The DOI matches its Crossref record; 33 of the 35 references it cites were found in a registry or an index.
Multicenter phase II trial of temozolomide in patients with glioblastoma multiforme at first relapse
Open accessAbstract
Background Recurrent glioblastoma multiforme (GBM) is resistant to most therapeutic endeavors, with low response rates and survival rarely exceeding six months. There are no clearly established chemotherapeutic regimens and the aim of treatment is palliation with improvement in the quality of life.Patients and methods We report an open-label, uncontrolled, multicenter phase II trial of temozolomide in 138 patients (intent-to-treat [ITT] population) with glioblastoma multiforme at first relapse and a Karnofsky performance status (KPS) > or = 70. One hundred twenty-eight patients were histologically confirmed with GBM or gliosarcoma (GS) by independent central review. Chemotherapy-naïve patients were treated with temozolomide 200 mg/m2/day orally for the first five days of a 28-day cycle. Patients previously treated with nitrosourea-containing adjuvant chemotherapy received 150 mg/m2/day for the first five days of a 28-day cycle. In the absence of grade 3 or 4 toxicity, patients on the 150 mg/m2 dose schedule were eligible for a 200 mg/m2 dose on the next cycle.Results The primary endpoint was six-month progression-free survival assessed with strict radiological and clinical criteria. Secondary endpoints included radiological response and Health-related Quality of Life (HQL). Progression-free survival at six months was 18% (95% confidence interval (CI): 11%-26%) for the eligible-histology population. Median progression-free survival and median overall survival were 2.1 months and 5.4 months, respectively. The six-month survival rate was 46%. The objective response rate (complete response and partial response) determined by independent central review of gadolinium-enhanced magnetic resonance imaging (MRI) scans was 8% for both the ITT and eligible-histology populations, with an additional 43% and 45% of patients, respectively, having stable disease (SD). Objectively assessed response and maintenance of a progression-free status were both associated with HQL benefits (characterized by improvements over baseline in HQL domains). Temozolomide had an acceptable safety profile, with only 9% of therapy cycles requiring a dose reduction due to thrombocytopenia. There was no evidence of cumulative hematologic toxicity.Conclusions Temozolomide demonstrated modest clinical efficacy, with an acceptable safety profile and measurable improvement in quality of life in patients with recurrent GBM. The use of this drug should be explored further in an adjuvant setting and in combination with other agents.
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“and the average historical TTP is 9.5 ± 1.6 weeks.”
From Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors (2007) · cites this paper as [26]
In the citing paper
“The average historical PFS6 based on the above studies is 15.3 ± 3.8%”
From Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors (2007) · cites this paper as [26]
In the citing paper
“OS averaged 29.3 ± 6 weeks (see SI Table 2).”
From Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors (2007) · cites this paper as [26]
In the citing paper
“Efficacy analysis was performed for 10 recurrent GBM patients by comparing TTP, PFS6, and OS in recurrent GBM patients treated with the NovoTTF-100A device with the TTP, PFS6, and OS of recurrent GBM patients in a literature based historical control group (10, 25–28).”
From Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors (2007) · cites this paper as [26]
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“Temozolomide demonstrated an acceptable safety profile and measurable improvement in quality of life in patients with recurrent glioblastoma multiforme [9, 85].”
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“The use of TMZ should be explored further in an adjuvant setting and in combination with other agents and therapies (Brada et al., 2001; Stupp et al., 2002).”
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“Only the five studies providing effectiveness data for temozolomide in patients with AA or GBM are reported here (Table 1).”
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“0 77 van den Bent 2001(28)* AO 30 (ITT) 3 (10) 6 (20) 8 (27) 9 (30) — 43 7 — Harris 2001(10)* AA and AA/AO 31 (ITT) 5 (16) 5 (16) 7 (23) 10 (32) 7 — 13 — GBM 25 (ITT) 0 (0) 5 (20) 5 (20) 5 (20) 1 — 9 — All 56 (ITT) 5 (9) 10 (18) 12 (21) 15 (27) 6 — 11 — Yung 2000(11)* GBM 112 (ITT) 0 (0) 6 (5) 45 (40) 6 (5) Approx.”
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“[7 ] U n it ed S ta te s S in g le -a rm p h a se II 1 5 0 – 0 0 m g /m 2”
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“2 months, which compares favorably to the best results obtained in other studies using XRT or other radiation treatment modalities for recurrent GBM (13) and to the results reported for treatment by TMZ at recurrence (14).”
ResultBoiardi, A., Bartolomei, M., Silvani, A., Eoli, M., Salmaggi, A., Lamperti, E., Milanesi, I. M., Botturi, A., Rocca, P. A., Bodei, L., et al. (2005) · Journal of Neuro-Oncology · doi:10.1007/s11060-004-1497-5 · Cited by 47
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“Although there are multiple anti-neoplastic treatments, the outcome for recurrent GBM patients is disappointing, rarely exceeding 6 months [7–9].”
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“…day 1 5 every 28 days in adults with recurrent or progressive grade III or grade IV (oligodendro-) glioma showed objective response rates varying from 8, 11, 23, 35 and 44%, respectively (Brada et al, 2001; Bower et al, 1997; Brandes et al, 2001; Yung et al, 1999; Chinot et al, 2001, respectively).”
BackgroundTemozolomide in malignant glioma
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“Recent studies of temozolomide and procarbazine at first recurrence in patients with GBM reported median progressionfree survivals of 9 to 12 weeks and overall survival times of 23 to 29 weeks after chemotherapy was initiated [2,17].”
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Self-citationAutomated Tumor Volumetry Using Computer-Aided Image Segmentation
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“Thrombocytopenia 0 0 3†(16) Anemia 0 0 0 Asthenia/fatigue 0 1 (5) 0 Nausea 0 3 (16) 0 Vomiting 3 (16) 1 (5) 0 Skin (rash/itching) 4 (21) 1 (5) 0”
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“Recurrent glioblastoma (GBM) is resistant to most therapeutic strategies, with response rates being low and survival rarely exceeding 6 months [1, 2].”
BackgroundVirotherapy against malignant glioma stem cells
Dey, M., Ulasov, I. V., & Lesniak, M. S. (2009) · Cancer Letters · doi:10.1016/j.canlet.2009.04.045 · Cited by 37
“-PA Author M anuscript N IH -PA Author M anuscript N IH -PA Author M anuscript [5,6] and finally oral alkylating agent like Temozolomide (TMZ) [7,8] showed small but significant increase in median survival.”
BackgroundInfluentialCost of temozolomide therapy and global care for recurrent malignant gliomas followed until death
Wasserfallen, J.-B., Ostermann, S., Leyvraz, S., & Stupp, R. (2005) · Neuro-Oncology · doi:10.1215/s1152851704000687 · Cited by 37
“It has demonstrated modest activity in patients with melanoma (Middleton et al., 2000) and recurrent high-grade glioma (Brada et al., 2001; Yung et al., 2000).”
BackgroundSelf-citationTemozolomide: The evidence for its therapeutic efficacy in malignant astrocytomas
Mason, W. P. (2009) · Core evidence · doi:10.2147/ce.s6010 · Cited by 37
“4 months.(53) Patients treated with a variety of chemotherapeutic agents in a study conducted by Wong and colleagues(55) had a similar mOS of 5.”
BackgroundStupp, R., Hottinger, A. F., van den Bent, M. J., Dietrich, P., & Brandes, A. A. (2008) · Annals of Oncology · doi:10.1093/annonc/mdn474 · Cited by 37
“Nevertheless, TMZ chemotherapy, when given for recurrent disease, has also demonstrated efficacy [28–30].”
BackgroundSelf-citationBalañá, C., Pousa, A. L., Berrocal, A., Yayá, R., Herrero, A., Garc�a, J.-L., Martín‐Broto, J., Benavides, M., Cerd�-nicol�s, M., Ballester, R., et al. (2004) · Journal of Neuro-Oncology · doi:10.1007/s11060-004-9175-1 · Cited by 37
Is protracted low-dose temozolomide feasible in glioma patients?
Tosoni, A., Cavallo, G., Ermani, M., Scopece, L., Franceschi, E., Ghimenton, C., Gardiman, M. P., Pasetto, L. M., Blatt, V., & Brandes, A. A. (2006) · Neurology · doi:10.1212/01.wnl.0000196465.83423.ec · Cited by 37
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The role of targeted therapies in the management of progressive glioblastoma
Olson, J. J., Nayak, L., Ormond, D. R., Wen, P. Y., Kalkanis, S. N., & Ryken, T. C. (2014) · Journal of Neuro-Oncology · doi:10.1007/s11060-013-1339-4 · Cited by 35
Leimgruber, A., Ostermann, S., Yeon, E. J., Buff, E., Maeder, P. P., Stupp, R., & Meuli, R. A. (2005) · International Journal of Radiation Oncology*Biology*Physics · doi:10.1016/j.ijrobp.2005.08.015 · Cited by 36
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“Temozolomide has been used in the treatment of primary and metastatic brain malignancy with reported success [1, 4, 30].”
BackgroundDose dense 1 week on/1 week off temozolomide in recurrent glioma: a retrospective study
Taal, W., Rijn, J. S.-V., Kros, J. M., van Heuvel, I., van der Rijt, C. C. D., Bromberg, J. E. C., Smitt, P. A. E. S., & van den Bent, M. J. (2012) · Journal of Neuro-Oncology · doi:10.1007/s11060-012-0832-5 · Cited by 34
“(PFS-6: 19–24%) [21–23] More in particular, Brandes et al.”
Wei, W., Chen, X., Ma, X., Wang, D., & Guo, Z. (2015) · Journal of Neuro-Oncology · doi:10.1007/s11060-015-1920-0 · Cited by 34
Brada, M., Ashley, S. E., Dowe, A., Gonsalves, A., Huchet, A., Pesce, G. A., Reni, M., Saran, F. H., Wharram, B., Wilkins, M., et al. (2005) · Annals of Oncology · doi:10.1093/annonc/mdi183 · Cited by 34
“Phase II studies tested the activity of temozolomide in patients with recurrent malignant glioma [14, 15, 19], as adjuvant and concomitant therapy [20] and in a neoadjuvant setting [21].”
BackgroundMethodResultInfluentialSelf-citationBroomfield, L. M., Alonso‐Moreno, C., Martín, E., Shafir, A., Posadas, I., Ceña, V., & Castro‐Osma, J. A. (2017) · Dalton Transactions · doi:10.1039/c7dt03369a · Cited by 34
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“clinical activity (albeit modest) in patients with melanoma(9) and in patients with recurrent high-grade glioma.(10,11) Compared with procarbazine, TMZ improved health-related quality of life in patients with recurrent GBM.”
BackgroundSelf-citationVera, K., Djafari, L., Faivre, S. J., Guillamo, J., Djazouli, K., Osorio, M., Parker, F., Cioloca, C., Abdulkarim, B., Armand, J., et al. (2003) · Annals of Oncology · doi:10.1093/annonc/mdh003 · Cited by 34
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Pegylated Liposomal Doxorubicin in Recurrent Malignant Glioma: Analysis of a Case Series
Glas, M., Koch, H., Hirschmann, B., Jauch, T., Steinbrecher, A., Herrlinger, U., Bogdahn, U., & Hau, P. (2007) · Oncology · doi:10.1159/000113052 · Cited by 30
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“Unfortunately, a significant portion of patients (∼55%) fail to respond to this chemoradiotherapy regimen (5, 6).”
The future of high-grade glioma: Where we are and where are we going
Chamberlain, M. C., Rhun, É. L., & Taillibert, S. (2015) · Surgical Neurology International · doi:10.4103/2152-7806.151331 · Cited by 34
Extended exposure to alkylator chemotherapy: delayed appearance of myelodysplasia
Chamberlain, M. C., & Raizer, J. J. (2008) · Journal of Neuro-Oncology · doi:10.1007/s11060-008-9764-5 · Cited by 32
Brain Tumor Immunotherapy: What have We Learned so Far?
Gool, S. W. V. (2015) · Frontiers in Oncology · doi:10.3389/fonc.2015.00098 · Cited by 31
“At the time of relapse, the prognosis is particularly poor, with reports of 100% mortality within 18months (7).”
BackgroundTemozolomide as Second-line Chemotherapy for Relapsed Gliomas
Trent, S., Kong, A. H., Short, S. C., Traish, D., Ashley, S., Dowe, A., Hines, F., & Brada, M. (2002) · Journal of Neuro-Oncology · doi:10.1023/a:1015788814667 · Cited by 31
“4 months) were observed in a second multicentre phase II trial of temozolomide in glioblastoma [7].”
BackgroundSelf-citationTerasaki, M., Ogo, E., Fukushima, S., Sakata, K., Miyagi, N., Abe, T., & Shigemori, M. (2007) · Surgical Neurology · doi:10.1016/j.surneu.2006.11.042 · Cited by 30
Economic Evaluation of Temozolomide in the Treatment of Recurrent Glioblastoma Multiforme
Martikainen, J. A., Kivioja, A., Hallinen, T., & Vihinen, P. (2005) · PharmacoEconomics · doi:10.2165/00019053-200523080-00006 · Cited by 31
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“Temozolomide in recurrent glioblastoma did not result in any long-term survivors [34], although in anaplastic astrocytoma, it seemed to result in some [35].”
BackgroundTherapeutic Advances in Malignant Glioma: Current Status and Future Prospects
Robins, H. I., Lassman, A. B., & Khuntia, D. (2009) · Neuroimaging Clinics of North America · doi:10.1016/j.nic.2009.08.015 · Cited by 29
Pharmacotherapies for the treatment of glioblastoma – current evidence and perspectives
Seystahl, K., Gramatzki, D., Roth, P., & Weller, M. (2016) · Expert Opinion on Pharmacotherapy · doi:10.1080/14656566.2016.1176146 · Cited by 29
“In recurrent glioblastoma, TMZ had been already used prior to its approval in newly diagnosed disease based on the data of two phase II trials, one single-arm study and one randomized trial showing superiority to procarbazine.[29,30] After establishment of the standard of care with TMZ in the newly diagnosed setting,…”
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Survival benefit of boron neutron capture therapy for recurrent malignant gliomas
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“FRT is known to improve survival in patients with high grade gliomas [4,5], however survival is limited even with current FRT techniques and chemotherapy [6–9], and, therefore, further increases in the efficacy of radiation may be beneficial.”
BackgroundLeptomeningeal dissemination of cerebellar malignant astrocytomas
Endo, H., Kumabe, T., Jokura, H., Shirane, R., Ariga, H., Takai, Y., & Yoshimoto, T. (2003) · Journal of Neuro-Oncology · doi:10.1023/a:1023983518341 · Cited by 28
“Although efficacy of temozolomide in progressive or recurrent high-grade glioma is reported in the recent literature [31,32], effectiveness in leptomeningeal dissemination is unclear.”
BackgroundThe use of temozolomide in recurrent malignant gliomas
Gaya, A. M., Rees, J. H., Greenstein, A., & Stebbing, J. (2002) · Cancer Treatment Reviews · doi:10.1053/ctrv.2002.0261 · Cited by 28
Recent Medical Management of Glioblastoma
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“Several dosing schedules of TMZ alone or other agents combined was associated with a PFS at 6 months of 45 % and a 1 year OS of 20 % [14, 28–30].”
BackgroundCurrent Management of Adult Diffuse Infiltrative Low Grade Gliomas
Rhun, É. L., Taillibert, S., & Chamberlain, M. C. (2016) · Current Neurology and Neuroscience Reports · doi:10.1007/s11910-015-0615-4 · Cited by 26
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“Median, range 2 (1-5) 3 (1-12) 2 (1-12) 2 (1-12)”
Efficacy of temozolomide treatment in patients with high-grade glioma.
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Kinetic studies of the effects of Temodal and quercetin on astrocytoma cells
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“With a 35% response rate in WHO grade III anaplastic astrocytomas, Temodal is trending towards increasing efficacy against lower grade tumors [3, 40].”
BackgroundGalectin-1 and immunotherapy for brain cancer
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Neuro-oncology, a decade of temozolomide and beyond
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Metadata
- Authors
- Brada, M., Hoang-Xuan, K., Rampling, R., Dietrich, P.-Y., Dirix, L. Y., Macdonald, D., Heimans, J. J., Zonnenberg, B. A., Bravo-Marques, J. M., Henriksson, R., Stupp, R., Yue, N., Bruner, J., Dugan, M., Rao, S., & Zaknoen, S.
- Affiliations
- Royal Marsden Hospital (GB)
- Beatson West of Scotland Cancer Centre (GB)
- University Hospital of Geneva (CH)
- KU Leuven (BE)
- University Medical Center Utrecht (NL)
- Instituto Português de Oncologia Francisco Gentil (PT)
- University Hospital of Umeå (SE)
- Johns Hopkins University (US)
- The University of Texas MD Anderson Cancer Center (US)
- ORCID
- Venue
- Annals of Oncology
- Publisher
- Elsevier BV
- Published
- 2001-02
- Volume
- 12
- Issue
- 2
- Pages
- 259-266
- ISSN
- 0923-7534 (ISSN-L)
- OpenAlex
- W2125643269
- Cited by
- 372
- References
- 35
- Citations by year
- 2026: 3 · 2025: 4 · 2024: 3 · 2023: 7 · 2022: 3 · 2021: 7 · 2020: 9 · 2019: 4 · 2018: 10 · 2017: 12 · 2016: 15 · 2015: 14 · 2014: 12 · 2013: 11 · 2012: 17
- FWCI
- 10.86
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Annals of Oncology (publishedVersion)
- PubMed (publishedVersion)
- reroDoc Digital Library (submittedVersion)
- IRIS (submittedVersion)
- SERVAL (Université de Lausanne) (submittedVersion)
- Funders
- University of California, San Francisco
- Topics
- Health Sciences › Medicine › Oncology › Glioma Diagnosis and Treatment
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Health Sciences › Medicine › Oncology › Ovarian cancer diagnosis and treatment
- Keywords
- temozolomide, recurrent glioblastoma, first relapse, gliosarcoma, progression-free survival, objective response rate, health-related quality of life, thrombocytopenia, chemotherapy toxicity, dose escalation, palliative care, overall survival, Karnofsky performance status
- MeSH terms
- Temozolomide, Adult, Aged, Brain Neoplasms, Dacarbazine, Female, Glioblastoma, Humans, Male, Middle Aged, Neoplasm Recurrence, Local, Prognosis, Quality of Life, Disease-Free Survival, Antineoplastic Agents, Alkylating
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