The Effect of in Patients with Postoperative Recurrent Non-small Cell Lung Cancer Harboring Mutations of the Epidermal Growth Factor Receptor

Background: It is unclear whether there is a difference in the effect of gefitinib treatment between patients with postoperative recurrent non-small cell lung cancer (NSCLC) and those with stage IV NSCLC harboring mutations in the epidermal growth factor receptor (EGFR). Methods: We retrospectively reviewed the medical records of consecutive patients with postoperative recurrent NSCLC (postoperative group) or stage IV NSCLC harboring EGFR mutations (stage IV group) who were treated with gefitinib at the Shizuoka Cancer Center between September 2002 and March 2012 to compare the effect of gefitinib and survival from treatment initiation. Results: A total of 168 patients were treated with gefitinib (postoperative group, 49 patients; stage IV group, 119 patients). The response rate of gefitinib treatment in the postoperative group was similar to that in the stage IV group (58 versus 61%, p = 0.613). In contrast, median progression-free survival (PFS; 15.8 versus 9.8 months, p < 0.001) and median overall survival (OS; 51.1 versus 22.2 months, p < 0.001) were significantly longer in the postoperative group. In addition, postoperative recurrent disease, performance status (0–1), and a single metastatic organ were independent favorable prognostic factors in the multivariate analysis of survival. Conclusions: PFS and OS were superior in patients with postoperative recurrent NSCLC harboring EGFR mutations treated by gefitinib than in those with stage IV disease. These results suggested that postoperative recurrent disease may be considered a stratification factor in clinical trials for NSCLC with and compared between the following groups: one group with postoperative recurrent NSCLC (postoperative group) and a second group with stage IV NSCLC diagnosis (stage IV group). All underwent a systematic evaluation and standardized staging procedures before the start of systemic treatment. Clinical stage was assigned based on the results of a physical examination, chest radiography, computed tomography scans of the chest and abdomen, computed tomography or magnetic resonance imaging of the brain, and bone scintigraphy or positron emission tomography. Patients were excluded if they had only postoperative local recurrence without distant metastases. Performance status (PS) was evaluated based on the Eastern Cooperative Oncology Group (ECOG) PS scale. EGFR mutations were examined by commercial clinical laboratories. Only one patient with a single brain metastasis was diagnosed as pathological stage IV NSCLC and was included in the postoperative group. Although both the primary lesion and brain metastasis were completely resected, the experienced postoperative disease recurrence. On the other hand, patients who received only exploratory thoracotomy were included in the stage IV group. Adjuvant chemotherapy in the postoperative group was not considered as first line chemotherapy in this study. If patients have symptomatic brain metastases, we selected stereotactic radiotherapy or whole brain radiotherapy before gefitinib in our institution.