ASCO Annual Meeting! Saturday 30 . Combination Therapy with Temsirolimus and Trabectedin for Recurrent Clear Cell Carcinoma of the Ovary: A phase II study with biomarker analysis.

Author(s): Masashi Takano, Hiroko Kouta, Kazuya Kudoh, Tsunekazu Kita, Ryoko Kikuchi, Morikazu Miyamoto, Tomoyuki Yoshikawa, Tomoko Goto, Kenichi Furuya, Yutaka Tamada, Arata Suga, Yoshihiro Kikuchi; National Defense Medical College, Tokorozawa, Japan; Tama-Hokubu Medical Center, Higashimurayama, Japan; Nara Prefectural Nara Hospital, Nara, Japan; Kyoundo Hospital, Chiyoda, Japan; Tachikawa Hospital, Tachikawa, Japan; Koshigaya City Hospital, Koshigaya, Japan; Ohki Memorial Kikuchi Cancer Center for Women, Tokorozawa, Japan

Abstract Disclosures

Abstract:

Background: Recurrent clear cell carcinoma (RCCC) of the ovary showed exceedingly chemo-resistant phenotype, especially in the case with recurrent or refractory to previous therapy. A phase II trial to evaluate the effect of combination therapy with temsirolimus and trabectedin for patients with RCCC was performed.

Methods: Eligible patients were as follows: (a) ECOG PS = 0~2 (b) histologically confirmed ovarian clear cell adenocarcinoma (c) diagnosed as platinum-resistant ovarian cancer (d) written informed consent.
Patients with RCCC were treated with weekly regimen using two drugs: 15mg/m2 of temsirolimus and 0.15mg/m2 of trabectedin (3 weeks, one week rest).
Treatment was continued until development of progressive disease (PD) or unmanageable adverse effects. There was no significant difference of serum level of VEGF according to the response evaluation. Biomarker analyses including serum VEGF and BNP were also conducted.

Results: A total of 21 patients were analyzed in the present study.
There were no cases that discontinued the therapy due to toxicities. Median age was 59 years (range: 30-69), and median number of previous chemotherapy was 3 (range: 1-6). All cases were assessable by RECIST and CTCAE.
One patient (5%) had a complete response (CR), and two cases (10%) achieved a partial response (PR), and 6 patients (29%) had a stable disease (SD) beyond three months, resulting in clinical benefit rate (CBR; CR+PR+SD > 3month) of 43%.
Median response duration in CBR case was 3.5 months (range: 3-40+). There were no cases that developed toxicities more than grade2. There was no significant difference of serum level of VEGF according to the response evaluation.

Conclusions: Combination therapy with temsirolimus and trabectedin was a candidate for salvage therapy for patients with RCCC. These results warrant further study in such clinical settings with biomarker analyses.