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Neoadjuvant chemotherapy followed by minimally invasive esophagectomy versus primary surgery for management of esophageal carcinoma: a retrospective study.

ABSTRACT: There is no consensus about the combined therapeutic strategy for esophageal squamous cell carcinoma in China. The quality control and standardization of surgery procedures were far from satisfactory in past neoadjuvant chemotherapy trials, which may underestimate the survival benefits. Therefore, we tried to evaluate the survival benefit of paclitaxel plus platinum followed by minimally invasive esophagectomy with total two-field lymphadenectomy patterns versus primary surgery. Between 06/2011 and 12/2014, there were 279 consecutive patients who underwent minimally invasive esophagectomy with total two-field lymphadenectomy; 83 received neoadjuvant chemotherapy and 196 primary surgery. Propensity score matching was used to compare neoadjuvant chemotherapy patients and 76 matched primary surgery patients. Effectiveness of neoadjuvant chemotherapy, adverse events, complications after the operation, and survival rates were evaluated. After propensity score matching, and compared with primary surgery, neoadjuvant chemotherapy was significantly associated with a better survival (P = 0.049). The overall clinical response rate of neoadjuvant chemotherapy was 77.1%. The pathological response rate was 20.5%. There was no significant difference in complication rates between two groups. Neoadjuvant chemotherapy with paclitaxel plus platinum followed by minimally invasive esophagectomy and total two-field lymphadenectomy have better OS over the primary surgery without serious adverse events.

SUBMITTER: Zheng Y

PROVIDER: S-EPMC6400690 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Neoadjuvant chemotherapy followed by minimally invasive esophagectomy versus primary surgery for management of esophageal carcinoma: a retrospective study.

Zheng Yan Y Li Yin Y Liu Xianben X Zhang Ruixiang R Wang Zongfei Z Sun Haibo H Liu Shilei S

Journal of Cancer 20190129 5

There is no consensus about the combined therapeutic strategy for esophageal squamous cell carcinoma in China. The quality control and standardization of surgery procedures were far from satisfactory in past neoadjuvant chemotherapy trials, which may underestimate the survival benefits. Therefore, we tried to evaluate the survival benefit of paclitaxel plus platinum followed by minimally invasive esophagectomy with total two-field lymphadenectomy patterns versus primary surgery. Between 06/2011 ...[more]

PMID: 30854116

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Project description:BackgroundFor patients with esophageal adenocarcinoma or cancer of the gastroesophageal junction, radical esophagectomy with 2-field lymphadenectomy is the cornerstone of the multimodality treatment with curative intent. Both conventional minimally invasive esophagectomy (MIE) and robot assisted minimally invasive esophagectomy (RAMIE) were shown to be superior compared to open transthoracic esophagectomy considering postoperative complications. However, no randomized comparison exists between MIE and RAMIE in the Western World for patients with esophageal adenocarcinoma.MethodsThis is an investigator-initiated and investigator-driven multicenter randomized controlled parallel-group superiority trial. All adult patients (age ≥ 18 and ≤ 90 years) with histologically proven, surgically resectable (cT1-4a, N0-3, M0) esophageal adenocarcinoma of the intrathoracic esophagus or adenocarcinoma of the gastroesophageal junction and with European Clinical Oncology Group performance status 0, 1 or 2 will be assessed for eligibility and included after obtaining informed consent. Patients (n = 218) with resectable esophageal adenocarcinoma of the intrathoracic esophagus or adenocarcinoma of the gastroesophageal junction are randomized to either RAMIE (n = 109) or MIE (n = 109). The primary outcome of this study is the total number of resected abdominal and mediastinal lymph nodes specified per lymph node station.ConclusionThis is the first randomized controlled trial designed to compare RAMIE to MIE as surgical treatment for resectable esophageal adenocarcinoma or adenocarcinoma of the gastroesophageal junction in the Western World. The hypothesis of the proposed study is that RAMIE will result in a higher abdominal and mediastinal lymph node yield specified per station compared to conventional MIE. Short-term results and the primary endpoint (total number of resected abdominal and mediastinal lymph nodes per lymph node station) will be analyzed and published after discharge of the last randomized patient within this trial.Trial registrationClinicalTrials.gov Identifier: NCT04306458 . Registered 13th March 2020, https://clinicaltrials.gov/ct2/show/NCT04306458; Date of first enrolment 18.01.2021; Target sample size 218; Recruitment status: Recruiting; Protocol version 2; Issue date 10.03.2020; Rev. 02.02.2021; Authors ET, PCvdS, PPG.

Project description:Minimally invasive esophagectomy is increasingly performed for the treatment of esophageal cancer, but it is unclear whether hybrid minimally invasive esophagectomy (HMIE) or totally minimally invasive esophagectomy (TMIE) should be preferred. The objective of this study was to perform a meta-analysis of studies comparing HMIE with TMIE. A systematic literature search was performed in MEDLINE, Embase, and the Cochrane Library. Articles comparing HMIE and TMIE were included. The Newcastle-Ottawa scale was used for critical appraisal of methodological quality. The primary outcome was pneumonia. Sensitivity analysis was performed by analyzing outcome for open chest hybrid MIE versus total TMIE and open abdomen MIE versus TMIE separately. Therefore, subgroup analysis was performed for laparoscopy-assisted HMIE versus TMIE, thoracoscopy-assisted HMIE versus TMIE, Ivor Lewis HMIE versus Ivor Lewis TMIE, and McKeown HMIE versus McKeown TMIE. There were no randomized controlled trials. Twenty-nine studies with a total of 3732 patients were included. Studies had a low to moderate risk of bias. In the main analysis, the pooled incidence of pneumonia was 19.0% after HMIE and 9.8% after TMIE which was not significantly different between the groups (RR: 1.46, 95% CI: 0.97-2.20). TMIE was associated with a lower incidence of wound infections (RR: 1.81, 95% CI: 1.13-2.90) and less blood loss (SMD: 0.78, 95% CI: 0.34-1.22) but with longer operative time (SMD:-0.33, 95% CI: -0.59--0.08). In subgroup analysis, laparoscopy-assisted HMIE was associated with a higher lymph node count than TMIE, and Ivor Lewis HMIE was associated with a lower anastomotic leakage rate than Ivor Lewis TMIE. In general, TMIE was associated with moderately lower morbidity compared to HMIE, but randomized controlled evidence is lacking. The higher leakage rate and lower lymph node count that was found after TMIE in sensitivity analysis indicate that TMIE can also have disadvantages. The findings of this meta-analysis should be considered carefully by surgeons when moving from HMIE to TMIE.

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.

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Neoadjuvant chemotherapy followed by minimally invasive esophagectomy versus primary surgery for management of esophageal carcinoma: a retrospective study.

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Neoadjuvant chemotherapy followed by minimally invasive esophagectomy versus primary surgery for management of esophageal carcinoma: a retrospective study.

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