Objectives. The aim of this study was to determine the efficacy and toxicit
y of single agent off-protocol, liposomal doxorubicin (Doxil Alza), in cons
ecutive patients with recurrent ovarian cancer and to investigate the influ
ence of HER-2/neu expression on response to liposomal doxorubicin,
Patients and methods, Retrospective analysis of 72 consecutive patients tre
ated, typically with liposomal doxorubicin 40 mg/m(2) q28 days between Janu
ary 1997 and December 1998.
Results. Twenty-nine patients (40%) had platinum- and taxane-resistant tumo
rs. Nineteen patients (27%) responded with clinical or radiological evidenc
e of response with reduction in CA-125 of > 50%. One complete response (CR)
and 7 partial responses (PRs) occurred in platinum- and taxane-resistant p
atients (radiological response (RR) 29%) and 8 PRs occurred in patients wit
h visceral metastases (RR 28%), Time to progression was 5.3 (2.1-12.1) mont
hs. Only 7 dose delays (3%) and 20 dose reductions (8%) were necessary in 2
65 cycles of treatment. Hematological toxicity was generally mild with grad
e (Gr) greater than or equal to III neutropenia in 1 (2%), Gr greater than
or equal to III thrombocytopenia in 1 (1%), and Or greater than or equal to
III anemia in 8 patients (11%). One patient (1%) was admitted with fever a
nd neutropenia. Other toxicity was minimal with Gr greater than or equal to
III mucositis occurring in 3 patients (4%), Gr greater than or equal to II
I cutaneous toxicity was seen in 6 patients (8%). Three patients (4%) had a
> 10% fall in ejection fraction but there was no unequivocal clinical hear
t failure, Conclusions. The data suggest that liposomal doxorubicin is an a
ctive drug in both taxane- and platinum-sensitive and resistant recurrent o
varian cancer. Liposomal doxorubicin is associated with tolerable toxicity
and is particularly well tolerated in patients with multiple prior lines of
treatment. (C) 2001 Academic Press.