title: Paclitaxel, cisplatin, leucovorin, and continuous infusion fluorouracil followed by concomitant chemoradiotherapy for locally advanced squamous cell carcinoma of the head and neck: a Hellenic Cooperative Oncology Group Phase II Study.
abstract: The primary objective of this phase II study was to access the complete response (CR) rate to a new innovative induction regimen in patients with locally advanced head and neck cancer (LA-HNC). From October 2000 until October 2003 a total of 38 eligible patients (33 men and 5 women) entered the study. The large majority of them presented with a performance status of 0-1 and with clinical stage IV disease. Treatment consisted of three cycles of induction chemotherapy (IC) with paclitaxel 175 mg/m2 in a 3-h infusion on d 1, leucovorin (LV) 200 mg/m2 over 20 min immediately followed by FU 400 mg/m2 bolus and then 600 mg/m2 as a 24-h continuous infusion on d 1 and 2 and a cisplatin 75 mg/m2 over 1-h infusion on d 2 every 3 wk. This was then followed by radiation (70 Gy) and weekly cisplatin 40 mg/m2. After the completion of IC, 6/38 (16%) patients had CR. The CR rate was increased to 66% post-concomitant chemoradiotherapy (CCRT). Neutropenia (37.5%), pain (62%), nausea/vomiting (21%), and alopecia (79%) were the most frequent side effects during IC. The most pronounced toxicities during chemoradiotherapy were stomatitis (62.5%) and xerostomia (53%). Median time to progression was 11.0 mo and median survival 16.7 mo. One- and 2-yr survival rates were 73% and 38%, respectively. In conclusion, this novel induction regimen is active, is well tolerated, and can be successfully followed by CCRT with weekly cisplatin. CCRT should remain standard treatment for patients with LA-HNC. Novel induction combinations, such as that reported in the present study, should be evaluated in combination with CCRT only in the context of clinical trials.
authors.affiliation: Department of Medical Oncology, PAPAGEORGIOU General Hospital, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece. fountzil@med.auth.gr
authors.forename: George
authors.initials: G
authors.lastname: Fountzilas
authors.forename: Christos
authors.initials: C
authors.lastname: Tolis
authors.forename: Anna
authors.initials: A
authors.lastname: Kalogera-Fountzila
authors.forename: Despina
authors.initials: D
authors.lastname: Misailidou
authors.forename: Periklis
authors.initials: P
authors.lastname: Tsekeris
authors.forename: Maria
authors.initials: M
authors.lastname: Karina
authors.forename: Angelos
authors.initials: A
authors.lastname: Nikolaou
authors.forename: Epaminondas
authors.initials: E
authors.lastname: Samantas
authors.forename: Thomas
authors.initials: T
authors.lastname: Makatsoris
authors.forename: Eleni
authors.initials: E
authors.lastname: Athanassiou
authors.forename: Dimosthenis
authors.initials: D
authors.lastname: Skarlos
authors.forename: Aristotelis
authors.initials: A
authors.lastname: Bamias
authors.forename: Nikolas
authors.initials: N
authors.lastname: Zamboglou
authors.forename: Theofanis
authors.initials: T
authors.lastname: Economopoulos
authors.forename: Sophia
authors.initials: S
authors.lastname: Karanastassi
authors.forename: Nicholas
authors.initials: N
authors.lastname: Pavlidis
authors.forename: John
authors.initials: J
authors.lastname: Daniilidis
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D006801:Humans; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel; D002945:Cisplatin; D002955:Leucovorin; D005472:Fluorouracil