Preliminary analysis of safety and efficacy of ELCC 2022 sequential chemoradiotherapy followed by durvalumab in stage III NSCLC

The 2022 European Lung Cancer Conference (ELCC) will be held from March 30 to April 2 local time, and a number of studies led by Chinese experts have been selected for this event
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As the most common pathological type of lung cancer, the treatment of non-small cell lung cancer (NSCLC) has always been the focus of academic attention
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The prognosis for stage III unresectable NSCLC is always generally poor, and in 2017, the PACIFIC study improved this situation, and curative concurrent chemoradiotherapy (cCRT) followed by durvalumab consolidation therapy significantly improved patient survival
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However, it is worth noting that concurrent chemoradiotherapy has high requirements on the physical condition of patients, which may limit the practical application of this scheme in clinical practice
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The PACIFIC-6 trial is a study evaluating the safety and efficacy of sequential chemoradiotherapy (sCRT) followed by durvalumab.
At this meeting, the researchers announced the analysis results, which are edited by Yimaitong as follows
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Research Background The phase III placebo-controlled trial PACIFIC suggested that cCRT followed by durvalumab significantly improved the survival benefit of patients with stage III unresectable NSCLC, and the safety was manageable
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Since many patients are not candidates for cCRT, the phase II trial PACIFIC-6 (NCT03693300) evaluated the safety of sCRT followed by durvalumab
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Here, the investigators report the primary endpoint safety analysis and secondary endpoint efficacy analysis of PACIFIC-6
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Research Methods The study included 117 patients with stage III NSCLC with ECOG PS≤2 and no disease progression after platinum-based sCRT.
The enrolled patients received 1500 mg of durvalumab q4w until disease progression and unacceptable toxicity.
Or the patient withdraws consent and the treatment lasts up to 24 months
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The primary endpoint of the study was the safety/tolerability of durvalumab, as assessed by the incidence of potentially treatment-related grade 3/4 adverse events (PRAEs) within 6 months
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Progression-free survival (PFS), objective response rate (ORR, as assessed by investigators according to RECIST v1.
1), and overall survival (OS) were secondary endpoints, and PFS and OS were analyzed by the Kaplane-Meier method
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Results 114 patients had a PS score of 0-1, and 3 patients had a PS score of 2
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The median age of patients was 68.
0 years (65.
8% of patients were ≥65 years old), 62.
4% were male, and 37.
6%, 50.
4%, and 11.
1% were stage IIIA, IIIB, and IIIC patients, respectively
.

98.
3% of patients had past or present health problems, mainly vascular (59.
0%), respiratory (53.
8%) and metabolic (51.
3%) diseases
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At the data cutoff on July 15, 2021, 37.
6% of patients remained on treatment, and the median duration of treatment for patients was 32.
0 weeks
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The ORR was 17.
1% for all patients and 13.
1% for those with PS 0-1
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The median PFS for all patients was 10.
9 months (95% CI, 7.
3-15.
6), and the 12-month PFS was 49.
6% (95% CI, 39.
5%-58.
9%)
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The median OS for all patients was 25.
0 months (95% CI, 25.
0-NC), and the 12-month OS was 84.
1% (95% CI, 75.
6%-89.
9%)
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Other survival results are shown in Table 1
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Table 1 Patient Survival Results Overall, 94.
9% of patients experienced adverse events (AEs) of any grade and 76.
9% of patients experienced PRAEs; 18.
8% of patients experienced grade 3/4 AEs and 4.
3% of patients experienced grade 3/4 PRAE, grade 3/4 PRAE pneumonitis occurred in 1.
7% of patients, and all grade 3/4 PRAEs occurred within 6 months of treatment
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21.
4% of AEs and 16.
2% of PRAEs led to drug discontinuation, of which pneumonia was the most common PRAE leading to drug discontinuation, accounting for 10.
3%
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Fatal AEs occurred in 2 patients (1.
7%), 1 of which was PRAE pneumonia
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Conclusions The safety of sCRT followed by durvalumab was similar to that of cCRT followed by durvalumab in the PACIFIC trial, and it showed good preliminary efficacy in the frail and elderly population
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References MC Garassino, J.
Mazieres, M.
Reck, et al.
Safety and efficacy outcomes with durvalumab after sequential chemoradiotherapy (sCRT) in stage III, unresectable NSCLC (PACIFIC-6).
ELCC 2022 108MO.
Edited by You Shi.
: Youshi Typesetting: Youshi Execution: Youshi's medical pulse and patient education lecture "Targeted Therapy Adverse Reaction Performance and Treatment" will start at 19:00 on April 7th, scan the poster and add a small assistant WeChat at the bottom left to watch more patient education Lectures, you can also get a doctor's free Q&A~ Famous teacher class, scan the code to enter▼▼▼