Tanja[a]
Fünfundsiebzig Patienten wurden mit Protokoll POG 9330 therapiert; zwei untaugliche Patienten schieden von der Studie aus, bevor man irgendeine Therapie anfing. Es gab einen kompletten Tumorrückgang und drei teilweise Tumorverkleinerungen (5,7%). Bei zwanzig Patienten stabilisierte sich die Krankheit für mehr als 2 Monate.
Quelle: Am J Pediatr Hematol Oncol 2001 Jun;23(5):277-281
Paclitaxel for the Treatment of Progressive or Recurrent Childhood Brain Tumors:
A Pediatric Oncology Phase II Study.
Hurwitz CA, Strauss LC, Kepner J, Kretschmar C, Harris MB, Friedman H, Kun L, Kadota R.
Maine Children´s Cancer Program, Scarborough, Maine, U.S.A. and The Barbara Bush Children´s Hospital at Maine Medical Center (C.A.H.), Portland, Maine, U.S.A.; Northwestern University Medical School and Children´s Memorial Hospital (L.C.S.), Chicago, Illinois, U.S.A.; Pediatric Oncology Group Statistical Office (J.K.), Gainesville, Florida, U.S.A.; Boston Floating Hospital (C.K.), Boston, Massachusetts, U.S.A.; Hackensack University Medical Center and UMDNJ-New Jersey Medical School (M.B.H.), Hackensack, New Jersey, U.S.A.; Duke University Medical Center (H.F.), Durham, North Carolina, U.S.A.; St. Jude Children´s Research Hospital (L.K.), Memphis, Tennessee, U.S.A.; and Children´s Hospital of San Diego (R.K.), San Diego, California, U.S.A.
PURPOSE: To assess the efficacy and define the toxicity of paclitaxel given at a dosage of 350 mg/m2 every 3 weeks as a 24-hour continuous infusion to children with recurrent or progressive primary brain tumors.
PATIENTS AND METHODS: Seventy-three eligible patients, ages 4 months to 19 years, with progressive or recurrent primary brain tumors were treated according to a Pediatric Oncology Group (POG) phase II protocol with paclitaxel (POG 9330). Tumor histologic strata included: astrocytoma (n = 4), malignant glioma (n = 13), medulloblastoma (n = 16), brain stem glioma (n = 15), ependymoma (n = 13), and miscellaneous histologies (n = 12). All patients had previous histologic confirmation of a primary intracranial or spinal cord tumor with magnetic resonance imaging or computed tomography documentation of unequivocally measurable progressive or recurrent disease. All patients had received previous therapy including surgery, radiation therapy, and/or chemotherapy, but no patient had been previously treated on more than one phase II trial. Paclitaxel was administered as a 24-hour intravenous infusion at a dosage of 350 mg/m2 every 3 weeks. Neurologic and neuroradiologic reevaluations were performed after every second course. Patients were allowed to continue therapy for a total of 18 cycles in the absence of progressive disease or unacceptable toxicity.
RESULTS: Seventy-five patients were enrolled onto the POG 9330 protocol; two ineligible patients were removed from the study before receiving any therapy. Of the 73 eligible patients, 72 were evaluable for toxicity and 70 were either fully or partially evaluable for disease response. There was one complete response and three partial responses (5.7%). Twenty patients had stable disease for more than 2 months. Toxicities included mild nausea, central nervous system toxicity, myelosuppression, and febrile neutropenia, including one septic death. One grade 2 and two grade 3 allergic reactions occurred. No cardiac toxicities or arthralgias were reported.
CONCLUSION: Paclitaxel is well tolerated in children with recurrent or progressive brain tumors at this dosage and schedule and may result in short-term disease stabilization in this patient population. The lack of a significant number of patients with measurable disease regression, however, precludes it from being identified as an active agent when administered as a single agent by 24-hour continuous infusion.