A randomized phase III study of docetaxel alone versus docetaxel plus S-1 in patients with previously treated non-small cell lung cancer: JMTO LC09-01.
Thorac Cancer
; 14(29): 2941-2949, 2023 10.
Article
em En
| MEDLINE
| ID: mdl-37609677
ABSTRACT
BACKGROUND:
This study evaluated the efficacy and safety of the combination chemotherapy of docetaxel plus S-1 in patients with previously treated non-small cell lung cancer (NSCLC) compared to docetaxel alone.METHODS:
Patients with previously treated NSCLC were randomly assigned to docetaxel alone (arm A) or a combination of docetaxel and S-1 (arm B) for a maximum of four cycles. The primary endpoint was overall survival (OS).RESULTS:
The study was terminated early because of poor accrual. The number of patients evaluated were 74 and 77 in arm A and arm B, respectively. The median OS was 9.8 months (95% confidence interval [CI] 6.8-15.2) and 12.3 months (95% CI 9.2-14.5) in arms A and B, respectively. In arms A and B, the median progression-free survival was 3.5 months (95% CI 2.7-4.0) and 4.1 months (95% CI 3.2-4.7), respectively. No statistically significant difference was observed in OS (hazard ratio [HR] 0.984, 95% CI 0.682-1.419, p = 0.4569) or progression-free survival (HR 0.823, 95% CI 0.528-1.282, p = 0.0953). The major toxicity was myelosuppression. The incidence of grade 3 or more neutropenia was higher in arm A than in arm B (44.6% vs. 35.1%). However, the incidence of grade 3 or more febrile neutropenia and infection with neutropenia (12.2% vs. 22.1%) was more frequently observed in arm B.CONCLUSIONS:
The prematurely terminated study did not show the benefit of two cytotoxic agents over single-agent therapy for previously treated NSCLC patients.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Carcinoma Pulmonar de Células não Pequenas
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Neoplasias Pulmonares
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Neutropenia
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article