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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Thieme Medical and Scientific Publishers Pvt. Ltd.
2015
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oai:doaj.org-article:642e5877e9e5444c8713e272457c87902021-12-02T16:24:57ZBiweekly gemcitabine and paclitaxel in patients with relapsed or metastatic squamous cell carcinoma of the head and neck2231-07702249-446410.4103/2231-0770.154195https://doaj.org/article/642e5877e9e5444c8713e272457c87902015-04-01T00:00:00Zhttp://www.thieme-connect.de/DOI/DOI?10.4103/2231-0770.154195https://doaj.org/toc/2231-0770https://doaj.org/toc/2249-4464Purpose: 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.Ammar SukariMarwan Al-HajeiliMohamed SalemLance HeilbrunDaryn SmithGeorge YooJohn R JacobsHo-Sheng LinOmer KucukThieme Medical and Scientific Publishers Pvt. Ltd.articlegemcitabinehead and neck cancerpaclitaxelMedicineRENAvicenna Journal of Medicine, Vol 05, Iss 02, Pp 36-41 (2015) |
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DOAJ |
| language |
EN |
| topic |
gemcitabine head and neck cancer paclitaxel Medicine R |
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gemcitabine head and neck cancer paclitaxel Medicine R 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 |
| 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. |
| format |
article |
| 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 |
| title |
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_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_sort |
biweekly gemcitabine and paclitaxel in patients with relapsed or metastatic squamous cell carcinoma of the head and neck |
| publisher |
Thieme Medical and Scientific Publishers Pvt. Ltd. |
| publishDate |
2015 |
| url |
https://doaj.org/article/642e5877e9e5444c8713e272457c8790 |
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