Topotecan plus carboplatin versus standard therapy with paclitaxel plus carboplatin (PC) or gemcitabine plus carboplatin (GC) or pegylated liposomal doxorubicin plus carboplatin (PLDC): a randomized phase III trial of the NOGGO-AGO-Study Group-AGO Austria and GEICO-ENGOT-GCIG intergroup study (HECTOR).

BACKGROUND: Randomized, phase III trial to evaluate safety and efficacy of topotecan and carboplatin (TC) compared with standard platinum-based combinations in platinum-sensitive recurrent ovarian cancer (ROC). PATIENTS AND METHODS: Patients were randomly assigned in a 1:1 ratio to the experimental TC arm (topotecan 0.75 mg/m2/ days 1-3 and carboplatin AUC 5 on day 3 every 3 weeks) or to one of the standard regimes [(PC) paclitaxel plus carboplatin; (GC) gemcitabine plus carboplatin; (PLDC) pegylated liposomal doxorubicin and carboplatin] which could be chosen by individual preference but before randomization. The primary end point was progression-free survival (PFS) after 12 months. Overall survival (OS), response rate, toxicity, quality of life and treatment preference regarding standard treatment were defined as secondary end points. RESULTS: A total of 550 patients were recruited. The PFS rate after 12 months was 37.0% for TC compared with 40.2% in the standard combinations (P = 0.470). The overall response rate was 73.1% for TC versus 75.1% for standard combinations (P = 0.149). After a median follow-up of 20 months, the median PFS was 10 months [95% confidence interval (CI) 9.4-10.6] and did not differ between both arms (P = 0.414). The median OS was 25 months in the TC arm versus 31 months in the standard arm (95% CI: 22.4-27.6 resp. 26.0-36.0; P = 0.163). Severe hematologic toxicities (grade 3/4) were rare in the experimental arm (P < 0.001), with 17.4% leucopenia, 27.8% neutropenia and 15.9% thrombopenia. CONCLUSION: The combination of carboplatin and topotecan was well tolerated with significant lower rates of severe hematological toxicities but did not improve PFS or OS in platinum-sensitive relapsed ovarian cancer compared with established standard regimens.

Amaurosis cortical transitoria por Metotrexato. A propósito de un caso / Transient cortical blindness due to Methotrexate. Report of a case

Propósito: Presentar un caso de amaurosis bilateral en el contexto de una encefalopotía metabólica en una paciente tratada por un linfoma de alto grado de malignidad mediante un esquema de poliquimioterapia que incluía Citarabina, Vincristina y Metotrexato como principales drogas neurotóxicas. Material y métodos: Paciente de 29 años que presentó una amaurosis cortical bilateral en el contexto de un síndrome de lisis tumoral tras administración de quimioterapia, comprometiéndose el aclaramiento plasmático de Metotrexato, citostático al que atribuimos la clínica neurológica que se describe y analiza. Resultado: La neurotoxicidad revirtió completamente tras el tratamiento de rescate con Leucovorin. Conclusiones: La amaurosis cortical es un tipo de toxicidad neurológica aguda del Metotrexato transitoria y reversible. Su tratamiento se basa en el soporte hemodinámico y el uso de Leucovorin (AU)