PMID- 23254795 OWN - NLM STAT- MEDLINE DCOM- 20130625 LR - 20141120 IS - 0018-1994 (Print) IS - 0018-1994 (Linking) VI - 58 IP - 11 DP - 2012 Nov TI - [Adverse events associated with temsirolimus for patients with metastatic renal cell carcinoma]. PG - 651-4 AB - Temsirolimus is an inhibitor of mammalian target of rapamycin, with proven efficacy against advanced renal cell carcinoma (RCC), particularly poor risk and/or non-clear cell RCC, in a randomized first-line phase III trial. In this trial, adverse events (AEs)>/=grade 3 occurred in 47.6% of patients treated with temsirolimus alone (n=208), and the common AEs included asthenia, anemia and hyperglycemia. During the observation period of this trial, drug-related pneumonitis was detected ; 4 patients developed temsirolimus-related pneumonitis, including 2 with >/=grade 3. To date, there have not been any reports analyzing data from a large number of Japanese RCC patients treated with temsirolimus. However, judging from our experience, the severity as well as the frequency of AEs associated with temsirolimus in Japanese patients seem to be similar to those in the Western population. In this study, we summarize our clinical experience with the use of temsirolimus focusing on its AEs and try to clarify the characteristics of temsirolimus-related AEs in Japanese patients, and then present our data relevant to this point from our clinical studies in order to discuss the significance of the management of AEs encountered during treatment with temsirolimus. FAU - Miyake, Hideaki AU - Miyake H AD - The Division of Urology, Kobe University Graduate School of Medicine. FAU - Fujisawa, Masato AU - Fujisawa M LA - jpn PT - Clinical Trial, Phase III PT - English Abstract PT - Journal Article PT - Randomized Controlled Trial PL - Japan TA - Hinyokika Kiyo JT - Hinyokika kiyo. Acta urologica Japonica JID - 0421145 RN - 0 (Antineoplastic Agents) RN - 624KN6GM2T (temsirolimus) RN - W36ZG6FT64 (Sirolimus) SB - IM MH - Antineoplastic Agents/*adverse effects MH - Carcinoma, Renal Cell/*drug therapy MH - Humans MH - Kidney Neoplasms/*drug therapy MH - Molecular Targeted Therapy/adverse effects MH - Neoplasm Metastasis MH - Pneumonia/chemically induced MH - Sirolimus/adverse effects/*analogs & derivatives EDAT- 2012/12/21 06:00 MHDA- 2013/06/26 06:00 CRDT- 2012/12/21 06:00 PHST- 2012/12/21 06:00 [entrez] PHST- 2012/12/21 06:00 [pubmed] PHST- 2013/06/26 06:00 [medline] PST - ppublish SO - Hinyokika Kiyo. 2012 Nov;58(11):651-4.