Stereotactic radiotherapy of the tumor bed compared to whole brain radiotherapy after surgery of single brain metastasis: Results from a randomized trial

Kępka, Lucyna; Tyc-Szczepaniak, Dobromira; Bujko, Krzysztof; Olszyna-Serementa, Marta; Michalski, Wojciech; Sprawka, Arkadiusz; Trabska-Kluch, B.; Komosinska, Katarzyna; Wasilewska-Teśluk, Ewa; Czeremszynska, B.

doi:10.1016/j.radonc.2016.10.005

Cited by 61 publications

(45 citation statements)

References 28 publications

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“…3 Findings from a previous randomised trial of 59 patients with resected brain metastases did not show non-inferiority of SRS compared with WBRT for neurological or cognitive failure, although the investigators stated that their trial was underpowered and that larger randomised trials were needed. 7 Additionally, the trial did not assess quality of life and measured cognitive function with an insensitive tool, the Mini–Mental State Examination. 13,24 Because adjuvant WBRT has not been shown to improve survival, 3,4,25 it is essential to adequately assess both quality of life and cognitive function to thoroughly understand the risks and benefits of the therapies to guide treatment decisions.…”

Section: Discussionmentioning

confidence: 99%

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Postoperative stereotactic radiosurgery compared with whole brain radiotherapy for resected metastatic brain disease (NCCTG N107C/CEC·3): a multicentre, randomised, controlled, phase 3 trial

Brown

Ballman

Cerhan

et al. 2017

The Lancet Oncology

934

780

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Summary Background Whole brain radiotherapy (WBRT) is the standard of care to improve intracranial control following resection of brain metastasis. However, stereotactic radiosurgery (SRS) to the surgical cavity is widely used in an attempt to reduce cognitive toxicity, despite the absence of high-level comparative data substantiating efficacy in the postoperative setting. We aimed to establish the effect of SRS on survival and cognitive outcomes compared with WBRT in patients with resected brain metastasis. Methods In this randomised, controlled, phase 3 trial, adult patients (aged 18 years or older) from 48 institutions in the USA and Canada with one resected brain metastasis and a resection cavity less than 5·0 cm in maximal extent were randomly assigned (1:1) to either postoperative SRS (12–20 Gy single fraction with dose determined by surgical cavity volume) or WBRT (30 Gy in ten daily fractions or 37·5 Gy in 15 daily fractions of 2·5 Gy; fractionation schedule predetermined for all patients at treating centre). We randomised patients using a dynamic allocation strategy with stratification factors of age, duration of extracranial disease control, number of brain metastases, histology, maximal resection cavity diameter, and treatment centre. Patients and investigators were not masked to treatment allocation. The co-primary endpoints were cognitive-deterioration-free survival and overall survival, and analyses were done by intention to treat. We report the final analysis. This trial is registered with ClinicalTrials.gov, number NCT01372774. Findings Between Nov 10, 2011, and Nov 16, 2015, 194 patients were enrolled and randomly assigned to SRS (98 patients) or WBRT (96 patients). Median follow-up was 11·1 months (IQR 5·1–18·0). Cognitive-deterioration-free survival was longer in patients assigned to SRS (median 3·7 months [95% CI 3·45–5·06], 93 events) than in patients assigned to WBRT (median 3·0 months [2·86–3·25], 93 events; hazard ratio [HR] 0·47 [95% CI 0·35–0·63]; p<0·0001), and cognitive deterioration at 6 months was less frequent in patients who received SRS than those who received WBRT (28 [52%] of 54 evaluable patients assigned to SRS vs 41 [85%] of 48 evaluable patients assigned to WBRT; difference −33·6% [95% CI −45·3 to −21·8], p<0·00031). Median overall survival was 12·2 months (95% CI 9·7–16·0, 69 deaths) for SRS and 11·6 months (9·9–18·0, 67 deaths) for WBRT (HR 1·07 [95% CI 0·76–1·50]; p=0·70). The most common grade 3 or 4 adverse events reported with a relative frequency greater than 4% were hearing impairment (three [3%] of 93 patients in the SRS group vs eight [9%] of 92 patients in the WBRT group) and cognitive disturbance (three [3%] vs five [5%]). There were no treatment-related deaths. Interpretation Decline in cognitive function was more frequent with WBRT than with SRS and there was no difference in overall survival between the treatment groups. After resection of a brain metastasis, SRS radiosurgery should be considered one of the standards of care as a less toxic alternative...

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Section: Discussionmentioning

confidence: 99%

“…6 Findings from the only study to directly address comparative efficacy for neurological or cognitive failure did not show non-inferiority of SRS compared with WBRT in the postoperative setting, and showed worse survival in the SRS treatment group than in the WBRT group. 7 …”

Section: Introductionmentioning

confidence: 99%

Postoperative stereotactic radiosurgery compared with whole brain radiotherapy for resected metastatic brain disease (NCCTG N107C/CEC·3): a multicentre, randomised, controlled, phase 3 trial

Brown

Ballman

Cerhan

et al. 2017

The Lancet Oncology

934

780

View full text Add to dashboard Cite

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“…Kocher et al reported results of the EORTC phase III trial demonstrating that overall intracranial progression (at initial or distant sites) was reduced in patients treated with adjuvant whole brain radiotherapy following surgery or SRS for brain metastases [8]. Recently, Kepka et al published results of a randomized trial examining neurological and cognitive function outcomes for patients with single brain metastases treated with surgery followed by single (1 × 15–18Gy) or hypofractionated stereotactic (5 × 5Gy) radiosurgery versus whole brain radiotherapy [23]. The study was underpowered but did not demonstrate non-inferiority of focal radiation compared to whole brain radiotherapy.…”

Section: Discussionmentioning

confidence: 99%

Clinical outcomes of patients with limited brain metastases treated with hypofractionated (5 × 6 Gy) conformal radiotherapy

Lockney

Wang

Gutin

et al. 2017

Radiotherapy and Oncology

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Background and Purpose Hypofractionated conformal radiotherapy (hfCRT) is used for larger brain metastases or metastases near critical structures. We investigated hfCRT outcomes for newly diagnosed brain metastases. Materials and Methods We identified 195 patients with 1–3 brain metastases who underwent 5 × 6Gy hfCRT for 231 lesions from 2007–2013. Associations among clinical factors, local control (LC), distant brain control (DC) and overall survival (OS) were tested using univariate and multivariate (MVA) Cox regression analysis and Kaplan-Meier method. Results Median follow-up was 12.8 months. One hundred forty-three (62%) lesions were treated with hfCRT post-operatively, and 88 (38%) with definitive hfCRT. LC for all lesions was 83% at 1 year. For lesions treated with post-operative hfCRT, tumor size (HR=4.7, p=0.04) and subtotal resection (HR=2.7, p=0.02) were predictive of local failure on MVA. For lesions ≥2.8cm in size, LC was 61% at 12 months for lesions status-post subtotal resection, compared to 84% status-post gross total resection (p=0.004). Extracranial disease presence was associated with worse DC (HR=1.8, p=0.008) and OS (HR=3.1, p<0.001). Conclusions We showed 5 × 6Gy hfCRT provides acceptable LC at 1 year for limited brain metastases. For large lesions not grossly resected, more aggressive strategies can be considered to improve LC.

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Section: Surgery For Newly Diagnosed Brain Metastasesmentioning

confidence: 99%

“…Over the past two decades, the use of WBRT for treatment of up to four BM has fallen out of favor at many centers, calling into question the justification of surgery with literature where WBRT was the sole comparator. [45][46][47][48][49][50][51][52] This shift toward SRS was due to the publication of high-quality data supporting the use of SRS over WBRT, showing comparative efficacy (sometimes even improved survival) and decreased radiation-induced toxicity (eg cognitive decline) associated with SRS ( Figure 4). While the use of SRS as a monotherapy has limitations, which include higher rates of salvage therapy, leptomeningeal disease, and distant tumor recurrences compared to WBRT, 47,53 the overall survival and cost-effectiveness of SRS alone vs SRS + WBRT favored SRS alone in two recent studies for up to 10 metastases.…”

Section: Surgery (±Wbrt) Vs Srs (±Wbrt)mentioning

confidence: 99%

Operative and peri‐operative considerations in the management of brain metastasis

et al. 2019

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The number of patients who develop metastatic brain lesions is increasing as the diagnosis and treatment of systemic cancers continues to improve, resulting in longer patient survival. The role of surgery in the management of brain metastasis (BM), particularly multiple and recurrent metastases, remains controversial and continues to evolve. However, with appropriate patient selection, outcomes after surgery are typically favorable. In addition, surgery is the only means to obtain a tissue diagnosis and is the only effective treatment modality to quickly relieve neurological complications or life‐threatening symptoms related to significant mass effect, CSF obstruction, and peritumoral edema. As such, a thorough understanding of the role of surgery in patients with metastatic brain lesions, as well as the factors associated with surgical outcomes, is essential for the effective management of this unique and growing patient population.

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Stereotactic radiotherapy of the tumor bed compared to whole brain radiotherapy after surgery of single brain metastasis: Results from a randomized trial

Cited by 61 publications

References 28 publications

Postoperative stereotactic radiosurgery compared with whole brain radiotherapy for resected metastatic brain disease (NCCTG N107C/CEC·3): a multicentre, randomised, controlled, phase 3 trial

Postoperative stereotactic radiosurgery compared with whole brain radiotherapy for resected metastatic brain disease (NCCTG N107C/CEC·3): a multicentre, randomised, controlled, phase 3 trial

Clinical outcomes of patients with limited brain metastases treated with hypofractionated (5 × 6 Gy) conformal radiotherapy

Operative and peri‐operative considerations in the management of brain metastasis

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