دورية أكاديمية
Nivolumab in Combination with Stereotactic Body Radiotherapy in Pretreated Patients with Metastatic Renal Cell Carcinoma. Results of the Phase II NIVES Study
| العنوان: | Nivolumab in Combination with Stereotactic Body Radiotherapy in Pretreated Patients with Metastatic Renal Cell Carcinoma. Results of the Phase II NIVES Study |
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| المؤلفون: | Masini C., Iotti C., De Giorgi U., Bellia R. S., Buti S., Salaroli F., Zampiva I., Mazzarotto R., Mucciarini C., Vitale M. G., Bruni A., Lohr F., Procopio G., Caffo O., Nole F., Morelli F., Baier S., Buttigliero C., Ciammella P., Timon G., Fantinel E., Carlinfante G., Berselli A., Pinto C. |
| المساهمون: | Masini, C., Iotti, C., De Giorgi, U., Bellia, R. S., Buti, S., Salaroli, F., Zampiva, I., Mazzarotto, R., Mucciarini, C., Vitale, M. G., Bruni, A., Lohr, F., Procopio, G., Caffo, O., Nole, F., Morelli, F., Baier, S., Buttigliero, C., Ciammella, P., Timon, G., Fantinel, E., Carlinfante, G., Berselli, A., Pinto, C. |
| بيانات النشر: | Elsevier B.V. |
| سنة النشر: | 2022 |
| المجموعة: | Università di Parma: CINECA IRIS |
| مصطلحات موضوعية: | Abscopal effect, Kidney cancer, Metastatic, Nivolumab, Stereotactic body radiotherapy |
| الوصف: | Background: 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. Objective: Our aim was to evaluate the efficacy and safety of SBRT in combination with nivolumab in second- and third-line mRCC patients. Design, setting, and participants: 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. Intervention: 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. Outcome measurements and statistical analysis: 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. Results and limitations: 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. Conclusions: 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. Patient summary: 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 ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/wos/WOS:000809752100018; journal:EUROPEAN UROLOGY; http://hdl.handle.net/11381/2913694Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85116170305 |
| DOI: | 10.1016/j.eururo.2021.09.016 |
| الإتاحة: | https://doi.org/10.1016/j.eururo.2021.09.016Test http://hdl.handle.net/11381/2913694Test |
| حقوق: | info:eu-repo/semantics/closedAccess |
| رقم الانضمام: | edsbas.43979124 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/j.eururo.2021.09.016 |
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