PURPOSE: This Phase II study was designed to determine the median survival time of adults with supratentorial glioblastoma treated with a combination of temozolomide (TMZ) and 13-cis-retinoic acid (cRA) given daily with conventional radiation therapy (XRT). METHODS AND MATERIALS: This was a single arm, open-labeled, Phase II study. Patients were treated with XRT in conjunction with cRA and TMZ. Both drugs were administered starting on Day 1 of XRT, and chemotherapy cycles continued after the completion of XRT to a maximum of 1 year. RESULTS: Sixty-one patients were enrolled in the study. Time to progression was known for 55 patients and 6 were censored. The estimated 6-month progression-free survival was 38% and the estimated 1-year progression-free survival was 15%. Median time to progression was estimated as 21 weeks. The estimated 1-year survival was 57%. The median survival was 57 weeks. CONCLUSIONS: The combined therapy was relatively well tolerated, but there was no survival advantage compared with historical studies using XRT either with adjuvant nitrosourea chemotherapy, with TMZ alone, or with the combination of TMZ and thalidomide. Based on this study, cRA does not seem to add a significant synergistic effect to TMZ and XRT.
PURPOSE: This Phase II study was designed to determine the median survival time of adults with supratentorial glioblastoma treated with a combination of temozolomide (TMZ) and 13-cis-retinoic acid (cRA) given daily with conventional radiation therapy (XRT). METHODS AND MATERIALS: This was a single arm, open-labeled, Phase II study. Patients were treated with XRT in conjunction with cRA and TMZ. Both drugs were administered starting on Day 1 of XRT, and chemotherapy cycles continued after the completion of XRT to a maximum of 1 year. RESULTS: Sixty-one patients were enrolled in the study. Time to progression was known for 55 patients and 6 were censored. The estimated 6-month progression-free survival was 38% and the estimated 1-year progression-free survival was 15%. Median time to progression was estimated as 21 weeks. The estimated 1-year survival was 57%. The median survival was 57 weeks. CONCLUSIONS: The combined therapy was relatively well tolerated, but there was no survival advantage compared with historical studies using XRT either with adjuvant nitrosourea chemotherapy, with TMZ alone, or with the combination of TMZ and thalidomide. Based on this study, cRA does not seem to add a significant synergistic effect to TMZ and XRT.
Authors: Mei-Yin C Polley; Kathleen R Lamborn; Susan M Chang; Nicholas Butowski; Jennifer L Clarke; Michael Prados Journal: J Clin Oncol Date: 2011-10-03 Impact factor: 44.544
Authors: Oliver Grauer; Christina Pascher; Christian Hartmann; Florian Zeman; Michael Weller; Martin Proescholdt; Alexander Brawanski; Thorsten Pietsch; Wolfgang Wick; Ulrich Bogdahn; Peter Hau Journal: J Neurooncol Date: 2011-03-04 Impact factor: 4.130
Authors: David E Gerber; Stuart A Grossman; Michel Zeltzman; Michele A Parisi; Lawrence Kleinberg Journal: Neuro Oncol Date: 2006-11-15 Impact factor: 12.300
Authors: Michael D Prados; Susan M Chang; Nicholas Butowski; Rebecca DeBoer; Rupa Parvataneni; Hannah Carliner; Paul Kabuubi; Jennifer Ayers-Ringler; Jane Rabbitt; Margaretta Page; Anne Fedoroff; Penny K Sneed; Mitchel S Berger; Michael W McDermott; Andrew T Parsa; Scott Vandenberg; C David James; Kathleen R Lamborn; David Stokoe; Daphne A Haas-Kogan Journal: J Clin Oncol Date: 2008-12-15 Impact factor: 44.544
Authors: Julia Alejandra Pezuk; María Sol Brassesco; Andressa Gois Morales; Jaqueline Carvalho de Oliveira; Harley Francisco de Oliveira; Carlos Alberto Scrideli; Luiz Gonzaga Tone Journal: Cancer Biother Radiopharm Date: 2013-05-28 Impact factor: 3.099
Authors: Nicholas Butowski; Kathleen R Lamborn; Mitchel S Berger; Michael D Prados; Susan M Chang Journal: J Neurooncol Date: 2007-04-25 Impact factor: 4.130