TY - JOUR
T1 - Radical radiotherapy with or without gemcitabine in patients with early stage medically inoperable non-small cell lung cancer
AU - Price, Allan
AU - Yellowlees, Ann
AU - Keerie, Catriona
AU - Russell, Susan
AU - Faivre-Finn, Corinne
AU - Gilligan, David
AU - Snee, Michael
AU - Skailes, Geraldine
AU - Hatton, Matthew
AU - Erridge, Sara
AU - Mohammed, Nazia
N1 - Funding Information:
The study was funded by a Grant based on patient accrual from Lilly Oncology to the University of Edinburgh . The manuscript was reviewed by Lilly Oncology before submission.
PY - 2012/9/1
Y1 - 2012/9/1
N2 - Background: Preclinical and phase I data suggest gemcitabine to be a potent radiosensitiser. This multicentre study addressed whether the addition of low dose gemcitabine to radical radiotherapy improved 2. year event-free survival in patients with medically inoperable stages I-II non-small cell lung cancer. Aim: To determine whether low dose gemcitabine increased event-free survival in patients with T1-2 N0-1 M0 NSCLC deemed unfit for surgery. Methods: Patients with T1-2 N0-1 M0 NSCLC deemed unfit for surgery were randomised to 3D conformal radiotherapy delivering 55Gy in 20 fractions over 4weeks to known sites of cancer with (Arm B) or without (Arm A) 100mg/m2 weekly gemcitabine. Results: Study entry was terminated early because of slow accrual. 111 patients were randomised between March 2003 and December 2005, of whom 4 withdrew consent and 2 were lost to follow-up. Median age was 75 (range 49-88). years and 67 (63%) were male. 86 (81%) were PS 0-1 and 31 (30%) Charlson index 2 or greater. Event-free survival in arm A and B, respectively, was 42% and 46% at 2. years and 20% and 31% at 5. years (p= 0.72), while overall survival was 56% and 52% at 2. years and 20% and 33% at 5. years (p= 0.87). Two deaths from accelerated interstitial lung disease were seen in arm B, but toxicity was otherwise mild. Conclusion: No evidence of an improvement in event-free survival was seen with the addition of weekly gemcitabine at this dose for patients with early stage NSCLC unfit for surgery, although the power of the study was low.
AB - Background: Preclinical and phase I data suggest gemcitabine to be a potent radiosensitiser. This multicentre study addressed whether the addition of low dose gemcitabine to radical radiotherapy improved 2. year event-free survival in patients with medically inoperable stages I-II non-small cell lung cancer. Aim: To determine whether low dose gemcitabine increased event-free survival in patients with T1-2 N0-1 M0 NSCLC deemed unfit for surgery. Methods: Patients with T1-2 N0-1 M0 NSCLC deemed unfit for surgery were randomised to 3D conformal radiotherapy delivering 55Gy in 20 fractions over 4weeks to known sites of cancer with (Arm B) or without (Arm A) 100mg/m2 weekly gemcitabine. Results: Study entry was terminated early because of slow accrual. 111 patients were randomised between March 2003 and December 2005, of whom 4 withdrew consent and 2 were lost to follow-up. Median age was 75 (range 49-88). years and 67 (63%) were male. 86 (81%) were PS 0-1 and 31 (30%) Charlson index 2 or greater. Event-free survival in arm A and B, respectively, was 42% and 46% at 2. years and 20% and 31% at 5. years (p= 0.72), while overall survival was 56% and 52% at 2. years and 20% and 33% at 5. years (p= 0.87). Two deaths from accelerated interstitial lung disease were seen in arm B, but toxicity was otherwise mild. Conclusion: No evidence of an improvement in event-free survival was seen with the addition of weekly gemcitabine at this dose for patients with early stage NSCLC unfit for surgery, although the power of the study was low.
KW - Chemotherapy
KW - Gemcitabine
KW - Non-small cell lung cancer
KW - Radiotherapy
KW - Randomised trial
UR - http://www.scopus.com/inward/record.url?scp=84865155326&partnerID=8YFLogxK
U2 - 10.1016/j.lungcan.2012.05.089
DO - 10.1016/j.lungcan.2012.05.089
M3 - Article
C2 - 22672970
AN - SCOPUS:84865155326
SN - 0169-5002
VL - 77
SP - 532
EP - 536
JO - Lung Cancer
JF - Lung Cancer
IS - 3
ER -