A phase 2 trial of durvalumab treatment following radiation monotherapy in patients with non-small cell lung cancer ineligible for stage III chemoradiotherapy: The SPIRAL-RT study.
Eur J Cancer
; 195: 113373, 2023 12.
Article
en En
| MEDLINE
| ID: mdl-37890349
ABSTRACT
BACKGROUND:
Although concurrent chemoradiotherapy (CCRT) followed by durvalumab is the standard treatment for patients with stage III non-small cell lung cancer (NSCLC), only half of the patients are allowed to receive CCRT in real-world settings. We evaluated the efficacy and safety of durvalumab after radiation monotherapy for NSCLC patients who are ineligible for chemoradiotherapy.METHODS:
A single-arm, prospective, open-label, multicenter phase II trial was conducted in Japan. The patients received radiation (54-66 Gy) followed by durvalumab (10 mg/kg every 2 weeks for up to 12 months). The primary endpoint was the 1-year progression-free survival (PFS) rate. The secondary endpoints were the objective response rate (ORR), PFS, overall survival (OS), and safety.RESULTS:
Between September 2019 and April 2021, 33 patients were enroled from eight institutions. The median patient age was 79 years, and the majority of patients were male (78.8%). The 1-year PFS rate was 39.1% (90% confidence interval [CI] 24.7-54.6%). Three patients (9.1%) had a performance status of 2. The ORR was 42.4% (95% CI 27.2-59.2%). The median PFS and OS were 8.9 (95% CI 7.4-19.4) and 20.8 (95% CI 15.8-not estimable) months, respectively. The most common adverse event was radiation pneumonitis (51.5%). The median treatment duration was 6.4 (range 0.50-12.0) months for durvalumab. At the endpoint, 30.3% (10/33) of the patients had completed 1 year of durvalumab therapy.CONCLUSIONS:
Durvalumab is an effective treatment with tolerable toxicity following radiation monotherapy in stage III NSCLC patients who are ineligible for chemoradiotherapy. TRIAL REGISTRATION JMA-IIA00434 (jRCT).Palabras clave
Texto completo:
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Bases de datos:
MEDLINE
Asunto principal:
Carcinoma de Pulmón de Células no Pequeñas
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Neoplasias Pulmonares
Límite:
Aged
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Female
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Humans
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Male
Idioma:
En
Revista:
Eur J Cancer
Año:
2023
Tipo del documento:
Article
País de afiliación:
Japón