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Background  Non‐small‐cell lung cancer ( NSCLC ) is the leading cause of death from cancer in China. Gefitinib is effective for patients with positive epidermal growth factor receptor gene mutation; however, acquired drug resistance counteracts the duration response. Hyperthermia is widely clinically applied in the treatment of solid tumors. This pilot study was designed to evaluate the feasibility of the combination of gefitinib and hyperthermia.    Methods  Patients newly diagnosed with advanced  NSCLC  were screened. Eleven patients who responded to first‐line gefitinib treatment were enrolled in the study. Along with 250 mg gefitinib daily, local radiofrequency hyperthermia was administered twice a week until tumor progression was observed. The serum, heat shock protein ( HSP )70, was also frequently detected during the course.    Results  The most common toxicity included skin rash (81.8%) and abnormal liver function (45.5%) when treated with gefitinib, and fatty scleroma (36.4%) was observed when combined with hyperthermia. Grade 3 side effects (skin rash) occurred in only one patient. Median progression‐free survival was 22 months (95% confidence interval [ CI] : 12.95–31.05 months) and median overall survival was 26 months (95%  CI : 22.81–29.19 months). Serum  HSP70  concentration increased and maintained a significantly high level compared with the baseline before hyperthermia administration.    Conclusions  The novel therapy of gefitinib combined with radiofrequency hyperthermia is safe and effective for advanced  NSCLC  patients. Whether an improvement in therapeutic efficacy is associated with the elevation of serum  HSP70  concentration requires further study.

Pilot study of radiofrequency hyperthermia in combination with gefitinib in gefitinib‐effective patients with advanced NSCLC