Randomized phase III study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic malignant melanoma
- PMID: 10623706
- DOI: 10.1200/JCO.2000.18.1.158
Randomized phase III study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic malignant melanoma
Erratum in
- J Clin Oncol 2000 Jun;18(11):2351
Abstract
Purpose: To compare, in 305 patients with advanced metastatic melanoma, temozolomide and dacarbazine (DTIC) in terms of overall survival, progression-free survival (PFS), objective response, and safety, and to assess health-related quality of life (QOL) and pharmacokinetics of both drugs and their metabolite, 5-(3-methyltriazen-1-yl)imidazole-4-carboximide (MTIC).
Patients and methods: Patients were randomized to receive either oral temozolomide at a starting dosage of 200 mg/m(2)/d for 5 days every 28 days or intravenous (IV) DTIC at a starting dosage of 250 mg/m(2)/d for 5 days every 21 days.
Results: In the intent-to-treat population, median survival time was 7.7 months for patients treated with temozolomide and 6.4 months for those treated with DTIC (hazards ratio, 1.18; 95% confidence interval [CI], 0.92 to 1.52). Median PFS time was significantly longer in the temozolomide-treated group (1.9 months) than in the DTIC-treated group (1.5 months) (P =.012; hazards ratio, 1.37; 95% CI, 1.07 to 1.75). No major difference in drug safety was observed. Temozolomide was well tolerated and produced a noncumulative, transient myelosuppression late in the 28-day cycle. The most common nonhematologic toxicities were mild to moderate nausea and vomiting, which were easily managed. Temozolomide therapy improved health-related QOL; more patients showed improvement or maintenance of physical functioning at week 12. Systemic exposure (area under the curve) to the parent drug and the active metabolite, MTIC, was higher after treatment with oral temozolomide than after IV administration of DTIC.
Conclusion: Temozolomide demonstrates efficacy equal to that of DTIC and is an oral alternative for patients with advanced metastatic melanoma.
Comment in
-
Temozolomide for advanced, metastatic melanoma.J Clin Oncol. 2000 May;18(10):2185. doi: 10.1200/JCO.2000.18.10.2185. J Clin Oncol. 2000. PMID: 10811684 No abstract available.
Similar articles
-
Temozolomide for Treating Malignant Melanoma.J Coll Physicians Surg Pak. 2015 Sep;25(9):680-8. J Coll Physicians Surg Pak. 2015. PMID: 26374366 Review.
-
Efficacy and side effects of dacarbazine in comparison with temozolomide in the treatment of malignant melanoma: a meta-analysis consisting of 1314 patients.Melanoma Res. 2013 Oct;23(5):381-9. doi: 10.1097/CMR.0b013e3283649a97. Melanoma Res. 2013. PMID: 23880781 Review.
-
Extended schedule, escalated dose temozolomide versus dacarbazine in stage IV melanoma: final results of a randomised phase III study (EORTC 18032).Eur J Cancer. 2011 Jul;47(10):1476-83. doi: 10.1016/j.ejca.2011.04.030. Epub 2011 May 18. Eur J Cancer. 2011. PMID: 21600759 Clinical Trial.
-
Health-related quality of life in patients with advanced metastatic melanoma: results of a randomized phase III study comparing temozolomide with dacarbazine.Cancer Invest. 2003;21(6):821-9. doi: 10.1081/cnv-120025084. Cancer Invest. 2003. PMID: 14735685 Clinical Trial.
-
Post hoc economic analysis of temozolomide versus dacarbazine in the treatment of advanced metastatic melanoma.J Clin Oncol. 2000 Apr;18(7):1474-80. doi: 10.1200/JCO.2000.18.7.1474. J Clin Oncol. 2000. PMID: 10735895 Clinical Trial.
Cited by
-
Revisiting Temozolomide's role in solid tumors: Old is gold?J Cancer. 2024 Apr 22;15(11):3254-3271. doi: 10.7150/jca.94109. eCollection 2024. J Cancer. 2024. PMID: 38817857 Free PMC article. Review.
-
Stereotactic body radiotherapy as a viable treatment on extracranial oligometastases in melanoma patients: a retrospective multicentric study.Front Oncol. 2024 Mar 5;14:1322515. doi: 10.3389/fonc.2024.1322515. eCollection 2024. Front Oncol. 2024. PMID: 38505592 Free PMC article.
-
Case report: Exceptional disease progression in a 70-year-old patient: generalized melanosis and melanuria in the course of metastatic melanoma - a case study.Front Oncol. 2024 Jan 29;14:1332362. doi: 10.3389/fonc.2024.1332362. eCollection 2024. Front Oncol. 2024. PMID: 38347840 Free PMC article.
-
Melanoma biology and treatment: a review of novel regulated cell death-based approaches.Cancer Cell Int. 2024 Feb 9;24(1):63. doi: 10.1186/s12935-024-03220-9. Cancer Cell Int. 2024. PMID: 38336727 Free PMC article. Review.
-
Evaluation of ABT-751, a novel anti-mitotic agent able to overcome multi-drug resistance, in melanoma cells.Cancer Chemother Pharmacol. 2024 May;93(5):427-437. doi: 10.1007/s00280-023-04624-6. Epub 2024 Jan 16. Cancer Chemother Pharmacol. 2024. PMID: 38226983 Free PMC article.
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical