title: Modified FLOX as first-line chemotherapy for metastatic colorectal cancer patients in the public health system in Brazil: Effectiveness and cost-utility analysis.
abstract: Incorporation of new drugs for treatment of metastatic colorectal cancer (mCRC) has led to a clear improvement in overall patient survival, the added cost of treatment, however, is a major concern worldwide. The cost-effectiveness of using a modified FLOX (mFLOX) regimen for treating mCRC patients was delineated. In this study, 82 consecutive mCRC patients were treated with leucovorin (LV) at 20 mg/m2in combination with weekly bolus of 5-fluorouracil (5-FU) (500 mg/m2) for 6 consecutive weeks and oxaliplatin (85 mg/m2) at weeks 1, 3 and 5, every 8 weeks. Overall survival (OS) and toxicity were evaluated. A Markov Model with a 2-year time horizon and 2-week cycles was developed, comparing mFLOX and mFOLFOX6 in a Brazilian environment. Health outcomes were measured in quality-ajusted life years (QALYs). The median overall period of survival was 19 months, while the estimated 1-year survival was 75%. Response by RECIST was assessed in 33 patients. Partial response was observed in 39.4% of patients, while 36.3% were stable. The mFLOX regimen cost was BRL 9,000, while the mFOLFOX6 BRL 22,000 (1 EUR=2.29 BRL), leading to an incremental costed of BRL 13,000, considering a 20-week period of first-line therapy. The incremental effect of the mFOLFOX was of 0,117 QALY. The incremental cost-effectiveness ratio of mFOLFOX6 was of BRL 110,344/QALY. The sensitivity analysis detected no differences in the outcome measures. In conclusion, the mFLOX is an active regimen in mCRC patients, possibly providing a cost-effective option in public health systems.
authors.affiliation: Clinical Oncology Department, Cancer Institute of the State of Sao Paulo (ICESP), CEP 01246-000; ; Clinical Oncology Department, University of Sao Paulo Medical School, CEP 01246-903;
authors.forename: Daniela R
authors.initials: DR
authors.lastname: Nebuloni
authors.affiliation: Clinical Oncology Department, Cancer Institute of the State of Sao Paulo (ICESP), CEP 01246-000; ; Clinical Oncology Department, University of Sao Paulo Medical School, CEP 01246-903;
authors.forename: Milena P
authors.initials: MP
authors.lastname: Mak
authors.affiliation: Clinical Oncology Department, Cancer Institute of the State of Sao Paulo (ICESP), CEP 01246-000; ; Clinical Oncology Department, University of Sao Paulo Medical School, CEP 01246-903;
authors.forename: Fabiano Hahn
authors.initials: FH
authors.lastname: Souza
authors.affiliation: Clinical Oncology Department, Cancer Institute of the State of Sao Paulo (ICESP), CEP 01246-000; ; Oncology Center, Sírio-Libanês Hospital, CEP 01308-050, Sao Paulo, SP, Brazil.
authors.forename: Daniel F
authors.initials: DF
authors.lastname: Saragiotto
authors.affiliation: Clinical Oncology Department, Cancer Institute of the State of Sao Paulo (ICESP), CEP 01246-000;
authors.forename: Thiago
authors.initials: T
authors.lastname: Júlio
authors.affiliation: Clinical Oncology Department, Cancer Institute of the State of Sao Paulo (ICESP), CEP 01246-000; ; Clinical Oncology Department, University of Sao Paulo Medical School, CEP 01246-903;
authors.forename: Gilberto
authors.initials: G
authors.lastname: DE Castro
authors.affiliation: Clinical Oncology Department, Cancer Institute of the State of Sao Paulo (ICESP), CEP 01246-000;
authors.forename: Jorge
authors.initials: J
authors.lastname: Sabbaga
authors.affiliation: Clinical Oncology Department, Cancer Institute of the State of Sao Paulo (ICESP), CEP 01246-000;
authors.forename: Paulo M
authors.initials: PM
authors.lastname: Hoff
keywords: 5-fluorouracil; colorectal cancer; cost-utility; leucovorin; oxaliplatin