ral effusion, who were not suitable for radiation. And other 10 patients refused to sign the informed consent form for radiotherapy. Overview of this study was fully explained to every eligible patient, every enrolled patient had signed an informed consent form and asked to keep one copy. Patients' characteristics were presented in Table 1. Treatment exposure 249 docetaxel infusions and 626 times of hyperthermia were administered totally. Median dosage of docetaxel was 40 mg/m2 (range, 30–40 mg/m2), median endurable temperature was 42.3°C (range, 41.3–43.0°C). There were 13 patients (44.8%) completing 4 cycles of chemo- therapy and 32 times of hyperthermia, 2 patients (6.9%) had been administered only 1 cycle of chemotherapy and 2 times of hyperthermia. Toxicity 8 patients (27.6%) discontinued study treatment, 6 of them due to toxicities: 4 because of grade 3 neutropenia, and 2 because of grade 4 neutropenia; the other 2 patients withdrew their informed consent form. No patient termi- nated treatment because of the side effect of RF hyperther- mia. 6 patients (20.7%) experienced a dose reduction to 30 mg/m2 due to toxicities (5 patients due to neutropenia, 1 patient due to arthralgia). Patients treated Age Median Range Gender Male Female Histological subtype Squamous carcinoma Adenocarcinoma Stage IIIa (T2N2M0/T3N2M0) IIIb (T2N3M0/T4N1M0/T4N2M0) ECOG performance status 0 1 2 Prior chemotherapy (cycles) Gemcitabine and cisplatin Vinorelbine and cisplatin Paclitaxel and cisplatin Prior radiotherapy 29 57 35–72 21 8 11 18 12 12 5 12 (8/4) 17 (2/8/7) 14 (46) 8 (21) 7 (26) 11 - - - 72.4 27.6 37.9 62.1 41.4 58.6 41.4 41.4 17.2 48.3% 27.6% 24.1% 37.9% BMC Cancer 2007, 7:189 http://www.biomedcentral.com/1471-2407/7/189 Table 1: Patients' characteristics Characteristics Number of patients Percentage Table 2: Main toxicities per patient Treatment delays were applied in 5 patients (17.2%), 4 delays occurred due to neutropenia, the other one occurred due to abnormal level of alanine aminotrans- ferase (>2.5 × ULN). 3 patients (10.3%) experienced grade 1 empyrosis after heated, no related treatment was administered. This side effect released in 48 hours, not even one time of hyper- thermia was delayed for this reason. Main toxicities were summarized in Table 2. Response There were 27 patients (93.1%) who had been evaluated for response. No patient achieved a complete remission (CR), 7 patients (25.9%) achieved a partial remission (PR), 11 patients (40.7%) were evaluated as a stable dis- ease (SD), and 9 patients (33.3%) experienced a progres- sion disease (PD). Overall response rate was 25.9%, tumor control rate (CR + PR + SD) was 66.6%. Survival analysis The median follow-up time was 16 months (range 12–18 months), 4 patients (13.8%) were lost at follow up, their PFS/OS (months) was recorded as following: 0/2, 0/2, 0/ 5, 0/7. Median PFS was 4 months (range 0–13 months, 95% CI: 1.9–6.1 months), one year progression free sur- vival rate was 10.3% (Figure 1). Median OS was 11 months (range 2–18+ months, 95% CI: 9.3–12.8 months), one year survival rate was 44.8% (Figure 2). At the time of analysis, 5 patients were still alive. Toxicity Hematological Hemoglobin Neutrophils Platelets Non-hematological Palpitation Edema Fatigue Sweating Weight loss Alopecia Nausea Taste disturbance Vomiting SGOT (AST) SGPT (ALT) Insomnia Arthralgia Headache Myalgia Grade 1 Grade 2 Grade 3 Grade 4 2(6.9%) 5(17.2%) 1(3.4%) 1(3.4%) 2(6.9%) 6(20.7%) 4(13.8%) 3(10.3%) 5(17.2%) 5(17.2%) 1(3.4%) 2(6.9%) 3(10.3%) 1(3.4%) 3(10.3%) 2(6.9%) 2(6.9%) 0 0 4(13.8%) 1(3.4%) - 1(3.4%) 2(6.9%) 0 1(3.4%) 2(6.9%) 2(6.9%) 0 3(10.3%) 0 1(3.4%) 0 0 0 0 0 5(17.2%) 0 - 0 0 - 0 - 1(3.4%) - 0 1(3.4%) 1(3.4%) 0 1(3.4%) 0 1(3.4%) 0 2(6.9%) 0 - 0 0 - - - - - 0 0 0 - 0 0 0 Page 3 of 5 (page number not for citation purposes)