P.D. : Esta Presentación podría NO estar a Cargo de Pharma Mar .*****************************************************************
A phase II study of the Gynecologic Oncology Group (GOG).
Abstrac 5046 .
Author(s): B. J. Monk, M. Sill, J. L. Walker, P. Hanjani, R. P. Edwards, J. Rotmensch, K. De Geest, A. J. Bonebrake; University of California, Irvine Medical Center, Orange, CA; Gynecologic Oncology Group Statistical and Data Center, Buffalo, NY; University of Oklahoma Health Sciences Center, Oklahoma City, OK; Abington Memorial Hospital, Abington, PA; Magee-Women's Hospital of the University of Pittsburgh Medical Center, Pittsburgh, PA; Rush-Presbyterian St. Luke's Medical Center, Chicago, IL; University of Iowa Hospitals and Clinics, Iowa City, IA; Cancer Research for the Ozarks-Cox Health, Springfield, MO
Background: To estimate the activity of docetaxel 60 mg/m2 IV over 1 hr followed by trabectedin 1.1 mg/m2 over 3 hrs with filgrastim, pegfilgrastim, or sargramostim every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
Methods: Patients with recurrent and measurable disease, acceptable organ function, and PS ≤ 2 were eligible. The number of prior cytotoxic regimens was limited to 3 (including no more than 1 non-platinum, non-taxane regimen). Patients receiving only 1 prior cytotoxic regimen (platinum-based regimen for management of primary disease) must have had a platinum-free interval of < 12 mo. A two-stage design was utilized with a target sample size of 35 subjects per stage. Another GOG study within the same protocol queue involving a single agent taxane yielded 8 responses (16%) among 49 subjects (90% CI 8.6-28.5%) and served as a historical control for direct comparison. The current study was designed to determine if the current regimen increased the probability of response by 20% with 90% power while limiting the probability of declaring regimens with similar activity as the historical control as being interesting to 10%. The minimum number of responses to declare the regimen interesting was 21
Results: 71 patients were enrolled with 70 being eligible and evaluable at this time (prior regimens:1 = 29%, 2 = 51%, 3 = 20%). The median number of cycles was 6 (396 total cycles). The number of patients responding was 21 (30%; 90% CI 21-40%). The odds ratio for responding was 2.2 (90% 1-sided CI 1.09-Infinity). The median progression-free survival and overall survival was 4.4 mo and 12.5 mo, respectively. The median response duration was 8.4 mo. Numbers of subjects with grade 3/4 toxicity included: neutropenia 6/14; constitutional 8/0; GI (excluding nausea/vomiting) 10/0; metabolic 9/1; pain 6/0. There were no treatment related deaths nor cases of liver failure.
Conclusions: This combination is well tolerated and appears more active than single agent taxane therapy in those with recurrent ovarian and peritoneal cancer after failing multiple lines of chemotherapy. Further study is warranted.