A prospective multicentre phase II study of cisplatin and weekly docetaxel as first-line treatment for recurrent or metastatic nasopharyngeal cancer (KCSG HN07-01)

Jun Ho Ji, Tak Yun, Sung Bae Kim, Jung Hun Kang, Ji Chan Park, In Sung Cho, Chang Hak Sohn, Dae Seog Heo, Joung Soon Jang, Sang Won Shin, Deok Won Hwang, Jong Mu Sun, Keunchil Park, Myung Ju Ahn

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Abstract

Background: The purpose of this phase II study was to determine the efficacy and toxicity of cisplatin and weekly docetaxel combination chemotherapy as a first-line treatment in patients with recurrent or metastatic nasopharyngeal cancer. Patients and Methods: Recurrent or metastatic nasopharyngeal cancer patients were enrolled and received a combination of weekly docetaxel (35 mg/m2 on Day1 and Day8) and cisplatin (70 mg/m2 D1) every 21 days, for up to a maximum of 6 cycles. The primary endpoint was objective response rate, and the secondary endpoints included toxicity of combination chemotherapy, progression-free survival, overall survival and 1-year survival rate. Results: In total, 47 patients were enrolled and analysed, and 46 patients (97.9%) completed the planned protocol. In an intent-to-treat analysis, 6 patients (12.8%) achieved complete response (CR) and 27 patients (57.4%) showed partial response (PR), with an objective response rate of 70.2%. The median progression-free survival and overall survival were 9.6 months (95% C.I. 5.7-13.5 months) and 28.5 months (95% C.I. 16.9-40.1 months), respectively, and the 1-year survival rate was 89.9%. The common grade 3 adverse events were stomatitis (1.2%), neutropenia (0.8%), anaemia (0.8%), infection (0.8%) and diarrhoea (0.8%). Grade 4 adverse events were not observed in this study. Conclusions: The combination chemotherapy of cisplatin and weekly docetaxel is highly effective and shows favourable toxicity as a first-line chemotherapy in patients with recurrent or metastatic nasopharyngeal cancer.

Original languageEnglish
Pages (from-to)3198-3204
Number of pages7
JournalEuropean Journal of Cancer
Volume48
Issue number17
DOIs
Publication statusPublished - 2012 Nov 1

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docetaxel
Nasopharyngeal Neoplasms
Cisplatin
Combination Drug Therapy
Therapeutics
Disease-Free Survival
Survival Rate
Stomatitis
Survival
Neutropenia

Keywords

  • Cisplatin
  • Nasopharyngeal cancer
  • Weekly docetaxel

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

A prospective multicentre phase II study of cisplatin and weekly docetaxel as first-line treatment for recurrent or metastatic nasopharyngeal cancer (KCSG HN07-01). / Ji, Jun Ho; Yun, Tak; Kim, Sung Bae; Kang, Jung Hun; Park, Ji Chan; Cho, In Sung; Sohn, Chang Hak; Heo, Dae Seog; Jang, Joung Soon; Shin, Sang Won; Hwang, Deok Won; Sun, Jong Mu; Park, Keunchil; Ahn, Myung Ju.

In: European Journal of Cancer, Vol. 48, No. 17, 01.11.2012, p. 3198-3204.

Research output: Contribution to journalArticle

Ji, JH, Yun, T, Kim, SB, Kang, JH, Park, JC, Cho, IS, Sohn, CH, Heo, DS, Jang, JS, Shin, SW, Hwang, DW, Sun, JM, Park, K & Ahn, MJ 2012, 'A prospective multicentre phase II study of cisplatin and weekly docetaxel as first-line treatment for recurrent or metastatic nasopharyngeal cancer (KCSG HN07-01)', European Journal of Cancer, vol. 48, no. 17, pp. 3198-3204. https://doi.org/10.1016/j.ejca.2012.06.009
Ji, Jun Ho ; Yun, Tak ; Kim, Sung Bae ; Kang, Jung Hun ; Park, Ji Chan ; Cho, In Sung ; Sohn, Chang Hak ; Heo, Dae Seog ; Jang, Joung Soon ; Shin, Sang Won ; Hwang, Deok Won ; Sun, Jong Mu ; Park, Keunchil ; Ahn, Myung Ju. / A prospective multicentre phase II study of cisplatin and weekly docetaxel as first-line treatment for recurrent or metastatic nasopharyngeal cancer (KCSG HN07-01). In: European Journal of Cancer. 2012 ; Vol. 48, No. 17. pp. 3198-3204.
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T1 - A prospective multicentre phase II study of cisplatin and weekly docetaxel as first-line treatment for recurrent or metastatic nasopharyngeal cancer (KCSG HN07-01)

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AU - Kim, Sung Bae

AU - Kang, Jung Hun

AU - Park, Ji Chan

AU - Cho, In Sung

AU - Sohn, Chang Hak

AU - Heo, Dae Seog

AU - Jang, Joung Soon

AU - Shin, Sang Won

AU - Hwang, Deok Won

AU - Sun, Jong Mu

AU - Park, Keunchil

AU - Ahn, Myung Ju

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N2 - Background: The purpose of this phase II study was to determine the efficacy and toxicity of cisplatin and weekly docetaxel combination chemotherapy as a first-line treatment in patients with recurrent or metastatic nasopharyngeal cancer. Patients and Methods: Recurrent or metastatic nasopharyngeal cancer patients were enrolled and received a combination of weekly docetaxel (35 mg/m2 on Day1 and Day8) and cisplatin (70 mg/m2 D1) every 21 days, for up to a maximum of 6 cycles. The primary endpoint was objective response rate, and the secondary endpoints included toxicity of combination chemotherapy, progression-free survival, overall survival and 1-year survival rate. Results: In total, 47 patients were enrolled and analysed, and 46 patients (97.9%) completed the planned protocol. In an intent-to-treat analysis, 6 patients (12.8%) achieved complete response (CR) and 27 patients (57.4%) showed partial response (PR), with an objective response rate of 70.2%. The median progression-free survival and overall survival were 9.6 months (95% C.I. 5.7-13.5 months) and 28.5 months (95% C.I. 16.9-40.1 months), respectively, and the 1-year survival rate was 89.9%. The common grade 3 adverse events were stomatitis (1.2%), neutropenia (0.8%), anaemia (0.8%), infection (0.8%) and diarrhoea (0.8%). Grade 4 adverse events were not observed in this study. Conclusions: The combination chemotherapy of cisplatin and weekly docetaxel is highly effective and shows favourable toxicity as a first-line chemotherapy in patients with recurrent or metastatic nasopharyngeal cancer.

AB - Background: The purpose of this phase II study was to determine the efficacy and toxicity of cisplatin and weekly docetaxel combination chemotherapy as a first-line treatment in patients with recurrent or metastatic nasopharyngeal cancer. Patients and Methods: Recurrent or metastatic nasopharyngeal cancer patients were enrolled and received a combination of weekly docetaxel (35 mg/m2 on Day1 and Day8) and cisplatin (70 mg/m2 D1) every 21 days, for up to a maximum of 6 cycles. The primary endpoint was objective response rate, and the secondary endpoints included toxicity of combination chemotherapy, progression-free survival, overall survival and 1-year survival rate. Results: In total, 47 patients were enrolled and analysed, and 46 patients (97.9%) completed the planned protocol. In an intent-to-treat analysis, 6 patients (12.8%) achieved complete response (CR) and 27 patients (57.4%) showed partial response (PR), with an objective response rate of 70.2%. The median progression-free survival and overall survival were 9.6 months (95% C.I. 5.7-13.5 months) and 28.5 months (95% C.I. 16.9-40.1 months), respectively, and the 1-year survival rate was 89.9%. The common grade 3 adverse events were stomatitis (1.2%), neutropenia (0.8%), anaemia (0.8%), infection (0.8%) and diarrhoea (0.8%). Grade 4 adverse events were not observed in this study. Conclusions: The combination chemotherapy of cisplatin and weekly docetaxel is highly effective and shows favourable toxicity as a first-line chemotherapy in patients with recurrent or metastatic nasopharyngeal cancer.

KW - Cisplatin

KW - Nasopharyngeal cancer

KW - Weekly docetaxel

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