Low-dose intermittent alemtuzumab in the treatment of Sezary syndrome: clinical and immunologic findings in 14 patients. Bernengo, M., G., Quaglino, P., Comessatti, A., Ortoncelli, M., Novelli, M., Lisa, F., & Fierro, M., T. Haematologica, 92(6):784-794, 2007.
Low-dose intermittent alemtuzumab in the treatment of Sezary syndrome: clinical and immunologic findings in 14 patients [link]Website  abstract   bibtex   
BACKGROUND AND OBJECTIVES: Alemtuzumab may be effective in Sezary syndrome (SS), an aggressive cutaneous T-cell lymphoma, but is associated with severe hematologic toxicity and infections. This study investigated whether low-dose subcutaneous alemtuzumab can induce hematologic, immunologic, and clinical responses similar to those obtained with the standard regimen, but with less toxicity. DESIGN AND METHODS: Fourteen SS patients were enrolled: 11 had relapsed/refractory disease and three had untreated SS with high counts of circulating Sezary cells (SC). Four received 3 mg alemtuzumab on day 1, 10 mg on day 3, then 15 mg on alternating days; circulating SC were evaluated after the fourth 15 mg dose and treatment was interrupted in the presence of counts <1,000/mm (3). A reduced dosage (3 mg on day 1, then 10 mg on alternating days) was administered to the remaining patients, with SC counted before every injection, until a reduction to values of <1,000/mm (3). RESULTS: The median SC count decreased by 95.5%. Overall, 12/14 patients (85.7%) achieved a clinical response, with three complete responses (21.4%). After a median follow-up of 16 months, the median time-to-treatment failure is 12 months. Infectious complications occurred in 28.6% of patients, all included in the group treated with 15 mg. No patient in the group treated with 10 mg developed hematologic toxicity or infections. An early recovery of circulating NK, B and CD3+CD8+ cells occurred after the first cycle. INTERPRETATION AND CONCLUSIONS: Subcutaneous alemtuzumab at very low doses (10 mg maximum per administration), given for a short period based on SC levels, has a good toxicity profile, high response rate and causes durable remissions in SS patients with high tumor burden in the peripheral blood.
@article{
 title = {Low-dose intermittent alemtuzumab in the treatment of Sezary syndrome: clinical and immunologic findings in 14 patients},
 type = {article},
 year = {2007},
 identifiers = {[object Object]},
 keywords = {Aged,Aged, 80 and over,Antibodies, Monoclonal/*administration & dosage/to,Antibodies, Neoplasm/*administration & dosage/toxi,Cell Count,Drug Administration Schedule,Female,Humans,Immune System/cytology,Male,Middle Aged,Remission Induction,Sezary Syndrome/*drug therapy/pathology,Treatment Outcome},
 pages = {784-794},
 volume = {92},
 websites = {http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=17550851},
 edition = {2007/06/07},
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 source_type = {Journal Article},
 language = {eng},
 notes = {<m:note>Bernengo, Maria Grazia<m:linebreak/>Quaglino, Pietro<m:linebreak/>Comessatti, Alessandra<m:linebreak/>Ortoncelli, Michela<m:linebreak/>Novelli, Mauro<m:linebreak/>Lisa, Francesco<m:linebreak/>Fierro, Maria Teresa<m:linebreak/>Clinical Trial<m:linebreak/>Italy<m:linebreak/>Haematologica<m:linebreak/>Haematologica. 2007 Jun;92(6):784-94.</m:note>},
 abstract = {BACKGROUND AND OBJECTIVES: Alemtuzumab may be effective in Sezary syndrome (SS), an aggressive cutaneous T-cell lymphoma, but is associated with severe hematologic toxicity and infections. This study investigated whether low-dose subcutaneous alemtuzumab can induce hematologic, immunologic, and clinical responses similar to those obtained with the standard regimen, but with less toxicity. DESIGN AND METHODS: Fourteen SS patients were enrolled: 11 had relapsed/refractory disease and three had untreated SS with high counts of circulating Sezary cells (SC). Four received 3 mg alemtuzumab on day 1, 10 mg on day 3, then 15 mg on alternating days; circulating SC were evaluated after the fourth 15 mg dose and treatment was interrupted in the presence of counts <1,000/mm (3). A reduced dosage (3 mg on day 1, then 10 mg on alternating days) was administered to the remaining patients, with SC counted before every injection, until a reduction to values of <1,000/mm (3). RESULTS: The median SC count decreased by 95.5%. Overall, 12/14 patients (85.7%) achieved a clinical response, with three complete responses (21.4%). After a median follow-up of 16 months, the median time-to-treatment failure is 12 months. Infectious complications occurred in 28.6% of patients, all included in the group treated with 15 mg. No patient in the group treated with 10 mg developed hematologic toxicity or infections. An early recovery of circulating NK, B and CD3+CD8+ cells occurred after the first cycle. INTERPRETATION AND CONCLUSIONS: Subcutaneous alemtuzumab at very low doses (10 mg maximum per administration), given for a short period based on SC levels, has a good toxicity profile, high response rate and causes durable remissions in SS patients with high tumor burden in the peripheral blood.},
 bibtype = {article},
 author = {Bernengo, M G and Quaglino, P and Comessatti, A and Ortoncelli, M and Novelli, M and Lisa, F and Fierro, M T},
 journal = {Haematologica},
 number = {6}
}
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