Phase II trial of radiosurgery for one to three newly diagnosed brain metastases from renal cell carcinoma, melanoma, and sarcoma: An eastern cooperative oncology group study (E 6397)

Rafael Manon, Anne O'Neill, Jonathan Knisely, Maria Werner-Wasik, Hillard M. Lazarus, Henry Wagner, Mark Gilbert, Minesh Mehta

Research output: Contribution to journalArticle

144 Citations (Scopus)

Abstract

Purpose: Long-term brain metastases survivors are at risk for neurologic morbidity after whole-brain radiotherapy (WBRT). Retrospective radiosurgery (RS) reports found no survival difference when compared with WBRT. Before RS alone was evaluated with delayed WBRT in a phase III trial, the feasibility of RS alone was tested prospectively. Patients and Methods: Patients with renal cell carcinoma, melanoma, or sarcoma; one to three brain metastases; and performance status of 0 to 2 were enrolled. Exclusion criteria were leptomeningeal disease; metastases in medulla, pons, or midbrain; or liver metastases. On the basis of tumor size, patients received 24, 18, or 15 Gy RS. At recurrence, management was discretionary. The primary end point was 3- and 6-month intracranial progression. Results: Between July 1998 and August 2003, 36 patients were accrued; 31 were eligible. Median follow-up was 32.7 months and the median survival was 8.3 months (95% CI, 7.4 to 12.2). Three- and 6-month intracranial failure with RS alone was 25.8% and 48.3%. Failure within and outside the RS volume, when in-field and distant intracranial failures were scored independently, was 19.3% and 16.2% (3 months) and 32.2% and 32.2% (6 months), respectively. Approximately 38% of patients experienced death attributable to neurologic cause. There were three grade 3 toxicities related to RS. Conclusion: Intracranial failure rates without WBRT were 25.8% and 48.3% at 3 and 6 months, respectively. Delaying WBRT may be appropriate for some subgroups of patients with radioresistant tumors, but routine avoidance of WBRT should be approached judiciously.

Original languageEnglish (US)
Pages (from-to)8870-8876
Number of pages7
JournalJournal of Clinical Oncology
Volume23
Issue number34
DOIs
StatePublished - Dec 1 2005

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Radiosurgery
Renal Cell Carcinoma
Sarcoma
Melanoma
Neoplasm Metastasis
Radiotherapy
Brain
Nervous System
Survival
Pons
Mesencephalon
Survivors
Neoplasms
Morbidity
Recurrence
Liver

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Manon, Rafael ; O'Neill, Anne ; Knisely, Jonathan ; Werner-Wasik, Maria ; Lazarus, Hillard M. ; Wagner, Henry ; Gilbert, Mark ; Mehta, Minesh. / Phase II trial of radiosurgery for one to three newly diagnosed brain metastases from renal cell carcinoma, melanoma, and sarcoma : An eastern cooperative oncology group study (E 6397). In: Journal of Clinical Oncology. 2005 ; Vol. 23, No. 34. pp. 8870-8876.
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title = "Phase II trial of radiosurgery for one to three newly diagnosed brain metastases from renal cell carcinoma, melanoma, and sarcoma: An eastern cooperative oncology group study (E 6397)",
abstract = "Purpose: Long-term brain metastases survivors are at risk for neurologic morbidity after whole-brain radiotherapy (WBRT). Retrospective radiosurgery (RS) reports found no survival difference when compared with WBRT. Before RS alone was evaluated with delayed WBRT in a phase III trial, the feasibility of RS alone was tested prospectively. Patients and Methods: Patients with renal cell carcinoma, melanoma, or sarcoma; one to three brain metastases; and performance status of 0 to 2 were enrolled. Exclusion criteria were leptomeningeal disease; metastases in medulla, pons, or midbrain; or liver metastases. On the basis of tumor size, patients received 24, 18, or 15 Gy RS. At recurrence, management was discretionary. The primary end point was 3- and 6-month intracranial progression. Results: Between July 1998 and August 2003, 36 patients were accrued; 31 were eligible. Median follow-up was 32.7 months and the median survival was 8.3 months (95{\%} CI, 7.4 to 12.2). Three- and 6-month intracranial failure with RS alone was 25.8{\%} and 48.3{\%}. Failure within and outside the RS volume, when in-field and distant intracranial failures were scored independently, was 19.3{\%} and 16.2{\%} (3 months) and 32.2{\%} and 32.2{\%} (6 months), respectively. Approximately 38{\%} of patients experienced death attributable to neurologic cause. There were three grade 3 toxicities related to RS. Conclusion: Intracranial failure rates without WBRT were 25.8{\%} and 48.3{\%} at 3 and 6 months, respectively. Delaying WBRT may be appropriate for some subgroups of patients with radioresistant tumors, but routine avoidance of WBRT should be approached judiciously.",
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Phase II trial of radiosurgery for one to three newly diagnosed brain metastases from renal cell carcinoma, melanoma, and sarcoma : An eastern cooperative oncology group study (E 6397). / Manon, Rafael; O'Neill, Anne; Knisely, Jonathan; Werner-Wasik, Maria; Lazarus, Hillard M.; Wagner, Henry; Gilbert, Mark; Mehta, Minesh.

In: Journal of Clinical Oncology, Vol. 23, No. 34, 01.12.2005, p. 8870-8876.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Phase II trial of radiosurgery for one to three newly diagnosed brain metastases from renal cell carcinoma, melanoma, and sarcoma

T2 - An eastern cooperative oncology group study (E 6397)

AU - Manon, Rafael

AU - O'Neill, Anne

AU - Knisely, Jonathan

AU - Werner-Wasik, Maria

AU - Lazarus, Hillard M.

AU - Wagner, Henry

AU - Gilbert, Mark

AU - Mehta, Minesh

PY - 2005/12/1

Y1 - 2005/12/1

N2 - Purpose: Long-term brain metastases survivors are at risk for neurologic morbidity after whole-brain radiotherapy (WBRT). Retrospective radiosurgery (RS) reports found no survival difference when compared with WBRT. Before RS alone was evaluated with delayed WBRT in a phase III trial, the feasibility of RS alone was tested prospectively. Patients and Methods: Patients with renal cell carcinoma, melanoma, or sarcoma; one to three brain metastases; and performance status of 0 to 2 were enrolled. Exclusion criteria were leptomeningeal disease; metastases in medulla, pons, or midbrain; or liver metastases. On the basis of tumor size, patients received 24, 18, or 15 Gy RS. At recurrence, management was discretionary. The primary end point was 3- and 6-month intracranial progression. Results: Between July 1998 and August 2003, 36 patients were accrued; 31 were eligible. Median follow-up was 32.7 months and the median survival was 8.3 months (95% CI, 7.4 to 12.2). Three- and 6-month intracranial failure with RS alone was 25.8% and 48.3%. Failure within and outside the RS volume, when in-field and distant intracranial failures were scored independently, was 19.3% and 16.2% (3 months) and 32.2% and 32.2% (6 months), respectively. Approximately 38% of patients experienced death attributable to neurologic cause. There were three grade 3 toxicities related to RS. Conclusion: Intracranial failure rates without WBRT were 25.8% and 48.3% at 3 and 6 months, respectively. Delaying WBRT may be appropriate for some subgroups of patients with radioresistant tumors, but routine avoidance of WBRT should be approached judiciously.

AB - Purpose: Long-term brain metastases survivors are at risk for neurologic morbidity after whole-brain radiotherapy (WBRT). Retrospective radiosurgery (RS) reports found no survival difference when compared with WBRT. Before RS alone was evaluated with delayed WBRT in a phase III trial, the feasibility of RS alone was tested prospectively. Patients and Methods: Patients with renal cell carcinoma, melanoma, or sarcoma; one to three brain metastases; and performance status of 0 to 2 were enrolled. Exclusion criteria were leptomeningeal disease; metastases in medulla, pons, or midbrain; or liver metastases. On the basis of tumor size, patients received 24, 18, or 15 Gy RS. At recurrence, management was discretionary. The primary end point was 3- and 6-month intracranial progression. Results: Between July 1998 and August 2003, 36 patients were accrued; 31 were eligible. Median follow-up was 32.7 months and the median survival was 8.3 months (95% CI, 7.4 to 12.2). Three- and 6-month intracranial failure with RS alone was 25.8% and 48.3%. Failure within and outside the RS volume, when in-field and distant intracranial failures were scored independently, was 19.3% and 16.2% (3 months) and 32.2% and 32.2% (6 months), respectively. Approximately 38% of patients experienced death attributable to neurologic cause. There were three grade 3 toxicities related to RS. Conclusion: Intracranial failure rates without WBRT were 25.8% and 48.3% at 3 and 6 months, respectively. Delaying WBRT may be appropriate for some subgroups of patients with radioresistant tumors, but routine avoidance of WBRT should be approached judiciously.

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