Paclitaxel and gemcitabine vs. paclitaxel and pegylated liposomal doxorubicin in advanced non–nasopharyngeal head and neck cancer. An efficacy and cost analysis randomized study conducted by the Hellenic Cooperative Oncology Group
Open Access
- 21 June 2006
- journal article
- research article
- Published by Elsevier BV in Annals Of Oncology
- Vol. 17 (10), 1560-1567
- https://doi.org/10.1093/annonc/mdl151
Abstract
Background: The prognosis of patients with recurrent and/or metastatic head and neck cancer (HNC) is poor. Median survival of these patients following chemotherapy is in the range of 6 to 9 months. In the present randomized phase III trial we compared two new combinations containing new drugs with proven activity in phase II studies with patients with HNC. Patients and methods: From November 1999 until November 2004, 166 eligible patients with HNC were enrolled in the study. They were treated with paclitaxel 175 mg/m2 on day 1 and gemcitabine 1000 mg/m2 on days 1 and 8 every 3 weeks (group A, 85 patients) or with paclitaxel, as in group A, and pegylated liposomal doxorubicin 40 mg/m2 on day 1 every 4 weeks (group B, 81 patients). Results: There was no significant difference in response rate (20% versus 29%, P = 0.21), time to disease progression (median; 4.4 months versus 6.0 months, P = 0.09) and survival (median; 8.6 months versus 11.05 months, P = 0.25). Both regimens were generally well tolerated. The most frequently reported side effect, apart from alopecia, was neutropenia. Overall, there was no significant difference in severe toxicity between the two treatment arms. Conclusions: The present study could not demonstrate a survival benefit with either regimen. Both treatments were well tolerated. Randomized studies comparing each of the two regimens with standard chemotherapy are warranted.Keywords
This publication has 14 references indexed in Scilit:
- Randomized Phase III Evaluation of Cisplatin Plus Fluorouracil Versus Cisplatin Plus Paclitaxel in Advanced Head and Neck Cancer (E1395): An Intergroup Trial of the Eastern Cooperative Oncology GroupJournal of Clinical Oncology, 2005
- Locoregional effects of pegylated liposomal doxorubicin (Caelyx®) in irradiated area: a phase I–II study in patients with recurrent squamous cell carcinoma of the head and neckEuropean Journal Of Cancer, 2004
- Pegylated liposomal doxorubicin hydrochloride (PLD) and paclitaxel in recurrent or metastatic head and neck carcinoma: a phase I/II study conducted by the Hellenic Cooperative Oncology Group (HeCOG)Anti-Cancer Drugs, 2004
- Phase III Comparison of High-Dose Paclitaxel + Cisplatin + Granulocyte Colony-Stimulating Factor Versus Low-Dose Paclitaxel + Cisplatin in Advanced Head and Neck Cancer: Eastern Cooperative Oncology Group Study E1393Journal of Clinical Oncology, 2001
- Paclitaxel and gemcitabine in advanced non-nasopharyngeal head and neck cancer: A phase II study conducted by the Hellenic Cooperative Oncology GroupAnnals Of Oncology, 1999
- CONSORT: An Evolving Tool to Help Improve the Quality of Reports of Randomized Controlled TrialsJAMA, 1998
- Treatment of advanced breast cancer with sterically stabilized liposomal doxorubicin: results of a multicenter phase II trial.Journal of Clinical Oncology, 1997
- Costs, effects and C/E‐ratios alongside a clinical trialHealth Economics, 1994
- A phase II study of Gemcitabine (LY 188011) in patients with advanced squamous cell carcinoma of the head and neckAnnals Of Oncology, 1994
- Docetaxel (Taxotere®): An active drug for the treatment of patients with advanced squamous cell carcinoma of the head and neckAnnals Of Oncology, 1994