Survival comparable between preoperative, perioperative chemotherapy in early-stage NSCLC
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The use of preoperative chemotherapy alone instead of a regimen that also included perioperative chemotherapy did not extend survival in a cohort of patients with early-stage non–small cell lung cancer, according to results of a randomized, multicenter phase 2 study.
The open-label trial included 528 patients with resectable stage I-II NSCLC.
Researchers assigned 267 patients to the preoperative group. They received two preoperative cycles of chemotherapy, and those who responded received two additional preoperative cycles.
Researchers assigned the other 261 patients to the perioperative group. They received two preoperative cycles of chemotherapy, and those who responded received two additional postoperative cycles.
Researchers predicted the preoperative chemotherapy regimen would lead to a detectable increase in survival. However, 3-year OS rates between the two arms were similar between the preoperative and perioperative groups (67.4% vs. 67.7%; HR=1.01; 95% CI, 0.79-1.30). Rates of 3-year DFS, response, toxicity and postoperative mortality also were similar.
Researchers observed pathologic complete response in 22 patients (8.2%) assigned to preoperative regimen compared with 16 patients (6.1%) in the perioperative group.
The rate of responders who received the third and fourth cycles of chemotherapy was significantly higher in the preoperative group (90.4% vs. 75.2%; P=.001).
In addition to comparing chemotherapy strategies, researchers also designed the study to compare two chemotherapy regimens — gemcitabine plus cisplatin vs. paclitaxel plus carboplatin. Results showed no difference in 3-year OS (HR=0.97; 95% CI, 0.76-1.25) or response rates between the two regimens.