Survival with Cemiplimab in Recurrent Cervical Cancer

被引：273

作者：

Tewari, K. S. ^{[1
]}

Monk, B. J. ^{[2
,3
]}

Vergote, I ^{[4
]}

Miller, A. ^{[5
]}

de Melo, A. C. ^{[7
]}

Kim, H-S ^{[10
]}

Kim, Y. M. ^{[11
]}

Lisyanskaya, A. ^{[12
]}

Samouelian, V ^{[15
]}

Lorusso, D. ^{[16
,17
]}

Damian, F. ^{[8
]}

Chang, C-L ^{[18
,19
]}

Gotovkin, E. A. ^{[13
]}

Takahashi, S. ^{[20
]}

Ramone, D. ^{[9
]}

Pikiel, J. ^{[22
]}

Mackowiak-Matejczyk, B. ^{[23
]}

Alia, E. M. Guerra ^{[24
]}

Colombo, N. ^{[25
,26
]}

Makarova, Y. ^{[14
]}

Rischin, D. ^{[27
]}

Lheureux, S. ^{[28
]}

Hasegawa, K. ^{[21
]}

Fujiwara, K. ^{[21
]}

Li, J. ^{[6
]}

Jamil, S. ^{[6
]}

Jankovic, V ^{[6
]}

Chen, C-, I ^{[6
]}

Seebach, F. ^{[6
]}

Weinreich, D. M. ^{[6
]}

Yancopoulos, G. D. ^{[6
]}

Lowy, I ^{[6
]}

Mathias, M. ^{[6
]}

Fury, M. G. ^{[6
]}

Oaknin, A. ^{[29
]}

机构：

[1] Univ Calif Irvine, Dept Gynecol & Obstet, Div Gynecol Oncol, City Tower,333 City Blvd West,Suite 1400, Orange, CA 92868 USA

[2] Univ Arizona, Arizona Oncol, Div Gynecol Oncol, Phoenix, AZ USA

[3] Creighton Univ, Phoenix, AZ USA

[4] Katholieke Univ Leuven, Univ Hosp, Dept Gynecol & Obstet, Div Gynecol Oncol, Leuven, Belgium

[5] Roswell Pk Comprehens Canc Ctr, Dept Biostarist & Bioinformat, Buffalo, NY USA

[6] Regeneron Pharmaceut, Tarrytown, NY USA

[7] Brazilian Natl Canc Inst, Div Clin Res & Technol Dev, Rio De Janeiro, Brazil

[8] Pontificia Univ Catolica Rio Grande do Sul, Hosp Sao Lucas, Ctr Pesquisa Oncol, Porto Alegre, RS, Brazil

[9] Pio XII Fdn, Barretos Canc Hosp, Dept Clin Oncol, Sao Paulo, Brazil

[10] Seoul Natl Univ, Coll Med, Dept Obstet & Gynecol, Seoul, South Korea

[11] Univ Ulsan, Asan Med Ctr, Dept Obstet & Gynecol, Seoul, South Korea

[12] St Petersburg State Budgetary Inst Hlth Care, St Petersburg, Russia

[13] State Budget Hlth Care Inst Ivanovo Reg Oncol Dis, Ivanovna, Russia

[14] Clin Oncol Dispensary 1, State Budgetary Inst Hlth Care, Krasnodar, Russia

[15] Univ Montreal, Ctr Hosp Univ Montreal, Ctr Rech Ctr Hosp Univ Montreal, Div Gynecol Oncol,Dept Obstet & Gynecol, Montreal, PQ, Canada

[16] Fdn Policin Univ Gemelli A IRCCS, Div Gynecol Oncol, Dept Women & Child & Lealth, Rome, Italy

[17] Univ Cattolica Sacro Cuore, Dept Life Sci & Publ Hlth, Largo Agostino Gemelli, Rome, Italy

[18] Mackay Mem Hosp, Dept Obstet & Gynecol, Taipei, Taiwan

[19] Mackay Med Coll, Dept Med, Taipei, Taiwan

[20] Canc Inst Hosp Japanese Fdn Canc Res, Dept Med Oncol, Tokyo, Japan

[21] Saitama Med Univ Int Med Ctr, Dept Gynecol Oncol, Hidaka, Japan

[22] Szpitale Pomorskie, Dept Oncol, Gdynia, Poland

[23] Bialostockie Ctr Onkol, Dept Gynecol Oncol, Bialostockie, Poland

[24] Hosp Ramon & Cajal, Dept Med Oncol, Madrid, Spain

[25] Univ Milano Bicocca, Dept Gynecol Oncol, Milan, Italy

[26] Ist Europeo Oncol IRCCS, Milan, Italy

[27] Peter MacCallum Canc Ctr, Dept Med Oncol, Melbourne, Vic, Australia

[28] Princess Margaret Canc Ctr, Div Med Oncol & Hematol, Toronto, ON, Canada

[29] Hosp Univ Vali dHebron, Vali dHebron Barcelona Hosp Campus, Vall dHebron Inst Oncol, Gynecol Canc Program, Barcelona, Spain

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2022年 / 386卷 / 06期

关键词：

OPEN-LABEL; MODELS; PD-L1;

D O I：

10.1056/NEJMoa2112187

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

BACKGROUND Patients with recurrent cervical cancer have a poor prognosis. Cemiplimab, the fully human programmed cell death 1 (PD-1)-blocking antibody approved to treat lung and skin cancers, has been shown to have preliminary clinical activity in this population. METHODS In this phase 3 trial, we enrolled patients who had disease progression after first-line platinum-containing chemotherapy, regardless of their programmed cell death ligand 1 (PD-L1) status. Women were randomly assigned (1:1) to receive cemiplimab (350 mg every 3 weeks) or the investigator's choice of single-agent chemotherapy. The primary end point was overall survival. Progression-free survival and safety were also assessed. RESULTS A total of 608 women were enrolled (304 in each group). In the overall trial population, median overall survival was longer in the cemiplimab group than in the chemotherapy group (12.0 months vs. 8.5 months; hazard ratio for death, 0.69; 95% confidence interval [CI], 0.56 to 0.84; two-sided P<0.001). The overall survival benefit was consistent in both histologic subgroups (squamous-cell carcinoma and adenocarcinoma [including adenosquamous carcinoma]). Progression-free survival was also longer in the cemiplimab group than in the chemotherapy group in the overall population (hazard ratio for disease progression or death, 0.75; 95% CI, 0.63 to 0.89; two-sided P<0.001). In the overall population, an objective response occurred in 16.4% (95% CI, 12.5 to 21.1) of the patients in the cemiplimab group, as compared with 6.3% (95% CI, 3.8 to 9.6) in the chemotherapy group. An objective response occurred in 18% (95% CI, 11 to 28) of the cemiplimab-treated patients with PD-L1 expression greater than or equal to 1% and in 11% (95% CI, 4 to 25) of those with PD-L1 expression of less than 1%. Overall, grade 3 or higher adverse events occurred in 45.0% of the patients who received cemiplimab and in 53.4% of those who received chemotherapy. CONCLUSIONS Survival was significantly longer with cemiplimab than with single-agent chemotherapy among patients with recurrent cervical cancer after first-line platinum-containing chemotherapy.

引用

页码：544 / 555

页数：12

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