A phase II study of docetaxel in patients with metastatic squamous cell carcinoma of the head and neck

Couteau, C.; Chouaki, N.; Leyvraz, Serge; Oulid-Aissa, D.; Lebecq, A.; Domenge, C.; Groult, V.; Bordessoule, S.; Janot, F.; Forni, M; Armand, Jean‐Pierre

doi:10.1038/sj.bjc.6690715

Cited by 88 publications

(43 citation statements)

References 20 publications

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“…In three phase II studies (Table 1), single-agent docetaxel (100 mg m À2 ) administered on day 1 every 3 weeks produced response rates ranging from 21 to 42% (Catimel et al, 1994;Dreyfuss et al, 1996;Couteau et al, 1999). As expected, grade III -IV neutropenia was the principal toxicity in these studies.…”

Section: Potential Of Docetaxel In Scchnmentioning

confidence: 52%

“…In the first study, TPFL-5, 23 patients with stage III -IV SCCHN received docetaxel 25 -60 mg m À2 d1 (day 1), cisplatin 25 mg m À2 d1 -5, 5-FU 700 mg m À2 (N ¼ 21) or 800 mg m À2 (N ¼ 2) d2 -5 and leucovorin 500 mg m À2 d1 -5 every 4 weeks for three cycles (Colevas et al, 1998). The ORR prior to definitive, twice daily radiation therapy was 100%, consisting of 14 Dreyfuss et al (1996) 100 mg m À2 29 42 d1 q3w Couteau et al (1999) 100 mg m À2 21 21 d1 q3w complete responses (CRs; 61%) and nine partial responses (PRs; 39%). Updated survival data (median follow-up 43 months) revealed both the 3-year overall survival and disease-free survival rates to be 78% .…”

Section: Docetaxel Plus Modified Pfl Regimensmentioning

confidence: 99%

“…Perhaps the most promising agents have been the taxanes. In particular, the taxane docetaxel has demonstrated significant single-agent activity in recurrent SCCHN (Catimel et al, 1994;Dreyfuss et al, 1996;Couteau et al, 1999). Docetaxel is similar to paclitaxel with respect to its general mechanism of action (tubulin stabilization and cell cycle arrest), and the two share a number of pharmacological characteristics (Colevas and Posner, 2001).…”

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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: Potential Of Docetaxel In Scchnmentioning

confidence: 52%

Section: Docetaxel Plus Modified Pfl Regimensmentioning

confidence: 99%

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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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“…A phase II clinical trial of docetaxel monotherapy for the treatment of advanced/recurrent ESCC reported a response rate of 20.4%. These findings indicate that docetaxel may be a useful chemotherapeutic agent for the treatment of ESCC (9)(10)(11)(12).…”

Section: Introductionmentioning

confidence: 78%

Radiation-sensitizing effect of low-concentration docetaxel on human esophageal squamous cell carcinoma cell lines

Tabuchi

Ozawa

Koyanagi

et al. 2011

Experimental and Therapeutic Medicine

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Abstract. Esophageal squamous cell carcinoma (ESCC)is more sensitive to radiation and chemotherapy than other cancers of the digestive system, and combined modality therapy may represent a promising treatment method. The radiation-sensitizing effect of docetaxel on ESCC cell lines was investigated. A colony formation assay was performed in which ESCC cell lines (TE2, TE3) and A431 were exposed to docetaxel (from 1.0x10 -11 to 10 -7 M) for 3 h to determine the concentration of docetaxel that was not able to kill individual cells (i.e., the non-cytocidal concentration). Individual cell lines were then exposed to the non-cytocidal concentration of docetaxel prior to, during, and after irradiation to determine whether the timing of docetaxel administration affected cell survival. In addition, flow-cytometry was performed, and the cell cycle was examined prior to and after docetaxel exposure to assess the mechanism of docetaxel as a radiation sensitizer. Docetaxel exhibited a concentration-dependent cytocidal effect, with a different IC 50 for each cell type. Almost no cytocidal effect was observed at the following docetaxel concentrations: A431, ≤1.0x10 -10 M; TE-2 and TE-3, ≤1.0x10 -9 M. Concurrent treatment with docetaxel and radiation tended to decrease cell survival in all the cell lines compared with docetaxel or radiation alone. Cell survival was lowest when the cells were treated using X-ray irradiation after docetaxel exposure (p<0.05). Flow cytometry revealed that in all three cell lines, docetaxel exposure increased the G2/M cell fraction with a higher increase in the cell line that exhibited the highest radiosensitivity. This study demonstrated that the administration of docetaxel at a non-cytocidal concentration prior to radiotherapy produced a synergistic cell-killing effect in SCC cell lines.

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“…[10][11][12] Taxanes are effective and promising new agents, particularly docetaxel which has demonstrated significant single-agent activity in recurrent SCCHN. 3,13,14 Docetaxel is similar to paclitaxel with respect to its general mechanism of action (tubulin stabilization and G 2 /M cell cycle arrest), 15 however, docetaxel and paclitaxel have somewhat different pharmacodynamics and toxicities that are important in combined regimens. Recurrent or metastatic SCCHN patients treated with docetaxel-cisplatin has shown encouraging response rates and tolerability profiles which has lead to the use of docetaxel regimens as induction therapy for locally advanced disease.…”

Section: Introductionmentioning

confidence: 99%

Low Dose Fractionated Radiation Potentiates the Effects of Taxotere in Nude Mice Xenografts of Squamous Cell Carcinoma of Head and Neck

Spring¹,

Arnold²,

Shajahan³

et al. 2004

Cell Cycle

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This study evaluated the combined effect of Low Dose Fractionated Radiation (LDFRT) and Taxotere (TXT) therapy on the growth of SCCHN (squamous cell carcinoma of head and neck; SQ-20B, a p53 mutant SCCHN cell line) tumors in a nude mouse model to exploit the increased hyper radiation sensitivity (HRS) phenomenon present in G 2 /M cell cycle phase when induced by low doses of radiation that was demonstrated in in vitro settings. Seventy-eight animals were randomized into one control group and 5 treatment groups (treatments were administered weekly for six weeks). Tumor regression was observed in all the groups, however, tumor regression was not significant in 2 Gy or TXT or 2 Gy plus TXT treated groups when compared to control group. The tumor regression was significant in both the LDFRT group (p < 0.0043) and LDFRT + TXT group (p < 0.0006) when compared to the other groups. A significantly prolonged tumor growth delay was observed in LDFRT group (p < 0.0081). Importantly, in combination of TXT and LDFRT, no tumor regrowth was observed in 12 out of 13 mice since LDFRT + TXT treatment caused a sustained regression of tumors for 9 weeks. Molecular analysis of resected tumor specimens demonstrated that Bax levels were elevated with a concomitant increase in cytochrome c release into the cytosol in treatment Group VI. These findings strongly suggest that LDFRT can be used in combination with TXT to potentiate the effects of drug on tumor regression through an apoptotic mode of death. Furthermore, the G 2 /M cell cycle arrest by TXT appears to be an important component of the enhanced apoptotic effect of TXT + LDFRT combined treatment.

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A phase II study of docetaxel in patients with metastatic squamous cell carcinoma of the head and neck

Abstract: -1 was found in the pharmacokinetic analysis. Docetaxel is active in this selected population with metastatic SCCHN, with a good tolerance.

Cited by 88 publications

References 20 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

Radiation-sensitizing effect of low-concentration docetaxel on human esophageal squamous cell carcinoma cell lines

Low Dose Fractionated Radiation Potentiates the Effects of Taxotere in Nude Mice Xenografts of Squamous Cell Carcinoma of Head and Neck

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