1. A phase II study of levofolinic acid and 5-fluorouracil plus cisplatin in patients with advanced head and neck squamous cell carcinoma.
- Author
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Gebbia V, Testa A, Valenza R, Zerillo G, Restivo S, Cupido G, Ingria F, Barbaccia C, Spadafora G, and Cannata G
- Subjects
- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Squamous Cell pathology, Carcinoma, Squamous Cell radiotherapy, Carcinoma, Squamous Cell surgery, Cisplatin administration & dosage, Combined Modality Therapy, Female, Fluorouracil administration & dosage, Head and Neck Neoplasms pathology, Head and Neck Neoplasms radiotherapy, Head and Neck Neoplasms surgery, Humans, Leucovorin administration & dosage, Male, Middle Aged, Neoplasm Staging, Stereoisomerism, Antineoplastic Combined Chemotherapy Protocols toxicity, Carcinoma, Squamous Cell drug therapy, Cisplatin toxicity, Fluorouracil toxicity, Head and Neck Neoplasms drug therapy, Leucovorin toxicity
- Abstract
Forty patients with advanced squamous cell carcinoma of the head and neck (SCHNC) were treated with a combination of levofolinic acid 100 mg/m2+5-fluorouracil 375 mg/m2 in a 4-hour infusion plus cisplatin 20 mg/m2 in a 2-hour infusion for 5 consecutive days, repeated every 21-28 days. In the group of 20 previously untreated patients, a 90% overall response rate (ORR) with a 30% complete response rate (CRR) was obtained. In the group of 20 pretreated patients with recurrent and/or metastatic SCHNC, a 55% ORR with 15% CRR was achieved. This treatment was given on an outpatient basis and was generally very well tolerated with only 2 patients requiring hospitalization. Grade 1-2 gastrointestinal and hematological side effects were the most frequent toxicities. One patient had grade 4 liver toxicity, 1 had grade 4 anemia, and 1 grade 3 neurotoxicity. This treatment seems very active in both previously untreated and pretreated patients. However, in the latter group the mean duration of complete response (12.2+ months) and of partial response (7.4+ months) are, in our opinion, still unsatisfactory.
- Published
- 1993
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