Elsevier

Radiotherapy and Oncology

Volume 88, Issue 3, September 2008, Pages 359-367
Radiotherapy and Oncology

Lung cancer SBRT
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

https://doi.org/10.1016/j.radonc.2008.07.019Get rights and content

Abstract

Background and Aims

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 15 Gy × 3. 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).

Material and 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 45 Gy 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.

Conclusion

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.

Section snippets

Patient population

Sixty patients with stage I (T1 or T2), peripherally located non-small cell lung cancer, were recruited at seven different centres in Sweden, Norway and Denmark, from August 2003 to September 2005. The baseline characteristics of the patient group are reported in Table 1. They were referred to the radiotherapy units via multidisciplinary conferences which included pulmonologists, oncologists, surgeons, pathologists and radiologists. The patient was then discussed in a SBRT specific conference

Tumour control

At median follow-up of 23 months (3–42) one local relapse combined with distant metastases and one local relapse alone had occurred resulting in a local control rate of 96%. Two patients developed regional failure combined with distant metastases, and five patients were reported with distant metastases alone. Altogether nine patients (16%) have failed during follow-up period (Fig. 1). Twenty patients (35%) died during follow-up, and in 20% (4/20) of the cases death was related to lung cancer

Discussion

This is a report of toxicity (subjective and objective measures) as a function of pre-existing CVD versus COPD, observed and analyzed in an on-going prospective phase II SBRT trial. Only reports of gross rates are given since sample sizes are small and events too few to permit statistical comparisons. Overall, treatment is so far well tolerated and tumour control rates high. Regarding subjective lung toxicity parameters, no difference in pneumonitis rates was observed between groups. However, a

Conclusion

The results of the present analysis of stereotactic body radiotherapy, for medically inoperable patients with stage I NSCLC, show an excellent local control with limited side effects even for patients with severe COPD. In the group of cases with serious CVD there was a subtle post-treatment decrease in performance status that will have to be confirmed in larger patient series of similarly treated patients. At present, however, the promising tumour control obtained with the radiation doses used

Acknowledgments

We gratefully would like to acknowledge funding of the study by the Nordic Cancer Union and the Stockholm Cancer Society. We also would like to gratefully acknowledge Mats Hellström for help with logistics of the study and Ronny Westberg for advice on statistics.

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