@article{7b99273e16d0430baa2ab8dc95c915f8,
title = "The safety of temozolomide in the treatment of malignancies",
abstract = "Background: Temozolomide (TMZ) has demonstrated clinical antitumor activity. In the US and the EU, TMZ is licensed for the treatment of glioblastoma multiforme concurrently with radiation followed by a maintenance treatment, and for refractory anaplastic astrocytoma or glioblastoma multiforme. TMZ is also approved for metastatic melanoma in > 20 countries worldwide. Objectives: To ascertain the safety profile of TMZ. Methods: Synthesis of evidence from published clinical trials and the investigator's brochure of the manufacture. Conclusion: For a cytotoxic cancer-treatment agent, TMZ has an acceptable safety profile. Lymphopenia is common in patients treated with all doses and schedules of TMZ. All patients receiving TMZ should be observed for lymphopenia and potential opportunistic infections, particularly when it is combined with other immune suppressive therapies.",
keywords = "Clinical activity, Pharmacology, Safety consideration, Temozolomide",
author = "Van, {Anh Trinh} and Patel, {Sapna Pradyuman} and Hwu, {Wen Jen}",
note = "Funding Information: Chemotherapy remained controversial for use in GBM. For > 20 years, the standard treatment for GBM was surgery followed by radiation with the addition of chemotherapy offering only a modest increase in response rates. Several adjuvant chemotherapeutic agents were evaluated including carmustine (BCNU), topotecan and weekly paclitaxel. Stupp et al. described promising survival data for patients with newly diagnosed GBM treated with concomitant radiation and TMZ followed by maintenance TMZ [18]. The European Organization for Research and Treatment of Cancer (EORTC) Brain Tumor and Radiotherapy Groups and the National Cancer Institute of Canada Clinical Trials Group subsequently conducted a multinational Phase III study in patients with newly diagnosed GBM. A total of 573 patients were randomized to receive RT (60 Gy: 2 Gy/day, 5 days/week for 6 weeks) alone or RT plus TMZ (concomitant TMZ 75 mg/(m2 day), 7 days/week for a maximum of 49 days, followed by adjuvant TMZ 150 – 200 mg/m2, 5/28-day for up to six cycles starting 4 weeks after the end of RT). A statistically significant increase in overall survival was noted with a median improvement of 2.5 months in patients treated with concurrent TMZ [19]. This led the FDA to approve a further indication for TMZ as concomitant treatment with radiotherapy and as maintenance therapy for newly diagnosed GBM [16].",
year = "2009",
month = jul,
doi = "10.1517/14740330902918281",
language = "English (US)",
volume = "8",
pages = "493--499",
journal = "Expert Opinion on Drug Safety",
issn = "1474-0338",
publisher = "Informa Healthcare",
number = "4",
}