title: Efficacy and safety of sorafenib in advanced renal cell cancer and validation of Heng criteria.
abstract: BACKGROUND
  Sorafenib is an established upfront treatment option for metastatic RCC (mRCC). There is no published literature regarding its performance in Indian Patients. We present an analysis of Sorafenib use in our institute and attempt to validate the Heng criteria as a prognostic score in these patients.
  
  
  METHODS
  Patients who received Sorafenib as first line treatment for advanced RCC from June 2012 to December 2015 were prognosticated by Heng criteria and retrospectively analysed for baseline demographics, toxicity, response and outcomes.
  
  
  RESULTS
  82 patients (65 males, 17 females) with a median age of 57 years were included for final analysis. Median ECOG PS was 1, 95.2 % of the patients had Stage IV disease and clear cell was the predominant histology (79.4%). 23.2%, 42.7% and 34.1% of patients were classified as low, intermediate and high risk by Heng's criteria, respectively. Dose reduction was required in 24.4% of patients, while 14.6% required permanent cessation of Sorafenib due to intolerable or recurrent side effects. Common adverse events included HFS (68.2%), mucositis (35.3%), fatigue (35.3%), rash (32.9%) and hypertension (25.6%). Response rate observed was 18.2%, while clinical benefit rate was 57.2% in the 57 patients where response was evaluable. Median progression free survival was 7.75 months (5.45-10.05) and median overall survival (OS) was 12.18 months (9.61 - 14.76). Median OS was 19.6, 16.1 and 10.3 months respectively for low, intermediate and high risk patients by Heng criteria and the criteria was statistically discriminatory for the 3 groups for OS (p=0.045, chi-square test).
  
  
  CONCLUSIONS
  Sorafenib is a viable upfront treatment option for metastatic RCC in Indian patients with acceptable PFS, although a high incidence of HFS, mucositis and rash is observed. The Heng score has discriminatory value in mRCC with Sorafenib and can be considered for routine use in the clinic.
authors.affiliation: Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India.
authors.forename: A
authors.initials: A
authors.lastname: Joshi
authors.affiliation: Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India.
authors.forename: A
authors.initials: A
authors.lastname: Ramaswamy
authors.affiliation: Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India.
authors.forename: V
authors.initials: V
authors.lastname: Noronha
authors.affiliation: Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India.
authors.forename: V M
authors.initials: VM
authors.lastname: Patil
authors.affiliation: Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India.
authors.forename: A
authors.initials: A
authors.lastname: Chandrasekharan
authors.affiliation: Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India.
authors.forename: A
authors.initials: A
authors.lastname: Goel
authors.affiliation: Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India.
authors.forename: A
authors.initials: A
authors.lastname: Sahu
authors.affiliation: Department of Radiodiagnosis, Tata Memorial Hospital, Mumbai, Maharashtra, India.
authors.forename: N
authors.initials: N
authors.lastname: Sable
authors.affiliation: Department of Nuclear Medicine, Tata Memorial Hospital, Mumbai, Maharashtra, India.
authors.forename: A
authors.initials: A
authors.lastname: Agrawal
authors.affiliation: Department of Pathology, Tata Memorial Hospital, Mumbai, Maharashtra, India.
authors.forename: S
authors.initials: S
authors.lastname: Menon
authors.affiliation: Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India.
authors.forename: K
authors.initials: K
authors.lastname: Prabhash
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000627:therapeutic use*; D011446:Prospective Studies; D000077157:Sorafenib; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib