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NCCN Flash Updates: NCCN Guidelines Updated

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®), the NCCN Drugs and Biologics Compendium (NCCN Compendium^®), the NCCN Radiation Therapy Compendium™, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC™) for Prostate Cancer. These NCCN Guidelines^® are currently available as Version 1.2022.


Link directly to the Updates section of the NCCN Guidelines: 
Prostate Cancer
 

• General: Terminologies modified to be more inclusive of all sexual and gender identities.
• Initial Prostate Cancer Diagnosis and Workup (PROS-1):
  • This page was extensively revised.
• Initial Risk Stratification and Staging Workup for Clinically Localized Disease (PROS-2):
  • Columns for germline testing and molecular/biomarker analysis of tumor were removed from this page and included in a principles page: Principles of Genetics and Molecular/Biomarker Analysis.
  • Third column header modified: Imaging Additional Evaluation
  • Bullets revised under Additional Evaluation: 
    • Very low and low risk: Consider confirmatory prostate biopsy ± mpMRI if not performed prior to biopsy to establish candidacy for active surveillance
    • Favorable intermediate risk: Consider confirmatory prostate biopsy ± mpMRI if not performed prior to biopsy for those considering to establish candidacy for active surveillance
  • Favorable intermediate risk, removed the following bullets from Additional Evaluation column:
    • Bone imaging: not recommended for staging
    • Pelvic ± abdominal imaging: recommended if nomogram predicts >10% probability of pelvic lymph node involvement
  • Unfavorable intermediate, high, and very-high risk, added the following bullet to Additional Evaluation column: Bone and soft tissue imaging
  • Unfavorable intermediate, removed the following bullets from Additional Evaluation column:
    • Bone imaging: recommended if T2 and PSA >10 ng/mL
    • Pelvic ± abdominal imaging: recommended if nomogram predicts >10% probability of pelvic lymph node involvement
  • High and very high risk, removed the following bullets from Additional Evaluation column:
    • Bone imaging: recommended
    • Pelvic ± abdominal imaging: recommended if nomogram predicts >10% probability of pelvic lymph node involvement
• Initial Risk Stratification and Staging Workup for Clinically Localized Disease (PROS 2A):
  • Replaced previous footnote with: Tumor-based molecular assays and germline genetic testing are other tools that can assist with risk stratification. See Principles of Genetics and Molecular/Biomarker Analysis (PROS-B) to determine if a patient is an appropriate candidate for germline genetic testing, and see Principles of Risk Stratification (PROS-C) to determine if a patient is an appropriate candidate for tumor-based molecular assays.
  • Added footnote i: Bone imaging can be achieved by conventional technetium-99m-MDP bone scan. Plain films, CT, MRI, or PET/CT or PET/MRI with F-18 sodium fluoride, C-11 choline, F-18 fluciclovine, Ga-68 PSMA-11, or F-18 piflufolastat PSMA can be considered for equivocal results on initial bone imaging. Soft tissue imaging of pelvis, abdomen, and chest can include chest CT and abdominal/pelvic CT or abdominal/pelvic MRI. mpMRI is preferred over CT for pelvic staging. Alternatively, Ga-68 PSMA-11 or F-18 piflufolastat PSMA PET/CT or PET/MRI can be considered for bone and soft tissue (full body) imaging. See Principles of Imaging (PROS-D). (Also for PROS-10, PROS-11A)
  • Added footnote j: Because of the increased sensitivity and specificity of PSMA-PET tracers for detecting micro metastatic disease compared to conventional imaging (CT, MRI) at both initial staging and biochemical recurrence, the Panel does not feel that conventional imaging is a necessary prerequisite to PSMA-PET and that PSMA-PET/CT or PSMA-PET/MRI can serve as an equally effective, if not more effective front-line imaging tool for these patients. (Also for PROS-9, -10, -11A, -12, -13)
• Very-Low-Risk Group (PROS-3):
  • Adjuvant therapy for Adverse feature(s) and no lymph node metastases: Changed Observation to Monitoring, with consideration of early RT for a detectable and rising PSA or PSA >0.1 ng/mL. (Also on PROS-4 through PROS-7)
• Low-Risk Group (PROS-4):
  • Modified: Active surveillance (preferred)
• Favorable-Intermediate-Risk Group (PROS-5)
  • Adjuvant therapy for lymph node metastases: Changed Observation to Monitoring, with consideration of early treatment for a detectable and rising PSA or PSA >0.1 ng/mL. (Also on PROS-6 and PROS-7)
• High- or Very-High-Risk Group (PROS-7):
  • Initial therapy, changed format and added abiraterone option:
    • EBRT + ADT (2 y) + abiraterone (for very-high-risk only)
• Genetic and Molecular Biomarker Analysis for Prostate cancer, page was removed. (previously PROS-8)
• Regional Risk Group (PROS-8):
  • Added: RP + PLND with adjuvant therapy options
• Footnotes (PROS-8A):
  • Added footnote: The fine-particle formulation of abiraterone can be used instead of the standard form (category 2B; other recommended option).
• Monitoring (PROS-9):
  • Modified footnote ii: Document castrate levels of testosterone if on ADT clinically indicated. Workup for progression should include bone and soft tissue evaluation. Bone imaging can be achieved by conventional technetium-99m-MDP bone scan. Plain films, CT, MRI, or PET/CT or PET/MRI with F-18 sodium fluoride, C-11 choline, F-18 fluciclovine, Ga-68 PSMA-11, or F-18 piflufolastat PSMA can be considered for equivocal results on initial bone imaging. Soft tissue imaging of pelvis, abdomen, and chest can include chest CT and abdominal/pelvic CT or abdominal/pelvic MRI. Alternatively, Ga-68 PSMA-11 or F-18 piflufolastat PSMA PET/CT or PET/MRI can be considered for bone and soft tissue (full body) imaging. See Principles of Imaging (PROS-D). bone imaging, chest CT, and abdominal/pelvic CT with contrast or abdominal/pelvic MRI with and without contrast. If there is no evidence of metastases, consider C-11 choline PET/CT or PET/MRI or F-18 fluciclovine PET/CT or PET/MRI for further soft tissue and bone evaluation or F-18 sodium fluoride PET/CT or PET/MRI for further bone evaluation. The Panel remains unsure of what to do when M1 is suggested by these PET tracers but not on conventional imaging. (also on PROS-10 through PROS-13)
• Radical Prostatectomy PSA Persistence/Recurrence (PROS-10):
  • Added: Bone and soft tissue imaging
  • Removed the following bullets: 
    • Bone imaging,
    • Chest CT
    • Abdominal/pelvic CT or abdominal/pelvic MRI
    • C-11 choline or F-18 fluciclovine PET/CT or PET/MRI
  • Removed footnote: F-18 sodium fluoride or C-11 choline or F-18 fluciclovine PET/CT or PET/MRI can be considered after bone scan for further evaluation when clinical suspicion of bone metastases is high.
  • Removed footnote: Histologic confirmation is recommended whenever feasible due to significant rates of false positivity.
• Radiation Therapy Recurrence (PROS-11):
  • Added: Consider: Bone and soft tissue imaging
  • Removed the following bullets:
    • Bone Imaging
    • Prostate MRI
  • Removed the following bullets: Consider:
    • Chest CT
    • Abdominal/pelvic imaging CT or abdominal/pelvic MRI
    • C-11 choline or F-18 fluciclovine PET/CT or PET/MRI
• Systemic Therapy for Castration-Naive Prostate Cancer (PROS-12):
  • Revised: Consider periodic imaging for patients with M1 to monitor treatment response
  • Footnote added: PSADT and Grade Group should be considered when deciding whether to begin ADT for patients with M0 disease.
  • Footnote modified: The term "castration-naïve" is used to define patients who have not been treated with ADT and those who are not on ADT at the time of progression.
• Systemic Therapy for M1 CRPC (PROS-14):
  • Revised second bullet: Tumor testing for MSI-H or dMMR and for homologous recombination gene mutations (HRRm), if not previously performed.
  • Removed bullet: Germline and tumor testing for homologous recombination gene mutations if not previously performed.
  • Added bullet: Consider tumor mutational burden (TMB) testing
  • Small cell/neuroendocrine prostate cancer: First-line and subsequent treatment options: 
    • Added: Cabazitaxel/carboplatin
  • Footnote added: Germline testing for HRRm is recommended if not performed previously. See Principles of Genetics and Molecular/Biomarker Analysis (PROS-B).
• Systemic Therapy for M1 CRPC: Adenocarcinoma (PROS-15):
  • Prior novel hormone therapy/No prior docetaxel:
    • Second bullet, third sub-bullet revised: Pembrolizumab for MSI-H, dMMR, or TMB >10 mut/Mb
  • Prior docetaxel/no prior novel hormone therapy:
    • Second bullet, third sub-bullet revised: Pembrolizumab for MSI-H, dMMR, or TMB >10 mut/Mb
  • Prior docetaxel and prior novel hormone therapy:
    • Second bullet, third sub-bullet revised: Pembrolizumab for MSI-H, dMMR, or TMB >10 mut/Mb
• Footnotes (PROS-15A):
  • Footnote removed: Patients with disease progression on a given therapy should not repeat that therapy, with the exception of docetaxel, which can be given as a rechallenge after progression on a novel hormone therapy in the metastatic CRPC setting in men who have not demonstrated definitive evidence of progression on prior docetaxel therapy in the castration-naïve setting.
• Principles of Life Expectancy Estimation (PROS-A):
  • Fourth bullet modified: If using a life expectancy table, life expectancy can should then be adjusted using the clinician’s assessment of overall health as follows
  • Fifth bullet modified: Examples of upper, middle, and lower quartiles of life expectancy at selected ages are included 5-year increments of age are reproduced in the NCCN Guidelines for Older Adult Oncology for life expectancy estimation.
• Principles of Genetics and Molecular/Biomarker Analysis (PROS-B):
  • This section has been extensively revised.
• Principles of Risk Stratification (PROS-C):
  • This section is new.
• Principles of Imaging (PROS-D 2 of 3):
  • Bone Imaging (continued):
    • Third bullet modified: Bone scans and soft tissue imaging (CT or MRI) in patients men with metastatic prostate cancer or non-metastatic progressive prostate cancer may be obtained regularly during systemic therapy to assess clinical benefit.
    • Fifth bullet revised: PET imaging/CT for deletion of bone metastatic disease in patients with M0 CRPC.
    • Fifth bullet, second sub-bullet revised: Plain films, CT, MRI, PET/CT or PET/MRI with F-18 piflufolastat PSMA, Ga-68 PSMA-11, F-18 sodium fluoride, C-11 choline, or F-18 fluciclovine can be considered for equivocal results on initial bone scan.
    • Fifth bullet, third sub-bullet added: Ga-68 PSMA-11 or F-18 piflufolastat PSMA PET/CT or PET/MRI (full body imaging) can be considered as an alternative to bone scan.
    • Deleted: F-18 sodium fluoride PET/CT or PET/MRI may be used to detect bone metastatic disease with greater sensitivity but less specificity than standard bone scan imaging.
• Principles of Imaging (PROS-D 3 of 3):
  • Positron Emission Tomography (PET)
    • Bullets were reordered and revised.
    • First bullet added: PSMA-PET refers to a growing body of radiopharmaceuticals that target PSMA on the surface of prostate cells. There are multiple PSMA radiopharmaceuticals at various stages of investigation. At this time, the NCCN Guidelines only recommend the currently FDA-approved PSMA agents, F-18 piflufolastat (DCFPyL) and Ga-68 PSMA-11. See Table 2 in the Discussion section for more detail.
    • Second bullet added: F-18 piflufolastat PSMA or Ga-68 PSMA-11 PET/CT or PET/MRI can be considered as an alternative to standard imaging of bone and soft tissue for initial staging, the detection of biochemically recurrent disease, and as workup for progression with bone scan plus CT or MRI for the evaluation of bone, pelvis, and abdomen.
    • Fourth bullet added: Studies suggest that F-18 piflufolastat PSMA or Ga-68 PSMA-11 PET imaging have a higher sensitivity than C-11 choline or F-18 fluciclovine PET imaging, especially at very low PSA levels.
    • Fifth bullet added: Because of the increased sensitivity and specificity of PSMA-PET tracers for detecting micrometastatic disease compared to conventional imaging (CT, MRI) at both initial staging and biochemical recurrence, the Panel does not feel that conventional imaging is a necessary prerequisite to PSMA-PET and that PSMA-PET/CT or PSMA-PET/MRI can serve as an equally effective, if not more effective front-line imaging tool for these patients.
    • Sixth bullet added: Histologic or radiographic confirmation of involvement detected by PET imaging is recommended whenever feasible due to the presence of false positives. Although false positives exist, literature suggests that these are outweighed by the increase in true positives detected by PET relative to conventional imaging. To reduce the false-positive rate, physicians should consider the intensity of PSMA-PET uptake and correlative CT findings in the interpretation of scans. Several reporting systems have been proposed but will not have been validated or widely used.
    • Bullet removed: The use of PET/CT or PET/MRI imaging using tracers other than F-18 FDG for staging of small-volume recurrent or metastatic prostate cancer is a rapidly developing field wherein most of the data are derived from single-institution series or registry studies. FDA clearance and reimbursement for some tests makes unlikely the conduct of clinical trials to evaluate their utility and impact upon oncologic outcome.
    • Bullet removed: PET/CT or PET/MRI for detection of biochemically recurrent disease.
    • Bullet removed: Histologic confirmation is recommended whenever feasible due to significant rates of false positivity.
• Principles of Active Surveillance and Observation (PROS-E 1 of 2):
  • Third bullet revised: Active surveillance is preferred for patients men with very-low-risk prostate cancer and life expectancy ≥20 years and for men with low-risk prostate cancer and life expectancy ≥10 years. Observation is preferred for patients men with low-risk prostate cancer with life expectancy <10 years.
  • Sixth bullet revised: Cancer progression (risk group reclassification) may have occurred if: Higher grade cancer Gleason Grade 4 or 5 cancer is found upon repeat prostate biopsy. 
  • Seventh bullet revised: Patients with clinically localized prostate cancers who are candidates for definitive treatment and Patients who choose active surveillance should have regular follow-up.
  • Seventh bullet, ninth sub-bullet revised: A repeat prostate biopsy should be considered no is not generally recommended more often than annually to assess for disease progression unless clinically indicated. because PSA kinetics may not be as reliable for predicting progression.
• Definitive Radiation Therapy General Principles (PROS-F 1 of 5):
  • Third bullet removed: Brachytherapy boost, when added to EBRT plus ADT in men with NCCN intermediate- and high-risk prostate cancer, has demonstrated improved biochemical control over EBRT plus ADT alone in randomized trials, but with higher toxicity.
  • Brachytherapy, added the following bullets: 
    • Interstitial implantation of prostate +/- proximal seminal vesicles with temporary (high dose-rate, HDR) or permanent (low dose- rate, LDR) radioactive sources for monotherapy or as "boost" when added to EBRT should be performed in practices with adequate training, experience, and quality assurance measures.
    • Patient selection should consider aspects of gland size, baseline urinary symptoms, and prior procedures (ie, transurethral resection prostate) that may increase risk of adverse effects. Neoadjuvant ADT to shrink a gland to allow treatment should balance its additional toxicity with this benefit.
    • Brachytherapy boost, when added to EBRT and ADT, improves biochemical control. To address historical trial data concern for increased toxicity incidence, careful patient selection and contemporary planning associated with lesser toxicity, such as use of recognized organ at risk dose constraints, use of high-quality ultrasound and other imaging, and prescription of dose as tightly as possible to the target without excessive margins.
  • Brachytherapy, bullet removed: Patients with a very large prostate or very small prostate, symptoms of bladder outlet obstruction (high International Prostate Symptom Score [IPSS]), or a previous transurethral resection of the prostate (TURP) are more difficult to implant and may suffer increased risk of side effects. Neoadjuvant ADT may be used to shrink the prostate to an acceptable size; however, increased toxicity would be expected from ADT and prostate size may not decline in some patients despite neoadjuvant ADT. Potential toxicity of ADT must be balanced against the potential benefit of target reduction.
• Post-Prostatectomy Radiation Therapy (PROS-F 4 of 5):
  • First bullet modified: The panel recommends use of nomograms and consideration of age and comorbidities, clinical and pathologic information, PSA levels, and PSADT, and Decipher molecular assay to individualize treatment discussion. Patients with high Decipher genomic classifier scores (GC >0.6) should be strongly considered for EBRT and addition of ADT when the opportunity for early EBRT has been missed. Decipher molecular assay is recommended to inform adjuvant treatment, if adverse features are found after RP.
  • First bullet, first sub-bullet modified: EBRT with 2 years of anti-androgen therapy with 150 mg/day of bicalutamide demonstrated improved overall and metastasis-free survival on a prospective randomized trial (RTOG 9601) versus radiation alone in the salvage setting. A secondary analysis of RTOG 9601 found that patients with PSA ≤ 0.6 ng/mL had no OS improvement with the addition of the antiandrogen to EBRT. In addition, results of a retrospective analysis of RP specimens from patients in 9601 suggest that those with low PSA and a low Decipher score derived less benefit (development of distant metastases, OS) from bicalutamide than those with a high Decipher score.
  • First bullet, second sub-bullet revised: EBRT with 6 months of ADT (LHRH agonist) improved biochemical or clinical progression at 5 years on a prospective randomized trial (GETUG-16) versus radiation alone in patients with rising PSA levels between 0.2 and 2.0 ng/mL after RP.
  • First bullet, third sub-bullet added: The ongoing SPPORT trial (NCT00567580) of patients with PSA levels between 0.1 and 2.0 ng/mL at least 6 weeks after RP has reported preliminary results on clinicaltrials.gov. The primary outcome measure of percentage of participants free from progression (FFP) at 5 years was 70.3 (95% CI, 66.2–74.3) for those who received EBRT to the prostate bed and 81.3 (95% CI, 77.9–84.6) for those who also received 4–6 months of ADT (LHRH agonist plus antiandrogen).
• Principles of Surgery (PROS-G):
  • Pelvic Lymph Dissection 
    • First bullet revised: An extended PLND will discover metastases approximately twice as often as a limited PLND. Extended PLND provides more complete staging and may cure some patients men with microscopic metastases; therefore, an extended PLND is preferred when PLND is performed.
• Principles of Androgen Deprivation Therapy (PROS-H 1 of 5):
  • ADT for Clinically Localized (N0,M0) Disease:
    • Sixth bullet added: Abiraterone can be added to EBRT and 2 years of ADT in patients with very-high-risk prostate cancer. In the STAMPEDE trial, the hazard ratios for OS with the addition of abiraterone to EBRT and ADT in patients with node-negative disease was 0.69 (95% CI, 0.49–0.96).
  • ADT for Regional (N1,M0) Disease:
    • Second bullet, third sub-bullet removed: Neither formulation of abiraterone should be given following progression on the other formulation.
• Principles of Androgen Deprivation Therapy (PROS-H 2 of 5):
  • ADT for Metastatic Castration-Naïve Disease:
    • Removed: ADT is the gold standard for men with metastatic prostate cancer. 
    • Added: ADT with treatment intensification is preferred for most patients with metastatic prostate cancer. ADT alone is appropriate for some patients.
• Principles of Androgen Deprivation Therapy (PROS-H 3 of 5):
  • Secondary Hormone Therapy for M0 or M1 CRPC:
    • Third bullet, third sub-bullet, first sub-bullet removed: Ketoconazole
    • Third bullet, third sub-bullet, fourth sub-bullet removed: Estrogens including diethylstilbestrol (DES)
    • Fifth bullet removed: Ketoconazole ± hydrocortisone should not be used if the disease progressed on abiraterone.
    • Sixth bullet removed: DES has cardiovascular and thromboembolic side effects at any dose, but frequency is dose and agent dependent. DES should be initiated at 1 mg/day and increased, if necessary, to achieve castrate levels of serum testosterone (<50 ng/dL). Other estrogens delivered topically or parenterally may have less frequent side effects but data are limited.
• Principles of Non-Hormonal Systemic Therapy Immunotherapy and Chemotherapy (PROS-I 1 of 3):
  • Added new section: Non-Hormonal Systemic Therapy for Very-High-Risk Prostate Cancer
    • First bullet added: Docetaxel can be added to EBRT and 2 years of ADT in patients with very-high-risk prostate cancer. In the STAMPEDE trial, the hazard ratio for OS in 96 randomized patients with nonmetastatic disease was 0.93 (95% CI, 0.60–1.43) with the addition of docetaxel to EBRT and ADT.
• Principles of Non-Hormonal Therapy Systemic Therapy (PROS-I 2 of 3): 
  • Immunotherapy, third bullet modified: Pembrolizumab (for MSI-H, dMMR, or TMB >10 mut/Mb)
    Immunotherapy, third bullet modified: Pembrolizumab (for MSI-H, dMMR, or TMB >10 mut/Mb)
• Principles of Non-Hormonal Therapy Systemic Therapy (PROS-I 2 of 3): Principles of Non-Hormonal Therapy Systemic Therapy (PROS-I 2 of 3): 
  • First bullet added: Docetaxel can be added to EBRT and 2 years of ADT in patients with very-high-risk prostate cancer. In the STAMPEDE trial, the hazard ratio for OS in 96 randomized patients with nonmetastatic disease was 0.93 (95% CI, 0.60–1.43) with the addition of docetaxel to EBRT and ADT.

NCCN has published updates to the NCCN Guideline and the NCCN Compendium^® for Management of Immunotherapy-Related Toxicities. These NCCN Guidelines are currently available as Version 4.2021. 

Link directly to the Updates section of the NCCN Guidelines:
Immunotherapy-Related Toxicities

• Management of CAR T-Cell-Related Toxicities (CART-3 and CART-5)
  • The following footnote was added to address the limited availability of tocilizumab: 
    • Under conditions of limited tocilizumab availability, consider one of the following conservation strategies:
      • Limit tocilizumab use to a maximum of 2 doses during a CRS episode
      • Consider using steroids more aggressively during a CRS episode
      • If necessary, consider replacing second dose of tocilizumab with siltuximab or anakinra, although there is very limited evidence to support this approach.

Previous updates to the NCCN Guidelines Management of Immunotherapy-Related Toxicities can be found in the UPDATES section of the current version.




NCCN has published updates to the NCCN Guidelines, and the NCCN Compendium for Breast Cancer. These NCCN Guidelines are currently available as Version 8.2021. 

Link directly to the Updates section of the NCCN Guidelines:
Breast Cancer

• Systemic Therapy Regimens for HER2-Negative, Recurrent Unresectable (Local or Regional) or Stage IV (M1) Disease (BINV-Q, 1 of 8)
  • Option moved from "other recommended regimens" to "preferred regimens": Sacituzumab govitecan-hziy (for TNBC)
  • Footnote g modified: For adult patients with metastatic TNBC who received at least two prior therapies, with at least one line for metastatic disease.
• Additional Targeted Therapies and Associated Biomarker Testing for Recurrent Unresectable (local or regional) OR Stage IV (M1) Disease (BINV-R, 1 of 3)
  • Option removed: Atezolizumab + albumin-bound paclitaxel (for TNBC)
  • Option added: Dostarlimab-gxly (Useful in Certain Circumstances, for any breast cancer subtype)
    • Footnote h added: Dostarlimab-gxly is indicated for adult patients with MSI-H/dMMR unresectable or metastatic tumors that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.
    • Dose added: Dostarlimab-gxly: 500 mg IV on day 1; Cycled every 21 days for cycles 1-4; Followed by 1,000 mg IV on day 1 of cycle 5; Cycled every 42 days starting with cycle 5. (BINV-R, 2 of 3)
    • Reference added: Berton D, Banerjee S, Curigliano G, et al. Antitumor activity of dostarlimab in patients with mismatch repair–deficient (dMMR) tumors: a combined analysis of 2 cohorts in the GARNET study. Poster presented at American Society for Clinical Oncology (ASCO), Virtual Meeting, June 4–8, 2021. [Abstract ID: 2564] (BINV-R, 3 of 3)

Previous updates to the NCCN Guidelines for Breast Cancer can be found in the UPDATES section of the current version.



 

For the complete updated versions of the NCCN Guidelines, NCCN Guidelines with NCCN Evidence Blocks™, the NCCN Drugs & Biologics Compendium (NCCN Compendium^®), the NCCN Biomarkers Compendium^®, the NCCN Chemotherapy Order Templates (NCCN Templates^®), the NCCN Radiation Therapy Compendium™, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC™), please visit NCCN.org.

To view the NCCN Guidelines for Patients^®, please visit NCCN.org/patientguidelines.

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