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

• Published in: Clinical oncology (Royal College of Radiologists (Great Britain)) Vol. 17; no. 5; pp. 332 - 336
• Main Authors: Burmeister, B.H., Fielding, D.I., Ramsay, J.R., Baumann, K.C., Dauth, M., Walpole, E.T.
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.08.2005
• Subjects: Adult; Aged; Carcinoma, Non-Small-Cell Lung - radiotherapy; Chemoradiation; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Humans; Lung Neoplasms - radiotherapy; Male; Maximum Tolerated Dose; Middle Aged; non-small cell lung cancer; Radiation Pneumonitis - etiology; radiation therapy; Radiotherapy - adverse effects; Radiotherapy Dosage; Time Factors; non-small cell lung cancer; Chemoradiation; radiation therapy
• ISSN: 0936-6555; 1433-2981
• DOI: 10.1016/j.clon.2005.03.013

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). 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 30Gy in 15 fractions over 3 weeks. Gemcitabine was given weekly before and within 3h of fractions 1, 6 and 11. The study was designed as a dose-escalation study, commencing at 100mg/m2 and increasing at levels of 50mg/m2, until the maximum tolerated dose (MTD) was reached. The MTD was regarded as being 150mg/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. 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.