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First results of safety profile of nivolumab (NIVO) in combination with stereotactic body radiotherapy (SBRT) in II and III line of patients (pts) with metastatic renal cell carcinoma (mRCC) in NIVES Study

Date

30 Sep 2019

Session

Poster Display session 3

Presenters

Cristina Masini

Citation

Annals of Oncology (2019) 30 (suppl_5): v356-v402. 10.1093/annonc/mdz249

Authors

C. Masini1, P. Ciammella2, G. Timon2, R. Gnoni1, U.F.F. De Giorgi3, S.R. Bellia4, S. Buti5, F. Salaroli6, M. Milella7, R. Mazzarotto8, C. Mucciarini9, M.G. Vitale10, A. Bruni11, G. Procopio12, S. Kinspergher13, F. Nole14, F. Morelli15, G. Pappagallo16, C. buttigliero17, C. Pinto18

Author affiliations

  • 1 Oncology Unit, Medical Oncology Unit, Clinical Cancer Centre, AUSL-IRCCS, Reggio Emilia, Italy, 42100 - Reggio Emilia/IT
  • 2 Radiation Oncology Unit, Radiation Oncology Unit, AUSL - IRCCS di Reggio Emilia, Italy, 42100 - Reggio Emilia/IT
  • 3 Oncology Unit, Istituto Tumori della Romagna I.R.S.T., 47014 - Meldola/IT
  • 4 Radiotherapy Unit, Istituto Tumori della Romagna I.R.S.T., 47014 - Meldola/IT
  • 5 Medical Oncology Unit, Medical Oncology Unit, University Hospital of Parma, Parma, Italy, 43126 - Parma/IT
  • 6 Radiotherapy Unit, Radiotherapy Unit, University Hospital of Parma, Parma, Italy, 43126 - Parma/IT
  • 7 Oncology, Università degli Studi di Verona, 37129 - Verona/IT
  • 8 Radiotherapy Unit, Azienda Ospedaliera Universitaria integrata di Verona, 37129 - Verona/IT
  • 9 Medical Oncology Unit, Ospedale Ramazzini di Capri, 41012 - Carpi/IT
  • 10 Department Of Hematology And Oncology, Azienda Ospedaliera Universitaria di Modena, Modena, Italy, 41122 - Modena/IT
  • 11 Radiotherapy Unit, Azienda Ospedaliera Universitaria di Modena, Modena, Italy, 41122 - Modena/IT
  • 12 Oncologia Medica, Istituto Nazionale dei Tumori di Milano - Fondazione IRCCS, 20133 - Milan/IT
  • 13 Department Of Medical Oncology, Santa Chiara Hospital, Trento, Italy, .... - Trento/IT
  • 14 Medical Oncology, Istituto Europeo di Oncologia, 20141 - Milan/IT
  • 15 Dipartimento Di Onco-ematologia, Fondazione IRCCS Ospedale Casa Sollievo della Sofferenza, 71013 - SAN GIOVANNI ROTONDO (FG)/IT
  • 16 Oncology Dept., Unita Locale Socio Sanitaria 13 P.O Mirano, 30035 - Mirano/IT
  • 17 Medical Oncology, Azienda Ospedaliera Universitaria San Luigi Gonzaga, 10043 - Orbassano/IT
  • 18 Clinical Canncer Centre, Medical Oncology Unitr, Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS, 42100 - Reggio Emilia/IT
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Background

NIVO is an anti-programmed cell death-1 (PD-1) monoclonal antibody; it might work even better when combined with SBRT improving clinical outcomes with a phenomenon known as abscopal effect. To date there are limited data on safety profile of combined SBRT and NIVO in mRCC. We report for the first time the toxicities occurred in phase II NIVES Study.

Methods

This is a phase II, single arm, multicentre study in pts with mRCC with progression disease after≤2 prior anti-angiogenic therapies and with measurable non-brain metastatic sites, at least one of which potentially suitable for SBRT. The pts included received hypofractionated radiation in one lesion at dose of 10 Gy/3 fractions after 7 days from the first infusion of NIVO. NIVO will be given as flat dose of 240 mg on day 1 every 14 days for 6 months, then switch to 480 mg q4-weekly in responding pts until PD or unacceptable toxicity. Descriptive statistics are reported for patient/tumor/treatment characteristics and observed severe Adverse Events (AEs) graded by CTCAE v. 4.03.

Results

Sixty-nine pts were enrolled from July 2017 to March 2019 in 11 Italian centers. 79.7% of pts had clear cell histology, median age was 67 years (range 43-85), 82.6% were male. ECOG PS was 0 in 57 pts (82.6%), only 18.8% pts had received 2 previous lines of therapy. The most frequent sites of SBRT were lung (39.4% of pts), lymphonodes (16.7%) and bone (10.6%). Toxicities of grade (G) 3-4 related to NIVO were experienced in 13 pts (18.8%); all G3-4 toxicities were outside of the irradiated area. The most frequently observed G3-4 treatment-related AEs included diarrhea (5.8%), fatigue (4.3%), anemia (2.9%) and increase of amylase/lipase (2.9%). To date no G3-4 pneumonitis were observed. Six pts (8.7%) were hospitalized due to treatment-related SAEs. Overall, 5 of 69 treated pts (7.2%) discontinued therapy because of G3-4 AEs. At the time of this analysis 32/69 pts (46%) are still on treatment.

Conclusions

Concurrent NIVO plus SBRT is generally well tolerated, without increased rates of common severe toxicity. Definitive data of toxicities and efficacy of the combination of immunotherapy and radiotherapy are not yet mature.

Clinical trial identification

NCT03469713.

Editorial acknowledgement

Legal entity responsible for the study

GOIRC.

Funding

GOIRC.

Disclosure

C. Masini: Travel / Accommodation / Expenses: BMS, Janssen, Astellas, Bayer; Advisory / Consultancy: Pfizer, Novartis, Sanofi. U.F.F. De Giorgi: Research grant / Funding (institution): AstraZeneca, Roche, Sanofi; Advisory / Consultancy: Astellas, Bayer, BMS, Ipsen, Janssen, Merck, Pfizer, Sanofi; Travel / Accommodation / Expenses: BMS, Ipsen, Janssen, Pfizer. S. Buti: Advisory / Consultancy: BMS, Pfizer, MSD. M. Milella: Speaker Bureau / Expert testimony: AstraZeneca, Pfizer, EUSA Pharma. M.G. Vitale: Speaker Bureau / Expert testimony: Astellas, Ipsen, Janssen, Pierre Fabre, BMS, Pfizer, Novartis; Travel / Accommodation / Expenses: Astellas, Pfizer, Ipsen, Janssen, BMS, Novartis; Advisory / Consultancy: Janssen, BMS. G. Procopio: Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Bayer, BMS, Ipsen, MSD, Novartis, Pfizer. F. Nole: Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: BMS, Ipsen, Pfizer, Bayer, Novartis, MSD. G. Pappagallo: Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Ipsen, BMS, Astellas, Janssen, Bayer, Pfizer, Novartis. C. Pinto: Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Roche, BMS, MSD, Janssen, Pfizer, Novartis, Ipsen, Lilly, Bayer. All other authors have declared no conflicts of interest.

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