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Neoadjuvant chemotherapy followed by minimally invasive esophagectomy is safe and feasible for treatment of esophageal squamous cell carcinoma.

ABSTRACT: The advantage of neoadjuvant chemotherapy (NAC) followed by open esophagectomy for treatment of esophageal squamous cell carcinoma has been widely recognized. However, the safety and feasibility of NAC for patients receiving minimally invasive esophagectomy (MIE) remain controversial. The purpose of this study was to evaluate the potential impact of prior neoadjuvant chemotherapy on the clinical outcome of MIE by comparing two groups of patients, MIE alone and NAC plus MIE.From May 2013 to July 2017, 124 patients with esophageal squamous cell carcinoma underwent MIE in our department, with 57 cases receiving NAC plus MIE and 67 cases receiving MIE alone. Perioperative parameters and short-term postoperative survival were compared between these two groups to evaluate the safety and feasibility of NAC given before MIE.The group with NAC plus MIE had slightly longer operating time, more blood loss, higher morbidity, increased chance of surgical intensive care unit stay, and longer surgical intensive care unit stay time than the group with MIE alone. However, there was no statistically significant difference between these two groups (P?>?0.05). The number of lymph nodes harvested was similar in the two groups without significant difference (P?>?0.05). The overall survival was not significantly different between these two groups either (P?>?0.05), although before surgery the clinical stage of the group with NAC plus MIE was more advanced than the group with MIE alone.NAC followed by MIE is safe and feasible for treatment of esophageal squamous cell carcinoma. NAC does not negatively impact the therapeutic outcome of MIE.

SUBMITTER: Ma S

PROVIDER: S-EPMC5792721 | biostudies-other | 2018 Feb

REPOSITORIES: biostudies-other

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Neoadjuvant chemotherapy followed by minimally invasive esophagectomy is safe and feasible for treatment of esophageal squamous cell carcinoma.

Ma Shaohua S Ma Shaohua S Yan Tiansheng T Liu Dandan D Wang Keyi K Wang Jingdi J Song Jintao J Wang Tong T He Wei W Bai Jie J Jin Liang L Chen Xiaoxin X

Thoracic cancer 20180110 2

<h4>Background</h4>The advantage of neoadjuvant chemotherapy (NAC) followed by open esophagectomy for treatment of esophageal squamous cell carcinoma has been widely recognized. However, the safety and feasibility of NAC for patients receiving minimally invasive esophagectomy (MIE) remain controversial. The purpose of this study was to evaluate the potential impact of prior neoadjuvant chemotherapy on the clinical outcome of MIE by comparing two groups of patients, MIE alone and NAC plus MIE.<h4 ...[more]

PMID: 29319236

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Project description:ImportanceSafety and efficacy of neoadjuvant chemoradiotherapy (nCRT) vs neoadjuvant chemotherapy (nCT) for treatment of locally advanced esophageal squamous cell carcinoma (ESCC) remain uncertain given lack of high-level clinical evidence.ObjectiveTo compare safety and long-term survival of nCRT followed by minimally invasive esophagectomy (MIE) with that of nCT followed by MIE for patients with locally advanced ESCC.Design, setting, and participantsA prospective, multicenter, open-label, randomized clinical trial that compared safety and efficacy of nCRT vs nCT followed by MIE for patients with locally advanced ESCC. From January 1, 2017, to December 31, 2018, 264 patients with ESCC of clinical stages from cT3 to T4aN0 to 1M0 were enrolled. Analysis was performed on an intention-to-treat basis from January 1, 2017, to August 30, 2020.InterventionsEligible patients were randomized to the nCRT group (n = 132) or the nCT group (n = 132) by a computer-generated random system. The chemotherapy, based on paclitaxel and cisplatin, was administered to both groups, while 40 Gy of concurrent radiotherapy was added for the nCRT group. At about 6 weeks after neoadjuvant therapy, MIE via thoracoscopy and laparoscopy was performed for the patients in both groups.Main outcomes and measuresThe primary outcome was 3-year overall survival. Secondary outcomes included postoperative complications, mortality, postoperative pathologic outcome, recurrence-free survival time, and quality of life.ResultsAmong 264 patients (226 men [85.6%]; mean [SD] age, 61.4 [6.8] years), postoperative morbidity was 47.4% in the nCRT group (54 of 114) and 42.6% in the nCT group (46 of 108), with no significant difference between groups (difference, 4.8%; 95% CI, -8.2% to 17.5%; P = .48). Distribution of the severity of complications was similar between the 2 groups based on Clavien-Dindo classification. The 90-day perioperative mortality rate was 3.5% for the nCRT group (4 of 114) and 2.8% for the nCT group (3 of 108) (P = .94). The R0 resection rates were similar between groups (109 of 112 [97.3%] vs 100 of 104 [96.2%]; P = .92). However, patients in the nCRT group had a higher pathologic complete response (residual tumor, 0%) rate (40 of 112 [35.7%] vs 4 of 104 [3.8%]; P < .001) and a higher rate of negative lymph nodes (ypN0, 74 of 112 [66.1%] vs 48 of 104 [46.2%]; P = .03) than those in the nCT group. One-year overall survival using intention-to-treat analysis was 87.1% in the nCRT group (115 of 132) and 82.6% in the nCT group (109 of 132) (P = .30). Furthermore, deaths caused by tumor progression or recurrence were significantly less in the nCRT group than in the nCT group (9 of 132 [6.8%] vs 19 of 132 [14.4%]; P = .046); however, deaths from nontumor causes were similar (8 of 132 [6.1%] vs 4 of 132 [3.0%]; P = .24).Conclusions and relevanceInitial results of the trial showed that nCRT followed by MIE has similar safety to and better histopathologic outcome than nCT followed by MIE for treatment of locally advanced ESCC.Trial registrationClinicalTrials.gov Identifier: NCT03001596.

Project description:BACKGROUND:Currently, there are three main surgical approaches for resectable esophageal cancer: open transthoracic esophagectomy (OTE), conventional minimally invasive esophagectomy (MIE) and robot-assisted esophagectomy (RAE). Previous studies had demonstrated the better short-term outcomes in MIE or RAE when compared to OTE, respectively. However, to date, no prospective study was designed to compare these two minimally invasive approaches (MIE and RAE). The primary objective of this study is to compare the outcomes on survival, safety and efficacy, quality of life between RAE and MIE in the treatment for resectable esophageal squamous cell carcinoma (ESCC). METHODS:This study is designed as a multicenter, prospective, randomized, non-inferiority phase III clinical trial, investigating the safety and efficacy of RAE compared with MIE in the treatment of resectable ESCC. Eligible patients are randomly assigned to either RAE (n?=?180) or MIE (n?=?180) group. The follow-up visits will be scheduled at 3, 6, 9, and 12?months in the first two years, and then every 6?months until the end of the study. During the follow-up period, clinical data and quality of life questionnaires will be examined. The primary endpoint is the 5-year overall survival (OS). The secondary endpoints are 3-year OS, 5-year disease-free survival (DFS), short-term outcomes as well as quality of life. DISCUSSION:This is the first prospectively randomized controlled trial designed to compare RAE with MIE as surgical treatment for resectable ESCC. According to our hypothesis, RAE will result in at least similar oncologic outcomes and long-term quality of life, but with a shorter operation time, lower percentage of perioperative complications, lower blood loss, and shorter hospital stay when compared with MIE. This study started in July 2017. Follow-up will terminate after 5?years from the time when the last patient was enrolled. TRIAL REGISTRATION:ClinicalTrial.gov: NCT03094351 (March 29, 2017). The trial was prospectively registered.

Project description:To update our experiences with minimally invasive McKeown esophagectomy for esophageal cancer.We retrospectively reviewed the medical records of 445 consecutive patients who underwent minimally invasive McKeown esophagectomy between January 2009 and July 2015 at the Cancer Hospital of Chinese Academy of Medical Sciences and used 103 patients who underwent open McKeown esophagectomy in the same period as controls. Among 375 patients who underwent total minimally invasive McKeown esophagectomy, 180 in the early period were chosen for the study of learning curve of total minimally invasive McKeown esophagectomy. These 180 minimally invasive McKeown esophagectomies performed by five surgeons were divided into three groups according to time sequence as group 1 (n = 60), group 2 (n = 60) and group 3 (n = 60).Patients who underwent total minimally invasive McKeown esophagectomy had significantly less intraoperative blood loss than patients who underwent hybrid minimally invasive McKeown esophagectomy or open McKeown esophagectomy (100 mL vs 300 mL vs 200 mL, P = 0.001). However, there were no significant differences in operation time, number of harvested lymph nodes, or postoperative morbidity including incidence of pulmonary complication and anastomotic leak between total minimally invasive McKeown esophagectomy, hybrid minimally invasive McKeown esophagectomy and open McKeown esophagectomy groups. There were no significant differences in 5-year survival between these three groups (60.5% vs 47.9% vs 35.6%, P = 0.735). Patients in group 1 had significantly longer duration of operation than those in groups 2 and 3. There were no significant differences in intraoperative blood loss, number of harvested lymph nodes, or postoperative morbidity including incidence of pulmonary complication and anastomotic leak between groups 1, 2 and 3.Total minimally invasive McKeown esophagectomy was associated with reduced intraoperative blood loss and comparable short term and long term survival compared with hybrid minimally invasive McKeown esophagectomy or open Mckeown esophagectomy. At least 12 cases are needed to master total minimally invasive McKeown esophagectomy in a high volume center.

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Neoadjuvant chemotherapy followed by minimally invasive esophagectomy is safe and feasible for treatment of esophageal squamous cell carcinoma.

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Neoadjuvant chemotherapy followed by minimally invasive esophagectomy is safe and feasible for treatment of esophageal squamous cell carcinoma.

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