Abstract
7324 Background: Induction chemotherapy with platinum-containing doublets followed by definitive loco-regional treatment is currently considered the treatment of choice for pts with stage III NSCLC. Based on evidence produced by our group that FDR-Gem results in a longer PFS when combined with CDDP in the metastatic setting (Ceribelli et al., Cancer 2003) and on recent studies suggesting that the addition of selective COX-2 inhibitors to CBDCA/Paclitaxel combinations may improve results in the neoadjuvant setting (Altorki et al., JCO 2003), we have elected to investigate the activity of Celecoxib combined with FDR-Gem/DDP as induction treatment for locally advanced NSCLC pts. Methods: Treatment consisted of continuous Celecoxib (400 mg b.i.d.) combined with FDR-Gem (1200 mg/m2 infused at 10 mg/m2/min on days 1 and 8) and CDDP (80 mg/m2 on day 1) given q3 wks for three cycles. Upon restaging, non-progressive pts underwent surgery and/or definitive RT, as evaluated by a multidisciplinary team. Results: 19 pts (median age 59 yrs, range 43–68; M/F 14/5; IIIA/IIIB: 13/6; PS 0/1: 17/2) have been accrued to date and are evaluable for response and toxicity. Three pts (16%) achieved a cCR, 7 (37%) a PR, 7 (37%) had SD, and 2 (10%) progressed on therapy. Nine pts underwent radical surgery, of whom 2 showed a pCR with no evidence of viable tumor cells in the resected specimen; 5 pts underwent RT with curative intent, 1 of whom became resectable and underwent radical surgery after RT. Toxicity was manageable with G3 neutropenia and anemia in 6/19 and 5/19 pts, respectively, and only 1 pt experiencing G3 vomiting. Treatment delays/25% dose reductions were necessary in 14/114 and 9/114 administrations, respectively. One pt discontinued Celecoxib due to G2 erosive duodenitis. With a median follow-up of 42 wks (range 13–74), 9 pts are alive and free from progression. Conclusions: Celecoxib combined with FDR-Gem/CDDP shows promising activity in locally advanced NSCLC and warrants further investigation in the neoadjuvant setting. Accrual is ongoing to reach a planned target of 42 evaluable patients. No significant financial relationships to disclose.
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