164236-176

Safety and efficacy of extended bevacizumab (BEV) therapy in elderly (≥70 years) patients (pts) treated for newly diagnosed ovarian cancer (OC) in the international ROSiA study.

Subcategory: 
Category: 
Gynecologic Cancer
Session Type and Session Title: 
Poster Session, Gynecologic Cancer
Abstract Number: 

5535

Poster Board Number: 
Board #358
Citation: 
J Clin Oncol 34, 2016 (suppl; abstr 5535)
Author(s): 
Frédéric Selle, Nicoletta Colombo, Jacob Korach, Cesar Mendiola, Nicolas Martin, Stephen Robb, Amit M. Oza; Groupe Hospitalier Diaconesses Croix Saint Simon and Alliance Pour la Recherche en Cancérologie, Paris, France; European Institute of Oncology and University of Milan-Bicocca, Milan, Italy; Sheba Medical Center, Tel Hashomer, Israel; Hospital Universitario 12 De Octubre, Madrid, Spain; F. Hoffmann-La Roche Ltd., Basel, Switzerland; Princess Margaret Hospital, University of Toronto, Toronto, ON, Canada

Abstract Disclosures

Abstract: 

Background: The single-arm ROSiA safety study explored an extended duration of front-line BEV for OC. We report exploratory analyses of safety and efficacy according to age. Methods: After primary debulking surgery, pts with FIGO stage IIB‒IV or grade 3 stage I‒IIA OC received 4‒8 cycles of paclitaxel (weekly or q3w), carboplatin AUC 5–6 q3w, and BEV 15 (or 7.5) mg/kg q3w, followed by single-agent BEV for up to 24 mo (or longer at the investigator’s discretion) or until progression if earlier. The primary endpoint was safety; progression-free survival (PFS; by RECIST/symptomatic deterioration) was a secondary endpoint. Results: Of 1021 pts enrolled, 121 (12%) were aged ≥ 70 years and 44 (4%) were ≥ 75 years. Compared with pts < 70 years, the elderly subgroup included more pts with hypertension (HTN) at baseline (70% vs 28%, respectively), stage IIIB–IV disease (84% vs 76%), and ECOG performance status ≥ 1 (39% vs 29%). A 15 mg/kg BEV dose was chosen in 83% vs 90% of pts aged ≥ 70 vs < 70 years, respectively. The median BEV duration was 14.6 vs 15.9 mo, respectively; BEV was continued for > 15 mo in 49% vs 53% and for > 24 mo in 21% vs 30%. BEV was discontinued for reasons other than disease progression in 53% vs 41% (22% vs 17% for unacceptable toxicity). There was no excess of fatal AEs, including thromboembolic events (TEs), in older vs younger pts. Conclusions: BEV-treated pts aged ≥ 70 years had higher incidences of low-grade diarrhea and grade ≥ 3 HTN, TE and asthenia than those < 70 years, but no other relevant increase in toxicity. Median PFS of ~2 years is similar to that in younger pts despite the worse prognosis. Older age should not preclude use of BEV in carefully selected OC pts aged ≥ 70 years. Given the higher background HTN prevalence, elderly pts should be monitored more closely while receiving BEV. Clinical trial information: NCT01239732

Parameter< 70 years (n = 900)≥ 70 years (n = 121)
Any AE, %
HTN5460
Neutropenia4950
Anemia3244
Fatigue3736
Diarrhea2535
Epistaxis3024
Asthenia1222
Grade ≥ 3 AE, %6580
HTN2241
TE*27
Asthenia16
Proteinuria42
GI perforation13
Median PFS, mo (95% CI)25.6 (23.7‒28.4)23.7 (18.6‒27.9)
RECIST response rate, % (95% CI)74 (69‒79)64 (50‒76)

*Wide group of AE terms; AE = adverse event