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/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.

Prognostic Value of FDG-PET in patients with oropharyngeal carcinoma treated with concurrent chemoradiotherapy.

PURPOSE: The purpose of this study was to evaluate the predictive value of 2-deoxy-2-[F-18]fluoro-D-glucose-positron emission tomography (FDG-PET) following concurrent chemoradiotherapy (CRT) on survival in patients with carcinoma of the oropharynx (OPC). METHODS: Eighteen patients with primary OPC who underwent PET pre- and post-CRT were evaluated prospectively for survival. The prognostic performance of post-CRT PET and CT for recurrence was compared. RESULTS: Patients with positive post-CRT PET exhibited significantly lower 2-year cause-specific survival and disease-free survival (50% vs. 91%, P < 0.05 and 0% vs. 83%, P < 0.0001); however, patients with positive post-CRT CT did not exhibit any significant difference (67% vs. 83%, P = 0.416 and 50% vs. 75%, P = 0.070). Other factors, such as clinical and pre-CRT PET variables, also did not indicate any significant difference. The accuracy of prediction of residual and local recurrence for post-CRT PET and CT (local%/regional%) was 83%/94% and 83%/78%, respectively. CONCLUSION: OPC patients with positive post-CRT PET exhibit poor survival. The prognostic accuracy of post-CRT PET is superior to that of CT. The results of post-CRT FDG-PET should be included in the management of the OPC patients.