Long term results of a phase II trial of induction chemotherapy with uracil-ftegafur (UFT), vinorelbine and cisplatin (UFTVP) followed by radiotherapy concomitant with UFT and carboplatin (RT/UFTJ) in non-resectable locally advanced (stage IV-B) squamous cell head and neck carcinoma and peripheral blood stem cell support (PBSCS) with febrile neutropenia.
OBJECTIVE
To evaluate the response of advanced squamous cell head and neck carcinoma to a combination of induction chemotherapy and radiotherapy.


METHODS
We present long-term results of a phase II trial of Induction Chemotherapy with UFT 200 mg/m(2) p.o. days 1 to 21, Vinorelbine 25 mg/m(2) i.v. days 1 and 8 and Cisplatin 100 mg/m(2) i.v. day 1 (UFTVP) each 21 days for 4 courses, followed by Radiotherapy concomitant with UFT 100 mg/m(2) p.o. daily and Carboplatin AUC = 0.5 i.v. weekly (RT/UFTJ) in patients (pts) with Non-Resectable Locally Advanced (Stage IV-B) Squamous Cell Head and Neck Carcinoma (IV-B-SCHNC). Primary endpoint was Complete Response to induction UFTVP and secondary endpoints were Disease Free Status Rate after locoregional treatment and long-term Overall Survival. Between 1994 and 1997, 32 pts were included.


RESULTS
Complete Response to Induction UFTVP was 59% (95% CI: 48%-70%). Main toxicity of UFTVP was G 3,4 neutropenia (94% of pts; 25% developed febrile neutropenia and 1 of this pts dead). After Induction Chemotherapy with UFTVP, 30 pts received radiotherapy and 25 of them received concomitant Carboplatin and UFT (RT/UFTJ): main toxicity was mucositis (G3-4: 72%) and one patient died during RT/UFTJ because pneumonia. Twenty-five pts (78%) were alive and disease free at the end of the whole treatment. Actuarial 5 year Overall survival is 32%.


CONCLUSIONS
Although toxicity is important, this approach has interesting activity and deserves further investigation.
Rivera
Fernando
F
Department of Medical Oncology, Hospital Universitario Marqués de Valdecilla, Santander, Spain. oncrhf@humv.es
Vega-Villegas
María E
ME
López-Brea
Marta F
MF
García-Castaño
Almudena
A
de Juan
Ana
A
Ramos
Francisco Javier
FJ
Collado
Antonio
A
Galdós
Piedad
P
Rubio
Antonio
A
del Valle
Adolfo
A
Rama
Julio
J
Mayorga
Marta
M
Sanz-Ortiz
Jaime
J
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy* / Q000628:therapy*; D002945:Cisplatin / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D005260:Female; D005334:Fever / Q000139:chemically induced; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy* / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D036102:Peripheral Blood Stem Cell Transplantation; D011379:Prognosis; D015996:Survival Rate; D005641:Tegafur / Q000627:therapeutic use; D013997:Time Factors; D014498:Uracil / Q000627:therapeutic use; D014747:Vinblastine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077235:Vinorelbine
D000970:Antineoplastic Agents; D005641:Tegafur; D014498:Uracil; D014747:Vinblastine; D016190:Carboplatin; D002945:Cisplatin; D000077235:Vinorelbine