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More patients with rectal cancer are
candidates for a watch-and-wait approach
R
eal-world data from the large,
observational International Watch and
Wait Database Consortium suggests
that omitting surgery in strictly selected
patients with a clinical complete response
does not compromise outcomes.
Maxime Van Der Valk, MD, of Leiden
University Medical Center, The Netherlands,
explained that rectal cancer treatment
strategies vary widely across and within
countries, but surgery is a standard component
of care. In most countries, patients with stage
2–4 rectal cancer receive chemotherapy and/
or radiation before surgery.
Though in about 20% of patients, the
tumour disappears completely disappears
after presurgery therapy, it is not standard to
reassess or restage the tumour to determine
whether surgery is still needed.
The 3-year survival rate among patients
who received watch-and-wait care after
initial cancer treatment was 91%, similar
to historic survival rates for patients who
undergo surgery. This is welcome news, as
rectal surgery carries the risk of debilitating
complications, such as colostomy and urinary
and sexual problems.
The International Watch and Wait Database
includes 35 institutions in 11 countries.
The database was established in 2014 and
is the largest series of patients with rectal
cancer for whom surgery was omitted after
chemotherapy and radiation.
The analysis included 802 patients with
no signs of residual cancer after induction
treatment, based on physical exam, endoscopy,
or MRI or CT scans following chemotherapy
and radiation. All patients received watch-
and-wait care, which included intensive
monitoring for cancer recurrence. In the
first 2 years, patients visited the hospital
every 3 months for endoscopy, MRI scans,
and physical exams.
Watch and wait is not yet a standard of care
for patients with rectal cancer in any country,
and is used in fewer than 5% of patients.
No universal watch-and-wait strategy has
been adopted for rectal cancer. Worldwide,
presurgery treatment varies significantly,
as well as approaches for determining
whether a tumour regresses or disappears
after chemoradiation and for monitoring for
recurrence.
After a median follow-up of 2.6 years, 25%
of patients underwent delayed surgery for
recurrence. Distant metastases had occurred
in 7% (n=49) of patients. The 3-year survival
rate was 91% among all patients, and 87%
among those who experienced local cancer
recurrence. This is consistent with historic
data from patients who undergo surgery.
Dr van der Valk said, “Despite the excellent
outcomes in our study, the decision to
undergo surgery is personal. Faced with the
risk of permanent colostomy, some patients
avoid surgery. Others opt not to deal with the
uncertainty of potential recurrence.”
The consortium continues to collect all
available prospective and retrospective data
on watch-and-wait strategies in rectal cancer.
Further data collection and analysis may
inform international guidelines on treatment
and surveillance for patients with rectal
cancer.
PracticeUpdate Editorial Team
Adjuvant GemOx does not improve relapse-free survival in localised
biliary tract cancer
N
o significant difference in relapse-free
survival was observed between gem-
citabine and oxaliplatin (GemOx) and
surveillance in a multicentre, randomised
phase 3 trial in patients with localised biliary
tract cancer, reports outcome of PRODIGE
12-ACCORD 18.
Julien Edeline, MD, of Eugene Marquis
Comprehensive Cancer Center, Rennes,
France, explained that no standard postsur-
gery adjuvant treatment is recommended in
localised biliary tract cancer. Gemcitabine
combined with platinum is the standard
chemotherapy for advanced biliary tract
cancer.
Dr Edeline and colleagues set out to deter-
mine whether GemOx would improve
relapse-free survival while maintaining
health-related quality of life. “Despite the
high risk of relapse,” he said, “there is no
proven adjuvant therapy after surgery for bil-
iary tract cancer.”
Patients were randomised within 3 months
of R0 or R1 resection of a localised biliary
tract cancer (intrahepatic, perihilar, extra-
hepatic cholangiocarcinoma or gallbladder
cancer) to either GemOx 85 for 12 cycles
(experimental armA) or surveillance (stand-
ard arm B).
Coprimary endpoints were relapse-free
survival and health-related quality of life. A
total of 190 patients and 126 relapse-free
events were required to show an increase
in median relapse-free survival from 18 to
30 months.
Between 2009 and 2014, 196 patients were
included in 33 French centres. Baseline
characteristics were balanced, with similar
primary sites. R0 resection rates were 86.2%
(arm A) vs 87.9% (arm B).
Lymph node invasion was present in 37.2%
vs 36.4%, in arm A, a median of 12 (mean
9.3, range 0–12) cycles were delivered. Max-
imal grade of adverse events was grade 3 in
57.5% vs 22.2%, and grade 4 in 17.0% vs
9.1%, respectively.
One patient died in each arm. The main
grade 7.0% vs 9.1% French centres.
Median follow-up duration was 44.3
months, with 54 and 64 relapse-free sur-
vival events in arm A vs B, respectively. No
significant difference in relapse-free survival
was observed between arms.
Median relapse-free survival was 30.4 (95%
CI 15.4–45.8) vs 22.0 months (95% CI
13.6–38.3) in arms A and B, respectively.
After 4-years, relapse-free survival was
39.3% (95% CI 28.4% –50.0%) vs 33.2%
(95% CI 23.1–43.7%). Global Health
health-related quality of life scores did not
differ at 12 (70.8 vs 83.3) or 24 months
(75.0 vs 83.3).
Dr Edeline said, “Adjuvant chemotherapy
using GemOx for biliary tract cancer was
feasible and associated with expected tox-
icities and no deterioration of health-related
quality of life.”
He continued, “No significant difference
in relapse-free survival was observed, how-
ever, between GemOx and surveillance in
patients with localised biliary tract can-
cer. New trials are required to improve the
results in localised biliary tract cancer.
“Results of this first large phase III trial of a
modern regimen in the adjuvant setting lead
to the conclusion that adjuvant chemother-
apy cannot be recommended in biliary tract
cancer.”
PracticeUpdate Editorial Team
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