Lenalidomide Approved for Mantle Cell Lymphoma Patients by FDA

Today, June 5 the FDA approved lenalidomide capsules for the treatment of patients with mantle cell lymphoma (MCL), who have experienced relapse or progression after receiving two prior therapies including bortezomib.

According to the FDA press release:

“The approval was based a single-arm, multicenter clinical trial enrolling 134 patients with mantle cell lymphoma who have relapsed after or were refractory to bortezomib or a bortezomib-containing regimen. All 134 patients received prior treatment with bortezomib and 60% were documented to have disease refractory to bortezomib therapy. Patients received a median of 4 prior therapies for MCL. The median age was 67 years, 81% were male, 96% were Caucasian, and 61% had MCL for at least 3 years.

The efficacy endpoints were overall response rate (ORR) and duration of response (DOR). The ORR was defined as the proportion of patients whose best response was complete response (CR), complete response unconfirmed (CRu), or partial response (PR). In the 133 patients who were evaluable for efficacy, the ORR was 26% (95% CI: 18.4, 33.9). CR or CRu was achieved by 9 patients (7%) and 25 patients (19%) achieved a PR. The median DOR for the 34 patients who achieved a CR, CRu, or PR was 16.6 months (95% CI: 7.7, 26.7).”

Here at the Weill Cornell Lymphoma Program we will endeavor to follow up with any further announcement regarding this new development.

Weill Cornell’s Dr. John Leonard Named Chair of NCI’s Alliance for Clinical Trials in Oncology Lymphoma Committee

Weill Cornell’s Dr. John Leonard has been named chair of the Lymphoma Committee for the prestigious Alliance for Clinical Trials in Oncology, sponsored by the National Cancer Institute (NCI).

John Leonard, MD
John Leonard, MD

Dr. Leonard is the Associate Dean for Clinical Research at Weill Cornell Medical College, the director of the Joint Clinical Trials Office at NewYork-Presbyterian Hospital/Weill Cornell Medical College, and the clinical director of the Weill Cornell Lymphoma Program. An internationally-recognized hematology and oncology expert specializing in the treatment of lymphoma, Dr. Leonard has been a pioneer in the development of novel lymphoma therapeutics. .

In his role as chair of the NCI-sponsored Lymphoma Committee, Dr. Leonard will help guide the national agenda for lymphoma research by developing, supporting and shepherding Phase II and Phase III clinical trials funded by NCI at medical centers around the United States. Dr. Leonard will direct a team of lymphoma clinical and laboratory researchers from academic and community medical centers across the country to create and implement new standards of treatment as well as foster the development of novel therapeutics.

“I am honored and deeply humbled to be chosen to lead this vital national effort to improve cancer care for patients in the United States,” said Dr. Leonard. “This appointment, I believe, is a true reflection of the programs and major accomplishments we’ve made here at Weill Cornell in advancing lymphoma research and clinical care. We are recognized as a leading center internationally in contributing new approaches to lymphoma management, and I am excited to continue collaborating with colleagues both here and across the country to move the field forward and improve the effectiveness of therapies that are available for patients.”

Lymphoma and Infection: Do I Need to Take Medication to Prevent Infection?

By Jessica Lewis, PA

In some instances, patients may be started on medicines to prevent or minimize infection. Infection in patients with impaired immune system function (due to lymphoma or treatment of lymphoma) can be life threatening. Ultimately, your doctor will determine whether to start such medications, but some current literature helps medical providers make this decision. The National Comprehensive Cancer Network (NCCN) is a not-for-profit alliance between 21 different cancer-treating centers within the USA. Research generated from physicians in these institutions is used to develop evidence-based recommendations to help guide healthcare providers. The American Society of Clinical Oncology (ASCO) is a not-for-profit group of physicians, who focus on patient-oriented clinical research, education, prevention, and delivery of patient care.

The NCCN and ASCO provide summaries of factors that predict a lymphoma patient’s risk of developing fever and infection. These factors include age, performance status, type of cancer, status of disease (remission vs. active disease), type of treatment, the presence of a low infection-fighting white blood cell count (neutropenic), and prior episodes of fever with chemotherapy treatment. Patients with lymphoma are generally classified as having intermediate risk, although some patients with CLL or T-cell lymphoma may be considered high risk.

Prevention of bacterial infections: Common prophylactic medications include levofloxacin or ciprofloxacin. Prophylaxis is recommended for intermediate or high-risk patients, including patients that are expected to have neutropenia. There have been few randomized-controlled trials that have investigated the use of antibiotics to prevent development of fever and infection in lymphoma patients that are receiving chemotherapy. The largest randomized-controlled study, by Cullen et al in 2005, included 1,565 patients with solid cancers and lymphomas treated with chemotherapy that would lower the white blood cell count.  In this study, patients were randomly assigned a placebo or levofloxacin. The authors found a decrease in the incidence of fever and decreased rates of probable infection and hospitalization. However, patients who received levofloxacin did not have a statistically significant decreased rate of severe infection (including lethal infections). As per 2012 NCCN and ASCO guidelines, the use of levofloxacin prophylaxis is only recommended for patients with neutropenia that lasts longer than 7 days.

Prevention of fungal infections: Medications to prevent fungal infections are not usually needed in lymphoma patients. ASCO guidelines recommend considering prophylaxis only for patients with profoundly low white blood cell counts (ANC <100) longer than 7 days. Additionally, patients should limit exposure to construction or demolition sites, and quit cigarette smoking to reduce risk of fungal infections.

Prevention of viral infections: Antiviral medications may be recommended. If you have been exposed to hepatitis B infection, you may be started on medication to prevent this from becoming an active infection. If you had the chicken pox as a child you are at risk of developing shingles, and you may benefit from preventative medication. Patients with lymphoma should not receive the shingles vaccine.

PCP prevention: Some patients are at risk of developing pneumonia, caused by Pneumocytus jirovecii (also referred to as PCP). You may require preventative medication, typically with TMP-SMX, if you are on steroids for a prolonged period of time (>1 month), or are receiving treatment with alemtuzumab or purine analogs (i.e., fludarabine).

Other preventative measures: ASCO 2012 guidelines recommended all patients who are receiving cancer treatment to receive the seasonal flu vaccine, along with their family and household contacts. Guidelines from the Centers for Disease Control (CDC) include administration of a pneumococcal vaccine in all patients with lymphoma.