Page 17 - Kidney Cancer Research Network of Canada (KCRNC) consensus statement on the role of cytoreductive nephrectomy for patients with metastatic renal cell carcinoma
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CUAJ – Consensus Statement                                                                         Mason et al
                                                                                  KCRNC consensus: Cytoreductive nephrectomy for mRCC




                                        Table 1. Phase 3 randomized trials investigating the role of CN in patients with mRCC in the targeted therapy era

                                        Trial                       Patient             Intervention            Control             Outcomes               Sample          Median          Results for primary

                                                                 population                   arm                 arm                                         size        followup                 outcome
                                        CARMENA[3]  Clear cell mRCC,  CN followed by                            sunitinib         Primary – OS              n=452            50.2                HR for OS:
                                                               ECOG 0-1, No                sunitinib              alone            Secondary –                             months          0.89 (95% CI, 0.71 to
                                                              prior systemic or                                                      Objective                                                       1.10)

                                                                    surgical                                                      response, PFS,
                                                                 treatment for                                                      Treatment
                                                                      RCC                                                          compliance,
                                                                                                                                    Safety and

                                                                                                                                  adverse events
                                                                                                                                                                   *
                                        SURTIME [4]           Clear cell mRCC,             sunitinib               CN          Primary – Disease            n=99             30.9             Progression at 28
                                                                                                                                                                                                           **
                                                                ECOG 0-1, no           followed by CN           followed        progression at 28                          months                  weeks :
                                                              prior systemic or          followed by          by sunitinib             weeks                                                Upfront CN - 42.0%

                                                                    surgical               sunitinib                            Secondary – OS,                                             Upfront sunitinib –
                                                                 treatment for                                                       Objective                                                      42.9%
                                                                      RCC                                                        response, Safety                                                   p>0.99
                                                                                                                                   and adverse
                                                                                                                                       events

                                        TARIBO [68]           Clear cell mRCC,  CN followed by  sunitinib or                      Primary – OS              n=270             ***                      ***
                                                              ECOG 0-1, Good              sunitinib or         Pazopanib           Secondary –           (estimated)
                                                               or intermediate            Pazopanib               alone              Objective

                                                               risk disease, no                                                   response, PFS,
                                                              prior systemic or                                                     Safety and
                                                                    surgical                                                     adverse events,
                                                                 treatment for                                                      Biomarker
                                                                      RCC                                                             analysis
                                        * Initial accrual target was 458 patients.  Preliminary results presented at the 2017 European Society of Medical Oncology annual
                                                                                         **
                                        meeting.   *** Enrollment ongoing. CI: confidence interval; CN: cytoreductive nephrectomy; HR: hazard ratio; mRCC: metastatic renal
                                        cell carcinoma; OS: overall survival; PFS: progression-free survival.
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