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

Shoichi Fujii, Tomonori Akagi, Masafumi Inomata, Hiroshi Katayama, Junki Mizusawa, Mitsuyoshi Ota, Shuji Saito, Yusuke Kinugasa, Shigeki Yamaguchi, Takeo Sato, Seigo Kitano, Japan Clinical Oncology Group, Shoichi Fujii, Tomonori Akagi, Masafumi Inomata, Hiroshi Katayama, Junki Mizusawa, Mitsuyoshi Ota, Shuji Saito, Yusuke Kinugasa, Shigeki Yamaguchi, Takeo Sato, Seigo Kitano, Japan Clinical Oncology Group

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.).

Keywords: colorectal cancer; laparoscopic colectomy; randomized controlled trial; transitional impact.

Figures

Figure 1
Figure 1
Study profile. First period: October 2004 to December 2005, second period: January 2006 to December 2007, third period: January 2008 to March 2009. LAP, laparoscopic surgery; OP, open surgery
Figure 2
Figure 2
Change in short‐term outcomes and conversion rate to open from laparoscopic surgery over time. First period: October 2004 to December 2005, second period: January 2006 to December 2007, third period: January 2008 to March 2009. LAP, laparoscopic surgery; OP, open surgery
Figure 3
Figure 3
Change in early postoperative complication outcomes over time. First period: October 2004 to December 2005, second period: January 2006 to December 2007, third period: January 2008 to March 2009. LAP, laparoscopic surgery; OP, open surgery
Figure 4
Figure 4
Overall survival. First period: October 2004 to December 2005, second period: January 2006 to December 2007, third period: January 2008 to March 2009. HR, hazard ratio; LAP, laparoscopic surgery; OP, open surgery
Figure 5
Figure 5
Relapse‐free survival. First period: October 2004 to December 2005, second period: January 2006 to December 2007, third period: January 2008 to March 2009. HR, hazard ratio; OP, open surgery; LAP, laparoscopic surgery

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