Multi-institutional validation of the prognostic value of Ki-67 labeling index in patients treated with radical prostatectomy

Romain Mathieu, Shahrokh F. Shariat, Christian Seitz, Pierre I. Karakiewicz, Harun Fajkovic, Maxine Sun, Yair Lotan, Douglas S. Scherr, Ashutosh Tewari, Francesco Montorsi, Alberto Briganti, Morgan Rouprêt, Ilaria Lucca, Vitaly Margulis, Michael Rink, Luis A. Kluth, Malte Rieken, Alexander Bachman, Evanguelos Xylinas, Brian D. RobinsonKarim Bensalah, Markus Margreiter

Research output: Contribution to journalArticlepeer-review

18 Scopus citations


Objective: Several smaller single-center studies have reported a prognostic role for Ki-67 labeling index in prostate cancer. Our aim was to test whether Ki-67 is an independent prognostic marker of biochemical recurrence (BCR) in a large international cohort of patients treated with radical prostatectomy (RP). Methods: Ki-67 immunohistochemical staining on prostatectomy specimens from 3,123 patients who underwent RP for prostate cancer was retrospectively performed. Univariable and multivariable Cox regression models were used to assess the association of Ki-67 status with BCR. Results: Ki-67 positive status was observed in 762 (24.4 %) patients and was associated with lymph node involvement (LNI) (p = 0.039). Six hundred and twenty-one (19.9 %) patients experienced BCR. The estimated 3-year biochemical-free survivals were 85 % for patients with negative Ki-67 status and 82.1 % for patients with positive Ki-67 status (log-rank test, p = 0.014). In multivariable analysis that adjusted for the effects of age, preoperative PSA, RP Gleason sum, seminal vesicle invasion, extracapsular extension, positive surgical margins, lymphovascular invasion, and LNI, Ki-67 was significantly associated with BCR (HR = 1.19; p = 0.019). Subgroup analysis revealed that Ki-67 is associated with BCR in patients without LNI (p = 0.004), those with RP Gleason sum 7 (p = 0.015), and those with negative surgical margins (p = 0.047). Conclusion: We confirmed Ki-67 as an independent predictor of BCR after RP. Ki-67 could be particularly informative in patients with favorable pathologic characteristics to help in the clinical decision-making regarding adjuvant therapy and optimized follow-up scheduling.

Original languageEnglish (US)
Pages (from-to)1165-1171
Number of pages7
JournalWorld journal of urology
Issue number8
StatePublished - Aug 27 2015


  • Disease recurrence
  • Ki-67
  • Prognosis
  • Prostate cancer
  • Radical prostatectomy

ASJC Scopus subject areas

  • Urology


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