The safety of temozolomide in the treatment of malignancies.
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.


OBJECTIVE
To ascertain the safety profile of TMZ.


METHODS
Synthesis of evidence from published clinical trials and the investigator's brochure of the manufacture.


CONCLUSIONS
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.
Trinh
Van Anh
VA
1University of Texas M.D. Anderson Cancer Center, Department of Melanoma Medical Oncology, 1515 Holcombe Boulevard, Box 0377, Houston, TX 77030, USA.
Patel
Sapna Pradyuman
SP
Hwu
Wen-Jen
WJ
D018906:Antineoplastic Agents, Alkylating / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy / Q000009:adverse effects; D003606:Dacarbazine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D006801:Humans; D008231:Lymphopenia / Q000139:chemically induced*; D009325:Nausea / Q000139:chemically induced; D009369:Neoplasms / Q000188:drug therapy*; D009503:Neutropenia / Q000139:chemically induced; D011878:Radiotherapy / Q000009:adverse effects; D000077204:Temozolomide; D013921:Thrombocytopenia / Q000139:chemically induced; D014839:Vomiting / Q000139:chemically induced
D018906:Antineoplastic Agents, Alkylating; D003606:Dacarbazine; D000077204:Temozolomide