title: C-reactive Protein in Patients with Metastatic Clear Cell Renal Carcinoma: An Important Biomarker for Tumor-associated Inflammation.
abstract: Two consecutive multi-center phase II trials were designed to prove the hypothesis, whether therapeutic modeling of tumor-associated inflammatory processes could result in improved tumor response.Therapy in both trials consisted of low-dose capecitabine 1g/m2 twice daily p.o. for 14 days, every 3 weeks, day 1+, and rofecoxib 25 mg daily p.o., day 1+ (from 11/04 etoricoxib 60 mg daily instead) plus pioglitazone 60 mg daily p.o., day 1+. In study II low-dose IFN-alpha 4.5 MU sc. three times a week, week 1+, was added until disease progression.Eighteen, and 33 patients, respectively, with clear cell renal carcinoma and progressive disease were enrolled. Objective response (48%) was exclusively observed in study II (PR 35%, CR 13%), and paralleled by a strong CRP response after 4 weeks on treatment, p = 0.0005, in all 29 pts (100%) with elevated CRP levels. Median progression-free survival could be more than doubled from a median of 4.7 months (95% CI, 1.0 to 10.4) to 11.5 months (6.8 to 16.2) in study II, p = 0.00001. Median overall survival of population II was 26 months.Efficacious negative regulation of tumor-associated inflammation by transcription modulators may result in a steep increase of tumor response and survival.
authors.affiliation: Department of Hematology and Oncology, University Hospital of Regensburg.Department of Urology, University Hospital of Regensburg, Germany.
authors.forename: Albrecht
authors.initials: A
authors.lastname: Reichle
authors.forename: Jochen
authors.initials: J
authors.lastname: Grassinger
authors.forename: Klaus
authors.initials: K
authors.lastname: Bross
authors.forename: Jochen
authors.initials: J
authors.lastname: Wilke
authors.forename: Thomas
authors.initials: T
authors.lastname: Suedhoff
authors.forename: Bernhard
authors.initials: B
authors.lastname: Walter
authors.forename: Wolf-Ferdinand
authors.initials: WF
authors.lastname: Wieland
authors.forename: Anna
authors.initials: A
authors.lastname: Berand
authors.forename: Reinhard
authors.initials: R
authors.lastname: Andreesen
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