Ja. Bonner et al., Phase III comparison of twice-daily split-course irradiation versus once-daily irradiation for patients with limited stage small-cell lung carcinoma, J CL ONCOL, 17(9), 1999, pp. 2681-2691
Purpose: Because small-cell lung cancer is a rapidly proliferating tumor, i
t was hypothesized that it may be more responsive to thoracic irradiation (
TI) given twice-daily than once-daily. This hypothesis was tested in a phas
e III trial.
Patient and Methods: Patients with limited-stage small-cell lung cancer wer
e entered onto a phase III trial, and all patients initially received three
cycles of etoposide (130 mg/m(2) x 3) and cisplatin (30 mg/ m(2) x 3). Sub
sequently, patients who did not have progression to a distant site (other t
han brain) were randomized to twice-daily thoracic irradiation (TDTI) versu
s once-daily thoracic irradiation (ODTI) given concomitantly with two addit
ional cycles of etoposide (100 mg/m2 x 3) and cisplatin (30 mg/m2 x 3). The
irradiation doses were TDTI, 48 Gy in 32 fractions, with a 2.5-week break
after the initial 24 Gy, and ODTI, 50.4 Gy in 28 fractians. After thoracic
irradiation, the patients received a sixth cycle of eroposidelcisplatin, fa
llowed by prophylactic cranial irradiation (30 Gy/15 fractions) if they had
a complete response.
Results: Of 311 assessable patients enrolled in the trial, 262 underwent ra
ndomization to TDTI or ODTI. There were no differences between the two trea
tments with respect to local-only progression rates, overall progression ra
tes, or overall survival. The patients who received TDTI had greater esopha
gitis(greater than or equal to grade 3) than those who received ODTI (12.3%
v 5.3%; P = .05), Although patients received thoracic irradiation encompas
sing the postchemotherapy volumes, only seven of 90 local failures were out
of the portal of irradiation.
Conclusion: When TI is delayed until the fourth cycle of chemotherapy, TDTI
does not result in improvement in local control or survival compared with
ODTI. (C) 1999 by American Society of Clinical Oncology.