CONFLICTOS DE INTERES

• De acuerdo al código de conducta de ANDI:

• SPEAKER – ADVISORY - INVESTIGACIÓN:

• Amgen, Bristol, Astrazeneca, Janssen, Sanofi, Roche, Novartis,
Recordati Rare Diseases, Farma de Colombia, Takeda/Shire,
Abbott, Biopas, Tecnofarma, MSN, Apellis, PTC Therapeutics,
Human Bioscience, Pfizer, Alexion, ACMI, ACHO, ArgenX, GELL.

• ESTO NO AFECTA LA OBJETIVIDAD DE LA PONENCIA.

CASO CLÍNICO MRPA: Abril 2011, 70 años
Antecedentes
- HTA, DISLIPIDEMIA A EXPENSAS DE COLESTEROL, OTROS TTO:
ARTROSIS.
- LOSARTAN/HCTZ, NIFEDIPINO
- HISTORIA DE CA DE TIROIDES (TIROIDECTOMIA TOTAL - ACETAMINOFEN SI DOLOR.
24/01/1999 X CA TIROIDES PAPILAR VARIANTE - AL PARECER IODOTERAPIA NÚMERO 2, MARZO YSEP
FOLICULAR). 2009.
- LEVOTIROXINA 100MCG DIA
- GLAUCOMA CON PERDIDA DE VISION DE OI. - ATORVASTATINA 10 MG NOCHE
- CALCITRIOL 0.5MCG, BIMATOPROST
- POST COLECISTECTOMIA, HAT XHUA. - CARBOXIMETILCELULOSA.
- CALCIONIT D
- PADRE: CA DE COLÓN, MADRE DM. - DORZOLAMIDA +TIMOLOL +BRIMONIDINA

CASO CLÍNICO MRPA: Abril 2011, 70 años

Antecedentes
- CA de MAMA DERECHA ESTADO TRATAMIENTO ONCOLÓGICO:
IIA T2N0M0.
- MRM + VG 04/01/2012. (71 a)
- PATOLOGIA:
- DUCTAL INFILTRANTE CON - RT MARZO 2012.
BORDES LIBRES, GANGLIOS
0/22. - TAMOXIFENO 20 MG DÍA DESDE
2012 HASTA 2019. (78 a)
- RE+, PR NEG, HER2 NEG.

CASO CLÍNICO MRPA:

Cuadro y Tratamiento inicial
2014: 73 años 2019 : 78 años

2020 : 79 años
2016 : 75 años
CASO CLÍNICO MRPA: Cuadro y Tratamiento inicial
CON TODAS LAS HERRAMIENTAS
ACTUALES DISPONIBLES…..

CUAL HUBIESE SIDO EL

TRATAMIENTO QUE
HUBIESES INSTAURADO
PARA DOÑA MRPA?
2021: 80 años
CASO CLÍNICO MRPA: Junio 2022, 81 años
Hallazgos en GGO
CASO CLÍNICO MRPA: Junio 2022, 81 años
Hallazgos en GGO
CASO CLÍNICO MRPA: Agosto 2022, 81 años
Hallazgos en TAC Tórax 3D
CASO CLÍNICO MRPA: Agosto 2022, 81 años
Hallazgos en TAC Tórax 3D
CASO CLÍNICO MRPA: Agosto 2023, 82 años
Hallazgos en GGO
CASO CLÍNICO MRPA: Agosto 2023, 82 años
Hallazgos en GGO
CASO CLÍNICO MRPA: Agosto 2023, 82 años
Hallazgos en RMN Columna Cervical Simple
CASO CLÍNICO MRPA: Agosto 2023, 82 años
Hallazgos en RMN Columna Cervical Simple
CASO CLÍNICO MRPA: Agosto 2023, 82 años
Hallazgos en RMN Tórax Simple (Reja Costal)
CASO CLÍNICO MRPA:
Septiembre 2023,
82 años
Hallazgos en PET CT
CASO CLÍNICO MRPA: Septiembre 2023, 82 años
Hallazgos en PET CT
SE CONFIRMA
HISTOPATOLÓGICAMENTE LA
LESIÓN, CON IGUAL
FENOTIPO…..
CUAL HUBIESE SIDO EL TRATAMIENTO
QUE HUBIESES INSTAURADO PARA
DOÑA MRPA?
Y SU HUBIERAS TOMADO LA
CONDUCTA DISCUTIDA 11 AÑOS
ATRÁS …..

ENTONCES AHORA CUAL HUBIESE

SIDO EL TRATAMIENTO QUE
HUBIESES INSTAURADO PARA
DOÑA MRPA?
Overall Survival With First-
Line
Palbociclib Plus an
Aromatase Inhibitor
(AI) vs AI in Metastatic
Breast Cancer:
A Large Real-World Database
Analysis

Rugo H, et al. ESMO BC 2022. Poster

169P.

Breakthroughs that change patients’ lives 21

 P-REALITY X: Palbociclib REAl-world first-LIne
comparaTive effectiveness studY eXtended
Objective
• To evaluate the effectiveness of first-line PAL + AI, as compared with AI alone, in patients with HR+/HER2– MBC treated in
real-world clinical practice in the United States

Method • Retrospective, cohort analysis of electronic health records within the US Flatiron Health Analytic Database

Endpoints:
KEY ELIGIBILITY CRITERIA • Primary - OS*
• Secondary - rwPFS†
• Postmenopausal women and men aged ≥18
years with HR+/HER2‒ mBC (N = 2888) PAL+AI Statistical analyses:
• Index date i.e., starting date of the first line (n=1,324) • Unadjusted analyses were conducted first
mBC treatment (PAL plus AI or AI alone) from • sIPTW as the primary analysis was performed to balance
03 February 2015 to 31 March 2020 baseline demographic and clinical characteristics
• Follow up from index date to death, study end
AI • 1:1 PSM was conducted as sensitivity analysis
(data cut-off, 30 September 2020), or last visit, (n=1,564) • Median survival times and 95% CIs for OS and rwPFS were
whichever occurred first estimated using the weighted Kaplan-Meier method.
• 6 months follow available • Cox proportional hazards model was used to compute the HR
and the corresponding 95% CI.

*OS w as defined as the time in months from the index date to death from any cause. †rwPFS w as defined as the number of months from index date to the date of the first documentation of real-w orld
progressive disease or death due to any cause, w hichever occurred first.
AI=aromatase inhibitor; CI=confidence interval; CR=complete response; HR=hazard ratio; mBC=metastatic breast cancer; OS=overall survival; PAL=palbociclib; PSM=propensity score matching;
rw PFS=real-world progression-free survival; sIPTW=stabilized inverse probability treatment w eighting. Rugo H, et al. ESMO BC 2022. Poster 169P.

22
 P-REALITY X: Patient characteristics 1 (1/3)
After sIPTW and PSM, all groups were generally well balanced (≤0.10 standardized difference)
Unadjusted Total Cohort Cohort after sIPTW Cohort after PSM
PAL + AI AI alone Standardized PAL + AI AI alone Standardized PAL + AI AI alone Standardized
Characteristic N = 1324 N = 1564 difference N = 1572 N = 1137 difference N = 939 N = 939 difference
Age, y
Mean (SD) 67.1 (9.6) 70.9 (9.7) –0.3949 69.4 (10.8) 69.5 (8.2) –0.0161 68.7 (9.5) 69.4 (9.4) –0.0783
Median (IQR) 67 (61–74) 72 (64–80) 70 (63–78) 70 (63–79) 69 (63–76) 70 (63–78)
Age at mBC diagnosis, n (%), y
18-49 48 (3.6) 41 (2.6) 0.0577 44 (2.8) 34 (3.0) –0.0134 26 (2.8) 22 (2.3) 0.0270
50-64 468 (35.4) 375 (24.0) 0.2509 437 (27.8) 329 (28.9) –0.0238 257 (27.4) 269 (28.7) –0.0285
65-74 495 (37.4) 500 (32.0) 0.1140 532 (33.8) 394 (34.7) –0.0172 376 (40.0) 356 (37.9) 0.0437
≥75 313 (23.6) 648 (41.4) -0.3868 559 (35.6) 380 (33.5) 0.0445 280 (29.8) 292 (31.1) –0.0278
Sex, n (%)
Male† 10 (0.76) 19 (1.2) –0.0465 17 (1.1) 12 (1.0) 0.0056 8 (0.85) 10 (1.1) –0.0219
Female 1314 (99.2) 1545 (98.8) 1555 (98.9) 1125 (99.0) 931 (99.2) 929 (98.9)
Race/ethnicity,* n (%)
White 900 (68.0) 1059 (67.7) 0.0057 1063 (67.6) 766 (67.4) 0.0044 591 (62.9) 636 (67.7) –0.1008
Black 107 (8.1) 136 (8.7) –0.0222 134 (8.5) 96 (8.5) 0.0019 83 (8.8) 71 (7.6) 0.0466
Other 317 (23.9) 369 (23.6) 0.0082 375 (23.9) 274 (24.1) –0.0060 265 (28.2) 232 (24.7) 0.0797
Practice type,* n (%)
Community 1208 (91.2) 1449 (92.7) –0.0518 1449 (92.2) 1,048 (92.1) 0.0016 865 (92.1) 868 (92.4) –0.0120
Academic 116 (8.8) 115 (7.4) 123 (7.8) 89 (7.9) 74 (7.9) 71 (7.6)
Insurance, n (%)
Commercial health plan plus any
388 (29.3) 507 (32.4) –0.0674 474 (30.2) 353 (31.0) –0.0182 290 (30.9) 292 (31.1) –0.0046
other
Commercial health plan 332 (25.1) 325 (20.8) 0.1023 372 (23.7) 251 (22.1) 0.0375 208 (22.2) 210 (22.4) –0.0051
Medicare 59 (4.5) 72 (4.6) –0.0071 67 (4.3) 48 (4.3) 0.0011 46 (4.9) 37 (3.9) 0.0466
Medicaid 16 (1.2) 15 (0.96) 0.0241 16 (1.0) 12 (1.0) –0.0030 9 (0.96) 8 (0.85) 0.0112
Other payer type 529 (40.0) 645 (41.2) –0.0262 643 (40.9) 473 (41.6) –0.0148 386 (41.1) 392 (41.8) –0.0130

*Variable used in PSM model. †IBRANCE is approved for used in males in the US but not necessarily in other parts of the world. AI=aromatase inhibitor; IQR=interquartile range; mBC=metastatic breast cancer; PAL=palbociclib; PSM=propensity score matching; SD=standard deviation; sIPTW=stabilized
inverse probability treatment weighting. The balance in important prognostic baseline characteristics was assessed using a standardized differences approach, with a standardized difference of ≥0.10 considered indicative of practical significance. 2 1. Rugo H, et al. ESMO BC 2022. Poster 169P; 2. Austin PC.
Stat. Med. 2014;33:1242-1258.
 P-REALITY X:
Select patient characteristics before and after sIPTW
Visceral disease*† Age at mBC diagnosis ECOG PS*

Unadjusted sIPTW Unadjusted sIPTW Unadjusted sIPTW

100 100 100

25.8 29.3 29.7 23.6 26.7

33.5 35.6 33.5 35.9 31.0 31.7
80 80 41.4 80
Patients (%)

11.6
60 sIPTW 60 sIPTW 60 sIPTW 15.9 14.9
37.4 17.3
33.8 34.7 24.0
40 40 32.0 40 23.0 22.8
74.2 70.7 70.3 21.4
66.5

20 20 35.4 20 37.7
27.8 28.9 30.1 30.6
24.0 25.4

0 0 3.6 2.6 2.8 3.0 0

PAL + AI AI PAL + AI AI PAL + AI AI PAL + AI AI PAL + AI AI PAL + AI AI

NO YES 18-49 50-64 65-74 ≥75 0 1 2, 3 or 4 ND

*Variable used in PSM model. †Visceral disease was defined as metastatic disease in the lung and/or liver; patients could hav e had other sites of metastases. No visceral disease was defined as no lung
or liver metastases.
AI=aromatase inhibitor; mBC=metastatic breast cancer; ND=not determined; PAL=palbociclib; sIPTW= stabilized inverse probability treatment weighting.
Rugo H, et al. ESMO BC 2022. Poster 169P.

CC 2mins
P-REALITY X: Overall survival before and after sIPTW and PSM
Unadjusted analysis sIPTW PSM
100 100 100

80 80 80
Overall Survival (%)

Overall Survival (%)

Overall Survival (%)
60 60 60

PAL+ AI AI PAL+ AI AI PAL+ AI AI

40 (n=1324) (n=1564) 40
(n=1572) (n=1137)
40 (n=939) (n=939)

Median OS, 53.4 40.4 Median OS, 49.1 43.2 Median OS, 57.8 43.5
20 months (95% CI) (48.7‒58.6) (36.3‒44.9) 20 months (95% CI) (45.2‒57.7) (37.6‒48.0) 20 months (95% CI) (47.2‒NE) (37.6‒48.9)

HR=0.67 [95% CI: 0.60–0.76], p<0.0001 HR=0.76 [95% CI: 0.65–0.87], p=0.0001 HR=0.72 [95% CI: 0.62–0.83], p<0.0001
0 0 0
0 6 12 18 24 30 36 42 48 54 60 66 0 6 12 18 24 30 36 42 48 54 60 66 0 6 12 18 24 30 36 42 48 54 60 66

Time (months) Time (months) Time (months)

PAL + AI 1324 1251 1049 857 694 521 378 267 174 102 47 11 PAL + AI 1572 1465 1214 988 775 588 435 296 192 112 53 14 PAL + AI 939 884 731 579 450 349 261 184 122 76 40 11

AI 1564 1390 1163 949 768 608 501 396 279 180 98 28 AI 1137 1014 852 697 577 463 380 299 210 135 73 21 AI 939 846 711 585 485 394 326 262 186 117 62 18

PAL+ AI AI PAL+ AI AI PAL+ AI AI

Median follow-up Median follow-up Median follow-up
25.0 (13.8–38.3) 23.3 (11.8–42.3) 23.9 (12.8–38.0) 24.5 (12.0–42.9) 23.4 (13.1–37.8) 24.9 (12.4–44.4)
(IQR), months (IQR), months (IQR), months

Median OS* was significantly longer among patients who received PAL+ AI vs AI alone before and after sIPTW and PSM

Note: Observational retrospective analyses are designed to evaluate associations among variables and cannot establish causality; they are not intended for direct comparison with clinical trials.

*OS was defined as the time in months from the index date to death from any cause.
AI=aromatase inhibitor; CI=confidence interval; HR=hazard ratio; IQR=interquartile range; OS=overall survival;
PAL=palbociclib; PSM=propensity score matching; sIPTW=stabilized inverse probability of treatment weighting.
Rugo H, et al. ESMO BC 2022. Poster 169P. CC 2mins
 P-REALITY X: Overall survival by subgroup (sIPTW) (1 of 2)
Patients, n (%) OS (PAL+AI vs AI alone)
Subgroup HR 95% CI
PAL+AI AI alone HR (95% CI)
All patients 1572 1137 0.76 0.65-0.87
Age 18-49 y 44 34 1.29 0.58-2.89
Age 50-64 y 437 329 0.85 0.67-1.08
Age 65-74 y 532 394 0.72 0.57-0.90
Age ≥75 y 559 380 0.69 0.52-0.91
Male 17 12 0.11 0.01-0.95
Female 1555 1125 0.77 0.66-0.88
Race, white 1063 766 0.79 0.67-0.94
Race, black 134 96 0.44 0.27-0.70
Race, other 375 274 0.78 0.58-1.06
Community practice 1449 1048 0.78 0.67-0.90
Academic practice 123 89 0.52 0.31-0.86
Stage at initial Dx, I 198 145 0.62 0.42-0.92
Stage at initial Dx, II 407 300 0.91 0.69-1.20
Stage at initial Dx, III 261 188 0.86 0.59-1.27
Stage at initial Dx, IV 530 390 0.68 0.55-0.84
Stage at initial Dx, ND 176 114 0.63 0.39-1.01
ECOG PS at baseline, 0 472 348 0.76 0.60-0.97
ECOG PS at baseline, 1 362 259 0.82 0.62-1.09
ECOG PS at baseline, 2, 3 or 4 251 169 1.00 0.69-1.45
ECOG PS at baseline, ND 487 361 0.60 0.46-0.79
Favours Favours
0.01 0.1 PAL+AI 1 AI 10

AI=aromatase inhibitor; Dx=diagnosis; ECOG PS=Eastern Cooperative Oncology Group performance status; ND=not documented; PAL=palbociclib; sIPTW=stabilized inverse probability of treatment weighting. Rugo H, et al. ESMO BC 2022. Poster 169P.
 P-REALITY X: Overall survival by subgroup (sIPTW) (2 of 2)
Patients, n (%) OS (PAL+AI vs AI alone)
Subgroup HR 95% CI
PAL+AI AI alone HR (95% CI)
Initial Dx to metastatic Dx, de novo 530 390 0.68 0.55-0.84
Initial Dx to metastatic Dx, ≤1 y 74 43 0.45 0.18-1.11
Initial Dx-metastatic Dx, >1 to ≤5 y 271 288 1.18 0.86-1.61
Initial Dx-metastatic Dx, >5 y 696 414 0.74 0.59-0.93
Metastatic sites, 1 793 589 0.79 0.66-0.95
Metastatic sites, 2 352 261 0.57 0.44-0.73
Metastatic sites, ≥3 242 176 0.79 0.58-1.07
Metastatic sites, ND 186 111 0.91 0.49-1.68
Bone-only disease* 589 440 0.77 0.62-0.95
No bone-only disease 982 697 0.73 0.61-0.88
Brain metastases 26 43 1.35 0.68-2.69
No brain metastases 1546 1094 0.75 0.65-0.87
Visceral disease † 460 337 0.61 0.49-0.77
No visceral disease† 1112 800 0.82 0.69-0.99
Favours Favours
0.01 0.1 PAL+AI 1 AI 10

• A consistent OS benefit with PAL + AI compared with AI alone was generally observed across most subgroups examined
• OS benefits were observed regardless of race and among patients with and without visceral or bone -only disease

Note: Observational retrospective analyses are designed to evaluate associations among variables and cannot establish causality; they are not intended for direct comparison with clinical trials.

*Bone-only disease was defined as metastatic disease in the bone only. †Visceral disease was defined as metastatic disease in the lung and/or liver; patients could have had
other sites of metastases. No visceral disease was defined as no lung or liver metastases.
AI=aromatase inhibitor; Dx=diagnosis; ND=not documented; PAL=palbociclib; sIPTW=stabilized inverse probability of treatment weighting.
Rugo H, et al. ESMO BC 2022. Poster 169P.
 P-REALITY X: Real-world PFS before and after sIPTW
and PSM
Unadjusted analysis sIPTW PSM
100 100 PAL+ AI AI 100 PAL+ AI AI
PAL+ AI AI
(n=1324) (n=1564) (n=1572) (n=1137) (n=939) (n=939)
Median rwPFS, 80 Median rwPFS, 19.3 13.9 Median rwPFS, 19.8 14.9
80 19.8 13.9 80
months (95% CI) months (95% CI) (17.5‒20.7) (12.5‒15.2) months (95% CI) (17.3‒21.9) (12.9‒16.9)
(17.9‒21.7) (12.7‒15.2)

Real-world PFS (%)

Real-world PFS (%)

Real-world PFS (%)

60 HR=0.68 [95% CI: 0.62–0.76], p<0.0001 60 HR=0.70 [95% CI: 0.62–0.78], p<0.0001 60 HR=0.72 [95% CI: 0.63–0.82], p<0.0001

40 40 40

20 20 20

0 0 0
0 6 12 18 24 30 36 42 48 54 60 66 0 6 12 18 24 30 36 42 48 54 60 66 0 6 12 18 24 30 36 42 48 54 60 66

Time (months) Time (months) Time (months)

PAL + AI 1324 982 650 440 299 208 133 85 55 26 11 1 PAL + AI 1572 1129 729 489 316 223 145 94 62 29 12 1 PAL + AI 939 682 439 288 196 137 93 61 40 22 11 1

AI 1564 669 435 293 195 126 88 60 35 16 7 0 AI 1137 489 320 215 147 93 60 41 23 10 4 0 AI 939 431 283 189 130 82 55 41 25 10 3 0
PAL+ AI AI PAL+ AI AI PAL+ AI AI
Median follow-up Median follow-up Median follow-up
25.0 (13.8–38.3) 23.3 (11.8–42.3) 23.9 (12.8–38.0) 24.5 (12.0–42.9) 23.4 (13.1–37.8) 24.9 (12.4–44.4)
(IQR), months (IQR), months (IQR), months

Median rwPFS* was significantly longer among patients who received PAL+ AI vs AI alone before and after sIPTW and PSM

Note: Observational retrospective analyses are designed to evaluate associations among variables and cannot establish causality; they are not intended for direct comparison with clinical trials.
*rwPFS was defined as the number of months from index date to the date of the first documentation of real-world progressive disease or death due to any cause, whichever occurred first. AI=aromatase inhibitor; CI=confidence interval; HR=hazard
ratio; IQR=interquartile range; PAL=palbociclib; PSM=propensity score matching; rwPFS=real-world progression-free survival; sIPTW=stabilized inverse probability of treatment weighting.
Rugo H, et al. ESMO BC 2022. Poster 169P.

CC 2mins