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breast cancer

PADA-1 Trial: With Early Identification of ESR1 Mutation, Switch to Fulvestrant in Metastatic Breast Cancer

Switching from an aromatase inhibitor to fulvestrant upon early identification of the ESR1 mutation in plasma—before disease progression—doubled progression-free survival in the phase III PADA-1 trial, presented at the 2021 San Antonio Breast Cancer Symposium.1 “PADA-1 is the first trial to...

breast cancer

EMERALD Trial: Oral Selective Estrogen Receptor Degrader as Second- or Third-Line Therapy for Advanced Breast Cancer

Use of the first investigational oral selective estrogen receptor degrader (SERD) elacestrant significantly reduced the risk of death or disease progression and lengthened progression-free survival compared with standard-of-care endocrine therapy with fulvestrant or an aromatase inhibitor in...

breast cancer

Metformin Added to Standard Adjuvant Chemotherapy Fails to Improve Outcomes in Early Breast Cancer

The addition of metformin, a drug commonly used to treat type 2 diabetes, to standard adjuvant treatment failed to improve invasive disease–free survival or overall survival for hormone receptor–positive or –negative breast cancer, according to the results of a large landmark trial led by the...

Expert Point of View: Matthew J. Ellis, MB, BChir, PhD, FACP

The final results of the phase III PALLAS trial1 are “deeply disappointing,” said session moderator Matthew J. Ellis, MB, BChir, PhD, FACP, Professor of Medicine and Director of the Lester and Sue Smith Breast Center at Baylor College of Medicine. The results of the final primary analysis of...

breast cancer

Final Analysis of PALLAS Trial: No Benefit of Adjuvant Palbociclib Plus Endocrine Therapy in Early Breast Cancer

The final protocol-defined analysis of the phase III PALLAS trial confirmed the negative results of the second interim analysis, showing no benefit of palbociclib plus endocrine therapy in the adjuvant breast cancer setting. Michael Gnant, MD, of the Medical University of Vienna, reported these...

Evidence Supports Ovarian Function Suppression Plus Aromatase Inhibitor in Premenopausal Women With Early Breast Cancer

The benefits of ovarian function suppression were sustained long term for premenopausal women with hormone receptor–positive breast cancer, according to updates from SOFT and TEXT, two randomized, controlled trials, presented at the 2021 San Antonio Breast Cancer Symposium.1 A separate large...

breast cancer

MONALEESA Analyses Show Widespread Benefit for Ribociclib in Hormone Receptor–Positive, HER2-Negative Breast Cancer

Further analyses of the MONALEESA metastatic breast cancer trials have shown that the benefit of ribociclib plus endocrine therapy in the first-line setting extends to most intrinsic molecular subtypes and is consistent across multiple subgroups. The studies were presented at the 2021 San Antonio...

breast cancer

RxPONDER Update Explores Benefit of Chemotherapy in Subgroups

Updated results of the SWOG S1007 RxPONDER trial confirmed the key takeaway from the previous analysis: adjuvant chemotherapy benefits premenopausal women but not postmenopausal women with hormone receptor–positive, HER2-negative disease, one to three positive lymph nodes, and a 21-gene Oncotype DX ...

breast cancer

Identifying Women With Triple-Negative Breast Cancer Who May Benefit From Pembrolizumab Plus Chemotherapy

Results of the phase III randomized KEYNOTE-355 trial showed that the addition of the PD-1 inhibitor pembrolizumab to investigator’s choice of first-line chemotherapy improved progression-free and overall survival in women with metastatic triple-negative breast cancer compared with placebo and...

breast cancer

KEYNOTE-522: Sensitivity Analyses Confirm Value of Neoadjuvant Pembrolizumab in Triple-Negative Breast Cancer

Updated results from the pivotal KEYNOTE-522 trial have confirmed the benefit of neoadjuvant therapy with pembrolizumab plus chemotherapy in patients with early triple-negative breast cancer.1 The results were presented at the 2021 San Antonio Breast Cancer Symposium by Peter Schmid, MD, PhD,...

breast cancer

Clinical Trials Underway for T-DXd in Breast Cancer

The current standard of care for the neoadjuvant treatment of HER2-positive early-stage breast cancer consists of trastuzumab plus pertuzumab and polychemotherapy. But some patients, particularly those with locally advanced or inflammatory disease, still relapse and die. Furthermore, multiagent...

breast cancer

T-DXd Shows Activity in HER2-Low, HER2-Undetectable Breast Cancer

The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) has led to practice changes in previously treated HER2-positive metastatic breast cancer. Most notably, in the DESTINY-Breast03 trial, treatment with T-DXd produced a doubling in 12-month progression-free survival vs...

prostate cancer

ARASENS Trial: Addition of Darolutamide to Androgen-Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

As presented at the 2022 ASCO Genitourinary Cancers Symposium and reported in The New England Journal of Medicine by Smith et al, the phase III ARASENS trial has shown significantly improved overall survival with the addition of darolutamide to androgen-deprivation therapy and docetaxel in men with ...

bladder cancer
immunotherapy

Daniel P. Petrylak, MD, on Bladder Cancer: Study EV-103 Cohort H Findings on Enfortumab Vedotin-ejfv

Daniel P. Petrylak, MD, of Yale Cancer Center, discusses new data on the antitumor activity of neoadjuvant treatment with enfortumab vedotin-ejfv monotherapy in patients with muscle-invasive bladder cancer who are not eligible for cisplatin.

multiple myeloma
immunotherapy

Isatuximab-Containing Induction Therapy for Multiple Myeloma Increases Measurable Residual Disease Negativity

For the first-line treatment of newly diagnosed multiple myeloma, the percentage of patients achieving measurable residual disease (MRD, previously called minimal residual disease) negativity was significantly greater when the anti-CD38 monoclonal antibody isatuximab was added to a standard...

multiple myeloma

Studies Evaluate Screening for Early Multiple Myeloma

Precursors to multiple myeloma were identified by population screening in two studies reported at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition. The prevalence of monoclonal gammopathies was determined in the PROMISE trial using cutting-edge technology in a high-risk ...

myelodysplastic syndromes

PANTHER: No Significant Benefit for Pevonedistat Plus Azacitidine in Higher-Risk Myelodysplastic Syndrome

The phase III PANTHER trial, which evaluated pevonedistat plus azacitidine vs azacitidine alone in higher-risk myelodysplastic syndromes, chronic myelomonocytic leukemia, and low–blast count acute myeloid leukemia (AML) failed to meet its primary endpoint of event-free survival,1 though lessons...

lymphoma
immunotherapy

ZUMA-7: Axicabtagene Ciloleucel Quadruples Event-Free Survival in Large B-Cell Lymphoma

In the primary analysis of the phase III ZUMA-7 trial, examining second-line therapy for relapsed or refractory large B-cell lymphoma, the CAR T-cell therapy axicabtagene ciloleucel led to a fourfold increase in event-free survival over the standard of care. These findings were presented at the...

lymphoma
immunotherapy

TRANSFORM: Lisocabtagene Maraleucel Improves Outcomes in Relapsed or Refractory Large B-Cell Lymphoma

Chimeric antigen receptor (CAR) T-cell therapy with lisocabtagene maraleucel could prove to be the new standard-of-care treatment for patients with relapsed or refractory large B-cell lymphoma in the second-line setting, according to data presented at the 2021 American Society of Hematology (ASH)...

lymphoma
immunotherapy

POLARIX: Addition of Polatuzumab Vedotin-piiq to Standard of Care Significantly Reduces Progression of Diffuse Large B-Cell Lymphoma

As a first-line treatment of inter­mediate- or high-risk diffuse large B-cell lymphoma, the addition of the antibody-drug conjugate polatuzumab vedotin-piiq to standard-of-care therapy resulted in a 27% reduction in the relative risk of disease progression, relapse, or death, with a similar safety...

issues in oncology

Reflecting on the Past 50 Years of Cancer Progress and Looking Ahead to the Next 50 Years of Advances

In December 2021, Nobel laureates, cancer center directors, physicians, scientists, politicians, public health officials, and patient advocates gathered at the Richard Nixon Presidential Library and Museum in Yorba Linda, California, to celebrate the 50th anniversary of the signing of the National...

breast cancer

ASCO Updates Guidance on Use of Abemaciclib and Endocrine Therapy in Patients With High-Risk Early Breast Cancer

A rapid update to the ASCO guideline on optimal adjuvant chemotherapy and targeted therapy for early breast cancer provides guidance on the use of the oral cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor abemaciclib with endocrine therapy in patients with high-risk early breast cancer.1 The...

hematologic malignancies

In Case You Missed It: Brief Highlights From the 2021 ASH Annual Meeting & Exposition

COVID has upended our world, and medical conferences have had to adapt to ever-shifting sands depending on the behavior of the variants of the virus that emerge. The 2021 American Society of Hematology (ASH) Annual Meeting & Exposition was no exception, offering a hybrid meeting for in-person...

colorectal cancer

GALAXY Trial: Circulating Tumor DNA Appears Prognostic in Resected Colorectal Cancer

The use of circulating tumor DNA (ctDNA) assays in early-stage colorectal cancer is highly prognostic for recurrence and may help identify patients who could benefit from adjuvant chemotherapy, according to findings from the GALAXY trial, presented at the 2022 ASCO Gastrointestinal Cancers...

prostate cancer
genomics/genetics

New Data Validate Clinical Utility of Genomic Classifier Test to Help Guide Therapy for Men With Intermediate-Risk Prostate Cancer

New data validating the clinical utility of the Decipher prostate genomic classifier for guiding treatment selection in men with intermediate-risk prostate cancer was presented at the 2022 ASCO Genitourinary Cancers Symposium (Abstract 269). Data from the randomized phase III NRG/RTOG 0126 study,...

prostate cancer
genomics/genetics

PARP Inhibitor Plus Abiraterone Benefits Subgroups of Patients With Metastatic Castration-Resistant Prostate Cancer

The combination of the poly (ADP-ribose) polymerase (PARP) inhibitor niraparib plus abiraterone acetate and prednisone as first-line therapy significantly improved radiographic progression-free survival vs abiraterone and placebo alone in men with metastatic castration-resistant prostate cancer...

solid tumors

Similar Efficacy but Better Tolerability for Ripretinib vs Sunitinib in Second-Line GIST Therapy

In the INTRIGUE trial, reported during the January 2022 session of the virtual ASCO Plenary Series, the tyrosine kinase inhibitor ripretinib was not superior to sunitinib in the second-line treatment of patients with advanced gastrointestinal stromal tumors (GIST) but was better tolerated.1...

leukemia

AGILE: Addition of Ivosidenib to Azacitidine Triples Median Overall Survival in Difficult-to-Treat AML Population

In patients with newly diagnosed acute myeloid leukemia (AML) with an IDH1 mutation who were ineligible for intensive chemotherapy, the addition of the IDH1 inhibitor ivosidenib to azacitidine significantly improved survival vs azacitidine alone, according to data presented at the 2021 American...

leukemia

Fixed-Duration Venetoclax Plus Ibrutinib Achieves Deep and Durable MRD Remissions in CLL

Two different trials presented at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition found that fixed-duration treatment with ibrutinib and venetoclax achieved deep and sustained undetectable measurable residual disease (MRD) status when used as first-line therapy for...

leukemia

Improved Outcomes With Time-Limited Venetoclax Combinations vs Chemoimmunotherapy in Fit Patients with CLL

Administering time-limited regimens that were combinations of venetoclax plus obinutuzumab or venetoclax plus obinutuzumab and ibrutinib was superior to chemoimmunotherapy in achieving undetectable measurable residual disease in the peripheral blood at month 15 in fit patients with chronic...

hematologic malignancies
covid-19

Aggressive Supportive Treatment for COVID-19 May Be Needed in Patients With Hematologic Cancers

New research underscores the need for aggressive support of patients hospitalized with blood cancer and COVID-19, according to data presented at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition. Two studies of one of the largest data sets of patients with blood cancer...

bladder cancer
immunotherapy

Neoadjuvant Enfortumab Vedotin-ejfv in Cisplatin-Ineligible Patients With Muscle-Invasive Bladder Cancer

The antibody-drug conjugate enfortumab vedotin-ejfv is effective in patients with muscle-invasive bladder cancer who are not eligible for cisplatin chemotherapy, according to data from cohort H of the phase IB/II EV-103 clinical trial being presented at the 2022 ASCO Genitourinary Cancers Symposium ...

hematologic malignancies

CHIP Mutations Associated With Lower Risk of Alzheimer’s Disease

The presence of clonal hematopoiesis of indeterminate potential, or CHIP, increases the risk of developing a myeloid malignancy and also cardiovascular disease—which are well-established findings—but it may also protect against developing Alzheimer’s disease, according to findings reported at the ...

breast cancer

Does Daily Aspirin Help Prevent Breast Cancer Recurrence?

Taking aspirin daily does not prevent breast cancer recurrence, according to research presented by Wendy Y. Chen, MD, MPH, a medical oncologist at Dana-Farber Cancer Institute, during the February 2022 ASCO Plenary Series session (Abstract 360922). Results of a double-blind phase III study of more...

breast cancer

RxPONDER Trial: Another Step in Defining Which Patients With Breast Cancer May Be Spared Adjuvant Cytotoxic Chemotherapy

As reported by Kalinsky et al and summarized in this issue of The ASCO Post, an interim analysis of the phase III RxPONDER trial showed that the addition of adjuvant chemotherapy to endocrine therapy improved invasive disease–free survival among premenopausal—but not postmenopausal—women with...

hepatobiliary cancer
immunotherapy

HIMALAYA Trial: First-Line Tremelimumab Plus Durvalumab Improves Overall Survival in Unresectable Hepatocellular Carcinoma

Patients with advanced, unresectable hepatocellular carcinoma may be gaining another first-line treatment option. In the global phase III HIMALAYA trial, a single priming dose of tremelimumab plus regular-interval durvalumab significantly improved overall survival, according to Ghassan K....

hepatobiliary cancer
immunotherapy

TOPAZ-1: Overall Survival Prolonged With First-Line Immunotherapy Plus Chemotherapy in Biliary Tract Cancer

For the first time, a phase III study has shown an overall survival benefit for upfront treatment using immunotherapy plus chemotherapy in advanced biliary tract cancer. In the TOPAZ-1 trial, the addition of the anti–PD-L1 agent durvalumab to gemcitabine plus cisplatin significantly improved...

breast cancer

PALLAS Trial in Hormone Receptor–Positive, HER2-Negative Breast Cancer: Defining the Role of Adjuvant CDK4/6 Inhibition

Over the past 7 years, the introduction of combined endocrine therapy with cyclin-dependent kinase (CDK) 4/6 inhibitors resulted in a dramatic improvement in outcomes for patients with metastatic, hormone receptor–positive, HER2-negative breast cancer. Early attempts to modulate the cell cycle with ...

multiple myeloma

In All Candor, What Does CANDOR Bring to the Table in Relapsed or Refractory Multiple Myeloma?

An updated analysis of the phase III CANDOR study—recently reported by Usmani et al and summarized in this issue of The ASCO Post—confirmed a significant progression-free survival benefit for the combination of daratumumab, carfilzomib, and dexamethasone (KdD) over carfilzomib and dexamethasone...

skin cancer

FDA Approves Tebentafusp-tebn for the Treatment of Unresectable or Metastatic Uveal Melanoma

On January 26, the U.S. Food and Drug Administration (FDA) granted approval to tebentafusp-tebn (Kimmtrak) for the treatment of adult patients with HLA-A*02:01–positive, unresectable or metastatic uveal melanoma. Tebentafusp’s approval establishes several firsts: as the first T-cell receptor...

gastrointestinal cancer

Similar Efficacy—but Better Tolerability—for Ripretinib vs Sunitinib in Previously Treated Patients With Advanced GIST

In the INTRIGUE trial, the tyrosine kinase inhibitor ripretinib was not superior to sunitinib in the second-line treatment of patients with advanced gastrointestinal stromal tumors (GIST); however, the agent was better tolerated. These findings were presented by Michael C. Heinrich, MD, FACP, and...

breast cancer
issues in oncology

Study Identifies Black Race as Risk Factor for Lymphedema After Axillary Dissection in Women With Breast Cancer

Black women with breast cancer had significantly higher rates of lymphedema after axillary lymph node dissection compared with Hispanic, White, and Asian women in a prospective study of breast cancer–related lymphedema presented at the 2021 San Antonio Breast Cancer Symposium (SABCS). In fact,...

global cancer care

Cancer on the Global Stage: Incidence and Cancer-Related Mortality in Burundi

The ASCO Post is pleased to continue this occasional special focus on the worldwide cancer burden. In this issue, we feature a close look at the cancer incidence and mortality rates in Burundi. The aim of this special feature is to highlight the global cancer burden for various countries of the...

lung cancer
immunotherapy

Adjuvant Atezolizumab in IMpower010: Moving the Needle in Early-Stage NSCLC

Adjuvant platinum-based chemotherapy for early-stage non–small cell lung cancer (NSCLC) is currently almost an afterthought and is taken for granted as a standard of care for patients with stage II to IIIA NSCLC after resection. The earliest meta-analysis, published in 1995,1 gave the first hint of ...

lung cancer
immunotherapy

Promise and Need for More Progress in Treatment of Squamous Cell NSCLC

A greater understanding of the mutational landscape in non–small cell lung cancer (NSCLC) has identified key oncogenes, such as EGFR, ALK, ROS, RET, and BRAF, among others. These discoveries, coupled with the availability of specific targeted small-molecule inhibitors, have transformed the...

Ian E. Krop, MD, PhD, Named Chief Clinical Research Officer, Associate Cancer Center Director for Clinical Research at Yale Cancer Center

Ian E. Krop, MD, PhD, has been appointed Chief Clinical Research Officer, Associate Cancer Center Director for Clinical Research, and Director of the Yale Cancer Center Clinical Trials Office. Dr. Krop will assume his new position on March 2, 2022. “I’m pleased to announce Dr. Krop will work with ...

gastroesophageal cancer
immunotherapy

Pembrolizumab Plus Chemotherapy in Advanced Esophageal Cancer: Good News for Some, but More Work to Be Done

Multiple comparisons of traditional cytotoxic chemotherapy combinations that began decades ago led to the adoption of the platinum plus fluorouracil doublet as the standard of care for treatment of recurrent or metastatic esophageal cancer.1 Other combinations created by the addition and/or...

skin cancer
immunotherapy

Circadian Timing of Immune Checkpoint Inhibitors: Beyond Good Times and Bad Times

After almost a century of limited efficacy of cancer immunotherapy,1 the breakthrough happened in 2012 with the discovery of immune checkpoint inhibitors,2,3 leading to the 2018 Nobel Prize in Physiology or Medicine for James P. Allison and Tasuku Honjo. Yet about 40% of patients on immune...

hepatobiliary cancer
immunotherapy

Durvalumab Plus Gemcitabine/Cisplatin Improves Survival in Patients With Advanced Biliary Tract Cancer: TOPAZ-1

Biliary tract cancer is a rare and often fatal disease comprised primarily of bile duct and gallbladder cancers; it is diagnosed in about 12,000 individuals each year in the United States. The cancer has a 5-year relative survival rate of 25% for localized intrahepatic bile duct cancers and just...

breast cancer

Role of Radiologist Experience and Fatigue Level in Recommending Additional Imaging for Patients Undergoing Breast Cancer Screening

Less experienced radiologists are more likely to recommend additional imaging for women undergoing breast cancer screening when they read digital breast tomosynthesis (DBT) images later in the day, according to a new study published by Bernstein et al in the journal Radiology. The results highlight ...

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