Nonresected non-small-cell lung cancer in Stages I through IIIB: accelerated, twice-daily, high-dose radiotherapy--a prospective Phase I/II trial with long-term follow-up.
OBJECTIVE
Our purpose was to investigate the tolerability of accelerated, twice-daily, high-dose radiotherapy. The secondary endpoints were survival and locoregional tumor control.


METHODS
Thirty consecutive patients with histologically/cytologically proven non-small-cell lung cancer were enrolled. Tumor Stage I, II, IIIA, and IIIB was found in 7, 3, 12, and 8 patients, respectively. We applied a median of 84.6 Gy (range, 75.6-90.0 Gy) to the primary tumors, 63.0 Gy (range, 59.4-72.0 Gy) to lymph nodes, and 45 Gy to nodes electively (within a region of about 6 cm cranial to macroscopically involved sites). Fractional doses of 1.8 Gy twice daily, with an interval of 11 hours, were given, resulting in a median treatment time of 35 days. In the majority of patients the conformal target-splitting technique was used. In 19 patients (63%) two cycles of induction chemotherapy were given. The median follow-up time of survivors is 72 months (range, 62-74 months).


RESULTS
We found Grade 1, 2 and 3 acute esophageal toxicity in 11 patients (37%), 2 patients (7%), and 2 patients (7%), respectively. Grade 2 acute pneumonitis was seen in 2 patients (7%). No late toxicity greater than Grade 1 was observed. The actual overall survival rates at 2 and 5 years are 63% and 23%, respectively; the median overall survival, 27.7 months. In 9 patients a local failure occurred, 7 of them presenting initially with an atelectasis without availability of 18-fluorodeoxyglucose-positron emission tomography staging at that time. In 4 patients recurrence occurred regionally.


CONCLUSIONS
This Phase I/II trial with long-term follow-up shows low toxicity with promising results for survival and locoregional tumor control.
Wurstbauer
Karl
K
Department of Radiation Oncology, Paracelsus Medical University, Salzburg, Austria. k.wurstbauer@salk.at
Deutschmann
Heinz
H
Kopp
Peter
P
Kranzinger
Manfred
M
Merz
Florian
F
Nairz
Olaf
O
Studnicka
Michael
M
Sedlmayer
Felix
F
D000368:Aged; D000369:Aged, 80 and over; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D004947:Esophagus / Q000528:radiation effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D016609:Neoplasms, Second Primary / Q000473:pathology; D011832:Radiation Injuries / Q000150:complications / Q000473:pathology; D017564:Radiation Pneumonitis / Q000209:etiology; D011879:Radiotherapy Dosage; D012074:Remission Induction / Q000379:methods; D015996:Survival Rate