Currently Viewing:
Evidence-Based Oncology May/June
I-SPY Trials Seek Effective New Drug Combinations Using Adaptive Trial Design
Ben Leach
Third-Party Validation of Observed Savings From an Oncology Pathways Program
Bruce A. Feinberg, DO; Scott Milligan, PhD; Joseph Cooper, BS; Winston Wong, PharmD; Daniel Winn, MD; Neil Schneider, ASA, MAAA; Sheamus Parkes, FSA, MAAA; and Jeffrey Scott, MD
Tailor Treatment Plans to Improve Outcomes in Managing NSCLC
Katie Sullivan
Health Plan Innovations in Delivery System Reforms
Karen Ignagni
Framing the Debate: The Trends in Mastectomy Rates
Jennifer Klem, PhD
Looking at Specialty Pharmaceutical Rejections
Dea Belazi, PharmD, MPH
The Impact of Health Reform's State Exchanges
The Changing Landscape of Oncology: Impact for Payers and Providers
Dawn Holcombe, MBA
Sledge Expects 'Big Data' to Generate Big Changes
Anita T. Shaffer
Use of Personalized Medicine to Select Adjuvant Breast Cancer Therapy
Anna Azvolinsky, PhD
Currently Reading
NCCN Guidelines Update: NCCN 18th Annual Conference, Advancing the Standards of Cancer Care

NCCN Guidelines Update: NCCN 18th Annual Conference, Advancing the Standards of Cancer Care

At the 18th Annual Conference of the National Comprehensive Cancer Network (NCCN), experts presented the latest updates to the NCCN Clinical Practice Guidelines in Oncology. The conference also featured 2 roundtable discussions that covered topics including cancer treatment costs, disparities in the quality and value of oncology care, the implications of big data in the field of oncology, and personalized cancer care. Here are perspectives from key opinion leaders on the NCCN Guidelines Updates.

Ovarian Cancer

Robert J. Morgan, MD


City of Hope Comprehensive Cancer Center

"There are no major changes to the ovarian cancer guidelines this year. The biggest management change may occur in the

coming year due to our improved understanding of the role of bevacizumab in treating recurrent epithelial ovarian cancer. The publication of the OCEANS trial resulted in an addition to the guidelines of the regimen of carboplatin/gemcitabine/bevacizumab to the list of acceptable recurrence therapies.We’ll have more clarity next year when the results of the AURELIA  trial in platinum-resistant disease are published. In this trial, a progression-free survival benefit in patients with platinum-resistant disease has been reported.”
  • Bevacizumab (Avastin) currently carries a category 2B recommendation in recurrence therapy, but the results of  the AURELIA trial may have an impact on clinical guidelines going forward. In frontline treatment, bevacizumab is a category 3 recommendation.
  • The new guidelines refine the guidance for physicians following patients with less-common histopathologies, including sex cord stromal tumors and germ cell tumors. Germ cell tumors, which are often seen in young people, can be exquisitely sensitive to chemotherapy. The 2013 edition of the guidelines adds published surveillance strategies for patients postchemotherapy, including a suggested follow-up regimen after completion of treatment during and after the first 5 years that specifies recommendations for performing radiographic imaging and serum tumor marker tests, for example. The recommendations for follow-up for germ cell tumors include serum tumor markers for the first 2 years after treatment is completed. They can then be omitted because virtually all of these tumors recur within that time frame if they are destined to recur. However, sex cord stromal tumors must be followed more aggressively, even following the first 5 years, due to their tendency to exhibit late recurrences.
  • Surgical treatment recommendations have also been updated.Appendectomy has been added to other reasonable surgical options in staging and debulking for both early- and late-stage disease as a strategy to optimize cytoreduction in aggressive gynecologic cancers. The definition of optimal surgical debulking is evolving.
Colorectal Cancer

Leonard Saltz, MD


Memorial Sloan-Kettering Cancer Center

“For the treatment of metastatic disease, 2 new drugs [zivaflibercept and regorafenib] not previously available to colorectal cancer patients have been incorporated into the guidelines, and there is 1 change of substance in how we use existing drugs. These 3 therapies all involve to some degree targeting vascularendothelial growth factor, a protein that stimulates production of new blood vessels, and all produced modest benefits. The gains we see are statistically significant, but it’s open to discussion whether they are clinically significant.” 
  • Regorafenib (Stivarga) was approved by the US Food and Drug Administration following an expedited review as a single-agent, last-line salvage therapy for patients with good performance status whose cancer has progressed after treatment with all other standard therapies.
  • Bevacizumab (Avastin) is now recommended for use as a secondline therapy in combination with chemotherapy (fluoropyrimidineirinotecan or fluoropyrimidine-oxaliplatin) for the treatment of patients whose disease has progressed after a first-line program with a bevacizumab-containing regimen. Previously, the guidelines  supported its use in first- or second-line therapy, but did not support its use in both first- and second-line treatments.
  • Ziv-aflibercept (Zaltrap) was added as a second-line treatment used in combination with FOLFIRI (5-fluorouracil, leucovorin, and irinotecan) for patients whose cancer is resistant to or has progressed following treatment with a first-line oxaliplatin-containing regimen.
  • While the guidelines were changed to allow for either second-line use of bevacizumab or second-line use of ziv-aflibercept, it’s important for clinicians to understand that the data do not support using both—meaning they do not support using second-line bevacizumab and then second-line ziv-aflibercept with the same chemotherapy.Second-line use of ziv-aflibercept is an alternative option to secondline bevacizumab, but not a new treatment paradigm.
  • For earlier-stage patients, there is 1 important change to the guidelines: The guidelines allow for use of  oxaliplatin in patients with stage II disease with higher risk, but this is no longer a preferred option. Instead, the guidelines now state that good-risk stage II patients should not receive oxaliplatin.
Breast Cancer

Clifford A. Hudis, MD


Memorial Sloan-Kettering Cancer Center

“A key change in the guidelines in HER2-positive breast cancer is the incorporation of pertuzumab [Perjeta], the second monoclonal antibody targeting this receptor. A related and recent addition is ado-trastuzumab emtansine [Kadcyla, or T-DM1] for patients with tumors refractory to conventional trastuzumab. Outside of HER2-positive disease, the use of the first available agent targeting the PI3 kinase pathway, specifically the mammalian target of rapamycin (mTOR), represents a new approach to the palliative use of aromatase inhibitors. All of these changes are exciting as they suggest that ongoing translational clinical trials may lead to rapid improvements in the management of patients.”
  • Ado-trastuzumab emtansine was added as a preferred therapeutic option for the treatment of HER2-positive  metastatic breast cancer, including patients who have been previously treated with trastuzumab.
  • Consider use of everolimus (Afinitor) in addition to exemestane for women with hormone receptor–positive advanced breast cancer previously treated with nonsteroidal aromatase inhibitors, based on the results of the BOLERO-2 trial.
Melanoma

Anthony J. Olszanski, MD

Fox Chase Cancer Center

“The NCCN Guidelines for melanoma are relatively mature, reflecting clinically significant updates occurring over the last 2 years, including the addition of 2 new drugs—the first to show a survival benefit in advanced disease. Ipilimumab is an immunomodulator and vemurafenib is available to patients with mutations in the BRAF gene. Data on emerging medicines is even more promising. In disease management and decision making, there is an ongoing evolution toward risk-based management as compared to stage-based management.”
  • Ipilimumab (Yervoy), vemurafenib (Zelboraf), high-dose IL-2, and clinical trials are now listed as preferred regimens in  advanced disease. Patients receiving ipilimumab must be monitored for immune-mediated complications, and those taking vemurafenib, for dermatologic complications.
  • Of note, a recent trial combining ipilimumab and vemurafenibshowed signs of excessive toxicity. Combination strategies should only be attempted within a clinical trial setting.
  • Imatinib is now a potential treatment for c-KIT–mutated tumors.
  • Guideline updates clarified that routine imaging is not recommended for patients with stage I and II melanoma. The  panel left the extent of imaging in patients with stage III disease to the discretion of the treating physician, given that data on its usefulness remain inconclusive.
  • The panel continues to refine the guidance on sentinel lymph node biopsies. For patients with very thin tumors (<0.76 mm), the likelihood of nodal disease is low and sentinel lymph node biopsy is not routinely recommended.
  • The panel is developing guidelines for ocular melanoma, which may be in place by 2014.
Survivorship

Crystal S. Denlinger, MD


Fox Chase Cancer Center

“I think the most important aspect of these guidelines is that they are a first attempt to develop a standard of care and guidelines for addressing the issues of cancer survivorship that are prevalent in the cancer survivor population. The committee has developed an assessment tool for clinicians to highlight which issues are important for each patient.”

The first-ever expert and consensus-driven standardized guidelines on survivorship were published this year, defining the major issues that arise among cancer survivors and providing a framework to manage potential long-term and latent side effects of cancer and treatment. The guidelines provide screening, evaluation, and treatment recommendations for the most common issues cancer survivors face, and are to be used in the multidisciplinary care of survivors. The guidelines focus on 8 major issues: anxiety and depression, cognitive function, exercise, fatigue, immunizationand infections, pain, sexual function, and sleep disorders. The multidisciplinary team that developed the guidelines included oncologists, gynecologists, mental health professionals, infectious disease experts, exercise physiologists, and primary care nurses.
  • The NCCN defined cancer survivor as a patient diagnosed with cancer who is balancing his or her life.
  • Different from the standard NCCN Guidelines based on tumor type, these are a library of algorithms that can each be used independently.
  • The guidelines recommend periodic assessment for all survivors at regular intervals to assess disease status, performance status,medications, comorbidities, and evaluation of prior cancer and treatments.
Renal Cell Carcinoma

Roberto Pili, MD


Roswell Park Cancer Institute

“The changes to the NCCN Guidelines are minor this year. There have not been any new therapies this year. We are still trying to understand how to best sequence the therapies we have already. Recent combination trials, unfortunately, have shown that these agents together are either not effective or too toxic. But other combinations and sequencing trials are under way…What is anticipated and could have an impact is the anti–PD-1 antibody that is currently in phase III. This immunotherapy appears to have significant activity in renal cell carcinoma, and hopefully we will see an anti–PD-1 approved in the future.”
  • Interferon alpha was removed as a treatment option for patients with clear cell histology who have been previously treated.
  • As a post-first-line therapy option for metastatic clear cell or nonclear cell renal cell cancer with predominantly sarcomatoid features, the chemotherapy combination of gemcitabine plus doxorubicin or gemcitabine plus capecitabine was added as a category 3 option.
Thyroid Cancer

Robert I. Haddad, MD


Dana-Farber Cancer Institute

 
Copyright AJMC 2006-2018 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
x
Welcome the the new and improved AJMC.com, the premier managed market network. Tell us about yourself so that we can serve you better.
Sign Up
×

Sign In

Not a member? Sign up now!