Phase II trial of weekly paclitaxel and carboplatin (wTJ) for endometrial cancer (EC): Results of a Kansai Clinical Oncology Group trial (KCOG0015) in Japan.

Abstract

5085 Background: The chemotherapy (CT) for recurrent or post operative high risk patients (pts) of EC has not been established. Previously, we reported the usefulness of wTJ in EC for preliminary results (Ito et al; Proc ASCO 2002). Here we report the final results. METHODS Eligibility criteria included: histologically confirmed primary advanced or recurrent EC (group A), post-operative pts having high risk factors (above FIGO stage IC, G3 histology, capillary space invasion) (group B). Each cycle considered of three-weekly drug administrations: paclitaxel 80mg/m2 on days 1, 8 and 15 and carboplatin AUC 5 on day 1 as a 1-hr infusion of each drug, and more than 3 cycles of administration were planned. RESULTS Between 05/2000 and 03/2002, a total of 40 pts (median age was 58, range:30 -70) were enrolled and administered 163 cycles. Thirty-six pts (93%) completed more than 3 cycles (median 4, range:1-9). ECOG performance status (PS) was 0-1 in 39 pts, PS 2 in 1 pt. Thirty-eight pts (95%) had no prior CT. Group A contained 17 pts (6 recurrent pts, 8 neo-adjuvant CT pts for bulky stage IIb -IV, and 3 pts had post operative residual tumor). Group B contained 23 pts (primary stage I:10, II:5, III:6, IV:2pts). Toxicity, response and QOL were assessed by NCI-CTC ver2.0J in all pts, RECIST in 15pts had measurable disease in group A and EORTC-QLQC30J in 19 pts obtained their approval, respectively. Hematological toxicities(G3/G4) were neutropenia (31%/33%), thrombocytopenia (6%/0%). Febrile neutropenia was not observed. Reversible G3 hypersensitivity (5%) and G2 cardiotoxicity (3%: reversible PVC) were observed. The response rate was 80% (12/15) with 3CR, 9PR and 3SD. No pts remarkably failed own QOL in this trial. Now the median follow up period of group A is 28 months (range 15-40). The median time to progression and survival are 15+ (range 5-32+) and 25+ months (range 5-40+), respectively. And the median follow up period of group B is 26 months (range 18-39). No pts relapsed and all pts are alive. CONCLUSIONS This wTJ regimen was highly effective and feasible for EC pts. No significant financial relationships to disclose.

Cite this paper

@article{Ito2004PhaseIT, title={Phase II trial of weekly paclitaxel and carboplatin (wTJ) for endometrial cancer (EC): Results of a Kansai Clinical Oncology Group trial (KCOG0015) in Japan.}, author={Kiyoshi Ito and Souichi Adachi and Y Itani and Toshikatu Nobunaga and Mitsuyo Shintani and Hiroshi Tsubamoto and Kohei Hosokawa and Hideki Fujita and Yoshinori Nakata and Naoya Yamazaki}, journal={Journal of clinical oncology : official journal of the American Society of Clinical Oncology}, year={2004}, volume={22 14_suppl}, pages={5085} }