination in part 1, to evaluate the safety and preliminary efficacy of once-daily rivoceranib 805 mg in patients with unresectable or advanced gastric cancer.
Results
A total of 61 patients were enrolled in parts 1 (n=25), 2 (n=30), and 3 (n=6). In parts 1 and 2, patients were white (45.5%) or Asian (54.5%), and 65.6% were male. The most common grade ≥ 3 adverse events were hypertension (32.7%), hyponatremia (10.9%), and hypophosphatemia (10.9%). The objective response rate (ORR) was 15.2%. In part 3, dose-limiting toxicities occurred in two out of six patients: grade 3 febrile neutropenia decreased appetite, and fatigue. The ORR was 33%.
Conclusion
The recommended phase 2 dose of rivoceranib was determined to be 685 mg once daily, which showed adequate efficacy with a manageable safety profile (NCT01497704 and NCT02711969).

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Therapeutic Implication of Intracavitary Instillation of Interferon-alpha-2b in Advanced Solid Tumors: Yeul Hong Kim; J Korean Cancer Assoc. 1994;26(3):510-519.

Abstract PDF: Malignant pleural effusions and ascites are distressing complications in solid cancer patients with considerable management problems. Intracavitary immunotherapy has been studied recently in a variety of solid tumors that otherwise might be incurable. Using the intraperitoneal administration of a cytokine, such as the interferons and the interleukins, some complete regressions of tumors have been documented. But those trials were applied for malignant lesions that are isolated to the peritoneal cavity, such as residual ovarian cancer. To evaluate the clinical implications of intracavitary interferon-alpha-2b(IFN-a2b) instillation with or without systemic chemotherapy in various solid tumors, thirteen patients (five with gastric, four with hepatic, two with bronchial, one with ovarian, and one with pancreatic tumor) with carcinoma- tous pleural effusions or ascites were treated with intracavitary instillation of IFN-a2b 6MU or 10MU on day 1, 8, 15, repeated every 28 days. Two patients who had recurrent ascites after ini- tial response, were retreated by same method and total IS cases were evaluable. Ten patients were treated with intracavitary IFN-a2b and systemic chematherapy (six with oral UFT and Leucovorin, two with Etoposide, Ifosfomide, and Cisplatin, one with Cyclophsphamide, Adriamycin, and Cisplatin, one with Etoposide, Leucovorin, and Cisplatin). Nine cases (60%) showed clinical evidence of therapeutic benefit by disaPPearance of malignant ascites or pleural effusion. The response ranged from 8 to 44+ weeks with a median of 12+ weeks. Especially responders treated with intracavitary IFN-a2b and systemic chemotherapy showed long- er duration of response. Fever (8/15) and abdominal pain (4/15) were the most common side effects. Patients who treated with IFN-a2b instil1ation only did not show any significant side effects and leukopenia and mucositis which developed after combined therapy with chemotherapy were not seem to be related with IFN-a2b instillation. These results suggest a role of intracavitary IFN-a2b instillation for control of malignant ascites and pleural effusion in advanced solid tumor. Also minor side effects of intracavitary IFNMb instillation suggest that this treatment can be combined safely with systemic chemotherapy.

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