title: Randomized trial of radiation therapy plus procarbazine, lomustine, and vincristine chemotherapy for supratentorial adult low-grade glioma: initial results of RTOG 9802.
abstract: OBJECTIVE
  A prior Radiation Therapy Oncology Group (RTOG) clinical trial in anaplastic oligodendroglioma suggested a progression-free survival benefit for procarbazine, lomustine, and vincristine (PCV) chemotherapy in addition to radiation therapy (RT), as have smaller trials in low-grade glioma (LGG).
  
  
  METHODS
  Eligibility criteria included supratentorial WHO grade 2 LGG, age 18 to 39 years with subtotal resection/biopsy, or age ≥ 40 years with any extent resection. Patients were randomly assigned to RT alone or RT followed by six cycles of PCV. Survival was compared by using the modified Wilcoxon and log-rank tests.
  
  
  RESULTS
  In all, 251 patients were accrued from 1998 to 2002. Median overall survival (OS) time and 5-year OS rates for RT versus RT + PCV were 7.5 years versus not reached and 63% versus 72%, respectively (hazard ratio [HR]; 0.72; 95% CI, 0.47 to 1.10; P = .33; log-rank P = .13). Median progression-free survival (PFS) time and 5-year PFS rates for RT versus RT + PCV were 4.4 years versus not reached and 46% versus 63%, respectively (HR, 0.6; 95% CI, 0.41 to 0.86; P = .06; log-rank P = .005). OS and PFS were similar for all patients between years 0 and 2. After 2 years, OS and PFS curves separated significantly, favoring RT + PCV. For 2-year survivors (n = 211), the probability of OS for an additional 5 years was 74% with RT + PCV versus 59% with RT alone (HR, 0.52; 95% CI, 0.30 to 0.90; log-rank P = .02).
  
  
  CONCLUSIONS
  PFS but not OS was improved for adult patients with LGG receiving RT + PCV versus RT alone. On post hoc analysis, for 2-year survivors, the addition of PCV to RT conferred a survival advantage, suggesting a delayed benefit for chemotherapy.
authors.affiliation: Department of Radiation Oncology, Wake Forest University School of Medicine, 2000 W. First St, Winston-Salem, NC 27104, USA. eshaw@wakehealth.edu
authors.forename: Edward G
authors.initials: EG
authors.lastname: Shaw
authors.forename: Meihua
authors.initials: M
authors.lastname: Wang
authors.forename: Stephen W
authors.initials: SW
authors.lastname: Coons
authors.forename: David G
authors.initials: DG
authors.lastname: Brachman
authors.forename: Jan C
authors.initials: JC
authors.lastname: Buckner
authors.forename: Keith J
authors.initials: KJ
authors.lastname: Stelzer
authors.forename: Geoffrey R
authors.initials: GR
authors.lastname: Barger
authors.forename: Paul D
authors.initials: PD
authors.lastname: Brown
authors.forename: Mark R
authors.initials: MR
authors.lastname: Gilbert
authors.forename: Minesh P
authors.initials: MP
authors.lastname: Mehta
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D059186:Chemoradiotherapy, Adjuvant / Q000009:adverse effects; D016009:Chi-Square Distribution; D018572:Disease-Free Survival; D005910:Glioma / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008130:Lomustine / Q000008:administration & dosage; D008875:Middle Aged; D015999:Multivariate Analysis; D060787:Neoplasm Grading; D011344:Procarbazine / Q000008:administration & dosage; D016016:Proportional Hazards Models; D018570:Risk Assessment; D012307:Risk Factors; D015173:Supratentorial Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D011344:Procarbazine; D014750:Vincristine; D008130:Lomustine