A phase II study of weekly paclitaxel and epirubicin in recurrent or refractory squamous cell carcinoma of the head and neck

Tso Fu Wang, Sung Chao Chu, Ruey Ho Kao, Chao Yuan Yao, Chi Cheng Li

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Objective: The combination of taxanes and anthracyclines has been proved to be active for treatment of many cancers. We conducted a phase II study to determine the response and toxicity of paclitaxel and epirubicin (TE) in patients with incurable squamous cell carcinoma of the head and neck (SCCHN). Methods: Patients with metastatic or recurrent SCCHN and adequate hematologic, renal and hepatic function and a Karnofsky performance status ≥60% were enrolled. Prior chemotherapy and/or radiotherapy were permitted with 4-week interval. The regimen was paclitaxel 60 mg/ m2 and epirubicin 20 mg/m2, on Days 1, 8 and 15, as an intravenous infusion, repeated every 28 days. Patients with disease progression or unacceptable toxicity were excluded from the study. Results: The current study was intended to treat 43 patients butclosed at the planned interim analysis due to early evidence of insufficient efficacy than expectation. Fifteen patients with a median age of 52 years (range, 37-72 years) were accrued. Previously, most patients had received radiotherapy and chemotherapy, and a majority (87%) of patients had treatment-free interval of <6 months. Median Karnofsky performance status was 70% (range, 60-90%). There was one clinical response (7%) and another three (20%) had stable disease. Median overall survival time was 4.5 months. The most common major toxicity was infection (47%), which caused four treatment-related mortalities. Grade 3-4 neutropenia occurred in five patients, but other toxicities were mild and manageable. Conclusions: In the population with majority of refractory disease of SCCHN, the response rate to TE was lower than expected. Such dose schedule is not recommended unless in chemotherapy naïve patients or in combination with newer agents.

Original languageEnglish
Pages (from-to)459-463
Number of pages5
JournalJapanese Journal of Clinical Oncology
Volume38
Issue number7
DOIs
Publication statusPublished - Aug 12 2008
Externally publishedYes

Fingerprint

Epirubicin
Paclitaxel
Karnofsky Performance Status
Drug Therapy
Radiotherapy
Carcinoma, squamous cell of head and neck
Taxoids
Anthracyclines
Neutropenia
Intravenous Infusions
Disease Progression
Appointments and Schedules
Therapeutics
Kidney
Survival
Mortality
Liver

Keywords

  • Epirubicin
  • Head and neck
  • Paclitaxel
  • Platinum refractory
  • Squamous cell carcinoma

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

Cite this

A phase II study of weekly paclitaxel and epirubicin in recurrent or refractory squamous cell carcinoma of the head and neck. / Wang, Tso Fu; Chu, Sung Chao; Kao, Ruey Ho; Yao, Chao Yuan; Li, Chi Cheng.

In: Japanese Journal of Clinical Oncology, Vol. 38, No. 7, 12.08.2008, p. 459-463.

Research output: Contribution to journalArticle

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abstract = "Objective: The combination of taxanes and anthracyclines has been proved to be active for treatment of many cancers. We conducted a phase II study to determine the response and toxicity of paclitaxel and epirubicin (TE) in patients with incurable squamous cell carcinoma of the head and neck (SCCHN). Methods: Patients with metastatic or recurrent SCCHN and adequate hematologic, renal and hepatic function and a Karnofsky performance status ≥60{\%} were enrolled. Prior chemotherapy and/or radiotherapy were permitted with 4-week interval. The regimen was paclitaxel 60 mg/ m2 and epirubicin 20 mg/m2, on Days 1, 8 and 15, as an intravenous infusion, repeated every 28 days. Patients with disease progression or unacceptable toxicity were excluded from the study. Results: The current study was intended to treat 43 patients butclosed at the planned interim analysis due to early evidence of insufficient efficacy than expectation. Fifteen patients with a median age of 52 years (range, 37-72 years) were accrued. Previously, most patients had received radiotherapy and chemotherapy, and a majority (87{\%}) of patients had treatment-free interval of <6 months. Median Karnofsky performance status was 70{\%} (range, 60-90{\%}). There was one clinical response (7{\%}) and another three (20{\%}) had stable disease. Median overall survival time was 4.5 months. The most common major toxicity was infection (47{\%}), which caused four treatment-related mortalities. Grade 3-4 neutropenia occurred in five patients, but other toxicities were mild and manageable. Conclusions: In the population with majority of refractory disease of SCCHN, the response rate to TE was lower than expected. Such dose schedule is not recommended unless in chemotherapy na{\"i}ve patients or in combination with newer agents.",
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AU - Chu, Sung Chao

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AU - Yao, Chao Yuan

AU - Li, Chi Cheng

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N2 - Objective: The combination of taxanes and anthracyclines has been proved to be active for treatment of many cancers. We conducted a phase II study to determine the response and toxicity of paclitaxel and epirubicin (TE) in patients with incurable squamous cell carcinoma of the head and neck (SCCHN). Methods: Patients with metastatic or recurrent SCCHN and adequate hematologic, renal and hepatic function and a Karnofsky performance status ≥60% were enrolled. Prior chemotherapy and/or radiotherapy were permitted with 4-week interval. The regimen was paclitaxel 60 mg/ m2 and epirubicin 20 mg/m2, on Days 1, 8 and 15, as an intravenous infusion, repeated every 28 days. Patients with disease progression or unacceptable toxicity were excluded from the study. Results: The current study was intended to treat 43 patients butclosed at the planned interim analysis due to early evidence of insufficient efficacy than expectation. Fifteen patients with a median age of 52 years (range, 37-72 years) were accrued. Previously, most patients had received radiotherapy and chemotherapy, and a majority (87%) of patients had treatment-free interval of <6 months. Median Karnofsky performance status was 70% (range, 60-90%). There was one clinical response (7%) and another three (20%) had stable disease. Median overall survival time was 4.5 months. The most common major toxicity was infection (47%), which caused four treatment-related mortalities. Grade 3-4 neutropenia occurred in five patients, but other toxicities were mild and manageable. Conclusions: In the population with majority of refractory disease of SCCHN, the response rate to TE was lower than expected. Such dose schedule is not recommended unless in chemotherapy naïve patients or in combination with newer agents.

AB - Objective: The combination of taxanes and anthracyclines has been proved to be active for treatment of many cancers. We conducted a phase II study to determine the response and toxicity of paclitaxel and epirubicin (TE) in patients with incurable squamous cell carcinoma of the head and neck (SCCHN). Methods: Patients with metastatic or recurrent SCCHN and adequate hematologic, renal and hepatic function and a Karnofsky performance status ≥60% were enrolled. Prior chemotherapy and/or radiotherapy were permitted with 4-week interval. The regimen was paclitaxel 60 mg/ m2 and epirubicin 20 mg/m2, on Days 1, 8 and 15, as an intravenous infusion, repeated every 28 days. Patients with disease progression or unacceptable toxicity were excluded from the study. Results: The current study was intended to treat 43 patients butclosed at the planned interim analysis due to early evidence of insufficient efficacy than expectation. Fifteen patients with a median age of 52 years (range, 37-72 years) were accrued. Previously, most patients had received radiotherapy and chemotherapy, and a majority (87%) of patients had treatment-free interval of <6 months. Median Karnofsky performance status was 70% (range, 60-90%). There was one clinical response (7%) and another three (20%) had stable disease. Median overall survival time was 4.5 months. The most common major toxicity was infection (47%), which caused four treatment-related mortalities. Grade 3-4 neutropenia occurred in five patients, but other toxicities were mild and manageable. Conclusions: In the population with majority of refractory disease of SCCHN, the response rate to TE was lower than expected. Such dose schedule is not recommended unless in chemotherapy naïve patients or in combination with newer agents.

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