Non-Hodgkin Lymphoma in Elderly Patients Above the Age of 80 in the Rituximab Era

NCT ID: NCT00902434

Last Updated: 2014-07-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-04-30

Brief Summary

This is an exploratory analysis that is investigating the pattern of care in patients over the age of 80 who were diagnosed with non-Hodgkin lymphoma (NHL). This study will look at the dose intensity and density implemented in this patient population to calculate whether patients received the full course of therapy, received less duration of treatment, or received lower doses of the drugs administered. Furthermore, the investigators would explore time to disease progression for these patients regardless of the treatment received and investigate whether patient outcomes differ based on the type of therapy or dose intensity/density given.

This study is looking at retrospectively evaluating patients with NHL who are over the age of 80 at our institution between 2001-2007. It is anticipated that about 50 patients will be included in this study.

Detailed Description

Non-Hodgkin Lymphoma (NHL) is a malignant disease of the lymphoid and hematopoetic system with an annual incidence of 60,000 cases/year in the United States accounting for over 18,000 deaths annually. NHL is a heterogeneous malignancy with a median age of 65 at the time of diagnosis. Most clinical trials that have established current standards of care did not include elderly patients, especially those who are above the age of 80. Reasons for such under representation are not well-defined but several factors are hypothesized. Patients above the age of 80 have many co-morbid conditions that might exclude them from enrollment on clinical studies that are usually designed for more fit individuals. In addition, investigators are often reluctant to propose trials to elderly patients as their response to therapy might be suboptimal compared with younger patients affecting the overall data.

Well-designed published studies as to how patients over the age of 80 are being managed in the community or academic setting are lacking. There is no agreed-upon treatment algorithm for these patients and recommended approach varies based on the treating physician, the institution, and each individual patient.

Some physicians chose to offer dose reductions while others might omit chemotherapy and use monoclonal antibodies alone. Furthermore, treatment duration and the number of cycles given might vary considerably in this patient subgroup for a variety of reasons, mainly toxicity. In addition, it is unclear whether the histologic distribution of NHL is similar in older patients. In other words, it is not clear whether patients over the age of 80 are commonly diagnosed with diffuse large cell lymphoma (DLCL) and follicular lymphoma (FL) similar to younger individuals. Most importantly, these expected variations in treatment strategies might have inferior outcomes when compared to younger patient population. Looking at histologic subtype, treatment strategies, and outcomes in patients over the age of 80 is useful for patients and physicians alike. It is plausible that our current standards do not apply to this very-older patient population arguing for offering them clinical trials or novel agents even as an initial approach. On the other hand, we might discover that these older patients fare well despite these variations arguing that their disease biology is different especially if we note changes in histologic distribution.

Conditions

Non-Hodgkin's Lymphoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients with any NHL diagnosis regardless of histology who are over the age of 80 at the time of diagnosis will be included and analyzed.
• Data on age, gender, performance status, and major co-morbid conditions will be collected.
• Histology of the diagnosed NHL will be recorded. The grade (1, 2, or 3) for those who were diagnosed with follicular lymphoma will also be recorded.
• Stage of the disease, presence of bulky nodes and B symptoms will also be recorded.
• PET scan results if available.
• Type of treatment received will be recorded.
• Responses to therapy.
• Outcomes of treatment implemented and toxicities incurred.
• Subsequent therapies if applicable.

Exclusion Criteria

• None. All charts of patients who are above the age of 80 at the time of NHL diagnosis will be analyzed.

• Minimum Eligible Age: 80 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oncology Specialists, S.C.

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sigrun Hallmeyer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chadi Nabhan, MD

Role: PRINCIPAL_INVESTIGATOR

Oncology Specialists, S.C.

Other Identifiers

0903

Identifier Type: -

Identifier Source: org_study_id