Risk Assessment of Febrile Neutropenia and Grade 3-4 Neutropenia in Patients With Non-hematological Cancer Treated With Conventional Chemotherapy

Predictive Models of Risk Assessment of Febrile Neutropenia and Grade 3-4 Neutropenia in Patients With Non-hematological Cancer Treated With Conventional Chemotherapy.

The purpose of this study is to identify prognostic factors and to develop predictive models of risk of febrile neutropenia and neutropenia grade 3/4 in patients with solid tumors receiving chemotherapy with schemas that have an inherent risk of febrile neutropenia of 10-20%.

Inclusion Criteria:

• Male or female > 18 years
• Histologically confirmed solid tumor.
• Subjects who have not received chemotherapy and / or radiotherapy in the last 3 months.
• Subject to initiate a chemotherapy (ie, cycle 1, day 1)
• The chemotherapy regimen should have an inherent risk of febrile neutropenia of 10-20%.
• Planning a minimum of 3 cycles chemotherapy.
• Adequate bone marrow reserve defined by: leukocytes ≥ 3,000 / mm3, platelets ≥ 100.000/mm3; neutrophils ≥ 1,500 / mm3.
• Adequate hepatic and renal function, defined by: bilirubin <1.5 times the normal value, ALT and AST <3 times the normal range (both can be elevated up to 5 times the normal value in patients with known liver metastases); creatinine <1.5 times upper normal value
• ECOG ≤ 2.
• Informed consent

Exclusion Criteria:

• Patients under treatment with an investigational treatment.
• Active infection in the last 72 h before starting chemotherapy.
• Indication of chemotherapy dose intensity or chemotherapy included in the risk rating of febrile neutropenia <10% or >20%.
• Patients with concomitant chemoradiotherapy.
• Patients being treated with biological drugs in monotherapy.
• Any other condition causing neutropenia.
• History of bone marrow transplant or stem cells.