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Build Back Better Act Passes in the House, Moves to Senate

On November 19, 2021, the Build Back Better Act passed the U.S. House of Representatives with a vote of 220–213. The legislation contains significant health-care provisions, some of which are outlined below. Drug Pricing—The legislation contains prescription drug pricing reforms designed to address ...

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...

hepatobiliary cancer
immunotherapy

Expert Point of View: Ian Chau, MD

Invited discussant Ian Chau, MD, Consultant Medical Oncologist at The Royal Marsden Hospital in London and Surrey in the United Kingdom, said the findings from COSMIC-3121 are not mature enough to establish cabozantinib/atezolizumab as a new front-line option for advanced hepatocellular carcinoma...

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 ...

sarcoma

Sirolimus Protein-Bound Particles for Malignant Perivascular Epithelioid Cell Tumor

On November 22, 2021, sirolimus protein-bound particles for injectable suspension (albumin-bound) was approved for treatment of adults with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor.1 Supporting Efficacy Data Approval was supported by findings in the...

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...

global cancer care

The Cancer Research Institute in Morocco: A Center of Excellence Illustrating Progress in Africa in the Age of Global Oncology

The enthusiasm behind the open access initiative sprang from the need for scientific research that is accessible to everyone worldwide. Open knowledge based on open access also aimed to increase good research practices such as reproducibility and transparency.1 This movement was launched by...

leukemia

Measurable Residual Disease Kinetics: A Potential New Tool in CLL

Achieving undetectable measurable residual disease (MRD) is an important milestone in the treatment of patients with chronic lymphocytic leukemia (CLL) as well as those with other hematologic malignancies undergoing treatment. Now a small phase II study, presented at the 2021 American Society of...

breast cancer
immunotherapy

Expert Point of View: Hope S. Rugo, MD, FASCO

Invited discussant of the ­KEYNOTE-355 trial, Hope S. Rugo, MD, FASCO, one of the coauthors of the study, had presented the survival data at the 2021 European Society of Medical Oncology (ESMO) Annual Congress.1 The San Antonio presentation was a more in-depth evaluation of survival by different...

prostate cancer

NCCN Guidelines for Prostate Cancer: Panel Clarifies Role of Active Surveillance for Low-Risk Prostate Cancer

In October 2021, the National Comprehensive Cancer Network (NCCN) prostate caycer panel modified its guidelines (NCCN Clinical Practice Guidelines in Oncology [NCCN Guidelines®]) for low-risk prostate cancer to remove the word “preferred option” for active surveillance, giving equal weight to...

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...

lung cancer

Addition of First-Line Veliparib to Chemotherapy in Advanced Squamous Cell NSCLC: No Survival Benefit in Current Smokers, but Potential Benefit Among Biomarker-Selected Patients

In a phase III trial reported in the Journal of Clinical Oncology, Suresh S. Ramalingam, MD, of Winship Cancer Institute, Emory University School of Medicine, and colleagues found that the addition of the PARP inhibitor veliparib to platinum-based chemotherapy did not improve overall survival in...

issues in oncology

Diversity in Clinical Trials Career Development Program

The Bristol Myers Squibb Foundation, the National Medical Fellowships, and the American Association for Cancer Research (AACR) recently announced the first group of 52 physicians selected for its Diversity in Clinical Trials Career Development Program. The 52 physicians selected by an independent...

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...

covid-19

Positive Practice Changes After the COVID-19 Pandemic: From the Advanced Practice Provider Perspective

The COVID-19 pandemic may have changed some aspects of health care forever. At the 2021 JADPRO Live Virtual event, a panel discussion focused on how several cancer centers faced challenges, and what changes the participants view as positive.1 JADPRO Live is an annual educational conference for...

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 ...

colorectal cancer

Colorectal Cancer Screening: Preferences of Gastroenterologists and Primary Care Clinicians

Despite the availability of several effective screening tests, colorectal cancer screening rates remain below national goals. Although colonoscopy is the most often recommended screening method, a new study has found that the preferences of primary care clinicians have shifted toward noninvasive...

issues in oncology

Study Examines Possible Clinical Trial Bias From Undisclosed Censoring

New research published by Wilson et al in JNCCN–Journal of the National Comprehensive Cancer Network found that only 59% of oncology clinical trials studied provided adequately defined rules for censoring. The researchers examined published randomized control trials supporting U.S. Food and Drug...

immunotherapy
supportive care
hematologic malignancies

Study Examines a Potential Approach to Mitigate CAR T-Cell Therapy Toxicity

Research demonstrating a novel approach that may reduce cytokine-release syndrome associated with chimeric antigen receptor (CAR) T-cell therapy was presented by Marcela Maus, MD, PhD, and colleagues at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 1723)...

leukemia

Ibrutinib Plus Fludarabine, Cyclophosphamide, and Rituximab for Younger Patients With CLL

A study presented by Matthew S. Davids, MD, of Dana-Farber Cancer Institute, and colleagues at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 640) suggests that a 2.5-year regimen involving ibrutinib and chemoimmunotherapy may provide deep and lasting...

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....

lymphoma

POLARIX: Pola-R-CHP vs R-CHOP for Previously Untreated Patients With DLBCL

The POLARIX study found patients with diffuse large B-cell lymphoma (DLBCL) had a significantly higher likelihood of survival without disease progression 2 years after receiving a new drug combination known as pola-R-CHP (polatuzumab vedotin-piiq with rituximab, cyclophosphamide, doxorubicin, and...

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...

HHS Secretary Becerra Names Lawrence Tabak, DDS, PhD, Acting Director of NIH

Health and Human Services Secretary Xavier Becerra recently announced that Lawrence A. Tabak, DDS, PhD, Principal Deputy Director of the National Institutes of Health (NIH), will serve as Acting Director of the NIH effective December 20, 2021.   Earlier this year, current NIH Director Francis S....

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...

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)...

leukemia
genomics/genetics

Ivosidenib/Azacitidine vs Azacitidine Alone in Patients With Newly Diagnosed IDH1-Mutated AML

In the phase III AGILE trial, the combination of ivosidenib and azacitidine was found to be superior in treating newly diagnosed patients with IDH1-mutated acute myeloid leukemia (AML) compared to azacitidine alone in terms of event-free survival, the study’s primary endpoint. The combination also...

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...

leukemia

Study Reveals Underrepresentation of AYA Hispanic Patients in a Large ALL Clinical Trial

A study of U.S. adolescent and young adult patients with acute lymphoblastic leukemia (ALL) found that Hispanic patients were significantly underrepresented in a large clinical trial compared with the general patient population. The study, presented by Muffly et al at the 2021 American Society of...

leukemia

Outcomes Among Pediatric and Young Adult Patients With ALL Differ By Race, Ethnicity, and Socioeconomic Status

A study of nearly 25,000 patients with acute lymphoblastic leukemia (ALL) aged up to 30 years old revealed significant gaps in survival rates between White, Hispanic, and Black patients, as well as worse outcomes among those of lower socioeconomic status. Biologic or genetic factors accounted for...

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...

lung cancer

I’m Living—and Thriving—With Stage IV Non–Small Cell Lung Cancer

A diagnosis, in 2020, of stage IV adenocarcinoma non–small cell lung cancer (NSCLC) was found accidentally. I was 55 at the time and in the best physical shape of my life. I had spent the previous year and a half on a diet and exercise regimen that had rendered me 35 pounds lighter and feeling...

leukemia

Brexucabtagene Autoleucel for Relapsed or Refractory B-Cell Precursor ALL

On October 1, 2021, the CD19-directed chimeric antigen receptor (CAR) T-cell therapy brexucabtagene autoleucel was approved for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).1 The product is available only through a restricted program under a Risk Evaluation ...

Expect Questions on Use of Low-Dose Aspirin to Help Prevent Colorectal Cancer

Following a review of new data and additional analyses of previous data concerning colorectal cancer, the U.S. Preventive Services Task Force (USPSTF) “concluded the evidence is inadequate that low-dose aspirin use reduces colorectal cancer incidence or mortality.”1 Consequently, a draft...

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...

pain management

The High Price of Pain

According to the Centers for Disease Control and Prevention (CDC), from 1999 to 2019, nearly 247,000 people died from overdoses involving prescription opioids in the United States. According to the CDC, the problem can be broken into three waves. The first began with an increase in prescribing...

Reclaiming a Complicated Genius Who Pursued Cancer With Single-Minded Fury

The Nobel Laureate Otto Warburg was regarded as one of the most significant biochemists of the 20th century, whose exhaustive research led to an understanding of cancer that remains significant to this day. Warburg was also one of the most despised figures in his homeland of Nazi Germany. As a...

Erudition and Assessment on the Longest War in the Modern Era

A little after noon on December 23, 1971, President Richard Nixon entered the White House state dining room. Before 137 esteemed guests from government, science, and industry, he signed the landmark National Cancer Act. It was, in short, a national commitment to conquer cancer. President Nixon...

Early Operation With General Anesthesia

The text and photograph here are excerpted from a four-volume series of books titled Oncology: Tumors & Treatment, A Photographic History, The Anesthesia Era 1845–1875 by Stanley B. Burns, MD, FACS, and Elizabeth A. Burns. The photograph appears courtesy of Stanley B. Burns, MD, and The Burns...

Last Hug

“Good evening, doc; I wanted to check on you and update you on my mom” read the text message on a late Thursday afternoon. I recognized the sender; it was not uncommon for me to share my cell phone number with patients and their families. Having been a caretaker of my own parents’ medical needs, I...

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...

Three Investigators Named Winners of MSK Cancer Center’s 2021 Paul Marks Prize for Cancer Research

Memorial Sloan Kettering Cancer Center (MSK) is proud to announce three recipients of this year’s Paul Marks Prize for Cancer Research. The prize recognizes a new generation of leaders in cancer research who are making significant contributions to the understanding of cancer or are improving the...

breast cancer

Abemaciclib With Endocrine Therapy in Adjuvant Treatment of Early Breast Cancer

On October 12, 2021, abemaciclib was approved for use with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adults with hormone receptor–positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki67 score ≥ 20%, as determined by...

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