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Journal of Thoracic Oncology:
doi: 10.1097/01.JTO.0000284307.70961.a0
Poster Abstracts: SCLC: Combined Modality Therapy: SCLC: Combined Modality Therapy Posters, Mon, Sept 3

Surgery and radiotherapy versus radiotherapy in patients with small-cell lung cancer (SCLC) responding to chemotherapy with paclitaxel, etoposide phosphate, and carboplatin (TEC) - analysis of a randomized phase- II-trial: P1-209

Reck, Martin1; Baumann, Michael2; Gatzemeier, Ulrich1; Passlick, Bernward3; Thomas, Michael4

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1 Department of Thoracic Oncology, Hospital Grosshansdorf, Grosshansdorf, Germany 2 Department of Radiotherapy, University Hospital Dresden, Dresden, Germany 3 Department of Thoracic Surgery, University Hospital Freiburg, Freiburg, Germany 4 Center for Thoracic Oncology, University Hospital Heidelberg, Heidelberg, Germany

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Background:

Despite high response rates following chemo- and radiotherapy in SCLC, long term survival remain poor because of high incidence and early onset of local and distant recurrence. The role of surgery in SCLC is still not defined, but non- randomized data suggest an advantage in survival for patients with limited disease. The regimen of paclitaxel, etoposide phosphate and carboplatin has shown efficacy and low toxicity in a randomized phase III trial. Objectives: The primary objective was to compare overall survival of SCLC patients (stage I-III) who responded to TEC followed by surgery and local radiotherapy versus local radiotherapy only.

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Regimen:

Patients with SCLC stage I-III and functional operability were treated with 4 cycles of paclitaxel 135 mg/m2 d 4, etoposide phosphate 125 mg/m2 d 1-3 and carboplatin AUC 5, d 4 (q d 22). Patients with PR or CR were randomized to local radiotherapy and either brain irradiation with 36 Gy ( in case of CR) (arm A) or surgery followed by local radiotherapy and brain irradiation (in case of R0/R1 resection). (arm B) Results: Due to slow recruitment the study was closed 2004. 98 patients (72 male/26 female) mainly in good performance status (97 ECOG 0/1, 1 ECOG 2) entered the study. 39.5% of the patients had N0/1 disease, 51% N2 and 6% N3 disease. RR after chemotherapy was 92.7 % (34.9% CR, 57.8% PR). Hematological toxicity was moderate with WBC CTC 3/4 31.6%, anemia CTC 3 5.1% and thrombocytopenia CTC 3 3% of patients. Non- hematological toxicity was low. 69 patients were randomized (36 arm A, 33 arm B) and 21 patients underwent surgery with a R0 resection rate of 91.7%. The median dose of irradiation in arm B was 56 Gy (46-76 Gy). Toxicity of radiotherapy and surgery was low and well manageable. Median survival was 15.2 m (Arm A) and 16.0 m (Arm B, p= 0.61). Median PFS was 15.2 m (Arm A) and 15.7 m (Arm B, p= 0.79).

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Conclusions:

Multimodal therapy in SCLC is feasible and requires further investigation. TEC produced a high response rate of 92.7%.

Copyright © 2007 by the European Lung Cancer Conference and the International Association for the Study of Lung Cancer.

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