Surgery (S) alone, preoperative (preop) paclitaxel/carboplatin (PC) chemotherapy followed by S, or S followed by adjuvant (adj) PC chemotherapy in early-stage non-small cell lung cancer (NSCLC): Results of the NATCH multicenter, randomized phase III trial
E. Felip, B. Massuti, G. Alonso, J. L. González-Larriba, C. Camps, D. Isla, E. Costas, J. J. Sánchez, F. Griesinger, R. Rosell
Background: In early stage NSCLC, most patients (pts) relapse despite complete surgical resection. There is, therefore, a rationale for effective systemic therapy to reduce the risk of recurrence. The NATCH phase III trial was designed to address whether preop or adj PC improves disease-free survival (DFS) compared to S alone in early-stage NSCLC.
Methods: Chemotherapy-na?ve consenting pts with clinical stage I (>2 cm), II, T3N1 were randomized to S alone, or 3 cycles of preop PC (P:200 mg/m2/ C AUC:6 on day 1 every 3wk) followed by S, or S followed by 3 cycles of adj PC at the same schedule. The study was designed to determine whether preop or adj PC resulted in a 15% absolute improvement in 5-year DSF, with 80% power and with a two-tailed log-rank test conducted at the .05 significance level. Planned sample size was 624 pts. Current median follow-up is 43 months (mo).
Results: Between April 2000 and May 2007, 624 pts were accrued, 212 in S alone arm, 201 in preop arm, and 211 in adj arm; 28 pts were ineligible. Data is now available for 582 pts. Median age 64 yrs, 88% male; 50% squamous cell, 38% adenocarcinoma, 8% large cell; 11% T1N0 (>2 cm), 66% T2N0, 20.4% II, 2% T3N1. In the preop arm 93% of pts received 3 chemotherapy cycles, response rate was 55% and progression 6%. In the adj arm 65% of pts received 3 chemotherapy cycles. Resection procedures: lobectomy or bilobectomy in 66%; pneumonectomy in 24%, and explorative thoracotomy in 7% of pts; post-operative mortality was 5.2% with no differences among arms. 8% of pts in the preop arm had pCR. The 5-year DFS rate is 39% in S arm, 40.5% in preop, and 39.3% in adj. Median DFS is 28 mo in S arm, 32 mo in preop, and 24 mo in adj arm (p=.71). An exploratory analysis showed a tendency towards longer median DFS in favor of preop chemotherapy for pts achieving radiological response (62 mo; p=.09).
Conclusions: In this preliminary analysis DFS is not significantly different among arms. More pts in the preop arm received the planned chemotherapy treatment. Updated results will be presented at the meeting.
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