2023-03-27 カリフォルニア大学サンディエゴ校(UCSD)
子宮内膜がんは、発症率と死亡率が増加しているがんの一つであり、2040年までに女性の間で最も多く見られるがんの3番目になると予想されている。化学療法だけが現在の治療法であるが、今後は免疫療法と化学療法の組み合わせを用いる治療法が一般的になる可能性がある。
<関連情報>
進行性子宮内膜がんに対するペムブロリズマブと化学療法の併用について Pembrolizumab plus Chemotherapy in Advanced Endometrial Cancer
Ramez N. Eskander,Michael W. Sill,Lindsey Beffa,Richard G. Moore,Joanie M. Hope,Fernanda B. Musa,Robert Mannel,Mark S. Shahin,Guilherme H. Cantuaria,Eugenia Girda,Cara Mathews,Juraj Kavecansky,Charles A. Leath III,Lilian T. Gien,Emily M. Hinchcliff,Shashikant B. Lele,Lisa M. Landrum,Floor Backes,Roisin E. O’Cearbhaill,Tareq Al Baghdadi,Emily K. Hill, Premal H. Thaker, Veena S. John, Stephen Welch, Amanda N. Fader, Matthew A. Powell and Carol Aghajanian
New England Journal of Medicine Published:March 27, 2023
Abstract
BACKGROUND
Standard first-line chemotherapy for endometrial cancer is paclitaxel plus carboplatin. The benefit of adding pembrolizumab to chemotherapy remains unclear.
METHODS
In this double-blind, placebo-controlled, randomized, phase 3 trial, we assigned 816 patients with measurable disease (stage III or IVA) or stage IVB or recurrent endometrial cancer in a 1:1 ratio to receive pembrolizumab or placebo along with combination therapy with paclitaxel plus carboplatin. The administration of pembrolizumab or placebo was planned in 6 cycles every 3 weeks, followed by up to 14 maintenance cycles every 6 weeks. The patients were stratified into two cohorts according to whether they had mismatch repair–deficient (dMMR) or mismatch repair–proficient (pMMR) disease. Previous adjuvant chemotherapy was permitted if the treatment-free interval was at least 12 months. The primary outcome was progression-free survival in the two cohorts. Interim analyses were scheduled to be triggered after the occurrence of at least 84 events of death or progression in the dMMR cohort and at least 196 events in the pMMR cohort.
RESULTS
In the 12-month analysis, Kaplan–Meier estimates of progression-free survival in the dMMR cohort were 74% in the pembrolizumab group and 38% in the placebo group (hazard ratio for progression or death, 0.30; 95% confidence interval [CI], 0.19 to 0.48; P<0.001), a 70% difference in relative risk. In the pMMR cohort, median progression-free survival was 13.1 months with pembrolizumab and 8.7 months with placebo (hazard ratio, 0.54; 95% CI, 0.41 to 0.71; P<0.001). Adverse events were as expected for pembrolizumab and combination chemotherapy.
CONCLUSIONS
In patients with advanced or recurrent endometrial cancer, the addition of pembrolizumab to standard chemotherapy resulted in significantly longer progression-free survival than with chemotherapy alone. (Funded by the National Cancer Institute and others; NRG-GY018 ClinicalTrials.gov number, NCT03914612. opens in new tab.)
