A multicenter, phase 2 study reveals that neoadjuvant camrelizumab, an anti-PD-1 antibody, combined with either chemotherapy or apatinib, shows promising efficacy in patients with initially unresectable stage II-III non-small cell lung cancer (NSCLC). The study offers a potential new strategy to convert unresectable tumors into resectable ones, providing new hope for patients with limited treatment options.
The research, published in [insert journal name here if known] , enrolled patients into two arms: Arm A received camrelizumab plus platinum-doublet chemotherapy, while Arm B received camrelizumab plus apatinib for patients with PD-L1-positive tumors. The primary endpoint was the major pathological response (MPR) rate.
Study Results
In Arm A, 50% of patients (15/30) underwent surgery after neoadjuvant treatment, with MPR and pathological complete response (pCR) rates both at 20.0% (95% CI 4.3-48.1). The objective response rate (ORR) was 33.3% (95% CI 11.8-61.6). In Arm B, 42.9% of patients (9/21) underwent surgery, with MPR and pCR rates of 55.6% (95% CI 21.2-86.3) and 11.1% (95% CI 0.3-48.2), respectively. The ORR in Arm B was 55.6% (95% CI 21.2-86.3).
With a median follow-up of 22.4 months, the median event-free survival (EFS) was not reached in Arm A and was 16.8 months in Arm B. Grade 3 or above treatment-related adverse events occurred in 26.7% of patients in Arm A and 14.3% in Arm B.
Impact and Context
Lung cancer remains the leading cause of cancer-related deaths worldwide. NSCLC accounts for 85-90% of all lung cancer cases. While immunotherapy has revolutionized the treatment of advanced NSCLC, its role in initially unresectable disease is still evolving. This study provides prospective evidence that neoadjuvant immunotherapy can potentially convert unresectable tumors into resectable ones.
Predictive Biomarkers
Biomarker analysis revealed that baseline TYROBP expression was predictive of treatment response in Arm B, suggesting a potential marker for patient selection in camrelizumab and apatinib combination therapy.
Study Design and Patient Population
The study enrolled patients with initially unresectable stage II-III NSCLC, as determined by a multidisciplinary clinical team. Unresectability was defined by tumor invasion of vital structures, multi-station lymph node metastasis, or the inability to achieve R0 resection even with pneumonectomy. Patients in Arm A received camrelizumab (200 mg) and platinum-doublet chemotherapy every 3 weeks for 2-4 cycles. Arm B patients received camrelizumab (200 mg) and apatinib (250 mg daily) for 2-4 cycles.
Limitations
The study acknowledges limitations including the small sample size, lack of a control group, and imbalances in patient characteristics. Further studies with larger cohorts are needed to validate these findings and explore potential predictive biomarkers comprehensively.
Conclusion
The study concludes that neoadjuvant camrelizumab plus platinum-doublet chemotherapy or apatinib demonstrates preliminary efficacy and manageable toxicity in patients with initially unresectable stage II-III NSCLC, offering a potential pathway to convert these tumors into resectable disease.
