A retrospective observational study on the safety and efficacy of first-line treatment with bevacizumab combined with FOLFIRI in metastatic colorectal cancer

Abstract

Background:Combination of bevacizumab and FOLFIRI has currently become one of the standard therapeutic regimens. However, published information is still limited. The objective of the present retrospective observational study is to analyse the response and toxicity of first-line treatment with FOLFIRI+bevacizumab in patients with metastatic colorectal cancer (mCRC).Methods:Data were collected from patients from nine Spanish sites diagnosed with mCRC, ECOG⩽2, whose first treatment for advanced disease was at least three cycles of FOLFIRI+bevacizumab.Results:A total of 95 patients were enrolled into the study: 64.2% males, median age of 59 years (53.2–67.1 years), ECOG=0–1 in 96.9% of patients. The main site of primary tumour was the colon (69.7%), and most metastases occurred in the liver (71.6%). Clinical benefit was detected in 67.4% (57.0–76.6; 95% confidence interval (CI)), with 8.4% of CR and 42.1% of PR. Median TTP was 10.6 months (10.0–11.3; 95% CI), PFS was 10.6 months (9.8–11.3; 95% CI), and OS was 20.7 months (17.1–24.2; 95% CI). Main grade I–II toxicities included haematological toxicity (35.8%), diarrhea (27.3%), mucositis (25.3%), asthenia (19.0%), haemorrhages (11.6%), and emesis (10.6%). Toxicities reaching grades III–IV were haematological toxicity (9.5%), diarrhea (8.5%), mucositis (5.3%), hepatic toxicity (2.1%), asthenia (2.1%), proteinuria (1.1%), emesis (1.1%), pain (1.1%), and colics (1.1%).Conclusion:Results of this study support the beneficial effect of adding bevacizumab to FOLFIRI regimen in terms of efficacy and show a favourable tolerability profile.

Leucovorin, Fluorouracil, and Irinotecan (FOLFIRI) plus Bevacizumab for Metastatic Colorectal Cancer

“…3 Grade 1 or 2 nausea or vomiting was reported in 10% and 11% of patients, respectively. 11 Grade 3 or 4 nausea or vomiting was reported in 6% to 11% and 1% to 11% of patients, respectively. 1,10,12 Prophylactic antiemetic therapy with a serotonin antagonist is recommended.…”

“…The addition of bevacizumab to a fluorouracil-based regimen has resulted in increased progression-free and overall survival in patients with metastatic colorectal cancer (mCRC). 1-3,7-13…”

“…FOLFIRI plus bevacizumab (Table 1) has been used to treat metastatic colorectal cancer. 1-3,10-13 FOLFIRI plus bevacizumab is recommended as a first-line therapy for mCRC. 14…”

“…In the trials reviewed, diarrhea of any grade was reported in 71% of patients 10,12 ; grade 3 and 4 diarrhea was reported in 2% to 12% of patients. 1,10-12…”

Cerebral venous thrombosis presenting with headache as the only symptom in a patient with metastatic colon cancer treated with bevacizumab: case report

“…[1] Metastatik kolon kanserinin tedavisinde FOLFIRI rejimine ek olarak uygulandığında etkinliğinin ve tolerabilitesinin yüksek olduğu gösterilmiştir. [2,3] Ancak, gastrointestinal perforasyon, yara iyileşmesi komplikasyonu, hemoraji, arteriyel tromboemboli, hipertansif kriz, nefrotik sendrom ve konjestif kalp yetersizliği gibi ciddi, ölümle sonuçlanabilen yan etkilerinin olduğu bilinmektedir. [4] Bu yazıda sunulan olguda, bevacizumab tedavisi altında iken şiddetli başağrıları ortaya çıkmış ve ardından serebral venöz tromboz (SVT) tanısı almıştır.…”