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


Background:

  • 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.


Results:

  • 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.


Authors' Conclusions

  • 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.


Clinical/Scientific Implications:

  • 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.

Blogs

Homeopathy: What You Should Know
by The 4Wholeness Team
July 22, 2015