Effect of pentoxifylline on radiation response of non-small cell lung cancer: a phase III randomized multicenter trial.
OBJECTIVE
The objectives of this prospective clinical trial were to determine whether pentoxifylline improves the radiation response and survival in patients with non-small cell lung cancer.


METHODS
From July 1993 through October 1994, 64 patients with histologically confirmed Stage I, II and III non-small cell lung cancer were randomly divided into pentoxifylline (Pento)+Radiotherapy (RT) group and RT alone group. Out of the 64 patients, only 47 patients who had measurable tumors on chest X-ray views were analyzed and divided into Pento+RT group (n=27) and RT alone group (n=20). Total tumor dose of 65-70 Gy was delivered as conventional fractionated radiation schedules. Pento was given to the patients 3 x 400 mg/day with a daily dose of 1200 mg during RT.


RESULTS
Complete response (CR), partial response (PR), and stable in Pento+RT group were three (11%), 13 (48%), and 11 (41%), respectively, as compared with corresponding values of three (15%), 13 (65%), and four (20%) in the RT alone group. The median time to relapse in the Pento+RT group was 11 months which was 2 months longer than for the RT alone group (P>0.05). All the patients in both groups showed lower than or equal to grade 2 dysphagia, odynophagia, pulmonary fibrosis, and pneumonitis. The median survival was 18 months in the Pento+RT group and 7 months in the RT alone group. The 1-year survival rate was 60% in the Pento+RT group and 35% in the RT alone group, the 2-year survival rate was 18% in the Pento+RT group and 12% in the RT alone group. But these differences were not statistically significant (P>0.05).


CONCLUSIONS
We concluded that Pento is a modestly effective radiation response modifier and provide benefit in the treatment of non-small cell lung cancer.
Chon-buk National University Hospital and Institute for Medical Sciences, Chon-Ju, South Korea.
H C
HC
Kwon
S K
SK
Kim
W K
WK
Chung
M J
MJ
Cho
J S
JS
Kim
J S
JS
Kim
S R
SR
Moon
W Y
WY
Park
S J
SJ
Ahn
Y K
YK
Oh
H G
HG
Yun
B S
BS
Na
D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D019583:Dose Fractionation, Radiation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D010431:Pentoxifylline / Q000008:administration & dosage*; D011336:Probability; D011446:Prospective Studies; D011837:Radiation-Protective Agents / Q000008:administration & dosage*; D011878:Radiotherapy / Q000379:methods*; D018714:Radiotherapy, Adjuvant; D016019:Survival Analysis; D016896:Treatment Outcome
D011837:Radiation-Protective Agents; D010431:Pentoxifylline