Phase II study of docetaxel, cisplatin, and concurrent radiation followed by platinum-based adjuvant chemotherapy for technically unresectable, locally advanced head and neck squamous cell carcinoma.
BACKGROUND
Phase I study of weekly administration of low-dose docetaxel/cisplatin concurrent with conventionally fractionated radiotherapy for locally advanced head and neck squamous cell carcinoma suggested the recommended dose of docetaxel at 10 mg/m2and cisplatin at 20 mg/m2. Phase II study of the concurrent chemoradiotherapy for technically resectable disease showed satisfactory results.


METHODS
This phase II study was designed to address efficacy and safety when patients with technically unresectable disease were treated with concurrent chemoradiotherapy, followed by two cycles of moderate-dose platinum-based adjuvant chemotherapy: docetaxel, cisplatin, and fluorouracil (modified TPF). Modified TPF was replaced with docetaxel/carboplatin when renal impairment became evident. Surgical salvage was considered when residual or recurrent locoregional disease was technically resectable and free of distant metastasis.


RESULTS
Of 33 enrolled patients, 31 were analyzable: 24 (78 %) and 18 (58 %) patients completed chemoradiotherapy and adjuvant chemotherapy, respectively; 15 (48 %) patients completed study treatment per protocol, and overall complete response rate was 45 %. Seven patients underwent surgical salvage, which was successful in 4 patients. At a median follow-up of 60.8 months for surviving patients, median progression-free survival and median overall survival were 16.2 and 39.9 months, respectively. Grade 3 or 4 toxicity included mucositis (77 %) and dysphagia (45 %) during the chemoradiotherapy period and neutropenia (100 %) and febrile neutropenia (35 %) during the adjuvant period. No patient died of toxicity.


CONCLUSIONS
The tested regimen seems effective, although there is room for improvement in adjuvant chemotherapy because of the high toxicity and low compliance of modified TPF.
Department of Otorhinolaryngology-Head and Neck Surgery, Osaka University School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Susumu
S
Nakahara
Department of Otorhinolaryngology-Head and Neck Surgery, Osaka University School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Yukinori
Y
Takenaka
Department of Radiation Oncology, Osaka University School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Kazuhiko
K
Ogawa
Department of Otorhinolaryngology-Head and Neck Surgery, Osaka University School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Suetaka
S
Nishiike
Department of Otorhinolaryngology-Head and Neck Surgery, Osaka University School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Yoshifumi
Y
Yamamoto
Department of Radiation Oncology, Osaka University School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Yuji
Y
Seo
Department of Radiation Oncology, Osaka University School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Fumiaki
F
Isohashi
Department of Radiation Oncology, Osaka University School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Osamu
O
Suzuki
Department of Radiation Oncology, Osaka University School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Yasuo
Y
Yoshioka
Department of Radiation Oncology, Osaka University School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Iori
I
Sumida
Department of Otorhinolaryngology-Head and Neck Surgery, Osaka University School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Tadashi
T
Yoshii
Department of Otorhinolaryngology-Head and Neck Surgery, Osaka University School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Yoichiro
Y
Tomiyama
Department of Otorhinolaryngology-Head and Neck Surgery, Osaka University School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan. hinohara@ent.med.osaka-u.ac.jp.
Hidenori
H
Inohara
D000328:Adult; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000628:therapy; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects / Q000379:methods; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D000077143:Docetaxel; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006258:Head and Neck Neoplasms / Q000473:pathology / Q000628:therapy; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000175:diagnosis / Q000209:etiology; D010043:Outcome and Process Assessment, Health Care; D010984:Platinum / Q000008:administration & dosage / Q000009:adverse effects; D012074:Remission Induction / Q000379:methods; D016879:Salvage Therapy / Q000379:methods; D000077195:Squamous Cell Carcinoma of Head and Neck; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
D043823:Taxoids; D000077143:Docetaxel; D010984:Platinum; D002945:Cisplatin; D005472:Fluorouracil
Adjuvant chemotherapy; Chemoradiotherapy; Cisplatin; Docetaxel; Unresectable head and neck squamous cell carcinoma