title: Prospective clinical trial of preoperative sunitinib in patients with renal cell carcinoma.
abstract: OBJECTIVE
  Sunitinib is an approved treatment for metastatic renal cell carcinoma. We performed a prospective clinical trial to evaluate the safety and clinical response to sunitinib administered before nephrectomy in patients with localized or metastatic clear cell renal cell carcinoma.
  
  
  METHODS
  Patients with biopsy proven clear cell renal cell carcinoma were enrolled in the study and treated with 37.5 mg sunitinib malate daily for 3 months before nephrectomy. The primary end point was safety.
  
  
  RESULTS
  In an 18-month period 20 patients were enrolled. The most common toxicities were gastrointestinal symptoms and hematological effects. Grade 3 toxicity developed in 6 patients (30%). No surgical complications were attributable to sunitinib treatment. Of the 20 patients 17 (85%) experienced reduced tumor diameter (mean change -11.8%, range -27% to 11%) and cross-sectional area (mean change -27.9%, range -43% to 23%). Enhancement on contrast enhanced computerized tomography decreased in 15 patients (mean HU change -22%, range -74% to 29%). After tumor reduction 8 patients with cT1b disease underwent laparoscopic partial nephrectomy. Surgical parameters, such as blood loss, transfusion rate, operative time and complications, were similar to those in patients who underwent surgery during the study period and were not enrolled in the trial.
  
  
  CONCLUSIONS
  Preoperative treatment with sunitinib is safe. Sunitinib decreased the size of primary renal cell carcinoma in 17 of 20 patients. Future trials can be considered to evaluate neoadjuvant sunitinib to maximize nephron sparing and decrease the recurrence of high risk, localized renal cell carcinoma.
authors.affiliation: Department of Urology, Roswell Park Cancer Institute, Buffalo, New York, USA.
authors.forename: Nicholas J
authors.initials: NJ
authors.lastname: Hellenthal
authors.forename: Willie
authors.initials: W
authors.lastname: Underwood
authors.forename: Remedios
authors.initials: R
authors.lastname: Penetrante
authors.forename: Alan
authors.initials: A
authors.lastname: Litwin
authors.forename: Shaozeng
authors.initials: S
authors.lastname: Zhang
authors.forename: Gregory E
authors.initials: GE
authors.lastname: Wilding
authors.forename: Bin T
authors.initials: BT
authors.lastname: Teh
authors.forename: Hyung L
authors.initials: HL
authors.lastname: Kim
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000601:surgery; D005260:Female; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009392:Nephrectomy; D011300:Preoperative Care; D011446:Prospective Studies; D011758:Pyrroles / Q000627:therapeutic use*; D000077210:Sunitinib
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib