due to be treated with cisplatin-
based HEC, Karthaus et al reported
that, in the acute phase, the
majority of patients (89.4% in the
oral palonosetron group and 86.2%
in the IV palonosetron group)
achieved a CR. The non-inferiority
of oral palonosetron compared
with IV palonosetron was thus
demonstrated, as assessed by the
primary efficacy endpoint (CR
in the acute phase) in both the
full analysis set and per-protocol
populations. All the planned
sensitivity analyses supported
the non-inferiority of oral
palonosetron compared with IV
palonosetron. The two treatment
groups also showed comparable
CR in the delayed (76.2% oral vs
74.8% IV) and overall phases (73.7
oral vs 70.2 IV), and the results of
the secondary efficacy endpoints
in all three phases were similar.
Thus, the results of the secondary
efficacy endpoints also support the
demonstration of non-inferiority. 24
The safety of IV palonosetron
has been demonstrated in several
Phase III clinical trials. 20,25–27
Karthaus et al comment that
their study further supports these
findings as the safety profiles
of oral palonosetron and IV
palonosetron were comparable and
raised no new concerns. 24
The use of orally administered
antiemetics for prophylaxis of
nausea and emesis in patients
receiving HEC treatment, in
particular, for the control of
38 | 2019 | hospitalpharmacyeurope.com
nausea and vomiting on the first
day of cisplatin treatment has been
questioned. 28 The study by Karthaus
et al clearly demonstrated the non-
inferiority of oral palonosetron
versus IV palonosetron
administration when both are
used with dexamethasone. 24 The
use of oral palonosetron might
be beneficial, as it would allow
a more convenient prophylaxis,
which is proven to be effective
in controlling CINV caused by
HEC. This may be of particular
help for patients who receive
treatment in an outpatient setting.
A similar study of efficacy and
safety assessing the non-inferiority
of oral versus IV formulations of
palonosetron has been performed
also in the MEC setting. 29
Oral combination therapy might
be another attractive option for
some patients and there is some
evidence that fixed combinations
can encourage improved
adherence compared with giving
drugs separately. 30
Because their mechanisms
of action target different
neurotransmitter pathways
involved in nausea and vomiting,
combination therapy with a NK 1
RA and 5-HT 3 RA represents a
rational therapeutic strategy. 31,32
For example, NEPA (an oral
fixed combination of netupitant
300mg and palonosetron
0.5mg) given on day one of each
chemotherapy cycle together with
dexamethasone, was effective and