National Cancer Institute - NCI Division of Cancer Treatment and ...

LV, a less burdensome treatment regimen,
would lead to the same improvement in
three-year DFS.
Following MOSAIC, CTEP sponsored a
trial known as NSABP C-07, which was a
randomized prospective study designed
to determine whether bolus 5-FU/LV plus
oxaliplatin (FLOX) would increase threeyear
DFS compared to a bolus schedule
of 5-FU/LV alone.
More than 2400 patients with early-stage
colon cancer were randomized to receive
either bolus 5-FU/LV or FLOX. The primary
endpoint was DFS. Events were defined as
first recurrence, second primary cancer, or
death. The median follow-up for patients
who were still alive was 34 months. Threeyear
DFS was 76.5 percent for the group
of patients who received FLOX and 71.6
percent for the group who received bolus
5-FU/LV.
The addition of oxaliplatin to weekly bolus
5-FU/LV significantly improved three-year
DFS in patients with stage II and III colon
cancer. The NSABP C-07 trial confirmed
and extended the results of the MOSAIC
trial by demonstrating that oxaliplatin
in combination with a bolus schedule of
5-FU/LV resulted in a similar benefit for
patients with early-stage colon cancer.
Wolmark N, Wieand HS, Kuebler JP, Colangelo
L, Smith RE. A phase III trial comparing FULV to
FULV + oxaliplatin in stage II or III carcinoma of
the colon: results of NSABP Protocol C-07. Proc
Am Soc Clin Oncol 2005:23;246S.
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Perioperative recovery was faster in the laparoscopic-surgery
group than in the open-colectomy group, as reflected by
shorter hospital stays and briefer use of parenteral narcotics
and oral analgesics.
Laparoscopic Colectomy Is an
Acceptable Alternative to Open
Colectomy for Colon Cancer
The Clinical Outcomes of Surgical Therapy
Study Group, through the CTEP clinical
trials cooperative groups, conducted a trial
at 48 institutions that randomly assigned
872 patients with adenocarcinoma of the
colon to undergo traditional open or laparoscopically
assisted colectomy performed
by credentialed surgeons.
This prospective, randomized trial found
that laparoscopic colectomy was a safe
alternative to open colectomy for patients
with curable colon cancer. The primary
endpoint of the study was time to tumor
recurrence. Based on a median follow-up
of 4.4 years, the rates of tumor recurrence
at three years were similar in the two
groups—16 percent among patients in
the group that underwent laparoscopic
surgery and 18 percent among patients
who received traditional surgery. There
was no significant difference between
groups in the time to recurrence or
OS for patients with any stage of cancer.
Perioperative recovery was faster in the
laparoscopic-surgery group than in the
open-colectomy group, as reflected by
shorter hospital stays and briefer use of
parenteral narcotics and oral analgesics.
Clinical Outcomes of Surgical Therapy Study
Group. A comparison of laparoscopically assisted
and open colectomy for colon cancer. N Engl J
Med 2004:350;2050–9.
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