Biweekly gemcitabine and paclitaxel in patients with relapsed or metastatic squamous cell carcinoma of the head and neck
Purpose: We conducted a Phase II, clinical trial to evaluate the efficacy and safety of a biweekly gemcitabine and paclitaxel (GEMTAX) regimen as second-line treatment in patients with recurrent or metastatic unresectable, squamous cell carcinoma of the head and neck (SCCHN). The primary endpoint wa...
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| Format: | Article |
| Language: | English |
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Thieme Medical and Scientific Publishers Pvt. Ltd.
2015-04-01
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| Series: | Avicenna Journal of Medicine |
| Subjects: | |
| Online Access: | http://www.thieme-connect.de/DOI/DOI?10.4103/2231-0770.154195 |
| _version_ | 1818430445708115968 |
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| author | Ammar Sukari Marwan Al-Hajeili Mohamed Salem Lance Heilbrun Daryn Smith George Yoo John R Jacobs Ho-Sheng Lin Omer Kucuk |
| author_facet | Ammar Sukari Marwan Al-Hajeili Mohamed Salem Lance Heilbrun Daryn Smith George Yoo John R Jacobs Ho-Sheng Lin Omer Kucuk |
| author_sort | Ammar Sukari |
| collection | DOAJ |
| description | Purpose: We conducted a Phase II, clinical trial to evaluate the efficacy and safety of a biweekly gemcitabine and paclitaxel (GEMTAX) regimen as second-line treatment in patients with recurrent or metastatic unresectable, squamous cell carcinoma of the head and neck (SCCHN). The primary endpoint was response rate. Patients and Methods: Patients with recurrent unresectable or metastatic platinum refractory SCCHN, who had performance status ≤2 and adequate organ function, were eligible. Gemcitabine (3000 mg/m 2 intravenous) and paclitaxel (150 mg/m 2 intravenous) was given on days 1 and 15of 4 weeks cycle, until patients had disease progression or unacceptable toxicity. Results: Disease control (partial response [PR] + complete response [CR] + stable disease [SD]) was noted in 19 patients (54%) and overall response (CR + PR) was noted in 8 patients (23%). However, the most frequent response outcomes were progressive disease in 16 patients (46%) and SD in 11 patients (31%). The most frequent Grade 3-4 adverse events were lymphopenia in 38 patients (75%), anemia in 20 patients (39%), and infection in 16 patients (31%). Median progression-free survival was 3.6 months; median overall survival was 6.3 months. Conclusion: The biweekly GEMTAX regimen has statistically significant grade 3 and 4 adverse events and has meaningful clinical activity as a second-line treatment in patients with recurrent or metastatic SCCHN who have received prior chemotherapy. This regimen may particularly be a useful treatment option in patients who progressed in <6 months of concurrent chemoradiotherapy with high-dose cisplatin and/or have recurrent/metastatic platinum refractory SCCHN. |
| first_indexed | 2024-12-14T15:33:32Z |
| format | Article |
| id | doaj.art-642e5877e9e5444c8713e272457c8790 |
| institution | Directory Open Access Journal |
| issn | 2231-0770 2249-4464 |
| language | English |
| last_indexed | 2024-12-14T15:33:32Z |
| publishDate | 2015-04-01 |
| publisher | Thieme Medical and Scientific Publishers Pvt. Ltd. |
| record_format | Article |
| series | Avicenna Journal of Medicine |
| spelling | doaj.art-642e5877e9e5444c8713e272457c87902022-12-21T22:55:48ZengThieme Medical and Scientific Publishers Pvt. Ltd.Avicenna Journal of Medicine2231-07702249-44642015-04-010502364110.4103/2231-0770.154195Biweekly gemcitabine and paclitaxel in patients with relapsed or metastatic squamous cell carcinoma of the head and neckAmmar Sukari0Marwan Al-Hajeili1Mohamed Salem2Lance Heilbrun3Daryn Smith4George Yoo5John R Jacobs6Ho-Sheng Lin7Omer Kucuk8Karmanos Cancer Institute, Detroit, MI; Department of Hematology & Oncology, Wayne State University, Detroit, MI, Saudi ArabiaDepartment of Medicine, King Abdulaziz University, Jeddah, Saudi ArabiaDepartment of Hematology & Oncology, Wayne State University, Detroit, MI, Saudi ArabiaKarmanos Cancer Institute, Detroit, MI, Saudi ArabiaKarmanos Cancer Institute, Detroit, MI, Saudi ArabiaKarmanos Cancer Institute, Detroit, MI, Saudi Arabia; Department of Otolaryngology & Head and Neck Surgery, Wayne State University, Detroit, MI, USAKarmanos Cancer Institute, Detroit, MI, Saudi Arabia; Department of Otolaryngology & Head and Neck Surgery, Wayne State University, Detroit, MI, USAKarmanos Cancer Institute, Detroit, MI, Saudi Arabia; Department of Otolaryngology & Head and Neck Surgery, Wayne State University, Detroit, MI, USAWinship Cancer Institute, Emory University, Atlanta, GA, USAPurpose: We conducted a Phase II, clinical trial to evaluate the efficacy and safety of a biweekly gemcitabine and paclitaxel (GEMTAX) regimen as second-line treatment in patients with recurrent or metastatic unresectable, squamous cell carcinoma of the head and neck (SCCHN). The primary endpoint was response rate. Patients and Methods: Patients with recurrent unresectable or metastatic platinum refractory SCCHN, who had performance status ≤2 and adequate organ function, were eligible. Gemcitabine (3000 mg/m 2 intravenous) and paclitaxel (150 mg/m 2 intravenous) was given on days 1 and 15of 4 weeks cycle, until patients had disease progression or unacceptable toxicity. Results: Disease control (partial response [PR] + complete response [CR] + stable disease [SD]) was noted in 19 patients (54%) and overall response (CR + PR) was noted in 8 patients (23%). However, the most frequent response outcomes were progressive disease in 16 patients (46%) and SD in 11 patients (31%). The most frequent Grade 3-4 adverse events were lymphopenia in 38 patients (75%), anemia in 20 patients (39%), and infection in 16 patients (31%). Median progression-free survival was 3.6 months; median overall survival was 6.3 months. Conclusion: The biweekly GEMTAX regimen has statistically significant grade 3 and 4 adverse events and has meaningful clinical activity as a second-line treatment in patients with recurrent or metastatic SCCHN who have received prior chemotherapy. This regimen may particularly be a useful treatment option in patients who progressed in <6 months of concurrent chemoradiotherapy with high-dose cisplatin and/or have recurrent/metastatic platinum refractory SCCHN.http://www.thieme-connect.de/DOI/DOI?10.4103/2231-0770.154195gemcitabinehead and neck cancerpaclitaxel |
| spellingShingle | Ammar Sukari Marwan Al-Hajeili Mohamed Salem Lance Heilbrun Daryn Smith George Yoo John R Jacobs Ho-Sheng Lin Omer Kucuk Biweekly gemcitabine and paclitaxel in patients with relapsed or metastatic squamous cell carcinoma of the head and neck Avicenna Journal of Medicine gemcitabine head and neck cancer paclitaxel |
| title | Biweekly gemcitabine and paclitaxel in patients with relapsed or metastatic squamous cell carcinoma of the head and neck |
| title_full | Biweekly gemcitabine and paclitaxel in patients with relapsed or metastatic squamous cell carcinoma of the head and neck |
| title_fullStr | Biweekly gemcitabine and paclitaxel in patients with relapsed or metastatic squamous cell carcinoma of the head and neck |
| title_full_unstemmed | Biweekly gemcitabine and paclitaxel in patients with relapsed or metastatic squamous cell carcinoma of the head and neck |
| title_short | Biweekly gemcitabine and paclitaxel in patients with relapsed or metastatic squamous cell carcinoma of the head and neck |
| title_sort | biweekly gemcitabine and paclitaxel in patients with relapsed or metastatic squamous cell carcinoma of the head and neck |
| topic | gemcitabine head and neck cancer paclitaxel |
| url | http://www.thieme-connect.de/DOI/DOI?10.4103/2231-0770.154195 |
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