Stereotactic body radiotherapy for medically inoperable patients with stage I non-small cell lung cancer - a first report of toxicity related to COPD/CVD in a non-randomized prospective phase II study.
OBJECTIVE
In a retrospective study using stereotactic body radiotherapy (SBRT) in medically inoperable patients with stage I NSCLC we previously reported a local control rate of 88% utilizing a median dose of 15Gyx3. This report records the toxicity encountered in a prospective phase II trial, and its relation to coexisting chronic obstructive pulmonary disease (COPD) and cardio vascular disease (CVD).


METHODS
Sixty patients were entered in the study between August 2003 and September 2005. Fifty-seven patients (T1 65%, T2 35%) with a median age of 75 years (59-87 years) were evaluable. The baseline mean FEV1% was 64% and median Karnofsky index was 80. A total dose of 45Gy was delivered in three fractions at the 67% isodose of the PTV. Clinical, pulmonary and radiological evaluations were made at 6 weeks, 3, 6, 9, 12, 18, and 36 months post-SBRT. Toxicity was graded according to CTC v2.0 and performance status was graded according to the Karnofsky scale.


RESULTS
At a median follow-up of 23 months, 2 patients had relapsed locally. No grade 4 or 5 toxicity was reported. Grade 3 toxicity was seen in 12 patients (21%). There was no significant decline of FEV1% during follow-up. Low grade pneumonitis developed to the same extent in the CVD 3/17 (18%) and COPD 7/40 (18%) groups. The incidence of fibrosis was 9/17 (53%) and pleural effusions was 8/17 (47%) in the CVD group compared with 13/40 (33%) and 5/40 (13%) in the COPD group.


CONCLUSIONS
SBRT for stage I NSCLC patients who are medically inoperable because of COPD and CVD results in a favourable local control rate with a low incidence of grade 3 and no grade 4 or 5 toxicity.
Baumann
Pia
P
Divisions of Oncology and Hospital Physics, Radiumhemment, Karolinska University Hospital, Sweden.
Nyman
Jan
J
Hoyer
Morten
M
Gagliardi
Giovanna
G
Lax
Ingmar
I
Wennberg
Berit
B
Drugge
Ninni
N
Ekberg
Lars
L
Friesland
Signe
S
Johansson
Karl-Axel
KA
Lund
Jo-Smund
JS
Morhed
Elisabeth
E
Nilsson
Kristina
K
Levin
Nina
N
Paludan
Merete
M
Sederholm
Christer
C
Traberg
Anders
A
Wittgren
Lena
L
Lewensohn
Rolf
R