Hypofractionated accelerated radiotherapy (HART) with concurrent and adjuvant temozolomide in newly diagnosed glioblastoma: a phase II randomized trial (HART-GBM trial)

Mallick, Supriya; Kunhiparambath, H.; Gupta, Seema; Benson, Rony; Sharma, S.; Laviraj, M.A.; Upadhyay, Ashish Datt; Julka, Pramod Kumar; Sharma, Dayanand; Rath, Goura Kishor

doi:10.1007/s11060-018-2932-3

Cited by 38 publications

(28 citation statements)

References 30 publications

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“…No patient developed late toxicity. Mallick et al [18] compared conventionally fractionated radiation therapy (CRT) and hypofractionated accelerated radiation therapy (HART) in 83 patients with GBM who were between the ages of 16 and 65 years old. The prescribed dose was 50 Gy over 25 fractions to CTV50, followed by a boost of 10 Gy over 5 fractions to CTV60 in the CRT arm.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of moderately hypofractionated simultaneous integrated boost intensity-modulated radiotherapy combined with temozolomide for the postoperative treatment of glioblastoma multiforme: a single-institution experience

Liu

Chen

et al. 2019

Radiat Oncol

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Purpose Despite recent advances in multimodal treatments, the prognosis of patients with glioblastoma multiforme (GBM) remains poor. The aim of this study was to evaluate the efficacy of moderately hypofractionated simultaneous integrated boost intensity-modulated radiotherapy (SIB-IMRT) combined with temozolomide (TMZ) for the postoperative treatment of GBM. Materials and methods From February 2012 to February 2018, 80 patients with newly diagnosed and histologically confirmed GBM in our institute were reviewed retrospectively. All patients underwent complete resection or partial resection surgery and then received hypofractionated SIB-IMRT with concomitant TMZ followed by adjuvant TMZ. A total dose of 64 Gy over 27 fractions was delivered to the gross tumor volume (GTV), clinical target volume 1 (CTV1) received 60 Gy over 27 fractions, and CTV2 received 54 Gy over 27 fractions. The progression-free survival (PFS) and overall survival (OS) rates and the toxicities were evaluated. Prognostic factors were analyzed using univariate and multivariate Cox models. Results The median follow-up was 16 months (range, 5~72 months). The median PFS was 15 months, and the 1-, 2-, and 3-year PFS rates were 56.0, 27.6, and 19.5%, respectively. The median OS was 21 months, and the 1-, 2-, 3-, and 5-year OS rates were 77.6, 41.6, 32.8, and 13.4%, respectively. The toxicities were mild and acceptable. Age, KPS scores and the total number of TMZ cycles were significant factors influencing patient survival. Conclusion Moderately hypofractionated SIB-IMRT combined with TMZ is a feasible and safe treatment option with mild toxicity and good PFS and OS.

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Section: Discussionmentioning

confidence: 99%

Efficacy of moderately hypofractionated simultaneous integrated boost intensity-modulated radiotherapy combined with temozolomide for the postoperative treatment of glioblastoma multiforme: a single-institution experience

Liu

Chen

et al. 2019

Radiat Oncol

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“…Additionally, the possibility of using HFRT to treat patients between the ages of 16 and 65 years with newly diagnosed GB has been analyzed in a randomized phase II study in New Delhi, India [17]. Eighty-nine patients were randomized to CFRT (60 Gy in 30 fractions of 2 Gy) or HFRT (60 Gy in 20 fractions to high-risk PTV and 50 Gy in 20 fractions to low-risk PTV).…”

Section: Discussionmentioning

confidence: 99%

Hypofractionated radiation therapy and temozolomide in patients with glioblastoma and poor prognostic factors. A prospective, single-institution experience

et al. 2019

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Background Hypofractionated radiation therapy is a feasible and safe treatment option in elderly and frail patients with glioblastoma. The aim of this study was to evaluate the effectiveness of hypofractionated radiation therapy with concurrent temozolomide in terms of feasibility and disease control in primary glioblastoma patients with poor prognostic factors other than advanced age, such as post-surgical neurological complications, high tumor burden, unresectable or multifocal lesions, and potential low treatment compliance due to social factors or rapidly progressive disease. Material and methods GTV included the surgical cavity plus disease visible in T1WI-MRI, FLAIR-MRI and in the MET-uptake. The CTV was defined as the GTV plus 1.5–2 cm margin; the PTV was the CTV+0.3 cm margin. Forty, fourty-five, and fifty grays in 15 fractions were prescribed to 95% of PTV, CTV, and GTV, respectively. Treatment was delivered using IMRT or the VMAT technique. Simultaneously, 75 mg/m 2 /day of temozolomide were administered. Results Between January 2010 and November 2017, we treated a total of 17 patients. The median age at diagnosis was 68-years; median KPS was 50–70%. MGMT -methylation status was negative in 5 patients, and 8 patients were IDH -wildtype. Eight of 18 patients were younger than 65-years. Median tumor volume was 26.95cc; median PTV volume was 322cc. Four lesions were unresectable; 6 patients underwent complete surgical resection. Median residual volume was 1.14cc. Progression-free survival was 60% at 6 months, 33% at 1-year and 13% at 2-years (median OS = 7 months). No acute grade 3–5 toxicities were documented. Symptomatic grade 3 radiation necrosis was observed in one patient. Conclusions Patients with poor clinical factors other than advanced age can be selected for hypofractionated radiotherapy. The OS and PFS rates obtained in our series are similar to those in patients treated with standard fractionation, assuring good treatment adherence, low rates of toxicity and probable improved cost-effectiveness.

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“…Four randomized controlled trials (two phase III, two phase II) [15][16][17][18] and 7 observational studies (8 arms) [19][20][21][22][23][24][25] were identified (flow-chart: see Fig. 1).…”

Section: Resultsmentioning

confidence: 99%

Survival after hypofractionation in glioblastoma: a systematic review and meta-analysis

et al. 2020

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Background: Glioblastoma multiforme (GBM) has a poor prognosis despite a multi modal treatment that includes normofractionated radiotherapy. So, various hypofractionated alternatives to normofractionated RT have been tested to improve such prognosis. There is need of systematic review and meta-analysis to analyse the literature properly and maybe generalised the use of hypofractionation. The aim of this study was first, to perform a metaanalysis of all controlled trials testing the impact of hypofractionation on survival without age restriction and secondly, to analyse data from all non-comparative trials testing the impact of hypofractionation, radiosurgery and hypofractionated stereotactic RT in first line. Materials/Methods: We searched Medline, Embase and Cochrane databases to identify all publications testing the impact of hypofractionation in glioblastoma between 1985 and March 2020. Combined hazard ratio from comparative studies was calculated for overall survival. The impact of study design, age and use of adjuvant temozolomide was explored by stratification. Meta-regressions were performed to determine the impact of prognostic factors. Results: 2283 publications were identified. Eleven comparative trials were included. No impact on overall survival was evidenced (HR: 1.07, 95%CI: 0.89-1.28) without age restriction. The analysis of non-comparative literature revealed heterogeneous outcomes with limited quality of reporting. Concurrent chemotherapy, completion of surgery, immobilization device, isodose of prescription, and prescribed dose (depending on tumour volume) were poorly described. However, results on survival are encouraging and were correlated with the percentage of resected patients and with patients age but not with median dose. Conclusions: Because few trials were randomized and because the limited quality of reporting, it is difficult to define the place of hypofactionation in glioblastoma. In first line, hypofractionation resulted in comparable survival outcome with the benefit of a shortened duration. The method used to assess hypofractionation needs to be improved.

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Hypofractionated accelerated radiotherapy (HART) with concurrent and adjuvant temozolomide in newly diagnosed glioblastoma: a phase II randomized trial (HART-GBM trial)

Abstract: HART is comparable to CRT in terms of survival outcome. HART arm had no excess treatment interruption and minimal toxicity. Dose escalation, reduction in overall treatment time, is the advantages with use of HART.

Cited by 38 publications

References 30 publications

Efficacy of moderately hypofractionated simultaneous integrated boost intensity-modulated radiotherapy combined with temozolomide for the postoperative treatment of glioblastoma multiforme: a single-institution experience

Efficacy of moderately hypofractionated simultaneous integrated boost intensity-modulated radiotherapy combined with temozolomide for the postoperative treatment of glioblastoma multiforme: a single-institution experience

Hypofractionated radiation therapy and temozolomide in patients with glioblastoma and poor prognostic factors. A prospective, single-institution experience

Survival after hypofractionation in glioblastoma: a systematic review and meta-analysis

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