Carboplatin/5-fluorouracil treatment of recurrent cervical carcinoma: a phase II study with long-term follow-up.
OBJECTIVE
To evaluate the response rate, progression-free (PFS) and overall survival in patients with recurrent carcinoma of the cervix (RCC) treated with carboplatin (CBDCA; cis-diamine-1, 1-cyclobutane dicarboxylate platinum II) 300 mg/m2 or according to Calverts formula, CBDCA dose [(GFR + 25) x AUC = 51 mg intravenous (iv) day 1 and 5-FU (5-fluorouracil) 1000 mg/m2 iv day 1 to 5, every 4 weeks.


METHODS
From June 1989 to October 1992, 25 patients were enrolled in this phase II study. All patients were evaluated for toxicity, response and survival data.


RESULTS
No patients obtained objective response. Eleven patients had stable disease. The median progression-free survival for these patients was 9 months (range 2 to 38), and the median survival was 17 months (range 3 - 50). For all patients the median overall survival was 11 months (range 2 - 50). Four patients survived for more than 1 year. Two of these patients survived for more than 4 years. The toxicity was tolerable with bone marrow suppression as the major problem.


CONCLUSIONS
Eleven patients (44%) with RCC obtained stable disease and four patients (16%) survived for more than one year. These poor results make this combination regimen insufficient and it should not be used in treating RCC.
Paulsen
T
T
Department of Gynaecologic Oncology, The Norwegian Radium Hospital, Montebello, Oslo.
Kaern
J
J
Tropé
C
C
D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D018196:Carcinoma, Adenosquamous / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D002294:Carcinoma, Squamous Cell / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality
D000964:Antimetabolites, Antineoplastic; D016190:Carboplatin; D005472:Fluorouracil