Sara Pedretti1, Laura Masini2, Enrico Turco3, Luca Triggiani4, Marco Krengli2, Bruno Meduri3, Luigi Pirtoli5, Paolo Borghetti1, Ludovica Pegurri1, Nada Riva6, Roberto Gatta1, Vincenzo Fusco7, Silvia Scoccianti8, Alessio Bruni3, Umberto Ricardi9, Riccardo Santoni10, Stefano M Magrini11, Michela Buglione11. 1. Radiation Oncology Department, ASST Spedali Civili Brescia, Piazzale Spedali Civili 1, 25123, Brescia, Italy. 2. Radiation Oncology Department, AOU Maggiore Della Carità, East Piedmont University, viale Mazzini 18, 28100, Novara, Italy. 3. Radiation Oncology Department, AOU Policlinico Di Modena, Largo del Pozzo, 71, 41125, Modena, Italy. 4. Radiation Oncology Department, Brescia University, Piazzale Spedali Civili 1, 23123, Brescia, Italy. triggioluca@hotmail.it. 5. Radiation Oncology Department, AOUS, Siena University, Viale Mario Bracci, 53100, Siena, Italy. 6. Radiation Oncology Department, IRST IRCSS, Via Piero Maroncelli, 40, 47014, Meldola, FC, Italy. 7. Radiation Oncology Departmenti, IRCSS, via S. Pio 1, 85028, Rionero in Vulture, PZ, Italy. 8. Radiation Oncology Department, Florence University and AUOC Ospedale Careggi, Largo Brambilla, 3, 50134, Firenze, Italy. 9. Radiation Oncology Department, AO Città Della Salute E Della Scienza, Via Genova 3, 10126, Turin, Italy. 10. Radiation Oncology Department, Fondazione Policlinico Tor Vergata, Viale Oxford 81, 00133, Rome, Italy. 11. Radiation Oncology Department, Brescia University, Piazzale Spedali Civili 1, 23123, Brescia, Italy.
Abstract
INTRODUCTION: In RPA V-VI glioblastoma patients both hypofractionated radiotherapy and exclusive temozolomide can be used; the purpose of this trial is to compare these treatment regimens in terms of survival and quality of life. METHODS:Patients with histologic diagnosis of glioblastoma were randomized to hypofractionated radiotherapy (RT-30 Gy in 6 fractions) and exclusive chemotherapy (CHT-emozolomide 200 mg/m2/day 5 days every 28 days). Overall (OS) and progression free survival (PFS) were evaluated with Kaplan Maier curves and correlated with prognostic factors. Quality- adjusted survival (QaS) was evaluated according to the Murray model (Neurological Sign and Symptoms-NSS) RESULTS:From 2010 to 2015, 31 pts were enrolled (CHT: 17 pts; RT: 14pts). Four pts were excluded from the analysis. RPA VI (p = 0.048) and absence of MGMT methylation (p = 0.001) worsened OS significantly. Biopsy (p = 0.048), RPA class VI (p = 0.04) and chemotherapy (p = 0.007) worsened PFS. In the two arms the initial NSS scores were overlapping (CHT: 12.23 and RT: 12.30) and progressively decreased in both group and became significantly worse after 5 months in CHT arm (p = 0.05). Median QaS was 104 days and was significantly better in RT arm (p = 0.01). CONCLUSIONS: The data obtained are limited by the poor accrual. Both treatments were well tolerated. Patients in RT arm have a better PFS and QaS, without significant differences in OS. The deterioration of the NSS score would seem an important parameter and coincide with disease progression rather than with the toxicity of the treatment.
RCT Entities:
INTRODUCTION: In RPA V-VI glioblastomapatients both hypofractionated radiotherapy and exclusive temozolomide can be used; the purpose of this trial is to compare these treatment regimens in terms of survival and quality of life. METHODS:Patients with histologic diagnosis of glioblastoma were randomized to hypofractionated radiotherapy (RT-30 Gy in 6 fractions) and exclusive chemotherapy (CHT-emozolomide 200 mg/m2/day 5 days every 28 days). Overall (OS) and progression free survival (PFS) were evaluated with Kaplan Maier curves and correlated with prognostic factors. Quality- adjusted survival (QaS) was evaluated according to the Murray model (Neurological Sign and Symptoms-NSS) RESULTS: From 2010 to 2015, 31 pts were enrolled (CHT: 17 pts; RT: 14pts). Four pts were excluded from the analysis. RPA VI (p = 0.048) and absence of MGMT methylation (p = 0.001) worsened OS significantly. Biopsy (p = 0.048), RPA class VI (p = 0.04) and chemotherapy (p = 0.007) worsened PFS. In the two arms the initial NSS scores were overlapping (CHT: 12.23 and RT: 12.30) and progressively decreased in both group and became significantly worse after 5 months in CHT arm (p = 0.05). Median QaS was 104 days and was significantly better in RT arm (p = 0.01). CONCLUSIONS: The data obtained are limited by the poor accrual. Both treatments were well tolerated. Patients in RT arm have a better PFS and QaS, without significant differences in OS. The deterioration of the NSS score would seem an important parameter and coincide with disease progression rather than with the toxicity of the treatment.
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