title: Sunitinib in metastatic renal cell carcinoma (mRCC): a developing country experience. Do our patients behave differently than the Western patients?
abstract: BACKGROUND
  Metastatic renal cell carcinoma (mRCC) has historically been refractory to cytotoxic and hormonal agents. IL-2 and IFN-α provide response in a minority of patients. Small molecule tyrosine kinase inhibitors and monoclonal antibodies have established a role in the setting of mRCC. However, there is a lack of data from the Indian subcontinent. The aim of this study was to look whether our patients behave similarly as reported in the Western data to targeted agents, especially sunitinib.
  
  
  METHODS
  The study was a prospective observational study conducted for a period of 5 years from 2011 to 2016. Sixty-three patients received targeted agents and were recruited in the study. Five patients were excluded for various reasons, and three were lost to follow-up. Fifty-five patients were properly studied and followed up. Fifty patients received sunitinib, four patients received sorafenib, and one patient received parenteral temsirolimus. Patients were followed for AEs and survival.
  
  
  RESULTS
  The most common AEs in patients taking sunitinib were fatigue (70 %), hand-foot syndrome (62 %), skin rash (58 %), mucosal inflammation (58 %), anorexia (42 %), skin discoloration (42 %), followed by dry mouth, dysgeusia, dyspepsia, dry skin, dry mouth, hair color changes, hypothyroidism, alopecia, oral pain/stomatitis, hypertension, decreased weight, photosensitivity, peripheral edema, erythema, and others. The median overall survival in our patients was 13.2 (95 % CI 10.1-16.5), progression-free survival was 8.1 months (95 % CI 6.4-10.5), and objective response was seen in 36 %.
  
  
  CONCLUSIONS
  Non-Western patients behave differently with sunitinib therapy compared to Western patients. Our patients have more mucocutaneous side effects and lesser overall survival.
authors.affiliation: Department of Medical Oncology, Sher-i-Kashmir Institute Of Medical Sciences (SKIMS), Srinagar, India.
authors.forename: Mohmad Hussain
authors.initials: MH
authors.lastname: Mir
authors.affiliation: Department of Internal Medicine, Sher-i-Kashmir Institute Of Medical Sciences (SKIMS), Srinagar, India. khalidchangal@gmail.com.|Department of Internal Medicine, Mercy St. Vincent Medical Center, 2213 Cherry Street, Toledo, OH, USA. khalidchangal@gmail.com.
authors.forename: Khalid Hamid
authors.initials: KH
authors.lastname: Changal
authors.affiliation: Department of Medical Oncology, Sher-i-Kashmir Institute Of Medical Sciences (SKIMS), Srinagar, India.
authors.forename: Shiekh Aejaz
authors.initials: SA
authors.lastname: Aziz
authors.affiliation: Department of Medical Oncology, Sher-i-Kashmir Institute Of Medical Sciences (SKIMS), Srinagar, India.
authors.forename: Gull Mohammad
authors.initials: GM
authors.lastname: Bhat
authors.affiliation: Department of Medical Oncology, Sher-i-Kashmir Institute Of Medical Sciences (SKIMS), Srinagar, India.
authors.forename: Abdul Rashid
authors.initials: AR
authors.lastname: Lone
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000855:Anorexia / Q000139:chemically induced; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000556:secondary; D003906:Developing Countries; D018572:Disease-Free Survival; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D005500:Follow-Up Studies; D060831:Hand-Foot Syndrome / Q000209:etiology; D006801:Humans; D007194:India; D007211:Indoles / Q000009:adverse effects* / Q000627:therapeutic use; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D052016:Mucositis / Q000139:chemically induced; D009536:Niacinamide / Q000031:analogs & derivatives / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000627:therapeutic use; D010859:Pigmentation Disorders / Q000139:chemically induced; D011446:Prospective Studies; D011758:Pyrroles / Q000009:adverse effects* / Q000627:therapeutic use; D066066:Response Evaluation Criteria in Solid Tumors; D020123:Sirolimus / Q000031:analogs & derivatives / Q000627:therapeutic use; D000077157:Sorafenib; D000077210:Sunitinib; D015996:Survival Rate; D044465:White People; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D010671:Phenylurea Compounds; D011758:Pyrroles; D009536:Niacinamide; C401859:temsirolimus; D000077157:Sorafenib; D000077210:Sunitinib; D020123:Sirolimus
keywords: Metastatic renal cell carcinoma; Sunitinib; Targeted therapy