/ 4 *** Study IGR L Oreal R&I 1. Algorithm for dermocosmetic use in the management of cutaneous side effects associated with targeted therapy in oncology published by the Journal of the European Academy of Dermatology & Venereology and Breast Cancer: Targets and Therapy
ONCOLOGY: LA ROCHE-POSAY BY YOUR SIDE FOR BETTER SKIN THROUGHOUT CANCER Because 2/3 of cancer patients suffer from serious skin side effects caused by radiation and chemotherapy***, La Roche-Posay developed, together with dermatologists & oncologists, training for health care professionals. For patients, we offer free products and advice (via dedicated website) on how to better maintain the skin barrier function throughout their cancer treatments.
La Roche-Posay has worked alongside dermatologists for more than a decade in the detection and prevention of skin cancer. In 2013, La Roche-Posay joined forces with dermatologists and oncologists in advancing research into the cutaneous side effects of cancer treatments in order to offer adapted dermocosmetic care. Two multicenter observational studies conducted by oncologists with 400 radiotherapy and/or chemotherapy patients demonstrated the effectiveness of dermocosmetics in preventing cutaneous side effects.
La Roche-Posay has spent many months talking with and listening to women affected by cancer, taking the time to understand the toll that treatment takes on their daily lives and discovering, above all, their inability to bring it up with their oncologist as side effects are deemed secondary by patients in the face of treatment itself. La Roche-Posay has thus identified the need within the scientific community to bridge the gap between dermatology and oncology. Today dermocosmetics can play a crucial role in accompanying patients to help fight against side effects of invasive treatment. The brand is committed to training and building awareness among healthcare professionals such as doctors, nurses or pharmacists on the cutaneous side effects and how to care for them. La Roche-Posay released a consensus paper dedicated to this topic which was published by some of the most prestigious scientific journals1.
of cancer patients suffer from serious skin side effects caused by radiation and chemotherapy
HELPING CANCER PA TIENTS
ON A DAILY BASIS.
LA ROCHE-POSAY & ONCOLOGY:
The tolerance of the products when applied on the irradiated area was
evaluated as excellent to good for 92% to 97% of the patients depending
on the product.
A. BERGER(1), C. REGUEIRO(2), T. HIJAL(3), D. PASQUIER(4), P. JARDEL(1), C. DE LA FUENTE(2), C. LAMBERT(3), X. LIEM(4),
C. DEWAS(4), F. LE TINIER(4), V. PANET-RAYMOND(3), B. COCHE-DEQUEANT(4), E. LARTIGAU(4), D. MOYAL(5), S. SEITE(5), J.R. BENSADOUN(1 )
(1)CHU Poitiers, France, (2)Puerta de Hierro Hospital, Madrid, Spain, (3)McGill Hospital, Montreal, Canada,
(4)Centre Oscar Lambret, Lille, France, (5)La Roche-Posay Dermatological Laboratoires, Asnières, France,
In general, it is estimated that over 50% of patients undergoing an anti-cancer treatment develop
one or more reactions of the skin, hair or nails. These toxicities can have a physical, functional,
psychological, emotional and social negative impact. Therefore, it is common practice in
oncology to recommend to patients starting a treatment to adopt a proactive special care to
minimize the impact of cutaneous side effects and to maximize the benefit of treatment. The
objective of this multicenter observational study was to evaluate the tolerability and interest
in the use of dermo-cosmetic products in the prevention of cutaneous side effects for breast
cancer treatment by exclusive or adjuvant radiotherapy.
253 women 60 years old on average (min 34, max 85) starting radiotherapy were included
in different cancer services in France (n=122), Canada (n=69) and Spain (n=62).
95% had a tumor removal prior to radiotherapy and 5% a total mastectomy. In 92% of
cases, an adjuvant treatment was administered with radiation therapy. Average surface treated by radiotherapy
4.3 +/- 2.1 palms (Min. 1; Max. 10) Average duration of treatment 5.6 +/- 1.3 weeks (Min. 3; Max. 9) Average number of radiotherapy fractions 26.8 +/- 5.7 fractions (Min. 15; Max. 35) Average dose by irradiation
2.2 +/- 0.3 grey (Min. 1.7; Max. 3.2) Total dose received 56.9+/- 7.6 grey (Min. 42; Max. 66)Products supplied: Selenium-rich Thermal Spring Water, Cleansing Oil, Body Emollient
AP+, Healing Balm B5, Sunscreen SPF50+ Smooth lotion. Evaluations of any skin-related adverse event were performed before and after the treatment
sessions (T6 +/- 2 weeks). Physicians evaluated cancer treatment-related skin toxicities (oe-
dema, erythema, dryness, desquamation) and gave at the end of the study their opinion on
the skin benefit brought to the patients thanks to the products. At the end of the study, the
patients evaluated the benefit brought by the products using the Patient Benefit Index (PBI)
questionnaire. PBI questionnaire is about the effect of the products in reducing social,
psychological, therapy and physical impairments and in having confidence in healing. The PBI
score range goes from 0 = no benefit to 4 = important benefit. A PBI score > 1 indicates a relevant
treatment benefit. The results analysis was performed according to two categories of users;
the low users and the heavy users. These two categories were defined on the basis of the
number of products used (0 to 5) and on the frequency of usage (never used = 0; from time to
time= 0.5; often= 1; every day = 2 - score ranging from 0 to 10). Low users category (0-4.5); heavy users category (5-10).
Observed skin toxicities related to the anti-cancer therapy. A significant difference between the low users and the heavy users was
observed on the time frame of onset regarding skin secondary effects
related to the radiotherapy for the effects occurring quickly (delay ≤ 10 days). There are less skin toxicities in the case of heavy users.
EVALUATION OF NON-PHARMACEUTICAL SKIN-CARE PRODUCTS IN THE DAILY
PREVENTION, TREATMENT AND PALLIATIVE CARE OF SKIN TOXICITY DURING RADIOTHERAPY
Skin benefit brought by the products to the patient according to the physicians.
A significant difference was observed between the low users and the heavy users with a positive physician s opinion on the skin benefit respectively in 32% versus 64%.
Delay ≤ 10 days p=0.031 (S)
18.1% 7.9%
40.3% 33.1%
Delay ≤ 14 days p=0.308 (NS)
Low users (n=72) Heavy users (n=127)Difference10.2%
Difference 7.2%
% p at ie nt s
50%
40%
30%
20%
10%
0%
PBI scores. On average, there was a PBI score > 1 and a tendency for a better benefit brought by the products for the heavy users compared to the low users.
67%
14% 2%1% 1%
16%
0 I IIA IIB IIIA IIIB
Classification UICC - % patients
n=205 n=207 n=200 n=64
59%
37%
4% 0%
68%
29%
2%1%
64%
31%
3%1%
66%
26%
7% 2%
53%
41%
6% 0%
Excellent Good Medium Bad
70%
60%
50%
40%
30%
20%
10%
0% n=156
% p at ie nt s
Selenium-rich Thermal
Spring Water
Cleansing Oil Body Emollient AP+
Healing Balm B5
Sunscreen SPF50+
Smooth lotion
Evaluation of the products tolerance on the irradiated zone
Results obtained on 253 patients initiating an exclusive or adjuvant radiotherapy following a breast cancer have shown an
excellent tolerance of the products applied on the irradiated area and the interest of the dermocosmetic products in particular to
delay the onset of the cutaneous side effects. The heavy users presented benefits more important than low users. These results
support the international recommendations and importance to use adequate skin care products to minimize the impact of secondary
cutaneous reactions.
Time frame to event onset from radiotherapy start
Neutral opinion
66%
Negative opinion 2%
Positive opinion
32%
Low users n=90
Neutral opinion
32%
Negative opinion 4%
Positive opinion
64%
Heavy users n=141
86.4%
13.6%
Relevant treatment benefit (PBI>1) No relevant treatmentbenefit (PBI≤1)
Low users n=88
PBI 2.7±1.2
93%
7%
Relevant treatment benefit (PBI>1) No relevant treatment benefit (PBI≤1)
Heavy users n=143
PBI 2.9±1.2
p = 0.095
p≤0.0001 (S)
INTRODUCTION
PATIENTS AND METHODS
RESULTS
CONCLUSION
19%
14%
62%
5%EVALU ATION
OF NO N-PHA
RMAC EUTIC
AL SK IN-CA
RE PR ODUC
TS IN THE D
AILY P REVEN
TION
TREAT MENT
AND P ALLIA
TIVE C ARE O
F SKIN TOXIC
ITY DU RING
CHEM OTHE
RAPY
V. DEL L ACQ
UA 1, D. LÜ
FTNER 2, F. SE
LLE 3, A. KH
ALIL 3, M.C.
LEON ARDI
1, A. DE LA TO
RRE T OMÁS
4, M. VE RGOU
LIDOU 2, G. SH
ENOU DA
5, J. RO MERO
FERN ANDE
Z4, R. OREC
CHIA 1, D. MO
YAL 6, S. SE
ITE 6
INTRO DUCTI
ON
PATIEN TS AN
D MET HODS
RESUL TS
CONC LUSIO
N
In gen eral, it
is esti mated
that o ver 50
% of p atients
under going
an ant i-canc
er trea tm nt
develo p one
or mor e react
ions of the sk
in, hair or nai
ls. The se toxi
cities c an hav
e a phy sical, f
unctio nal, ps
ycholo gical, e
motion al and
social negat
ive imp act. Th
erefor e,
it is co mmon
prac i ce in o
ncolog y to re
comm end to
patien ts star
ting a treatm
ent to adopt
a proa ctive s
pecial care t
o mini mize t
he imp act of
cutane ous sid
e effec ts and
to ma ximize
the be nefit o
f treatm ent. Th
e obje ctive o
f this m ulticen
ter obs ervatio
nal
study was to
evalua te the
tolerab ility an
d inter est in t
he use of der
mocos metic
produ cts in t
he pre ventio
n of cu taneou
s side effects
for ca ncer tr
eatme nt by c
hemot herapy
.
These result
s obta ined o
n 147 p atients
during a chem
othera py alo
ne or a t the s
ame ti me or
after a radiot
herapy have s
hown a n exce
llent to leranc
e of th e prod
ucts u sed an
d the i nteres
t of the dermo
cosme tic pro
ducts in part
icular to
improv e the c
linical signs.
The h eavy u
sers pr esente
d bene fits mo
re imp ortant
than l ow use
rs. The se resu
lts sup port th
e inter nation
al reco mmen
dation s and t
he imp ortanc
e to us e adeq
uate sk in care
produ cts to m
inimiz e the i
mpact
of seco ndary
cutane ous re
action s.
(1)Istituto Europ
ea Di O ncolog
ia, Mila n, Italy
, (2)Cha rité Co
mpreh ensive
Cancer Center
, Berlin , Germ
any, (3)Tenon
Hospit al, Par
is, Fran ce,
(4)Puerta de Hie
rro Hos pital, M
adrid, S pain,
(5)McGill Hospit
al, Mon treal, C
anada , (5)
La Roc he-Pos
ay Der matolo
gical L aborat
ories, A snières
, Franc e
147 su bjects
(Male n=43
, Fema le n=1
04) 59 years
old a verage
(min 28,
max 8 4) wer
e inclu ded in
differe nt can
cer ser vices i
n Fran ce (n=
48), It aly
(n=43 ), Ger
many (n=36
), Spa in (n=
19) an d Can
ada (n =9). 3
9% of the
subjec ts had
fema le can
cer (o vary,
breast etc.),
31% had d
igestiv e
syste cance
r, 20% had h
ead an d neck
cance r and 1
0% ha d othe
r canc er
(leuke mia, p
ancrea s etc.).
Moreo ver, 61
% had fair sk
in (skin type I
to III) a nd
39% h ad dar
k skin (skin t
ype IV to VI).
Therap eutic t
reatme nt type
s (n=14 7)
Chemo therap
y proto col and
molec ules
Numb er of p
lanned cycles
5.3 ± 3 .3 cycl
es (Min : 1; Ma
x: 16)
Cycle d uration
19.2 ± 8.0 da
ys (Min : 5; Ma
x: 51)
88% o f patie
nts sta rted a
standa rd che
mothe rapy, 2
7% fol lowed
a Mon oCT
protoc ol whe
reas 7 3% a
PolyCT one.
80% u sed al
kylatin g agen
ts, 44%
used a ntimet
abolite s, 30%
used s pindle
poiso n, 21%
used D NA mo
difiers
and 12 % use
d othe r mole
cules.
Produ cts sup
plied
A kit of 12
produ cts wa
s sup plied
before the
first t reatme
nt: LR P
Therm al Spr
ing W ater, B
ody B alm A
P+, C leansin
g Oil, Heali
ng Ba lm
B5, S unscre
en SP F50+
lotion, Daily
skin care
for se nsitive
skin
contai ning
Neuro sensin
e and LRP
Ther mal S
pring Water,
Derm o-
cleans er fo
r sen sitive
skin, Sunsc
reen Melt-in
crea m SP
F50+,
Extra gentle
sham poo,
Hands crea
m, Po dologi
c cre am, S
ilicium
colorle ss nail
polish (in on
e cent re only
).
Evalua tions
At the initiatio
n and at the
end (T 9 +/- 3
weeks later)
of the study,
physic ians
evalua ted ca
ncer-tr eatme
nt rela ted sk
in tox icities
(oedem a, ery
thema ,
drynes s, desq
uamat ion, pi
gment ation d
isorde rs and
cracks ). Cuta
neous
comfo rt and
toleran ce of t
he pro ducts
suppli ed, ph
ysician overal
l opini on,
patien t satis
faction (via th
e Patie nt Ben
efit Ind ex) we
re rep orted.
Patien t
Benefi t Inde
x (PBI ) ques
tionna ire is a
bout t he eff
ect of the pr
oducts in
reduci ng so
cial, p sychol
ogical , thera
py and physi
cal im pairme
nts an d
in hav ing co
nfiden ce in h
ealing . The P
BI sco re ran
ge go es from
0 = n o
benefi t to 4
= imp ortant
bene fit. A
PBI sc ore >
1 indic ates a
releva nt
treatm ent be
nefit. The re
sults a nalysis
was p erform
ed acc ording
to tw o
catego ries of
users define
d on t he bas
is of th e num
ber of produ
cts use d
and on the fr
equen cy of u
sage: l ow use
rs cate gory (0
to 6 p roduct
s used
often o r every
day), h eavy u
sers ca tegory
(7 or m ore us
ed ofte n or ev
eryday ).
Freque ncy of
use of the pr
oducts and di
stribut ion of
the low and he
avy us ers
The fiv e prod
ucts m ost oft
en use d were
: 1. Cl eansin
g Oil; 2. Han
ds cre am; 3.
Body
Balm AP+; 4
. Extra gentl
e sham poo; 5
. Podo logic c
ream. 72% o
f patie nts us
ed 5
produc ts or m
ore du ring th
e study and 44
% used 7 prod
ucts or more,
often or ever
y day.
(n=147 )
n %
% Wom en %
Men
Low u sers
79 54
57 43
Heav y users
63 43
90 10
Not e valuab
le 5
3
At bas eline,
40 pa tients
(27%) decla
red at least
one sk in reac
tion. D uring
the tim e
course of th
e stud y, 44
patien ts (31%
) decl ared a
n agg ravatio
n of s kin re
action s.
The p ercent
age o f patie
nts wi th agg
ravatio n is s
ignific antly
lower for th
e hea vy
users of pro
ducts (22%)
in co mparis
on to the lo
w use rs (40
%) (p= 0.029
5). Th is
differe nce be
tween the 2
groups is part
icularl y obse
rved fo r eryth
ema (p =0.015
9) and
desqu amatio
n (p=0 .0275)
.
Aggrav ation o
f the c linical
signs
Low us ers
Heavy users
p = 0.0 295 (S
)
22%
40%
mean differe
nce
17.3%
60%
40%
20%
0%
% o
f p at
ie nt
s
Evolut ion sum
mary o f the c
linical signs
Heavy users
Low users
Clinica l signs
appea red mo
re ofte n on lo
w user s than
on hea vy use
rs (p=0 .0177)
The o verall
opinio n of t
he ph ysician
s, at t he en
d of t he stu
dy, ab out th
e skin
benefi t broug
ht to th e patie
nts tha nks to
the pro ducts k
it was s ignific
ant (p< 0.000
1) and
signifi cantly
bette r for th
e heav y user
s with 100%
of go od opi
nion th an for
the lo w
users w ith 92%
of goo d opin
ion (p= 0.009
4).
Low us ers
n=77
Heavy users
n=63 8%
14%
78%
Very g ood
Good
Quite g ood
Neithe r good
nor ba d
In ave rage,
there was a
PBI> 1 (me
an sco re 3 +
/-1) in dicatin
g a re levant
bene fit
afford ed by
produ cts to
the pa tients.
In add ition, i
n the h eavy u
sers g roup, 1
00% o f
patien ts noti
ced a r elevan
t bene fit brou
ght by the pr
oducts with a
globa l PBI s
core 3 .2
in com pariso
n to 91 .8% of
patien ts with
a glob al scor
e 2.8 f or the
low us ers.
Low us ers
n=73
Heavy users
n=61
8,2%
91,8%
100%
Releva nt trea
tment
benefi t (PBI>
1)
No rel evant t
reatme nt
benefi t (PBI≤
1)
PBI sc ore
2.8±1. 1
p=0.0 495 (S
) PBI sc
ore
3.2±0 .7
Therm al Spr
ing
Water (n=94
)
Lipika r
Clean sing O
il
(n=12 7)
Lipika r Balm
AP+
(n=13 0)
Cicap last
Balm B5
(n=11 3)
Anthe lios S
PF 50 +
Smoo th
lotion (n=44
)
Anthe lios m
elt-
in cre am
SPF 5 0+ (n
=58)
Toler iane U
ltra
(n=119 )
Toler iane
Derm o-Cle
anser
(n=11 4)
Keriu m Ext
ra
Gentl e Sha
mpoo
(n=13 1)
Lipika r Xera
nd
(hand s)
(n=13 1)
Lipika r
Podol ogics
(feet) (n=11
9)
Siliciu m
colorl ess na
il
polis h (N=
31)
Siliciu m col
orless nail p
olish (N=31
)*
*Admin
istrete d in on
ly one cente
r
70%
60%
50%
40%
30%
20%
10%
0%
Evalua tion of
produ cts tol
erance on the
whole body
The pr oducts
tolera nce on
the wh ole bo
dy
was ra ted go
od to e xcellen
t by m ore
than 8 9% of
the pa tients.
15% 16% 3%
31% 35
CT alo ne
Neoad juvant
CT
Adjuva nt CT
Conco mitant
RT-CT
Seque ntial R
T-CT
Excell ent
Good
Mediu m
Bad
} Apparition of one or several signsPresence of at least one sign at both visitsAbsence of all signs at both visits Disapp
earanc e
}11% 35% 22%
32%
58%
8% 13%
21%
p=0.0 220 (S
) 15%
16% 3%
31% 35
CT alo ne
Neoad juvant
CT
Adjuva nt CT
Conco mitant
RT-CT
Seque ntial R
T-CT
RT: Ra diothe
rapy C T: Che
mothe rapy
2/3
radiotherapy and/or chemotherapy patients
multicenter observational studies2
400