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Transitional impact of short- and long-term outcomes of a randomized controlled trial to evaluate laparoscopic versus open surgery for colorectal cancer from Japan Clinical Oncology Group Study JCOG0404.

ABSTRACT: Background:The JCOG0404 randomized controlled trial conducted to compare laparoscopic surgery (LAP) with open surgery (OP) for stage II/III colon cancer showed better short-term outcomes and equal long-term outcomes of LAP versus OP. Technical instrumentation of surgery and anticancer agents given during the registration period might have affected the outcomes. Aim:To evaluate outcomes according to the registration periods. Methods:The overall registration period was divided into three periods (first: 2004-2005, second: 2006-2007 and third: 2008-2009). Short-term and long-term outcomes were compared between registration periods. Results:In total, 1057 patients were registered. Numbers of patients undergoing each approach for each of the three periods (1st/2nd/3rd) were 528 for OP (106/244/178) and 529 for LAP (106/246/177). Operation time (minutes) did not change between the periods for OP (160/156/161) or LAP (205/211/219). Blood loss (mL) gradually decreased in the latter two periods: (119/80/75) for OP and (35/28/25) for LAP. Incidence of complications (%) decreased in the latter periods for OP (27.6/20.3/21.3), whereas that for LAP remained consistently low (14.3/14.8/13.6). There was no particular trend in 5-year overall survival and recurrence-free survival depending on the period regardless of treatment. D3 dissection rates were 95% or more for all periods in both groups. Conclusions:Operation time and survival rates did not change over time, whereas blood loss in OP improved in the latter periods. Quality control applied in this trial might have been effective in producing such safe endpoints. (ClinicalTrials.gov, number NCT00147134, UMIN Clinical Trials Registry, number C000000105.).

SUBMITTER: Fujii S

PROVIDER: S-EPMC6524094 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Transitional impact of short- and long-term outcomes of a randomized controlled trial to evaluate laparoscopic versus open surgery for colorectal cancer from Japan Clinical Oncology Group Study JCOG0404.

Fujii Shoichi S Akagi Tomonori T Inomata Masafumi M Katayama Hiroshi H Mizusawa Junki J Ota Mitsuyoshi M Saito Shuji S Kinugasa Yusuke Y Yamaguchi Shigeki S Sato Takeo T Kitano Seigo S

Annals of gastroenterological surgery 20190326 3

<h4>Background</h4>The JCOG0404 randomized controlled trial conducted to compare laparoscopic surgery (LAP) with open surgery (OP) for stage II/III colon cancer showed better short-term outcomes and equal long-term outcomes of LAP versus OP. Technical instrumentation of surgery and anticancer agents given during the registration period might have affected the outcomes.<h4>Aim</h4>To evaluate outcomes according to the registration periods.<h4>Methods</h4>The overall registration period was divide ...[more]

PMID: 31131359

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Project description:Studies evaluating the outcomes after laparoscopic resections of transverse colon cancers are scant. This manuscript aimed to compare surgical and oncological outcomes after laparoscopic (Lap) and open procedures for transverse colon carcinomas. All consecutive patients who underwent resection for a cancer located in the transverse colon between 2003 and 2019 were reviewed. Patients were categorized according to the surgical approach (Lap versus open) and groups were compared. Outcome measures were the short-term results, complications and functional recovery; moreover, recurrence-free survival (RFS) and overall survival (OS) rates were compared overall and after propensity score matching (PSM) based on age, sex, ASA classification, BMI, carcinoembryonic antigen (CEA) level, use of postoperative chemotherapy, location of tumour, stage and grading, operation time, blood loss and complications. Of 248 transverse resections reviewed, 146 (81 Lap and 65 open) were selected for data analysis. Blood loss, fluid intake and the incidence of wound infection were significantly lower and the hospital stay was significantly shorter in the Lap group (P < 0.001). The operation time and incidence of complications (Clavien-Dindo classification grade 3 or above) did not differ significantly between the two groups. Mean follow-up was of 75.4 months in the Lap group and 78.6 months in the open group. Regression analyses showed that OS was associated with the postoperative carcinoembryonic antigen (CEA) level (hazard ratio 1.18 (95 per cent c.i. 1.10 to 1.27); P < 0.001), BMI (hazard ratio 0.81 (95 per cent c.i. 0.68 to 0.96); P = 0.017), operation time (hazard ratio 0.99 (95 per cent c.i. 0.97 to 1.00; P = 0.010), and postoperative chemotherapy (hazard ratio 0.27 (95 per cent c.i. 0.08 to 0.96); P = 0.042), while RFS was associated with the postoperative CEA level (hazard ratio 1.13 (95 per cent c.i. 1.07 to 1.20); P < 0.001). PSM selected 42 patients for data comparison of long-term results, and showed no significant differences between groups (RFS: P = 0.530; OS: P = 0.561). Lap and open resections for transverse colon cancer provided similar outcomes in terms of severe post-operative complication and long-term results.

Project description:ImportanceSurgery represents the mainstay treatment of colorectal liver metastases. Indications for the laparoscopic approach in this setting have been widened and there is a need to confirm the benefits of minimally invasive liver surgery (MILS) in patients with complex disease states.ObjectiveTo compare outcomes of laparoscopic surgery with those of open surgery for liver metastases from colorectal cancer, focusing on the characteristics of modern MILS and therefore overcoming possible selection bias related to different policies for patients' eligibility for MILS over time.Design, setting, and participantsA cohort study of 885 resections performed for liver metastases from colorectal cancer between January 1, 2004, and June 30, 2017, at the Hepatobiliary Surgery Unit of San Raffaele Hospital, Milano, Italy, comprising 187 laparoscopic and 698 open resections. Procedures performed using the MILS approach with a ratio of MILS to total resections per year of more than 30% were considered and were matched by propensity scores (ratio of 1:4) to procedures performed using the open approach with a ratio of MILS to total resections per year of less than 30%.Main outcomes and measuresThe primary end point was short-term outcomes, including morbidity, mortality, functional recovery, and interval between surgery and adjuvant treatments; the secondary end point was long-term outcomes.ResultsAmong this cohort (104 patients in the MILS group; 46 women and 58 men; median age, 62 years [range, 35-81 years]; and 412 patients in the open group; 181 women and 231 men; median age, 60 years [range, 37-80 years]), primary end-point data showed a significantly higher incidence of postoperative morbidity in patients who underwent open resections compared with those who underwent MILS (94 [22.8%] vs 21 [20.2%]; P = .04). Patients in the MILS group had fewer major complications (Dindo-Clavien grades III-V) compared with patients in the open group (Dindo-Clavien grades III-V; 7 [6.7%] vs 35 [8.5%]; P = .03) as well as shorter lengths of stay (median [range] duration, 3 [2-35] vs 5 [4-37] days; P = .02). Oncologic results were not compromised by the laparoscopic approach.Conclusions and relevanceIn this study, the results of the propensity score matching analysis between modern laparoscopic surgery and previous open surgery appear to confer more comparable cohorts for complexity, further supporting the advantages of laparoscopy in the surgical treatment of liver metastases from colorectal cancer. The increase in use that laparoscopy has experienced appears to be based on increased feasibility, widening of eligibility criteria for patients, enhanced clinical effectiveness, and oncologic outcomes. All these elements together suggest that up to 70% of patients appear to be candidates for this minimally invasive surgical approach in high-volume centers.

Project description:BACKGROUND:Laparoscopic surgery for rectal cancer is widely performed all over the world and several randomized controlled trials have been reported. However, the usefulness of laparoscopic surgery compared with open surgery has not been demonstrated sufficiently, especially for the low rectal area. OBJECTIVE:The aim of this study was to investigate the hypothesis that laparoscopic primary tumor resection is safe and effective when compared with the open approach for locally advanced low rectal cancer. PATIENTS AND METHODS:Data from patients with clinical stage II to III low rectal cancer below the peritoneal reflection were collected and analyzed. The operations were performed from 2010 to 2011. Short-term outcomes and long-term prognosis were analyzed with propensity score matching. RESULTS:Of 1608 cases collated from 69 institutes, 1500 cases were eligible for analysis. The cases were matched into 482 laparoscopic and 482 open cases. The mean height of the tumor from the anal verge was 4.6?cm. Preoperative treatment was performed in 35% of the patients. The conversion rate from laparoscopic to open surgery was 5.2%. Estimated blood loss during laparoscopic surgery was significantly less than that during open surgery (90 vs 625?mL, P < 0.001). Overall, the occurrence of complications after laparoscopic surgeries was less than that after open surgeries (30.3% vs 39.2%, P = 0.005). Three-year overall survival rates were 89.9% [95% confidence interval (95% CI) 86.7-92.4] and 90.4% (95% CI 87.4-92.8) in the laparoscopic and open groups, respectively, and no significant difference was seen between the 2 groups. No significant difference was observed in recurrence-free survival (RFS) between the 2 groups (3-year RFS: 70.9%, 68.4 to 74.2 vs 71.8%, 67.5 to 75.7). CONCLUSION:Laparoscopic surgery could be considered as a treatment option for advanced, low rectal cancer below the peritoneal reflection, based on the short-term and long-term results of this large cohort study (UMIN-ID: UMIN000013919).

Dataset Information

Transitional impact of short- and long-term outcomes of a randomized controlled trial to evaluate laparoscopic versus open surgery for colorectal cancer from Japan Clinical Oncology Group Study JCOG0404.

Publications

Transitional impact of short- and long-term outcomes of a randomized controlled trial to evaluate laparoscopic versus open surgery for colorectal cancer from Japan Clinical Oncology Group Study JCOG0404.

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