334P - Preliminary results of HKNPC-1001 trial to evaluate the role of induction TPF followed by weekly docetaxel and cetuximab in combination with intens...

Date 20 December 2015
Event ESMO Asia 2015 Congress
Session Poster presentation 2
Topics Anti-Cancer Agents & Biologic Therapy
Head and Neck Cancers
Surgery and/or Radiotherapy of Cancer
Presenter Roger Ngan
Citation Annals of Oncology (2015) 26 (suppl_9): 93-102. 10.1093/annonc/mdv527
Authors R.K. Ngan1, W.T. Ng2, D.L. Kwong3, S. Tung4, C.C. Yau5, S.F. Leung6, W.Y. Chan2, M. Lung3, A.W. Lee3
  • 1Clinical Oncology, Queen Elizabeth Hospital, 1 - Kowloon/HK
  • 2Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong/HK
  • 3Clinical Oncology, The University of Hong Kong, Hong Kong/HK
  • 4Clinical Oncology, Tuen Mun Hospital, Tuen Mun/HK
  • 5Clinical Oncology, Princess Margaret Hospital, Kowloon/HK
  • 6Clinical Oncology, Prince of Wales Hospital, Shatin/HK

Abstract

Aim/Background

This phase II trial aims to study the efficacy of using induction TPF chemotherapy (docetaxel, cisplatin and fluorouracil) for 3 cycles followed by weekly docetaxel and cetuximab in concurrence with Intensity Modulated Radiotherapy (IMRT) re-irradiation in patients with advanced locoregional recurrent nasopharyngeal carcinoma (NPC).

Methods

We aim to enroll 45 patients with recurrent NPC (T3 – T4, N0 – N1, M0) to be treated with TPF induction chemotherapy (docetaxel 75 mg/m2 D1, cisplatin 75 mg/m2 D1, fluorouracil 750 mg/m2 D1-D4) every 3 weeks for 3 cycles, followed by weekly docetaxel (15 mg/m2) and cetuximab (400 mg/m2 in initial dose, then 250 mg/m2 in subsequent doses) for 7 weeks in concurrence with IMRT (60Gy over 30 fractions, 5 fractions per week). So far, 32 patients have been recruited: 26 patients had completed the treatment, 1 died and 5 patients withdrew from study after 1 cycle of TPF. The median follow-up period was 19 months.

Results

The local progression free rate at 2 years was 74.2%. The 2 year overall survival was 66.8%. The most frequently reported acute side effects (≥grade 3) in TPF induction phase were neutropenia (37.5%) and hyponatremia (28.1%) and 5 patients withdrew after the first cycle of TPF due mostly to fatigue. During IMRT, the most common acute side effect (≥grade 3) was mucositis (23.0%). So far, 12.5% patients had died of cancer. Temporal lobe necrosis (TLN) developed in 8 cases and 5 patients died due to treatment related complications (2 epistaxis, 1 TLN, 1 sudden death after cycle 1 TPF and 1 chest infection after completion of whole course of treatment).

Conclusions

In this preliminary analysis, induction TPF appears to be poorly tolerated. Promising early local control and survival rates achieved after intensive chemo-re-irradiation should be carefully weighed against the occurrence of potentially lethal early toxicities and late complications.

Clinical trial identification

NCT01326559

Disclosure

All authors have declared no conflicts of interest.