The research findings of a team of lung cancer specialists from China were published recently online by renowned international publication, Journal of Clinical Oncology.
"Our results suggest promise for the use of biomarker-guided neoadjuvant treatment strategies in stage IIIA-N2 non-small cell lung cancer," said Wu Yilong, tenured professor of Guangzhou-based Guangdong Lung Cancer Institute, who is the principal investigator of the Chinese Thoracic Oncology Group (CTONG) study.
"This is the first study to demonstrate efficacy and tolerance superiority for target therapy over chemotherapy in the neoadjuvant setting of stage IIIA-N2 EGFR (epidermal growth factor receptor) mutated NSCLC (non–small-cell lung cancer)," he said at a press conference in Guangzhou on June 17.
A total of 386 patients from 17 centers in China were screened and 72 were finally enrolled. The objective response rate (ORR) for neoadjuvant erlotinib versus gemcitabine plus cisplatin chemotherapy was 54.1percent versus 34.3 percent. After neoadjuvant therapy, 83.8 percent of patients in the erlotinib group and 68. 6 percent in the gemcitabine plus cisplatin group underwent surgery.
Median progression-free survival (PFS) was significantly longer with erlotinib at 21. 5 months versus gemcitabine plus cisplatin chemotherapy at 11.4 months. Overall survival for erlotinib versus chemothrapy was 45.8 months versus 39.2 months. Grade 3 and 4 toxicities were fewer in the erlotinib arm (0) compared to the gemcitabine plus cisplatin arm (29.4 percent), said Zhong Wenzhao, a lung cancer surgeon of Wu's team.
Lung cancer is the malignant tumor with the highest morbidity and mortality in the world. IIIA-N2 is the most challenging subgroup in clinical diagnosis and treatment.
"Cisplatin-based doublet chemotherapy as neoadjuvant treatment for stage IIIA-N2 NSCLC only gives patients a 5 percent five-year overall survival benefit," Wu said, explaining the unmet medical needs in this patient population.
This study was initiated by CTONG in December 2011 and lasts for eight years due to the complexity and challenge of surgical clinical research.
"EGFR tyrosine kinase inhibitors (TKI) , such as erlotinib, is included in the national health insurance. The treatment costs of patients are significantly reduced. Such high-efficiency and low-toxicity target drugs can benefit more Chinese patients. The results offer us the rationale to consider neoadjuvant EGFR TKI and make a major step forward in the field for patients with early-stage lung cancer," Wu said.