CHICAGO—Adding paclitaxel(Drug information on paclitaxel) (Taxol) and G-CSF support to the standard regimen of doxorubicin(Drug information on doxorubicin) and cisplatin(Drug information on 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 chemotherapy.

HER2/neu Overexpression

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.