A Multi-Center, Open-Label, Randomized, Two-Arm Study, to Evaluate the Efficacy of Osimertinib with Early Intervention SRS Treatment Compared to the Continuation of Osimertinib Alone, in Patients with EGFR-Mutated NSCLC and Asymptomatic Brain Metastases

2022 ◽  
Vol 112 (2) ◽  
pp. e15-e16
Author(s):  
P.A. Blumenfeld ◽  
G. Marwaha ◽  
Y. Shoshan ◽  
J. Feldman ◽  
H. Nechushtan ◽  
...  
Keyword(s):  
Early Intervention ◽  
Brain Metastases ◽  
Open Label ◽  
Egfr Mutated

Five-year overall survival from the anti-PD1 brain collaboration (ABC Study): Randomized phase 2 study of nivolumab (nivo) or nivo+ipilimumab (ipi) in patients (pts) with melanoma brain metastases (mets).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9508-9508
Author(s):  
Georgina V. Long ◽  
Victoria Atkinson ◽  
Serigne Lo ◽  
Alexander David Guminski ◽  
Shahneen Kaur Sandhu ◽  
...  
Keyword(s):  
Brain Metastases ◽  
Braf Inhibitor ◽  
Local Therapy ◽  
Leptomeningeal Disease ◽  
Open Label ◽  
Phase 2 Study ◽  
Melanoma Brain Metastases ◽  
Secondary Endpoints ◽  
Local Brain ◽  
Clinical Trial Information

9508 Background: Preliminary data from the ABC (76 pts) and CheckMate 204 (94 pts) trials showed that nivo and nivo+ipi have activity in active melanoma brain metastases, with durable responses in a subset of pts. Here, we report updated 5-yr data from all pts enrolled on the ABC trial (NCT02374242). Methods: This open-label ph2 trial enrolled 3 cohorts of pts with active melanoma brain mets naïve to anti-PD1/PDL1/PDL2/CTLA4 from Nov 2014-Apr 2017. Pts with asymptomatic brain mets with no prior local brain therapy were randomised to cohort A (nivo 1mg/kg + ipi 3mg/kg, Q3Wx4, then nivo 3mg/kg Q2W) or cohort B (nivo 3mg/kg Q2W). Cohort C (nivo 3mg/kg Q2W) had brain mets i) that failed local therapy, ii) with neuro symptoms and/or iii) with leptomeningeal disease. Prior BRAF inhibitor (BRAFi) was allowed. The primary endpoint was best intracranial response (ICR) ≥wk12. Key secondary endpoints were IC PFS, overall PFS, OS, & safety. Results: A total of 76 pts (med f/u 54 mo) were enrolled; median age 59y, 78% male. For cohorts A, B and C: elevated LDH 51%, 58% and 19%; V600BRAF 54%, 56% and 81%; prior BRAFi 23%, 24%, 75%. Efficacy and toxicity are shown in the table. There were no treatment-related deaths. 1/17 deaths in cohort A & 4/16 in cohort B were due to IC progression only. Conclusions: Nivo monotherapy and ipi+nivo are active in melanoma brain mets, with durable responses in the majority of patients who received ipi+nivo upfront. A study of upfront ipi+nivo+/-SRS is underway (NCT03340129). Clinical trial information: NCT02374242. [Table: see text]

scholarly journals CMET-30. BRAIN METASTASES FROM EGFR-MUTATED NSCLC WHICH HAD ACQUIRED RESISTANCE TO EGFR-TKI. ~LESS-FREQUENT T790M AND PRESERVED RESPONSE TO OTHER TKIs~

2018 ◽  
Vol 20 (suppl_6) ◽  
pp. vi60-vi60
Author(s):  
Toshihiko Iuchi ◽  
Tsukasa Sakaida ◽  
Yuzo Hasegawa ◽  
Yasushi Yoshida ◽  
Hironori Ashinuma ◽  
...  
Keyword(s):  
Brain Metastases ◽  
Acquired Resistance ◽  
Egfr Mutated ◽  
Egfr Tki

scholarly journals TRLS-02. Trial in Progress: A Multicenter Phase 3 Study to Establish the Diagnostic Performance of 18F-Fluciclovine PET in Detecting Recurrent Brain Metastases after Radiation Therapy (REVELATE)

2021 ◽  
Vol 3 (Supplement_3) ◽  
pp. iii5-iii5
Author(s):  
Eugene Teoh ◽  
Alain Chaglassian ◽  
Nancy Tainer
Keyword(s):  
Radiation Therapy ◽  
Brain Metastases ◽  
Diagnostic Performance ◽  
Brain Mri ◽  
Primary Objective ◽  
Open Label ◽  
Conventional Mri ◽  
Specificity And Sensitivity ◽  
Neurosurgical Intervention

Abstract Background Brain metastases occur in up to 40% of patients with cancer and are associated with poor prognosis and considerable levels of recurrence. Consequently, close follow-up with serial brain MRI is performed post-treatment to monitor for recurrent disease. Although conventional MRI (CE-T1-weighted and FLAIR/T2-weighted) is the recommended follow-up modality, it has poor specificity with limited ability to differentiate between true disease recurrence and treatment-related changes such as radiation necrosis. Therefore, alternative imaging options are sought in order to help physicians confidently diagnose treatment-related changes and thus reliably stratify the risk of continuation of a therapeutic regimen, especially given the morbidity associated with current treatments. Amino acid PET imaging agent, 18F-fluciclovine, has increased uptake in brain tumors relative to normal tissue and may be useful for detecting recurrent brain metastases. Methods NCT04410133 is a prospective, open-label, single-arm, single-dose (185 MBq ±20%) study with a primary objective to confirm the diagnostic performance of 18F-fluciclovine PET (read with conventional MRI for anatomical reference) for detection of recurrent brain metastases where MRI is equivocal. Approximately 150 subjects with solid tumor brain metastases who have undergone radiation therapy will be enrolled in this multicenter trial (~18 US sites) if they have a lesion considered equivocal on MRI that requires further confirmatory diagnostic procedures such as biopsy/neurosurgical intervention or clinical follow-up. Subjects will undergo 18F-fluciclovine PET <28 days after the equivocal MRI and 2–21 days pre-biopsy/neurosurgical intervention. Clinical follow-up will occur for 6m post-18F-fluciclovine PET. Secondary objectives include evaluation of subject- and lesion-level 18F-fluciclovine negative and positive percent agreement (equivalent to specificity and sensitivity respectively) for recurrent brain metastases, inter-reader and intra-reader agreement, and safety evaluations. Enrolment began in October 2020 and the trial is open at the time of submission.

scholarly journals NEIM-02. TRIAL IN PROGRESS: A MULTICENTER PHASE 3 STUDY TO ESTABLISH THE DIAGNOSTIC PERFORMANCE OF 18F-FLUCICLOVINE PET IN DETECTING RECURRENT BRAIN METASTASES AFTER RADIATION THERAPY (REVELATE)

2021 ◽  
Vol 3 (Supplement_4) ◽  
pp. iv6-iv7
Author(s):  
Samuel T Chao ◽  
Alain Chaglassian ◽  
Nancy Tainer ◽  
Eugene J Teoh
Keyword(s):  
Radiation Therapy ◽  
Brain Metastases ◽  
Diagnostic Performance ◽  
Brain Mri ◽  
Primary Objective ◽  
Open Label ◽  
Conventional Mri ◽  
Specificity And Sensitivity ◽  
Neurosurgical Intervention

Abstract BACKGROUND Brain metastases occur in up to 40% of patients with cancer and are associated with poor prognosis and considerable levels of recurrence. Consequently, close follow-up with serial brain MRI is performed post-treatment to monitor for recurrent disease. Although conventional MRI (CE-T1-weighted and FLAIR/T2-weighted) is the recommended follow-up modality, it has poor specificity with limited ability to differentiate between true disease recurrence and treatment-related changes such as radiation necrosis. Therefore, alternative imaging options are sought in order to help physicians confidently diagnose treatment-related changes and thus reliably stratify the risk of continuation of a therapeutic regimen, especially given the morbidity associated with current treatments. Amino acid PET imaging agent, 18F-fluciclovine, has increased uptake in brain tumors relative to normal tissue and may be useful for detecting recurrent brain metastases. METHODS NCT04410133 is a prospective, open-label, single-arm, single-dose (185 MBq ±20%) study with a primary objective to confirm the diagnostic performance of 18F-fluciclovine PET (read with conventional MRI for anatomical reference) for detection of recurrent brain metastases where MRI is equivocal. Approximately 150 subjects with solid tumor brain metastases who have undergone radiation therapy will be enrolled in this multicenter trial (~18 US sites) if they have a lesion considered equivocal on MRI that requires further confirmatory diagnostic procedures such as biopsy/neurosurgical intervention or clinical follow-up. Subjects will undergo 18F-fluciclovine PET <42 days after the equivocal MRI and 1–21 days pre-biopsy/neurosurgical intervention. Clinical follow-up will occur for 6m post-18F-fluciclovine PET. Secondary objectives include evaluation of subject- and lesion-level 18F-fluciclovine negative and positive percent agreement (equivalent to specificity and sensitivity, respectively) for recurrent brain metastases, inter-reader and intra-reader agreement, and safety evaluations. Enrolment began in October 2020 and the trial is open at the time of submission.

scholarly journals Brain metastases in patients with EGFR -mutated or ALK -rearranged non-small-cell lung cancers

Lung Cancer ◽  
2015 ◽  
Vol 88 (1) ◽  
pp. 108-111 ◽  
Author(s):  
Deepa Rangachari ◽  
Norihiro Yamaguchi ◽  
Paul A. VanderLaan ◽  
Erik Folch ◽  
Anand Mahadevan ◽  
...  
Keyword(s):  
Brain Metastases ◽  
Small Cell ◽  
Small Cell Lung ◽  
Lung Cancers ◽  
Egfr Mutated
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