scholarly journals Response assessment of melanoma brain metastases treated by stereotactic radiotherapy or immunotherapy or both: A comparison of RECIST 1.1, RANO and iRANO criteria

2019 ◽  
Vol 30 ◽  
pp. v149
Author(s):  
E. Le Rhun ◽  
F. Wolpert ◽  
M. Fialek ◽  
P. Devos ◽  
N. Andratschke ◽  
...  
2019 ◽  
Vol 1 (Supplement_1) ◽  
pp. i17-i17
Author(s):  
Emilie Le Rhun ◽  
Fabian Wolpert ◽  
Maud Fialek ◽  
Patrick Devos ◽  
Nicolaus Andratschke ◽  
...  

Abstract BACKGROUND: The evaluation of response for brain metastases (BM) may be challenging in the context of treatment by stereotactic radiotherapy (SRT) or immunotherapy or both. METHODS: We reviewed clinical and neuroimaging data of 62 melanoma patients with newly diagnosed BM treated by the combination of immunotherapy and SRT (n=33, group A), immunotherapy alone (n=10, group B) or SRT alone or in combination with other systemic therapies (n=19, group C). Response was assessed using RECIST 1.1, RANO or iRANO criteria. RESULTS: BRAF mutations were noted in 26 patients. 54 patients (87%) had 1–3 metastases. The median DS-GPA was 3. After a median follow-up of 30.5 months, 39 patients have experienced CNS progression, 16 (48.5%) in group A, 9 (90%) in group B, 14 (73.5%) in group C. Median PFS was 129.5 days (range 82–532) in group A, 75 days (range 35–203) in group B, 136 days (range 59–514) in group C. Forty-seven patients (76%) had died at the time of the analysis, 22 (66.5%) in group A, 7 (70%) in group B, 18 (94.5%) in group C. Median OS was 345 days (range 65–1824) in group A, 174.5 days (range 50–1361) in group B, 409 days (range 102–1244) in group C. 52 MRI scans were available for central review: pseudoprogression was documented in 9 patients (29%) in group A, 0 (0%) in group B, 5 (29.5%) in group C. Response rates were similar with all three sets of response criteria. Progressive disease was less often called when applying iRANO to assess SRT target lesions. CONCLUSIONS: Despite the retrospective nature and the small sample size, these data may indicate that the omission of SRT from first-line treatment may compromise outcome. Pseudoprogression is uncommon with immunotherapy alone; pseudoprogression rates were similar after SRT alone or in combination with immunotherapy or other systemic treatment.


2019 ◽  
Vol 133 ◽  
pp. S676
Author(s):  
S. Lambert ◽  
A. Huchet ◽  
R. Trouette ◽  
V. Karahissarlian ◽  
C. Pouypoudat ◽  
...  

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS9600-TPS9600 ◽  
Author(s):  
Maria Gonzalez ◽  
Angela M. Hong ◽  
Matteo S. Carlino ◽  
Victoria Atkinson ◽  
Wei Wang ◽  
...  

TPS9600 Background: Nivolumab combined with ipilimumab is active in melanoma brain metastases, with intracranial response rates > 55% and durable survival in treatment naïve patients (pts) (Long GV et al Lancet Onc 2018; Tawbi H et al NEJM 2018). We seek to determine if the addition of stereotactic radiotherapy (SRS) results in improved intracranial outcomes. Methods: This is a multisite, open-label, phase 2 trial in systemic treatment-naïve pts with melanoma brain metastases. Pts must have ≥1 asymptomatic brain metastases that are ≥5mm and ≤40mm as per modified RECIST 1.1, on gadolinium-enhanced MRI, and no history of previous treatment with SRS. Eligible pts are randomly assigned to either receive nivolumab plus ipilimumab with SRS or nivolumab plus ipilimumab alone. Nivolumab (1mg/kg) and ipilimumab (3mg/kg) are given every 3 weeks for 4 doses. Following induction, 480mg nivolumab is given every 4 weeks until progression, unacceptable toxicity, or a maximum of 2 years. SRS is administered as single fraction of 16-22Gy, or hypofractionated for larger lesions (24-27Gy in 3 fractions), within 7 days of immunotherapy commencement. Pts will be evaluated for intracranial and extracranial tumour response, and overall response, every 6 weeks to week 24 and 12 weekly thereafter until overall disease progression or death. The primary endpoint is neurologic specific survival (NSS) at 12 months. Secondary endpoints include intracranial response rate, intracranial PFS, overall PFS, overall progression free survival, overall survival, neurocognitive function and incidence of radiation necrosis. 109 patients in each cohort (218 total) will achieve > 80% power at the significance level (alpha) of 0.10 to detect a minimum absolute increase of 9% in the NSS rate at 12 months. Clinical trial information: NCT03340129.


2017 ◽  
Vol 28 (6) ◽  
pp. 669-675 ◽  
Author(s):  
Orit Kaidar-Person ◽  
Timothy M. Zagar ◽  
Allison Deal ◽  
Stergios J. Moschos ◽  
Matthew G. Ewend ◽  
...  

2019 ◽  
Vol 133 ◽  
pp. S456-S457
Author(s):  
A. Paix ◽  
F. Thillays ◽  
F. Courtault-Deslandes ◽  
I. Pop ◽  
J. Biau ◽  
...  

2017 ◽  
Vol 17 (4) ◽  
pp. 347-356 ◽  
Author(s):  
Elisabetta Trino ◽  
Cristina Mantovani ◽  
Serena Badellino ◽  
Umberto Ricardi ◽  
Andrea Riccardo Filippi

2012 ◽  
Vol 73 (S 02) ◽  
Author(s):  
M. Amit ◽  
L. Laider-Trejo ◽  
A. Shabtay ◽  
Z. Gil

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