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Journal of Thoracic Oncology:
doi: 10.1097/01.JTO.0000283095.94217.eb
Proffered Paper Abstracts: Session A1: Combined Modality Therapy in NSCLC I, Monday, September 3: Combined Modality Therapy in NSCLC I, Mon, 13:45 - 15:30

Randomized multicenter german trial of surgery plus radiotherapy versus tri-modality treatment of operable stage IIIA NSCLC - long-term follow-up results: A1-06

Eberhardt, Wilfried E.1; Korfee, Sönke1; Pöttgen, Christoph2; Wagner, Horst3; Gauler, Thomas1; Passlick, Bernward4; Stamatis, Georgios5; von Pawel, Joachim3; Budach, Volker6; Wilke, Hansjochen7; Stuschke, Martin2

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1 Dept. of Internal Medicine (Cancer Res.), West German Cancer Centre, University Hospital of the University of Duisburg-Essen, Essen, Germany 2 Dept. of Radiation Therapy, West German Cancer Centre, Essen, Germany 3 Asklepios Klinik Gauting, Gauting, Germany 4 Clinics for Thoracic Surgery, University Hopital, Freiburg, Germany 5 Dept. of Thoracic Endoscopy and Thoracic Surgery, Ruhrlandklinik Essen-Heidhausen, Essen, Germany 6 Clinic for Radiation Oncology, Charite Campus-Mitte, Berlin, Germany 7 Kliniken Essen-Mitte; Huyssen-Stiftung, Essen, Germany

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Rationale:

1994, selected patients(pts) early stage IIIA-NSCLC (operable, 1-2 LN involved at mediastinoscopy, no clinical N2, no bulky/extranodal disease) were taken to upfront surgery(S) at centers in Europe/North America. We compared this approach to aggressive tri-modality therapy - induction chemotherapy(CTx), preoperative radiochemotherapy(RTx/CTx) and definitive S - in a multicenter randomized GERMAN KREBSHILFE trial (full trials grant).

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Patients and Methods:

operable IIIA pts (criteria above, mediastinoscopy, central T3N0-1, WHO 0,1) stratified (TN-group, center) and randomized: arm A - S and postoperative RTx (50-60 Gy); arm B - induction CTx (3 x cisplatin(P) 60 mg/m2 d 1+7/etoposide(E) 150 mg/m2 d 3,4,5) + concurrent RTx/CTx (45 Gy; 1.5 Gy bid; 1 x P 50 mg/m2 d 2 + 9, E 100 mg/m2 d 4,5,6) + S (+ prophylactic cranial irradiation (PCI) - 15 x 2 Gy = 30 Gy in 3 wks) (preliminary data: Eberhardt et al, Lung Cancer 2003;41:S63(O-213), Suppl 2).

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Results:

11/94 to 7/01 112 pts randomized. 6 pts (3/arm) not eligible (misstaging, pts refusal, early progression prior any study therapy). 106 pts eligible for complete analysis 3/2007: Pts characteristics M 90 F 16; age median (med) 59 (37-71); SCC 55 adeno-ca 35 LCC 16; A: n = 51 pts T3N0-1 3 T1-2N2 38 T3N2 10; B: n = 55 pts T3N0-1 3 T1-2N2 45 T3N2 7. A: S 50/50 probatory thoracotomy (PT) 5/50 R1/2 10/50 complete resection (R0) 35/50; B: S 39/54 PT 1/54 R1/2 6/54 R0 32/54; peri- and postoperative morbidity/mortality not significantly different between A/B (rate of early postoperative deaths, infections, stump insufficiencies, bleeding, embolisms, postop duration of hospitalization, time on postop respirator, time on ICU). Strong trend for more limited surgical resections following induction: number of pneumonectomies: A 22,B 11. Although terminated early due to slow accrual/emerging data for adjuvant CTx(IALT), the survival(surv) results as follows: median(med) overall surv: A 15 mo vs B 29 mo (p = 0.15 Wilcoxon W); med event-free surv: 9 mo vs 15 mo (p = 0.12 W); med disease specific(spec) surv 10 mo vs 18 mo ( p = 0.026 W). 5-year overall surv 18% vs 16%; event-free surv: 20% vs 24%; disease spec surv 23% vs 24%. Beyond 3 yrs from randomization intercurrent events (co-morbidities) and second cancers predominant reason for deaths. Med surv of pts still alive 3/07: 94 mo(n = 14,73+-149+).

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Conclusion:

This tri-modality protocol was feasible/safe in the multicenter setting. S following complex bi-modality induction did not show increased morbidity/mortality. Strong trend towards lung-sparing surgery in the arm with preoperative complex induction (down-staging? organ-sparing effect?). Results of this trial mandate rate of less extensive S interventions (eg. lobectomies) as further important endpoint to be added within clinical trials of comparable pts populations (significant risk for pneumonectomy at thoracotomy). Although surv data favoured tri-modality in the first four yrs - overall no of pts randomized does not allow valid conclusions concerning this endpoint. Currently, data on brain-relapse -free surv are analyzed with different policy for PCI in both arms (PCI vs no PCI).

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

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