title: A phase II trial of prolonged, continuous infusion of low-dose gemcitabine plus cisplatin in patients with advanced malignant pleural mesothelioma.
abstract: OBJECTIVE
  Low-dose, prolonged infusion of gemcitabine has effects similar to standard doses in several cancers. We evaluated the toxicity and efficacy of low-dose gemcitabine in prolonged infusion plus cisplatin in patients with advanced pleural mesothelioma.
  
  
  METHODS
  Patients with mesothelioma received gemcitabine (250 mg/m(2)) in a 6-h infusion plus cisplatin (35 mg/m(2)) on days 1 and 8 every three weeks. We used the modified response evaluation criteria in solid tumours. This study is registered in clinical trials (NCT01869023).
  
  
  RESULTS
  We included 39 patients; 82.1 % were low risk according to the European Organisation for Research and Treatment of Cancer prognostic group. Partial response was observed in 53.8 % (21/39), stable disease in 33.3 % (13/39) and progression in 12.8 % (5/39). The median progression-free survival was 6.9 months (95 % CI 3.2-10.6 months), and the associated factors were the EORTC risk and histology. The median overall survival was 20.7 months (95 % CI 10.7-30.8 months). The functional, physical and emotional roles and dyspnoea, insomnia and pain symptom scales improved. The most commonly graded 3/4 side effects were neutropenia (24.4 %), lymphopenia (14.6 %), thrombocytopenia (14.7 %) and anaemia (12.2 %).
  
  
  CONCLUSIONS
  Low-dose, prolonged gemcitabine infusion plus cisplatin has acceptable toxicity and high efficacy with improved quality of life, representing an affordable regimen for the low-income population.
authors.affiliation: Thoracic Oncology Unit, Experimental Oncology Laboratory, Instituto Nacional de Cancerología (INCan), San Fernando # 22, Col. Sección XVI, Tlalpan, C.P. 14080, Mexico, D.F., Mexico, ogarrieta@gmail.com.
authors.forename: Oscar
authors.initials: O
authors.lastname: Arrieta
authors.forename: Diego
authors.initials: D
authors.lastname: López-Macías
authors.forename: Víctor-Osvaldo
authors.initials: VO
authors.lastname: Mendoza-García
authors.forename: Ludwing
authors.initials: L
authors.lastname: Bacon-Fonseca
authors.forename: Wendy
authors.initials: W
authors.lastname: Muñoz-Montaño
authors.forename: Eleazar-Omar
authors.initials: EO
authors.lastname: Macedo-Pérez
authors.forename: Saé
authors.initials: S
authors.lastname: Muñiz-Hernández
authors.forename: Monika
authors.initials: M
authors.lastname: Blake-Cerda
authors.forename: José-Francisco
authors.initials: JF
authors.lastname: Corona-Cruz
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008654:Mesothelioma / Q000188:drug therapy* / Q000401:mortality; D000086002:Mesothelioma, Malignant; D008875:Middle Aged; D011379:Prognosis; D011788:Quality of Life; D016019:Survival Analysis; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine