We evaluated the activity and toxicity of two sequences of taxol combi
ned with vinorelbine in disseminated malignant melanoma, metastatic be
yond regional lymph nodes, Fifteen previously untreated patients, nine
males and six females (median age 56 years), were enlisted between Ma
y 1994 and February 1995. Eight patients received vinorelbine 30 mg/m(
2) (maximum dose 50 mg) first, followed 24 h later by taxol 120 mg/m(2
) (maximum dose 240 mg) infused over 3 h (the V/T sequence). Seven pat
ients received the reverse (T/V) sequence. In 79 administered courses
there were no anaphylactic episodes, the main toxicity being alopecia
(WHO grade 3). Significant neutropenia, emesis or neuropathy was not o
bserved in either schedule (WHO grades 0 or 1), Three major responses,
all with the V/T sequence, were seen; one complete (CR) in nodal and
cutaneous sites lasting 13 months and two partial (PR), omental, ascit
es in one and hepatic, splenic and nodal in the other, lasting 7 and 6
months, respectively. Clinically meaningful tumor regressions, not qu
alifying strictly for the criteria of major response, were observed in
two additional patients in the T/V sequence, Taxol combined with vino
relbine is active against disseminated malignant melanoma, The importa
nce of sequencing the two drugs remains to be determined with accrual
of more patients into the study.