Nivolumab showed an overall survival (OS) benefit in pretreated metastatic renal cell carcinoma (mRCC). The role of stereotactic body radiotherapy (SBRT) in mRCC remains to be defined.
Our aim was to evaluate the efficacy and safety of SBRT in combination with nivolumab in second- and third-line mRCC patients.
The NIVES study was a phase II, single-arm, multicenter trial in patients with mRCC with measurable metastatic sites who progressed after antiangiogenic therapy, of whom at least one was suitable for SBRT.
The patients received SBRT to a lesion at a dose of 10 Gy in three fractions for 7 d from the first infusion of nivolumab. Nivolumab was given at an initial dose of 240 mg every 14 d for 6 mo and then 480 mg q4-weekly in responding patients.
We hypothesized that nivolumab plus SBRT improves the objective response rate (ORR) compared with nivolumab alone from 25% (derived from historical controls) to 40%. Secondary endpoints were progression-free survival (PFS), OS, disease control rate (DCR) of irradiated and nonirradiated metastases, and safety.
Sixty-nine patients were enrolled from July 2017 to March 2019. The ORR was 17% and the DCR was 55%. The median PFS was 5.6 mo (95% confidence interval [CI], 2.9-7.1) and median OS 20 mo (95% CI, 17-not reached). After 1.5 yr of follow-up, 23 patients died. The median time to treatment response was 2.8 mo and median duration of response was 14 mo. No new safety concerns arose.
We did not find sufficient evidence to suggest that nivolumab in combination with SBRT provides an added benefit in pretreated mRCC patients; it should however be evaluated in patients with oligometastatic or oligoprogressive disease.
Nivolumab in combination with stereotactic body radiotherapy does not provide evidence of increased outcomes in metastatic renal cell carcinoma patients. However this approach was safe and showed a good response of the irradiated lesions.
European urology. 2021 Sep 30 [Epub ahead of print]
Cristina Masini, Cinzia Iotti, Ugo De Giorgi, Roberto Salvatore Bellia, Sebastiano Buti, Francesco Salaroli, Ilaria Zampiva, Renzo Mazzarotto, Claudia Mucciarini, Maria Giuseppa Vitale, Alessio Bruni, Frank Lohr, Giuseppe Procopio, Orazio Caffo, Franco Nole, Franco Morelli, Susanne Baier, Consuelo Buttigliero, Patrizia Ciammella, Giorgia Timon, Emanuela Fantinel, Gabriele Carlinfante, Annalisa Berselli, Carmine Pinto
Medical Oncology Unit, Clinical Cancer Centre, AUSL-IRCCS di Reggio Emilia, Reggio Emilia, Italy. Electronic address: ., Radiation Oncology Unit, Clinical Cancer Centre, AUSL-IRCCS di Reggio Emilia, Reggio Emilia, Italy., Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy., Radiotherapy Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy., Medical Oncology Unit, University Hospital of Parma, Parma, Italy., Radiotherapy Unit, University Hospital of Parma, Parma, Italy., Medical Oncology Unit, University Hospital, AOUI Verona, Italy., Radiotherapy Unit, University Hospital, AOUI Verona, Italy., Medical Oncology Unit, Ramazzini Hospital, Carpi, Italy., Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy., Radiation Therapy Unit, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy., Department of Medical Oncology, Istituto Nazionale dei Tumori IRCCS, Milan, Italy., Oncology Unit, S. Chiara Hospital, Trento, Italy., Medical Oncology Division of Urogenital and Head & Neck Tumors IEO, European Institute of Oncology IRCCS, Milan, Italy., Department of Oncology, IRCCS Ospedale Casa Sollievo della Sofferenza, Opera di Padre Pio, San Giovanni Rotondo, Italy., Oncologia Medica Ospedale Regionale, Bolzano Azienda Sanitaria Alto Adige, Bolzano, Italy., Department of Oncology, AOU San Luigi Gonzaga, University of Turin, Orbassano (Turin), Italy., Medical Oncology Unit, Clinical Cancer Centre, AUSL-IRCCS di Reggio Emilia, Reggio Emilia, Italy., Pathology Unit, Clinical Cancer Centre, AUSL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.