Phase II study of neoadjuvant therapy with nab-paclitaxel and cisplatin followed by surgery in patients with locally advanced esophageal squamous cell carcinoma

Abstract

BackgroundWe carried out a phase II study to evaluate the efficiency and safety of the combination of nanoparticle albumin bound-paclitaxel (nab-paclitaxel) and cisplatin as preoperative chemotherapy for locally advanced esophageal squamous cell carcinoma (ESCC)ResultsFrom Oct 2011 to Dec 2012, 35 patients were enrolled and received neoadjuvant chemotherapy. Thirty patients underwent surgery and achieved a 100% R0 resection. Pathological complete response (pCR) rate was 13.3% and near pCR rate was 6.7%. Down-staging was achieved in 19 patients. With median follow-up of 37.8 months, 16 patients were still alive. One-, 2- and 3- year overall survival (OS) rate was 90.0%, 70.0% and 43.3%, respectively. This treatment resulted in a median disease-free survival (DFS) of 34.7 months and a median OS of 37.8 months. Median DFS and OS of down-staged patients were significantly longer than those of non-downstaged patients. The grade 4 toxicities during neoadjuvant chemotherapy were limited to neutropenia (2.9%) and vomiting (2.9%).MethodsPatients with locally advanced ESCC (stage IIA to IIIC) and performance status 0-1 were enrolled and received two cycles of nab-paclitaxel (100 mg/m2) on day 1, 8, 22 and 29, and cisplatin (75 mg/m2) on day 1 and 22, followed by resection. Two cycles of adjuvant chemotherapy with the same regimen were given. Postoperative radiotherapy was permitted and decided by radiation therapist.ConclusionWeekly nab-paclitaxel with three-weekly cisplatin seems effective and safe as a neoadjuvant chemotherapy strategy for locally advanced ESCC. Down-staged patients have favorable outcome.ClinicalTrials.gov IdentifierNCT01258192

Efficacy and safety of weekly nab-paclitaxel plus cisplatin with concurrent intensity-modulated radiotherapy in patients with inoperable, locally advanced esophageal cancer: a pilot trial

“…In a clinical trial reported by Fan et al, in which 77.1% of the population had stage III esophageal cancer, the ORR for all patients who received two cycles of nab-paclitaxel plus cisplatin chemotherapy was 65.7%. 11 Similarly, in a study of 33 patients with recurrence or metastasis of advanced esophageal cancer, a radiographic response was observed in 60.6% of those who received two to six cycles of nab-paclitaxel plus cisplatin. 15 Previous studies have also shown that paclitaxel-based chemoradiotherapy for esophageal cancer leads to ORRs of 50%–73%.…”

“…A recent Phase II clinical trial in locally advanced esophageal cancer reported R0 resection, pathologic complete response, and pathologic downstaging rates of 100%, 13.3%, and 63.3%, respectively, with acceptable tolerability, in patients treated with concurrent nab-paclitaxel plus cisplatin chemotherapy followed by surgery. 11 However, little is known about the efficacy of nab-paclitaxel-based chemoradiotherapy in this indication. The present clinical trial was therefore designed to evaluate the efficacy and safety of nab-paclitaxel plus cisplatin administered concurrently with radiotherapy in Chinese patients with inoperable, locally advanced esophageal cancer.…”

Weekly nanoparticle albumin bound-paclitaxel in combination with cisplatin versus weekly solvent-based paclitaxel plus cisplatin as first-line therapy in Chinese patients with advanced esophageal squamous cell carcinoma

“… 18 – 20 In addition, weekly nab-PTX in combination with DDP has been used for locally advanced ESCC, which showed a pathological complete response (CR) rate of 13.3% and a near pathological CR rate of 6.7% in a Phase II study. 21 Moreover, a Phase II study has shown that weekly PTX plus DDP is an active regimen with excellent tolerability for advanced gastric and gastroesophageal cancer. 22 …”

Recent Progress in the Neoadjuvant Treatment Strategy for Locally Advanced Esophageal Cancer

“…Apart from adjusting the dosage and frequency of medication, the renewal of drugs as well as the continuous optimization of different drug combinations have also become the critical research issues of nCT for EC. Nab-paclitaxel (Nab-PC), a new generation formulation of paclitaxel, has been used with cisplatin and has shown excellent performance in terms of the down-staging rate, R0 resection, and pCR rate [38]. S-1, developed in Japan, is a kind of oral fluorouracil alternative to infusional 5-FU and is considered effective and safe in treating patients with advanced SCC [15,39].…”