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This article comes from the NEJM Journal Watch Maintenance Immunotherapy for Extensive-Stage Small-Cell Lung Cancer Maintenance Immunotherapy Comment Author: Charu Aggarwal, MD, MPH For patients with no disease progression after first-line chemotherapy In patients, maintenance therapy with double checkpoint blockade failed to prolong overall survival.
Patients with extensive-stage small cell lung cancer (ES-SCLC) receive platinum-based chemotherapy to achieve rapid remission, but the duration is often short, and the outcome is still poor.
In the past 2 years, we have observed that in the first-line treatment of ES-SCLC, the addition of anti-programmed death receptor ligand-1 antibody (PD-L1) to the platinum-etoposide dual-drug therapy prolonged the patient The overall survival (although the range is not large), thus establishing a new standard treatment.
Before the US FDA approved atezolizumab (and recently duvalizumab) for first-line treatment, the standard treatment was 4 to 6 cycles of platinum dual-drug therapy and subsequent observations.
The CheckMate 451 trial evaluated the effect of maintenance immunotherapy in ES-SCLC patients after receiving 3 to 4 cycles of chemotherapy.
In this double-blind phase III trial, 834 patients were randomly divided into three groups: nivoliumab + ipilimumab (nivolumab 1 mg/kg + ipilimumab 3 mg/kg, every 3 The medication was administered once a week for 4 cycles, followed by nivolumab 240 mg, once every 2 weeks), nivolumab monotherapy (240 mg, once every 2 weeks) or placebo.
Patients were included in the criteria for completing platinum-based chemotherapy within 9 weeks before participating in the study and no disease progression occurred.
There was no significant difference in overall survival (main outcome) between the nivolumab+ipilimumab group and the nivolumumab monotherapy group from the placebo group (hazard ratios of 0.
92 and 0.
84, respectively).
Patients with tumor mutation burden ≥13 mutations/megabases have a tendency to prolong overall survival after treatment with active drugs, but this is not a preset endpoint.
No new safety signals were found.
Comments: For ES-SCLC patients with stable disease or initial remission after chemotherapy, maintenance immunotherapy with nivolumab + ipilimumab or nivolumab alone did not extend survival.
Why chemotherapy combined with immunotherapy in the first-line treatment prolonged survival, but sequential immunotherapy in maintenance treatment after chemotherapy failed to extend survival? This is still a question worthy of further study.
At the same time, the standard treatment for ES-SCLC is still 4 cycles of chemotherapy + immunotherapy, followed by a 1-year anti-PD-L1 maintenance treatment.
Commented articles Owonikoko TK et al.
Nivolumab and ipilimumab as maintenance therapy in extensive-disease small-cell lung cancer: CheckMate 451.
J Clin Oncol 2021 Mar 8; [e-pub].
(https://doi.
org/10.
1200 /JCO.
20.
02212) Related reading NEJM Journal Watch The NEJM Journal Watch is published by the NEJM Group.
Internationally renowned doctors are invited to comment on important papers in the medical field to help doctors understand and use the latest developments.
"NEJM Frontiers of Medicine" is translated several times a week, published on the app and official website, and selected 2-3 articles are published on WeChat.
Copyright information This article was translated, written or commissioned by the "NEJM Frontiers of Medicine" jointly created by the Jiahui Medical Research and Education Group (J-Med) and the "New England Journal of Medicine" (NEJM).
The Chinese translation of the full text and the included diagrams are exclusively authorized by the NEJM Group.
If you need to reprint, please leave a message or contact nejmqianyan@nejmqianyan.
cn.
Unauthorized translation is an infringement, and the copyright owner reserves the right to pursue legal liabilities.
Patients with extensive-stage small cell lung cancer (ES-SCLC) receive platinum-based chemotherapy to achieve rapid remission, but the duration is often short, and the outcome is still poor.
In the past 2 years, we have observed that in the first-line treatment of ES-SCLC, the addition of anti-programmed death receptor ligand-1 antibody (PD-L1) to the platinum-etoposide dual-drug therapy prolonged the patient The overall survival (although the range is not large), thus establishing a new standard treatment.
Before the US FDA approved atezolizumab (and recently duvalizumab) for first-line treatment, the standard treatment was 4 to 6 cycles of platinum dual-drug therapy and subsequent observations.
The CheckMate 451 trial evaluated the effect of maintenance immunotherapy in ES-SCLC patients after receiving 3 to 4 cycles of chemotherapy.
In this double-blind phase III trial, 834 patients were randomly divided into three groups: nivoliumab + ipilimumab (nivolumab 1 mg/kg + ipilimumab 3 mg/kg, every 3 The medication was administered once a week for 4 cycles, followed by nivolumab 240 mg, once every 2 weeks), nivolumab monotherapy (240 mg, once every 2 weeks) or placebo.
Patients were included in the criteria for completing platinum-based chemotherapy within 9 weeks before participating in the study and no disease progression occurred.
There was no significant difference in overall survival (main outcome) between the nivolumab+ipilimumab group and the nivolumumab monotherapy group from the placebo group (hazard ratios of 0.
92 and 0.
84, respectively).
Patients with tumor mutation burden ≥13 mutations/megabases have a tendency to prolong overall survival after treatment with active drugs, but this is not a preset endpoint.
No new safety signals were found.
Comments: For ES-SCLC patients with stable disease or initial remission after chemotherapy, maintenance immunotherapy with nivolumab + ipilimumab or nivolumab alone did not extend survival.
Why chemotherapy combined with immunotherapy in the first-line treatment prolonged survival, but sequential immunotherapy in maintenance treatment after chemotherapy failed to extend survival? This is still a question worthy of further study.
At the same time, the standard treatment for ES-SCLC is still 4 cycles of chemotherapy + immunotherapy, followed by a 1-year anti-PD-L1 maintenance treatment.
Commented articles Owonikoko TK et al.
Nivolumab and ipilimumab as maintenance therapy in extensive-disease small-cell lung cancer: CheckMate 451.
J Clin Oncol 2021 Mar 8; [e-pub].
(https://doi.
org/10.
1200 /JCO.
20.
02212) Related reading NEJM Journal Watch The NEJM Journal Watch is published by the NEJM Group.
Internationally renowned doctors are invited to comment on important papers in the medical field to help doctors understand and use the latest developments.
"NEJM Frontiers of Medicine" is translated several times a week, published on the app and official website, and selected 2-3 articles are published on WeChat.
Copyright information This article was translated, written or commissioned by the "NEJM Frontiers of Medicine" jointly created by the Jiahui Medical Research and Education Group (J-Med) and the "New England Journal of Medicine" (NEJM).
The Chinese translation of the full text and the included diagrams are exclusively authorized by the NEJM Group.
If you need to reprint, please leave a message or contact nejmqianyan@nejmqianyan.
cn.
Unauthorized translation is an infringement, and the copyright owner reserves the right to pursue legal liabilities.
