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Abstract: Slide Presentations |

PROSPECTIVE PHASE II PROTOCOL OF STEREOTACTIC BODY RADIOTHERAPY FOR MEDICALLY UNRESECTABLE PATIENTS WITH STAGE 1 NON-SMALL CELL LUNG CANCER FREE TO VIEW

Mark D. Williams, MD*; David Miller, MD; Ron McGary, MD; Robert Timmerman, MD
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Indiana University, Franklin, IN


Chest


Chest. 2005;128(4_MeetingAbstracts):206S. doi:10.1378/chest.128.4_MeetingAbstracts.206S-a
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Abstract

PURPOSE:  To determine the risk/benefit profile of stereotactic body radiotherapy in patients with medically unresectable stage 1 non-small cell lung cancer (NSCLC).

METHODS:  We recently completed a phase II study of stereotactic body radiotherapy, which enrolled patients with medically unresectable stage 1 non-small lung cancer. Patients with T1N0 and T2N0 biopsy-proven tumors received 2000 cGy/fraction times 3 fractions and 2200 cGy/fraction times 3 fractions, respectively. Baseline pulmonary function tests (FEV1, FVC, DLCO) and p02 were performed at baseline, 3 and 6 months. Kaplan Meier estimates for overall and disease-free survival were calculated. Treatment toxicity was assessed using standard National Cancer Institute guidelines. In addition an independent safety board determined whether any death was possibly related to the radiotherapy.

RESULTS:  A total of 34 T1N0 and 36 T2N0 patients were enrolled from 11/2002 to 08/2004. 30/70 (43%) were on oxygen at baseline. Kaplan Meier estimates indicate a median survival of 32.6 months and actuarial 1-yr overall and disease-free survival of 81.1% and 79%, respectively. As of 5/01/2005, 25 patients have died with 5 deaths felt to be possibly related to the radiotherapy. After a median follow-up of 23 months, 2 local, 4 regional and 2 distant recurrences occurred. 14 patients developed a decrease in pulmonary function and 3 patients suffered radiation fibrosis. Baseline pulmonary function values were: FEV1 1.12 liters, FVC 2.31 liters, DLCO 11.17 and pO2 72.6. At 3 months values were: FEV1 1.19, FVC 2.54, DLCO 10.67 and pO2 67.7. At 6 months post radiotherapy values were: FEV1 1.14, FVC 2.54, DLCO 10.67 and pO2 67.6.

CONCLUSION:  In this fragile population, high dose stereotactic body radiotherapy for medically unresectable stage 1 NSCLC appears to have a favorable benefit/risk profile. Specifically, there was no significant decrease in pulmonary function for the overall population at 3 and 6 months.

CLINICAL IMPLICATIONS:  Frail patients with medically unresectable stage 1 NSCLC appear to tolerate high doses of targeted radiotherapy. This novel therapy should be further studied in a large multicenter trial.

DISCLOSURE:  Mark Williams, None.

2:30 PM - 4:00 PM


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