Trial Outcomes & Findings for Treatment Patterns & Clinical Outcomes of Palbociclib Combinations in HR+HER2-MBC (NCT NCT04937660)

A total of 185 participants were enrolled in the study. Of these, 183 participants initiated palbociclib treatment and constituted the full analysis set (Full analysis set included all participants who fulfilled the eligibility criteria).

Treatment Patterns & Clinical Outcomes of Palbociclib Combinations in HR+HER2-MBC

Percentage of participants who were progression free was defined as percentage of participants who were alive and for whom no progression of disease was reported. Progression of disease was defined as an increase in visible disease and/or presence of any new lesions, which were evaluated as per local guidelines by the clinician and were collected in the electronic case report form (e-CRF). Kaplan-Meier method was used.

Percentage of participants who were progression free was defined as percentage of participants who were alive and for whom no progression of disease was reported. Progression of disease was defined as an increase in visible disease and/or presence of any new lesions, which were evaluated as per local guidelines by the clinician and were collected in the e-CRF. Kaplan-Meier method was used.

Percentage of participants who were progression free was defined as percentage of participants who were alive and for whom no progression of disease was reported. Progression of disease was defined as an increase in visible disease and/or presence of any new lesions, which were evaluated as per local guidelines by the clinician and were collected in the e-CRF. Kaplan-Meier method was used.

Percentage of participants who were progression free was defined as percentage of participants who were alive and for whom no progression of disease was reported. Progression of disease was defined as an increase in visible disease and/or presence of any new lesions, which were evaluated as per local guidelines by the clinician and were collected in the e-CRF. Kaplan-Meier method was used.

Percentage of participants who were alive at 1 year post palbociclib initiation were reported in this outcome measure.

Percentage of participants who were alive at 2 years post palbociclib initiation were reported in this outcome measure.

ORR was defined as the percentage of participants with an overall tumor response of complete response (CR) or partial response (PR) or stable disease. Complete response was defined as complete reduction of all visible disease; partial response was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease; stable disease was defined as no change in overall size of visible disease, also including cases where some lesions increased in size and some lesions decreased in size. The responses were evaluated as per local guidelines by the clinician and were collected in the e-CRF.

Data for time from initial breast cancer diagnosis to recurrence of breast cancer was collected at baseline from participants medical records.

Breast cancer stages included Stage I,IIA,IIB,IIIA,IIIB,IIIC as determined using Tumor Node Metastasis (TNM) classification system. Stage I: cancer is small and only in breast tissue or may be found in lymph nodes close to breast. Stage 2: there is cancer in breast or nearby lymph nodes or both. Stage IIA: no tumor found in breast, but cancer is found in one to three axillary lymph nodes, tumor measures 2 centimeter (cm) or smaller; IIB: tumor is larger than 2 cm. Stage 3: cancer is found in lymph nodes close to breast, skin of breast, or chest wall. Stage IIIA: any size tumor; spread to four to nine lymph nodes. Stage IIIB: any size tumor and has spread to chest wall and/or skin of breast and may have spread to up to nine axilliary lymph nodes or near breastbone. Stage IIIC: any size tumor and may have spread to chest wall or skin of breast and ten or more lymph nodes. Higher stage indicates more advanced disease.

Number of participants classified according to node status were reported in this outcome measure. Node status included: N0, N1, N2, N3, NX. N0: there is no cancer in nearby lymph nodes, N1, N2 and N3: number and location of lymph nodes that contained cancer and NX: cancer is nearby lymph nodes cannot be measured.

Number of participants classified according to menopausal status were reported in this outcome measure. Menopausal status included: pre-menopausal and post-menopausal.

Number of participants classified according to palbociclib combination prescribed (palbociclib plus letrozole/aromatase inhibitor and palbociclib plus fulvestrant) at palbociclib treatment initiation were reported in this outcome measure.

Number of participants classified according to sites of metastases (visceral and non-visceral) were reported in this outcome measure.

Number of participants classified according to metastatic status (denovo advanced BC and recurrent/relapse advanced BC) were reported in this outcome measure.

Number of participants categorized according to family history of breast cancer (Yes/No) were reported in this outcome measure.

Number of participants categorized according to treatment schedule of 3 weeks on, 1 week off (Yes) were reported in this outcome measure.

Number of participants categorized according to palbociclib dose (75 milligram \[mg\], 100 mg and 125 mg) were reported in this outcome measure.

Number of participants categorized according to accompanying endocrine treatments were reported in this outcome measure. Accompanying endocrine treatments included: tamoxifen/NOLVADEX , toremifene / FARESTON, raloxifene / EVISTA, anastrozole / ARIMIDEX, letrozole / FEMARA, exemestane / AROMASIN, fulvestrant / FASLODEX, goserlin acetate / Zoaldex, leuprorelin /Lupron, triptorelin / Decapeptyl, degarelix / Firmagon. One participant may have received more than one endocrine treatment accompanying palbociclib treatment.

Number of participants with palbociclib dose interruption were reported in this outcome measure.

Number of participants with dose delays were reported in this outcome measure.

Number of participants who discontinued palbociclib treatment were reported in this outcome measure.

Duration of palbociclib treatment was defined as time (in days) from first to last day in palbociclib treatment.

Number of participants according to supportive therapies received during palbociclib combination treatment were reported in this outcome measure. Supportive therapies included: zoledronic acid, calcium supplement, alfacalcidol, letrozole, vitamin D, gabapentin, tramadol, denosumab, granisetron, morphine, filgrastim, metoclopramide, dexamethasone, domperidone, duloxetine, fulvestrant, ondansetron, prednisolone, citalopram, itopride, oxycodone, pregabalin, sertraline. One participant may have received more than one supportive therapy.

Number of participants categorized according to adjuvant therapies were reported in this outcome measure. Adjuvant therapies included: adjuvant chemotherapy, adjuvant hormonal therapy, experimental adjuvant therapy, neoadjuvant chemotherapy, neoadjuvant hormonal therapy, radiotherapy and surgery. One participant may have received more than one type of adjuvant therapy.

Time between start of palbociclib treatment and end of therapy for early/locally advanced BC was calculated as date of initiation of palbociclib treatment - date of end of therapy for early/locally advanced therapy. Time between start of palbociclib treatment and end of adjuvant therapy for early/locally advanced breast cancer was collected at baseline from participant's medical records.

Number of participants according to therapies received before palbociclib treatment were reported in this outcome measure. Therapies included: MBC chemotherapy, MBC hormonal therapy (other than Palbociclib combination), combination therapy, other therapy, radiotherapy and surgery. One participant may have received more than one type of therapy. Therapies for which non-zero data were available have been reported below.

Number of participants according to first subsequent therapy received after palbociclib treatment discontinuation were reported in this outcome measure. Subsequent therapies included systemic therapy, radiotherapy, surgery and other therapy. Subsequent therapies for which non-zero data were available have been reported below.

EORTC QLQ-30 included five functional scales (physical functioning, role, emotional, cognitive and social functioning), nine symptom scales (fatigue, nausea or vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties, and a global health status scale (GHS). The GHS/QoL scale ranged from 1=very poor to 7=excellent. All other items ranged from 1=not at all to 4=very much. A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS and functional scales, and 0 being the best and 100 being the worst for symptom scales.