BACKGROUND:
A
recent phase III trial compared the efficacy of
cisplatin-topotecan (a
topoisomerase I inhibitor) followed by carboplatin-paclitaxel (Arm 1)
versus paclitaxel-carboplatin (Arm 2) in women with newly diagnosed
stage IIB or greater ovarian cancer. There was a significantly lower
response rate in the experimental arm compared to standard treatment,
and less likelihood of normalized CA125 within the first 3 months. At
43 months follow-up, there were no significant group differences in
progression-free survival.
There were also significantly more side
effects in the experimental arm.
METHODS:
The
current study examined quality of life (QoL) endpoints using the
European Organization for Research and Treatment of Cancer Quality of
Life Questionnaire C30 (EORTC QLQ-C30) and the ovarian cancer module,
QLQ-OV28, administered prior to randomization, at day 1 of treatment
cycles 3, 5, and 7, at completion of the last cycle, and at 3 and
6 months following completion of chemotherapy.
RESULTS:
Global
QoL, physical symptoms, fatigue, and role, emotional, cognitive and
social function (all from the EORTC QLQ-C30) significantly improved in
both treatment arms, with no significant between-arm differences.
Between-group differences in pain, insomnia, and peripheral neuropathy
reported while on treatment did not differ at follow-up. Nausea and
vomiting improved more with standard treatment both during and after
treatment. Body image significantly differed between the groups only at
cycle 5 (more deterioration in Arm 2) but group differences disappeared
at follow-up. A stratified analysis of global QoL by debulking surgery
status found no greater effect indicating that overall improvements in
QoL were unrelated to surgical recovery.
CONCLUSIONS:
There
was no significant QoL advantage of cisplatin-topotecan. This finding,
combined with no progression-free survival conferred by this
combination, reaffirms carboplatin-paclitaxel as the standard of care
for women with newly diagnosed ovarian cancer.
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