Benefit of adjuvant immunotherapy in renal cell carcinoma: A myth or a reality?

<div><p>Background</p><p>The benefit of adjuvant immunotherapy after nephrectomy in renal cell carcinoma (RCC) is controversial. The present study aimed to examine the possible benefit of adjuvant immunotherapy in various clinical settings.</p><p>Methods</p><p>We retrospectively reviewed 436 patients with pT1-3N0-2M0 RCC who underwent radical or partial nephrectomy with curative intent at our institution between 1981 and 2009. Of them, 98 (22.5%) patients received adjuvant interferon-α (IFN-α) after surgery (adjuvant IFN-α group), while 338 (77.5%) did not (control group). The primary endpoint was cancer-specific survival (CSS). Univariate and multivariate analyses were conducted using log-rank tests and Cox proportional hazards models, respectively.</p><p>Results</p><p>Fifty-two (11.9%) patients died from RCC with a median follow-up period of 96 months. Preliminary univariate analyses comparing CSS among treatment groups in each TNM setting revealed that CSS in the control group was equal or superior to that in the adjuvant IFN-α group in earlier stages, while the opposite trend was observed in more advanced stages. We evaluated the TNM cutoffs and demonstrated maximized benefit of adjuvant IFN-α in patients with pT2b-3cN0 (<i>P</i> = 0.0240). In multivariate analysis, ≥pT3 and pN1-2 were independent predictors for poor CSS in all patients. In the subgroups with ≥pT2 disease (<i>n</i> = 123), pN1-2 and no adjuvant treatment were significant poor prognostic factors.</p><p>Conclusions</p><p>Adjuvant immunotherapy after nephrectomy may be beneficial in pT2b-3cN0 RCC. Careful consideration is, however, required for interpretation of this observational study because of its selection bias and adverse effects of IFN-α.</p></div

Additional file 1: Table S1. of Toremifene, a selective estrogen receptor modulator, significantly improved biochemical recurrence in bone metastatic prostate cancer: a randomized controlled phase II a trial

CONSORT 2010 checklist of information to include when reporting a cluster randomised trial. (DOCX 30 kb

Patient demographics stratified by perioperative change in voided volume (ΔVV).

(DOCX)</p

Univariate and multivariate analyses of cancer-specific survival in patients with ≥pT2 disease (<i>n</i> = 123).

<p>Univariate and multivariate analyses of cancer-specific survival in patients with ≥pT2 disease (<i>n</i> = 123).</p

Changes between pre- and post-RARP uroflowmetry parameters.

Waterfall plots of changes in (A) voided volume, (B) post-void residual urine, and (C) maximum flow rate. The tables below detail the exact number of patients and percentage of total in groups stratified by values of clinical significance. Abbreviations RARP: robot-assisted radical prostatectomy, ΔVV: perioperative change in voided volume, ΔPVR: perioperative change in post-void residual urine, ΔMFR: perioperative change in maximum flow rate.</p

Survival curves depicting cancer-specific survival in the radical prostatectomy (RP) and external beam radiotherapy (EBRT) groups, in (A) all (<i>P</i> = 0.0010), (B) low-risk (<i>P</i> <0.0001), (C) intermediate-risk (<i>P</i> = 0.1820), and (D) high-risk patients (<i>P</i> = 0.0233), respectively.

<p>Each <i>P</i>-value indicates the result of log-rank test.</p

S1 File -

(DOCX)</p

Patient demographics.

Patient demographics.</p

Changes in uroflowmetry results stratified by predictive factors.

Box-plots of (A) perioperative change in maximum flow rate when stratified by prostate volume, (B) perioperative change in maximum flow rate when stratified by age, and (C) perioperative change in post-void residual volume when stratified by prostate volume. Median, interquartile, and standard deviation are shown. A significant difference was seen in each parameter when stratified by their respective predictive factors. Abbreviations RARP: robot-assisted radical prostatectomy, PV: prostate volume.</p

Analysis of risk factors for perioperative change in uroflowmetry parameters.

Analysis of risk factors for perioperative change in uroflowmetry parameters.</p