Phase II Randomized Trial of Temozolomide and Concurrent Radiotherapy in Patients With Brain Metastases

Antonadou, D.; Paraskevaidis, M.; Sarris, George E.; Coliarakis, N.; Economou, I.; Karageorgis, P.; Throuvalas, N.

doi:10.1200/jco.2002.04.140

Cited by 311 publications

(178 citation statements)

References 28 publications

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“…WBI was gave as 40 Gy over 4 weeks, TMZ 75 mg/m2 per day, days 1-28; subsequent TMZ 200 mg/m2 per day, days 1-5/28-d cycle for six cycles but these results were not confirmed with brain metastases from lung cancer in phase III study conducted by the same authors (14,15).…”

Section: Discussion:-mentioning

confidence: 61%

“…However, individually, only one out of 7 randomized controlled trials RCTs included in this meta-analysis showed a some survival improvement following the addition of temozolomide to radiotherapy, with median survival times of 7and 8.6 months in the RT arm and TMZ plus RT arm, respectively (15). In four randomized controlled trials that compare radiotherapy to concomitant TMZ and RT, the OS was lower in patients who were treated with combination TMZ and RT (11,(19)(20)(21) It is hard to compare the results of our study, that was performed on a homogenous group of patients ;with the previously mentioned studies which included more heterogeneous groups of patients and with different treatment regimens.…”

Section: Discussion:-mentioning

confidence: 99%

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Concurrent Whole Brain Irradiation With or Without Temozolomide in Treatment of Brain Metastases From Breast Cancer.

Abdelgawad¹,

Ismail²,

Sarhan³

2017

IJAR

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Background : to evaluate the response rate , survival and safety of the combination of temozolamide and whole brain radiotherapy in breast cancer patients with previously untreated brain metastases Patients and Methods:40 patients with brain metastases were divided in two groups Control arm(A): patients received whole brain radiotherapy(WBRT) at a dose of 30 Gy in 10 daily fractions over 2 weeks. TMZ plus WBI arm (B): patients treated with (WBRT) at a dose of 30 Gy in 10 daily fractions over 2 weeks concomitant with temozolamide. The primary endpoint was overall response (OR) Secondary endpoints were progression free survival (PFS) and overall survival ( OS) Results: Patients who received WBI and TMZ had an overall response of 45% compared with 40% in WBI alone with no statistically significant difference. Brain metastasis progression was observed in 45% in the control group(A) versus 15% in group B with a statistically significant difference (p=0.038) . Median progression free survival ( PFS) was 6 months in group A but 9.5 in group B with non significant difference. One year progression free survival was 37.5% in group A versus 45% in group B . One year overall survival was 33.3% in group A versus 47.8% in group B . Median overall survival was 7 months in group A versus 11 months in group B with non-significant difference. Most of patients had tolerable side effects and recovered eventually. Conclusion: Although, the combination of WBRT and TMZ was safe and appeared to improve local control , OS and PFS of BMs from breast cancer in this study, this improvement was non-significant, and further studies with larger number of patients are needed to get significant results.

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Section: Discussion:-mentioning

confidence: 61%

Section: Discussion:-mentioning

confidence: 99%

Concurrent Whole Brain Irradiation With or Without Temozolomide in Treatment of Brain Metastases From Breast Cancer.

Abdelgawad¹,

Ismail²,

Sarhan³

2017

IJAR

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“…Antonodau et al in a randomized phase II study and in a confirmatory phase III study comparing TMZ plus WBRT to WBRT alone in population largely consisting of lung cancer patients, reported a significantly greater overall response in the patients receiving TMZ [25,26]. Instead, in a preliminary report of Verger et al, a response of only 16% was noted with WBRT plus TMZ in 85 patients, half of whom had lung cancer [27].…”

Section: Discussionmentioning

confidence: 98%

Oral temozolomide in heavily pre-treated brain metastases from non-small cell lung cancer: Phase II study

Giorgio¹,

Giuffrida²,

Pappalardo³

et al. 2005

Lung Cancer

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Summary Introduction:The primary tumour type most likely to metastasize to the brain is lung cancer. In heavily pre-treated patients, limited therapeutic option is available and the results of availability therapies reported in literature are disappointing. The present phase II study was designed to assess the efficacy and safety of temozolomide (TMZ) as palliative treatment for brain metastases (BrM) in NSCLC patients pre-treated with WBRT and at least one line of chemotherapy for metastatic brain disease. Material and methods: Temozolomide was administered orally at 150 mg/mq/day for five consecutive days for the first cycle, doses were increased to 200 mg/mq/day for 5 days every 28 days for subsequent cycles if no grade 3/4 haematological toxicity was observed. Eligibility criteria included cytological or histological confirmed NSCLC; BrM, recurrent or progressing after WBRT and at least one line of chemotherapy. A total of 30 consecutive patients entered the study and received the allocated treatment.Results: Three patients (10%) achieved an objective response (OR) of BrM with two complete remission. Stable disease and progressive disease were achieved in 3 (10%) and 24 patients (80%), respectively. A correlation between response to TMZ * Corresponding author. and sensitivity to the previous first line chemotherapy was reported. Time to progression and overall survival were examined both for responder patients and for all included patients. For long-term survivors, we considered the patients who survived >12 months after the start of TMZ. According to this definition, three patients resulted long-term survivors: 2 with OR and 1 with stable brain disease. No grades 3 or 4 toxicity occurred. The total of treatment-related adverse events were mild or moderate (G1-2) in intensity. No patients discontinued TMZ as a result of treatment-related toxicity. Discussion: The results of the present trial clearly demonstrates that TMZ is active and safe in BrM NSCLC patients previously treated with WBRT and at least one line of chemotherapy.

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“…WBRT is the most common and effective standard treatment for lung cancer patients with multiple brain metastases or lesions that are inoperable (Antonadou et al, 2002;Guerrieri et al, 2004;Verger et al, 2005). WBRT can rapidly relieve neurologic symptoms caused by BM, control the local progression of metastasis, improve the neurological function and quality of life, and prolong progression free survival time of these patients (Postmus et al, 2000).…”

Section: Discussionmentioning

confidence: 99%

“…WBRT can rapidly relieve neurologic symptoms caused by BM, control the local progression of metastasis, improve the neurological function and quality of life, and prolong progression free survival time of these patients (Postmus et al, 2000). However, WBRT may cause radioactive nerve damage, even lead to brain atrophy and necrosis (Antonadou et al, 2002;Gijtenbeek et al, 2011), which is particularly a concern in large doses of radiation. The limitation on the dose of WBRT makes it difficult to completely eradicate the tumor.…”

Section: Discussionmentioning

confidence: 99%

Whole Brain Radiotherapy Plus Chemotherapy in the Treatment of Brain Metastases from Lung Cancer: A Meta-analysis of 19 Randomized Controlled Trails

Liu¹,

Zeng²,

Qin³

et al. 2012

Asian Pacific Journal of Cancer Prevention

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Phase II Randomized Trial of Temozolomide and Concurrent Radiotherapy in Patients With Brain Metastases

Abstract: Temozolomide is safe, and a significant improvement in response rate was observed when administered in combination with radiotherapy in patients with previously untreated brain metastases. A larger randomized trial is warranted to verify these results.

Cited by 311 publications

References 28 publications

Concurrent Whole Brain Irradiation With or Without Temozolomide in Treatment of Brain Metastases From Breast Cancer.

Concurrent Whole Brain Irradiation With or Without Temozolomide in Treatment of Brain Metastases From Breast Cancer.

Oral temozolomide in heavily pre-treated brain metastases from non-small cell lung cancer: Phase II study

Whole Brain Radiotherapy Plus Chemotherapy in the Treatment of Brain Metastases from Lung Cancer: A Meta-analysis of 19 Randomized Controlled Trails

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