Phase II trial of nab-paclitaxel in the treatment of recurrent or persistent advanced cervix cancer: A gynecologic oncology group study

Abstract

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/m2 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.

Paralytic ileus due to a novel anticancer drug, nab-paclitaxel: A case report

“…According to previous results from several clinical trials, the incidence of neuropathy of nab-paclitaxel containing regimen ranged between 2.9 and 17% (4,15), however, all of the neuropathy occurred in peripheral nerve, with no report of autonomic nerve involvement. The present study hypothesized that autonomic nervous system toxicity of nab-paclitaxel may be a probable contributing factor in this case.…”

Randomized clinical study of SCP pacliataxel in patients with advanced cervical cancer

“…Cancer of the cervix is the most common gynaecological malignancy worldwide [1] and second most common cancer in women worldwide and represents 15% of all female cancers [2]. More than 85% of the global burden occurs in developing countries, where it accounts for 13% of all female cancers [3].…”

“…In patients with advanced and disseminated disease, chemotherapy or radiation is used for symptomatic palliative care as deemed appropriate [6]. For patients with advanced, persistent or recurrent squamous cell carcinoma of the cervix no longer amenable to surgical resection or radiation therapy, the prognosis is poor [2]. The 2-year survival rate of the patients with persistent or recurrent disease was 21.7%, with median survival period of 17 months [7].…”

“…The 2-year survival rate of the patients with persistent or recurrent disease was 21.7%, with median survival period of 17 months [7]. The study of new agents for the treatment of advanced cervical cancer is clearly necessary [2]. Metastatic cervical cancer occurs in 15-61% of cases, and available oncology therapies do not offer the prospect of a cure in the majority of patients.…”

“…Paclitaxel has a broad spectrum of activity against many gynaecologic malignancies including ovarian, uterine and cervical cancer [2]. Hence a new technology was invented to stabilize the paclitaxel better called SCP "Specific Conjugate Particle" technology; The negative effect of compounds with low solubility include poor absorption and bioavailability, insufficient solubility for IV dosing, development challenges leading to increasing the development cost and time, the burden shifted to patient (frequent high-dose administration) 1.…”