000			02641na a2200253 4500
003			H12O
005			20180417112804.0
008			130622s2012 xxx||||| |||| 00| 0 eng d
040			_cH12O
041			_aeng
100			_aCiruelos Gil, Eva María _91082 _eOncología Médica
100			_aCortés-Funes Castro, Hernán _91181 _eOncología Médica
100			_aPaz-Ares Rodríguez, Luis _91811 _eOncología Médica
245	0	0	_aPhase I and pharmacokinetic study of trabectedin 3-hour infusion every three weeks in patients with advanced cancer and alteration of hepatic function. _h[artículo]
260			_bMedical Oncology, _c2012
300			_a29(3):2240-50.
500			_aFormato Vancouver: Pardo B, Salazar R, Ciruelos E, Cortés-Funes H, García M, Majem M, et al. Phase I and pharmacokinetic study of trabectedin 3-hour infusion every three weeks in patients with advanced cancer and alteration of hepatic function. Med Oncol. 2012 Sep;29(3):2240-50.
501			_aPMID: 21660618
504			_aContiene 35 referencias
520			_aMaximum tolerated dose (MTD), recommended dose (RD), and pharmacokinetics (PK) were evaluated for trabectedin 3-h every-3-weeks schedule in 33 cancer patients stratified according to liver dysfunction degree as per baseline alkaline phosphatase (AP). Stratification was as follows: stratum I [upper limit of normal (ULN) < AP ≤ 1.5 × ULN; n = 16], stratum II [1.5 × ULN < AP ≤ 2.5 × ULN; n = 12], and stratum III [AP >2.5 × ULN; n = 5] (bilirubin <2.5 × ULN for all 3 strata). In each stratum, patients were treated in sequential cohorts at escalating doses. Dose-limiting toxicities (DLTs) were grade 3 transaminase increases not recovering baseline values on day 21, febrile neutropenia/grade 4 neutropenia lasting >5 days and AP increase more than twice over baseline. The MTD and RD for stratum I (mild baseline AP) was 1.3 mg/m(2). Recruitment was stopped early in strata II/III (moderate/severe baseline AP) without reaching the MTD due to slow accrual and difficulty in finding patients. Biochemical parameters other than AP (bilirubin, AST or ALT) were similar between strata. No relevant PK differences were found between strata. In conclusion, the MTD and RD (1.3 mg/m(2)) were confirmed only for stratum I. Stratification criteria based on baseline AP apparently did not segregate the patients according to their liver dysfunction degree. Antitumor activity was found in patients with pretreated ovarian cancer.
710			_9303 _aServicio de Oncología Médica
856			_uhttp://pc-h12o-es.m-hdoct.a17.csinet.es/pdf/pc/9/pc9857.pdf _ySolicitar documento
942			_n0 _2ddc _cART
999			_c9857 _d9857