RSR 13 Plus Cranial Radiation Therapy Improves Survival in Patients With Brain Metastases Compared to RTOG Recursive Partitioning Analysis Brain Metastases Database
William Levin, MD
OncoLink Assistant Editor
Last Modified: October 25, 2000
Presenter: E. Shaw
Affiliation: Wake Forest University School of Medicine
- RSR 13 is a potential enhancer of ionizing radiation by decreasing hemoglobin-O2 binding affinity and increasing tumor oxygenation.
- This is a Phase II open label study design to assess the efficacy/safety of RSR 13 plus external beam radiation therapy (RT) in patients with brain metastases.
- The primary endpoint was survival compared to the Radiation Therapy Oncology Group Recursive Partitioning Analysis Brain Metastases Database (RTOG RPA BMD).
Materials and Methods:
- Eligibility: Age > 18, KPS > 70, brain metastases.
- 57 patients were enrolled and evaluated, the majority of these patients had metastatic disease from either a primary lung or breast cancer.
- Patients received cranial RT, 30 Gy in 10 fractions of 3 Gy each, proceeded by RSR 13, 75- 100 mg/kg IV over 30 minute infusion.
- 80% of pts. Completed over 90% of RSR 13 doses.
- 40% of patients required dose reduction of RSR 13
- 30% of patients had severe adverse effects which included: hypoxemia, hypotension, acute renal failure, altered mental status, and allergic reaction.
- There were no treatment related deaths.
- The pts. treated with RSR 13 had a median survival of 6.4 months versus 4.1 months for the RTOG RPA BMD group (p < 0.02).
- At 6 month follow-up, survival rates were 51% versus 35% in favor of the RSR 13 group.
- Death due to brain metastases was decreased with the use of RSR 13, 11% versus 37% for the RTOG RPA BMD group.
- RSR 13 plus cranial RT resulted in significant improvement in survival as well as a reduction in death due to brain metastases compared to the RTOG RPA BMD group.
- The use of hemoglobin-oxygen modifiers such as RSR 13 may increase tumor oxygenation in patients with metastatic brain disease.
- Combined with cranial irradiation, RSR 13 may offer a survival benefit for these patients, who generally have poor prognosis.