Phase II study of perioperative chemotherapy with cisplatin (C) and pemetrexed (P) in non-small cell lung cancer (NSCLC)

• Published in: Journal of clinical oncology Vol. 30; no. 15_suppl; p. e17535
• Main Authors: Farooq, Aamer, Dy, Grace K., Demmy, Todd L., Bogner, Paul, Nowadly, Cynthia, Tan, Wei, Chen, Hongbin, Yendamuri, Saikrishna S., Nwogu, Chukwumere E., Bushunow, Peter Walter, Adjei, Alex A., Ramnath, Nithya
• Format: Journal Article
• Language: English
• Published: 20.05.2012
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/jco.2012.30.15_suppl.e17535

Abstract only e17535 Background: Pathological complete response (pCR) with neoadjuvant chemotherapy is associated with improved survival in many solid tumors. We evaluated efficacy and tolerability of neoadjuvant plus adjuvant C+P in this phase II trial. Methods: We recruited patients (pts) with clinical stage IB-IIIA (TNM 7th ed) NSCLC, ECOG performance status (PS) 0-1 in this single-arm phase II trial using two-stage design with 90% power to detect pCR rate of >10% (vs null hypothesis of <2%). Pre-treatment mediastinal biopsy was required. Protocol was amended in 2009 to exclude squamous histology. Pts received 3 cycles of C 75mg/m 2 + P 500mg/m 2 (day 1 every 21 days) followed by surgical resection. Two cycles were delivered adjuvantly within 60-80 days after surgery. The primary end point was pCR. Secondary endpoints were objective response rate (ORR), overall survival (OS), disease-free survival (DFS), and adverse events (AEs). Results: 38 pts were enrolled with median age of 62 yrs, 19 males: 19 females. 74% (N=28) had ECOG PS 0. Preoperatively, 26% (N=10) had squamous histology, 29% (N=11) had biopsy-proven N2 involvement. Median of 4 cycles were administered. ORR was 29% (11 pts with PR). 4 pts did not undergo surgery (3 had disease progression; one became hypoxic during intubation in the OR). Resection status was R2 in 9% (3 of 34 pts), remaining pts had R0 resection. 6 pts had documented N2 clearance; median DFS (mDFS) and OS (mOS) of these pts have not reached (NR) vs 15 and 24 months respectively, in pts with persistent N2 disease. CTC grade 3+ nonhematologic AEs (<10%) include arterial thrombosis, bronchopleural fistula, empyema, hyperglycemia, fatigue and tinnitus. There was no pCR seen and thus accrual to 2nd stage was not pursued. There was no correlation between DFS or OS with ORR or pre-operative stage. There was statistically signification association between DFS with histology (favoring squamous, p=0.03) and post-op stage (p=0.024). The table shows mDFS and mOS in months according to pre-op stage. Conclusions: While the primary endpoint was not met, this regimen is active and well-tolerated perioperatively in NSCLC pts. [Table: see text]