Τίτλος:
Atezolizumab, Bevacizumab, and Chemotherapy for Newly Diagnosed Stage
III or IV Ovarian Cancer: Placebo-Controlled Randomized Phase III Trial
(IMagyn050/GOG 3015/ENGOT-OV39)
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
PURPOSE To evaluate the addition of the humanized monoclonal
antiprogrammed death ligand-1 (PD-L1) antibody, atezolizumab, to
platinum-based chemotherapy and bevacizumab in newly diagnosed stage III
or IV ovarian cancer (OC).
METHODS This multicenter placebo-controlled double-blind randomized
phase III trial (ClinicalTrials.gov identifier: NCT03038100) enrolled
patients with newly diagnosed untreated International Federation of
Gynecology and Obstetrics (FIGO) stage III or IV OC who either had
undergone primary cytoreductive surgery with macroscopic residual
disease or were planned to receive neoadjuvant chemotherapy and interval
surgery. Patients were stratified by FIGO stage, Eastern Cooperative
Oncology Group performance status, tumor immune cell PD-L1 staining, and
treatment strategy and randomly assigned 1:1 to receive 3-weekly cycles
of atezolizumab 1,200 mg or placebo (day 1, cycles 1-22), with
paclitaxel plus carboplatin (day 1, cycles 1-6) plus bevacizumab 15
mg/kg (day 1, cycles 2-22), omitting perioperative bevacizumab in
neoadjuvant patients. The co-primary end points were
investigator-assessed progression-free survival and overall survival in
the intention-to-treat and PD-L1-positive populations.
RESULTS Between March 8, 2017, and March 26, 2019, 1,301 patients were
enrolled. The median progression-free survival was 19.5 versus 18.4
months with atezolizumab versus placebo, respectively (hazard ratio,
0.92; 95% CI, 0.79 to 1.07; stratified log-rank P = .28), in the
intention-to-treat population and 20.8 versus 18.5 months, respectively
(hazard ratio, 0.80; 95% CI, 0.65 to 0.99; P = .038), in the
PD-L1-positive population. The interim (immature) overall survival
results showed no significant benefit from atezolizumab. The most common
grade 3 or 4 adverse events were neutropenia (21% with atezolizumab v
21% with placebo), hypertension (18% v 20%, respectively), and anemia
(12% v 12%).
CONCLUSION Current evidence does not support the use of immune
checkpoint inhibitors in newly diagnosed OC. Insight from this trial
should inform further evaluation of immunotherapy in OC. (C) 2021 by
American Society of Clinical Oncology
Συγγραφείς:
Moore, Kathleen N.
Bookman, Michael
Sehouli, Jalid
Miller,
Austin
Anderson, Charles
Scambia, Giovanni
Myers, Tashanna
and Taskiran, Cagatay
Robison, Katina
Maenpaa, Johanna and
Willmott, Lyndsay
Colombo, Nicoletta
Thomes-Pepin, Jessica and
Liontos, Michalis
Gold, Michael A.
Garcia, Yolanda
Sharma,
Sudarshan K.
Darus, Christopher J.
Aghajanian, Carol and
Okamoto, Aikou
Wu, Xiaohua
Safin, Rustem
Wu, Fan and
Molinero, Luciana
Maiya, Vidya
Khor, Victor K.
Lin, Yvonne
G.
Pignata, Sandro
Περιοδικό:
Journal of Clinical Oncology
Εκδότης:
Lippincott, Williams & Wilkins
DOI:
10.1200/JCO.21.00306
