A phase I study of moderate-dose radiation therapy and weekly gemcitabine in patients with locally advanced non-small cell lung cancer not suitable for radical chemoradiation therapy.
OBJECTIVE
To describe the toxicity and response seen in patients receiving moderate-dose radiation therapy with concurrent weekly low-dose gemcitabine in the management of locally advanced non-small cell lung cancer (NSCLC).


METHODS
Eighteen patients with confirmed NSCLC were enrolled over a 17-month period from August 2000 until January 2002. All had localised disease but were considered unsuitable for curative therapy. Radiation therapy was given to a dose of 30 Gy in 15 fractions over 3 weeks. Gemcitabine was given weekly before and within 3 h of fractions 1, 6 and 11. The study was designed as a dose-escalation study, commencing at 100 mg/m2 and increasing at levels of 50 mg/m2, until the maximum tolerated dose (MTD) was reached.


RESULTS
The MTD was regarded as being 150 mg/m2. The major acute toxicity observed was oesophagitis. Skin reactions were also reported. The overall response rate in all patients was 88%, with 44% achieving a complete response.


CONCLUSIONS
The combination of gemcitabine and moderate-dose radiation therapy is feasible, and offers low toxicity and excellent response rates in patients with localised NSCLC not suitable for high-dose therapy.
Burmeister
B H
BH
University of Queensland, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia. bryan_burmeister@health.qld.gov.au
Fielding
D I
DI
Ramsay
J R
JR
Baumann
K C
KC
Dauth
M
M
Walpole
E T
ET
D000328:Adult; D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000532:radiotherapy*; D003841:Deoxycytidine / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D006801:Humans; D008175:Lung Neoplasms / Q000532:radiotherapy*; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D017564:Radiation Pneumonitis / Q000209:etiology; D011878:Radiotherapy / Q000009:adverse effects; D011879:Radiotherapy Dosage; D013997:Time Factors; D000093542:Gemcitabine
D003841:Deoxycytidine; D000093542:Gemcitabine