Phase II study of temozolomide and cisplatin as primary treatment prior to radiotherapy in newly diagnosed glioblastoma multiforme patients with measurable disease. A study of the Spanish Medical Neuro-Oncology Group (GENOM)

Bala�a, Carmen; L�pez-pousa, Antonio; Berrocal, A.; Yaya-Tur, Ricardo; Herrero, Ana; Garc�a, Jose-luis; Mart�n-broto, Javier; Benavides, Manuel; Cerd�-nicol�s, Miguel; Ballester, R.; Balart, J.; Capellades, Jaume

doi:10.1007/s11060-004-9175-1

Cited by 29 publications

(16 citation statements)

References 28 publications

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“…They constitute almost 30% of our patients and a larger proportion have an adequate KPS to be included in trials of promising agents detected in phase II studies on recurrent patients. The neo-adjuvant design of two or three cycles before radiotherapy has not worsened the results on survival of 'biopsy-only' patients and minimises the confounding factor of surgery in the response evaluation [21][22][23]. Antiangiogenic therapy seems to be especially promising for reaching these objectives [24].…”

Section: Discussionmentioning

confidence: 99%

Clinical course of high-grade glioma patients with a “biopsy-only” surgical approach: a need for individualised treatment

et al. 2007

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Section: Discussionmentioning

confidence: 99%

Clinical course of high-grade glioma patients with a “biopsy-only” surgical approach: a need for individualised treatment

et al. 2007

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“…The grade 4 vomiting and nausea have an incidence of 4-6% whereas the grade 3 ranges from1% to 6%; nevertheless in a study the incidence of these symptoms is increased to 24% [51]. The association between TMZ and cisplatin increases the incidence of gastric symptoms up to 17-20% [20,23]: the gastric toxicity of the is thought to be the cause of this increase.…”

Section: Non-haematologic Toxicitymentioning

confidence: 92%

“…The association between cisplatin and TMZ [20,23,30] offers clinical results that appear better than those obtained with a standard schedule of TMZ alone and comparable to those obtained using TMZ combined with other anticancer drugs [25]. Other than haematological toxicity with 37% of leukopenia [20], also otoxicity (6%) [30], nausea and vomiting [23] are reported; the increased incidence and duration of these side effects, compared to single use of TMZ were expected, and are thought to be linked to the inherent emetogenic potential of cisplatin.…”

Section: Drug Interactionsmentioning

confidence: 99%

“…Other than haematological toxicity with 37% of leukopenia [20], also otoxicity (6%) [30], nausea and vomiting [23] are reported; the increased incidence and duration of these side effects, compared to single use of TMZ were expected, and are thought to be linked to the inherent emetogenic potential of cisplatin. One patient died for a septic shock due to chemotherapy [20].…”

Section: Drug Interactionsmentioning

confidence: 99%

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The Safety of the Temozolomide in Patients with Malignant Glioma

Dario¹,

Tomei

2006

CDS

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The temozolomide is a promising orally cytotoxic agent used in malignant glioma. The survival curve improvement after drug administration appears to be statistically significant. The review of temozolomide side effects is carried out by search on literature data found on web and is divided on the 4 grades of toxicity according to the National Cancer Institute Common Toxicity Criteria, version 2.0. The adverse effects related with TMZ administration are divided in three categories: myelosuppression, non haematologic toxicity, and infections. The main adverse effect is the myelosuppression that appears to be rather low and reversible as well as the vomiting or nausea. The different schedules of administration are analysed. The frequency of concomitant infections is underlined. In particular, if available, the relationship between temozolomide and other cytotoxic agents or anticonvulsivant drugs is analysed to clarify the possibility of increase of toxicity. The temozolomide is used also in children but the toxicity could be more frequent.

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“…An overall RR of 42% with a MPFS of 4 months and OS of 13 months were observed. A phase II study with neoadjuvant combination chemotherapy of TMZ plus cisplatin on 40 newly diagnosed GBM showed a RR of 45% (95% CI, 27%–58%) and OS of 12.5 months 43. Overall survival is comparable with the standard sequence of TMZ and RT followed by TMZ.…”

Section: Different Schedules Of Tmz Administrationmentioning

confidence: 96%

Critical appraisal of temozolomide formulations in the treatment of primary brain tumors: patient considerations

García¹,

Clopés²,

Bruna³

et al. 2009

CMR

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Chemotherapy is assuming an increasingly important role in the treatment of malignant gliomas, of which temozolomide (TMZ) is a key part. TMZ belongs to a class of second-generation imidazotetrazinone prodrugs that exhibit linear pharmacokinetics and do not require hepatic metabolism for activation to the active metabolite. New intravenous (iv) TMZ formulations have recently been approved based on studies of bioequivalence between iv and oral TMZ. The efficacy of TMZ was initially evaluated in patients with recurrent disease but phase II and III trials in newly diagnosed gliomas are available. The results of a large phase III trial that compared RT alone vs RT concomitant with oral TMZ created a new standard of adjuvant treatment. Efficacy data for iv TMZ on which its approval was based are those extrapolated from clinical trials with oral TMZ. No comparative data are available on the differences in tolerability and patient satisfaction between oral and iv formulations of TMZ, or for quality of life. New oral formulations could encourage the adherence of patients to treatment. Although patients presumably would prefer oral treatment, iv formulations may be an alternative in noncompliant patients or patients for whom good adherence could not be expected.

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Phase II study of temozolomide and cisplatin as primary treatment prior to radiotherapy in newly diagnosed glioblastoma multiforme patients with measurable disease. A study of the Spanish Medical Neuro-Oncology Group (GENOM)

Abstract: This regimen has significant activity, as it induces objective responses even in biopsy-only patients, appearing to improve their median survival. A better combination schedule is needed to improve the toxicity profile.

Cited by 29 publications

References 28 publications

Clinical course of high-grade glioma patients with a “biopsy-only” surgical approach: a need for individualised treatment

Clinical course of high-grade glioma patients with a “biopsy-only” surgical approach: a need for individualised treatment

The Safety of the Temozolomide in Patients with Malignant Glioma

Critical appraisal of temozolomide formulations in the treatment of primary brain tumors: patient considerations

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