Phase I-II trial of gemcitabine-based first-line chemotherapies for small cell lung cancer in elderly patients with performance status 0-2: the G-STEP trial.
J Thorac Oncol
; 7(1): 233-42, 2012 Jan.
Article
em En
| MEDLINE
| ID: mdl-22031232
ABSTRACT
INTRODUCTION:
Treatment of elderly patients with small cell lung cancer (SCLC) is based on scanty evidence.METHODS:
Patients with extensive SCLC, age >70 years, and performance status 0-2 were eligible for a study looking for optimal two-drug combination of gemcitabine (Gem) with vinorelbine (Vin), etoposide (Eto), cisplatin (Cis), or carboplatin (Car). Gemcitabine dose was the same (1000 mg/m2, days 1-8) in all combinations. A two-stage minimax flexible design for response was applied to GemVin combination (Vin 25 mg/m2, days 1-8). For GemCar, GemCis, GemEto, a phase I-II Bayesian design was applied, looking for the optimal dose of the partner drugs. Objective response rate ≥ 60% and unacceptable toxicity ≤ 25% were required to define a combination worthy of further studies.RESULTS:
Median age of 78 eligible patients was 74 years. GemVin produced a 36.7% objective response rate. GemEto and GemCis arms were found not sufficiently active. GemCar produced 16 responses (14 with area under the curve [AUC] 3.5 and 2 with AUC 4.0) in 26 patients (61.5%) and 6 cases of unacceptable toxicity (3 at each Car dose).CONCLUSIONS:
In elderly patients with extensive SCLC, GemVin, GemEto, and GemCis are not enough active and do not merit further studies. Gem plus Car might deserve further attention.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Protocolos de Quimioterapia Combinada Antineoplásica
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Carcinoma de Células Pequenas
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Desoxicitidina
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Neoplasias Pulmonares
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Aspecto:
Patient_preference
Limite:
Aged
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Aged80
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Female
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Humans
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Male
Idioma:
En
Revista:
J Thorac Oncol
Ano de publicação:
2012
Tipo de documento:
Article
País de afiliação:
Itália