title: Effect of imaging and catheter characteristics on clinical outcome for patients in the PRECISE study.
abstract: The PRECISE study used convection enhanced delivery (CED) to infuse IL13-PE38QQR in patients with recurrent glioblastoma multiforme (GBM) and compared survival to Gliadel Wafers (GW). The objectives of this retrospective evaluation were to assess: (1) catheter positioning in relation to imaging features and (2) to examine the potential impact of catheter positioning, overall catheter placement and imaging features on long term clinical outcome in the PRECISE study. Catheter positioning and overall catheter placement were scored and used as a surrogate of adequate placement. Imaging studies obtained on day 43 and day 71 after resection were each retrospectively reviewed. Catheter positioning scores, catheter overall placement scores, local tumor control and imaging change scores were reviewed and correlated using Generalized Linear Mixed Models. Cox PH regression analysis was used to examine whether these imaging based variables predicted overall survival (OS) and progression free survival (PFS) after adjusting for age and KPS. Of 180 patients in the CED group, 20 patients did not undergo gross total resection. Of the remaining 160 patients only 53% of patients had fully conforming catheters in respect to overall placement and 51% had adequate catheter positioning scores. Better catheter positioning scores were not correlated with local tumor control (P = 0.61) or imaging change score (P = 0.86). OS and PFS were not correlated with catheter positioning score (OS: P = 0.53; PFS: P = 0.72 respectively), overall placement score (OS: P = 0.55; PFS: P = 0.35) or imaging changes on day 43 MRI (P = 0.88). Catheter positioning scores and overall catheter placement scores were not associated with clinical outcome in this large prospective trial.
authors.affiliation: Department of Neurology, University of San Francisco, 350 Parnassus Ave, Suite 609, San Francisco, CA 94117, USA. muellers@neuropeds.ucsf.edu
authors.forename: Sabine
authors.initials: S
authors.lastname: Mueller
authors.forename: Mei-Yin
authors.initials: MY
authors.lastname: Polley
authors.forename: Benjamin
authors.initials: B
authors.lastname: Lee
authors.forename: Sandeep
authors.initials: S
authors.lastname: Kunwar
authors.forename: Christoph
authors.initials: C
authors.lastname: Pedain
authors.forename: Eva
authors.initials: E
authors.lastname: Wembacher-Schröder
authors.forename: Stephan
authors.initials: S
authors.lastname: Mittermeyer
authors.forename: Manfred
authors.initials: M
authors.lastname: Westphal
authors.forename: John H
authors.initials: JH
authors.lastname: Sampson
authors.forename: Michael A
authors.initials: MA
authors.lastname: Vogelbaum
authors.forename: David
authors.initials: D
authors.lastname: Croteau
authors.forename: Susan M
authors.initials: SM
authors.lastname: Chang
mesh_terms: D057785:Catheters; D016543:Central Nervous System Neoplasms / Q000175:diagnosis* / Q000188:drug therapy* / Q000401:mortality; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005098:Exotoxins / Q000627:therapeutic use*; D005500:Follow-Up Studies; D005909:Glioblastoma / Q000175:diagnosis* / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D018793:Interleukin-13 / Q000627:therapeutic use*; D007391:International Cooperation; D017567:Karnofsky Performance Status; D016014:Linear Models; D008279:Magnetic Resonance Imaging / Q000379:methods; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D016017:Odds Ratio; D016016:Proportional Hazards Models; D011993:Recombinant Fusion Proteins; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D005098:Exotoxins; C521502:IL13-PE38; D007155:Immunologic Factors; D018793:Interleukin-13; D011993:Recombinant Fusion Proteins