title: Concurrent and adjuvant temozolomide-based chemoradiotherapy schedules for glioblastoma. Hypotheses based on two prospective phase II trials.
abstract: OBJECTIVE
  To investigate the impact of nonstandard concomitant temozolomide (TMZ) administration in two prospective phase II studies for glioblastoma (GBM).
  
  
  METHODS
  From October 2000 to June 2008, 104 patients were enrolled in two studies: 25 in RT-TMZ-10.00 and 79 in RT-TMZ-01.04. Adjuvant radiotherapy (RT) was used with a total dose of 59.4 Gy (1.8 Gy/day). Patients received concomitant TMZ (75 mg/m(2)/day) from Monday to Friday during the first and last weeks of RT in the RT-TMZ-10.00 study and from Monday to Friday during all weeks of RT in the RT-TMZ-01.04 trial. Adjuvant TMZ (200 mg/m(2)) was administered for 5 days every 28 days.
  
  
  RESULTS
  Median progression-free (PFS) and overall survival (OS) were 9 and 16 months, respectively, with no significant difference between the two groups (p = 0.5 and 0.14, respectively). The 2- and 5-year OS rates were 32 and 3 %, respectively, and similar to those observed with standard treatment regimens.
  
  
  CONCLUSIONS
  Our data support the hypothesis that adjuvant TMZ is more important than concomitant chemotherapy (CH) and that RT is the more important element of the concomitant treatment schedule.
authors: Department of Radiation Oncology, Catholic University of the Sacred Heart, Largo A. Gemelli, 00135, Rome, Italy.
authors: M
authors: M
authors: Balducci
authors: A
authors: A
authors: Fiorentino
authors: P
authors: P
authors: De Bonis
authors: S
authors: S
authors: Chiesa
authors: A
authors: A
authors: Mangiola
authors: G C
authors: GC
authors: Mattiucci
authors: G R
authors: GR
authors: D'Agostino
authors: V
authors: V
authors: Frascino
authors: G
authors: G
authors: Mantini
authors: A R
authors: AR
authors: Alitto
authors: C
authors: C
authors: Colosimo
authors: C
authors: C
authors: Anile
authors: V
authors: V
authors: Valentini
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use; D001932:Brain Neoplasms / Q000401:mortality* / Q000628:therapy*; D059186:Chemoradiotherapy, Adjuvant / Q000401:mortality*; D017322:Clinical Trials, Phase II as Topic; D003131:Combined Modality Therapy / Q000401:mortality; D003606:Dacarbazine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D005909:Glioblastoma / Q000401:mortality* / Q000628:therapy*; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008875:Middle Aged; D015995:Prevalence; D011446:Prospective Studies; D018570:Risk Assessment; D015996:Survival Rate; D000077204:Temozolomide; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018906:Antineoplastic Agents, Alkylating; D003606:Dacarbazine; D000077204:Temozolomide
references: Int J Radiat Oncol Biol Phys. 1999 Dec 1;45(5):1175-84
references: 10613310
references: Anticancer Drugs. 1997 Jan;8(1):92-7
references: 9147618
references: Strahlenther Onkol. 2008 Nov;184(11):572-9
references: 19016015
references: Int J Radiat Oncol Biol Phys. 1993 May 20;26(2):239-44
references: 8387988
references: Lancet Oncol. 2009 May;10(5):459-66
references: 19269895
references: J Clin Oncol. 1998 Dec;16(12):3851-7
references: 9850030
references: Anticancer Res. 2003 Nov-Dec;23(6D):5159-64
references: 14981983
references: Cancer Res. 2001 Mar 1;61(5):1957-63
references: 11280752
references: Future Oncol. 2011 Nov;7(11):1335-46
references: 22044206
references: J Neurooncol. 2012 May;108(1):173-7
references: 22382781
references: Cancer. 2010 Aug 1;116(15):3663-9
references: 20564147
references: J Natl Cancer Inst. 1993 May 5;85(9):704-10
references: 8478956
references: J Clin Oncol. 2005 Apr 1;23(10):2372-7
references: 15800329
references: Int J Radiat Oncol Biol Phys. 2010 May 1;77(1):92-7
references: 19683876
references: Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1511-9
references: 19931733
references: Neuro Oncol. 2010 Jun;12(6):595-602
references: 20511183
references: Neuro Oncol. 2012 Jan;14(1):79-86
references: 21993440
references: J Neurooncol. 2010 Mar;97(1):95-100
references: 19705066
references: Strahlenther Onkol. 2005 Mar;181(3):157-63
references: 15756519
references: Strahlenther Onkol. 2010 Oct;186(10):558-64
references: 20936460
references: Lancet. 2002 Mar 23;359(9311):1011-8
references: 11937180
references: Int J Radiat Oncol Biol Phys. 2008 Jul 15;71(4):999-1005
references: 18258384
references: Neurol Clin. 2007 Nov;25(4):975-1003, viii-ix
references: 17964023
references: J Clin Oncol. 2007 Sep 10;25(26):4127-36
references: 17827463
references: N Engl J Med. 2005 Mar 10;352(10):987-96
references: 15758009
references: Gynecol Oncol. 2000 Sep;78(3 Pt 1):324-8
references: 10985888