title: Pilot study of adoptive immunotherapy with sentinel node-derived T cells in muscle-invasive urinary bladder cancer.
abstract: OBJECTIVE
  The aim of this study was to determine by computed tomography (CT) whether treatment with tumor-draining lymph-node-derived expanded autologous T lymphocytes results in objective responses and/or improved survival in patients with metastatic urinary bladder cancer (UBC) and to record the toxicity of the treatment.
  
  
  METHODS
  Eighteen patients with metastatic UBC were prospectively selected from two centers. The preoperative staging was T2-T4bN1-2 and/or M0-M1 or MX. Tumor-draining lymph nodes were harvested at intended cystectomy for the extraction of T lymphocytes. This was followed by expansion of the T lymphocytes in a cell culture, and subsequent reinfusion of these autologous tumor-specific T lymphocytes. Responses to therapy were evaluated by CT scans according to Response Evaluation Criteria In Solid Tumors (RECIST) and clinical follow-up, according to the research protocol.
  
  
  RESULTS
  Nine out of 18 patients were treated. Treatment was feasible and safe. In two out of nine immunologically treated patients, objective responses were detected in terms of diminished or obliterated nodal metastases. When excluding three patients with disseminated osseous metastases plus one with a T4b tumor left in situ, a success rate of two out of six treated patients was seen. The two responders had survival times of 35 and 11 months, respectively. No toxicity was recorded.
  
  
  CONCLUSIONS
  Infusion of expanded autologous tumor-specific T lymphocytes is feasible and safe, and objective responses according to RECIST were recorded. One objective responder to immunotherapy displayed notably long overall survival.
authors.affiliation: a 1 Department of Surgical and Perioperative Sciences, Urology and Andrology, Umeå University , Umeå, Sweden.
authors.forename: Amir
authors.initials: A
authors.lastname: Sherif
authors.affiliation: b 2 Department of Clinical Sciences, Surgery and Urology, Danderyd Hospital, Karolinska Institutet , Sweden.
authors.forename: Mudhar N
authors.initials: MN
authors.lastname: Hasan
authors.affiliation: c 3 Department of Diagnostic Radiology, Karolinska University Hospital, Karolinska Institutet , Stockholm, Sweden.
authors.forename: Eva
authors.initials: E
authors.lastname: Radecka
authors.affiliation: d 4 Servicio de Radiología, Hospital Universitario Insular de Gran Canaria , Las Palmas, Spain.
authors.forename: Alvaro Lozano
authors.initials: AL
authors.lastname: Rodriguez
authors.affiliation: e 5 Department of Surgery and Urology, Mälarsjukhuset , Eskilstuna, Sweden.
authors.forename: Sarab
authors.initials: S
authors.lastname: Shabo
authors.affiliation: f 6 Translational Immunology Unit, Department of Medicine, Karolinska University Hospital, Karolinska Institutet , Stockholm, Sweden.
authors.forename: Mona
authors.initials: M
authors.lastname: Karlsson
authors.affiliation: g 7 Department of Urology, Hirslanden Klinik , Aarau, Switzerland.
authors.forename: Martin C
authors.initials: MC
authors.lastname: Schumacher
authors.affiliation: f 6 Translational Immunology Unit, Department of Medicine, Karolinska University Hospital, Karolinska Institutet , Stockholm, Sweden.
authors.forename: Per
authors.initials: P
authors.lastname: Marits
authors.affiliation: f 6 Translational Immunology Unit, Department of Medicine, Karolinska University Hospital, Karolinska Institutet , Stockholm, Sweden.
authors.forename: Ola
authors.initials: O
authors.lastname: Winqvist
keywords: Adoptive cellular immunotherapy; sentinel lymph-node biopsy; urinary bladder neoplasms