Randomized Phase III Trial of Induction Chemotherapy With Docetaxel, Cisplatin, and Fluorouracil Followed by Surgery Versus Up-Front Surgery in Locally Advanced Resectable Oral Squamous Cell Carcinoma

Zhong, Lipeng; Zhang, Chen Ping; Ren, Guo Xin; Guo, Wei; William, William N.; Sun, Jian; Han, Zhaolong; Tu, Wen Yong; Jiang, Li; Cai, Yi; Wang, Li Zhen; Fan, Xin; Wang, Zhong He; Hu, Yong; Ji, Tong; Yang, Wen Jun; W, Ye; Li, Jun; He, Yue; Wang, Yan An; Xu, Li; Wang, Bo Song; Kies, Merrill S.; Lee, John; Myers, Jeffrey N.; Zhang, Zhi Yuan

doi:10.1200/jco.2012.43.8820

Cited by 270 publications

(237 citation statements)

References 23 publications

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“…efficacy rate of TPF therapy was comparable to the previously reported 80.6% clinical response rate to preoperative TPF chemotherapy (16). Furthermore, the 22.2% in vitro efficacy rate of PF therapy in this study was comparable to the reported clinical response rate of 20 to 30% (17,18).…”

Section: Discussionsupporting

confidence: 76%

Clinical study on collagen gel droplet-embedded culture drug sensitivity test for multidrug combination chemotherapy and super selective intra-arterial infusion chemoradiotherapy in oral squamous cell carcinoma

et al. 2017

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Abstract. Using trace three-dimensional culture, the collagen gel droplet-embedded culture drug sensitivity test (CD-DST) can be tested even in cases with a small number of cells, including oral squamous cell carcinoma (OSCC), and evaluation of the antitumor effect with a drug concentration close to the in vivo level is possible. The present report aimed to evaluate the utility of the CD-DST in the assessment of the in vitro efficacy of single-agent and multidrug combination chemotherapy for OSCC in comparison with the clinical response rates and to examine the possible clinical application of CD-DST for such cases. A total of 33 OSCC patients from whom 33 samples were obtained from January 2010 to September 2015 were included. CD-DST was performed, individually and in combination, on the three drugs [i.e., cisplatin (CDDP), 5-fluorouracil (5-FU), and docetaxel (DOC)] and on super selective intra-arterial infusion chemoradiotherapy (IACRT). The overall evaluable rate of the CD-DST in OSCC was 81.8% (27 of 33 cases) and the sensitivity to each anticancer drug was evaluated. The in vitro efficacy rates of IACRT, cisplatin + 5-fluorouracil, and docetaxel + cisplatin + 5-fluorouracil (TPF) confirmed the estimated clinical response rates. In 14 of 33 patients, the results of CD-DST were compared with clinical efficacy, which was judged based on measurable lesions on imaging. For TPF therapy, the sensitivity test of the IACRT had a positive predictive value of 90.9% (10 of 11 cases) and a negative predictive value of 100% (3 of 3 cases); the accuracy of the susceptibility test for the anticancer agents was 92.8% (13 of 14 cases). The CD-DST may be useful in selecting multidrug combination chemotherapy and IACRT for OSCC, however, accumulation of further clinical data is required in the future. IntroductionThe treatment of advanced or unresectable oral squamous cell carcinoma (OSCC) is multidisciplinary and entails the use of both multidrug combination chemotherapy and radiotherapy (1-3). The usefulness of super selective intraarterial infusion chemoradiotherapy (IACRT) to deliver high concentrations of anticancer drugs to tumors has been reported (4). The selection of such anticancer drugs for IACRT had been based on statistical information and clinical reports on a number of cases (1-3); however, the expected therapeutic effects of these anticancer drugs have not been consistent and adverse events were common. Therefore, drug sensitivity testing prior to administration of an anticancer agent is ideal to avoid the serious side effects of less effective anticancer drugs. Collagen gel droplet-embedded culture drug sensitivity test (CD-DST) uses an image colorimetric method to assess the combination of an anticancer drug and microcollagen gel embedded in a three-dimensional serum-free culture medium (3 to 10x10 3 cells/30 µg/drop) (5,6). It is a susceptibility test that is currently widely applied in various clinical fields, including gastrointestinal cancer (7-9). However, reports on the use of CD-DST in OSCC were few a...

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Section: Discussionsupporting

confidence: 76%

Clinical study on collagen gel droplet-embedded culture drug sensitivity test for multidrug combination chemotherapy and super selective intra-arterial infusion chemoradiotherapy in oral squamous cell carcinoma

et al. 2017

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“…The 11 HNSCC patients receive two round combined cisplatin, docetaxel and 5-fuorouracil (TPF) therapy with the same protocol of Zhang's clinical trial (NCT01542931). 53 …”

Section: Human Hnscc Tissue Samplesmentioning

confidence: 99%

LAG-3 confers poor prognosis and its blockade reshapes antitumor response in head and neck squamous cell carcinoma

et al. 2016

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Immunotherapy with immune checkpoint molecule-specific monoclonal antibody have obtained encouraging results from preclinical studies and clinical trials, which promoted us to explore whether this kind of immunotherapy could be applicable to head and neck squamous cell carcinoma (HNSCC). Lymphocyte activation gene-3 (LAG-3) is an immune checkpoint control protein that negatively regulates T cells and immune response. Here, using the human tissue samples, we report these findings that LAG-3 is overexpressed on tumorinfiltrating lymphocytes (TILs; p < 0.001) and its overexpression correlates with the high pathological grades, lager tumor size and positive lymph node status in human primary HNSCC. Survival analysis identifies LAG-3 as a prognostic factor independent of tumor size and pathological grades for primary HNSCC patients with negative lymph node status (p D 0.014). Study in immunocompetent genetically defined HNSCC mouse model reports that LAG-3 is upregulated on CD4 C T cells, CD8 C T cells and CD4 C Foxp3 C regulatory T cells (Tregs). In vivo study, administration of LAG-3-specific antibody retards tumor growth in a way associated with enhanced systemic antitumor response by potentiating the antitumor response of CD8 C T cells and decreasing the population of immunosuppressive cells. Taken together, our results offer a preclinical proof supporting the immunomodulatory effects of LAG-3 and suggest a potential therapeutic target of immunotherapy for HNSCC.

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“…Induction chemotherapy with platinum-based agents and 5-FU has achieved improved results compared with the current classic therapies in terms of survival, locoregional disease control and organ function and, most importantly, in terms of swallowing function maintenance and voice preservation (17). In the TAX 323 trial, 358 patients with inoperable SCCHN were enrolled.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and toxicity of docetaxel combination chemotherapy for advanced squamous cell cancer of the head and neck

Albers¹,

Grabow²,

Qian³

et al. 2017

Molecular and Clinical Oncology

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Abstract. The aim of the present study was to evaluate the clinical effectiveness and toxicity of docetaxel with 5-fluorouracil and cisplatin as combination treatment in patients with curable or metastatic/recurrent head and neck cancer by a retrospective cohort study of patients treated at a single institution between 2007 and 2012. Patients with locally advanced, metastatic and/or recurrent squamous cell carcinoma of the head and neck (SCCHN), who were treated with a combination therapy including docetaxel, were considered as eligible. Survival data, clinical side effects, quality of life (QoL) and toxicity profile were retrieved from patient charts, analyzed and scored according to the National Cancer Institute Common Toxicity Criteria, version 4, and the Response Evaluation Criteria In Solid Tumors, version 1.1. An overall response rate of 86% and a 3-year survival of 65.1% were observed. The median progression-free survival was 32 months. The cumulative incidence after 3 years was 16.9% for local recurrence and 10.4% for distant metastasis. Leukopenia (58%) and anemia (51%) were the most common hematological toxicities, followed by hepatotoxicity (53%) and nausea (27%). A total of 31% of the patients experienced a compromise in their QoL following therapy completion. In conclusion, docetaxel in combination with cisplatin and 5-fluorouracil was found to effectively prolong survival in patients with locally advanced and/or recurrent metastatic SCCHN. The overall survival, progression-free survival and response rates were in accordance with those reported by previous clinical trials. Therefore, this therapy protocol is recommended for patients with SCCHN in the curative as well as the palliative settings. IntroductionHead and neck cancer is mostly of squamous cell origin (squamous cell carcinoma of the head and neck; SCCHN) and is the 10th most common type of cancer, with >630,000 cases diagnosed annually (1). Over 350,000 deaths from head and neck cancer were estimated to have occurred in 2008 worldwide (2). The frequency, incidence rates and locations of SCCHN vary widely among countries and continents (2-4).Following the introduction of the TAX 323 and 324 studies, induction chemotherapy drew significant scientific and clinical interest, leading to further investigations (3,5,6). The use of docetaxel in the treatment regimen was evaluated in those studies. Docetaxel promotes tubulin polymerization and affects the formation of stable microtubules, which leads to cell death (7). Recent results from multicenter studies and a current meta-analysis demonstrated that the combination of docetaxel with 5-fluorouracil (5-FU) and cisplatin (TPF regimen) is more efficacious compared with the classic regimen of cisplatin plus 5-FU (PF regimen) as induction chemotherapy for advanced head and neck cancer (8). The TPF regimen achieved longer progression-free survival, better locoregional control and higher response rates (9,10). An explanation for this advantage may be a better control of local and metastatic disease. Ano...

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Randomized Phase III Trial of Induction Chemotherapy With Docetaxel, Cisplatin, and Fluorouracil Followed by Surgery Versus Up-Front Surgery in Locally Advanced Resectable Oral Squamous Cell Carcinoma

Cited by 270 publications

References 23 publications

Clinical study on collagen gel droplet-embedded culture drug sensitivity test for multidrug combination chemotherapy and super selective intra-arterial infusion chemoradiotherapy in oral squamous cell carcinoma

Clinical study on collagen gel droplet-embedded culture drug sensitivity test for multidrug combination chemotherapy and super selective intra-arterial infusion chemoradiotherapy in oral squamous cell carcinoma

LAG-3 confers poor prognosis and its blockade reshapes antitumor response in head and neck squamous cell carcinoma

Efficacy and toxicity of docetaxel combination chemotherapy for advanced squamous cell cancer of the head and neck

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