Results of a randomised phase II study comparing docetaxel with methotrexate in patients with recurrent head and neck cancer

Guardiola, Emmanuel; Peyrade, Fréd́eric; Chaigneau, L.; Cupissol, Didier; Tchiknavorian, X.; Bompas, Emmanuelle; Madroszyk, A.; Ronchin, P.; Schneider, M.; Bleuze, J.P.; Blay, Jean‐Yves; Pivot, Xavier

doi:10.1016/j.ejca.2004.05.019

Cited by 105 publications

(52 citation statements)

References 13 publications

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“…A phase II randomized trial showed higher response rates for weekly docetaxel compared to methotrexate in pretreated patients (27 vs. 15%, respectively). However, the poor survival rates in both treatment arms warrant the search for more active regimens with acceptable toxicity [14]. Therefore, this study was designed to determine the efficacy and safety of the combination of weekly docetaxel plus cetuximab in platinum-pretreated patients with recurrent and/or metastatic SCCHN.…”

Section: Introductionmentioning

confidence: 99%

Phase II Study of Cetuximab in Combination with Docetaxel in Patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck after Platinum-Containing Therapy: A Multicenter Study of the Arbeitsgemeinschaft Internistische Onkologie

et al. 2013

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Background: Cetuximab and docetaxel have single-agent activity in squamous cell carcinoma of the head and neck (SCCHN). The efficacy of their combination was evaluated in platinum-pretreated patients with recurrent and/or metastatic SCCHN. Patients and Methods: A total of 84 patients were treated with docetaxel 35 mg/m² weekly for a maximum of 6 cycles and concomitant cetuximab 250 mg/m² weekly until disease progression or unacceptable toxicity. The primary endpoint was the objective response rate and secondary endpoints included the response rate in relation to platinum sensitivity, progression-free survival (PFS), overall survival (OS) and toxicity. Results: Nine (11%) patients achieved a partial response and 34 (40%) stable disease, resulting in a disease control rate of 51%. Response to treatment was 49% in previously platinum-sensitive and 50% in previously platinum-resistant disease. The median PFS was 3.1 months and the median OS 6.7 months. The most common grade 3 or 4 adverse events were mucositis (8%), pneumonia (8%), fatigue (8%) and skin reactions (14%). Sepsis occurred in 3 patients. Conclusion: Cetuximab plus docetaxel is an active treatment regimen with moderate toxicity in SCCHN patients. However, no superiority in comparison with monotherapy could be shown. Responsiveness and survival were independent of previous platinum sensitivity.

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Section: Introductionmentioning

confidence: 99%

Phase II Study of Cetuximab in Combination with Docetaxel in Patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck after Platinum-Containing Therapy: A Multicenter Study of the Arbeitsgemeinschaft Internistische Onkologie

et al. 2013

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“…A weekly dose of 40-60mg/m 2 of methotrexate were considered standard therapy with variable response rate recorded between 3.9-25%. Overall survival reported with MTX was around 6 months [8][9][10][11] . In our study, we witnessed 12.5% response rate and 5 months median overall survival which is comparable with published data.…”

Section: Safetymentioning

confidence: 99%

“…So, we have to give this toxic regimen to patients with good performance status (0-1) 10,15 . In a phase III trial 218 patients with R/M-SCCHN were randomized to either PF or cisplatin-paclitaxel.…”

Section: Safetymentioning

confidence: 99%

Palliative Chemotherapy in Recurrent or Metastatic Squamous cell carcinoma of the head and neck, NEMROCK experience

Atef

Sakr

El-Nahas

2013

Kasr-Al-Aini J.of Clin. Onc. and Nuc. Med.

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“…The response rates with conventional chemotherapeutic agents generally reach 15-30% with a response duration of 3-5 months [5,6,7]. Several randomized trials have shown that combination chemotherapy showed a higher response rate, but this comes at the price of increased toxicity and without any significant survival advantage [8].…”

Section: Introductionmentioning

confidence: 99%

“…As monotherapies, the EGFR inhibitors have modest overall activity with response rates of 1-11% for gefitinib [19] and erlotinib [20]. However, compared to a conventional chemotherapy regimen with methotrexate, gefitinib showed equal survival rates but fewer side effects [7]. …”

Section: Introductionmentioning

confidence: 99%

Analysis of the EGFR Mutation Status in Head and Neck Squamous Cell Carcinoma before Treatment with Gefitinib

Bontognali

Pless²,

Brutsche³

et al. 2013

Oncol Res Treat

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Background: The efficacy of chemotherapy in metastatic and recurrent squamous cell carcinomas of the head and neck (HNSCC) remains unsatisfactory. Gefitinib offers a new therapeutic option with comparable results and better tolerability than chemotherapy. We conducted this study to see if mutations in the epidermal growth factor receptor (EGFR) might predict the therapeutic benefit in HNSCC patients. Patients and Methods: In a pilot trial, 8 patients with metastatic or recurrent HNSCC were treated palliatively with gefitinib (500 mg/day orally). Forceps biopsies were taken to confirm tumor recurrence and to perform an EGFR mutation analysis. Results: The EGFR status could be determined in 6 of the 8 patients. 5 patients had no EGFR gene mutation, and 1 patient showed a silent guanine-to-adenosine mutation in position 2607. Even without any relevant mutation in the EGFR, we observed partial remission in 3 of 6 patients treated with gefitinib. We also observed that an additional 4 patients had stable disease for at least 10 weeks. The median progression-free survival was 6.25 months, and the median overall survival was 7.39 months. Conclusion: In HNSCC, there are tumor responses to gefitinib without protein-altering mutations in the EGFR gene.

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Results of a randomised phase II study comparing docetaxel with methotrexate in patients with recurrent head and neck cancer

Cited by 105 publications

References 13 publications

Phase II Study of Cetuximab in Combination with Docetaxel in Patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck after Platinum-Containing Therapy: A Multicenter Study of the Arbeitsgemeinschaft Internistische Onkologie

Phase II Study of Cetuximab in Combination with Docetaxel in Patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck after Platinum-Containing Therapy: A Multicenter Study of the Arbeitsgemeinschaft Internistische Onkologie

Palliative Chemotherapy in Recurrent or Metastatic Squamous cell carcinoma of the head and neck, NEMROCK experience

Analysis of the EGFR Mutation Status in Head and Neck Squamous Cell Carcinoma before Treatment with Gefitinib

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