Long-Term Survival (S) Of Induction Chemotherapy (Ctx) With Three Cycles Cisplatin (Cis)/Paclitaxel (Pac) Followed By Concurrent (Cc) Chemoradiation (Ctx/Rtx) Cis/Etoposide (Eto) And 45 Gy (1.5 Gy Bid) Plus Surgery (Surg): Phase Ii Results (Cistaxol)

7047 Background: CTx/RTx followed by SURG remains possible treatment (Tx) for pts with stage IIIA(N2) NSCLC (Albain, Lancet 2009) and selected IIIB (Eberhardt, JCO 1998; Stupp, Lancet Oncol 2009). Here we report long-term S from a prospective phase-II with trimodality Tx (CISTAXOL) that served as predecessor/baseline dataset for our ongoing randomized phase-III (ESPATÜ) (Poettgen, Int J Radiat Oncol Biol Phys 2010). Methods: Pts with histopathologically (mediastinoscopy) proven IIIA(N2) and selected IIIB NSCLC received three CTx cycles cis (50 mg/m2 d 1+8) and pac (175 mg/m2 d 1) qd 22. This was followed by cc CTx/RTx including cis 50 mg/m2 d 2 + 9 and eto 100 mg/m2 d 4-6 cc with 45 Gy (1.5 Gy bid). Three to five weeks after end of RTx pts received SURG if possible. In pts determined inoperable at end of RTx, a definitive CTx/RTx-boost (20 Gy; 2 Gy qd) was added. Here we report ten-year (overall) OS for this cohort and look for exploratory subgroups. Results: Pts accrual from 3/1999 to 2/2002. Pts characteristics: 64 (IIIA(N2) 24; IIIB 40); gender m 48; f 16; PS 0-1; histo: adeno (ADC) 17; squamous cell (SCC) 28; large cell (LCC) 17; NOS 2; age: median 52.5 (range 28-69). 36 pts taken to SURG: R0 32; R1/R2 3; exploratory 1; pCR 16. Long-term exploratory OS analysis (5-y-OS %, 10-y-OS %): med S of all pts still alive on f-up: 8 y 10 mo; all pts 30.1 27.8; IIIA(N2) 34.3 34.3; IIIB 27.7 23.8 (ns log rank); groups defined by pre-Tx factors: histo SCC 46.2 41.0 LCC 23.5 23.5 ADC 11.8 11.8 p = 0.0075 log rank; age < 50 45.9 45.9 age ≥ 50 23.1 20.3 p = 0.035 log rank; groups defined by Tx-dependent factors: R0 46.4 46.4 no R0 14.6 9.7 p = 0.0013 log rank ; R0/pCR 66.0 66.0 R0/vital TU 27.0 27.0 p = 0.03 log rank. Conclusions: long-term S of CISTAXOL defines the rationale for our ongoing randomized trial with SURG after induction Tx in selected pts with stage IIIA/IIIB. Interestingly, histo and age turn out to be important factors in exploratory analysis. ADC and older pts demonstrate poor prognosis even with trimodality. We will prospectively validate these findings in ESPATÜ and perform competing risk analysis.