[Concomitant radiochemotherapy with cisplatin (CDDP), 5-fluorouracil (5-FU) and mitomycin C (MMC) in locally advanced carcinoma of the oropharynx. Results of a phase II trial].
In order to improve loco-regional control in locally advanced oropharyngeal carcinoma, a phase II trial was designed to establish the feasibility of concomitant conventional radiotherapy and three cycles of chemotherapy at day 1, 21 and 42 with cisplatin (CDDP) 20 mg/m2 and 5-fluorouracil (5-FU) 400 mg/m2 day 1 to day 4, and mitomycin C (MMC) 10 mg/m2 day 1. From March 1990 to September 1993, 27 patients (mean age: 55) were included in this study. Three patients (11%) were T2N0, 19 (70%) T3 (T3N0: n = 9, T3N1: n = 1, T3N2: n = 5, T3N3: n = 4), and 5 (19%) T4 (T4N0: n = 1, T4N1: n = 1, T4N2: n = 2, T4N3: n = 1). With a mean follow-up of 34 months (17-59), ten patients (37%) were alive, free of disease; among the 17 other patients, seven died with cancer. Loco-regional control rate was 85%. One and 2-year survival rates were respectively 48 and 31% for overall and disease-free survival; respective corrected overall survival rates were 68 and 61%. Grade 3 or 4 mucositis was 81%; enteral feeding was necessary for 63% of the patients; mean loss of weight was 5.7 kg. Grade > 2 thrombopenia occurred in 11 patients (41%), grade > 2 neutropenia in eight patients (29%) , grade > 2 anemia in four patients (15%). Febrile neutropenia or aplasia occurred in five patients (19%). Two patients (7%) died during treatment of haematological or infectious complications related to the treatment. Another patient died 2 months after treatment with grade 4 thrombopenia and septicemia. Addition of MMC to 5-FU and CDDP might have been partly responsible of this increased toxicity. A high complete response rate has been achieved with this concomitant radio-polychemotherapy, but with a severe digestive and haematological toxicity, which did not allow to conclude to the feasibility of this therapeutic association.
Berger
C
C
Clinique d'oncologie et radiotherapie, 37044 Tours Cedex, France.
Chapet
S
S
Calais
G
G
Reynaud-Bougnoux
A
A
Garand
G
G
le Floch
O
O
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D004361:Drug Tolerance; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects; D009367:Neoplasm Staging; D009959:Oropharyngeal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D011879:Radiotherapy Dosage; D015996:Survival Rate; D016896:Treatment Outcome
D016685:Mitomycin; D002945:Cisplatin; D005472:Fluorouracil
Radiothérapie et chimiothérapie concomitante par cisplatine (CDDP), 5-fluorouracile (5-FU) et mitomycine C (MMC) pour le traitement des cancers localement évolués de l'oropharynx. Résultats d'un essai de phase II.