NCCN Biosimilars White Paper Published

At the end of September 2011, JNCCN published the NCCN Biosimilars White Paper: Regulatory, Scientific, and Patient Safety Perspectives, which provides guidance regarding the challenges health care providers and other key stakeholders face in incorporating biosimilars into oncology practice in the United States. The FDA is expected to release an abbreviated regulatory process for the approval of biosimilars by the end of 2011, increasing the likelihood of biosimilar drugs used for oncology care entering the U.S. market in the future. The NCCN White Paper is based on the recommendations from the NCCN Biosimilars Work Group, composed of multidisciplinary thought leaders from NCCN Member Institutions and other groups, and discussion at the April 2011 NCCN Oncology Policy Summit: Biosimilars – Regulatory, Scientific, and Patient Safety Perspectives.

Use your smartphone to access the NCCN Biosimilars White Paper, or visit

NCCN Experts and Asian Oncologists Collaborate to Develop Resources to Improve Care for Patients with Cancer in China

As part of an ongoing effort to address increasing cancer rates in China, Asian oncologists have adopted evidence-based treatment guidelines in collaboration with the NCCN. A set of 10 NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): China Editions are now available online at, enabling NCCN information to improve the effectiveness of treatment for a broader population of patients with cancer. Updated 2011 NCCN Guidelines: China Editions are available for Breast, Cervical, Colon, Gastric, Kidney, Non–Small Cell Lung, Ovarian, Pancreatic, and Rectal Cancers, and Multiple Myeloma.

“This collaboration demonstrates our common goal of sharing resources and increasing familiarity and understanding of the NCCN Guidelines among Asian oncologists,” said William T. McGivney, PhD, CEO of NCCN. “It is critical that evidence-based guidelines for cancer care be implemented by experts across the globe in order to improve outcomes for all patients, regardless of where they live.”

Based on the NCCN Guidelines, the China Editions comprise the extensive expertise of more than 100 Chinese cancer specialists in collaboration with NCCN Guidelines Panel experts. The China Editions contain recommendations revised to account for genetic, pharmacological, and regulatory considerations of the Chinese population.

China has had a long-standing collaboration with NCCN in the development of the Chinese Editions of the NCCN Guidelines—the most authoritative reference for oncology practice in China. Expert clinicians across Asia recognize and routinely apply the NCCN Guidelines in practice. Of the 1.1 million unique visitors to every year, nearly 300,000 are from Asian countries.

NCCN's international collaborations continue to grow fostered by the demand for the development and publication of foreign editions of the NCCN Guidelines. To view the NCCN Guidelines: China Editions or additional information about NCCN global programs, visit

NCCN Guidelines Emphasize Patient Preference as Key to Selection of Maintenance Therapy in Follicular Lymphoma

Although therapeutic advances have improved survival of patients with follicular lymphoma (FL), the disease remains incurable, with inevitable relapse. This underscores the need for therapies and strategies to extend the duration of remission without significantly increasing toxicity while maintaining quality of life. The role of maintenance therapies in FL was discussed in detail by Andrew D. Zelenetz, MD, PhD, of Memorial Sloan-Kettering Cancer Center and chair of the NCCN Guidelines Panel for Non–Hodgkin's Lymphomas during the NCCN 6th Annual Congress: Hematologic Malignancies.

“Since follicular lymphoma responds well to therapy and is slow-growing, it is often thought of as a chronic disease. In the absence of symptoms, the disease has the potential to be managed through observation,” said Dr. Zelenetz.

However, some patients are uncomfortable knowing that they have an active lymphoma that is not being addressed with therapy.

Several approaches to postremission therapy are available. Patients with FL who have experienced response to first-line therapy have the option of being observed or treated with consolidation therapy. Phase III studies have demonstrated that consolidation with radioimmunotherapy (FIT trial) or rituximab (Rituxan, Genentech BioOncology and Biogen Idec) maintenance (PRIMA trial) is effective and improves progression-free survival.

Event-free survival is defined as the time from first induction infusion to progression, relapse, second tumor, or death from any cause.

Rituximab has also been shown to be effective when given for a second time at the time of relapse, after patients had experienced a previous response to rituximab. Whether rituximab maintenance treatment is superior to rituximab re-treatment (at the time of disease progression) has not yet been established.

“Past trials have shown significantly improved progression-free survival with rituximab maintenance, however no significant difference was seen in overall survival between the maintenance and re-treatment group,” noted Dr. Zelenetz. “Ongoing research will continue to evaluate this approach.”

Dr. Zelenetz emphasized that effect on overall survival is one of the most influential factors when weighing treatment decisions. However, phase III studies to date have not demonstrated an overall survival benefit in patients with FL undergoing postremission therapy.

“The NCCN Guidelines include postremission therapy (radioimmunotherapy consolidation or maintenance rituximab) as an option for patients responding to first-line chemoimmunotherapy,” said Dr. Zelenetz. “Given the absence of an overall survival benefit, the NCCN Non–Hodgkin's Lymphomas Guidelines Panel felt the decision to use postremission therapy has to be made on an individualized basis after discussing the pros and cons with the patient.”

Advances in CLL Therapy Offer Prolonged Survival; Toxicities Continue to Plague Elderly Patients

First-line chemoimmunotherapy options for patients with chronic lymphocytic leukemia (CLL) offer prolonged survival, yet there remains a void for effective therapies that can be tolerated by elderly patients with the disease, according to Susan O'Brien, MD, of the University of Texas MD Anderson Cancer Center. Dr. O'Brien emphasized the importance of assessing the condition of the patient and exploring the clinical usefulness of cytogenetic abnormalities when selecting therapy. Dr. O'Brien also discussed several promising agents in clinical trials during her presentation at the NCCN 6th Annual Congress: Hematologic Malignancies.

One of the most common cytogenetic abnormalities in patients with CLL is del(11q). Deletion of 11q is associated with extensive lymphadenopathy, disease progression, and shorter median survival. However, the alkylating agent–based chemoimmunotherapy regimen of fludarabine (Fludara, Genzyme/sanofi), cyclophosphamide (Cytoxan, Bristol-Myers Squibb), and rituximab (Rituxan, Genentech BioOncology and Biogen Idec), also known as FCR, has been shown to significantly improve clinical outcomes.

Dr. O'Brien discussed the results of a recent clinical trial demonstrating why FCR has become the standard of care for healthy, fit patients with CLL del(11q) as noted in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Non–Hodgkin's Lymphomas.

“The study demonstrated that FCR is superior compared to other regimens in improving progression-free survival and overall survival in patients with CLL,” said Dr. O'Brien. “More importantly, it demonstrates that the choice of initial treatment for CLL may alter the clinical course of the disease.”

A second common cytogenetic abnormality in patients with CLL is del(17p). Deletion of 17p is associated with low response rates with all treatments. Dr. O'Brien noted that because no standard treatment exists, the NCCN Guidelines recommend enrollment into a clinical trial.

Although a clinical trial is preferred, the NCCN Guidelines include a list of potential first-line therapy regimens for patients with del(17p). In addition, patients who have experienced partial or complete response to first-line therapy should be considered for allogeneic stem cell transplant.

Treating elderly patients or younger patients with significant comorbidities continues to be a challenge for physicians.

The FCR regimen can cause severe cytopenia during and after therapy and is not tolerated well by older patients. In addition, elderly patients often do not meet the creatinine clearance requirements to undergo a therapy such as FCR.

“Since CLL is primarily a disease of the elderly, the treatment strategy needs to remain highly individualized,” added Dr. O'Brien.

For patients with poor prognostic factors, Dr. O'Brien described several promising agents in clinical trials.

“The lack of myelosuppression, one of the largest issues in treating patients with CLL with the FCR regimen or almost any of the regimens, is particularly exciting with these novel agents,” said Dr. O'Brien.

Dr. O'Brien touched upon PCI-32765, a small molecule inhibitor of Bruton's tyrosine kinase (Btk) that has been shown to be highly active in inhibiting CLL cell migration and adhesion. In addition to being effective, she noted that it appears to be extremely well tolerated in patients.

A second agent being investigated is CAL-101, an orally bioavailable small molecule that inhibits PI3K delta. A phase I study testing CAL-101 with bendamustine (Treanda, Cephalon Oncology) and/or rituximab resulted in tumor shrinkage in all evaluable patients with CLL, including those with del(17p). The drug was well tolerated, and marked reductions in peripheral lymphadenopathy were observed.

“Research needs to focus on treatment options for the populations that are not suitable to receive FCR and other standard chemoimmunotherapy options,” said Dr. O'Brien. “With continued advances, the goal of therapy will no longer be to simply palliate symptoms, but to achieve long-term remission and improve survival while preserving a good quality of life.”

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