Mature results of a randomized trial of two doses of cisplatin for the treatment of ovarian cancer. Scottish Gynecology Cancer Trials Group.
OBJECTIVE
In 1992, we reported the first results of a randomized study in ovarian cancer, comprising two doses of cisplatin and indicated a significant difference (P = .0008) in median survival. Four years later, we now describe the results of this trial.


METHODS
After a median follow-up of 4 years and 9 months, 115 of 159 cases of advanced ovarian cancer, originally randomized to receive six cycles of cyclophosphamide 750 mg/m2 and either a high dose (HD) of 100 mg/m2 cisplatin or a low dose (LD) of 50 mg/m2 (LD) cisplatin, have now died.


RESULTS
The overall survival for HD and LD patients is 32.4% and 26.6%, respectively, and the overall relative death rate is 0.68 (P = .043). This represents a reduction in overall benefit with longer follow-up compared with the first 2 years (relative death rate of 0.52). Toxicity, particularly neurotoxicity, is still evident in the fourth year (10/31 on HD compared with 1/24 on LD).


CONCLUSIONS
Our recommended dose of cisplatin in combination schedule is therefore 75 mg/m2, representing the optimal balance between efficacy and toxicity.
Kaye
S B
SB
Department of Medical Oncology, Beatson Oncology Centre, Western Infirmary, Glasgow, United Kingdom.
Paul
J
J
Cassidy
J
J
Lewis
C R
CR
Duncan
I D
ID
Gordon
H K
HK
Kitchener
H C
HC
Cruickshank
D J
DJ
Atkinson
R J
RJ
Soukop
M
M
Rankin
E M
EM
Davis
J A
JA
Reed
N S
NS
Crawford
S M
SM
MacLean
A
A
Parkin
D
D
Sarkar
T K
TK
Kennedy
J
J
Symonds
R P
RP
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate
D003520:Cyclophosphamide; D002945:Cisplatin