title: Neoadjuvant Systemic Therapy Before Radical Prostatectomy in High-Risk Prostate Cancer Does Not Increase Surgical Morbidity: Contemporary Results Using the Clavien System.
abstract: BACKGROUND
  Multimodality therapies for men with high- and very high-risk prostate cancer, including neoadjuvant systemic therapy followed by subsequent radical prostatectomy (RP) are being increasingly explored despite the lack of adequate morbidity data.
  
  
  METHODS
  We analyzed the data from 215 consecutive patients with high- and very high-risk prostate cancer who were previously untreated or had received neoadjuvant systemic therapy. All patients underwent RP with extended pelvic lymph node dissection from 2006 to 2010 at a single tertiary care academic center. All complications within 90 days of surgery were defined and categorized by a 5-grade and 10-domain modification of the Clavien system. Univariable and multivariable logistic regression analyses were used to identify preoperative predictors for complications.
  
  
  RESULTS
  Of the 215 patients, 29% experienced a complication of any grade ≤ 90 days after surgery; 6% experienced grade ≥ 3, with no significant difference between either cohort (P = .50). On multivariate analysis, open RP (odds ratio [OR], 2.08; 95% confidence interval [CI], 1.11-3.90; P = .02) and preoperative hemoglobin (OR, 1.98; 95% CI, 1.05-3.72; P = .03) were independent predictors of the occurrence of any grade complication. For major complications (Clavien ≥ 3), a Charlson comorbidity index of 6 to 7 versus 3 to 5 (OR, 5.45; 95% CI, 1.57-18.98; P = .008) and the most recent year of surgery (OR, 4.73; 95% CI, 1.36-16.39; P = .01) were significant predictors on multivariable analysis.
  
  
  CONCLUSIONS
  The use of neoadjuvant systemic therapy did not appear to increase the risk of perioperative complications. These findings support current clinical trials, which might elucidate the oncologic benefit of this multimodality approach.
authors.affiliation: Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX.
authors.forename: Stephen B
authors.initials: SB
authors.lastname: Williams
authors.affiliation: Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX.
authors.forename: John W
authors.initials: JW
authors.lastname: Davis
authors.affiliation: Department of Biomedical Statistics, The University of Texas MD Anderson Cancer Center, Houston, TX.
authors.forename: Xuemei
authors.initials: X
authors.lastname: Wang
authors.affiliation: Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX.
authors.forename: Mary F
authors.initials: MF
authors.lastname: Achim
authors.affiliation: Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
authors.forename: Amado
authors.initials: A
authors.lastname: Zurita-Saavedra
authors.affiliation: Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX.
authors.forename: Surena F
authors.initials: SF
authors.lastname: Matin
authors.affiliation: Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX.
authors.forename: Louis L
authors.initials: LL
authors.lastname: Pisters
authors.affiliation: Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX.
authors.forename: John F
authors.initials: JF
authors.lastname: Ward
authors.affiliation: Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX.
authors.forename: Curtis A
authors.initials: CA
authors.lastname: Pettaway
authors.affiliation: Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX. Electronic address: bfchapin@mdanderson.org.
authors.forename: Brian F
authors.initials: BF
authors.lastname: Chapin
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects*; D003131:Combined Modality Therapy; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D059035:Perioperative Period; D011183:Postoperative Complications / Q000453:epidemiology* / Q000209:etiology; D011468:Prostatectomy / Q000009:adverse effects*; D011471:Prostatic Neoplasms / Q000473:pathology / Q000628:therapy*; D012307:Risk Factors; D016896:Treatment Outcome
keywords: Complications; High risk; Prostate cancer; Prostatectomy; Systemic therapy