Phase II Trial of Docetaxel, Cisplatin, Fluorouracil, and Leucovorin as Induction for Squamous Cell Carcinoma of the Head and Neck

Colevas, A. Dimitrios; Norris, Charles M.; Tishler, Roy B.; Fried, Marvin P.; Gomolin, Hilary; Amrein, Philip C.; Nixon, Asa J.; Lamb, Carolyn C.; Costello, Rosemary; Barton, J.; Read, R.; Adak, Sudeshna; Posner, Marshall R.

doi:10.1200/jco.1999.17.11.3503

Cited by 113 publications

(55 citation statements)

References 23 publications

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“…Primary tumour site clinical and pathological responses were 93 and 68%, respectively. The originally reported 2-year overall survival and disease-free survival rates were 87 and 57%, respectively (Colevas et al, 1999). A more recent analysis (median follow-up 30 months) reported the 2-year overall survival and disease-free survival rates as 83 and 53%, respectively .…”

Section: Docetaxel Plus Modified Pfl Regimensmentioning

confidence: 96%

“…A more recent analysis (median follow-up 30 months) reported the 2-year overall survival and disease-free survival rates as 83 and 53%, respectively . Haematological toxicity was generally mild, with grade III -IV neutropenia, thrombocytopenia, and anaemia reported during 8, 6 and 2% of cycles, respectively (Colevas et al, 1999). Mucositis was the most prominent nonhaematological grade III -IV event (48% of cycles), followed by nausea/vomiting (15% of cycles).…”

Section: Docetaxel Plus Modified Pfl Regimensmentioning

confidence: 98%

“…In an attempt to reduce hospitalisation, the TPFL-4 regimen was developed in which G-CSF was started earlier and treatment was compressed into the first 4 days of the 4-week cycle (Colevas et al, 1999). In all, 30 stage III -IV SCCHN patients received two loading doses of oral leucovorin 100 mg followed by docetaxel (60 mg m À2 ) d1 and then infusions of cisplatin (31.25 mg m À2 day À1 ), 5-FU (700 mg m À2 day À1 ) and leucovorin (500 mg m À2 day À1 ) over 4 days.…”

Section: Docetaxel Plus Modified Pfl Regimensmentioning

confidence: 99%

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Docetaxel induction therapy in locally advanced squamous cell carcinoma of the head and neck

Posner

Lefèbvre

2003

Br J Cancer

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Patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) are often treated with induction chemotherapy or chemoradiotherapy, but to date without major impact on survival. The combination of cisplatin -5-fluorouracil (5-FU) (PF) has been used as standard induction therapy; however, poor patient survival has stimulated investigation into new agents with potential activity in SCCHN. Docetaxel has significant single-agent activity in SCCHN and has been investigated in combination with PF regimens as induction therapy. The results of six phase II studies of docetaxel -PF regimens (TPF) as induction in locally advanced SCCHN patients are reviewed and reported. Consistently, high 2-year survival rates and overall response rates were demonstrated across the phase II trials in the range 42 -82 and 71 -100%, respectively. The toxicity profile seen with TPF-based regimens was acceptable. The primary toxicity was neutropenia, which together with gastrointestinal complaints accounted for the majority of adverse events. Given the encouraging phase II experience with TPF-based regimens, two large-scale phase III studies comparing TPF-based regimens with standard PF regimens are underway. The results have significant potential for validating the findings of the phase II studies, demonstrating improved survival and overall response of patients treated with docetaxel-based induction chemotherapy.

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Section: Docetaxel Plus Modified Pfl Regimensmentioning

confidence: 96%

Section: Docetaxel Plus Modified Pfl Regimensmentioning

confidence: 98%

Section: Docetaxel Plus Modified Pfl Regimensmentioning

confidence: 99%

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Docetaxel induction therapy in locally advanced squamous cell carcinoma of the head and neck

Posner

Lefèbvre

2003

Br J Cancer

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“…As an inhibitor of microtubule depolymerization, docetaxel is approximately twice as potent as paclitaxel, prompting many investigators to study its cytotoxicity in a variety of cell lines [25]. Further clinical studies have shown docetaxel to have potent anti-tumor activity against several human tumors, including ovarian [20], anthracycline-resistant breast [4,30], non-small cell lung [6,10,12] and head and neck squamous cell cancer [7,31]. However, its systemic use against CNS tumors has demonstrated no significant improvement in survival [9,29].…”

Section: Discussionmentioning

confidence: 99%

“…Its mechanism of action is through inhibition of tubulin depolymerization resulting in microtubule aggregation and cell death [33]. Docetaxel has shown efficacy in clinical trials against a variety of human tumors [4,6,7,10,12,20,30,31], as well as having been reported to act as a potent radiosensitizer against systemic malignancies [19,21,23,24]. In two Phase II trials, docetaxel showed no significant efficacy when given intravenously to patients with malignant glioma [9,29].…”

Section: Introductionmentioning

confidence: 99%

Interstitial Docetaxel (Taxotere), Carmustine and Combined Interstitial Therapy: a Novel Treatment for Experimental Malignant Glioma

et al. 2006

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Docetaxel (Taxotere ® ) is a hemisynthetic, anti-cancer compound with good preclinical and clinical activity in a variety of systemic neoplasms. We tested its activity against malignant gliomas using local delivery methods. Antitumor activity was assessed in vitro against human and rat brain-tumor cell lines. For in vivo evaluation, we incorporated docetaxel into a biodegradable polymer matrix, determined associated toxicity in the rat brain, and measured efficacy at extending survival in a rat model of malignant glioma. Also, we examined the combined local delivery of docetaxel with carmustine (BCNU) against the experimental intracranial glioma. Rats bearing intracranial 9L gliosarcomas were treated 5 days after tumor implantation with various polymers (placebo, 5% docetaxel, 3.8% BCNU, or 5% docetaxel and 3.8% BCNU combination). Animals receiving docetaxel polymers (n = 15, median survival 39.1 days) had significantly improved survival over control animals (n = 12, median survival 22.5 days, P = 0.01). Similarly, animals receiving BCNU polymers (n = 15, median survival 39.3 days, 13.3% long-term survivors) demonstrated an increase in survival compared to the controls (P = 0.04). Animals receiving the combination polymers demonstrated a modest increase in survival compared to either chemotherapeutic agent alone (n = 14, median survival 54.9 days, 28.6% long-term survivors) with markedly improved survival over controls (P = 0.003). We conclude that locally delivered docetaxel shows promise as a novel antiglioma therapy and that the combination of drug regimens via biodegradable polymers may be a great therapeutic benefit to patients with malignant glioma.

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An In Vivo Evaluation of Docetaxel Delivered Intratumorally in Head and Neck Squamous Cell Carcinoma

Yoo

Subramanian

Boinpally

et al. 2005

Arch Otolaryngol Head Neck Surg

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Phase II Trial of Docetaxel, Cisplatin, Fluorouracil, and Leucovorin as Induction for Squamous Cell Carcinoma of the Head and Neck

Cited by 113 publications

References 23 publications

Docetaxel induction therapy in locally advanced squamous cell carcinoma of the head and neck

Docetaxel induction therapy in locally advanced squamous cell carcinoma of the head and neck

Interstitial Docetaxel (Taxotere), Carmustine and Combined Interstitial Therapy: a Novel Treatment for Experimental Malignant Glioma

An In Vivo Evaluation of Docetaxel Delivered Intratumorally in Head and Neck Squamous Cell Carcinoma

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