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Clinical Trial
. 2016 Dec;21(6):1030-1037.
doi: 10.1007/s10147-016-0997-6. Epub 2016 Jun 15.

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

Susumu Nakahara  1 , Yukinori Takenaka  1 , Kazuhiko Ogawa  2 , Suetaka Nishiike  1 , Yoshifumi Yamamoto  1 , Yuji Seo  2 , Fumiaki Isohashi  2 , Osamu Suzuki  2 , Yasuo Yoshioka  2 , Iori Sumida  2 , Tadashi Yoshii  1 , Yoichiro Tomiyama  1 , Hidenori Inohara  3
Affiliations
Clinical Trial

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

Susumu Nakahara et al. Int J Clin Oncol. 2016 Dec.

Abstract

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/m2 and 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.

Conclusion: 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.

Keywords: Adjuvant chemotherapy; Chemoradiotherapy; Cisplatin; Docetaxel; Unresectable head and neck squamous cell carcinoma.

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