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).