BACKGROUND: We report the preliminary results of a phase II trial undertaken to determine the efficacy and the feasibility of gemcitabine (GEM) and radiotherapy in patients with inoperable stage III NSCLC.
METHODS: Between February, 2001 and June, 2003, 46 patients (37 males/9 females; median age 64 years) with clinical stage III NSCLC (41 cIIIA and 5 cIIIB), were enrolled in a combined chemo-radiation protocol with GEM as chemotherapeutic agent. GEM (350 mg/mq) was administered weekly for five consecutive weeks as a thirty minute intravenous infusion before radiotherapy (total dose: 50.4 Gy; 1.8 Gy/day). Toxicity was routinely assessed. Patients judged to be resectable at re-staging, underwent surgery.
RESULTS: Toxicity was moderate, except one grade 3 thrombopenia. All patients, except 5, were available for re-staging. No complete response was observed. 34 (82.9%) patients had a partial response, 5 (12.2%) stable disease, and 2 (4.9%) progression disease. 29/46 (63%) patients (27 cIIIA and 2 cIIIB) underwent surgery. Radical resection was possible in all cases. Surgery included 17 lobectomy, 4 bilobectomy, and 8 pneumonectomy. Mortality was nil. Morbidity was 13.8% (4/29). A pathological downstaging to stage 0-I was observed in 18 patients (62%). After a median follow-up of 13 months (range 2-28), 24 of operated patients (86.2%) are alive, with a median disease-free survival of 16 months. Overall 2-years survival was 66.1%, with a significant difference between resected and not-resected (82% vs 36%, p = 0.0002).
CONCLUSIONS: The results of this ongoing trial confirm the feasibility and the efficacy of GEM concurrent with radiotherapy.

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