Gemcitabine and paclitaxel in metastatic or recurrent squamous cell carcinoma of the head and neck: a phase I???II study

Stier, Sebastian; Koll, Caroline; Neuhaus, Thomas J.; Fronhoffs, Stefan; Forkert, Randolf; Tuohimaa, Arja; Vetter, Hans; Ko, Y.

doi:10.1097/00001813-200511000-00011

Cited by 3 publications

(3 citation statements)

References 38 publications

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“…They concluded that the combination of paclitaxel and gemcitabine is tolerated but shows insufficient clinical activity in patients with recurrent and/or metastatic SCCHN to warrant further trials. [ 27 ] However, biweekly GEMTAX has better efficacy and lower toxicity compared to the standard schedule of gemcitabine/paclitaxel, every 3 weeks. We have previously observed this regimen to be efficacious and well tolerated in patients with SCCHN[ 26 ] and NSCLC.…”

Section: Discussionmentioning

confidence: 99%

Biweekly gemcitabine and paclitaxel in patients with relapsed or metastatic squamous cell carcinoma of the head and neck

et al. 2015

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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/m2 intravenous) and paclitaxel (150 mg/m2 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 less than 6 months of concurrent chemoradiotherapy with high-dose cisplatin and/or have recurrent/metastatic platinum refractory SCCHN.

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Section: Discussionmentioning

confidence: 99%

Biweekly gemcitabine and paclitaxel in patients with relapsed or metastatic squamous cell carcinoma of the head and neck

et al. 2015

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“…In fact, these treatments of SCC reduce important side effects, but unfortunately, they are not balanced by significant increase in the survival rate. Treatment failure often results in a tumour recurrence and also metastasis 2 that must be treated with chemotherapy 3 , 4 . In this context, it could be an important goal to develop new approaches both for the first line treatment and in the long run for the second line one.…”

Section: Introductionmentioning

confidence: 99%

Drug Loaded Gingival Mesenchymal Stromal Cells (GinPa-MSCs) Inhibit In Vitro Proliferation of Oral Squamous Cell Carcinoma

Coccè

Farronato

Brini

et al. 2017

Sci Rep

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Human mesenchymal stromal cells (MSCs) have been widely investigated both for regenerative medicine and their antinflammatory/immunomodulatory capacity. However, their ability to home pathological tissues suggested the development of strategies for using MSCs as carrier to deliver drug into tumor microenvironment. MSCs obtained from different tissues can be loaded in vitro with anti-cancer drugs by a simple procedures. In this report, we studied MSCs isolated and expanded from gingival papilla (GinPa-MSCs), by testing their ability to uptake and release three important anti-neoplastic drugs: Paclitaxel (PTX), Doxorubicin (DXR) and Gemcitabine (GCB). The efficacy of drugs releasing GinPa-MSCs was studied on a pancreatic cancer cell line and confirmed in vitro against a line of tongue squamous cell carcinoma (SCC154). Our results demonstrated that GinPa-MSCs efficiently incorporate the drugs and then released them in active form and in sufficient amount to produce a dramatic inhibition of squamous cell carcinoma growth in vitro. If compared with other MSCs sources, the collection of GinPa-MSCs is poorly invasive and cells can be easily expanded and efficiently loaded with anti cancer drugs. In particular, gemcitabine loaded GinPa-MSCs provide a good “cell-mediated drug delivery system” for a future potential application in the context of the oral oncology.

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“…A prior phase I/II study with gemcitabine (800 mg/m2 on days 1 and 8, increased to 1000 mg) with escalating doses of paclitaxel resulted in an overall response rate of just 14.8% and median survival of 24 weeks. 20 In our study, we used the same drugs but with a higher dose of gemcitabine and a dosing interval of every 2 weeks, which may have accounted for improved efficacy. The every 2 week dosing interval allowed for complete hematologic recovery and may have facilitated the administration of high doses without prohibitive cytopenias.…”

Section: Discussionmentioning

confidence: 99%

Phase II trial of biweekly gemcitabine and paclitaxel with recurrent or metastatic squamous cell carcinoma of the head and neck: Southwest Oncology Group study S0329

et al. 2014

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Background A phase I study and an institutional pilot study in patients with metastatic/recurrent squamous cell carcinoma of the head and neck (SCCHN), utilizing biweekly gemcitabine-paclitaxel showed an overall response rate of 53%. This phase II trial was conducted to determine the feasibility, tolerability and efficacy of this combination. Methods Patients with metastatic/recurrent SCCHN were treated with gemcitabine (3,000 mg/m2) and paclitaxel (150mg/m2) on days 1 and 15 of every 28 day cycle. Results In 57 patients with measurable disease, median progression free survival was 4 months and median overall survival was 8 months. Overall response rate of 28% and disease stabilization in 19% was seen. There were no treatment related deaths with Grade 3/4 hematologic toxicity seen in 20% of the patients. Conclusions Biweekly gemcitabine-paclitaxel is feasible, well tolerated and demonstrated reasonable efficacy. This may be an alternative for patients who are not candidates for platinum-based chemotherapy.

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Gemcitabine and paclitaxel in metastatic or recurrent squamous cell carcinoma of the head and neck: a phase I???II study

Cited by 3 publications

References 38 publications

Biweekly gemcitabine and paclitaxel in patients with relapsed or metastatic squamous cell carcinoma of the head and neck

Biweekly gemcitabine and paclitaxel in patients with relapsed or metastatic squamous cell carcinoma of the head and neck

Drug Loaded Gingival Mesenchymal Stromal Cells (GinPa-MSCs) Inhibit In Vitro Proliferation of Oral Squamous Cell Carcinoma

Phase II trial of biweekly gemcitabine and paclitaxel with recurrent or metastatic squamous cell carcinoma of the head and neck: Southwest Oncology Group study S0329

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