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Safety and feasibility of motexafin gadolinium administration with whole brain radiation therapy and stereotactic radiosurgery boost in the treatment of ≤ 6 brain metastases: a multi-institutional phase II trial.

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.
AuthorsDerek 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
JournalJournal of neuro-oncology (J Neurooncol) Vol. 105 Issue 2 Pg. 301-8 (Nov 2011) ISSN: 1573-7373 [Electronic] United States
PMID21523486 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
Chemical References
  • Antineoplastic Agents
  • Metalloporphyrins
  • motexafin gadolinium
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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