Hope S. Rugo
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RISE UP for breast cancer 2024: conference highlights & takeaways Open
RISE UP (Revolutionizing Investigations to StEp Up Prevention) for breast cancer brought together leading cancer specialists, women’s health providers, basic and population scientists, regulators, politicians, industry leaders, patient adv…
View article: Circulating tumor DNA refines risk stratification of neoadjuvant therapy-resistant breast tumors
Circulating tumor DNA refines risk stratification of neoadjuvant therapy-resistant breast tumors Open
Early-stage breast cancers resistant to neoadjuvant therapy (NAT), characterized by high residual cancer burden (RCB) after treatment, have an increased risk of metastatic recurrence. Here, we show that circulating tumor DNA (ctDNA) detect…
View article: Multicenter Interspecialty Consensus on Experimental Oncology Drug–Related Ocular Adverse Event Reporting
Multicenter Interspecialty Consensus on Experimental Oncology Drug–Related Ocular Adverse Event Reporting Open
Importance The current ocular Common Terminology Criteria for Adverse Events (CTCAE) mix eye signs with symptoms and lack standardized clinical photographs and experimental oncology drug dose modification recommendations. Robust reporting …
Optimizing clinical monitoring and management guidelines for capivasertib in HR-positive/HER2-negative advanced breast cancer: expert opinion Open
Capivasertib, an AKT inhibitor, approved in combination with fulvestrant for hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer with ≥1 PIK3CA , AKT1 , and/or PTEN alterations, significantly…
View article: Characterization of the safety profile of trastuzumab deruxtecan by dose: a pooled analysis across DESTINY studies
Characterization of the safety profile of trastuzumab deruxtecan by dose: a pooled analysis across DESTINY studies Open
Background Trastuzumab deruxtecan (T-DXd), an approved human epidermal growth factor receptor 2 (HER2)-directed antibody–drug conjugate, may cause treatment-emergent adverse events (TEAEs), most commonly gastrointestinal and hematologic TE…
View article: Real-World Outcomes of Elacestrant in ER+, HER2−, <i>ESR1</i> -Mutant Metastatic Breast Cancer
Real-World Outcomes of Elacestrant in ER+, HER2−, <i>ESR1</i> -Mutant Metastatic Breast Cancer Open
Purpose: The EMERALD trial led to the approval of elacestrant for estrogen receptor (ER)–positive, HER2-negative, estrogen receptor 1 (ESR1)–mutated advanced or metastatic breast cancer (mBC) with disease progression following at least one…
View article: Enfortumab Vedotin in Patients With Previously Treated Advanced Breast Cancer in the Phase II EV-202 Study
Enfortumab Vedotin in Patients With Previously Treated Advanced Breast Cancer in the Phase II EV-202 Study Open
PURPOSE EV-202 (ClinicalTrials.gov identifier: NCT04225117 ) evaluated enfortumab vedotin (EV), a nectin-4–directed antibody-drug conjugate, in patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative (HR+/…
View article: Increasing awareness of and referral to support services in advanced breast cancer: a global expert review and call-to-action for 2025–2035 (Goal 7)
Increasing awareness of and referral to support services in advanced breast cancer: a global expert review and call-to-action for 2025–2035 (Goal 7) Open
Advanced breast cancer (ABC) represents a significant global health challenge, not only due to its high mortality rates but also because of the profound physical, emotional, and social burden it imposes on patients. Support services - enco…
View article: A Decade After Approval of the First CDK4/6 Inhibitor: A Look Back at Palbociclib’s Journey from Discovery to Approval and What’s Next in CDK Inhibition in Breast Cancer
A Decade After Approval of the First CDK4/6 Inhibitor: A Look Back at Palbociclib’s Journey from Discovery to Approval and What’s Next in CDK Inhibition in Breast Cancer Open
The initial approval of palbociclib in 2015 marked a major advancement in the treatment of hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC). As the first-in-class cyclin-d…
View article: Figure 2 from Gedatolisib Combined with Palbociclib and Letrozole in Patients with No Prior Systemic Therapy for Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
Figure 2 from Gedatolisib Combined with Palbociclib and Letrozole in Patients with No Prior Systemic Therapy for Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer Open
Survival in patients with no prior systemic therapy for advanced breast cancer in the full analysis population. Kaplan–Meier curve determined in the full analysis population of (A) PFS and (B) OS. PFS was determined by the time from the da…
View article: Data from Gedatolisib Combined with Palbociclib and Letrozole in Patients with No Prior Systemic Therapy for Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
Data from Gedatolisib Combined with Palbociclib and Letrozole in Patients with No Prior Systemic Therapy for Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer Open
Purpose:Nonclinical evidence demonstrating that estrogen receptor, cyclin-dependent kinases 4 and 6 (CDK4/6), and PI3K/AKT/mTOR (PAM) pathways cross-promote tumor proliferation in hormone receptor–positive (HR+)/HER2− breast cancer cell li…
View article: Table 1 from Gedatolisib Combined with Palbociclib and Letrozole in Patients with No Prior Systemic Therapy for Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
Table 1 from Gedatolisib Combined with Palbociclib and Letrozole in Patients with No Prior Systemic Therapy for Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer Open
Patient demographic and baseline disease characteristics in the full analysis population with no prior systemic therapy for advanced breast cancer.
View article: Supplementary Appendix1 from Gedatolisib Combined with Palbociclib and Letrozole in Patients with No Prior Systemic Therapy for Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
Supplementary Appendix1 from Gedatolisib Combined with Palbociclib and Letrozole in Patients with No Prior Systemic Therapy for Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer Open
Table S1 and Figure S1
View article: Table 2 from Gedatolisib Combined with Palbociclib and Letrozole in Patients with No Prior Systemic Therapy for Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
Table 2 from Gedatolisib Combined with Palbociclib and Letrozole in Patients with No Prior Systemic Therapy for Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer Open
Response rates to gedatolisib + palbociclib + letrozole in the response evaluable set.
View article: Table 4 from Gedatolisib Combined with Palbociclib and Letrozole in Patients with No Prior Systemic Therapy for Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
Table 4 from Gedatolisib Combined with Palbociclib and Letrozole in Patients with No Prior Systemic Therapy for Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer Open
Grade 3 or 4 TESAEs, of any cause, occurring in >1 patient, N = 41.
View article: Table 3 from Gedatolisib Combined with Palbociclib and Letrozole in Patients with No Prior Systemic Therapy for Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
Table 3 from Gedatolisib Combined with Palbociclib and Letrozole in Patients with No Prior Systemic Therapy for Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer Open
TEAEs (of any cause, occurring in >20% of patients in the safety analysis set; N = 41).
View article: Figure 1 from Gedatolisib Combined with Palbociclib and Letrozole in Patients with No Prior Systemic Therapy for Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
Figure 1 from Gedatolisib Combined with Palbociclib and Letrozole in Patients with No Prior Systemic Therapy for Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer Open
Best overall response and target lesion improvement. Percentage change from baseline in the sum of the diameters of all target lesions at the time of best response. There were five subjects with 100% target lesion responses, but they were …
View article: Clinical perspective on management of key adverse events with sacituzumab govitecan
Clinical perspective on management of key adverse events with sacituzumab govitecan Open
Sacituzumab govitecan (SG) is a first-in-class trophoblast cell surface antigen-2-directed antibody-drug conjugate that selectively delivers a well-characterized and potent payload of SN-38 to cancer cells and the surrounding environment. …
View article: Real-world progression-free survival of CDK4/6 inhibitors plus an aromatase inhibitor in HR-positive/HER2-negative metastatic breast cancer in United States routine clinical practice
Real-world progression-free survival of CDK4/6 inhibitors plus an aromatase inhibitor in HR-positive/HER2-negative metastatic breast cancer in United States routine clinical practice Open
Our study, the largest real-world CDK4/6i comparative effectiveness study to date, demonstrated no significant rwPFS differences between 1L palbociclib, ribociclib, and abemaciclib, plus AI, in patients with HR-positive/HER2-negative mBC.
View article: Identifying Patients With Low Relapse Rate Despite High-Risk Estrogen Receptor–Positive/Human Epidermal Growth Factor Receptor 2–Negative Early Breast Cancer: Development and Validation of a Clinicopathologic Assay
Identifying Patients With Low Relapse Rate Despite High-Risk Estrogen Receptor–Positive/Human Epidermal Growth Factor Receptor 2–Negative Early Breast Cancer: Development and Validation of a Clinicopathologic Assay Open
PURPOSE Escalation of adjuvant systemic therapies (eg, with cyclin-dependent kinase 4 and 6 inhibitors) is now indicated for patients with clinically defined high-risk estrogen receptor–positive (ER+)/human epidermal growth factor receptor…
View article: Comparative efficacy between real-world and randomized studies of palbociclib+endocrine therapy in HR-positive/HER2-negative metastatic breast cancer: systematic review and meta-analysis
Comparative efficacy between real-world and randomized studies of palbociclib+endocrine therapy in HR-positive/HER2-negative metastatic breast cancer: systematic review and meta-analysis Open
Background Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) combined with endocrine therapy are the standard-of-care for hormone receptor-positive (HR+)/HER2-negative (HER2−) metastatic breast cancer (MBC). Palbociclib, the first approved …
View article: Individual patient data meta-analysis of NEPA versus aprepitant-based antiemetic regimens for preventing chemotherapy-induced nausea and vomiting
Individual patient data meta-analysis of NEPA versus aprepitant-based antiemetic regimens for preventing chemotherapy-induced nausea and vomiting Open
Improved CINV prevention was observed with NEPA-based regimens, particularly during Days 3-5, highlighting its potential for managing prolonged nausea and vomiting associated with emerging anticancer targeted therapies.
View article: US expert Delphi consensus on the prevention and management of stomatitis in patients treated with datopotamab deruxtecan
US expert Delphi consensus on the prevention and management of stomatitis in patients treated with datopotamab deruxtecan Open
Summary Background Datopotamab deruxtecan (Dato-DXd) is an investigational antibody–drug conjugate that has shown promising results in phase III clinical trials of lung and breast cancers. Stomatitis is a common adverse event associated wi…