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Central Surgical Association

49th Annual Meeting

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Benefit of adjuvant chemotherapy for completely resected pN1 NSCLC is unrecognized: a subgroup analysis of the JBR10 trial
Omar Toubat1, Li Ding2, Keyue Ding3, *Sean C. Wightman1, Scott M. Atay1, Takashi Harano1, *Anthony W. Kim1, Elizabeth A. David1
1Surgery, Keck School of Medicine of USC, Los Angeles, California, United States, 2Department of Population and Public Health Sciences, Keck School of Medicine of USC, Los Angeles, California, United States, 3Department of Public Health Sciences, Queen's University, Kingston, Ontario, Canada

Objective: Previous studies have shown that nearly half of pN1 NSCLC patients in the United States do not receive guideline concordant adjuvant chemotherapy (AC). This is likely due to the perception that AC only marginally improves survival in this population. We evaluated the impact of AC on overall and recurrence free survival among completely resected pN1 NSCLC patients in a post-hoc subgroup analysis of the North American Intergroup phase III (JBR10) trial.

Methods: A post-hoc subgroup analysis was conducted using primary data from eligible, pathologically proven pN1 NSCLC patients enrolled in JBR10. Participants were randomized to cisplatin+vinorelbine (AC) or observation following complete resection. The primary endpoint was overall survival (OS). The secondary endpoint was recurrence free survival (RFS). Kaplan-Meier with log-rank tests were used to compare OS and RFS between the two treatment groups. Cox regression was used to identify factors associated with OS and RFS endpoints.

Results: In total, 482 participants were initially enrolled in JBR10 (stage IB n=219, 45.4% vs stage II n=263, 54.6%). Of 234 eligible participants with pathologically proven pN1 NSCLC, 118 (50.4%) were randomized to AC and 116 (49.6%) to observation following resection. As expected, baseline demographic, clinical, and tumor characteristics did not differ between the two treatment groups. AC and observation patients exhibited a similar median number of resected nodes (AC 7 vs observation 7, p=0.54) and positive nodes (AC 1.0 vs observation 1.0, p=0.92) after surgery. Kaplan-Meier analysis demonstrated that AC patients experienced significantly improved 5-year OS (AC 61.4% vs observation 41.0%, log-rank p=0.008) and 5-year RFS (AC 56.2% vs observation 39.9%, log-rank p=0.011) rates compared to patients randomized to observation. Cox regression analyses confirmed the OS (HR 0.583, 95% CI 0.402-0.846, p=0.005) and RFS (HR 0.573, 95% CI 0.395-0.830, p=0.003) benefit associated with AC compared to observation. In addition to not receiving AC, pneumonectomy resections were found to be independently associated with increased risk of mortality (HR 2.147, 95% CI 1.412-3.266, p<0.001) and increased risk of recurrence (HR 2.442, 95% CI 1.611-3.702, p<0.001) among pN1 participants.

Conclusions: In the JBR10 trial, treatment with AC resulted in a significant and durable OS and RFS advantage compared to observation alone for patients with completely resected pN1 NSCLC. These data suggest that pN1 NSCLC patients may experience a disproportionately greater clinical benefit from AC than the 6% survival advantage estimated by the Lung Adjuvant Cisplatin Evaluation pooled meta-analysis. Given the considerable disparities in the utilization of guideline concordant AC in North American practice, AC should not be deferred for completely resected pN1 NSCLC patients.

Figure 1. Kaplan-Meier analysis of (A) overall survival and (B) recurrence free survival for patients with completely resected pN1 NSCLC randomized to adjuvant chemotherapy (blue) vs. observation alone (red) in the JBR10 trial.

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