Neoadjuvant dose-modified docetaxel in squamous cell carcinoma of the head and neck: A phase 3 study.
Oral Dis
; 26(2): 285-294, 2020 Mar.
Article
en En
| MEDLINE
| ID: mdl-31830347
ABSTRACT
OBJECTIVE:
To evaluate the efficacy and safety of dose-modified docetaxel plus cisplatin and 5-fluorouracil (TPF) in Chinese patients with squamous cell carcinoma of the head and neck (SCCHN). MATERIALS ANDMETHODS:
This Phase III, open-label, multi-center study included Chinese adults with previously untreated TNM Stage III or IV SCCHN (NCT00995293). Patients were randomized (11) to induction chemotherapy with TPF (docetaxel 60 mg/m2 and cisplatin 60 mg/m2 on day 1 and 5-FU 750 mg/m2 per day continuous IV infusion on days 1-5) or PF (cisplatin 75 mg/m2 on day 1 and 5-FU 750 mg/m2 per day on days 1-5) every 3 weeks for 3-4 cycles. The primary endpoint was progression-free survival (PFS).RESULTS:
Median PFS in the TPF (n = 108) and PF (n = 111) groups was 400 days and 342 days (HR = 0.75; 95% CI, 0.53â1.06; p = .227), respectively. Overall response rate was higher for TPF versus PF (76.3% vs. 52.9%; p = .001), although this equalized following radiotherapy (75.0% vs. 73.9%). In the TPF and PF groups, ≥1 treatment-emergent adverse event was experienced by 104 (94.5%) and 110 (93.2%) patients, respectively.CONCLUSION:
Adding dose-modified docetaxel to PF did not significantly improve PFS but may increase anti-tumor activity in Chinese patients with locally advanced SCCHN.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Protocolos de Quimioterapia Combinada Antineoplásica
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Terapia Neoadyuvante
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Docetaxel
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Carcinoma de Células Escamosas de Cabeza y Cuello
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Neoplasias de Cabeza y Cuello
Tipo de estudio:
Clinical_trials
Límite:
Adolescent
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Adult
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Aged
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Humans
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Middle aged
Idioma:
En
Año:
2020
Tipo del documento:
Article