South Asian Journal of Cancer

ORIGINAL ARTICLE: GASTRO-INTESTINAL & HEPATOBILIARY CANCERS
Year
: 2017  |  Volume : 6  |  Issue : 4  |  Page : 144--146

Tolerance and adverse event profile with sorafenib in Indian patients with advanced hepatocellular carcinoma


Vikas Ostwal1, Tarachand Gupta1, Supriya Chopra2, Sherly Lewis2, Mahesh Goel3, Shraddha Patkar3, Nitin Shetty4, Anant Ramaswamy1 
1 Department of Medical Oncology, TMH, Mumbai, Maharashtra, India
2 Department of Radiation Oncology, TMH, Mumbai, Maharashtra, India
3 Department of Surgical Oncology, TMH, Mumbai, Maharashtra, India
4 Department of Intervention Radiology, TMH, Mumbai, Maharashtra, India

Correspondence Address:
Dr. Anant Ramaswamy
Department of Medical Oncology, TMH, Mumbai, Maharashtra
India

Background: The current standard of treatment for advanced hepatocellular cancer Hepatocellular carcinoma (HCC) is Sorafenib. Data regarding its tolerance and adverse event profile in Indian patients is scarce. Materials and Methods: The primary aim of this analysis was to assess the adverse events (Grade 3 and Grade 4 as per CTCAE v4.0) and requirements for dose reduction with sorafenib in advanced HCC. Details of consecutive patients started on 800 mg/day dosing were obtained from a prospectively maintained database (over a period of 6 months) and analyzed. Results: Thirty-nine patients were available for inclusion in the study. Median age was 58 years (range: 20–75). All patients were classified as Barcelona clinic liver cancer C. Common side effects seen were liver dysfunction (38.5%), hand-foot-syndrome-rash (HFSR) (Grade 2 and 3-25.6%), fatigue (Grade 2 and Grade 3–10.3%), and diarrhea (7.7%). Dose reduction was required in 43.6% of patients. Drug interruptions/cessation was required in 38.5% of patients within the first four months of treatment. Nearly 41% of patients required cessation of sorafenib due to intolerable side-effects while 28.2% stopped sorafenib due to progressive disease. At a median follow-up of 4.9 months, median event-free survival (EFS) was 4.20 months (95% confidence interval: 3.343–5.068). Conclusion: A higher incidence of liver dysfunction and HFSR is seen in Indian patients as compared to published data. A significant proportion of patients required cessation of sorafenib due to adverse events in our series. However, EFS remains on par with that seen in larger studies with sorafenib in advanced HCC.


How to cite this article:
Ostwal V, Gupta T, Chopra S, Lewis S, Goel M, Patkar S, Shetty N, Ramaswamy A. Tolerance and adverse event profile with sorafenib in Indian patients with advanced hepatocellular carcinoma.South Asian J Cancer 2017;6:144-146


How to cite this URL:
Ostwal V, Gupta T, Chopra S, Lewis S, Goel M, Patkar S, Shetty N, Ramaswamy A. Tolerance and adverse event profile with sorafenib in Indian patients with advanced hepatocellular carcinoma. South Asian J Cancer [serial online] 2017 [cited 2018 Dec 12 ];6:144-146
Available from: http://journal.sajc.org/article.asp?issn=2278-330X;year=2017;volume=6;issue=4;spage=144;epage=146;aulast=Ostwal;type=0