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Gefitinib as neoadjuvant therapy for resectable stage II-IIIA non-small cell lung cancer: A phase II study
Yang Zhang1, Fangqiu Fu1, Haichuan Hu1
1Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Institute of Thoracic Oncology, Fudan University, Shanghai, China; State Key Laboratory of Genetic Engineering, School of Life Sciences, Fudan University, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
Introduction:
Currently, limited data on tyrosine kinase inhibitors as neoadjuvant therapy exist. This prospective study aimed to investigate the efficacy and safety of preoperative gefitinib in patients with stage II-IIIA operable non-small cell lung cancer (NSCLC).
Methods:
This was a single-arm, phase II trial performed in the Shanghai Cancer Center. Between August 2013 and October 2015, patients with operable stage II-IIIA NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R mutation were enrolled. Patients were treated with preoperative gefitinib (250 mg once daily for 42 days), followed by surgical resection. The primary endpoint was objective response rate (ORR); secondary endpoints were the rate of major pathologic response (MPR), disease-free survival (DFS), overall survival, and adverse events (AEs). ORR was defined as the proportion of patients achieving complete response or partial response radiologically. MPR was defined as no more than 10% viable tumor.
Results:
Of the 35 eligible patients, 33 were considered as intention-to-treat population. ORR, the primary endpoint, was 54.5% (95% confidence interval [CI], 37.7-70.7), and the rate of MPR was 24.2% (95% CI, 11.9-40.4). Median DFS was 33.5 months (95% CI, 19.7-47.3); median overall survival was not reached. Skin toxicity (24/35,68.6%) and gastrointestinal symptoms (17/35,48.6%) were the most common AEs; no patients reported grade 3 or 4 AEs. After surgery, 4 patients experienced chylothorax (4/33,12.1%). Patients with MPR had a prolonged survival compared with those without (DFS, P = .019).
Conclusions:
Neoadjuvant therapy with gefitinib in patients with stage II-IIIA NSCLC is safe and may be a viable treatment for patients whose tumors have EGFR mutations. Patients with MPR were associated with improved survival.
Insights
Preoperative gefitinib shows promise as a safe neoadjuvant treatment for operable non-small cell lung cancer (NSCLC) with EGFR mutations. Patients achieving a major pathologic response (MPR) experienced significantly improved disease-free survival.
Area of Science:
- Oncology
- Medical Research
- Clinical Trials
Background:
- Limited data exist on tyrosine kinase inhibitors (TKIs) as neoadjuvant therapy for non-small cell lung cancer (NSCLC).
- Investigating neoadjuvant gefitinib offers potential for improving outcomes in operable NSCLC.
Purpose of the Study:
- To evaluate the efficacy and safety of preoperative gefitinib in patients with stage II-IIIA operable NSCLC.
- To determine the objective response rate (ORR) and major pathologic response (MPR) as primary and secondary endpoints.
Main Methods:
- A single-arm, phase II clinical trial involving 33 patients with operable stage II-IIIA NSCLC and EGFR mutations.
- Patients received preoperative gefitinib (250 mg daily for 42 days) followed by surgical resection.
- Endpoints included ORR, MPR, disease-free survival (DFS), overall survival, and adverse events (AEs).
Main Results:
- The objective response rate (ORR) was 54.5%, with a major pathologic response (MPR) rate of 24.2%.
- Median DFS was 33.5 months; overall survival data were not reached.
- Common adverse events included skin toxicity (68.6%) and gastrointestinal symptoms (48.6%); no grade 3 or 4 AEs were reported. Patients with MPR showed prolonged DFS (P = .019).
Conclusions:
- Neoadjuvant gefitinib is a safe and potentially viable treatment option for operable NSCLC patients with EGFR mutations.
- Achieving a major pathologic response (MPR) with neoadjuvant gefitinib is associated with improved survival outcomes.
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