Abstract 121P
Background
To explore the efficacy and safety of neoadjuvant Sintilimab and Anlotinib combined with chemotherapy for resectable NSCLC.
Methods
Before operation, the patients were treated with Sintilimab (200 mg) and Anlotinib (10 mg, po, day 1–14) combined with chemotherapy for 3 cycles, and surgery was performed 4 weeks after the last chemotherapy. After operation, patients were treated with Q3W of Sintilimab (200 mg) for 1 year. Primary end point: Complete pathological response (pCR). Secondary end point: Major pathological response (MPR), safety.
Results
39 patents were included in the study group, including 35 males and 4 females; 30 people with smoking index > 400, 9 people with smoking index < 400; There were 9 cases of adenocarcinoma and 30 cases of squamous cell carcinoma. In addition, 4, 6, 12 and 17 patients in this group were in stages IIA, IIB, IIIA, and IIIB, respectively. Thirty-five patients finally received surgical treatment, one patient refused any treatment due to grade 3 liver damage, and three patients refused surgery after completing neoadjuvant treatment. The pCR of intention to treat (ITT) population is 21 (53.8%), the MPR is 25 (64.1%). The pCR of Per-protocol (PP) population is 60%, and the MPR is 71.4%. According to RECIST 1.1, there was 1 case of progress disease, 9 cases of SD, 27 cases of PR and 2 cases of CR in ITT population. The pCR and ORR of squamous cell carcinoma is much higher than those of adenocarcinoma in ITT or PP population. There were three patients with EGFR mutation (included Exon 19 and L858R) in adenocarcinoma. The incidence rate of AE events above grade 3 related to treatment was 20 (51.3%).
Table: 121P| Patient characteristics (N,%) | |
|---|---|
| Age | |
| ≥60 | 24 (61.5) |
| <60 | 15 (38.5) |
| Sex | |
| Male | 35 (89.7) |
| Female | 4 (10.3) |
| Smoking Index | |
| ≥400 | 30 (76.9) |
| <400 | 9 (23.1) |
| Pathological type | |
| Squamous cell carcinoma | 30 (76.9) |
| Adenocarcinoma | 9 (23.1) |
| Clinical stage | |
| IIA | 4 (10.3) |
| IIB | 6 (15.4) |
| IIIA | 12 (30.8) |
| IIIB | 17 (43.5) |
| Pathological response | |
| PCR(ITT) | 21 (53.8) |
| MPR(ITT) | 25 (64.1) |
| PCR(PP) | 21 (60.0) |
| MPR(PP) | 25 (71.4) |
| Squamous cell carcinoma (PCR-PP, N = 26) | 19(73.1) |
| Squamous cell carcinoma (MPR-PP, N = 26) | 23(88.5) |
| Adenocarcinoma (PCR-PP, N = 9) | 3 (33.3) |
| Adenocarcinoma (MPR-PP, N = 9) | 3 (33.3) |
| RECIST 1.1 | |
| ORR(ITT) | 29 (74.4) |
| ORR(PP) | 25 (71.4) |
| Squamous cell carcinoma (ORR-PP, N = 26) | 21 (80.8) |
| Adenocarcinoma (ORR-PP, N = 9) | 5 (55.6) |
Conclusions
The neoadjuvant treatment of Sintilimab and Anlotinib combined with chemotherapy can significantly increase the pCR of resectable NSCLC, which is an effective treatment method. However, the perioperative AE events should be paid attention to.
Clinical trial identification
NCT05400070.
Legal entity responsible for the study
The authors.
Funding
The National Natural Science Foundation of China (No. 81871866) Miaozi Talent Fund of Tangdu Hospital of Air Force Military Medical University.
Disclosure
All authors have declared no conflicts of interest.