The efficacy of the
ACTH (4-9) analogue
Org 2766 in the prevention of subclinical
cisplatin neuropathy was assessed in a double-blind placebo-controlled multi-centre study in patients with
testicular cancer or
adenocarcinoma of unknown primary. Forty-two patients received at least four cycles of
cisplatin (100 mg/m2 per cycle), together with
subcutaneous injections of
Org 2766 (2 mg/day for 5 consecutive days) or placebo. Vibratory threshold was used as a measure of neuropathy. For each individual patient, the influence of
cisplatin on vibratory perception was quantified by the slope of the regression line between the natural logarithm of the vibratory thresholds and the number of cycles. From the slopes, the proportional increase of vibratory threshold per cycle of
cisplatin was calculated. On average, vibratory thresholds increased by 42% with each cycle of 100 mg/m2 of
cisplatin in the placebo group, and by 19% during treatment with
Org 2766. The influence of
cisplatin on vibratory thresholds was highly significant in the placebo group (P < 0.0001), and of borderline significance in the group treated with
Org 2766 (P = 0.06). The difference in slopes between the two groups was of borderline statistical significance (Wilcoxon's two-sample test: P = 0.06; analysis of variance: P = 0.04). These results show that
Org 2766 cannot completely prevent
cisplatin neuropathy in young men with
testicular cancer, but nerve damage may be ameliorated by the use of this
ACTH (4-9) analogue.