BACKGROUND: 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%; CI 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.
BACKGROUND: 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%; CI 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.
Authors: David W Nyman; Kimberley J Campbell; Evan Hersh; Kristen Long; Kelly Richardson; Vuong Trieu; Neil Desai; Michael J Hawkins; Daniel D Von Hoff Journal: J Clin Oncol Date: 2005-11-01 Impact factor: 44.544
Authors: Paul K Paik; Leonard P James; Gregory J Riely; Christopher G Azzoli; Vincent A Miller; Kenneth K Ng; Camelia S Sima; Robert T Heelan; Mark G Kris; Erin Moore; Naiyer A Rizvi Journal: Cancer Chemother Pharmacol Date: 2011-04-03 Impact factor: 3.333
Authors: E A Eisenhauer; P Therasse; J Bogaerts; L H Schwartz; D Sargent; R Ford; J Dancey; S Arbuck; S Gwyther; M Mooney; L Rubinstein; L Shankar; L Dodd; R Kaplan; D Lacombe; J Verweij Journal: Eur J Cancer Date: 2009-01 Impact factor: 9.162
Authors: Bradley J Monk; Michael W Sill; Robert A Burger; Heidi J Gray; Thomas E Buekers; Lynda D Roman Journal: J Clin Oncol Date: 2009-01-12 Impact factor: 44.544
Authors: Lívia Palmerston Mendes; Marilisa Pedroso Nogueira Gaeti; Paulo Henrique Marcelino de Ávila; Marcelo de Sousa Vieira; Bruna Dos Santos Rodrigues; Renato Ivan de Ávila Marcelino; Lílian Cristina Rosa Dos Santos; Marize Campos Valadares; Eliana Martins Lima Journal: Pharm Res Date: 2013-10-30 Impact factor: 4.200
Authors: Francisco Rodríguez; Pablo Caruana; Noa De la Fuente; Pía Español; María Gámez; Josep Balart; Elisa Llurba; Ramón Rovira; Raúl Ruiz; Cristina Martín-Lorente; José Luis Corchero; María Virtudes Céspedes Journal: Biomolecules Date: 2022-06-04
Authors: John K Chan; Wei Deng; Robert V Higgins; Krishnansu S Tewari; Albert J Bonebrake; Michael Hicks; Stephanie Gaillard; Pedro T Ramirez; Weldon Chafe; Bradley J Monk; Carol Aghajanian Journal: Gynecol Oncol Date: 2017-07-18 Impact factor: 5.482