Abstract |
To determine the safety, tolerability, and report on secondary efficacy endpoints of motexafin gadolinium (MGd) in combination with whole-brain radiotherapy (WBRT) and stereotactic radiosurgery (SRS) for patients with ≤ 6 brain metastases. We conducted an international study of WBRT (37.5 Gy in 15 fractions) and SRS (15-21 Gy) with the addition of MGd (5 mg/kg preceding each fraction beginning week 2). The primary endpoint was to evaluate the rate of irreversible grade 3 or any grade ≥ 4 neurotoxicity and establish feasibility in preparation for a phase III trial. Sixty-five patients were enrolled from 14 institutions, of which 45 (69%) received SRS with MGd as intended and were available for evaluation. Grade ≥ 3 neurotoxicity attributable to radiation therapy within 3 months of SRS was seen in 2 patients (4.4%), including generalized weakness and radionecrosis requiring surgical management. Immediately following the course of MGd plus WBRT, new brain metastases were detected in 11 patients (24.4%) at the time of the SRS treatment planning MRI. The actuarial incidence of neurologic progression at 6 months and 1 year was 17 and 20%, respectively. The median investigator-determined neurologic progression free survival and overall survival times were 8 (95% CI: 5-14) and 9 months (95% CI: 6-not reached), respectively. We observed a low rate of neurotoxicity, demonstrating that the addition of MGd does not increase the incidence or severity of neurologic complications from WBRT with SRS boost.
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Authors | Derek R McHaffie, Pierre Chabot, Anne Dagnault, John H Suh, Marie-Andrée Fortin, Eric Chang, Robert Timmerman, Luis Souhami, John Grecula, Abdenour Nabid, Chris Schultz, Maria Werner-Wasik, Laurie E Gaspar, David Brachman, Tarak Mody, Minesh P Mehta |
Journal | Journal of neuro-oncology
(J Neurooncol)
Vol. 105
Issue 2
Pg. 301-8
(Nov 2011)
ISSN: 1573-7373 [Electronic] United States |
PMID | 21523486
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antineoplastic Agents
- Metalloporphyrins
- motexafin gadolinium
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Topics |
- Adult
- Aged
- Antineoplastic Agents
(administration & dosage)
- Brain Neoplasms
(mortality, secondary, therapy)
- Combined Modality Therapy
- Cranial Irradiation
- Feasibility Studies
- Female
- Follow-Up Studies
- Humans
- International Agencies
- Male
- Metalloporphyrins
(administration & dosage)
- Middle Aged
- Neoplasm Recurrence, Local
(mortality, pathology, therapy)
- Neoplasms
(mortality, pathology, therapy)
- Radiosurgery
- Survival Rate
- Treatment Outcome
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