title: Bisphosphonates in patients with renal cell carcinoma and bone metastases: a sunitinib global expanded-access trial subanalysis.
abstract: OBJECTIVE
  To investigate retrospectively the effects of bone metastases and bisphosphonates in sunitinib-treated metastatic renal cell carcinoma patients.
  
  
  METHODS
  Patients in Groups (Gp) 1 and 2, but not Gp3, had bone metastases. Gp2 received bisphosphonates following standard practice.
  
  
  RESULTS
  Gp2 had less favorable prognosis than Gp1. Gp3 had fewer metastases and the best prognosis. More serious adverse events occurred in Gp2 versus Gp1. The difference in overall survival between Gp1 and Gp2 was not significant after adjusting for covariates. Significantly shorter overall survival in Gp1 versus Gp3 persisted after adjusting for covariates.
  
  
  CONCLUSIONS
  Bone metastases may have a negative prognostic impact in metastatic renal cell carcinoma. Bisphosphonates may have delayed early disease progression for prognostically worse sunitinib/bisphosphonate-treated patients.
authors.affiliation: Centre of Oncology, Medical School Split, University Hospital Split, Split, Spinciceva 1, 21000 Split, Croatia.
authors.forename: Eduard
authors.initials: E
authors.lastname: Vrdoljak
authors.affiliation: Royal Marsden Hospital, Fulham Road, London, SW3 6JJ, UK.
authors.forename: Martin
authors.initials: M
authors.lastname: Gore
authors.affiliation: Pfizer, Boulevard de la Plaine 17, 1050 Elsene/Ixelles (Brussels), Belgium.
authors.forename: Sophie
authors.initials: S
authors.lastname: Leyman
authors.affiliation: Department of Oncology, Central Clinical Hospital, Military Institute of Medicine, Szaserόw 128, 00-909 Warsaw, Poland.
authors.forename: Cezary
authors.initials: C
authors.lastname: Szczylik
authors.affiliation: Biotherapy Department, N. N. Blokhin Russian Cancer Research Centre, 24 Kashirskoe Shosse, Moscow 115478, Russia.
authors.forename: Galina
authors.initials: G
authors.lastname: Kharkevich
authors.affiliation: University Hospitals Leuven, Leuven Cancer Institute, Herestraat 49, 3000 Leuven, Belgium.
authors.forename: Patrick
authors.initials: P
authors.lastname: Schöffski
authors.affiliation: Department of Oncotherapy, University of Szeged, Korányi fasor 12, 6720, Szeged, Hungary.
authors.forename: Laszlo
authors.initials: L
authors.lastname: Torday
authors.affiliation: Department of Medical Oncology, National Cancer Institute, Vlárska 7, 833 91 Bratislava, Slovakia.
authors.forename: Josef
authors.initials: J
authors.lastname: Mardiak
authors.affiliation: Pfizer, 10646 Science Center Drive, La Jolla, San Diego, CA 92121, USA.
authors.forename: Ke
authors.initials: K
authors.lastname: Zhang
authors.affiliation: Pfizer, 235 East 42nd Street, New York, NY 10017, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Sajben
authors.affiliation: Department of Oncology, Assaf Harofeh Medical Center Zerifin, Beer Yacov, Tel Aviv 70300, Israel.
authors.forename: Avishay
authors.initials: A
authors.lastname: Sella
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D002292:Carcinoma, Renal Cell / Q000188:drug therapy / Q000401:mortality / Q000556:secondary*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007211:Indoles / Q000627:therapeutic use; D053208:Kaplan-Meier Estimate; D007680:Kidney Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D011758:Pyrroles / Q000627:therapeutic use; D000077210:Sunitinib; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D050071:Bone Density Conservation Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib
keywords: VEGF; angiogenesis inhibitor; metastasis; pamidronate; renal cell carcinoma; sunitinib; zoledronic acid