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A phase II study of daily carboplatin plus irradiation followed by durvalumab therapy for older adults (≥75 years) with unresectable III non-small-cell lung cancer and performance status of 2: NEJ039A. | LitMetric

AI Article Synopsis

  • The study investigates the effectiveness of durvalumab, an immunotherapy drug, after chemoradiotherapy in patients with unresectable locally advanced non-small-cell lung cancer (LA-NSCLC), particularly those with poorer performance status or older age.
  • In a phase II trial with 86 participants, 61 received durvalumab after low-dose carboplatin and radiotherapy, showing a 12-month progression-free survival (PFS) rate of 51%, exceeding the expected 35%.
  • The treatment was deemed effective, with a median overall survival of 28.1 months, but pneumonitis was noted as the most common severe side effect.*

Article Abstract

Background: Standard care for unresectable locally advanced non-small-cell lung cancer (LA-NSCLC) involves chemoradiotherapy followed by durvalumab. The clinical significance of durvalumab after chemoradiotherapy in patients with LA-NSCLC having a performance status of 2 or aged ≥75 years, however, remains unclear. Therefore, we investigated the clinical benefit of durvalumab after daily carboplatin plus thoracic concurrent radiotherapy.

Patients And Methods: In this prospective phase II study, daily low-dose carboplatin (30 mg/m) was administered before radiotherapy for the first 20 fractions and concurrent radiotherapy (60 Gy) followed by durvalumab. The primary endpoint was 12 months progression-free survival (PFS) rate from durvalumab initiation. The secondary endpoints included rate of therapeutic completion, PFS, overall survival, objective response rate, and safety.

Results: Of 86 patients who underwent chemoradiotherapy with daily carboplatin from September 2019 to October 2021, 61 (70.9%) received durvalumab consolidation. The performance status was 0, 1, and 2 in 28 (45.9%), 26 (42.6%), and 7 (11.5%) patients, respectively. The rate of therapeutic completion for durvalumab was 26.2% (16/61). The PFS rate of 12 months after durvalumab initiation was 51.0%, indicating that the primary endpoint was achieved because the expected value of 35% calculated from previous studies was exceeded. The objective response rate after chemoradiotherapy and durvalumab was 47.0% and 57.4%, respectively. The median PFS and overall survival were 12.3 and 28.1 months, respectively. The most common adverse event in grades 3 or 4 was pneumonitis (8.2%). One patient died because of interstitial pneumonitis.

Conclusions: Durvalumab consolidation after daily carboplatin with radiotherapy was effective and tolerable for LA-NSCLC vulnerable patients.

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Source
http://dx.doi.org/10.1016/j.esmoop.2024.103939DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11693428PMC

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