Bevacizumab ‘Efficient And Well Tolerated’ For Elderly Metastatic CRC Patients

Bevacizumab given alongside chemotherapy has met safety and efficacy criteria for use in geriatric patients with metastatic colorectal cancer

medwireNews: The addition of bevacizumab therapy is well tolerated and shows efficacy in elderly patients undergoing chemotherapy for metastatic colorectal cancer (mCRC), French researchers have found.

The PRODIGE 20 study included 102 patients aged at least 75 years old who were randomly assigned to receive bevacizumab plus a simplified LV5FU2, modified FOLFOX or modified FOLFIRI regimen, or chemotherapy alone, explain Thomas Aparicio, from Université Paris 7 in France, and co-investigators in the Annals of Oncology.

The trial used co-primary 4-month endpoints of efficacy – defined as stable disease or an objective response in at least 20% of patients without a 2-point or greater decrease in the Spitzer quality of life index – and safety – classified as more than 40% of patients being free from severe cardiovascular toxicities and unexpected hospitalisations.

The 102 patients were aged a median of 80 years and over a median of 6 months received a median of 12 cycles of chemotherapy and 16 cycles of bevacizumab.

Modified intention-to-treat analysis for 46 patients given bevacizumab plus chemotherapy showed that the efficacy and safety endpoints were met by 50.0% and 60.9% of patients, respectively. This compared with 57.8% and 71.1% of the 45 patients given chemotherapy alone, respectively, indicating that the addition of bevacizumab was "considered efficient and well tolerated," the investigators report.

The efficacy and safety endpoints were both achieved in 34.8% of the bevacizumab arm patients and 46.7% of the chemotherapy-only arm patients.

The most common grade 3–4 events in both the bevacizumab-treated patients and those given chemotherapy were neutropenia (11.8 vs 12.2%), diarrhoea (9.8 vs 10.2%) and thromboembolism (9.8 vs 6.1%), with an increased rate of grade 3–4 arterial hypertension noted for bevacizumab, as expected (13.7 vs 6.1%).

The authors emphasise that the PRODIGE 20’s randomised phase II study design was noncomparative and is therefore unable to demonstrate difference or superiority between the treatment arms.

Nevertheless, median progression-free survival (PFS) was 9.7 months with bevacizumab versus 7.8 months with chemotherapy alone, with 12-month rates of 37.3% versus 23.5%. The corresponding rates for overall survival (OS) were 21.7 versus 19.8 months, with 36-month OS achieved by 27.0% versus 10.1%.

Thus, although the primary safety criterion finding supports the use of chemotherapy alone, given that the addition of bevacizumab was associated with lower quality of life, unexpected hospitalisation and cardiovascular toxicity, the researchers suggest these effects may be “worthwhile given the longer PFS and OS.”

And a phase III trial looking at survival endpoints for the addition of bevacizumab in a geriatric patient population with mCRC “would be of interest”, they add.

Reference

Aparicio T, Bouché O, Taieb J, et al. Bevacizumab + chemotherapy versus chemotherapy alone in elderly patients with untreated metastatic colorectal cancer: a randomized phase II trial – PRODIGE 20 study results. Ann Oncol; Advance online publication 28 September 2017. doi: https://doi.org/10.1093/annonc/mdx529

medwireNews is an independent medical news service provided by Springer Healthcare. © 2017 Springer Healthcare part of the Springer Nature group