Phase II Evaluation of Temozolomide and 13-cis-Retinoic Acid for the Treatment of Recurrent and Progressive Malignant Glioma: A North American Brain Tumor Consortium Study

Jaeckle, Kurt A.; Hess, Kenneth R.; Yung, W.K. Alfred; Greenberg, Harry S.; Fine, Howard A.; Schiff, David; Pollack, Ian F.; Kuhn, John G.; Fink, Karen; Mehta, Minesh P.; Cloughesy, Timothy F.; Nicholas, M. Kelly; Chang, Susan M.; Prados, Michael D.

doi:10.1200/jco.2003.12.097

Cited by 146 publications

(78 citation statements)

References 22 publications

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“…The frequent administration of certain cytotoxic agents at low doses, known as 'metronomic chemotherapy', was more effective in targeting tumor endothelium than large single bolus doses followed by treatment-free period (2,3,9,20). The current studies demonstrated efficacy as salvage therapy in the treatment of patients with breast cancer and hormone-refractory prostate cancer (4,(18)(19)(20).…”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, there is little evidence of benefit of chemotherapy after tumor recurrence or progression. Since the majority of them are no longer candidates for further irradiation or surgical intervention, considerable efforts have been recently focused in the investigation of new chemotherapeutic agents and treatment schedules for recurrent glioblastoma (1)(2)(3)(4)(5)(6).…”

Section: Introductionmentioning

confidence: 99%

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A pilot study of metronomic temozolomide treatment in patients with recurrent temozolomide-refractory glioblastoma

Kong

Lee²,

Kim³

et al. 2006

Oncol Rep

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Abstract. Frequent regular administration of chemotherapeutic agents at low doses, known as 'metronomic chemotherapy', can increase the anti-angiogenic activity of the drugs, as has been confirmed by several other experimental tumor models. The aim of this pilot study was to evaluate the efficacy and safety of metronomic temozolomide (TMZ) treatment in twelve consecutive patients with recurrent TMZrefractory glioblastoma. The patients were administered by metronomic treatment schedule (continuous low-dose chemotherapy) with TMZ at a daily dose of 40 mg/m 2 . The median overall survival (OS) and progression-free survival (PFS) from the start of metronomic treatment were 11.0 months (95% CI, 5.2-10.5 months) and 6.0 months (95% CI, 0-12.3 months), respectively. During the follow-up period, complete response (CR) was not achieved in any patient, partial response (PR) in 2, and stable disease (SD) in 5 patients. Estimated PFS (CR+PR+SD) was 58.3% at 3 months. Grade III/IV toxicity according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) was not found. These results suggest that the change of chemotherapeutic schedule from conventional to metronomic treatment overcomes the chemo-resistance in patients with recurrent TMZ-refractory glio-blastoma without any major toxicity.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A pilot study of metronomic temozolomide treatment in patients with recurrent temozolomide-refractory glioblastoma

Kong

Lee²,

Kim³

et al. 2006

Oncol Rep

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“…As a single agent, cisretinoic acid has shown modest benefits in maintaining remission in malignant glioma [18][19][20] . Combination therapy with temozolomide and cis-retinoic acid at recurrence has shown considerable promise, yielding a 6-month progression-free survival (pfs-6) of 43% in a large phase ii study from the North American Brain Tumor Consortium 21 . However, that study antedated the use of temozolomide in chemoradiation strategies for newly diagnosed patients.…”

Section: Discussionmentioning

confidence: 99%

Extended Adjuvant Temozolomide with cis-Retinoic Acid for Adult Glioblastoma

et al. 2012

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Objective: To determine the toxicity and effectiveness of 24 months of adjuvant temozolomide (TMZ) with cis-retinoic acid (CRA) for patients with glioblastoma. Methods: This retrospective population-based review considered the charts of all patients diagnosed with glioblastoma in Manitoba and referred to a provincial cancer centre during 2002–2008. Consecutive patients came from a population-based referral centre and provincial cancer registry. All patients were treated according to the local standard of care with surgical resection followed by concurrent radiotherapy and TMZ 75 mg/m2 daily, followed by TMZ 150–200 mg/m2 for days 1–5, repeated every 28 days for up to 24 cycles, and CRA 50 mg/m2 twice daily for days 1–21, repeated every 28 days. The main outcome measures were safety, tolerability, and effectiveness of long-term TMZ and CRA. Results: Of 247 patients diagnosed with glioblastoma in Manitoba during the study period, 116 started concurrent chemoradiotherapy, and 80 received adjuvant TMZ. Of the patients who started concurrent chemoradiotherapy, 80 began adjuvant chemotherapy. Patients completed a median of 5.5 cycles of TMZ and 3 cycles of CRA. Grade 3 or 4 hematologic toxicity was noted in 16% of patients. Median overall survival was 15.1 months, and 26.7% of patients remained alive at 2 years. Conclusions: Extended adjuvant TMZ and CRA is well tolerated. However, the population-based effectiveness of this regimen is similar to the clinical trial efficacy of 6 months of adjuvant TMZ. Future studies in glioblastoma should incorporate duration of adjuvant chemotherapy into the study design.

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“…In the past years results, of several novel combinations of alkylating agents with drugs with a different mode of action investigated in recurrent GBM have been published: cisplatin and TMZ, 33 marimastat and TMZ, 34 cisretinoic acid and TMZ, 35 thalidomide and carmustine 36 ( Table 3). Each of these combinations report high response rates and favourable percentages of patients free from progression at six months.…”

Section: Temozolomide In Combination With Other Cytotoxic Agentsmentioning

confidence: 99%