Aims and background: Breast cancer refractory to known effective agents is
one of the major clinical problems frequently encountered in practice. Cisp
latin and vinorelbine are known to be active drugs in anthracycline-refract
ory cases. In this phase II study, the effectiveness and tolerability of ci
splatin and vinorelbine was investigated when used in combination as a salv
age regimen In the treatment of metastatic refractory breast cancer.
Study design: Twenty-four patients with advanced refractory breast cancer w
ho had been previously treated with a regimen containing doxorubicin were i
ncluded in the study. Six of the 24 patients also received taxanes after fa
ilure of doxorubicin. Cisplatin at 80 mg/m(2) on day 1 and vinorelbine at 2
5 mg/m(2) on days 1 and 8 were given every 3 weeks.
Results: A total of 98 cycles of chemotherapy was given, with a median of 4
/patient. The response rate was 25% (2 [8.3%] complete and 4 [16.7%] partia
l responses). The median survival rates were 14 months in responders and 5.
5 months in nonresponders (P = 0.0282). One complete and one partial respon
se were observed in patients previously treated with paclitaxel (overall re
sponse rate, 33%). The median response duration was 12.5 mo (range, 4-21) i
n complete and 4.5 mo (range, 1.5-13) in the partial response group. Grade
3 and 4 neutropenia occurred in 9 patients, with no toxic deaths. Grade 2-3
nausea and vomiting in 6 patients and grade 1 neuropathy in 1 patient were
noted.
Conclusions: Although the number of cases is insufficient to indicate that
the combination will be effective, it is noteworthy in consideration of ant
hracycline and taxane refractory cases. A combination of cisplatin and vino
relbine seems to be a reasonable and acceptable choice as an alternative sa
lvage regimen in such cases.