Abstract
Dacetuzumab, a CD40-targeted, humanized antibody, mediates antitumor activity through effector cell functions and direct apoptotic signal transduction. Preclinical studies demonstrated synergistic activity between dacetuzumab, gemcitabine and rituximab against non-Hodgkin lymphoma in vivo. A phase 1b safety/efficacy study of dacetuzumab in combination with rituximab and gemcitabine was conducted in relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Patients received dacetuzumab at doses of 8 or 12 mg/kg IV weekly with rituximab (375 mg/m2 IV weekly in cycle 1, then every 28 days) and gemcitabine (1000 mg/m2 IV, days 1, 8 and 15, or days 1 and 15). Thirty-three patients with a median age of 67 years were enrolled. Common adverse events (≥15%) were grade 1/2 cytokine release syndrome, nausea, fatigue, thrombocytopenia, headache, decreased appetite, dyspnea, neutropenia, pyrexia, anemia, diarrhea, edema, constipation and cough. Dacetuzumab-related grade 3/4 adverse events occurred infrequently. Six of 30 evaluable patients achieved a complete response (CR) and eight a partial response (PR) per investigator assessment for an overall response rate (ORR) of 47%.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 277-283 |
| Number of pages | 7 |
| Journal | Leukemia and Lymphoma |
| Volume | 54 |
| Issue number | 2 |
| DOIs | |
| State | Published - Feb 1 2013 |
| Externally published | Yes |
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Keywords
- Antibody-based immunotherapy
- Chemotherapeutic approaches
- Lymphoma and Hodgkin disease
ASJC Scopus subject areas
- Hematology
- Oncology
- Cancer Research
Cite this
Pilot study of dacetuzumab in combination with rituximab and gemcitabine for relapsed or refractory diffuse large B-cell lymphoma. / Forero-Torres, Andres; Bartlett, Nancy; Beaven, Anne; Myint, Han; Nasta, Sunita; Northfelt, Donald W.; Whiting, Nancy C.; Drachman, Jonathan G.; Lobuglio, Albert F.; Moskowitz, Craig.
In: Leukemia and Lymphoma, Vol. 54, No. 2, 01.02.2013, p. 277-283.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Pilot study of dacetuzumab in combination with rituximab and gemcitabine for relapsed or refractory diffuse large B-cell lymphoma
AU - Forero-Torres, Andres
AU - Bartlett, Nancy
AU - Beaven, Anne
AU - Myint, Han
AU - Nasta, Sunita
AU - Northfelt, Donald W.
AU - Whiting, Nancy C.
AU - Drachman, Jonathan G.
AU - Lobuglio, Albert F.
AU - Moskowitz, Craig
PY - 2013/2/1
Y1 - 2013/2/1
N2 - Dacetuzumab, a CD40-targeted, humanized antibody, mediates antitumor activity through effector cell functions and direct apoptotic signal transduction. Preclinical studies demonstrated synergistic activity between dacetuzumab, gemcitabine and rituximab against non-Hodgkin lymphoma in vivo. A phase 1b safety/efficacy study of dacetuzumab in combination with rituximab and gemcitabine was conducted in relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Patients received dacetuzumab at doses of 8 or 12 mg/kg IV weekly with rituximab (375 mg/m2 IV weekly in cycle 1, then every 28 days) and gemcitabine (1000 mg/m2 IV, days 1, 8 and 15, or days 1 and 15). Thirty-three patients with a median age of 67 years were enrolled. Common adverse events (≥15%) were grade 1/2 cytokine release syndrome, nausea, fatigue, thrombocytopenia, headache, decreased appetite, dyspnea, neutropenia, pyrexia, anemia, diarrhea, edema, constipation and cough. Dacetuzumab-related grade 3/4 adverse events occurred infrequently. Six of 30 evaluable patients achieved a complete response (CR) and eight a partial response (PR) per investigator assessment for an overall response rate (ORR) of 47%.
AB - Dacetuzumab, a CD40-targeted, humanized antibody, mediates antitumor activity through effector cell functions and direct apoptotic signal transduction. Preclinical studies demonstrated synergistic activity between dacetuzumab, gemcitabine and rituximab against non-Hodgkin lymphoma in vivo. A phase 1b safety/efficacy study of dacetuzumab in combination with rituximab and gemcitabine was conducted in relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Patients received dacetuzumab at doses of 8 or 12 mg/kg IV weekly with rituximab (375 mg/m2 IV weekly in cycle 1, then every 28 days) and gemcitabine (1000 mg/m2 IV, days 1, 8 and 15, or days 1 and 15). Thirty-three patients with a median age of 67 years were enrolled. Common adverse events (≥15%) were grade 1/2 cytokine release syndrome, nausea, fatigue, thrombocytopenia, headache, decreased appetite, dyspnea, neutropenia, pyrexia, anemia, diarrhea, edema, constipation and cough. Dacetuzumab-related grade 3/4 adverse events occurred infrequently. Six of 30 evaluable patients achieved a complete response (CR) and eight a partial response (PR) per investigator assessment for an overall response rate (ORR) of 47%.
KW - Antibody-based immunotherapy
KW - Chemotherapeutic approaches
KW - Lymphoma and Hodgkin disease
UR - http://www.scopus.com/inward/record.url?scp=84872047730&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84872047730&partnerID=8YFLogxK
U2 - 10.3109/10428194.2012.710328
DO - 10.3109/10428194.2012.710328
M3 - Article
C2 - 22775314
AN - SCOPUS:84872047730
VL - 54
SP - 277
EP - 283
JO - Leukemia and Lymphoma
JF - Leukemia and Lymphoma
SN - 1042-8194
IS - 2
ER -