CHICAGOAdding paclitaxel (Taxol) and G-CSF support to the standard
regimen of doxorubicin and cisplatin (Platinol) improved response rates and
increased survival by about 3 months for patients with advanced or recurrent
endometrial cancer in a randomized controlled phase III trial conducted by the
Gynecologic Oncology Group (GOG) (ASCO abstract 807).
Gini F. Fleming, MD, of the University of Chicago reported that the
three-drug regimen called TAP (taxane/anthracycline/platinum) increased
12-month survival from 50% to 59%, complete response from 7% to 22% ,and
partial response from 27% to 36%. It also advanced median progression-free
survival from 5.3 months to 8.3 months and median overall survival from 12.1
months to 15.3 months (see Table 1).
TAP was well tolerated hematologically, but produced more neuropathy and
gastrointestinal toxicity than the two-drug regimen identified as AP
(anthracycline/platinum), according to Dr. Fleming.
About half the women in both arms of the study (54% on TAP and 47% on AP)
did not complete all seven cycles of chemotherapy. Five treatment-related
deaths and five nonfatal cases of grade 3 congestive heart failure were
recorded among the 134 patients in the TAP arm; neither occurred among the 131
patients who received the standard protocol.
The trial, GOG177, enrolled 273 patients from December 1998 to August 2000.
Eight patients were later excluded and three patients on the TAP arm never
received therapy, but were included in the final analysis. None had had prior
The investigators were also interested in the extent of HER2/neu
overexpression in patients with advanced or recurrent endometrial cancer and
whether overexpression affected the outcome of doxorubicin-based therapy. They
were able to obtain tissues samples, mostly from primary tumors, for about 88%
of patients in the trial.