A phase II study of pembrolizumab and paclitaxel in patients with relapsed or refractory small-cell lung cancer.
Lung Cancer
; 136: 122-128, 2019 10.
Article
em En
| MEDLINE
| ID: mdl-31494530
ABSTRACT
OBJECTIVE:
Patients with etoposide/platinum-refractory extensive disease (ED) small-cell lung cancer (SCLC) have a dismal prognosis. We aimed to evaluate the efficacy and safety of pembrolizumab and paclitaxel combination therapy in these patients.METHODS:
In this multi-center, phase II study, ED-SCLC patients who showed progression after etoposide/platinum chemotherapy received paclitaxel 175â¯mg/m2 every 3 weeks for up to six cycles. Pembrolizumab 200â¯mg was added from the second cycle and continued until disease progression or unacceptable toxicity. The primary endpoint was the objective response rate (ORR) and the secondary endpoints were progression-free survival (PFS), overall survival (OS), safety, and biomarker analyses including programmed death-ligand 1 (PD-L1) expression, next-generation sequencing, and flow cytometric analysis of peripheral blood cells.RESULTS:
Of the 26 patients enrolled, the confirmed ORR was 23.1% (95%CI 6.9%-39.3%); complete response 3.9%, confirmed partial response [PR] 19.2%, stable disease 57.7%, progressive disease 7.7%, and not evaluable 11.5%. Including 4 cases of unconfirmed PRs, 38.5% of patients were responding and the disease control rate was 80.7%. The median PFS and OS were 5.0 months (95% CI 2.7-6.7) and 9.1 months (95% CI 6.5-15.0), respectively. The grade 3 or 4 adverse events observed included febrile neutropenia (7.7%), neutropenia (7.7%), asthenia (7.7%), hyponatremia (7.7%), and type I diabetes (7.7%). Targeted gene sequencing identified no specific genetic alterations correlated with the treatment, except for theMET copy number gain (PFS 10.5 versus 3.4 months, p = 0.019).CONCLUSIONS:
Pembrolizumab and paclitaxel combination therapy showed a moderate activity with acceptable toxicity in patients with refractory ED-SCLC.Palavras-chave
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Protocolos de Quimioterapia Combinada Antineoplásica
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Carcinoma de Pequenas Células do Pulmão
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Neoplasias Pulmonares
Tipo de estudo:
Clinical_trials
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Prognostic_studies
Limite:
Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article