Weekly Guideline Update for 3/26/2025

National Cancer Comprehensive Network (NCCN)

The NCCN guidelines can be found at www.nccn.org.

Biliary Tract Cancers Version 1.2025

NCCN Guidelines Summary: Biliary Tract Cancers (Version 1.2025)

The 2025 NCCN Guidelines for Biliary Tract Cancers introduce updates across gallbladder cancer, intrahepatic and extrahepatic cholangiocarcinoma, and mixed HCC-CCA, including the terminology update to metabolic dysfunction-associated steatotic liver disease (MASLD) in lieu of “fatty liver disease”. For intrahepatic cholangiocarcinoma, transplant evaluation was added for select unresectable cases, and multiphasic abdomen/pelvis CT/MRI with IV contrast is preferred over contrast-enhanced US. For HER2-positive tumors, trastuzumab/pertuzumab and tucatinib/trastuzumab combinations were clarified, and erdafitinib was added for FGFR2 fusion-positive cholangiocarcinomas (category 2A). Gallbladder cancer pathways now include minimally invasive resection for select patients and refined guidance on staging and biliary drainage. The guidelines also reflect expanded molecular testing guidance and options for targeted therapies and immunotherapies across disease subtypes.

Breast Cancer Version 3.2025

Two weeks ago, I published the updates for Breast Cancer Version 2.2025. Now, the NCCN has published an additional update to these guidelines, modifying AC (doxorubicin/cyclophosphamide) adjuvant therapy to be followed or preceded by carboplatin + taxane (paclitaxel or docetaxel) for select situations.

Central Nervous System Cancers (Version 5.2024)

The latest update for CNS cancers introduces a new Category 2A recommendation supporting the use of mirdametinib for both adult and pediatric patients (≥2 years) with NF1-associated symptomatic plexiform neurofibromas (PN) not amenable to complete resection. This addition, based on results from the ReNeu phase IIb trial, expands therapeutic options for a subset of patients with limited surgical interventions and represents a targeted approach for NF1-related PN management.

Cervical Cancer Version 4.2025

The latest update introduces a new Category 2A recommendation incorporating induction chemotherapy with carboplatin/paclitaxel followed by single-agent cisplatin (or carboplatin) and radiation per the INTERLACE protocol for patients with locally advanced cervical cancer.

Hepatocellular Carcinoma Version 1.2025

The 2025 NCCN guidelines for hepatocellular carcinoma (HCC) includes reclassification of liver disease terminology to metabolic dysfunction-associated steatotic liver disease (MASLD) and standardizing “Child-Pugh” to “Child-Turcotte-Pugh” across the guidelines. Key clinical updates include broader guidance for multidisciplinary evaluation. They have removed all footnotes concerning adjuvant atezolizumab-bevacizumab as a general recommendation, but the regimen does remain a category 1 preferred regimen first-line systemic therapy. Systemic therapy recommendations now include nivolumab plus ipilimumab as a category 2A first-line regimen and newly endorse entrectinib, larotrectinib, and repotrectinib for NTRK fusion-positive tumors (category 2A), while lenvatinib, sorafenib, and pembrolizumab were removed from subsequent-line options.

Pediatric Acute Lymphoblastic Leukemia Version 3.2025

The most recent update for pediatric ALL highlights expanded use of blinatumomab across multiple risk groups and treatment phases, including standard- and high-risk BCR::ABL1-negative/-like B-ALL, BCR::ABL1-positive B-ALL, and infant ALL, informed by AALL1731 and ECOG1910 data. Blinatumomab is now integrated into frontline consolidation and maintenance regimens, with emphasis on MRD-guided strategies. Safety concerns—including CRS and neurotoxicity—necessitate specialized monitoring and adherence to administration protocols. Inotuzumab ozogamicin’s hepatic sinusoidal obstructive syndrome (SOS) risk prompts ursodiol prophylaxis considerations. Updated infection control guidance underscores IVIG use during therapy and until B-cell recovery, with new recommendations for post-therapy vaccine management. The Principles of Systemic Therapy section was also extensively revised.

Testicular Cancer Version 2.2025

The discussion section has been modified to align with algorithm changes.

American College of Cardiology (ACC)

The 2025 ACC Concise Clinical Guidance on cardiogenic shock (CS) provides updated, practical recommendations for early recognition, stratification, and multidisciplinary management of CS due to acute myocardial infarction (AMI-CS) and heart failure (HF-CS). Key updates include a structured 24-hour roadmap (“SUSPECT CS”) to expedite diagnosis, advocacy for early use of invasive hemodynamics, and emphasis on CS team activation to improve outcomes. Notably, the guidance integrates findings from the DanGer Shock trial, supporting early microaxial flow pump use in select STEMI-CS patients, and outlines standardized algorithms for tMCS use. Pharmacologic support is recommended at the lowest effective dose and duration. Classification of CS centers by capabilities (Level 1–3) and coordination between them is emphasized for timely transfer and escalation.

American Urological Association (AUA) / Society for Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU)

The AUA/SUFU guidelines concerning the 2025 update to microhematuria are blocked by a firewall. AUA/SUFU does not grant access for external review and critique at this time. The following is a summary based solely on the abstract provided.

The 2025 AUA/SUFU guideline amendment on microhematuria incorporates updates driven by new evidence since the previous 2020 guidelines. Changes include a revised risk stratification framework to more precisely guide evaluation, refined recommendations on the selective use of urine-based tumor markers and cytology, and updated guidance on diagnostic pathways and surveillance strategies.

Commentary regarding AUA/SUFU and guidelines access

It is important for professional societies to provide benefits to their members. No doubt. However, by blocking access to guidelines and recommendations to non-members, including the general public, general clinicians, and policymakers, professional societies like AUA/SUFU are not helping healthcare providers, payors, and policymakers provide appropriate, evidence-based care to patients. This is a disservice to the patient and general public. The AUA/SUFU guidelines are not the only guidelines hidden behind member firewalls. Surely, professional societies like AUA/SUFU can find additional lucrative benefits to their members other than prohibiting the public from accessing guidelines and recommendations.

Commentary regarding CxBladder

CxBladder is the main reason that Day-Storms, LLC was interested in reading the exact verbiage within the guidelines. First, it should be noted that Day-Storms, LLC and no employee of Day-Storms, LLC has received compensation from Pacific Edge, the developer of the CxBladder suite of diagnostic tests.

CxBladder has been the subject of considerable discussion recently since Novitas, the Medicare Administrative Contractor, finalized a non-coverage determination ending reimbursement for CxBladder as well as several other genetic tests for oncologic conditions.

CxBladder includes a suite of non-invasive urine-based molecular diagnostic tests designed to safely rule out patients with low probability of bladder cancer. Some patients could potentially avoid unnecessary tests while healthcare resources could be used by other patients who may better benefit.

Pacific Edge has announced that the updated AUA/SUFU guidelines have now incorporated urine-based biomarkers, including CxBladder, for use with appropriately counseled intermediate-risk patients who want to avoid cystoscopy, an invasive procedure. Specifically, the company notes that their CxBladder Triage test is the only urine biomarker with “Grade A” evidence based on the STRATA and CREDIBLE studies.

Assuming that the company is being forthright, this news could potentially help with future positive coverage and in any appeals and responses to Novitas. It would be nice if AUA would make their guidelines publicly available to corroborate this as well as to see what other recommendations the professional society is offering, considering they want to be considered leaders within the urology field.

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