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14. High-Dose Neoadjuvant Chemoradiation Plus Surgery in Multi-Modality Treatment of Stage IIIA and IIIB Non-Small Cell Lung Cancer: Clinical Results of UMD-GCC 9953, A Prospective Phase II Study
King F Kwong, Martin J Edelman, Mohan Suntharalingam, Ziv Gamliel, Sonia P Bisaccia, Lindsay B Cooper, Nancy L Kennedy, Whitney Burrows, Petr Hausner, L. Austin Doyle, Mark J Krasna; Baltimore, MD

Objective: To evaluate a strategy of induction high-dose chemo-radiation (CH-XRT), followed by surgery, and consolidation chemotherapy in patients with biopsy-proven stage IIIA and IIIB non-small cell lung cancer (NSCLC).
Methods: All patients accrued into UMD-GCC 9953, a prospective phase II clinical trial of neoadjuvant concurrent platinum-based combination chemotherapy and hyperfractionated radiation followed by surgery with the primary end-point of mediastinal clearance, were reviewed.
Results: 47 total patients were entered into the study (33 IIIA, 14 IIIB; 15 men /32 women; median age, 56 years). 29 patients completed multi-modality treatment including surgery. 18 patients did not undergo surgery for the following reasons: 2 early deaths; 15 had persistent mediastinal disease after CH-XRT; and 1 had unchanged T4 tumor which remained inoperable. The surgical cohort (n=29) included 11 men (mean age 52, range 39-73) and 18 women (mean age 61, range 39-78). Pulmonary resections included lobectomies (n=22), pneumonectomies (n=4), and wedge resections (n=2). Additionally, 1 patient was found unresectable at surgery. In the surgical cohort, pre-treatment clinical stages were IIIA and IIIB in 21 cases and 8 cases, respectively. Complete surgical resection with negative margins was achieved in 28 patients (96.5% surgery cohort and 59.6% total study patients). There was no operative mortality. Radiotherapy was successfully tolerated in 46 patients with a mean total radiation dose of 68.7 Gy. Pathologic complete response (p-CR) was found in 27.6% patients (n=8). For the total group (n=47), median survival time (MST) is 29.4 months (2.4 years) and median event-free survival (MEFS) is 16.9 months (1.4 years). For the subset of patients completing neoadjuvant CH-XRT (n=37), the MST for patients with mediastinal clearance (n=22) has not yet been reached and for patients without mediastinal clearance (n=15), the MST is 28 months (p=0.16). MEFS for patients with mediastinal clearance (n=22) versus those without (n=15) were 16 months and 10.4 months, respectively (p=0.03).
Conclusions: Surgical resection of locally-advanced stage IIIA and IIIB NSCLC after neoadjuvant high-dose hyperfractionated radiation and concurrent chemotherapy can be performed safely. High-dose hyperfractionated radiation as part of a tri-modality treatment regimen can be successfully tolerated. Pre-treatment lymph node metastasis should not necessarily exclude patients from tri-modality treatment. Mediastinal clearance may be an important clinical achievement in these patients. Preliminary survival data from this treatment approach are promising.

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