title: Phase II trial with BCNU plus alpha-interferon in patients with recurrent high-grade gliomas.
abstract: A Phase II study with a combination of BCNU and alpha-interferon (IFN) was conducted in patients with high-grade glioma recurrent after surgery and radiation treatment in order to investigate tumor control and toxicity. Twenty-one non-chemotherapy pretreated patients were administered 6 MU alpha-IFN in a 2-h infusion followed by 150 mg/m2 BCNU i.v. on day 1. Three MU alpha-IFN were subsequently administered subcutaneously on alternating days three times a week, until recycling of the whole procedure on day 42. Among 21 patients, partial remission was obtained in 7 (33%; 95% CI = 15-57) and stable disease in 6 (29%; CI = 11-52); overall Kaplan-Meier median time to progression (TTP) was 4.5 months (CI = 4-9) and the overall median survival time (MST) was 7 months (CI = 5-13). In patients who underwent surgical redebulking prior to chemotherapy, TTP and MST were 9 (CI = 7-14) and 15 months (CI = 11.0-39.0); in patients who were not operated on again before chemotherapy, these values were 4 (CI = 2-5; log rank test, p = 0.0026) and 5.5 months (CI = 4-7; log rank test, p = 0.0012) respectively. The results of this regimen in relapsing patients, especially following surgical redebulking, are encouraging; toxicity is acceptable, and further studies on combined alpha-IFN and multiple-agent chemotherapy are warranted.
authors.affiliation: Department of Medical Oncology, Azienda Ospedaliera, Padova, Italy.
authors.forename: A A
authors.initials: AA
authors.lastname: Brandes
authors.forename: E
authors.initials: E
authors.lastname: Scelzi
authors.forename: P
authors.initials: P
authors.lastname: Zampieri
authors.forename: A
authors.initials: A
authors.lastname: Rigon
authors.forename: A
authors.initials: A
authors.lastname: Rotilio
authors.forename: P
authors.initials: P
authors.lastname: Amista
authors.forename: F
authors.initials: F
authors.lastname: Berti
authors.forename: M V
authors.initials: MV
authors.lastname: Fiorentino
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001792:Blood Platelets / Q000187:drug effects; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D002330:Carmustine / Q000008:administration & dosage* / Q000009:adverse effects; D003131:Combined Modality Therapy; D018450:Disease Progression; D005260:Female; D005909:Glioblastoma / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery; D005910:Glioma / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D006801:Humans; D007262:Infusions, Intravenous; D007279:Injections, Subcutaneous; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000601:surgery; D011994:Recombinant Proteins; D012074:Remission Induction; D015996:Survival Rate
chemical_list: D000970:Antineoplastic Agents; D018906:Antineoplastic Agents, Alkylating; D016898:Interferon-alpha; D011994:Recombinant Proteins; D002330:Carmustine