A phase II study of temozolomide in patients with newly diagnosed supratentorial malignant glioma before radiation therapy

Gilbert, Mark R.; Friedman, Henry S.; Kuttesch, John F.; Prados, Michael D.; Olson, Jeffrey J.; Reaman, Gregory H.; Zaknoen, Sara

doi:10.1215/s1522851702000091

Cited by 7 publications

(7 citation statements)

References 17 publications

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“…Gilbert et al [37] reported on 36 glioblastoma patients receiving standard-dose TMZ for up to four cycles. A complete response was observed in four patients and a partial response in 11 patients, for an overall response rate of 42% with a median PFS survival of 4 months and overall survival of 13 months.…”

Section: Temozolomide For Patients With Newly Diagnosed Glioblastomamentioning

confidence: 99%

Optimal role of temozolomide in the treatment of malignant gliomas

Stupp

Bent²,

Hegi³

2005

Curr Neurol Neurosci Rep

177

118

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Temozolomide (TMZ) is an alkylating agent that was approved for anaplastic astrocytoma and glioblastoma. Its role in the treatment of recurrent disease has been confirmed, and more importantly, alternative treatment schedules and combination regimens have been developed. A recent phase III trial has demonstrated a survival advantage for concomitant TMZ administration with radiotherapy in patients with newly diagnosed glioblastoma. Molecular studies suggest a strong predictive role of the DNA repair enzyme O6-methyl-guanine-DNA-methyl-transferase (MGMT) and outcome of TMZ-based chemotherapy. This review summarizes the current knowledge, highlights approved and nonapproved indications, and describes molecular studies that may allow us to identify the patients most likely to benefit from this treatment.

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Section: Temozolomide For Patients With Newly Diagnosed Glioblastomamentioning

confidence: 99%

Optimal role of temozolomide in the treatment of malignant gliomas

Stupp

Bent²,

Hegi³

2005

Curr Neurol Neurosci Rep

177

118

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“…The rationale behind this approach is to defer potentially severe long-term neurotoxic effects induced by CNS irradiation [20,21] and to facilitate the delivery of chemotherapeutic agents to the tumor site through non-altered blood vessels. Administration of TMZ before radiation therapy to patients with newly diagnosed glioblastoma or anaplastic astrocytoma induced a high radiographic response rate, but the effects were often only short-lived [22]. In the pivotal NOA-04 trial on sequential radiochemotherapy, comparing initial radiotherapy with chemotherapy [procarbacine, CCNU and vincristine (PCV) or TMZ], chemotherapy yielded statistically equivalent efficacy as compared to radiotherapy concerning time to treatment failure (which includes firstline and first relapse treatment) as well as progression-free survival (PFS) [23].…”

Section: Introductionmentioning

confidence: 99%

Temozolomide and 13-cis retinoic acid in patients with anaplastic gliomas: a prospective single-arm monocentric phase-II study (RNOP-05)

et al. 2011

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The objective of this prospective, monocentric phase-II pilot study was to evaluate toxicity and efficacy of neoadjuvant temozolomide (TMZ) and 13-cis retinoic acid (13-cRA) treatment in patients with newly diagnosed anaplastic gliomas after total or subtotal tumor resection. The primary endpoint of the study was median progression-free survival (PFS). Secondary endpoints were toxicity and PFS rates at 6, 12 and 24 months. Thirty-two adult patients were included in the study and treated with a median number of 10 TMZ and 13-cRA cycles (range 1-26). The majority of patients had favorable prognostic factors characterized by young age, complete resection, oligodendroglial histology, 1p/19q co-deletion, O6-methylguanine-DNA methyltransferase (MGMT) promotor methylation and isocitrate dehydrogenase 1 (IDH1) mutation. Grade 3/4 myelotoxicity occurred in 5/32 patients, and about 90% of patients suffered from grade 2/3 adverse events attributable to 13-cRA. The median PFS was 37.8 months (95% CI 22.2-53.4). The 6-, 12- and 24-month PFS rates were 84.4, 75 and 42.4%. The extent of tumor resection was the only prognostic factor associated with better PFS. TMZ and 13-cRA treatment did not improve PFS when retrospectively compared to the TMZ-treated group within the randomized NOA-04 phase-III trial. In conclusion, 13-cRA addition to TMZ in a neoadjuvant setting showed acceptable toxicity, but did not yield an advantage in PFS in patients with newly diagnosed anaplastic gliomas after total or subtotal tumor resection.

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“…In addition, its penetrance in the central nervous system could be useful in the setting of brain metastases [17]. The results of temozolomide treatment in a few cases of central nervous system germinoma refractory to conventional chemotherapy are reported in the literature [18], and at least 1 patient achieved stable disease [19]. Kondagunta et al [20], however, did not find any response in a series of 14 patients with cisplatin-refractory germ cell tumors.…”

Section: Discussionmentioning

confidence: 99%

Brief Report: Phase II Multicenter Study of Temozolomide in Patients with Cisplatin-Resistant Germ Cell Tumors

Maroto

Huddart²,

Muro³

et al. 2011

Oncology

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Purpose: To determine the activity and toxicity of temozolomide in a phase II multicenter trial in patients diagnosed with relapsed or cisplatin-refractory germ cell tumors. Patients and Methods: During a recruitment period of 30 months, 20 patients received temozolomide 150 mg/m²/day p.o. for 5 days every 4 weeks, escalating to 200 mg/m²/day if grade II toxicity was not observed in the first cycle. Eligibility criteria were tumor progression or relapse after previous cisplatin and ifosfamide-containing chemotherapy, creatinine clearance of >40 ml/min, and a performance status of 0–2. Results: The median age was 38 years (range 27–56). Seventeen patients had nonseminomatous tumors, and 3 had seminomatous tumors. Six of the patients had extragonadal primary tumors (3 retroperitoneal and 3 mediastinal). The median number of prior cisplatin-containing cycles was 11 (range 7–20). Eight patients received prior high-dose chemotherapy and 14 were refractory or absolutely refractory to cisplatin. A total of 45 cycles were administered. Two partial responses lasting 9 and 3.5 months (overall response rate 10%, 95% CI 1.2–31.7) were observed. One of these responses was seen in a patient with a cisplatin-refractory tumor that had previously been treated with high-dose chemotherapy. The median time to progression and the median overall survival were 1.5 and 3.1 months, respectively. Grade III hematological toxicity consisted of thrombocytopenia in 2 patients and anemia in 1 patient. No grade IV toxicity was observed. Conclusions: Temozolomide had some activity in heavily pretreated patients resistant to cisplatin-based chemotherapy.

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A phase II study of temozolomide in patients with newly diagnosed supratentorial malignant glioma before radiation therapy

Cited by 7 publications

References 17 publications

Optimal role of temozolomide in the treatment of malignant gliomas

Optimal role of temozolomide in the treatment of malignant gliomas

Temozolomide and 13-cis retinoic acid in patients with anaplastic gliomas: a prospective single-arm monocentric phase-II study (RNOP-05)

Brief Report: Phase II Multicenter Study of Temozolomide in Patients with Cisplatin-Resistant Germ Cell Tumors

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