[NEJM Evidence]a new digital journal (January 10, 2022)

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Original Article

Zilovertamab Vedotin Targeting of ROR1 as Therapy for Lymphoid Cancers

M.L. Wang and Others

In a Phase 1 trial, patients with refractory lymphoid cancers, an antibody-drug complex directed against ROR1 had no unexpected toxicities. About half of the patients with mantle cell lymphoma and diffuse large B-cell lymphoma had clinically meaningful responses.

DOI: 10.1056/EVIDoa2100001

Originally Published: October 12, 2021

Acetazolamide to Prevent Adverse Altitude Effects in COPD and Healthy Adults

M. Furian and Others

Furian and colleagues report on the results of two randomized controlled trials testing the use of acetazolamide to prevent the adverse effects of altitude on healthy older persons and in people with COPD. They find that acetazolamide decreased the incidence of altitude related adverse health events (primarily hypoxemia) in both populations with no evidence of adverse events.

DOI: 10.1056/EVIDoa2100006

Originally Published: December 22, 2021

Prescribed Water Intake in Autosomal Dominant Polycystic Kidney Disease

G.K. Rangan and Others

The effect of increased water intake on kidney cyst growth in patients with polycystic kidney disease was compared for two groups randomly assigned to either prescribed or ad libitum water intake. Over 3 years, there was no difference in height-corrected total kidney volume between the groups.

DOI: 10.1056/EVIDoa2100021

Originally Published: November 4, 2021

Regulatory T-Cell Response to Low-Dose Interleukin-2 in Ischemic Heart Disease

T.X. Zhao and Others

This phase 1b/2a, randomized, double-blind, placebo-controlled, dose-escalation trial tested low-dose subcutaneous aldesleukin (recombinant IL-2) in patients with ischemic heart disease. Low-dose IL-2 expanded Tregs, without adverse events of major concern. Single-cell RNA-sequencing of circulating immune cells was used to provide mechanistic assessment of the treatment’s effects.

DOI: 10.1056/EVIDoa2100009

Originally Published: November 22, 2021

Editorial

NEJM Evidence — A New Journal in the NEJM Group Family

C.A. Sacks and Others

In January 2022, the NEJM Group began publishing a new journal, NEJM Evidence. This monthly, peer-reviewed, online-only, general medical journal will publish original research, along the full spectrum of clinical investigation, that takes ideas and turns them into reality.

DOI: 10.1056/EVIDe2100015

Originally Published: January 10, 2022

ROR1 for Lymphoid Cancers

S.J. Schuster

This editorial discusses the first-in-human, phase 1 clinical trial of a novel antibody–drug conjugate, zilovertamab vedotin, in patients with relapsed or refractory mature B-cell malignancies.

DOI: 10.1056/EVIDe2100014

Originally Published: January 10, 2022

Can Additional Water a Day Keep the Cysts Away, in Patients with Polycystic Kidney Disease?

L.M. Moist

If a patient with autosomal dominant polycystic kidney disease could drink enough water to suppress arginine vasopressin release, would cyst growth be attenuated, thereby reducing the decline in kidney function over time? Louise M. Moist, M.D. discusses this randomized controlled trial.

DOI: 10.1056/EVIDe2100027

Originally Published: November 4, 2021

Review Article

Colorectal Cancer Screening — Approach, Evidence, and Future Directions

L.M. Helsingen and M. Kalager

Screening for colorectal cancer is widespread and successful but screening programs across the globe differ in their recommendations. In this article, Helsingen and Kalager review the evidence for different approaches to colorectal cancer screening and propose a framework for the eval‎uation of screening programs going forward.

DOI: 10.1056/EVIDra2100035

Originally Published: January 10, 2022

Clinical Trials Workshop

Independent Oversight of Clinical Trials through Data and Safety Monitoring Boards

S.R. Evans

DSMBs look after the welfare of patients enrolled in interventional clinical trials. DSMBs monitor for early establishment of efficacy, findings of harm, futility in obtaining a meaningful outcome, or changes in the ecology of care that render moot the question a trial aims to answer. This article opens a series of NEJM Evidence reviews about DSMBs.

DOI: 10.1056/EVIDctw2100005

Originally Published: January 10, 2022

Morning Report

A 66-Year-Old Man with Fever and Confusion

P. Ankomah, A.Y. Castillo, J.C. O’Neil, and H. Andrews

A 66-year-old man with Parkinson’s disease and hypertension presented to the ED with fever and confusion after returning to the U.S. from Cambodia. He was febrile with diaphoresis and rigors. What was the diagnosis?

DOI: 10.1056/EVIDmr2100037

Originally Published: January 10, 2022

Clinical Trials Case Study

Behind the Scenes of TOPCAT — Bending to Inform

M.A. Pfeffer and B. Claggett

When investigators in a 2013 RCT received their unblinded results, the data forced them to make a difficult decision — do they stay within conventional guidelines for data analysis or forge a new path? This Clinical Trial Case Study tells the story of how they dealt with the data dilemma for a heart failure treatment that affects millions of people.

DOI: 10.1056/EVIDctcs2100007

Originally Published: January 10, 2022

Tomorrow’s Trial

Should Combined Hormonal Contraception Be Stopped in the Perioperative Period?

K. Takvorian

A 34-year-old woman is scheduled to undergo surgery to manage a torn anterior cruciate ligament in her left knee. Her only medication is an estrogen- and progestin-containing oral contraceptive pill (OCP). Should she stop her combined oral contraception to reduce the risk of a postoperative blood clot?

DOI: 10.1056/EVIDtt2100050

Originally Published: January 10, 2022

Patient Platform

My Experience as a SPRINT Clinical Trial Participant

M. Taylor

This Patient Platform is from Moses Taylor, a participant in the Systolic Blood Pressure Intervention Trial (SPRINT) that was published in the New England Journal of Medicine (NEJM) in November 2015.

DOI: 10.1056/EVIDpp2100029

Originally Published: January 10, 2022

Stats, STAT!

Is Noninferior Not Inferior?

S. Kadire, C.C. Hardin, K. Takvorian, and C.A. Sacks

What is a non-inferiority trial margin? To answer this, ask whether you have ever weighed a tradeoff between the best version of something and an acceptable alternative. Restated, in a choice between two decisions, is one option not inferior to the other? Watch an animated video that explores the basis for non-inferiority trials, the meaning of non-inferiority margins, and the interpretation of a non-inferiority trial’s results.

DOI: 10.1056/EVIDstat2100040

Originally Published: January 10, 2022