Abstract
We present the results of a phase 2 study using thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) in the treatment of 50 patients older than 65 years with newly diagnosed multiple myeloma. Thalidomide 100 mg was administered orally at bedtime continuously, dexamethasone 40 mg was administered orally on days 1 to 4 and 9 to 12, and pegylated liposomal doxorubicin 40 mg/m2 was administered intravenously on day 1 over the 28-day cycle. Response was assessed according to the EBMT criteria. Seventeen (34%) patients achieved CR, 7 (14%) nCR, 5 (10%) VGPR, 15 (30%) PR, and 5 (10%) MR, resulting in an ORR of 98%. Only 1 patient (2%) presented progressive disease. Time to progression (TTP), event-free survival (EFS), and overall survival (OS) projected at 3 years were 60%, 57%, and 74%, respectively, and these parameters were significantly higher in those patients achieving a response of at least VGPR versus those who did not. Grade 3 and 4 nonhematologic adverse events were constipation (10%), fatigue (6%), tremors (4%), mucositis (4%), and palmar-plantar erythrodysesthesia (2%). Grade 3 and 4 neutropenia occurred in 12% of patients. Grade 3 and 4 infections and thromboembolic accidents were observed in 22% and 14% of patients, respectively. In the treatment of elderly patients with newly diagnosed multiple myeloma, ThaDD is a very effective regimen with manageable toxicity.
| Original language | English |
|---|---|
| Pages (from-to) | 2159-2164 |
| Number of pages | 6 |
| Journal | Blood |
| Volume | 108 |
| Issue number | 7 |
| DOIs | |
| Publication status | Published - Oct 1 2006 |
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ASJC Scopus subject areas
- Hematology
Cite this
Thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) for patients older than 65 years with newly diagnosed multiple myeloma. / Offidani, Massimo; Corvatta, Laura; Piersantelli, Maria Novella; Visani, Giuseppe; Alesiani, Francesco; Brunori, Marino; Galieni, Piero; Catarini, Massimo; Burattini, Maurizio; Centurioni, Riccardo; Ferranti, Mario; Rupoli, Serena; Scortechini, Anna Rita; Giuliodori, Luciano; Candela, Marco; Capelli, Debora; Montanari, Mauro; Olivieri, Attilio; Poloni, Antonella; Polloni, Claudia; Marconi, Monica; Leoni, Pietro.
In: Blood, Vol. 108, No. 7, 01.10.2006, p. 2159-2164.Research output: Contribution to journal › Article
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TY - JOUR
T1 - Thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) for patients older than 65 years with newly diagnosed multiple myeloma
AU - Offidani, Massimo
AU - Corvatta, Laura
AU - Piersantelli, Maria Novella
AU - Visani, Giuseppe
AU - Alesiani, Francesco
AU - Brunori, Marino
AU - Galieni, Piero
AU - Catarini, Massimo
AU - Burattini, Maurizio
AU - Centurioni, Riccardo
AU - Ferranti, Mario
AU - Rupoli, Serena
AU - Scortechini, Anna Rita
AU - Giuliodori, Luciano
AU - Candela, Marco
AU - Capelli, Debora
AU - Montanari, Mauro
AU - Olivieri, Attilio
AU - Poloni, Antonella
AU - Polloni, Claudia
AU - Marconi, Monica
AU - Leoni, Pietro
PY - 2006/10/1
Y1 - 2006/10/1
N2 - We present the results of a phase 2 study using thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) in the treatment of 50 patients older than 65 years with newly diagnosed multiple myeloma. Thalidomide 100 mg was administered orally at bedtime continuously, dexamethasone 40 mg was administered orally on days 1 to 4 and 9 to 12, and pegylated liposomal doxorubicin 40 mg/m2 was administered intravenously on day 1 over the 28-day cycle. Response was assessed according to the EBMT criteria. Seventeen (34%) patients achieved CR, 7 (14%) nCR, 5 (10%) VGPR, 15 (30%) PR, and 5 (10%) MR, resulting in an ORR of 98%. Only 1 patient (2%) presented progressive disease. Time to progression (TTP), event-free survival (EFS), and overall survival (OS) projected at 3 years were 60%, 57%, and 74%, respectively, and these parameters were significantly higher in those patients achieving a response of at least VGPR versus those who did not. Grade 3 and 4 nonhematologic adverse events were constipation (10%), fatigue (6%), tremors (4%), mucositis (4%), and palmar-plantar erythrodysesthesia (2%). Grade 3 and 4 neutropenia occurred in 12% of patients. Grade 3 and 4 infections and thromboembolic accidents were observed in 22% and 14% of patients, respectively. In the treatment of elderly patients with newly diagnosed multiple myeloma, ThaDD is a very effective regimen with manageable toxicity.
AB - We present the results of a phase 2 study using thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) in the treatment of 50 patients older than 65 years with newly diagnosed multiple myeloma. Thalidomide 100 mg was administered orally at bedtime continuously, dexamethasone 40 mg was administered orally on days 1 to 4 and 9 to 12, and pegylated liposomal doxorubicin 40 mg/m2 was administered intravenously on day 1 over the 28-day cycle. Response was assessed according to the EBMT criteria. Seventeen (34%) patients achieved CR, 7 (14%) nCR, 5 (10%) VGPR, 15 (30%) PR, and 5 (10%) MR, resulting in an ORR of 98%. Only 1 patient (2%) presented progressive disease. Time to progression (TTP), event-free survival (EFS), and overall survival (OS) projected at 3 years were 60%, 57%, and 74%, respectively, and these parameters were significantly higher in those patients achieving a response of at least VGPR versus those who did not. Grade 3 and 4 nonhematologic adverse events were constipation (10%), fatigue (6%), tremors (4%), mucositis (4%), and palmar-plantar erythrodysesthesia (2%). Grade 3 and 4 neutropenia occurred in 12% of patients. Grade 3 and 4 infections and thromboembolic accidents were observed in 22% and 14% of patients, respectively. In the treatment of elderly patients with newly diagnosed multiple myeloma, ThaDD is a very effective regimen with manageable toxicity.
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U2 - 10.1182/blood-2006-03-013086
DO - 10.1182/blood-2006-03-013086
M3 - Article
VL - 108
SP - 2159
EP - 2164
JO - Blood
JF - Blood
SN - 0006-4971
IS - 7
ER -