Challenges relating to solid tumour brain metastases in clinical trials, part 2: neurocognitive, neurological, and quality-of-life outcomes. A report from the RANO group

Lin, Nancy U.; Wefel, Jeffrey S.; Lee, Eudocia Q.; Schiff, David; Bent, Martin J. van den; Soffietti, Riccardo; Suh, John H.; Vogelbaum, Michael A.; Mehta, Minesh P.; Dancey, Janet; Linskey, Mark E.; Camidge, D. Ross; Aoyama, Hidefumi; Brown, Paul D.; Chang, Susan M.; Kalkanis, Steven N.; Barani, Igor J.; Baumert, Brigitta G.; Gaspar, Laurie E.; Hodi, F. Stephen; Macdonald, David R.; Wen, Patrick Y.

doi:10.1016/s1470-2045(13)70308-5

Cited by 123 publications

(82 citation statements)

References 68 publications

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“…This includes analysis of the index lesion, nonindex lesion, corticosteroid use, and clinical status. In creating the RANO criteria for brain metastases, Lin et al have provided excellent and thoughtful insight into optimally evaluating patients with brain metastases in two reviews with attention to response criteria and neurocognitive outcomes [67,68].…”

Section: Evaluation Of Response To Targeted Agents and Srsmentioning

confidence: 99%

The Rationale for Targeted Therapies and Stereotactic Radiosurgery in the Treatment of Brain Metastases

et al. 2016

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Brain metastases are the most common intracranial malignancy. Many approaches, including radiation therapy, surgery, and cytotoxic chemotherapy, have been used to treat patients with brain metastases depending on the patient's disease burden and symptoms. However, stereotactic surgery (SRS) has revolutionized local treatment of brain metastases. Likewise, targeted therapies, including small-molecule inhibitors and monoclonal antibodies that target cancer cell metabolism or angiogenesis, have transformed managing systemic disease. Prospective data on combining these treatments for synergistic effect are limited, but early data show favorable safety and efficacy profiles.The combination of SRS and targeted therapy will further individualize treatment, potentially obviating the need for cytotoxic chemotherapy or whole-brain radiation.There is a great need to pursue research into these exciting modalities and novel combinations to further improve the treatment of patients with brain metastases.This article discusses reported and ongoing clinical trials assessing the safety and efficacy of targeted therapy during SRS. The Oncologist 2016;21:244-251 Implications for Practice: Treatment of patients with brain metastases requires a multidisciplinary approach. Stereotactic radiosurgery is increasingly used in the upfront setting to treat new brain metastasis. Targeted therapies have revolutionized systemic treatment of many malignancies and may sometimes be used as initial treatment in metastatic patients. There is sparse literature regarding safety and efficacy of combining these two treatment modalities. This article summarizes the supporting literature and highlights ongoing clinical trials in combining radiosurgery with targeted therapy.

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Section: Evaluation Of Response To Targeted Agents and Srsmentioning

confidence: 99%

The Rationale for Targeted Therapies and Stereotactic Radiosurgery in the Treatment of Brain Metastases

et al. 2016

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“…Les Les signes et symptômes liés aux métastases cérébrales sont extrêmement variés selon leur nombre, leur volume, leur topographie et selon l'évolution de la maladie systémique. Les symptômes et signes cliniques les plus fréquemment observés sont les cépha-lées, la fatigue, une faiblesse musculaire, des troubles de la coordination, des crises d'épilepsie [6]. Les signes et symptômes en lien avec la toxicité des différents traitements ou avec des pathologies intercurrentes doivent également être recherchés.…”

Section: Soins De Supportunclassified

“…Le plus souvent les troubles concernent l'apprentissage, la mémoire, les fonctions exécutives, la dextérité motrice et sont davantage liés au volume tumoral et à la localisation qu'au nombre total de méta-stases [6]. Ils sont généralement associés à une moins bonne survie globale.…”

Section: Cognitionunclassified

“…L'objectif principal de la prise en charge des patients est donc de prolonger la survie en préservant avant tout l'autonomie et la qualité de vie. Les traitements ayant une pertinence clinique seront ceux considérés comme les plus appropriés au regard de leur impact sur la survie globale, de leur capacité à préserver l'indépendance fonctionnelle et à maintenir la qualité de vie, de leur capacité à contrôler et à pré-venir l'apparition de nouveaux symptômes et signes neurologiques et de leurs effets secondaires [6].…”

Section: Introductionunclassified

“…Ces domaines sont généralement évalués à l'aide de questionnaires remplis par le médecin, le personnel infirmier ou de recherche clinique, le patient ou l'entourage ou par une évaluation objective extensive incluant un bilan neuropsychologique. Il faut néanmoins garder à l'esprit que d'autres facteurs tels que les caractéristiques tumorales, la maladie extracérébrale et son traitement, les maladies associées des patients peuvent égale-ment influer [6].…”

Section: Introductionunclassified

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Soins de support, cognition, qualité de vie et métastases cérébrales

Rhun¹,

Taillibert²,

Blonski³

et al. 2015

Cancer/Radiothérapie

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Intracranial and Extracranial Progression and Their Correlation With Overall Survival After Stereotactic Radiosurgery in a Multi-institutional Cohort With Brain Metastases

et al. 2023

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ImportanceClinical trials for metastatic malignant neoplasms are increasingly being extended to patients with brain metastases. Despite the preeminence of progression-free survival (PFS) as a primary oncologic end point, the correlation of intracranial progression (ICP) and extracranial progression (ECP) events with overall survival (OS) is poorly understood for patients with brain metastases following stereotactic radiosurgery (SRS).ObjectiveTo determine the correlation of ICP and ECP with OS among patients with brain metastases completing an initial SRS course.Design, Setting, and ParticipantsThis multi-institutional retrospective cohort study was conducted from January 1, 2015, to December 31, 2020. We included patients who completed an initial course of SRS for brain metastases during the study period, including receipt of single and/or multifraction SRS, prior whole-brain radiotherapy, and brain metastasis resection. Data analysis was performed on November 15, 2022.ExposuresNon-OS end points included intracranial PFS, extracranial PFS, PFS, time to ICP, time to ECP, and any time to progression. Progression events were radiologically defined, incorporating multidisciplinary clinical consensus.Main Outcomes and MeasuresThe primary outcome was correlation of surrogate end points to OS. Clinical end points were estimated from time of SRS completion via the Kaplan-Meier method, while end-point correlation to OS was measured using normal scores rank correlation with the iterative multiple imputation approach.ResultsThis study included 1383 patients, with a mean age of 63.1 years (range, 20.9-92.8 years) and a median follow-up of 8.72 months (IQR, 3.25-19.68 months). The majority of participants were White (1032 [75%]), and more than half (758 [55%]) were women. Common primary tumor sites included the lung (757 [55%]), breast (203 [15%]), and skin (melanoma; 100 [7%]). Intracranial progression was observed in 698 patients (50%), preceding 492 of 1000 observed deaths (49%). Extracranial progression was observed in 800 patients (58%), preceding 627 of 1000 observed deaths (63%). Irrespective of deaths, 482 patients (35%) experienced both ICP and ECP, 534 (39%) experienced ICP (216 [16%]) or ECP (318 [23%]), and 367 (27%) experienced neither. The median OS was 9.93 months (95% CI, 9.08-11.05 months). Intracranial PFS had the highest correlation with OS (ρ = 0.84 [95% CI, 0.82-0.85]; median, 4.39 months [95% CI, 4.02-4.92 months]). Time to ICP had the lowest correlation with OS (ρ = 0.42 [95% CI, 0.34-0.50]) and the longest median time to event (median, 8.76 months [95% CI, 7.70-9.48 months]). Across specific primary tumor types, correlations of intracranial PFS and extracranial PFS with OS were consistently high despite corresponding differences in median outcome durations.Conclusions and RelevanceThe results of this cohort study of patients with brain metastases completing SRS suggest that intracranial PFS, extracranial PFS, and PFS had the highest correlations with OS and time to ICP had the lowest correlation with OS. These data may inform future patient inclusion and end-point selection for clinical trials.

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Challenges relating to solid tumour brain metastases in clinical trials, part 2: neurocognitive, neurological, and quality-of-life outcomes. A report from the RANO group

Cited by 123 publications

References 68 publications

The Rationale for Targeted Therapies and Stereotactic Radiosurgery in the Treatment of Brain Metastases

The Rationale for Targeted Therapies and Stereotactic Radiosurgery in the Treatment of Brain Metastases

Soins de support, cognition, qualité de vie et métastases cérébrales

Intracranial and Extracranial Progression and Their Correlation With Overall Survival After Stereotactic Radiosurgery in a Multi-institutional Cohort With Brain Metastases

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