1035P - The randomized study comparing the efficacy and safety of radio-chemotherapy plus adjuvant chemotherapy (CCRT) vs. Neo-adjuvant chemotherapy plus ra...

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Anti-Cancer Agents & Biologic Therapy
Head and Neck Cancers
Surgery and/or Radiotherapy of Cancer
Presenter Somvilai Chakrabandhu
Authors S. Chakrabandhu1, I. Chitapanarux1, R. Jiratrachu2, K. Pruegsanusak2, A. Pinitpatcharalerd3, J. Sukhaboon4, C. Tovanabutra5, A. Srisuthep6, N. Prasongsook7, V. Lorvidhaya1
  • 1Division Of Therapeutic Radiology And Oncology, Chiangmai university, 50200 - Chiangmai/TH
  • 2Division Of Radiotherapy, Songklanagarind Hospital, 90110 - Songkla/TH
  • 3Therapeutic Radiology, Rajavithi Hospital, 10400 - Bangkok/TH
  • 4Medical Oncology Unit, Lopburi Cancer Center, 15000 - Lopburi/TH
  • 5Division Of Radiation Oncology, Chonburi Cancer Center, 20000 - Chonburi/TH
  • 6Radiology, Bhumibol Adulyadej RTAF hospital, 10900 - Bangkok/TH
  • 7Medical Oncology Unit, Department Of Internal Medicine,, Phramongkutklao Hospital, 10400 - Bangkok/TH

Abstract

Purpose

Nasopharyngeal carcinoma is radio-chemosensitive. Local control and survival of patients with advanced disease treated by radiotherapy alone remains unsatisfactory. Chemotherapy has been combined with radiotherapy to increase local-regional control, decrease distant metastasis, and improve survival of the patients. We have developed a randomized trial comparing the efficacy and toxicities of CCRT versus NAC-RT for locally advanced nasopharyngeal cancer.

Patients and methods

A total of 175 patients were included in the study. The 87 patients received concurrent radio-chemotherapy daily 70 Gy/7 weeks with cisplatin 100 mg/m2 q 3 weeks then followed by adjuvant chemotherapy for 3 cycles (q 3 weeks), consisting of cisplatin 80 mg/m2 on day 1 and 5-FU 1,000 mg/m2 on day 1-4. The 88 patients received neoadjuvant chemotherapy for 3 cycles (q 3 weeks) consisting of docetaxel 75 mg/m2 on day 1, cisplatin 75 mg/m2 on day 1, and 5-FU 750 mg/m2 on days 1- 4 followed by concurrent radiotherapy daily 70 Gy/7 weeks with carboplatin AUC 1.5 weekly for 6 weeks.

Results

The number of patients who completed treatment for the CCRT group was 34 (39.1%) and for the NAC-RT group was 54 (61.4%). The most common reasons for study discontinuation were adverse events and patient's willingness. The grade 3 and 4 treatment-related adverse events were two times higher in the CCRT group (p < 0.06), mostly mucositis / stomatitis and nausea / vomiting. There was no difference in hematologic adverse events between groups. The 1-year progression-free survival rate was 91.8% and 89.3% in the CCRT and NAC-RT group, respectively. No evidence of disease at the time of this interim analysis was found in 76.5% in the CCRT group and 85.2% in the NAC-RT group.

Conclusion

Induction chemotherapy with docetaxel / cisplatin and 5-fluoro-uracil followed by concurrent radio-chemotherapy was tolerable and provided well control of disease. These interim early results revealed no difference in PFS but less side effects and increase number of the patients with no evidence of disease in the NAC-RT arm.

Disclosure

All authors have declared no conflicts of interest.