Perioperative toripalimab improves event-free survival in non-small cell lung cancer

1. In patients with resectable stage III non-small cell lung cancer, perioperative toripalimab plus chemotherapy increased rates of tumor and lymph node downstaging and improved event-free survival compared to chemotherapy alone.

2. Operative approach, complete resection, hospital stay, and perioperative complication rates remained comparable between study groups.

Evidence Rating Level: 1 (Excellent)

Study Rundown: For patients with resectable stage III non-small cell lung cancer, perioperative immune checkpoint inhibition may improve cancer treatment. However, there are concerns that checkpoint inhibitor toxicity could delay or complicate surgery. This post hoc analysis of the phase 3 Neotorch trial examined surgical outcomes among patients randomized to toripalimab plus platinum-based chemotherapy or placebo plus chemotherapy. Among 404 study participants, 314 underwent resection. Patients treated with neoadjuvant toripalimab were less likely to cancel their surgery. Surgical patients in both study arms featured similar operative approaches, resection completeness, procedure duration, blood loss, length of hospital stay, and postoperative complications. Toripalimab resulted in more frequent tumor and lymph node downstaging as well as longer event-free survival. These findings suggest that the addition of toripalimab to chemotherapy improved disease response and survival without compromising surgical feasibility or safety. Strengths of this study included its multicenter, double-blind, placebo-controlled design, balanced treatment groups, and detailed assessment of operative and oncologic outcomes. However, limitations included a predominantly male study population, potentially limiting generalizability. Additionally, the exclusion of nonsurgical patients may have introduced selection bias.

Click to read the study in JAMA Surgery

Relevant Reading: Perioperative Toripalimab in Stage III Non–Small Cell Lung Cancer

In-Depth [randomized controlled trial]: This double-blind, placebo-controlled randomized controlled clinical trial enrolled 404 patients with resectable stage IIIA or IIIB non-small cell lung cancer across 50 centers in China. Participants received platinum-based chemotherapy in addition to either three neoadjuvant cycles of 240 mg toripalimab or placebo. Patients then underwent surgery, one adjuvant combination cycle of either toripalimab or placebo with chemotherapy, then up to 13 maintenance cycles of the assigned study drug. The study analysis assessed surgical feasibility, perioperative safety, pathologic downstaging, and event-free survival. Surgery was not performed in 17.8% of patients assigned to toripalimab compared to 26.7% assigned to placebo (P = .03); among cancelled procedures, progression accounted for 13.9% versus 57.4%, respectively (P < .001). Of the 314 patients who underwent surgery, minimally invasive procedures occurred in 68.1% versus 66.9%, and complete R0 resection was achieved in 95.8% versus 92.6%. Median hospital stay was eight days in both groups. Any-grade surgical complications occurred in 22.3% with toripalimab and 15.5% with placebo, while grade 3 or worse complications occurred in 6.6% and 3.4%, respectively. Tumor downstaging was more frequent with toripalimab (80.7% vs. 50.7%, P < .001), as was lymph node downstaging (67.5% vs. 48.6%, P = .001). After a median follow-up of 18.3 months, median event-free survival was not reached with toripalimab and was 22.0 months with placebo (HR, 0.50; 95% CI, 0.33-0.74; P = .001). Overall, perioperative toripalimab improved disease response and reduced preoperative attrition without a clear deterioration in surgical outcomes.

Image: PD

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