Efficacy and safety of S-1 (tegafur, gimeracil, and oteracil potassium) concurrent with 3-dimensional conformal radiotherapy for newly diagnosed squamous cell carcinoma of the lung in elderly patients.

OBJECTIVE

This study evaluated the efficacy and safety of the combination drug tegafur, gimeracil, and oteracil potassium (S-1) concurrent with 3-dimensional conformal radiotherapy for newly diagnosed squamous cell carcinoma of the lung in elderly patients.

METHODS

Patients with pathologically or cytologically newly diagnosed lung squamous cell carcinoma (n=106) were randomly assigned to receive the combination of tegafur, gimeracil, and oteracil potassium (40mg/m(2), BID, d1-28, repeated every 6 weeks for 4 cycles) and concurrent 3D-conformal radiotherapy (60Gy; experimental group), or gemcitabine (800-1000mg/m(2), d1 and d8) repeated every 21 days for 4 cycles as well as 3D-conformal radiotherapy (control group).

RESULTS

The overall response rate (complete and partial responses) of the experimental group was 68.6%, which was significantly higher than that of the control group (38.5%; P=0.002). The median progression-free survival rates of the experimental and control groups were 11.8 months (95% confidence interval [CI]: 8.0-22.4) and 7.8 months (95% CI, 6.9-9.2), respectively (P=0.017). Adverse reactions included grade I/II radiation esophagitis and pneumonitis, with good tolerance. Grade III/IV adverse reactions of the experimental and control groups were leucopenia (20% cf. 56.6%, respectively; P=0.027), thrombocytopenia (3.9% cf. 25%; P=0.037), and gastrointestinal reaction (1.9% cf. 3.5%; P=0.35).

CONCLUSIONS

The efficacy of concurrent combination chemotherapy with tegafur, gimeracil, and oteracil potassium (S-1) and 3D-conformal radiotherapy for newly diagnosed squamous cell carcinoma of the lung in elderly patients was excellent, and all toxicities were well tolerated. This treatment might be considered a main regimen in the management of squamous cell carcinoma of the lung in elderly patients.