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Mollah e al. In e na ional Jou nal o Cu en Pha maceu ical Re iew and Resea ch
346
O iginal Resea ch A icle
A Clinico-Epidemiological S udy o Tumou PD-LI S a us in B eas
Cance
Golam Kib ia Mollah1, U am Mondal2, Abhishek Choudhu y3
1RMO Cum Clinical Tu o , M.S. (Gene al Su ge y), Depa men o Gene al Su ge y, Medical College,
Kolka a-700073
2Assis an P o esso , M.S. (Gene al Su ge y), Depa men o Gene al Su ge y, Medical College, Kolka a-
700073
3Resea ch Schola , M.Sc., Depa men o Zoology, Ballygunge Science College Campus, Uni e si y o
Calcu a, Kolka a-700019
Recei ed: 01-07-2025 / Re ised: 16-08-2025 / Accep ed: 01-09-2025
Co esponding Au ho : D . Golam Kib ia Mollah
Con lic o in e es : Nil
Abs ac
In oduc ion: B eas cance con inues o be he mos common malignancy among women globally and
ep esen s a signi ican cause o cance - ela ed mo ali y. I s he e ogenei y, encompassing di e se molecula
sub ypes and clinical beha io s, poses conside able challenges in diagnosis, p ognos ica ion, and ea men
selec ion.
Aims: To in es iga e he exp ession o PD-L1 and i s associa ion, i any, wi h he p ognosis o b eas ca cinoma
o a pa ien .
Ma e ials and Me hods: The p esen s udy was an ins i u ion based desc ip i e, c oss-sec ional and
obse a ional s udy. This S udy was conduc ed omJanua y 2020 o June 2021 a Medical College & Hospi al,
Kolka a. To al 52 pa ien s we e included in his s udy.
Resul : In ou s udy o 52 b eas ca cinoma pa ien s, PD-L1 exp ession was no signi ican ly associa ed wi h
age, socioeconomic s a us, pain, ulce a ion, o umo size. In asi e duc al ca cinoma was he p edominan
sub ype (78.8%), ollowed by lobula (17.3%) and medulla y ca cinoma (3.8%). A s ong associa ion was
obse ed be ween PD-L1 posi i i y and HER2 exp ession, as 75% o HER2-posi i e cases we e PD-L1 posi i e.
Impo an ly, PD-L1 posi i i y was linked o mo e agg essi e disease ea u es, including signi ican ly highe
nodal in ol emen (mean 10.88 s. 4.75, p < 0.0001) and inc eased dis an me as asis, pa icula ly o he lung
(31.3%) and bone (12.5%).
Conclusion: In conclusion, ou s udy demons a ed ha PD-L1 exp ession in b eas ca cinoma was no
signi ican ly in luenced by age, socioeconomic s a us, umo size, pain, o ulce a ion. Howe e , impo an
clinicopa hological co ela ions we e no ed. PD-L1 exp ession showed a s ong associa ion wi h HER2
posi i i y, sugges ing a po en ial link be ween hese bioma ke s.
Keywo ds: B eas cance . PD-L1, HER2, Me as asis, P ognosis, Bioma ke .
This is an Open Access a icle ha uses a unding model which does no cha ge eade s o hei ins i u ions o access and dis ibu ed unde
he e ms o he C ea i e Commons A ibu ion License (h p://c ea i ecommons.o g/licenses/by/4.0) and he Budapes Open Access
Ini ia i e (h p://www.budapes openaccessini ia i e.o g/ ead), which pe mi un es ic ed use, dis ibu ion, and ep oduc ion in any medium,
p o ided o iginal wo k is p ope ly c edi ed.
In oduc ion
B eas cance con inues o be he mos common
malignancy among women globally and ep esen s
a signi ican cause o cance - ela ed mo ali y [1].
I s he e ogenei y, encompassing di e se molecula
sub ypes and clinical beha io s, poses conside able
challenges in diagnosis, p ognos ica ion, and
ea men selec ion [2]. Recen ad ances in
immuno-oncology ha e highligh ed he pi o al ole
o immune checkpoin pa hways, pa icula ly he
p og ammed cell dea h p o ein 1 (PD-1) and i s
ligand PD-L1, in modula ing he umo
mic oen i onmen and in luencing disease
p og ession [3]. The in e ac ion be ween PD-1 on T
cells and PD-L1 on umo cells allows umo s o
e ade immune su eillance, he eby p omo ing
umo g ow h and me as asis [4]. E alua ing PD-L1
exp ession in b eas cance is he e o e essen ial o
iden i y po en ial he apeu ic a ge s and p edic
clinical ou comes [5]. PD-L1 exp ession has been
ound o co ela e wi h se e al clinicopa hological
pa ame e s. Highe PD-L1 exp ession is equen ly
associa ed wi h agg essi e umo ea u es,
including la ge umo size, highe his ological
g ade, and he p esence o lymph node me as ases
[6]. Fu he mo e, PD-L1 posi i i y is mo e
p e alen in ho mone ecep o -nega i e sub ypes,
pa icula ly iple-nega i e b eas cance (TNBC),
which is cha ac e ized by a poo p ognosis and
limi ed he apeu ic op ions [7]. Fo ins ance, Zhang
e al. [1] epo ed ha PD-L1 o e exp ession in
In e na ional Jou nal o Cu en Pha maceu ical Re iew and Resea ch e-ISSN: 0976-822X, p-ISSN: 2961-6042
Mollah e al. In e na ional Jou nal o Cu en Pha maceu ical Re iew and Resea ch
347
b eas umo s was signi ican ly associa ed wi h
lymph node me as asis, la ge umo size, and
es ogen ecep o nega i i y. Simila ly, Sob al-
Lei e e al. [5] obse ed ha PD-L1 exp ession
a ied among b eas cance sub ypes, highligh ing
i s po en ial as a bioma ke o agg essi e disease
pheno ypes. The p ognos ic signi icance o PD-L1
exp ession in b eas cance emains an a ea o
ongoing esea ch. Some s udies sugges ha high
PD-L1 exp ession co ela es wi h poo o e all
su i al (OS) and disease- ee su i al (DFS),
whe eas o he s ind no signi ican associa ion [2,8].
Fo example, Ci quei a e al. [2] conduc ed a me a-
analysis and demons a ed ha PD-L1 exp ession
was associa ed wi h age ≥50 yea s, lymph node-
nega i e s a us, p oges e one ecep o nega i i y,
ele a ed Ki-67, and HER2-nega i e s a us. The
inconsis ency in hese indings e lec s he
complexi y o PD-L1 biology and unde sco es he
need o u he popula ion-speci ic s udies [3,9].
The apeu ically, PD-L1 has eme ged as a
p omising a ge o immune checkpoin inhibi ion.
Immune checkpoin inhibi o s, such as
pemb olizumab and a ezolizumab, ha e shown
e icacy in PD-L1-posi i e TNBC, imp o ing
p og ession- ee su i al when combined wi h
chemo he apy [4,10]. This de elopmen
emphasizes he dual ole o PD-L1 as bo h a
p edic i e bioma ke o pa ien selec ion and a
he apeu ic a ge in b eas cance managemen
[7,10].
In he Indian con ex , b eas cance incidence is
ising, and i emains he leading malignancy
among women [6]. Despi e he inc easing clinical
ele ance o PD-L1- a ge ed he apies, s udies
e alua ing PD-L1 exp ession in Indian b eas
cance popula ions a e limi ed. Unde s anding he
p e alence o PD-L1 exp ession and i s associa ion
wi h clinicopa hological ea u es is c ucial o
op imizing ea men s a egies and guiding
he apeu ic decision-making [8, 9]. Popula ion-
speci ic da a could also in o m he applicabili y o
immuno he apy and help p edic ea men
esponse in his demog aphic [5, 10]. Conside ing
hese ac o s, his s udy aims o conduc a clinico-
epidemiological analysis o PD-L1 exp ession in
b eas cance , ocusing on i s p e alence,
associa ion wi h clinicopa hological pa ame e s,
and po en ial p ognos ic signi icance. By
elucida ing hese aspec s, he s udy in ends o
con ibu e o he g owing body o knowledge on
PD-L1 biology in b eas cance and suppo he
a ional implemen a ion o PD-L1- a ge ed
he apies, pa icula ly in he Indian popula ion [1–
10].
Ma e ials and Me hods
S udy A ea: Medical College & Hospi al, Kolka a.
S udy Popula ion: All pa ien s o B eas Cance
p esen ing o OPD, ER & indoo pa ien s o
Gene al Su ge y, Medical College & Hospi al, and
Kolka a.
S udy Pe iod: F om Janua y 2020 o June 2021.
Sample Size: Based on p e ious yea 's da a hey
expec o ec ui abou 50 pa ien s du ing he s udy
pe iod.
Sample Design: All pa ien s ul illing he inclusion
and exclusion c i e ia was included.
S udy Design: Ins i u ion based desc ip i e, c oss-
sec ional and obse a ional s udy.
Inclusion C i e ia: Any emale pa ien su e ing
om b eas ca cinoma.
Exclusion C i e ia: Pa ien s no consen ing o ake
pa in he s udy.
S udy Tools
• In o med Consen Fo m
• Family His o y- i any 1s deg ee o 2nd
deg ee amily membe is su e ing om b eas
ca cinoma o no
• Pe sonal His o y- pa i y, b eas eeding,
mens ual his o y
• Clinical examina ion o b eas
• Rou ine blood in es iga ions
• USG o b eas
• Mammog aphy/MRI/Bone scan
• Clinical p o o ma o abula ion o da a
• Tables & Diag ams o s a is ical analysis
S a is ical Analysis: Da a om he s udy we e
analyzed using SPSS so wa e, wi h con inuous
a iables (e.g., age, li e enzyme le els) exp essed
as mean ± SD and compa ed using - es s o Mann–
Whi ney U es s. Ca ego ical a iables (e.g.,
gende , CBD s ones, and complica ions) we e
p esen ed as equencies and pe cen ages, and
compa ed using Chi-squa e o Fishe ’s exac es s.
Diagnos ic accu acy (sensi i i y, speci ici y, PPV,
NPV, and accu acy) was calcula ed o MRCP- i s
and EUS- i s s a egies, using
ERCP/in aope a i e indings as he e e ence.
Kaplan-Meie analysis may be used o ime- o-
in e en ion compa isons. A p- alue < 0.05 was
conside ed signi ican .
Resul
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Mollah e al. In e na ional Jou nal o Cu en Pha maceu ical Re iew and Resea ch
348
Table 1: Dis ibu ion o PD-L1 Exp ession Acco ding o Age and Socioeconomic S a us in B eas Cance
Pa ien s
PD L1
Age in G oup
Nega i e
Posi i e
To al
P Value
21-30
5(13.9%)
0(0%)
5(9.6%)
0.4419
31-40
5(13.9%)
1(6.3%)
6(11.5%)
41-50
17(47.2%)
10(62.5%)
27(51.9%)
51-60
3(8.3%)
1(6.3%)
4(7.7%)
≥61
6(16.7%)
4(25%)
10(19.2%)
To al
36(100%)
16(100%)
52(100%)
Sex
Lowe Class
12(33.3%)
7(43.8%)
19(36.5%)
0.7699
Lowe Middle Class
13(36.1%)
5(31.3%)
18(34.6%)
Middle Class
11(30.6%)
4(25%)
15(28.8%)
To al
36(100%)
16(100%)
52(100%)
Table 2: Associa ion o PD-L1 Exp ession wi h Pain and Ulce a ion in B eas Cance Pa ien s
Nega i e
Posi i e
To al
P Value
Pain
No
9(25%)
1(6.3%)
10(19.2%)
0.1133
Yes
27(75%)
15(93.8%)
42(80.8%)
To al
36(100%)
16(100%)
52(100%)
Ulce a ion
No
29(80.6%)
16(100%)
45(86.5%)
0.0579
Yes
7(19.4%)
0(0%)
7(13.5%)
To al
36(100%)
16(100%)
52(100%)
Table 3: Co ela ion o PD-L1 Exp ession wi h His opa hological Type and HER2 S a us in B eas
Cance Pa ien s
PD L1
HPE
Nega i e
Posi i e
To al
IDC
28(77.8%)
13(81.3%)
41(78.8%)
LC
7(19.4%)
2(12.5%)
9(17.3%)
MC
1(2.8%)
1(6.3%)
2(3.8%)
To al
36(100%)
16(100%)
52(100%)
HER
Nega i e
32(88.9%)
4(25%)
36(69.2%)
Posi i e
4(11.1%)
12(75%)
16(30.8%)
To al
36(100%)
16(100%)
52(100%)
Table 4: Associa ion be ween Me as asis: PD L1
Pd L1
Me as asis
Nega i e
Posi i e
To al
Bone
0(0%)
2(12.5%)
2(3.8%)
Lung
0(0%)
5(31.3%)
5(9.6%)
No
36(100%)
9(56.3%)
45(86.5%)
To al
36(100%)
16(100%)
52(100%)
Table 5: Compa ison o Tumo Size and Nodal S a us be ween Nega i e and Posi i e G oups
Numbe
Mean
SD
Minimum
Maximum
Median
P-Value
T-Size
Nega i e
36
4.4611
1.6354
1.3
8.3
4.4
0.165
Posi i e
16
5.125
1.3988
2.5
8.1
4.9
Nodal S a us
Nega i e
36
4.75
3.3155
0
13
5
<0.0001
Posi i e
16
10.875
1.5438
9
14
10.5
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Mollah e al. In e na ional Jou nal o Cu en Pha maceu ical Re iew and Resea ch
349
Figu e 1: Co ela ion o PD-L1 Exp ession wi h His opa hological Type and HER2 S a us in B eas
Cance Pa ien s
Figu e 2: Associa ion be ween Me as asis: PD L1
In ou s udy o 52 pa ien s, PD-L1 exp ession was
obse ed o a y ac oss di e en age g oups and
socioeconomic s a a. Among he nega i e g oup
(n=36), he majo i y belonged o he 41–50 yea s
age g oup (17, 47.2%), ollowed by ≥61 yea s (6,
16.7%), whe eas in he posi i e g oup (n=16), he
highes p opo ion was also in he 41–50 yea s age
g oup (10, 62.5%), ollowed by ≥61 yea s (4, 25%).
Howe e , he associa ion be ween age and PD-L1
s a us was no s a is ically signi ican (p=0.4419).
Rega ding socioeconomic s a us, 33.3% o PD-L1
nega i e and 43.8% o posi i e pa ien s we e om
he lowe class, 36.1% and 31.3% espec i ely
om he lowe middle class, and 30.6% and 25%
espec i ely om he middle class. The dis ibu ion
ac oss socioeconomic ca ego ies also showed no
s a is ically signi ican associa ion wi h PD-L1
s a us (p=0.7699). In ou s udy o 52 pa ien s, pain
was epo ed by 42 (80.8%) indi iduals, o whom
27 (75%) we e PD-L1 nega i e and 15 (93.8%)
we e PD-L1 posi i e, while 10 pa ien s (19.2%)
had no pain. Al hough pain was mo e equen
among PD-L1 posi i e cases, he associa ion was
no s a is ically signi ican (p=0.1133). Ulce a ion
was p esen in 7 pa ien s (13.5%), all o whom
we e PD-L1 nega i e (19.4%), while none o he
PD-L1 posi i e cases had ulce a ion. The absence
o ulce a ion in PD-L1 posi i e cases sugges ed a
possible end, bu he associa ion did no each
s a is ical signi icance (p=0.0579). In ou s udy o
52 pa ien s, his opa hological examina ion (HPE)
e ealed ha in asi e duc al ca cinoma (IDC) was
he mos common sub ype, obse ed in 41 cases
(78.8%), comp ising 28 (77.8%) PD-L1 nega i e
and 13 (81.3%) PD-L1 posi i e cases. Lobula
ca cinoma (LC) accoun ed o 9 cases (17.3%),
wi h 7 (19.4%) PD-L1 nega i e and 2 (12.5%) PD-
L1 posi i e, while medulla y ca cinoma (MC) was
seen in only 2 cases (3.8%), one each in he
nega i e (2.8%) and posi i e (6.3%) g oups.
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Mollah e al. In e na ional Jou nal o Cu en Pha maceu ical Re iew and Resea ch
350
Rega ding HER2 s a us, 36 pa ien s (69.2%) we e
HER2 nega i e, o which 32 (88.9%) we e PD-L1
nega i e and 4 (25%) we e PD-L1 posi i e, while
16 pa ien s (30.8%) we e HER2 posi i e,
comp ising 4 (11.1%) PD-L1 nega i e and 12
(75%) PD-L1 posi i e cases, sugges ing a s ong
associa ion be ween HER2 posi i i y and PD-L1
exp ession.
In ou s udy, me as asis was p esen in 7 ou o 52
pa ien s (13.5%), while he emaining 45 pa ien s
(86.5%) showed no e idence o me as a ic sp ead.
Among PD-L1 posi i e pa ien s, me as asis was
mo e equen , wi h 2 cases (12.5%) in ol ing
bone and 5 cases (31.3%) in ol ing he lung. In
con as , none o he PD-L1 nega i e pa ien s had
bone o lung me as asis, as all 36 (100%) we e
me as asis- ee. This indica es ha PD-L1
exp ession was s ongly associa ed wi h he
p esence o dis an me as asis, pa icula ly o he
lung (31.3%) and bone (12.5%).
In ou s udy, he mean umo size among PD-L1
nega i e pa ien s was 4.46 ± 1.63 cm ( ange: 1.3–
8.3 cm; median: 4.4 cm), while among PD-L1
posi i e pa ien s i was sligh ly highe a 5.13 ±
1.40 cm ( ange: 2.5–8.1 cm; median: 4.9 cm).
Howe e , his di e ence was no s a is ically
signi ican (p = 0.165). In e ms o nodal s a us,
PD-L1 nega i e pa ien s had a mean nodal
in ol emen o 4.75 ± 3.32 ( ange: 0–13; median:
5), whe eas PD-L1 posi i e pa ien s showed
signi ican ly highe nodal in ol emen wi h a mean
o 10.88 ± 1.54 ( ange: 9–14; median: 10.5), and
his di e ence was highly signi ican (p < 0.0001).
Discussion
Ou indings in a 52-pa ien b eas cance coho
show ha PD-L1 posi i i y clus e ed wi h ad e se
clinicopa hological ea u es—mos no ably highe
nodal bu den, HER2 posi i i y, and p esence o
dis an me as asis—while age and socioeconomic
s a us we e no associa ed wi h PD-L1 s a us,
aligning wi h much o he con empo a y li e a u e.
Me a-analyses consis en ly link umou al PD-L1
exp ession o agg essi e biology, including highe
his ological g ade and lymph-node in ol emen ,
and o poo e su i al endpoin s in se e al se ings
[11–13, 20]. The s ong co-occu ence we obse ed
be ween PD-L1 posi i i y and HER2 posi i i y
mi o s epo s ha desc ibe biological and
he apeu ic c oss alk be ween HER2 signalling and
he PD-1/PD-L1 axis, as well as coho da a in
HER2-posi i e disease showing meaning ul
associa ions wi h esponse and p ognosis [14, 15,
19].
Ou demons a ion o subs an ially g ea e nodal
in ol emen in PD-L1–posi i e cases is conco dan
wi h pooled es ima es indica ing en iched PD-L1
exp ession in node-posi i e umou s [11–13,20].
The signal we no ed o me as a ic sp ead among
PD-L1–posi i e cases, pa icula ly o lung and
bone, i s wi h e idence ha PD-L1 ma ks mo e
agg essi e disease, al hough s udies also highligh
disco dance o PD-L1 s a us be ween p ima y and
me as a ic si es and he e ogenei y ac oss
compa men s, unde sco ing assay and sampling
conside a ions in ad anced disease [16,17].
His ology in ou se ies was domina ed by in asi e
duc al ca cinoma ac oss PD-L1 s a a, a
dis ibu ion ypical o published coho s [11–13].
Finally, he lack o associa ion wi h age (and wi h
socioeconomic s a us, which is a ely epo ed) is
in line wi h mul iple analyses ha ha e no shown
consis en ela ionships be ween PD-L1 and
demog aphic a iables once umou biology is
accoun ed o [11–13,20]. Collec i ely, hese da a
suppo inco po a ing PD-L1 es ing—pa icula ly
alongside HER2 s a us and nodal assessmen —in o
isk s a i ica ion amewo ks, while ecognizing
he need o s anda dized assays and a en ion o
in a- umou and empo al he e ogenei y when PD-
L1 guides he apy selec ion [15–17,20].
Conclusion
In conclusion, ou s udy demons a ed ha PD-L1
exp ession in b eas ca cinoma was no
signi ican ly in luenced by age, socioeconomic
s a us, umo size, pain, o ulce a ion. Howe e ,
impo an clinicopa hological co ela ions we e
no ed. PD-L1 exp ession showed a s ong
associa ion wi h HER2 posi i i y, sugges ing a
po en ial link be ween hese bioma ke s.
Fu he mo e, PD-L1 posi i i y was signi ican ly
co ela ed wi h highe nodal in ol emen and he
p esence o dis an me as asis, pa icula ly o he
lung and bone, highligh ing i s po en ial ole as an
indica o o agg essi e disease beha io and poo
p ognosis. These indings sugges ha PD-L1 may
se e as a aluable p ognos ic ma ke in b eas
cance , wa an ing u he explo a ion in la ge
coho s.
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