Article
Intraoperative radiotherapy after resection of brain metastases (INTRAMET) – interim analysis on safety/efficacy of a prospective phase II study
Intraoperative Radiotherapie nach der Resektion von Gehirnmetastasen (INTRAMET) – Ergebnisseeiner Interims-Sicherheits- und Wirksamkeitsanalyse einer prospektiven Phase II Studie
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Authors
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Stefanie Brehmer
- Universitätsklinikum Mannheim, Klinik für Neurochirurgie, Mannheim, Deutschland
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Alex Förster
- Universitätsklinikum Mannheim, Institut für Neuroradiologie, Mannheim, Deutschland
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Marcel Seiz-Rosenhagen
- Universitätsklinikum Mannheim, Klinik für Neurochirurgie, Mannheim, Deutschland
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Sven Clausen
- Universitätsklinikum Mannheim, Klinik für Strahlentherapie und Radioonkologie, Mannheim, Deutschland
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Frank Schneider
- Universitätsklinikum Mannheim, Klinik für Strahlentherapie und Radioonkologie, Mannheim, Deutschland
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Daniel Hänggi
- Universitätsklinikum Mannheim, Klinik für Neurochirurgie, Mannheim, Deutschland
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Nima Etminan
- Universitätsklinikum Mannheim, Klinik für Neurochirurgie, Mannheim, Deutschland
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Frank Anton Giordano
- Universitätsklinikum Mannheim, Klinik für Strahlentherapie und Radioonkologie, Mannheim, Deutschland
| Published: | June 26, 2020 |
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Outline
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Objective: Brain metastases occur in roughly 40% of patients diagnosed with systemic cancer. External beam radiotherapy (to the cavity or whole brain) lowers local recurrence rates but also prolongs the time to (systemic) salvage therapies after surgical treatment of metastases. We here present the interim data on INTRAMET, a phase II trial that evaluates safety and efficacy intraoperative radiotherapy (IORT) of the resection cavity.
Methods: INTRAMET is an investigator-initiated, monocentric, open-label, one-arm, prospective, phase II study that includes patients aged 18 years and older with newly diagnosed, resectable brain metastases with a KPS of 50 of better. Following resection of the macroscopic tumor, all patients receive IORT with 30 Gy prescribed to the margin of the resection cavity. The primary endpoint is local progression-free survival (L-PFS), secondary endpoints are time to salvage cancer therapy (TTST), overall survival (OS), global (cancer-specific) PFS, cognitive performance, quality of life and dose-limiting toxicities (DLT) defined as wound healing disorders, cerebral hemorrhage, ischemia or radionecrosis requiring surgical intervention. Radiological analyses are conducted by an external/independent neuroradiologist. We here report
- (i) safety and efficacy results of a planned safety/interim analysis after inclusion of 22 patients and
- (ii) on a pre-planned comparison of TTSTs of IORT-treated patients, compared to a control cohort of 108 patients treated with surgery and conventional radiotherapy within the same time period.
Results: The median follow-up in the IORT-group was 10.5 months [0.9-28.9]. Although 2 cases of radionecrosis at the surgical site occurred - both in combination with systemic immunotherapy treatment - no DLT were observed. 1 Patient had a confirmed local recurrence which occurred concomitant with multiple other new out-of-field metastases 41 days after treatment. At follow-up, 5 additional patients developed new out-of-field brain metastases [mean 215d], which were treated with rescue radiotherapy. The mean TTST after IORT was 41 days compared to 56 days in the control group (p=0.037), with a mean time to cerebral radiotherapy after surgery of 25 days.
Conclusion: IORT for cerebral brain metastases appears to be safe and effective. In addition, the time to systemic therapy is significantly reduced with less hospitalization, which is of high impact for patients’ quality of life.
