On March 4, 2022, the FDA approved nivolumab in combination with platinum-doublet chemotherapy for the neoadjuvant treatment of adult patients with resectable non-small cell lung cancer. This means that there is official official support for nivolumab in combination with chemotherapy in preoperative lung cancer patients.
What is neoadjuvant therapy?
In layman’s terms, treatment before surgery is a concept originally introduced from breast cancer. Including neoadjuvant chemotherapy, neoadjuvant radiotherapy, neoadjuvant immunotherapy, neoadjuvant endocrine therapy, etc. The benefits of neoadjuvant therapy before cancer surgery are reflected in three points:
1. Larger tumors shrink after treatment and are more convenient for surgery. Our professional term is called clinical downstaging. For example, although 5cm lung cancer can be operated, but after neoadjuvant treatment, it shrinks to less than 3cm, then the staging is different, from mid-stage lung cancer to early-stage lung cancer.
2. It can eliminate micrometastases. As we all know, the biggest reason why cancer is easy to recur and metastasize after surgery is that although the primary tumor is partially removed, the cancer cells may have run away before surgery. To other places, only CT can’t find it, we call it micrometastasis. Immunity declines after surgery, and the micrometastasized cancer cells will wait for the opportunity to make a comeback, leading to recurrence and metastasis. Neoadjuvant therapy can eliminate these micrometastases in advance.
3. Another advantage of judging the drug sensitivity of neoadjuvant therapy is to verify whether the drug is sensitive before surgery, because the tumor lesions exist at this time, and the comparison before and after treatment is effective. It’s obvious how sex is. For sensitive drugs, you can continue to use them after surgery.
The approval of nivolumab (O drug) for the neoadjuvant treatment of lung cancer is based on the results of a Phase III clinical study called CheckMate-816. The main inclusion criteria for the trial were: histologically confirmed stage IB (≥4 cm), stage II, or stage IIIA, ECOG performance status score of 0 or 1, and non-small cell lung cancer with measurable disease (RECIST1.1) .
358 patients were randomized to receive nivolumab (360 mg) in combination with platinum-containing doublet chemotherapy on the same day (one cycle every 3 weeks, for a total of 3 cycles) before surgery, or nivolumab (360 mg) alone Platinum doublet chemotherapy (3 cycles every 3 weeks) followed by surgery.
Outcomes were assessed based on two core outcomes—event-free survival (EFS) and pathological complete response (pCR). The results showed that compared with chemotherapy alone, preoperative use of nivolumab in combination with chemotherapy showed a statistically significant improvement in event-free survival (EFS) (31.6 months vs 20.8 months), patients with disease progression, The risk of recurrence or death was reduced by 37%. Twenty-four percent of patients in the nivolumab-chemotherapy group achieved a pathologic complete response, compared with 2.2% in the chemotherapy-alone group.
Nivolumab is the first approved PD-1 inhibitor combined with platinum-based two-drug chemotherapy for the neoadjuvant treatment of early-stage resectable NSCLC without the need for PD-L1 express the situation. At present, in terms of neoadjuvant therapy, domestic use is still required at their own expense, and patients can choose by themselves according to their economic conditions.