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A phase II trial of Docetaxel (D) and Cisplatin (C)
in locally advanced undifferentiated carcinoma of nasopharyngeal type

M. YAMOUNI - N.A. BENHADJI - Y. BELDJILALI - I. LAHLA - B. LARBAOUI - M. BRAHIMI - A. AIT SAID - K. BOUZID - D. DJELLALI
Service d'Oncologie Médicale CHU d'Oran

ECCO 12, Copenhague , 21-25 septembre 2003

Abstract

  • Aim of the study : To asses the antitumoral efficacy and the toxicity of neoadjuvant DC in patients (pts) with locally advanced UCNT (WHO type 3).
  • Patients and methods : previously untreated pts with histologically diagnosed locally advanced UCNT (stage IV A and IV B TNM/UICC 1997) were enrolled between April 2001 and April 2002 in this phase II study. Pts received D 75 mg/m2 and C 75 mg/m2 on day 1. Every pt received three cycles in a neoadjuvant setting. Before radiotherapy (4 to 6 weeks after the third cycle of DC). Pts were evaluated by clinical examination, nasofibroscopy with biopsy and CT Scan of nasopahrynx.
  • Results : All patients were evaluable for efficacy and toxicity. There are 63 pts (46 males, 19 females) with a median age of 41 years (range 18-69) and a performance status (WHO) of0-1 in 61 pts, 2 in pts. Fourteen pts had stage IVA and 51 pts had stage IVB. Response rate for the 65 pts were : complete pathologic response 44%. Partial response 46 %, stable disease 7% and progression 3%. The overall response rate (ORR) was 90 %. After 195 cycles, grade 3 and 4 toxicity (WHO) were neutropenia (15,5%) febrile neutropenia (3%) anaemia (1,9%) nausea and vomiting (23 %) diarrhoea (7%) mucositis (1%) reversible alopecia (71%). Two patients had onycolysis.
  • Conclusion : DC is an effective regimen with an acceptable safety profile in locally advanced UCNT.

Introduction

  • Algeria has an intermediate incidence : 5 per 10 000
  • At least 60 % of patients with UCNT have locally advanced disease, while 5 % to 6% have distant metastasis at diagnosis.
  • However, for stage IV UCNT, chemotherapy has now become an integral part of treatment, along with radiotherapy.
  • The standard chemotherapy regimen is BEP (Cisplatin, Epirubicin, Bleomycin).
  • Recent studies had demonstrated that Docetaxel is an active cytotoxic in the head and neck cancers.

Aim of the study

  • To assess the antitumoral efficacy and toxicity of Docetaxel and Cisplatin neo-adjuvant chemotherapy in patients with locally advanced UCNT.

Patients and methods

  • Inclusion criteria
    • Histologically proven locally UCNT (stage IVA ,IVB)
    • Age : 18-75 years
    • Chemo naive
    • WHO performance status 0-2
    • Measurable disease
    • Adequate hematologic, renal, liver functions.
    • Written consent.
  • Exclusion criteria
    • CNS metastasis
    • Others serious concomitant illness.
  • Design if study

Results

  • Patients characteristics
    • Patients numbers : 65
    • Age
      • Median : 41 years
      • Range : 18-69
    • Sex
      • Male : 46
      • Female : 19
    • Stage
      • IVA : 14
      • IVB: 51
  • Responses
      N S
    Complete pathologic response (pCR) 28 44%
    Partial response 30 46%
    Objective response 58 90%
    Stable disease 2 3%
    Progressive disease 5 7%
    Before chemotherapy
    Complete response after 1 cycle of chemothérapy

     

  • Toxicity NCI/CTC grade ¾ - n = 195 cycles
Non hematologic toxicity
Nausea and vomiting 23%
Diarrhoea 7%
Reversible alopecia 71%
Mucositis 1%
Hematologic Toxicity
Neutropenia 15,5%
Febrile neutropenia 3%
Anaemia 1,5%
  • Survival

Conclusion

  • Docetaxel and Cisplatin is an effective regimen with an acceptable safety profile in locally advanced UCNT.
  • These results must be confirmed by a phase III trial comparing this combination to the standard treatment (BEC, CF).
Communication transmise le 3 mars 2004, par le professeur Larbi ABID, abid@santemaghreb.com

 
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