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Tumori. 2019 Jun;105(3):243-252. doi: 10.1177/0300891619834126. Epub 2019 Mar 11.

Discontinuation of first-line bevacizumab in metastatic colorectal cancer: the BEAWARE Italian Observational Study.

Author information

1
1 UOC Oncologia Medica 1, Istituto Oncologico Veneto-IRCCS, Padova, Italy.
2
2 Divisione di Oncologia Medica, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale"-IRCCS, Naples, Italy.
3
3 UOC Oncologia, ASST Vimercate, Italy.
4
4 UOC Oncologia Medica, ASL Frosinone, Italy.
5
5 UOC Oncologia Medica 1, AOU Città Della Salute e Della Scienza, Torino, Italy.
6
6 UOC Oncologia Medica, AO Santa Croce e Carle, Cuneo, Italy.
7
7 UO Oncologia Medica, Ospedale Felice Lotti, Pontedera, Italy.
8
8 DIMI Università di Genova e Ospedale Policlinico San Martino, Genova, Italy.
9
9 UO Oncologia, A.O.R.N. 'A Cardarelli,' Napoli, Italy.
10
10 UO Oncologia Medica, ASST Sette Laghi, Varese, Italy.
11
11 Roche SpA Medical Affairs and CO, Monza, Italy.
12
12 OUC Oncologia, Policlinico Universitario Campus Bio-Medico, Rome, Italy.

Abstract

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.

KEYWORDS:

Metastatic colorectal cancer; bevacizumab; clinical practice; progression-free survival; therapy interruption

PMID:
30857495
DOI:
10.1177/0300891619834126
[Indexed for MEDLINE]

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