Platinum-based chemotherapy plus cetuximab for the first-line treatment of Japanese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck: results of a phase II trial.

Abstract

OBJECTIVE:

To assess the efficacy and safety of cetuximab in combination with cisplatin and 5-fluorouracil for first-line treatment of Japanese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.

METHODS:

In this open-label, single-arm, multicenter, Phase II study conducted in Japan, patients with confirmed recurrent and/or metastatic squamous cell carcinoma of the head and neck received weekly cetuximab (week 1, 400 mg/m(2); subsequent weeks, 250 mg/m(2)) plus a maximum of six three-weekly cycles of cisplatin (100 mg/m(2), day 1) and 5-fluorouracil (1000 mg/m(2)/day, 24-h infusion, days 1-4). The primary endpoint was the best overall response assessed by an independent review committee according to the modified World Health Organization criteria.

RESULTS:

In total, 33 patients received treatment. The most frequent primary tumor site was the hypopharynx (42%), and most patients had metastatic disease (85%). The best overall response rate as assessed by the independent review committee was 36% (95% confidence interval: 20, 55) and was significantly greater (P = 0.002) than the protocol-specified threshold of 15% at the one-sided 5% level. The disease control rate was 88%. The median progression-free survival and overall survival were 4.1 and 14.1 months, respectively. There were no unexpected safety concerns. Grade 3 or 4 adverse events were experienced by nearly all patients (32, 97%). No adverse events were fatal.

CONCLUSIONS:

The demonstrated efficacy and safety of cetuximab in combination with cisplatin and 5-fluorouracil for the first-line treatment of Japanese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck justify the further use of this combination treatment in this patient population .

• Authors: Takayuki Yoshino, Yasuhisa Hasegawa, Shunji Takahashi, Nobuya Monden, Akihiro Homma, Kenji Okami, Yusuke Onozawa, Masato Fujii, Takahide Taguchi, Barbara de Blas, Frank Beier, Makoto Tahara
• Journal: Japanese journal of clinical oncology (Jpn J Clin Oncol) Vol. 43 Issue 5 Pg. 524-31 (May 2013) ISSN: 1465-3621 [Electronic] England
• PMID: 23479384 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal, Humanized
• Cetuximab
• Cisplatin
• Fluorouracil

Topics

• Adult
• Aged
• Antibodies, Monoclonal, Humanized (administration & dosage)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Asian People
• Carcinoma, Squamous Cell (drug therapy, pathology, secondary)
• Cetuximab
• Cisplatin (administration & dosage)
• Disease-Free Survival
• Drug Administration Schedule
• Female
• Fluorouracil (administration & dosage)
• Head and Neck Neoplasms (drug therapy, pathology)
• Humans
• Japan
• Male
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy)
• Treatment Outcome