TY - JOUR
T1 - Discontinuation of first-line bevacizumab in metastatic colorectal cancer
T2 - the BEAWARE Italian Observational Study
AU - Lonardi, Sara
AU - Nasti, Guglielmo
AU - Fagnani, Daniele
AU - Gemma, Donatello
AU - Ciuffreda, Libero
AU - Granetto, Cristina
AU - Lucchesi, Sara
AU - Ballestrero, Alberto
AU - Biglietto, Maria
AU - Proserpio, Ilaria
AU - Bergamo, Francesca
AU - Proietti, Emanuela
AU - Tonini, Giuseppe
PY - 2019/6/1
Y1 - 2019/6/1
N2 - AIMS: BEAWARE investigated the pattern of first-line bevacizumab early interruption in the Italian real-world setting of metastatic colorectal cancer. METHODS: A total of 386 patients were followed for 15 months after first-line chemotherapy + bevacizumab start. The rate of bevacizumab interruption for progression or adverse drug reactions (ADRs) constituted the primary endpoint. RESULTS: A total of 78.2% of patients interrupted bevacizumab: 56.6% for progression, 7.3% for ADRs, and 36.1% for other reasons. Median treatment duration was 6.7, 2.5, and 4.6 months, respectively. Median progression-free survival was 10.3 months; however, 35.8% of patients were not progressed and were thus censored at the data cutoff of 15 months, while 21.8% were still receiving bevacizumab. Patients discontinuing for progression/ADRs more frequently had metastases in >1 site (p = .0001), and a shorter median progression-free survival (6.9 vs 13.9 months, p <.0001). CONCLUSIONS: In Italy, first-line bevacizumab is interrupted mainly for progression, only 7.3% due to adverse events, and about one third of cases for other reasons. In clinical practice, the attitude to treat until progression as per guidelines might be implemented. ClinicalTrials.gov Identifier: NCT01609075.
AB - AIMS: BEAWARE investigated the pattern of first-line bevacizumab early interruption in the Italian real-world setting of metastatic colorectal cancer. METHODS: A total of 386 patients were followed for 15 months after first-line chemotherapy + bevacizumab start. The rate of bevacizumab interruption for progression or adverse drug reactions (ADRs) constituted the primary endpoint. RESULTS: A total of 78.2% of patients interrupted bevacizumab: 56.6% for progression, 7.3% for ADRs, and 36.1% for other reasons. Median treatment duration was 6.7, 2.5, and 4.6 months, respectively. Median progression-free survival was 10.3 months; however, 35.8% of patients were not progressed and were thus censored at the data cutoff of 15 months, while 21.8% were still receiving bevacizumab. Patients discontinuing for progression/ADRs more frequently had metastases in >1 site (p = .0001), and a shorter median progression-free survival (6.9 vs 13.9 months, p <.0001). CONCLUSIONS: In Italy, first-line bevacizumab is interrupted mainly for progression, only 7.3% due to adverse events, and about one third of cases for other reasons. In clinical practice, the attitude to treat until progression as per guidelines might be implemented. ClinicalTrials.gov Identifier: NCT01609075.
KW - bevacizumab
KW - clinical practice
KW - Metastatic colorectal cancer
KW - progression-free survival
KW - therapy interruption
U2 - 10.1177/0300891619834126
DO - 10.1177/0300891619834126
M3 - Article
SN - 0300-8916
VL - 105
SP - 243
EP - 252
JO - Tumori
JF - Tumori
IS - 3
ER -