monoclonal
antibody, in combination with regimens based on 5FU/LV (or
capecitabine) ± irinotecan or oxaliplatin, considerably improved
prognosis of patients with metastatic colorectal cancer (mCRC).
However, potential adverse events such as hypertension, proteinuria,
bleeding, gastrointestinal perforation and thrombosis should
be considered especially in elderly patients. Aim of our study was
to assess bevacizumab-related adverse events and their influence
on quality of life in two groups of patients with mCRC.
Patients and methods. From January 2008 to June 2010 we
studied 59 patients with mCRC, receiving first-line chemotherapy
plus bevacizumab (5 mg/kg every 2 weeks), divided in two
groups, the first of 28 patients aged ≤70 years (range 35-70;
mean 58.4 years) and the second of 31 patients >70 years (range
71-79; mean 72.7 years). Patients with impaired renal function
and/or proteinuria ≥0.5 g/day were excluded. Adverse events
were defined according to the National Cancer Institute Common
Terminology Criteria (NCI-CTCAE v3.0.) Quality of life was assessed
with FACT-C, EORTC-C30 and CR38 questionnaires. Patients
were evaluated at baseline, at each cycle of therapy, three
and six months after the end of chemotherapy.
Results. Any grade hypertension occurred in 7 (25%) patients
≤70 years and in 9 (29%) older patients. Grade 3 hypertension,
requiring the initiation or a change of antihypertensive therapy,
was observed in 3 (10.7%) patients ≤70 years and in 4 (12.9%)
patients >70 years. Proteinuria occurred in 8 (28.6%) patients
≤70 years and in 9 (29%) older patients. Grade 4 hypertension
(hypertensive crisis) and/or grade 4 proteinuria (nephrotic syndrome)
was not seen. The FACT-C and EORTC questionnaires
showed that bevacizumab-related side effects had no impact on
quality of life.
Conclusion. In our study combination therapy with bevacizumab
was well tolerated with a generally manageable safety
profile in all patients. Bevacizumab-related adverse events such
as hypertension and proteinuria, while noting more prevalent in
patients aged >70 years, had no significant effects on quality of life