Τίτλος:
Safety and efficacy of single-agent bevacizumab-containing therapy in elderly patients with platinum-resistant recurrent ovarian cancer: Subgroup analysis of the randomised phase III AURELIA trial
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Background The AURELIA trial demonstrated significantly improved progression-free survival (PFS) with bevacizumab added to chemotherapy for platinum-resistant ovarian cancer (PROC). Methods Patients with PROC were randomised to receive investigator-selected single-agent chemotherapy alone or with bevacizumab. Post-hoc exploratory analyses assessed efficacy, safety and patient-reported outcomes according to age < 65 versus ≥ 65 years. Results In the 133 patients (37%) aged ≥ 65 years, baseline hypertension was more frequent and ascites was less common than in patients < 65 years. The magnitude of PFS benefit from bevacizumab was similar in patients ≥ 65 versus < 65 years (hazard ratio 0.44 [95% CI, 0.31–0.64] versus 0.49 [95% CI, 0.37–0.64], respectively, treatment–age interaction p = 0.58), with similar improvements in response rates. Grade ≥ 3 hypertension was more common with bevacizumab than chemotherapy alone in both subgroups, and more common in older than younger patients irrespective of treatment. However, there was no excess of other adverse events of specific interest for bevacizumab, including venous thromboembolic events, in older patients. More patients receiving bevacizumab in the younger but not the older subgroup showed improved gastrointestinal/abdominal symptoms. Conclusion In exploratory analyses, PFS and response rate improvement with bevacizumab were consistent in older and younger patients. Grade ≥ 3 hypertension was more common in elderly bevacizumab-treated patients; careful monitoring is recommended. Overall, bevacizumab-containing therapy was well tolerated in a selected population aged ≥ 65 years, suggesting a favourable benefit:risk profile. However, geriatric assessments are needed to improve selection of elderly patients potentially gaining symptom and quality of life improvements from bevacizumab-containing therapy. Clinical trials registration ClinicalTrials.gov NCT00976911. © 2016 Elsevier Inc.
Συγγραφείς:
Sorio, R.
Roemer-Becuwe, C.
Hilpert, F.
Gibbs, E.
García, Y.
Kaern, J.
Huizing, M.
Witteveen, P.
Zagouri, F.
Coeffic, D.
Lück, H.-J.
González-Martín, A.
Kristensen, G.
Levaché, C.-B.
Lee, C.K.
Gebski, V.
Pujade-Lauraine, E.
Περιοδικό:
Gynecologic Oncology
Εκδότης:
Academic Press Inc.
Λέξεις-κλειδιά:
bevacizumab; doxorubicin; paclitaxel; topotecan; antineoplastic agent; bevacizumab; doxorubicin; macrogol derivative; paclitaxel; platinum derivative; topotecan, adult; aged; Article; ascites; cancer chemotherapy; cancer recurrence; cancer resistance; congestive heart failure; controlled study; digestive system perforation; drug efficacy; drug safety; drug withdrawal; female; gastrointestinal hemorrhage; heart arrest; human; hypertension; major clinical study; multicenter study; open study; ovary cancer; patient-reported outcome; phase 3 clinical trial; priority journal; proteinuria; randomized controlled trial; venous thromboembolism; wound healing impairment; age; analogs and derivatives; chemically induced; clinical trial; disease free survival; drug resistance; hypertension; middle aged; Ovarian Neoplasms; pathophysiology; patient selection; tumor recurrence; very elderly, Adult; Age Factors; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Bevacizumab; Disease-Free Survival; Doxorubicin; Drug Resistance, Neoplasm; Female; Humans; Hypertension; Middle Aged; Neoplasm Recurrence, Local; Ovarian Neoplasms; Paclitaxel; Patient Selection; Platinum Compounds; Polyethylene Glycols; Topotecan
DOI:
10.1016/j.ygyno.2016.11.006
