TY - JOUR
T1 - A phase 3 trial of bevacizumab in ovarian cancer
AU - Jayson, Gordon
AU - Perren, Timothy J.
AU - Swart, Ann Marie
AU - Pfisterer, Jacobus
AU - Ledermann, Jonathan A.
AU - Pujade-Lauraine, Eric
AU - Kristensen, Gunnar
AU - Carey, Mark S.
AU - Beale, Philip
AU - Cervantes, Andreś
AU - Kurzeder, Christian
AU - Du Bois, Andreas
AU - Sehouli, Jalid
AU - Kimmig, Rainer
AU - Staḧle, Anne
AU - Collinson, Fiona
AU - Essapen, Sharadah
AU - Gourley, Charlie
AU - Lortholary, Alain
AU - Selle, Fred́eŕic
AU - Mirza, Mansoor R.
AU - Leminen, Arto
AU - Plante, Marie
AU - Stark, Dan
AU - Qian, Wendi
AU - Parmar, Mahesh K B
AU - Oza, Amit M.
PY - 2011/12/29
Y1 - 2011/12/29
N2 - Background: Angiogenesis plays a role in the biology of ovarian cancer. We examined the effect of bevacizumab, the vascular endothelial growth factor inhibitor, on survival in women with this disease. Methods: We randomly assigned women with ovarian cancer to carboplatin (area under the curve, 5 or 6) and paclitaxel (175 mg per square meter of body-surface area), given every 3 weeks for 6 cycles, or to this regimen plus bevacizumab (7.5 mg per kilogram of body weight), given concurrently every 3 weeks for 5 or 6 cycles and continued for 12 additional cycles or until progression of disease. Outcome measures included progressionfree survival, first analyzed per protocol and then updated, and interim overall survival. Results: A total of 1528 women from 11 countries were randomly assigned to one of the two treatment regimens. Their median age was 57 years; 90% had epithelial ovarian cancer, 69% had a serous histologic type, 9% had high-risk early-stage disease, 30% were at high risk for progression, and 70% had stage IIIC or IV ovarian cancer. Progression-free survival (restricted mean) at 36 months was 20.3 months with standard therapy, as compared with 21.8 months with standard therapy plus bevacizumab (hazard ratio for progression or death with bevacizumab added, 0.81; 95% confidence interval, 0.70 to 0.94; P = 0.004 by the log-rank test). Nonproportional hazards were detected (i.e., the treatment effect was not consistent over time on the hazard function scale) (P
AB - Background: Angiogenesis plays a role in the biology of ovarian cancer. We examined the effect of bevacizumab, the vascular endothelial growth factor inhibitor, on survival in women with this disease. Methods: We randomly assigned women with ovarian cancer to carboplatin (area under the curve, 5 or 6) and paclitaxel (175 mg per square meter of body-surface area), given every 3 weeks for 6 cycles, or to this regimen plus bevacizumab (7.5 mg per kilogram of body weight), given concurrently every 3 weeks for 5 or 6 cycles and continued for 12 additional cycles or until progression of disease. Outcome measures included progressionfree survival, first analyzed per protocol and then updated, and interim overall survival. Results: A total of 1528 women from 11 countries were randomly assigned to one of the two treatment regimens. Their median age was 57 years; 90% had epithelial ovarian cancer, 69% had a serous histologic type, 9% had high-risk early-stage disease, 30% were at high risk for progression, and 70% had stage IIIC or IV ovarian cancer. Progression-free survival (restricted mean) at 36 months was 20.3 months with standard therapy, as compared with 21.8 months with standard therapy plus bevacizumab (hazard ratio for progression or death with bevacizumab added, 0.81; 95% confidence interval, 0.70 to 0.94; P = 0.004 by the log-rank test). Nonproportional hazards were detected (i.e., the treatment effect was not consistent over time on the hazard function scale) (P
U2 - 10.1056/NEJMoa1103799
DO - 10.1056/NEJMoa1103799
M3 - Article
C2 - 22204725
SN - 1533-4406
VL - 365
SP - 2484
EP - 2496
JO - New England Journal Of Medicine
JF - New England Journal Of Medicine
IS - 26
ER -
