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Purpose Southwest Oncology Group 9504 demonstrated the feasibility and potential benefit of docetaxel consolidation after etoposide, cisplatin, and radiotherapy in patients with locally advanced non-small cell lung cancer. Our study assessed consolidation with either gemcitabine alone or with docetaxel after identical chemoradiation as used in Southwest Oncology Group 9504. Methods Patients with stage III non-small cell lung cancer and good performance status were included. Treatment consisted of concurrent cisplatin 50 mg/m 2 on days 1 and 8 plus etoposide 50 mg/m 2 on days 1 to 5 for two 28-day cycles plus radiotherapy (62 Gy, 2 Gy daily in 31 fractions over 7 weeks), followed by randomization to either gemcitabine 1000 mg/m 2 on days 1 and 8 (G) or gemcitabine 1000 mg/m 2 on days 1 and 8 plus docetaxel 75 mg/m 2 on day 1 (GD) every 21 days for three cycles. Results Eighty-three patients were entered, 81 received induction therapy, and 64 were randomized (32 in each arm). Grade 3 or four events, including neutropenia (56.3% vs. 28.1%, p = 0.03), anemia (18.8% vs. 3.1%, p = 0.05), and fatigue (15.6% vs. 6.3%, p = NS), were more frequent with GD compared with G. Among all patients, median survival from registration was 20.8 months (95% confidence interval: 16.4–33.8), and 2-year survival was 46.7% (95% confidence interval: 35.6–57.1). From randomization, median progression-free survival was 5.4 months for G and 13.4 months for GD, and median survival was 16.1 months for G and 29.5 months for GD. Two-year survival rates were 40.6% for G and 55.7% for GD. Conclusion The doublet, as expected, resulted in more toxicity, particularly myelosuppression and fatigue. Survival associated with the GD treatment arm of this trial exceeds that of previously reported trials.

Introduction We hypothesized that plasma transforming growth factor-²1 (TGF-²1) level and its dynamic change are correlated with the prognosis of locally advanced non-small cell lung cancer (NSCLC) treated with radiation therapy (RT). Methods Patients with stage IIIA or IIIB NSCLC treated with RT with or without chemotherapy were eligible for this study. Platelet poor plasma was collected from each patient within 1 week before RT (pre-RT) and at the 4th week during RT (during-RT). TGF-²1 level was measured with enzyme-linked immunosorbent assay. The primary end point was overall survival (OS) and the secondary end point was progression-free survival (PFS). Kaplan-Meier and Cox regression were used for risk factor evaluation. Results A total of 65 patients were eligible for the study. The median OS and PFS were 17.7 and 13.7 months, respectively. In univariate analysis, performance status, weight loss, radiation dose, and TGF-²1 ratio (during-RT/pre-RT TGF-²1 level) were all significantly correlated with OS. In the multivariate analysis, performance status, radiation dose, and TGF-²1 ratio were still significantly correlated with OS. The median OS was 30.7 months for patients with TGF-²1 ratio ≤1 versus 13.3 months for those with TGF-²1 ratio more than 1 ( p = 0.0029); and the median PFS was 16.8 months versus 7.2 months, respectively ( p = 0.010). Conclusions In locally advanced NSCLC, the decrease of TGF-²1 level during RT is correlated with favorable prognosis.

Introduction Primary small cell esophageal carcinoma (SCEC) is a rare and aggressive disease for which there is no recommended standard treatment at this time. Methods A total of 126 patients with SCEC, diagnosed histologically between May 1985 and June 2005 at our institution, were analyzed retrospectively. All were staged according to the Veterans' Administration Lung Study Group staging system. The TNM system for esophageal carcinoma (6th edition, American Joint Committee on Cancer) was also used for those who underwent esophagectomies. SPSS (10.0) software was used for statistical analysis. Cox's hazard regression model was performed to identify prognostic factors. The Kaplan-Meier and log-rank methods were used to estimate and compare survival rates. The χ 2 test was performed to examine frequencies between different groups. Results Through a median follow-up of 13 months, 108 patients died, 10 were alive, and 8 were lost to follow-up. Of the entire study population, the overall median survival time (MST) and 1-, 3-, and 5-year overall survival rates were 12.5 months and 52.2%, 15.9%, and 12.2%, respectively. For limited disease, the MST and 1-, 2-, and 3-year overall survival rates were 14.0 months and 62.1%, 30.8%, and 22.4%, respectively; for extensive disease, the respective values were 7.0 months and 29.3%, 13.6%, and 2.7% ( p = 0.0001). The MST of 14.5 months for cases who received chemotherapy was superior to that of 5.2 months for cases who did not ( p = 0.0001). Tumor stage, length of the primary lesion, and chemotherapy, but not surgery were independent prognostic factors in a multivariate analysis. Conclusions SCEC is systemic disease. Tumor stage and chemotherapy were independent prognostic factors. Systemic therapy, based on chemotherapy with radiotherapy, is recommended.