Abstract
BackgroundThe phase III PACIFIC trial (NCT02125461) established consolidation durvalumab as standard of care for patients with unresectable, stage III non-small-cell lung cancer (NSCLC) and no disease progression following chemoradiotherapy (CRT). In some cases, patients with stage IIIA-N2 NSCLC are considered operable, but the relative benefit of surgery is unclear. We report a post hoc, exploratory analysis of clinical outcomes in the PACIFIC trial, in patients with or without stage IIIA-N2 NSCLC.Materials and methodsPatients with unresectable, stage III NSCLC and no disease progression after ≥2 cycles of platinum-based, concurrent CRT were randomized 2 : 1 to receive durvalumab (10 mg/kg intravenously; once every 2 weeks for up to 12 months) or placebo, 1-42 days after CRT. The primary endpoints were progression-free survival (PFS; assessed by blinded independent central review according to RECIST version 1.1) and overall survival (OS). Treatment effects within subgroups were estimated by hazard ratios (HRs) from unstratified Cox proportional hazards models.ResultsOf 713 randomized patients, 287 (40%) had stage IIIA-N2 disease. Baseline characteristics were similar between patients with and without stage IIIA-N2 NSCLC. With a median follow-up of 14.5 months (range: 0.2-29.9 months), PFS was improved with durvalumab versus placebo in both patients with [HR = 0.46; 95% confidence interval (CI), 0.33-0.65] and without (HR = 0.62; 95% CI 0.48-0.80) stage IIIA-N2 disease. Similarly, with a median follow-up of 25.2 months (range: 0.2-43.1 months), OS was improved with durvalumab versus placebo in patients with (HR = 0.56; 95% CI 0.39-0.79) or without (HR = 0.78; 95% CI 0.57-1.06) stage IIIA-N2 disease. Durvalumab had a manageable safety profile irrespective of stage IIIA-N2 status.ConclusionsConsistent with the intent-to-treat population, treatment benefits with durvalumab were confirmed in patients with stage IIIA-N2, unresectable NSCLC. Prospective studies are needed to determine the optimal treatment approach for patients who are deemed operable.
Highlights
The results of the phase III PACIFIC trial demonstrated that durvalumab monotherapy improved survival in patients with unresectable, stage III non-small-Volume 7 - Issue 2 - 2022 cell lung cancer (NSCLC) and no disease progression following platinum-based, concurrent chemoradiotherapy
Baseline characteristics were broadly similar between patients with and without stage IIIA-N2 non-small-cell lung cancer (NSCLC) (Table 1)
At the data cut-off (DCO) for its primary analysis, progression-free survival (PFS) favored durvalumab compared with placebo in both patients with (HR 1⁄4 0.46; 95% confidence interval (CI) 0.33-0.65) and without (HR 1⁄4 0.62; 95% CI 0.48-0.80) stage IIIA-N2 disease [Figure 1; DCO: 13 February 2017, median follow-up: 14.5 months]
Summary
The results of the phase III PACIFIC trial demonstrated that durvalumab monotherapy (for up to 12 months) improved survival in patients with unresectable, stage III non-small-Volume 7 - Issue 2 - 2022 cell lung cancer (NSCLC) and no disease progression following platinum-based, concurrent chemoradiotherapy (cCRT). We report a post hoc, exploratory analysis of clinical outcomes with durvalumab in patients from the PACIFIC trial with or without stage IIIA-N2, unresectable NSCLC. The phase III PACIFIC trial (NCT02125461) established consolidation durvalumab as standard of care for patients with unresectable, stage III non-small-cell lung cancer (NSCLC) and no disease progression following chemoradiotherapy (CRT). Materials and methods: Patients with unresectable, stage III NSCLC and no disease progression after 2 cycles of platinum-based, concurrent CRT were randomized 2 : 1 to receive durvalumab (10 mg/kg intravenously; once every 2 weeks for up to 12 months) or placebo, 1-42 days after CRT. With a median follow-up of 14.5 months (range: 0.2-29.9 months), PFS was improved with durvalumab versus placebo in both patients with [HR 1⁄4 0.46; 95% confidence interval (CI), 0.330.65] and without (HR 1⁄4 0.62; 95% CI 0.48-0.80) stage IIIA-N2 disease.
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