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Mitogens

Palbociclib

HR + /HER2- Advanced/Metastatic Breast Cancer patients in Latin America

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To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments as first line therapy, regardless of combination partner and labelled use in real world settings across Latin America.

Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HR+/HER2- Advanced/Metastatic Breast Cancer In Real World Settings.

Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HORMONE RECEPTOR POSITIVE/ HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE (HR+/HER2-) Advanced/Metastatic Breast Cancer In Real World Settings

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. Disease progression (PD): greater than equal to (\>=) 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 millimeter (mm) or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.

Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.

Objective response rate was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on palbociclib combination therapy. CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.

Percentage of participants who were alive after 1 year post palbociclib combination treatment initiation were based on the Kaplan-Meier estimate.

Percentage of participants who were alive after 2 years post palbociclib treatment initiation were based on the Kaplan-Meier estimate.

Clinical benefit rate was defined as the percentage of participants achieving CR, PR or stable disease (SD) \>=24 weeks on palbociclib combination therapy. CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. Participants with 12-24 weeks follow up data who remained on palbociclib for the duration of their follow up without evidence of CR or PR or PD were censored.

SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater.

Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.

CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater.

CR was defined as complete resolution of all visible disease per the treating physicians opinion.

PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.

Number of participants who received supportive therapies during palbociclib treatment were reported.

Number of participants who received therapies post palbociclib treatment were reported.

Pfizer

Due to non-interventional nature of the study, data for non-SAEs and SAEs were not collected. The study was a retrospective study of existing medical records. There was no collection of adverse events in the study, so there is no report of adverse events in the results.

Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.

Palbociclib + Aromatase Inhibitor

Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.

Palbociclib + Fulvestrant

Total

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

Menopause Induced by LHRH Suppression

Menopause Induced by Surgery

Natural Menopause

Perimenopausal

Premenopausal

Menopause status at palbociclib initiation including menopause induced by Luteinizing hormone-releasing hormone (LHRH) suppression, menopause induced by surgery, natural menopause, perimenopausal and premenopausal were reported.

Number of Participants According to Menopause Status at Palbociclib Initiation

Argentina-Servicio de Salud Publico

Argentina-Seguridad Social

Argentina-PrivadoPrepagas

Mexico-ISSSTE

Mexico-Sedena

Mexico- PEMEX

Mexico-Aseguradora privada

Mexico-IMSS

Mexico-SSA

Mexico-Aseguradoras privadas

Chile-FONASA (El Fondo Nacional de Salud)

Chile-ISAPRE (Instituciones de Salud Previsional)

Costa rica/Panama-CSS (Caja de seguridad social)

Costa rica/Panama-Aseguradora privada

Colombia-Contributive regime (POS-C)

Colombia-Subsidized regime (POS-S)

Colombia-Special regime (i.e. teacher or military)

Colombia-Unknown

Number of participants according to the type of insurance plan was reported

Number of Participants According to Type of Insurance Plan

BRCA1

BRCA2

Androgen receptor

ESR1 mutation

Number of participants with positive status for following biomarkers: breast cancer type 1 (BRCA1) gene, breast cancer type 2 (BRCA2), androgen receptor and estrogen receptor 1 (ESR1) mutation were reported.

Number of Participants With Positive Biomarker Status

Unknown

Number of participants according to their family history of breast cancer as yes, no and unknown were reported.

Number of Participants According to Family History of Breast Cancer

Stage 0

Stage 1

Stage 2

Stage 3a

Stage 3b

Stage 3c

Stage 4

Number of participants according to stage at initial breast cancer diagnosis is presented. Staging used was American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM), where Stage 0=noninvasive ductal carcinoma in situ; Stage 1= tumor size up to 2 centimeters (cm) and no lymph node involved; Stage 2= tumor size between 2 to 5 cm, cancer has spread to lymph nodes; Stage 3a= any size tumor, spread to 4 to 9 lymph nodes.; Stage 3b=tumor has spread to chest wall; Stage 3c= any size tumor, spread to 10 or more lymph nodes; Stage 4 (metastatic)= any size tumor has spread to other organs.

Number of Participants According to Stage of Initial Breast Cancer

Lymph nodes, Regional

Lymph nodes, Distal

Number of participants with metastases to lymph nodes (regional and distal) were presented.

Here, number anaylzed signifies participants evaluable for this baseline measure.

Number of Participants With Metastases to Lymph Nodes

Grade 0

Grade 1

Grade 2

Grade 3

Grade 4

ECOG Performance status is used to measure quality of life of participants with grades ranging from 0 to 5; where Grade 0: Fully active; Grade 1: Restricted in physically strenuous activity but ambulatory; Grade 2: Ambulatory and capable of all self-care but unable to carry out any work activities; Grade 3: Capable of only limited self-care; Grade 4:Completely disabled and Grade 5: Dead. Higher scores indicated worsening of quality of life. Number of participants according to ECOG status were presented.

Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status

Number of participants prescribed palbociclib combination treatment for advanced/metastatic breast cancer were presented.

Number of Participants According to Diagnosis for Which Palbociclib Combination was Prescribed

Bone

Lymph node

Lung

Liver

Brain

Skin/soft tissue

Ovary

Other

Visceral disease

Non-visceral disease

Number of participants according to the sites of metastases was presented. Participant could have more than one site of metastases.

Number of Participants According to Different Sites of Metastases

De Novo

Recurrent

Number of participants with de novo and recurrent breast cancer occurrence were reported

Number of Participants With De novo and Recurrent Breast Cancer

Bradyarrhythmias

Cerebrovascular disease

Congestive heart failure

Chronic pulmonary disease

Connective tissue disease

Dementia

Diabetes with end organ damage

Diabetes without end organ damage

Depression

Electrolyte abnormalities

Hypertension

Long QT syndrome

Mild liver disease

Moderate to severe renal disease

Myelosuppression

Myocardial infarction

Peptic ulcer disease

Peripheral vascular disease

Unstable angina

None

Participants with their comorbidities diagnosed within 12 months prior to palbociclib initiation were reported.

Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation

Number of Participants Prescribed Palbociclib (Aromatase Inhibitor or Fulvestrant at First Line)

Age at Initial Breast Cancer Diagnosis

Age at Advanced Breast Cancer (ABC)/Metastatic Breast Cancer (mBC) Diagnosis

Time From Initial Breast Cancer Diagnosis to ABC/mBC Diagnosis

The date of palbociclib treatment initiation was the study baseline. Here, time from ABC/mBC diagnosis to palbociclib initiation was reported.

Time from ABC/mBC Diagnosis to Palbociclib Initiation

Adjuvant Chemotherapy

Adjuvant endocrine therapy

Number of participants who received adjuvant chemotherapy and adjuvant endocrine therapy for early breast cancer treatment were reported.

Number of Participants With Adjuvant Treatments Received Since Breast Cancer Diagnosis

Radiotherapy

Surgery

Number of participants who received radiotherapy and surgery for early breast cancer were reported.

Number of Participants who Received Radiotherapy or Surgery

Duration of adjuvant endocrine therapy for early breast cancer treatment is presented.

Duration of adjuvant endocrine therapy

Data was not collected for this baseline measure

Time Since end of Adjuvant Treatment

Time From Regimen Completion of Adjuvant Therapy to Diagnosis of ABC/mBC

The date of palbociclib treatment initiation was the study baseline. Here, time from initial breast cancer diagnosis to palbociclib initiation was reported.

Time From Initial Breast Cancer Diagnosis to Palbociclib Initiation

The date of palbociclib treatment initiation was the study baseline. Here, time from advanced/metastatic diagnosis to palbociclib initiation is reported.

Time From Advanced/Metastatic Diagnosis to Palbociclib Initiation

Full Analysis Set (FAS) comprised of participants for whom a complete medical record review was conducted.

Pfizer ClinicalTrials.gov Call Center

FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Progression Free Rate at Month 6

Progression Free Rate at Month 12

Progression Free Rate at Month 18

Progression Free Rate at Month 24

Objective Response Rate

Percentage of Participants Alive After 1 Year Post Palbociclib Combination Treatment Initiation

Percentage of Participants Alive After 2 Years Post Palbociclib Combination Treatment Initiation

Clinical Benefit Rate

Percentage of Participants With Stable Disease >=24 Weeks on Palbociclib

Survival Rate at Month 6

Survival Rate at Month 12

Survival Rate at Month 18

Survival Rate at Month 24

Time From Palbociclib Initiation to Initial Response Recorded

Time From Palbociclib Initiation to Complete Response

Time From Palbociclib Initiation to Partial Response

FAS comprised of participants for whom a complete medical record review was conducted.

Follow-up Time Since Palbociclib Initiation

Bisphosphonates

Non-steroidal anti-inflammatory drugs

Opioid extended release

Anti-emetics

Anti-anxiety drugs

Anti-depressants

Opioid immediate release

Other supportive care

Antibiotics

Nutritional support

Granulocyte colony stimulating factors

Antifungals

Red blood cell transfusion

Pruritus/rash treatments

Erythropoietin stimulating agents

Platelet transfusions

Antivirals

FAS comprised of participants for whom a complete medical record review was conducted. Participants could receive more than one supportive treatment.

Spots Global Cancer Trial Database for advanced breast cancer (abc)