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multiple myeloma

MRD Response–Adapted Therapy in Patients Receiving Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone Plus AHCT for Newly Diagnosed Multiple Myeloma

In the phase II MASTER trial reported in the Journal of Clinical Oncology, Luciano J. Costa, MD, PhD, and colleagues found that daratumumab, carfilzomib, lenalidomide, and dexamethasone (Dara-KRd) induction; autologous hematopoietic cell transplantation (AHCT); and measurable residual disease (MRD) ...

lymphoma
immunotherapy

Polatuzumab Vedotin-piiq Plus R-CHP vs R-CHOP for Previously Untreated Patients With DLBCL

In the phase III POLARIX trial reported in The New England Journal of Medicine, Tilly et al found that polatuzumab vedotin-piiq plus R-CHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) significantly improved progression-free survival vs R-CHOP (rituximab, cyclophosphamide, doxorubicin, ...

head and neck cancer

New National Study Finds Oropharyngeal Cancer Incidence and Mortality Is Rising in the United States

Oropharyngeal cancer incidence among men is continuing to rise rapidly in nearly all 50 U.S. states and among women living in states in the Midwest and Southeast regions, according to a new study published by Damgacioglu et al in JAMA Otolaryngology–Head & Neck Surgery. In addition, the...

lymphoma
immunotherapy

Second-Line Tisagenlecleucel vs Standard of Care in Aggressive B-Cell Lymphoma

As reported in The New England Journal of Medicine by Bishop et al, the phase III BELINDA trial showed no improvement in event-free survival with second-line tisagenlecleucel vs standard of care including salvage chemotherapy and autologous hematopoietic stem cell transplantation (HSCT) in patients ...

breast cancer

Breast Cancer Index May Predict Benefit of Extended Endocrine Therapy in Certain Patients With Hormone Receptor–Positive Disease

New data were presented at the 2021 San Antonio Breast Cancer Symposium demonstrating that the Breast Cancer Index (BCI) may predict preferential recurrence-prevention benefit from extended endocrine therapy and may also predict the overall benefit/risk and likelihood of improved health outcomes...

breast cancer
gynecologic cancers
survivorship

Effect of Bupropion vs Placebo on Sexual Desire in Postmenopausal Female Cancer Survivors

In a phase II trial (NRG-CC004) reported in the Journal of Clinical Oncology, Barton et al found that bupropion, a dopaminergic agent, did not improve sexual desire vs placebo as measured by the Female Sexual Function Index (FSFI) desire subscale among postmenopausal women with low desire scores...

lung cancer

Postoperative Radiotherapy for Patients With Completely Resected Stage IIIA NSCLC and N2 Involvement

In the European phase III Lung ART trial reported in The Lancet Oncology, Le Pechoux et al found that three-dimensional (3D) conformal postoperative radiotherapy (PORT) did not improve disease-free survival vs no PORT in patients with stage IIIA N2 non–small cell lung cancer (NSCLC) who had...

The Oncology Center of Excellence Encourages Submissions of Applied Regulatory Science Research Proposals

OCE Insights is an occasional column developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Julie A. Schneider, PhD, Associate Director for Research Strategy and Partnerships, OCE; Jennifer J. Gao, MD,...

multiple myeloma
immunotherapy

Daratumumab in Front-Line Treatment of Newly Diagnosed Transplant-Ineligible Multiple Myeloma: Questions Emerge From MAIA Trial

In the past decade, use of immunotherapy has arisen as a novel adjunct to multiple myeloma therapy. Daratumumab is the first anti-CD38 monoclonal antibody to be approved by the U.S. Food and Drug Administration (FDA), in November 2015, for use in treating relapsed or refractory multiple myeloma.1...

multiple myeloma
immunotherapy

MAIA Trial: Daratumumab Added to Lenalidomide Plus Dexamethasone Improves Overall Survival in Transplant-Ineligible Multiple Myeloma

As reported in The Lancet Oncology by Thierry Facon, MD, of the Centre Hospitalier Universitaire de Lille, and colleagues, a prespecified interim analysis of overall survival in the pivotal phase III MAIA trial has shown a significant benefit with the addition of daratumumab to...

hepatobiliary cancer
immunotherapy

COSMIC-312: Cabozantinib Plus Atezolizumab Improves Progression-Free Survival in Advanced Hepatocellular Carcinoma

The phase III COSMIC-312 study has met its primary endpoint, showing a significant improvement in progression-free survival with cabozantinib plus atezolizumab compared with sorafenib in treatment-naive hepatocellular carcinoma (HCC), investigators reported at a European Society for Medical...

lung cancer
genomics/genetics

Expert Point of View: Myung-Ju Ahn, MD, PhD

Myung-Ju Ahn, MD, PhD, Professor in the Department of Hematology and Oncology at Samsung Medical Center, Sungkyunkwan University School of Medicine, South Korea, said the novel regimen of sintilimab, IBI305, and chemotherapy is a promising approach in EGFR-mutated nonsquamous non–small cell lung...

lung cancer
genomics/genetics

ORIENT-31: Novel Four-Drug Regimen Evaluated in EGFR-Mutated NSCLC

A four-drug combination of the anti–PD-1 antibody sintilimab, the bevacizumab biosimilar IBI305, plus pemetrexed and cisplatin chemotherapy significantly improved progression-free survival compared with chemotherapy alone in patients with advanced nonsquamous non–small cell lung cancer (NSCLC) with ...

breast cancer

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 PALLAS ...

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...

breast cancer
immunotherapy

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...

More Than Two Dozen SABCS Presenters Receive Research Scholarships

Several of the researchersand scientists at the 42nd annual San Antonio Breast Cancer Symposium (SABCS), held December 10–14, attended the event on the basis of scholarships awarded through SABCS and its cosponsor, the American Association of Cancer Research (AACR). The goal of the scholarships is...

colorectal cancer

I Don’t Know Why I Got Young-Onset Colorectal Cancer

Throughout my adolescence and early adulthood, I had been plagued with digestive issues, including bouts of gastritis and constipation, which seemed normal for me and wasn’t too concerning. But by the time I turned 30, in 2015, the acid reflux I had been experiencing became so frequent and...

solid tumors
hematologic malignancies

2021 FDA Approvals of Drugs for Cancer Treatment

Over the past year, the U.S. Food and Drug Administration (FDA) granted approval to many novel drugs and new indications for older therapeutic agents used in oncology and hematology. NOVEMBER Pafolacianine for Ovarian Cancer Lesions: On November 29, pafolacianine (Cytalux), an imaging drug,...

breast cancer
colorectal cancer

Study Examines Rates of Breast and Colorectal Cancer Screening Among Rural Women

Women who live in urban areas and those residing in rural areas are screened for breast cancer at similar rates, but rural women are screened for colorectal cancer at significantly lower rates than their urban counterparts, research published by Shete et al in JAMA Network Open showed. The...

hepatobiliary cancer
immunotherapy

First-Line Nivolumab vs Sorafenib in Advanced Hepatocellular Carcinoma: Effect on Overall Survival

As reported in The Lancet Oncology by Thomas Yau, MD, and colleagues, the phase III CheckMate 459 trial has shown no improvement in overall survival with first-line nivolumab vs sorafenib in patients with advanced hepatocellular carcinoma. Study Details In the open-label trial, 743 patients not...

colorectal cancer

Solving the Conundrum of Young-Onset Colorectal Cancer

Although research so far has failed to uncover the root causes of the development of young-onset colorectal cancer, what is certain is that although colorectal cancer rates are declining in older adults, they are on a steady rise in people younger than age 50, especially those between the ages of...

breast cancer
immunotherapy

Adjuvant T-DM1/Pertuzumab vs Taxane/Trastuzumab/Pertuzumab in High-Risk HER2-Positive Breast Cancer

In the phase III KAITLIN trial reported in the Journal of Clinical Oncology, Ian E. Krop, MD, and colleagues found that adjuvant ado-trastuzumab emtansine (T-DM1) plus pertuzumab did not improve invasive disease–free survival vs a taxane plus trastuzumab/pertuzumab, both following...

Research From the 2021 ASH Annual Meeting & Exposition

The 2021 ASH Annual Meeting & Exposition took place from December 11 to 14. This week, we’re highlighting two studies featured as late-breaking abstracts at the meeting.

issues in oncology

WHO Launches a New Classification System for Pediatric Tumors, Incorporating Morphology, Immunohistochemistry Analysis, and Molecular Characteristics

A review article by Pfister et al published in Cancer Discovery summarizes the inaugural classification of pediatric tumors soon to be published by the International Agency for Research on Cancer as part of the new World Health Organization (WHO) Classification of Tumors series, including an online ...

multiple myeloma

CANDOR: Continued Progression-Free Survival Benefit With Carfilzomib, Dexamethasone, and Daratumumab vs Carfilzomib and Dexamethasone in Relapsed or Refractory Multiple Myeloma

In an updated analysis of the pivotal phase III CANDOR trial reported in The Lancet Oncology, Saad Z. Usmani, MD, and colleagues found that the addition of daratumumab to carfilzomib and dexamethasone (KdD) continued to show a large progression-free survival benefit in patients with relapsed or...

solid tumors

Addition of Monoclonal Antibody hu14.18K322A to Chemotherapy in Pediatric Patients With Newly Diagnosed High-Risk Neuroblastoma

In a single-institution phase II trial reported in the Journal of Clinical Oncology, Furman et al found that the addition of the humanized antidisialoganglioside monoclonal antibody hu14.18K322A to chemotherapy produced high rates of early and end-of-induction response and event-free survival in...

hepatobiliary cancer

Impact of Small Cell Undifferentiated Histology on Outcomes in Pediatric Hepatoblastoma

In an analysis from the Children’s Oncology Group study AHEP0731 reported in the Journal of Clinical Oncology, Trobaugh-Lotrario et al found that the presence of small cell undifferentiated histology elements did not appear to adversely affect outcomes in pediatric patients with hepatoblastoma....

lymphoma
immunotherapy

ZUMA-5 Trial: Axicabtagene Ciloleucel in Relapsed or Refractory Indolent Non-Hodgkin Lymphoma

As reported in The Lancet Oncology by Caron A. Jacobson, MD, and colleagues, the phase II ZUMA-5 trial showed that axicabtagene ciloleucel, an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, produced high rates of durable responses in patients with relapsed or refractory...

colorectal cancer
genomics/genetics

Sotorasib in Previously Treated Patients With KRAS G12C–Mutant Colorectal Cancer

In a prespecified analysis of the phase II CodeBreaK100 trial reported in The Lancet Oncology, Marwan Fakih, MD, and colleagues found that the KRAS G12C protein inhibitor sotorasib showed modest activity in patients with previously treated KRAS G12C–mutant colorectal cancer. Study Details The...

supportive care
hematologic malignancies

FDA Approves Abatacept-Based Combination for Prophylaxis of Acute Graft-vs-Host Disease

On December 15, the U.S. Food and Drug Administration (FDA) approved abatacept (Orencia) for the prophylaxis of acute graft-vs-host disease (GVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients aged 2 years and older undergoing hematopoietic stem...

head and neck cancer

Neoadjuvant Chemotherapy and Mandibular Preservation in Operable Oral Cavity Cancer

In an Indian single-institution phase II study reported in the Journal of Clinical Oncology, Chaukar et al found that neoadjuvant chemotherapy was associated with mandibular preservation in approximately half of previously untreated patients undergoing surgery for squamous cell carcinoma of the...

breast cancer
immunotherapy

Composite Biomarker Needed to Predict Benefit of Immunotherapy in Triple-Negative Breast Cancer

Although there is a biomarker that predicts response to the one approved immunotherapy agent for metastatic triple-negative breast cancer, “it is important to note there are no biomarkers of response to neoadjuvant immunotherapy in early-stage triple-negative breast cancer,” Elizabeth A....

issues in oncology

American Cancer Society Releases Updated Report on Status of Cancer Disparities in the United States

The American Cancer Society recently released its report on the status of cancer disparities in the United States for 2021. Researchers analyzed comprehensive and up-to-date data on racial/ethnic and socioeconomic disparities in cancer occurrence; this includes incidence, stage at diagnosis,...

lymphoma
immunotherapy

BELINDA Study: Second-Line Tisagenlecleucel Equivalent to Standard of Care for Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma

In an analysis of the phase III BELINDA trial presented by Bishop et al during the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract LBA-6), the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel was not found to improve event-free survival over the...

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Study Suggests Lack of Benefit With the Addition of Immune Checkpoint Inhibition to Chemotherapy in Low PD-L1–Expressing Gastric or Esophageal Adenocarcinoma

In an analysis reported in the Journal of Clinical Oncology, Zhao et al found that the addition of an immune checkpoint inhibitor to chemotherapy in trials of first-line treatment of advanced gastric or esophageal adenocarcinoma was not associated with benefit in low PD-L1–expressing subgroups not...

lymphoma

ZUMA-7 Primary Analysis: Second-Line Axicabtagene Ciloleucel Quadruples Event-Free Survival in Large B-Cell Lymphoma

In the primary analysis of the phase III ZUMA-7 trial, the chimeric antigen receptor (CAR) T-cell therapy axicabtagene ciloleucel led to a fourfold increase in event-free survival over the standard of care in the second-line treatment of relapsed or refractory large B-cell lymphoma, according to...

leukemia
myelodysplastic syndromes

Study Identifies Factors for Severe COVID-19 Illness Among Patients With Acute Leukemia or MDS

In separate analyses of 257 patients with acute leukemia or myelodysplastic syndrome (MDS) who developed COVID-19 and are part of the American Society of Hematology (ASH) RC COVID-19 Registry for Hematology, both neutropenia and having active MDS or leukemia (vs being in remission) were found to...

lymphoma

Addition of Romidepsin to CHOP in Previously Untreated Patients With Peripheral T-Cell Lymphoma

As reported in the Journal of Clinical Oncology by Bachy et al, the Lymphoma Study Association phase III Ro-CHOP trial showed no progression-free survival benefit with the addition of the histone deacetylase inhibitor romidepsin to CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)...

covid-19

European OnCovid Registry Analysis of Time-Dependent COVID-19 Mortality in Patients With Cancer

As reported in JAMA Oncology by researchers from the OnCovid Study Group, an updated analysis of the European OnCovid registry indicated that mortality due to COVID-19 infection has decreased over time for patients with cancer during the pandemic. Study Details The study included real-world data on ...

lymphoma
immunotherapy

L. Elizabeth Budde, MD, PhD, on Relapsed/Refractory Follicular Lymphoma: Early Results on Mosunetuzumab Monotherapy

L. Elizabeth Budde, MD, PhD, of City of Hope, discusses phase I/II findings that showed mosunetuzumab monotherapy induces deep and durable remissions in patients with relapsed or refractory follicular lymphoma who have received two or more prior lines of treatment, including those with...

leukemia
palliative care

Study Reveals Gaps in Code Status Discussions Among Patients With High-Risk AML

Oncologists and health-care professionals who treat patients with high-risk acute myeloid leukemia (AML) are missing important opportunities to have end-of-life discussions at earlier stages in the disease course, when patients are best able to discuss their options and preferences. These findings...

hematologic malignancies
covid-19

Antibody Response to COVID-19 Vaccination in Patients With Myeloid and Lymphoid Neoplasms

According to a German study by Rotterdam et al presented at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 218), about 15% of people with blood cancers and other blood disorders had no vaccination-related antibodies after receiving a COVID-19 vaccine....

hematologic malignancies
covid-19

ASH RC COVID-19 Registry for Hematology: Risk Factors for Hospitalization and Death Among Patients With Hematologic Malignancies Infected With COVID-19

Patients with blood cancers, particularly those with more advanced disease, are at increased risk for serious COVID-19 outcomes, including an elevated chance of severe illness or death from infection, according to an analysis of more than 1,000 patients in the ASH Research Collaborative (RC)...

myelodysplastic syndromes
leukemia
covid-19

Antibody Response to Second Dose of mRNA COVID-19 Vaccine in Patients With AML and MDS

In one of the largest studies to date of the antibody response to vaccination against COVID-19 in people who had been treated for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), patients responded well to two doses of the Moderna mRNA vaccine and saw a pronounced increase in levels ...

lymphoma
immunotherapy

TRANSFORM Trial: Lisocabtagene Maraleucel vs Standard of Care for Relapsed or Refractory Large B-Cell Lymphoma

An interim analysis of the TRANSFORM trial comparing the chimeric antigen receptor (CAR) T-cell immunotherapy lisocabtagene maraleucel to standard of care found that the CAR T-cell therapy significantly improved event-free survival for patients with large B-cell lymphoma that persisted or returned...

lymphoma
immunotherapy

Activity of Mosunetuzumab in Pretreated Patients With Relapsed or Refractory Follicular Lymphoma

The bispecific antibody mosunetuzumab achieved deep and durable remissions as monotherapy in patients with relapsed or refractory follicular lymphoma who had received two or more prior lines of therapy, according to pivotal results of a phase I/II trial presented at the 2021 American Society of...

The National Cancer Act of 1971

On December 23, 1971, President Richard M. Nixon signed the National Cancer Act into law. At that time, cancer was the nation’s second leading cause of death; only about one of two people diagnosed with cancer survived at least 5 years—compared with two of three people diagnosed with the disease...

colorectal cancer

Update on the Role of Low-Dose Aspirin in Colorectal Cancer Prevention

Updating its 2016 recommendation on the use of aspirin to prevent cardiovascular disease and colorectal cancer, the U.S. Preventive Services Task Force (USPSTF) issued a draft recommendation statement. It noted the potential harms of daily aspirin, with the most serious being bleeding in the...

The History of Medical Oncology in Europe, 1955–1985

In part 1 of this two-part review, we looked at early pioneers in the field of medical oncology in Europe, as well as the development of international cooperative trials and the formation of European oncology societies (see related articles below). In part 2, we explore how the field of medical...

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