title: A pilot study using carboplatin, vincristine, and temozolomide in children with progressive/symptomatic low-grade glioma: a Children's Oncology Group study†.
abstract: BACKGROUND
  This study was initiated to test the feasibility and toxicity of a regimen that alternates the administration of weekly carboplatin and vincristine with temozolomide in the management of children with progressive and/or symptomatic low-grade glioma.
  
  
  METHODS
  Eligible children received a 10-week induction regimen followed by six 10-week cycles of maintenance chemotherapy. Feasibility was evaluated with short-term and long-term endpoints. Short-term feasibility was evaluated by the ability to complete induction and 1 maintenance cycle in 24 weeks without >25% reduction in either carboplatin or temozolomide. Long-term feasibility was evaluated by the ability to administer induction and 4 maintenance cycles within 60 weeks without >25% reduction in either carboplatin or temozolomide. Efficacy was assessed by response to initial chemotherapy and 5-year event-free survival. Initial pathology was reviewed centrally.
  
  
  RESULTS
  Sixty-six patients were enrolled on the study. It was feasible to deliver the regimen, and toxicity was acceptable. The only significant toxicities were hematologic. Both the short-term and long-term feasibility endpoints were met. The short-term feasibility success rate was 87% (95% CI: 77%-96%) and the long-term feasibility success rate was 79% (95% CI: 68%-90%). The 5-year event-free survival was 46% (95% CI: 33%-58%) and the 5-year survival was 87% (95% CI: 75%-93%).
  
  
  CONCLUSIONS
  It was feasible to deliver the combination of weekly carboplatin and vincristine alternating with temozolomide to children with progressive/symptomatic low-grade glioma with acceptable toxicities. This combination appears to be effective in delaying progression. Further trials are needed to establish the relative efficacy of this regimen compared with other regimens in use.
authors: Texas Children's Cancer and Hematology Centers, Department of Pathology, Baylor College of Medicine, Houston, Texas (M.C., A.A., C.L.); Department of Preventive Medicine, University of Southern California, Los Angeles, California (S.P.E., M.K.); University of Texas Southwestern Medical Center, Dallas, Texas (M.M.); Children's National Medical Center, Washington DC (R.P.); St Jude Children's Research Hospital, Memphis, Tennessee (A.G.).
authors: Murali
authors: M
authors: Chintagumpala
authors: Texas Children's Cancer and Hematology Centers, Department of Pathology, Baylor College of Medicine, Houston, Texas (M.C., A.A., C.L.); Department of Preventive Medicine, University of Southern California, Los Angeles, California (S.P.E., M.K.); University of Texas Southwestern Medical Center, Dallas, Texas (M.M.); Children's National Medical Center, Washington DC (R.P.); St Jude Children's Research Hospital, Memphis, Tennessee (A.G.).
authors: Sandrah P
authors: SP
authors: Eckel
authors: Texas Children's Cancer and Hematology Centers, Department of Pathology, Baylor College of Medicine, Houston, Texas (M.C., A.A., C.L.); Department of Preventive Medicine, University of Southern California, Los Angeles, California (S.P.E., M.K.); University of Texas Southwestern Medical Center, Dallas, Texas (M.M.); Children's National Medical Center, Washington DC (R.P.); St Jude Children's Research Hospital, Memphis, Tennessee (A.G.).
authors: Mark
authors: M
authors: Krailo
authors: Texas Children's Cancer and Hematology Centers, Department of Pathology, Baylor College of Medicine, Houston, Texas (M.C., A.A., C.L.); Department of Preventive Medicine, University of Southern California, Los Angeles, California (S.P.E., M.K.); University of Texas Southwestern Medical Center, Dallas, Texas (M.M.); Children's National Medical Center, Washington DC (R.P.); St Jude Children's Research Hospital, Memphis, Tennessee (A.G.).
authors: Michael
authors: M
authors: Morris
authors: Texas Children's Cancer and Hematology Centers, Department of Pathology, Baylor College of Medicine, Houston, Texas (M.C., A.A., C.L.); Department of Preventive Medicine, University of Southern California, Los Angeles, California (S.P.E., M.K.); University of Texas Southwestern Medical Center, Dallas, Texas (M.M.); Children's National Medical Center, Washington DC (R.P.); St Jude Children's Research Hospital, Memphis, Tennessee (A.G.).
authors: Adekunle
authors: A
authors: Adesina
authors: Texas Children's Cancer and Hematology Centers, Department of Pathology, Baylor College of Medicine, Houston, Texas (M.C., A.A., C.L.); Department of Preventive Medicine, University of Southern California, Los Angeles, California (S.P.E., M.K.); University of Texas Southwestern Medical Center, Dallas, Texas (M.M.); Children's National Medical Center, Washington DC (R.P.); St Jude Children's Research Hospital, Memphis, Tennessee (A.G.).
authors: Roger
authors: R
authors: Packer
authors: Texas Children's Cancer and Hematology Centers, Department of Pathology, Baylor College of Medicine, Houston, Texas (M.C., A.A., C.L.); Department of Preventive Medicine, University of Southern California, Los Angeles, California (S.P.E., M.K.); University of Texas Southwestern Medical Center, Dallas, Texas (M.M.); Children's National Medical Center, Washington DC (R.P.); St Jude Children's Research Hospital, Memphis, Tennessee (A.G.).
authors: Ching
authors: C
authors: Lau
authors: Texas Children's Cancer and Hematology Centers, Department of Pathology, Baylor College of Medicine, Houston, Texas (M.C., A.A., C.L.); Department of Preventive Medicine, University of Southern California, Los Angeles, California (S.P.E., M.K.); University of Texas Southwestern Medical Center, Dallas, Texas (M.M.); Children's National Medical Center, Washington DC (R.P.); St Jude Children's Research Hospital, Memphis, Tennessee (A.G.).
authors: Amar
authors: A
authors: Gajjar
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use; D016190:Carboplatin / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003606:Dacarbazine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D005910:Glioma / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D060828:Induction Chemotherapy; D007223:Infant; D053208:Kaplan-Meier Estimate; D008297:Male; D010865:Pilot Projects; D000077204:Temozolomide; D016896:Treatment Outcome; D014750:Vincristine / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D018906:Antineoplastic Agents, Alkylating; D000972:Antineoplastic Agents, Phytogenic; D014750:Vincristine; D003606:Dacarbazine; D016190:Carboplatin; D000077204:Temozolomide
keywords: chemotherapy; low-grade glioma; temozolomide