Variability of inter-observer agreement on feasibility of partial nephrectomy before and after neoadjuvant axitinib for locally advanced renal cell carcinoma (RCC): independent analysis from a phase II trial

BJU Int. 2016 Apr;117(4):629-35. doi: 10.1111/bju.13188. Epub 2015 Jun 29.

Abstract

Objective: To evaluate how many patients could have undergone partial nephrectomy (PN) rather than radical nephrectomy (RN) before and after neoadjuvant axitinib therapy, as assessed by five independent urological oncologists, and to study the variability of inter-observer agreement.

Patients and methods: Pre- and post-systemic treatment computed tomography scans from 22 patients with clear cell renal cell carcinoma in a phase II neoadjuvant axitinib trial were reviewed by five independent urological oncologists. R.E.N.A.L. nephrometry score and κ statistics were calculated.

Results: The median R.E.N.A.L. nephrometry score changed from 11 before treatment to 10 after treatment (P = 0.002). Five tumours with moderate complexity before axitinib treatment remained moderate complexity after treatment. Of 17 tumours with high complexity before axitinib treatment, three became moderate complexity after treatment. The overall κ statistic was 0.611. Moderate-complexity κ was 0.611 vs a high-complexity κ of 0.428. Before axitinib treatment the κ was 0.550 vs 0.609 after treatment. After treatment with axitinib, all five reviewers agreed that only five patients required RN (instead of eight before treatment) and that 10 patients could now undergo PN (instead of three before treatment). The odds of PN feasibility were 22.8-times higher after treatment with axitinib.

Conclusions: There is considerable variability in inter-observer agreement on the feasibility of PN in patients treated with neoadjuvant targeted therapy. Although more patients were candidates for PN after neoadjuvant axitinib therapy, it remains difficult to identify these patients a priori.

Keywords: independent review; neoadjuvant; partial nephrectomy; renal cell carcinoma; targeted; therapy.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents / therapeutic use*
  • Axitinib
  • Carcinoma, Renal Cell / drug therapy
  • Carcinoma, Renal Cell / surgery*
  • Feasibility Studies
  • Female
  • Humans
  • Imidazoles / therapeutic use*
  • Indazoles / therapeutic use*
  • Kidney Neoplasms / drug therapy
  • Kidney Neoplasms / surgery*
  • Male
  • Middle Aged
  • Neoadjuvant Therapy
  • Nephrectomy / methods*
  • Observer Variation

Substances

  • Antineoplastic Agents
  • Imidazoles
  • Indazoles
  • Axitinib