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Alberts DS , Blessing JA , Landrum LM , Warshal DP , Martin LP , Rose SL , Bonebrake AJ , Ramondetta LM
Phase II trial of nab-paclitaxel in the treatment of recurrent or persistent advanced cervix cancer: A gynecologic oncology group study
Gynecologic Oncology. 2012 Dec;127(3) :451-455
AbstractBackground. Metastatic and recurrent, platinum resistant cervix cancer has an extremely poor prognosis. The Gynecologic Oncology Group has studied >20 cytotoxic drugs or drug combinations in the second-line, phase II setting of advanced, drug resistant cervix cancer. Methods. Nanoparticle, albumin-bound paclitaxel (nab-paclitaxel) was administered at 125 mg/m(2) IV over 30 minutes on days 1,8 and 15 of each 28 day cycle to 37 women with metastatic or recurrent cervix cancer that had progressed or relapsed following first-line cytotoxic drug treatment. A flexible, 2-stage accrual design that allowed stopping early for lack of treatment activity was utilized. Because of slow patient accrual, the second stage was not completed. Results. Of 37 patients enrolled, 2 were ineligible due to no prior cytotoxic chemotherapy, which left 35 eligible patients evaluable for response and tolerability. All of the eligible patients had 1 prior chemotherapy regimen and 27 of them had prior radiation therapy with concomitant cisplatin. The median number of nab-paclitaxel cycles were 4 (range 1-15). Ten (28.6%; Cl 14.6%-46.3%) of the 35 patients had a partial response and another 15 patients (42.9%) had stable disease. The median progression-free and overall survival were 5.0 and 9.4 months, respectively. The only NCI CTCAE grade 4 event was neutropenia in 2 patients (5.7%) which resolved following dose reduction. Grade 3 neurotoxicity was reported in 1 (2.9%) patient and resolved to grade 2 following dose discontinuation. Conclusions. Nab-paclitaxel has considerable activity and moderate toxicity in the treatment of drug resistant, metastatic and recurrent cervix cancer. (C) 2012 Elsevier Inc. All rights reserved.
NotesAlberts, David S. Blessing, John A. Landrum, Lisa M. Warshal, David P. Martin, Lainie P. Rose, Stephen L. Bonebrake, Albert J. Ramondetta, Lois M. National Cancer Institute [CA 27469, CA 37517] This study was supported in part by the National Cancer Institute grants to the Gynecologic Oncology Group Administrative Office (CA 27469) and the Gynecologic Oncology Group Statistical and Data Center (CA 37517). We would also like to thank Abraxis Bioscience, LLC, (a wholly owned subsidiary of Celgene Corporation) for their generous support. 20 Academic press inc elsevier science San diego 043fo