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Percutaneous Hepatic Perfusion (PHP) with Melphalan as a Treatment for Unresectable Metastases Confined to the Liver
Published on: July 31, 2016
Phase II study of darinaparsin in patients with advanced hepatocellular carcinoma
Jennifer Wu1, Charles Henderson, Lynn Feun
1Department of Medical Oncology, NYU School of Medicine, New York, NY, USA. Jennifer.wu@nyumc.org
Background:
Darinaparsin is a novel organic arsenic that reaches higher intracellular concentration with decreased toxicity compared to inorganic arsenic. We conducted a multi-center phase II study with darinaparsin in patients with advanced HCC.
Methods:
Eligibility criteria included unresectable or metastatic measurable HCC, up to two prior systemic treatments, ECOG performance status < or = 2, Child Pugh Class A or B and adequate organ functions. Darinaparsin was administered at 420 mg/m(2) intravenously, twice weekly at least 72 h apart for 3 weeks in a 4-week cycle. The primary end point was response rate. A Simon two-stage design was used.
Results:
Among 15 patients in the first stage, no objective responses were observed. Two patients had stable disease. The median number of cycles on study per patient was 2 (1-6). The median progression free survival and overall survival were 55 days (95% confidence interval: 50-59) and 190 days (95% confidence interval: 93-227), respectively. No treatment related hospitalizations or deaths occurred. Treatment related grade 1-2 toxicities included nausea, vomiting (26.7% each), fatigue (20%), anorexia and diarrhea (13.3% each). Grade 3 anorexia, wheezing, agitation, abdominal pain and SGPT were observed in 1 patient each (6.7%). One patient experienced grade 4 hypoglycemia (6.7%).
Conclusions:
Darinaparsin could be safely administered with tolerable toxicity profiles, and no QTc prolongation in patients with advanced HCC. However, at this dose and schedule, it has shown no objective responses in HCC and this trial was terminated as planned after the first stage of efficacy analysis.
Insights
Darinaparsin, a novel organic arsenic, showed tolerable toxicity in advanced hepatocellular carcinoma (HCC) patients. However, this phase II study found no objective responses, leading to early termination.
Area of Science:
- Oncology
- Pharmacology
- Hepatology
Background:
- Darinaparsin is a novel organic arsenic compound with improved intracellular concentration and reduced toxicity compared to inorganic arsenic.
- Advanced hepatocellular carcinoma (HCC) presents a significant therapeutic challenge, necessitating novel treatment strategies.
Purpose of the Study:
- To evaluate the safety and efficacy of darinaparsin in patients with advanced HCC.
- To determine the objective response rate of darinaparsin in this patient population.
Main Methods:
- A multi-center phase II study was conducted using a Simon two-stage design.
- Eligibility included unresectable or metastatic HCC, up to two prior systemic treatments, and adequate organ function (Child Pugh Class A or B).
- Darinaparsin was administered intravenously at 420 mg/m(2), twice weekly for 3 weeks in a 4-week cycle.
Main Results:
- No objective responses were observed among the 15 patients in the first stage; two achieved stable disease.
- Median progression-free survival was 55 days and median overall survival was 190 days.
- Darinaparsin demonstrated a tolerable toxicity profile with manageable grade 1-2 toxicities; grade 3/4 events were infrequent.
Conclusions:
- Darinaparsin can be safely administered to patients with advanced HCC with a tolerable toxicity profile and no QTc prolongation.
- At the tested dose and schedule, darinaparsin did not demonstrate objective responses in advanced HCC.
- The trial was terminated as planned after the first stage due to lack of efficacy.
