A FNCLCC French Sarcoma Group—GETO multicenter randomized phase II study of gemcitabine (G) versus gemcitabine and docetaxel (G+D) in patients with metastatic or relapsed leiomyosarcoma (LMS)

Abstract

10511 Background: We sought to determine the response of metastatic or relapsed LMS to G vs. G+D in a randomized multicenter phase II study initiated before the completion of a recently reported trial (JCO 2007 Maki.) Methods: Eligible patients have histologically proven leiomyosarcoma, metastatic LMS or with unresectable local relapse, one prior anthracycline-based regimen, age ≥18, measurable disease (RECIST criteria), PS ≤ 2, adequate organ function. Treatment is G 1,000 mg/m2 (over 100 minutes, d1+d8+d15) q28 days or G 900 mg/m2 (over 90 min, d1+d8) and docetaxel 100 mg/m2 (over 60 min, d8) q21 days; in the G+D arm, all patients receive lenograstim from day 9 to day 15, 25% dose reductions are employed for prior pelvic radiation. Tumoral evaluation is done every 2 cycles. The primary endpoint is the objective tumor response rate (CR+PR). At randomization, stratification is done by primary tumor location (uterus vs. soft tissue). Each stratum is considered as an independent phase II study. The Simon method was used to calculate the number of patients: for “uterus” study, 20 evaluable pts per arm for a 74% probability of selecting the arm that has a true response rate (RR) of 50%, the expected baseline RR is 40%. For the “non-uterus” study, 20 evaluable pts per arm for a 91,8% probability of selecting the arm that has a true RR of 40%, the expected baseline RR is 20%. Results: From 02/06 to 12/07, 40 pts were enrolled in the “non-uterus” study, 25 pts in the “uterus” study. Currently 58/65 pts are evaluable (35/40 in the “non-uterus” and 23/25 in the “uterus” study) and 64/65 are assessable for toxicity. The median age is 64 (range 29–78) for soft tissue and 56 (range 41–80) for uterus, the median number of cycles is 4 (range 0 to 8). In the G arm, toxicity is moderate. In the G+D arm one toxic death related to G5 thrombocytopenia occurred, 1 pt stopped treatment for G3 thrombocytopenia and 5 pts for non- hematologic toxicities. Conclusions: Final tumor response and toxicity results will be presented during the meeting. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration GlaxoSmithKline, Novartis, Pfizer, PharmaMar GlaxoSmithKline, Novartis, Pfizer, PharmaMar Chugai, Novartis