COST
Clinical Outcomes of Surgical Therapy (COST) Study: laparoscopically assisted versus open colectomy for colon cancer
Phase 3N = 872NCT00002575
- Population
- 872 patients with adenocarcinoma of the colon; the 2007 abstract describes them as having curable colon cancer.
- Design
- Non-inferiority randomised trial at 48 institutions of laparoscopically assisted versus open colectomy, performed by credentialed surgeons. Primary endpoint time to tumour recurrence; median follow-up 4.4 years in the 2004 report; the 2007 report followed patients for 8 years (median 7 years). ClinicalTrials.gov lists phase 3 and an enrolment of 810; the paper reports 872 randomised.
- Primary endpoint
- Time to recurrence
- Arms
- Open colectomy (control): Open colectomy
- Laparoscopically assisted colectomy (experimental): Laparoscopically assisted colectomy
- People
- Clinical Outcomes of Surgical Therapy Study Group, Clinical Outcomes of Surgical Therapy Study Group
3-year recurrence rateHR 0.86 (95% CI 0.63–1.17)Δ 3-year recurrence rate−2 pointsOSHR 0.91 (95% CI 0.68–1.21)Δ 36-month OS+1 pointsΔ 60-month DFS+0.8 pointsΔ 60-month OS+1.8 points
Show the numbers
| Endpoint | Analysis | Laparoscopically assisted colectomy | Open colectomy | Effect |
|---|---|---|---|---|
| 3-year recurrence rateRandomised patients with adenocarcinoma of the colon (872); the abstract does not label the analysis population | primarymedian follow-up 4.4 yearsClinical 2004 | 16% | 18% | HR 0.86 (95% CI 0.63–1.17)P=0.32The primary endpoint was time to tumour recurrence in a non-inferiority design. The abstract does not state the comparison direction for the recurrence hazard ratio (for death it says 'in the laparoscopic-surgery group'). Recurrence in surgical wounds was under 1 percent in both groups (P=0.50). |
| OSRandomised patients with adenocarcinoma of the colon (872); the abstract does not label the analysis population | primarymedian follow-up 4.4 yearsClinical 2004 | 86% at 3 y | 85% at 3 y | HR 0.91 (95% CI 0.68–1.21)P=0.51Overall survival is described as a secondary endpoint in the 2007 report (PMID 17893502); the primary endpoint was time to tumour recurrence. The abstract names the laparoscopic-surgery group for this hazard ratio. |
| DFSPatients with curable colon cancer randomised in COST (872) | long term-updatemedian follow-up 7 yearsFleshman 2007 | 69.2% at 5 y | 68.4% at 5 y | P=0.94Median follow-up of 7 years (range 5-10) as published; 5-year data on 90% of patients. Secondary endpoint (the primary endpoint was time to recurrence). |
| OSPatients with curable colon cancer randomised in COST (872) | long term-updatemedian follow-up 7 yearsFleshman 2007 | 76.4% at 5 y | 74.6% at 5 y | P=0.93Secondary endpoint. |
| Endpoint | Analysis | Laparoscopically assisted colectomy | Open colectomy | Effect |
|---|---|---|---|---|
| 3-year recurrence rateRandomised patients with adenocarcinoma of the colon (872); the abstract does not label the analysis population | primarymedian follow-up 4.4 yearsClinical 2004 | 16% | 18% | HR 0.86 (95% CI 0.63–1.17)P=0.32The primary endpoint was time to tumour recurrence in a non-inferiority design. The abstract does not state the comparison direction for the recurrence hazard ratio (for death it says 'in the laparoscopic-surgery group'). Recurrence in surgical wounds was under 1 percent in both groups (P=0.50). |
| OSRandomised patients with adenocarcinoma of the colon (872); the abstract does not label the analysis population | primarymedian follow-up 4.4 yearsClinical 2004 | 86% at 3 y | 85% at 3 y | HR 0.91 (95% CI 0.68–1.21)P=0.51Overall survival is described as a secondary endpoint in the 2007 report (PMID 17893502); the primary endpoint was time to tumour recurrence. The abstract names the laparoscopic-surgery group for this hazard ratio. |
| DFSPatients with curable colon cancer randomised in COST (872) | long term-updatemedian follow-up 7 yearsFleshman 2007 | 69.2% at 5 y | 68.4% at 5 y | P=0.94Median follow-up of 7 years (range 5-10) as published; 5-year data on 90% of patients. Secondary endpoint (the primary endpoint was time to recurrence). |
| OSPatients with curable colon cancer randomised in COST (872) | long term-updatemedian follow-up 7 yearsFleshman 2007 | 76.4% at 5 y | 74.6% at 5 y | P=0.93Secondary endpoint. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| 3-year recurrence rate | 0.86 | 0.63–1.17 |
| OS | 0.91 | 0.68–1.21 |
Appears in
Sources
Clinical Outcomes of Surgical Therapy Study Group, Nelson H, Sargent DJ, Wieand HS, Fleshman J, Anvari M, et al. A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med. 2004;350(20):2050-9.
Fleshman J, Sargent DJ, Green E, Anvari M, Stryker SJ, Beart RW Jr, et al. Laparoscopic colectomy for cancer is not inferior to open surgery based on 5-year data from the COST Study Group trial. Ann Surg. 2007;246(4):655-62; discussion 662-4.