RT Journal Article
SR Electronic
T1 Safety and Efficacy of Extended Bevacizumab Therapy in Elderly (≥70 Years) Versus Younger Patients Treated for Newly Diagnosed Ovarian Cancer in the International ROSiA Study
JF International Journal of Gynecologic Cancer
JO Int J Gynecol Cancer
FD BMJ Publishing Group Ltd
SP 729
OP 737
DO 10.1097/IGC.0000000000001221
VO 28
IS 4
A1 Frédéric Selle
A1 Nicoletta Colombo
A1 Jacob Korach
A1 César Mendiola
A1 Andres Cardona
A1 Youssef Ghazi
A1 Amit M. Oza
YR 2018
UL http://ijgc.bmj.com/content/28/4/729.abstract
AB Objective The single-arm ROSiA study explored an extended duration of frontline bevacizumab-containing therapy for ovarian cancer. Post hoc analyses explored safety and efficacy according to age.Patients and Methods After primary debulking surgery, patients with stage IIB–IV or grade 3 stage I–IIA ovarian cancer received 4–8 cycles of paclitaxel [weekly or every 3 weeks (q3w)], carboplatin AUC 5–6 q3w, and bevacizumab 15 (or 7.5) mg/kg q3w, followed by single-agent bevacizumab until progression or for up to 24 months. The primary end point was safety; progression-free survival (PFS) was a secondary end point.Results Of 1021 patients treated, 121 (12%) were aged 70 years or older and 44 (4%) were 75 years or older. Compared with younger patients, more patients aged 70 years or older had hypertension at baseline, stage IV disease, and Eastern Cooperative Oncology Group performance status 1 or above. Bevacizumab was continued for more than 15 months in 49% of older versus 53% of younger patients. Older patients experienced higher incidences of all-grade anemia (44% vs 32%), diarrhea (35% vs 25%), and asthenia (22% vs 12%), and grade ≥3 hypertension (41% vs 22%) and thromboembolic events (7% vs 2%) compared with younger patients. Fatal bevacizumab-related adverse events occurred in 1 (0.8%) older versus 5 (0.6%) younger patients. Median PFS was 23.7 (95% confidence interval, 18.6–27.9) versus 25.6 (95% confidence interval, 23.7–28.4) months in patients aged 70 or older versus those younger than 70 years, respectively.Conclusion Bevacizumab-treated patients aged 70 years or older had higher incidences of anemia, low-grade diarrhea, and asthenia, and grade ≥3 hypertension and thromboembolic events than those younger than 70 years, but no other relevant increase in toxicity. Median PFS of approximately 2 years is similar to that in younger patients despite the worse prognosis. Older age should not preclude bevacizumab therapy for ovarian cancer in carefully selected patients aged 70 years or older. Given the higher background hypertension prevalence, elderly patients should be monitored more closely while receiving bevacizumab.