Treatment Response of Chronic Lymphocytic Leukemia
The aim of treatment is to induce the longest possible remission of the disease, while reducing the disease impact. The forms of response to treatment are3,8-10:
Complete response—when the patient is symptom free and blood count/bone marrow examinations meet agreed-upon values
Partial response—a reduction in swelling of lymph nodes, liver, and spleen of at least 50% and the blood count meets agreed-upon values
Progressive disease—an increase in swelling of lymph nodes, liver, and spleen of at least 50% or new sites of swelling
Stable disease—all other responses
Complete and partial responses must last at least 2 months.
The success of therapy can be judged by the percentage of patients in which remission is obtained, although the patients have to be at the same disease stage at diagnosis for the comparison to be accurate.
Following successful treatment, patients may relapse after periods that vary from a few months to several years. The relapse is then retreated with either the same drug(s) or different ones. The response rate for relapsed patients is, unfortunately, usually lower than for those undergoing their first treatment.14
Campath is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).
WARNING: CYTOPENIAS, INFUSION REACTIONS, and INFECTIONS
Cytopenias: Serious, including fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia can occur in patients receiving Campath. Single doses of Campath greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia [see WARNINGS AND PRECAUTIONS (5.1)].
Infusion Reactions: Campath administration can result in serious, including fatal, infusion reactions. Carefully monitor patients during infusions and withhold Campath for Grade 3 or 4 infusion reactions. Gradually escalate Campath to the recommended dose at the initiation of therapy and after interruption of therapy for 7 or more days [see DOSAGE AND ADMINISTRATION (2) and WARNINGS AND PRECAUTIONS (5.2)].
Infections: Serious, including fatal, bacterial, viral, fungal, and protozoan infections can occur in patients receiving Campath. Administer prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and herpes virus infections [see DOSAGE AND ADMINISTRATION (2.2) and WARNINGS AND PRECAUTIONS (5.3)].
The most commonly reported adverse reactions are infusion reactions fever, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anemia), and infections (CMV viremia, CMV infection, other infections). In clinical trials, the frequency of infusion reactions was highest in the first week of treatment. Other commonly reported adverse reactions include vomiting, abdominal pain, insomnia and anxiety. The most commonly reported serious adverse reactions are cytopenias, infusion reactions, and immunosuppression/infections. See "Warnings and Precautions," and "Adverse Reactions" sections of full Prescribing Information.
Please see Full Prescribing Information (PDF).
