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JAMA (IF=157) Cheng Ying and other teams from Jilin Provincial Cancer Hospital found effective immunotherapy for small cell lung cancer: domestic PD-1 fills the gap in the first-line treatment of small cell lung cancer

 Last Update: 2022-10-20
 Source: Internet
 Author: User

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iNature

Lung cancer is one of the
most common cancers in our country.
Clinically, lung cancer is divided into two categories - small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC).

Although small cell lung cancer accounts for only 15% of all lung cancers, it is characterized by an abnormally high rate of proliferation, a significant propensity for early metastasis, and a poor
prognosis.

Programmed cell death 1 (PD-1) inhibitors in combination with chemotherapy have changed the approach to
first-line treatment for patients with extensive-stage small cell lung cancer (SCLC).
However, it is unclear whether the addition of programmed cell death 1 (PD-1) inhibitors to chemotherapy has similar or better efficacy
in patients with extensive-stage SCLC.

On September 27, 2022, Cheng Ying's team at Jilin Provincial Cancer Hospital published an online publication in the Journal of the American Medical Association, one of the world's top four medical journals Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients with Extensive-Stage Small Cell Lung Cancer", which confirms that serplulimab () compared with chemotherapy alone Serplulimab) in combination with chemotherapy resulted in a significant improvement in overall survival (median overall survival of 15.
4 months)
in patients with extensive-stage SCLC.

Small cell lung cancer (SCLC) accounts for about 15% of the total number of lung cancers and is the most aggressive subtype
of lung cancer.
It is divided into limited-stage small cell lung cancer (LS-SCLC) and ES-SCLC.

What they have in common is high degree of malignancy, early metastasis, rapid disease progression, and poor
overall prognosis.
In recent years, the emergence of immune checkpoint inhibitors has brought new hope
for the treatment of ES-SCLC.
Anti-PD-L1 monoclonal antibody combined chemotherapy has been recommended by authoritative guidelines at home and abroad as the first-line treatment plan for ES-SCLC, which has improved the overall survival of patients to a certain extent compared with chemotherapy, but the degree of improvement is relatively limited, and more effective treatment options
are still needed.
To assess the efficacy and adverse effects of the PD-1 inhibitor Serplulimab plus chemotherapy and placebo as first-line treatment for extensive-stage SCLC
.
This international double-blind phase III randomized clinical trial (ASTRUM-005) was conducted in 114 of six countries between September 12, 2019 and April 27, 2021 585 patients with extensive-stage SCLC who had not previously received systemic therapy were screened (mean age 61.
1 years [SD, 8.
67 years]; Of these, 104 (17.
8%) were female).

The researchers randomized patients to give 4.
5 mg/kg of Serplliumab (n = 389) or placebo (n = 196)
intravenously every 3 weeks in a 2:1 ratio.
All patients received intravenous carboplatin and etoposide every 3 weeks for 12 weeks
.
The primary outcomes were overall survival (prespecified significance threshold at interim analysis, 2-sided P < 0.
012) and 13 secondary outcomes, including progression-free survival and adverse events
.
A comparison of survival between the two groups (from the Journal of the American Medical Association) showed that the median overall survival in the Serplumab group (15.
4 months, [95% CI]) significantly longer than placebo (10.
9 months, [95% CI]) (hazard ratio: 0.
63 [95% CI, 0.
49-0.
82]; P < 0.
001).

Median progression-free survival (as assessed by an independent radiology review board) (5.
7 months [95% CI, 5.
5-6.
9 months]) was also longer in the Serplumab group than in the placebo group (4.
3 months [95% CI, 4.
2 to 4.
5 months]) (risk ratio 0.
48 [95% CI, 0.
38 to 0.
59]).

In addition, 129 (33.
2%) patients in the Serplumab group and 54 (27.
6%) in the placebo group experienced treatment-related adverse events
of grade 3 or greater.
Taken together, through this randomized clinical trial, Serplumab plus chemotherapy significantly improved overall survival compared with chemotherapy alone
in patients with previously untreated extensive-stage SCLC.
These results support the use of Serplumab plus chemotherapy as first-line treatment
in this patient population.

Informational message: https://jamanetwork.
com/journals/jama/article-abstract/2796691

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