News
2010 ASCO Annual Meeting
The 45th annual meeting of the
American Society of Clincal
Oncology was held on June 4–8,
2010, in Chicago, IL, USA
616
Maintenance rituximab
Maintenance rituximab improves
progression-free survival (PFS) in
patients with follicular lymphoma
who are responding to first-line
immunochemotherapy, according to
findings from the PRIMA trial. With a
median age of 56 years (range 22–87),
1018 patients were randomly assigned
to either 2 years of maintenance
rituximab or observation. 75% of
patients had previously received
R-CHOP. 2-year PFS, the primary
endpoint, was 82% (95% CI 78–86) for
the treatment group versus 66% (61–
70) for the observation group (hazard
ratio [HR] 0·50, 95% CI 0·39–0·64).
Infections were seen in 22% of the
control group versus 37% of those on
rituximab maintenance; grade 3–4
toxicities were noted in 16% and 22%,
respectively.
Sentinel node trial findings
Findings from the ACOSOG Z0011
and NSABP B-32 trials suggest axillary
lymph node dissection (ALND) can be
safely omitted in certain subsets of
patients with breast cancer. In the B-32
study, David Krag (Burlington, VT, USA)
and colleagues randomly assigned
5611 patients to either sentinel node
biopsy (SLNB) plus ALND or to SLNB
alone, with only those who were
node-positive subsequently having an
ALND. 3989 of the 5611 women had
negative nodes. 5-year overall survival
(OS) was 96·4% for the SLN plus ALND
group versus 95% and 5-year DFS was
89% versus 88·6%, respectively. In the
second study, reported by Armando
Giuliano (Santa Monica, CA, USA)
and colleagues, patients with one
or two SLNs with metastases after
SLNB were randomly assigned to
either ALND (n=445) or to no further
treatment (n=446). All patients had a
lumpectomy and opposing tangential
field irradiation. Median follow-up was
6·2 years. The study was underpowered,
but there were no differences between
groups for OS, DFS, or local-regional
recurrence; 5-year recurrence in the
breast was 3·7% for SLNB plus ALND
versus 2·1% for SLNB alone. “This study
does not support the routine use of
ALND in early nodal metastatic breast
cancer”, commented Giuliano.
Ipilimumab and melanoma
Ipilimumab—a human monoclonal
antibody that blocks T-cell inhibition
and potentiates T-cell activity—
significantly improves OS in patients
with pretreated, unresectable, advanced
melanoma, according to Steven O’Day
(Los Angeles, CA, USA) and colleagues.
Patients with stage III or IV melanoma
were randomly assigned in a 1:3:1
ratio to either ipilimumab plus placebo
(n=137), ipilimumab plus peptide
vaccine gp100 (n=403), or gp100
plus placebo (n=136). Median OS, the
primary endpoint, was 10·1 months,
10·0 months, and 6·4 months in each
of the three groups, respectively. At
4·5 years the survival curves remain
separated, commented O’Day.
Significant differences were also noted
in the disease control rate (DCR) and PFS
for ipilimumab-treated patients versus
gp100-treated patients. Treatment-
related grade 3–4 toxicities were noted
in 22·9%, 17·4%, and 11·4% of patients,
respectively, and treatment-related
deaths were noted in 1–3% of the trial
population. Two-thirds of the patients
in the ipilimumab groups had immune-
related adverse events; those of grade
1–2 were generally reversible and those
of grade 3–4 could be controlled by
steroids. The discussant of this trial,
Vernon Sondak (Tampa, FL, USA),
noted that only HLA-A*0201+ patients
participated, but said that there was
no sign that this patient group was
unrepresentative.
Oral ALK inhibitor in lung cancer
PF-1066 (crizotinib), an oral ATP-
competitive inhibitor of the ALK
and MET/HGF pathways, showed
activity in heavily pretreated patients
with non-small-cell lung cancer who
harboured the EML4–ALK fusion gene,
according to findings, reported by
Yung-Jue Bang (Seoul, South Korea),
and colleagues from an expanded
phase 2 study of the first-in-human
monotherapy trial with the inhibitor.
To date, 82 patients have been enrolled
in the study (age 51 years [25–78]);
96% had adenocarcinoma. The overall
response rate was 57% (95%CI 46–68)
with a 6-month PFS of 72% (61–83)
and DCR at 8 weeks of 87%. Median
PFS has not yet been reached. The
most common toxicities included
nausea, vomiting, and diarrhoea. An
estimated 3–5% of patients have this
fusion, but the discussant of this study,
Martin Edelman (Baltimore, MD,
USA), says that the actual numbers
represented by this percentage should
be considered when weighing up the
importance of the findings.
EMBRACE trial
Eribulin mesylate significantly
improves OS in patients with locally
recurrent or metastatic breast cancer,
according to findings reported by
Chris Twelves and colleagues (Leeds,
UK) from the EMBRACE phase 3 trial.
Patients were randomly assigned in
a 2:1 ratio to receive either eribulin
mesylate—a microtubule inhibitor—or
treatment according to the physician’s
choice (TPC). 762 patients received
treatment. The trial population was
heavily pretreated with a median
of four previous treatments; 73%
had previous capecitabine therapy.
Median OS, the primary endpoint, was
13·1 months for the eribulin-treated
patients versus 10·7 months (HR
0·81, 95% CI 0·66–0·99). Median PFS
was 3·7 months versus 2·3 months
(0·85, 0·70–1·03). Grade 3–4 asthenia
and fatigue were noted in 7·6%
of the eribulin-treated group and
neutropenia in 44%. 10% had serious
treatment-related adverse events
compared with 7% in the TPC group.
Emma Grainger
www.thelancet.com/oncology Vol 11 July 2010