Proceedings of the 51st Annual ASTRO Meeting S461

Conclusions: For patients with postoperative recurrence NSCLC, an excellent survival rate was observed by definitive RT. Pa-tients with regional lymph nodes recurrence showed better survival rate than those with local recurrence. Although no advantageof concurrent chemo-RT was shown in this retrospective analysis, a RT dose of . = 66 Gy seems important in the treatment ofpostoperative recurrence NSCLC.

Author Disclosure: I. Tachibana, None; T. Shibata, None; T. Nishikawa, None; R. Koike, None; K. Nakamatsu, None; S. Kana-mori, None; Y. Nishimura, None.

2621 Improved Patient Survival with Adjuvant External Beam Radiation Therapy following Radiofrequency

Ablation of Unresectable Primary and Metastatic Lung Tumors

J. M. Anaokar1, B. Rosenbluth2, J. H. Rundback2,3

1Beth Israel Medical Center, New York, NY, 2Holy Name Hospital, Teaneck, NJ, 3Columbia University College of Physicians andSurgeons, New York, NY

Purpose/Objective(s): Retrospective single-center evaluation of overall survival (OS) and progression-free survival (PFS) afterconformational Cool-Tip radiofrequency ablation (CCT-RFA), with or without adjuvant external beam radiation therapy (EBRT),for unresectable lung malignancies.

Materials/Methods: Thirty-seven consecutive patients (mean age 74.2, range, 33–93, male 45.9%) with primary lung cancer (n= 32) or pulmonary metastases (n = 5) underwent 40 CCT-RFAs for 43 lesions. Primary lung cancer patients included 16 StageI, 4 Stage II , 5 Stage III, 7 Stage IV. Baseline lesion size was # 3 cm in 16 and . 3 cm in 27. Fourteen patients receivedadjuvant RT (mean dose 6668 cGy, range, 5400–7200 cGy), the majority treated with IG-IMRT and without concurrent che-motherapy. CT and/or PET follow-ups were performed at 1, 3, 6 and 12 months, and annually to assess TP. Kaplan-Meier curveswere used to evaluate OS and PFS rates. Multiple variables were analyzed using the log–rank test, followed by Cox propor-tional-hazards regression to determine independent risk factors for OS and PFS. IRB exemption status was obtained prior todata review.

Results: OS and PFS rates in all patients at 6, 12, 18 and 24 months were 66.6%, 51.3%, 42.7% and 29.9%; and 54.6%, 42.3%,18.8% and 18.8%, respectively. There was a significant improvement (p \ 0.05) in OS and PFS with adjuvant EBRT and withsmaller tumor size; multivariate analyses also identified adjuvant EBRT and tumor size # 3 cm as independent predictors of im-proved OS and PFS. Median survival for patients receiving EBRT was 23.4 months vs. 6.4 months for patients not receiving EBRT(p \ 0.05). PFS for patients receiving EBRT was 14.1 months vs. 4.8 months for patients not receiving EBRT (p\0.05). OS forpatients with adjuvant EBRT and tumors #3cm was 100.0%, 85.7%, and 68.6% at 6, 12 and 24 months; PFS at these intervals was100.0%, 85.7%, and 51.4%.

Conclusions: Adjuvant RT following CCT-RFA independently predicted survival for patients with unresectable pulmonary ma-lignancies. Patients with adjuvant EBRT and tumors #3cm had the best OS and PFS following CCT-RFA. The use of CCT-RFAfollowed by EBRT in patients with small lesions may provide better OS and PFS for patients with unresectable lung tumors.

Author Disclosure: J.M. Anaokar, None; B. Rosenbluth, None; J.H. Rundback, None.

2622 A Phase II Randomized Trial with Captopril in Patients Who Have Received Radiation Therapy +/-

Chemotherapy for Stage II–IIIB Non–small Cell Lung Cancer and Stage I Central Non–small Cell LungCancer, or Limited-stage Small–cell Lung Cancer: RTOG 0123

W. Small1, J. James2, T. Moore3, D. Fintel1, S. Lutz4, B. Movsas5, M. Suntharalingam6, Y. Graces7, R. Ivker8, L. Berk9

1The Robert H. Lurie Comprehensive Cancer Center of Northwestern University Medical School, Chicago, IL, 2RTOG Statistics,Philadelphia, PA, 3Columbus CCOP, Columbus, OH, 4Blanchard Valley Radiation Oncology, Findlay, OH, 5Henry Ford HealthSystem, Detroit, MI, 6University of Maryland, Baltimore, MD, 7Mayo Clinic, Rochester, MN, 8Newark Beth Israel MedicalCenter, Newark, NJ, 9Moffitt, Tampa Bay, FL

Purpose/Objective(s): The primary objective of RTOG 0123 was to test the ability of captopril to alter the incidence of pulmonarydamage at 12 months after completion of radiation with secondary objectives including the pulmonary expression of MIP-1a, TNF-a, IL-1 and IL-6, QOL as measured by the EORTC QLQ-C30 and QLQ-LC13, and long term effects of captopril.

Materials/Methods: Eligible patients included Stage II–IIIB non–small cell lung cancer (NSCLC), Stage I central NSCLC, orlimited-Stage small–cell lung cancer. Planned total dose was $ 45 Gy with . 25% of the lung receiving . 20 Gy if deliveringradiotherapy alone. Surgery (\ pneumonectomy) and chemotherapy was allowed. BP was . 110/60 at registration. Initially, pa-tients were to be registered for the trial within 7 days prior to beginning radiotherapy. This was later amended to allow for regis-tration up to 48 hours prior to completion of radiotherapy. Patients who met eligibility for randomization (e.g. BP) were thenrandomized at the completion of radiotherapy to receive captopril for one year versus observation. The captopril was to be escalatedto 50 mg TID. Patients underwent toxicity evaluations, serum collections and QOL measurements at least every 3 months duringthe treatment period. Primary endpoint was incidence of radiation-induced pulmonary toxicity (CTCAE v3.0, Grades 2–4). 168randomized patients were required to have an 80 % power to detect a 40% reduction (from 50% to 30%) in radiation inducedlung toxicity based on one-sided Fisher’s exact test.

Results: 81 patients were accrued to the study between 6/4/2003 and 10/10/2007. Given the low accrual and randomization ratethe study was closed early. Statistical power was too low to detect the hypothesized difference in toxicity. 8 patients were inel-igible for registration or withdrew consent prior to randomization and 40 patients were not randomized postradiation. The reasonsincluded patient refusal (11), physician preference (6), ineligibility for randomization (5), disease progression/death (4), adverseevent during RT (3), and not specified (12). Of the remaining 33 patients randomized, 20 were analyzable (13 observation,7 captopril). The incidence of Grade 2+ pulmonary toxicity attributable to radiation therapy was 23 % (3/13) in the observationarm and 14 % (1/7) in the captopril arm. Due to low numbers on the QOL assessments, treatment differences in QOL were notevaluated.