Résumé
PURPOSEPlatinum-based doublets with concurrent and maintenance bevacizumab are standard therapy for ovarian cancer (OC) relapsing after a platinum-free interval (PFI) >6 months. Immunotherapy may be synergistic with bevacizumab and chemotherapy.PATIENTS AND METHODSATALANTE/ENGOT-ov29 (ClinicalTrials.gov identifier: NCT02891824), a placebo-controlled double-blinded randomized phase III trial, enrolled patients with recurrent epithelial OC, one to two previous chemotherapy lines, and PFI >6 months. Eligible patients were randomly assigned 2:1 to atezolizumab (1,200 mg once every 3 weeks or equivalent) or placebo for up to 24 months, combined with bevacizumab and six cycles of chemotherapy doublet, stratified by PFI, PD-L1 status, and chemotherapy regimen. Coprimary end points were investigator-assessed progression-free survival (PFS) in the intention-to-treat (ITT) and PD-L1 positive populations (alpha.025 for each population).RESULTSBetween September 2016 and October 2019, 614 patients were randomly assigned: 410 to atezolizumab and 204 to placebo. Only 38% had PD-L1 positive tumors. After 3 years' median follow-up, the PFS difference between atezolizumab and placebo did not reach statistical significance in the ITT (hazard ratio [HR], 0.83; 95% CI, 0.69 to 0.99; P =.041; median 13.5 v 11.3 months, respectively) or PD-L1 positive (HR, 0.86; 95% CI, 0.63 to 1.16; P =.30; median 15.2 v 13.1 months, respectively) populations. The immature overall survival (OS) HR was 0.81 (95% CI, 0.65 to 1.01; median 35.5 v 30.6 months with atezolizumab v placebo, respectively). Global health-related quality of life did not differ between treatment arms. Grade ¥3 adverse events (AEs) occurred in 88% of atezolizumab-treated and 87% of placebo-treated patients; grade ¥3 AEs typical of immunotherapy were more common with atezolizumab (13% v 8%, respectively).CONCLUSIONATALANTE/ENGOT-ov29 did not meet its coprimary PFS objectives in the ITT or PD-L1 positive populations. OS follow-up continues. Further research on biopsy samples is warranted to decipher the immunologic landscape of late-relapsing OC.
| langue originale | Anglais |
|---|---|
| Pages (de - à) | 4768-4778 |
| Nombre de pages | 11 |
| journal | Journal of Clinical Oncology |
| Volume | 41 |
| Numéro de publication | 30 |
| Les DOIs | |
| état | Publié - 20 oct. 2023 |
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Dans: Journal of Clinical Oncology, Vol 41, Numéro 30, 20.10.2023, p. 4768-4778.
Résultats de recherche: Contribution à un journal › Article › Revue par des pairs
TY - JOUR
T1 - Atezolizumab Combined with Bevacizumab and Platinum-Based Therapy for Platinum-Sensitive Ovarian Cancer
T2 - Placebo-Controlled Randomized Phase III ATALANTE/ENGOT-ov29 Trial
AU - Kurtz, Jean Emmanuel
AU - Pujade-Lauraine, Eric
AU - Oaknin, Ana
AU - Belin, Lisa
AU - Leitner, Katharina
AU - Cibula, David
AU - Denys, Hannelore
AU - Rosengarten, Ora
AU - Rodrigues, Manuel
AU - De Gregorio, Nikolaus
AU - Martinez García, Jeronimo
AU - Petru, Edgar
AU - Kocián, Roman
AU - Vergote, Ignace
AU - Pautier, Patricia
AU - Schmalfeldt, Barbara
AU - Gaba, Lydia
AU - Polterauer, Stephan
AU - Mouret Reynier, Marie Ange
AU - Sehouli, Jalid
AU - Churruca, Cristina
AU - Selle, Frédéric
AU - Joly, Florence
AU - D'Hondt, Véronique
AU - Bultot-Boissier, ‰milie
AU - Lebreton, Coriolan
AU - Lotz, Jean Pierre
AU - Largillier, Rémy
AU - Heudel, Pierre Etienne
AU - Heitz, Florian
AU - Kurtz, J. E.
AU - Abadie-Lacourtoisie, S.
AU - Abdeddaim, C.
AU - Alexandre, J.
AU - Augereau, P.
AU - Avenin, D.
AU - Azemar, M.
AU - Baba-Hamed, N.
AU - Bally, O.
AU - Barriere, J.
AU - Bazan, F.
AU - Berton, D.
AU - Bonichon-Lamichhane, N.
AU - Bonnin, N.
AU - Boughalem, E.
AU - Boustany Grenier, R.
AU - Brachet, P. E.
AU - Brocard, F.
AU - Bultot-Boissier, E.
AU - Cappiello-Bataller, M. A.
AU - Castanie, H.
AU - Chaigneau, L.
AU - Chakiba, C.
AU - Chocteau-Bouju, D.
AU - Combe, P.
AU - Comte, A.
AU - Coquan, E.
AU - Costan, C.
AU - Cottu, P.
AU - Crouzet, L.
AU - Cure, H.
AU - Dauba, J.
AU - Dawood, H.
AU - De Cock, L.
AU - De La Motte Rouge, T.
AU - Debelleix, C.
AU - Delbaldo, C.
AU - Demarchi, M.
AU - Deslandres, M.
AU - Despax, R.
AU - D'Hondt, V.
AU - Dillies-Legrain, A. F.
AU - Donnadieu, A.
AU - Dubot, C.
AU - Extra, J. M.
AU - Fabbro, M.
AU - Falandry, C.
AU - Fiteni, F.
AU - Floquet, A.
AU - Follana, P.
AU - Frenel, J. S.
AU - Freyer, G.
AU - Garbay-Decoopman, D.
AU - Gavoille, C.
AU - Girre, V.
AU - Gladieff, L.
AU - Goldwasser, F.
AU - Gratet, A.
AU - Grenier, J.
AU - Hardy-Bessard, A. C.
AU - Heudel, P. E.
AU - Joly, F.
AU - Jouinot, A.
AU - Kalbacher, E.
AU - Kaminsky, M. C.
AU - Lancry-Lecomte, L.
AU - Largillier, R.
AU - Le Du, F.
AU - Leary, A.
AU - Lebreton, C.
AU - Lefeuvre-Plesse, C.
AU - Lesoin, A.
AU - L'Haridon, T.
AU - Long, J.
AU - Lortholary, A.
AU - Lotz, J. P.
AU - Mansi, L.
AU - Martin-Babau, J.
AU - Martinez, M.
AU - Medioni, J.
AU - Meriaux, E.
AU - Meunier, J.
AU - Moïse, L.
AU - Moulin, J. F.
AU - Mouret-Reynier, M. A.
AU - Mousseau, M.
AU - Pautier, P.
AU - Peron, J.
AU - Perrin, C.
AU - Petit, T.
AU - Petran, D.
AU - Priou, F.
AU - Provansal, M.
AU - Raban, N.
AU - Ray-Coquard, I.
AU - Regnault De La Mothe, P.
AU - Riedl, C.
AU - Rodrigues, M.
AU - Roemer-Becuwe, C.
AU - Sabatier, R.
AU - Savinelli, F.
AU - Sebbag, C.
AU - Selle, F.
AU - Soulie, P.
AU - Spaeth, D.
AU - Sverdlin, R.
AU - Timar-David, M.
AU - Tredan, O.
AU - Tresca, P.
AU - Trillet-Lenoir, V.
AU - Valentin, T.
AU - Vano, Y. A.
AU - You, B.
AU - Heitz, F.
AU - Bronger, H.
AU - Buderath, P.
AU - De Gregorio, N.
AU - Fehm, T.
AU - Grischke, E. M.
AU - Gropp-Meier, M.
AU - Hartkopf, A.
AU - Jackisch, C.
AU - Koegel, M.
AU - Mueller, A.
AU - Park-Simon, T. W.
AU - Runnebaum, I.
AU - Schochter, F.
AU - Schmalfeldt, B.
AU - Schnappauf, B.
AU - Sehouli, J.
AU - Trillsch, F.
AU - Wimberger, P.
AU - Oaknin, A.
AU - Alarcon, J. D.
AU - Alonso, S.
AU - Alonso Herrero, A.
AU - Barretina, P.
AU - Casado, A.
AU - Churruca, C.
AU - Fernandez, I.
AU - Gaba, L.
AU - Garcia-Donas, J.
AU - Gonzalez, S.
AU - Marquina, G.
AU - Martinez-García, J.
AU - Redondo, A.
AU - Vicente, D.
AU - Marth, C.
AU - Aust, S.
AU - Petru, E.
AU - Reinthaller, A.
AU - Schauer, C.
AU - Cibula, D.
AU - Vergote, I.
AU - Altintas, S.
AU - Denys, H.
AU - Van Nieuwenhuysen, E.
AU - Rosengarten, O.
N1 - Publisher Copyright: © 2023 American Society of Clinical Oncology.
PY - 2023/10/20
Y1 - 2023/10/20
N2 - PURPOSEPlatinum-based doublets with concurrent and maintenance bevacizumab are standard therapy for ovarian cancer (OC) relapsing after a platinum-free interval (PFI) >6 months. Immunotherapy may be synergistic with bevacizumab and chemotherapy.PATIENTS AND METHODSATALANTE/ENGOT-ov29 (ClinicalTrials.gov identifier: NCT02891824), a placebo-controlled double-blinded randomized phase III trial, enrolled patients with recurrent epithelial OC, one to two previous chemotherapy lines, and PFI >6 months. Eligible patients were randomly assigned 2:1 to atezolizumab (1,200 mg once every 3 weeks or equivalent) or placebo for up to 24 months, combined with bevacizumab and six cycles of chemotherapy doublet, stratified by PFI, PD-L1 status, and chemotherapy regimen. Coprimary end points were investigator-assessed progression-free survival (PFS) in the intention-to-treat (ITT) and PD-L1 positive populations (alpha.025 for each population).RESULTSBetween September 2016 and October 2019, 614 patients were randomly assigned: 410 to atezolizumab and 204 to placebo. Only 38% had PD-L1 positive tumors. After 3 years' median follow-up, the PFS difference between atezolizumab and placebo did not reach statistical significance in the ITT (hazard ratio [HR], 0.83; 95% CI, 0.69 to 0.99; P =.041; median 13.5 v 11.3 months, respectively) or PD-L1 positive (HR, 0.86; 95% CI, 0.63 to 1.16; P =.30; median 15.2 v 13.1 months, respectively) populations. The immature overall survival (OS) HR was 0.81 (95% CI, 0.65 to 1.01; median 35.5 v 30.6 months with atezolizumab v placebo, respectively). Global health-related quality of life did not differ between treatment arms. Grade ¥3 adverse events (AEs) occurred in 88% of atezolizumab-treated and 87% of placebo-treated patients; grade ¥3 AEs typical of immunotherapy were more common with atezolizumab (13% v 8%, respectively).CONCLUSIONATALANTE/ENGOT-ov29 did not meet its coprimary PFS objectives in the ITT or PD-L1 positive populations. OS follow-up continues. Further research on biopsy samples is warranted to decipher the immunologic landscape of late-relapsing OC.
AB - PURPOSEPlatinum-based doublets with concurrent and maintenance bevacizumab are standard therapy for ovarian cancer (OC) relapsing after a platinum-free interval (PFI) >6 months. Immunotherapy may be synergistic with bevacizumab and chemotherapy.PATIENTS AND METHODSATALANTE/ENGOT-ov29 (ClinicalTrials.gov identifier: NCT02891824), a placebo-controlled double-blinded randomized phase III trial, enrolled patients with recurrent epithelial OC, one to two previous chemotherapy lines, and PFI >6 months. Eligible patients were randomly assigned 2:1 to atezolizumab (1,200 mg once every 3 weeks or equivalent) or placebo for up to 24 months, combined with bevacizumab and six cycles of chemotherapy doublet, stratified by PFI, PD-L1 status, and chemotherapy regimen. Coprimary end points were investigator-assessed progression-free survival (PFS) in the intention-to-treat (ITT) and PD-L1 positive populations (alpha.025 for each population).RESULTSBetween September 2016 and October 2019, 614 patients were randomly assigned: 410 to atezolizumab and 204 to placebo. Only 38% had PD-L1 positive tumors. After 3 years' median follow-up, the PFS difference between atezolizumab and placebo did not reach statistical significance in the ITT (hazard ratio [HR], 0.83; 95% CI, 0.69 to 0.99; P =.041; median 13.5 v 11.3 months, respectively) or PD-L1 positive (HR, 0.86; 95% CI, 0.63 to 1.16; P =.30; median 15.2 v 13.1 months, respectively) populations. The immature overall survival (OS) HR was 0.81 (95% CI, 0.65 to 1.01; median 35.5 v 30.6 months with atezolizumab v placebo, respectively). Global health-related quality of life did not differ between treatment arms. Grade ¥3 adverse events (AEs) occurred in 88% of atezolizumab-treated and 87% of placebo-treated patients; grade ¥3 AEs typical of immunotherapy were more common with atezolizumab (13% v 8%, respectively).CONCLUSIONATALANTE/ENGOT-ov29 did not meet its coprimary PFS objectives in the ITT or PD-L1 positive populations. OS follow-up continues. Further research on biopsy samples is warranted to decipher the immunologic landscape of late-relapsing OC.
UR - http://www.scopus.com/inward/record.url?scp=85169431199&partnerID=8YFLogxK
U2 - 10.1200/JCO.23.00529
DO - 10.1200/JCO.23.00529
M3 - Article
C2 - 37643382
AN - SCOPUS:85169431199
SN - 0732-183X
VL - 41
SP - 4768
EP - 4778
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 30
ER -