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Head Neck. 2018 Mar;40(3):475-484. doi: 10.1002/hed.25001. Epub 2017 Nov 11.

Dose-finding and efficacy confirmation trial of the superselective intra-arterial infusion of cisplatin and concomitant radiotherapy for locally advanced maxillary sinus cancer (Japan Clinical Oncology Group 1212): Dose-finding phase.

Author information

1
Department of Otolaryngology - Head and Neck Surgery, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan.
2
Department of Radiation Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
3
Division of Head and Neck Surgery, Miyagi Cancer Center, Sendai, Japan.
4
Department of Otolaryngology - Head and Neck Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.
5
Department of Head and Neck Surgery, Iwate Medical University School of Medicine, Morioka, Japan.
6
Department of Radiation Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
7
Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center, Tokyo, Japan.
8
Department of Otolaryngology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.
9
Department of Otolaryngology, Eiju General Hospital, Tokyo, Japan.
10
Division of Head and Neck Surgery, National Cancer Center Hospital East, Kashiwa, Japan.

Abstract

BACKGROUND:

We are currently undertaking a multi-institutional prospective trial of the superselective intra-arterial infusion of high-dose cisplatin with concomitant radiotherapy for patients with T4aN0M0 or T4bN0M0 locally advanced maxillary sinus squamous cell carcinomas (SCC). We herein report the results of the dose-finding phase.

METHODS:

The dose-finding phase sought to evaluate the incidence of dose-limiting toxicities and determine the recommended number of cycles of the intra-arterial infusion of cisplatin. In this phase, 100 mg/m2 of cisplatin was administered intra-arterially weekly for 7 weeks with concomitant radiotherapy (70 Gy).

RESULTS:

All 18 patients received a full dose of radiotherapy. The number of cycles of cisplatin was 7 in 13 patients and 6 in 5 patients. The dose-limiting toxicities were observed in 5 patients.

CONCLUSION:

These results indicated that this therapy is safe and well-tolerated at 7 cycles of cisplatin, which was determined to be the recommended number of cycles for locally advanced maxillary sinus SCC.

KEYWORDS:

chemoradiotherapy; cisplatin; intra-arterial; maxillary sinus cancer; squamous cell carcinoma

PMID:
29130565
DOI:
10.1002/hed.25001

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