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The NADIM study is one of the earlier neoadjuvant studies of immunotherapy combined with chemotherapy.
The results of the study announced at the 2018 WCLC Congress showed that chemotherapy combined with immunotherapy in the neoadjuvant stage is effective in locally advanced, potentially resectable NSCLC patients.
showed excellent antitumor efficacy
.
NSCLC accounts for 80%–85% of all lung cancer cases, and approximately 20% of NSCLC patients are diagnosed with stage IIIA (N2) disease
.
Even if these patients had surgically resected tumors, the clinical outcomes remained suboptimal: the median progression-free survival (PFS) was 13 months, and the 3-year survival rate was 30%
.
Lung Cancer Diagnosis
Previous studies have shown that only a small number of patients can achieve complete pathological remission (pCR) after induction chemotherapy, and neoadjuvant immunotherapy is expected to significantly improve the prognosis of patients
.
In 2018, a study reported the efficacy of nivolumab neoadjuvant therapy in NSCLC.
After 2 doses of nivolumab neoadjuvant therapy, 45% of 20 evaluable patients achieved major pathological response (MPR), of which , 10% of patients achieved pCR; a phase II study published in 2020 showed that atezolizumab + chemotherapy for neoadjuvant treatment of patients with resectable NSCLC, 57% of patients achieved MPR, of which, 33% of patients achieved pCR
However, whether neoadjuvant chemotherapy combined with immunotherapy can improve the complete pathological response in patients with resectable stage IIIA NSCLC has not been reported, and it is worth further research
.
The NADIM study (CA209-547, NCT03081689) is a phase II, single-arm, open-label, multicenter study in patients with locally advanced, resectable stage IIIA N2 NSCLC
.
The patient received chemotherapy plus nivolumab followed by adjunctive therapy for 1 year
.
In 2020, NADIM published its 2-year follow-up results in The Lancet .
Among 46 patients, 26 (56%) achieved pathological complete response (pCR), and the major pathological response rate [MPR (inc pCR)] was 74 %
.
On September 24, 2020, the updated follow-up data were published in the journal Lancet Oncology
.
The data showed that all patients underwent R0 resection, and the 12-month PFS rate was 95.
7%, the 18-month PFS rate was 87%, and the 24 -month PFS rate was 77.
On September 24, 2020, the updated follow-up data were published in the journal Lancet Oncology
At WCLC 2021, the NADIM study published data after a median follow-up of 37.
9 months for the entire group of patients
At WCLC 2021, the NADIM study published data after a median follow-up of 37.
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