TY - JOUR
TI - 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
AU - Fountzilas, G.
AU - Papakostas, P.
AU - Dafni, U.
AU - Makatsoris, T.
AU - Karina, M.
AU - Kalogera-Fountzila, A.
AU - Maniadakis, N.
AU - Aravantinos, G.
AU - Syrigos, K.
AU - Bamias, A.
AU - Christodoulou, C.
AU - Economopoulos, T.
AU - Kalofonos, H.P.
AU - Nikolaou, A.
AU - Angouridakis, N.
AU - Stathopoulos, G.
AU - Bafaloukos, D.
AU - Pavlidis, N.
AU - Daniilidis, J.
JO - Annals of Oncology
PY - 2006
VL - 17
TODO - 10
SP - 1560-1567
PB - 
SN - 0923-7534, 1569-8041
TODO - 10.1093/annonc/mdl151
TODO - amifostine;  antibiotic agent;  antiemetic agent;  antineoplastic agent;  bisphosphonic acid derivative;  dexamethasone;  doxorubicin;  erythropoietin;  gefitinib;  gemcitabine;  granulocyte colony stimulating factor;  new drug;  ondansetron;  paclitaxel;  pyridoxine, adult;  advanced cancer;  aged;  alopecia;  anemia;  arthralgia;  article;  bleeding disorder;  bone marrow toxicity;  cancer patient;  cancer survival;  clinical trial;  constipation;  controlled clinical trial;  controlled study;  cost benefit analysis;  diarrhea;  drug dose regimen;  drug efficacy;  drug fatality;  drug hypersensitivity;  drug tolerability;  fatigue;  febrile neutropenia;  female;  hand foot syndrome;  head and neck cancer;  health care organization;  human;  infection;  leukopenia;  major clinical study;  male;  mucosa inflammation;  myalgia;  nasopharynx cancer;  nausea;  neurotoxicity;  neutropenia;  peripheral neuropathy;  phase 3 clinical trial;  priority journal;  randomized controlled trial;  sensory neuropathy;  statistical significance;  survival time;  thrombocytopenia;  treatment outcome;  vomiting, Adult;  Aged;  Aged, 80 and over;  Antineoplastic Combined Chemotherapy Protocols;  Carcinoma, Squamous Cell;  Cost-Benefit Analysis;  Deoxycytidine;  Doxorubicin;  Female;  Greece;  Head and Neck Neoplasms;  Humans;  Male;  Middle Aged;  Paclitaxel;  Patient Compliance;  Polyethylene Glycols;  Survival Analysis;  Treatment Outcome
TODO - 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. © 2006 Oxford University Press.
ER -