Dose Attenuation of R-CHOP for the Treatment of Elderly Patients with Diffuse Large B Cell Lymphoma.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4458-4458
Author(s):  
Young Jin Choi ◽  
Kyung Woo Lee ◽  
Ho-Jin Shin ◽  
Jooseop Chung ◽  
Goon-Jae Cho
Keyword(s):  
Elderly Patients ◽  
Response Rate ◽  
International Prognostic Index ◽  
Survival Rates ◽  
Prognostic Index ◽  
Stage Iv ◽  
B Cell Lymphoma ◽  
Complete Response ◽  
Hematologic Toxicity ◽  
Chop Regimen

Abstract Backgrounds: More than half of the patients with newly diagnosed aggressive lymphomas are older than 60 years. The addition of rituximab to the conventional CHOP regimen, administered every 21 days, has conclusively demonstrated to lead to a significant improvement of the outcome in elderly patients with DLBCL and surivival benefit. The aim of this study was to evaluate the efficacy and toxicity of dose attenuated CHOP with rituximab 3 weekly in untreated elderly DLBCL. Methods: CHOP regimen consisted of cyclophosphamide(600mg/m2), doxorubicin(30mg/m2), vincristine (1mg/m2) on day 1, and prednisolone (20mg bid) given on day 1 to 5 every 3 weeks. Rituximab (375mg/m2) was administered the same day as CHOP. Results: This study included 37 patients with DLBCL with a median age of 70 years (range:64–81). Seventy six percent had an international prognostic index score>1, 35% had stage IV disease. Toxicity was calculated over 192 cycles administered. Grade 4 neutropenia developed in 2.6% of cycles and no grade 4 non-hematologic toxicity didn’t developed except asthenia (1 person). The overall response rate was 83.3% (complete response rate: 72.2%). 2 year overall and event free survival rates were 79.8% and 67%, respectively. Conclusions: Dose attenuated R-CHOP is effective and tolerable for elderly patients with DLBCL.

scholarly journals Phase 1/2a study of 177Lu-lilotomab satetraxetan in relapsed/refractory indolent non-Hodgkin lymphoma

2020 ◽  
Vol 4 (17) ◽  
pp. 4091-4101
Author(s):  
Arne Kolstad ◽  
Tim Illidge ◽  
Nils Bolstad ◽  
Signe Spetalen ◽  
Ulf Madsbu ◽  
...  
Keyword(s):  
Hodgkin Lymphoma ◽  
Overall Response Rate ◽  
Response Rate ◽  
Phase 1 ◽  
B Cell Lymphoma ◽  
Complete Response ◽  
Hematologic Toxicity ◽  
Overall Response ◽  
Non Hodgkin Lymphoma ◽  
Anti Cd20

Abstract For patients with indolent non-Hodgkin lymphoma who fail initial anti-CD20–based immunochemotherapy or develop relapsed or refractory disease, there remains a significant unmet clinical need for new therapeutic approaches to improve outcomes and quality of life. 177Lu-lilotomab satetraxetan is a next-generation single-dose CD37-directed radioimmunotherapy (RIT) which was investigated in a phase 1/2a study in 74 patients with relapsed/refractory indolent non-Hodgkin B-cell lymphoma, including 57 patients with follicular lymphoma (FL). To improve targeting of 177Lu-lilotomab satetraxetan to tumor tissue and decrease hematologic toxicity, its administration was preceded by the anti-CD20 monoclonal antibody rituximab and the “cold” anti-CD37 antibody lilotomab. The most common adverse events (AEs) were reversible grade 3/4 neutropenia (31.6%) and thrombocytopenia (26.3%) with neutrophil and platelet count nadirs 5 to 7 weeks after RIT. The most frequent nonhematologic AE was grade 1/2 nausea (15.8%). With a single administration, the overall response rate was 61% (65% in patients with FL), including 30% complete responses. For FL with ≥2 prior therapies (n = 37), the overall response rate was 70%, including 32% complete responses. For patients with rituximab-refractory FL ≥2 prior therapies (n = 21), the overall response rate was 67%, and the complete response rate was 24%. The overall median duration of response was 13.6 months (32.0 months for patients with a complete response). 177Lu-lilotomab satetraxetan may provide a valuable alternative treatment approach in relapsed/refractory non-Hodgkin lymphoma, particularly in patients with comorbidities unsuitable for more intensive approaches. This trial was registered at www.clinicaltrials.gov as #NCT01796171.

Re-Assessment of the Prognostic Value of International Prognostic Index (IPI) and Revised IPI (R-IPI) in Patients with Diffuse Large B-Cell Lymphoma Treated with or without Rituximab in Chinese Populations: A Retrospective Multicenter Study by Shanghai Lymphoma Research Group

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 2649-2649
Author(s):  
Honghui Huang ◽  
Fei Xiao ◽  
Fangyuan Chen ◽  
Ting Wang ◽  
Junmin Li ◽  
...  
Keyword(s):  
Prognostic Value ◽  
Cell Lymphoma ◽  
International Prognostic Index ◽  
Survival Rates ◽  
Prognostic Index ◽  
Progression Free Survival ◽  
B Cell Lymphoma ◽  
Free Survival ◽  
Large B Cell Lymphoma ◽  
Prognostic Groups

Abstract Abstract 2649 Background: The International Prognostic Index (IPI) is a widely accepted prognostic factor system for diffuse large B cell lymphoma (DLBCL) patients treated with chemotherapy. However, the prognostic value of IPI has been a focal point of the debate in the era of immuno-chemotherapy. Recently, the study of British Columbia group suggested that a revised IPI (R-IPI) which redistributed the IPI factors into 3 distinct prognostic groups provided a more clinically useful prediction of outcome for patients with DLBCL. In order to reassess the value of IPI and R-IPI in unselected Chinese population, we conducted this study. Methods: A multicenter retrospective analysis of DLBCL patients treated with CHOP-like chemotherapy alone or plus rituximab was performed by Shanghai Lymphoma Research Group. In total, 438 patients of newly diagnosed DLBCL treated at 6 participated hospitals were included during the period of 1997–2008. The prognostic value of IPI and R-IPI at diagnosis with regards to overall survival (OS) and progression-free survival (PFS) was evaluated. Results: The median age at diagnosis was 50 years (range, 18–83 years), and the median follow-up was 34 months (range, 3–145 months). Among them, 241 patients received CHOP-like regimen, whereas 197 had rituximab (R)-CHOP-like regimen. While IPI remained predictive in CHOP-like group, it could not distinguish between each prognostic category in the R-CHOP-like group (Fig.1). Redistribution of the IPI factors into a R-IPI identified three distinct prognostic groups with significantly different outcomes both in the patients treated with and without rituximab. In R-CHOP-like arm, these three risk groups had distinctly different rates of 3-year progression-free survival rates of 96%, 84.3% and 67.5% (P<0.001), respectively, and 3-year overall survival rates of 96%, 87.6% and 71.1% (P<0.001), respectively (Fig.2). Conclusions: Our study underscores the power of R-IPI as a simplified and more clinically relevant predictor of the disease outcomes than the standard IPI in Chinese DLBCL populations in the rituximab era, and it deserves a further study in larger population-based prospective study. Disclosures: No relevant conflicts of interest to declare.

R-EPOCH Is Superior to R-CHOP As a First-Line Regimen in De Novo DLBCL Patients with High Ki-67 Expression

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 5085-5085
Author(s):  
Jia-Jia Huang ◽  
Wenqi Jiang ◽  
Zhi-Ming Li
Keyword(s):  
De Novo ◽  
Conflicts Of Interest ◽  
Performance Status ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
Progression Free Survival ◽  
B Cell Lymphoma ◽  
First Line ◽  
Ki 67 ◽  
Chop Regimen

Abstract Diffuse large B-cell lymphoma (DLBCL) patients with high Ki-67 expression receive limited benefits from R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) therapy. This study aims to compare the R-EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) and R-CHOP regimens as first-line therapy in DLBCL patients with high Ki-67 expression. Data from 44 untreated DLBCL patients with high Ki-67 expression receiving R-EPOCH therapy were matched with those from 132 untreated DLBCL patients with high Ki-67 expression receiving R-CHOP therapy based on the International Prognostic Index (IPI: age, Ann Arbor stage, performance status, LDH level, number of extranodal sites), gender, and Ki-67 expression. In the R-EPOCH group, 42/44 patients were eligible for response evaluation. A total of 35 patients (83.3%) achieved complete remission (CR); 6 patients (14.3%) achieved partial remission (PR); and one patient (2.4%) exhibited progressive disease (PD) after 2 cycles of therapy. Patients in the R-EPOCH group presented better survival outcomes than those in the R-CHOP group (3-year overall survival [OS]: 89.9% vs. 70.2%, p=0.041; 3-year progression-free survival [PFS]: 86.6% vs. 59.7%, p=0.024). The survival superiority of the R-EPOCH over the R-CHOP regimen persisted when considering only patients of low-to-intermediate IPI risk, but it was not observed in those of high IPI risk. Our data suggest that R-EPOCH is superior to R-CHOP as a first-line regimen in DLBCL patients with high Ki-67 expression, especially in those of low-to-intermediate IPI risk. Disclosures No relevant conflicts of interest to declare.

CHOP-R + bortezomib as initial therapy for diffuse large B-cell lymphoma (DLBCL)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 8031-8031 ◽  
Author(s):  
J. P. Leonard ◽  
R. R. Furman ◽  
Y. K. Cheung ◽  
J. M. Vose ◽  
P. W. Glynn ◽  
...  
Keyword(s):  
High Risk ◽  
Phase I ◽  
B Cell ◽  
International Prognostic Index ◽  
Elevated Serum ◽  
Prognostic Index ◽  
B Cell Lymphoma ◽  
Serum Lactate Dehydrogenase ◽  
Hematologic Toxicity ◽  
Combination Regimen

8031 Background: Bortezomib is a proteasome inhibitor with anti-tumor activity in B cell malignancies. These effects, which may relate to NF-kappaB associated pathways, could sensitize tumor cells to standard chemotherapy-based regimens and enhance efficacy. We report findings of a phase I/II trial of dose-escalated bortezomib + standard CHOP-rituximab in DLBCL patients (accrual of the MCL cohort of this study remains ongoing). Methods: Patients with previously untreated DLBCL (n=40) received CHOP-21 + rituximab (375 mg/m2 each cycle) plus bortezomib at 0.7 mg/m2 (Arm 0, n=4), 1.0 mg/m2 (Arm 1, n=8) or 1.3 mg/m2 (Arm 2, n=28 including phase I and all phase II) on days 1 and 4 of each cycle Results: Median age (n=40) was 58 years (range 21–86), thirty-five subjects (88%) had stage III/IV disease at study entry, and 29 (73%) had elevated serum lactate dehydrogenase (LDH). Patients generally had unfavorable baseline international prognostic index (IPI) scores of 2 in 16 subjects (40%) and 3–5 in 19 subjects (48%). Median follow-up is 21 months (range 9 - 35 months). Treatment was generally well tolerated. Peripheral neuropathy occurred in 22 subjects (55%), with 45% grade 1, 5% grade 2 and 5% grade 3. Grade 4 hematologic toxicity included thrombocytopenia (15%) and leukopenia (15%). Four subjects (3 over age 75 and all with high risk IPI) died prior to first response assessment. Intent to treat (ITT) overall response rate (n=40) is 90% with 68% CR/CRu. For the evaluable subset (n=36), ORR was 100% with CR/CRu 75%. Kaplan-Meier estimate (n=40) of 2-year progression-free survival is 72%. Of all 19 enrolled (ITT) patients in the high-intermediate or high-risk IPI groups, 14 (74%) were alive without progression at last assessment. Correlation of outcome with cell of origin type (activated B cell vs germinal center) is ongoing. Conclusions: Bortezomib can be administered with acceptable toxicity in conjunction with CHOP-R chemotherapy. Efficacy findings with this combination regimen in newly-diagnosed DLBCL are encouraging and warrant further study. No significant financial relationships to disclose.

scholarly journals Comparing the Outcome of Diffuse Large B-Cell Lymphoma in Very Elderly Patients (age greater than 80 years) with Elderly Patients (age between 65 to 79 years)

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 5072-5072
Author(s):  
Charalampos S. Floudas ◽  
Ajay Dhakal ◽  
Sunjay Neupane ◽  
Pouyan Gohari ◽  
Abhinav B Chandra
Keyword(s):  
Elderly Patients ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
Progression Free Survival ◽  
B Cell Lymphoma ◽  
Elderly Group ◽  
Very Elderly ◽  
Free Survival ◽  
Significant Difference ◽  
Ecog Ps

Abstract Background Diffuse large B-cell lymphoma (DLBCL) is the most frequent NHL subtype and the risk for it increases with age. At the same time, in advanced countries, the population over 65 years old is increasing because of the continuous increase in life expectancy and as a result the incidence of DLBCL is increasing as well. Increasing age is a major determinant of therapeutic decisions since it is associated with the presence of concomitant diseases, however elderly (over 65 years old) and very elderly (>80 years old) patients are not often included in clinical trials. Consequently, the optimal management of patients in the very elderly has not been identified. We conducted a single-center retrospective study with the objective to compare the comorbidity profiles, chemotherapy offered and tolerance, as well as outcome between elderly and very elderly DLBCL patients. Method A chart review of patients diagnosed with DLBCL in our center from January 2008 to January 2014 identified 33 patients aged between 60 to 79 years (elderly group, EG) and 30 patients aged 80 or more (very elderly group, VEG). We analyzed the clinical and laboratory characteristics (gender, extranodal disease presence, International Prognostic Index (IPI) factors, ECOG performance status (PS), Charlson comorbidity index, B-symptoms, hemoglobin, serum albumin), Progression Free Survival (PFS) and Overall Survival (OS) in comparison between the two groups. Furthermore, we studied the percentage of patients that were offered chemotherapy in each group, the regimen that was offered and the completion of chemotherapy as planned. Results: Median age for the EG was 72 years and for the VEG was 84 years (80 - 93). Significant differences between EG and VEG were found in mean serum albumin concentration at diagnosis (3.48 vs. 2.77, p=0.008), ECOG PS (0.91 vs. 2.36, p=0.000), and International Prognostic Index (IPI) (1.76 vs. 2.54, p=0.023) between EG and VEG. Compared to EG, VEG patients were more likely to have comorbidities (100 vs. 81.8%, p=0.025) and extra-nodal disease (93.3% vs. 66.7%, p=0.012). Though there was no statistically significant difference in percent of patients receiving chemotherapy, greater percent of EG (60.6) received R-CHOP regimen compared to VEG (20.0, p=0.001). There was no significant difference in therapy related toxicity, but fewer patients in the VEG (60 vs. 90.5%, p=0.039) were able to complete the course of chemotherapy planned and fewer achieved CR (35.7% vs. 68.2, p=0.036). Median overall survival was 762 vs. 650 days (p=0.793) and median progression free survival was 704 vs. 331 days (p= 0.180) for EG versus VEG. Conclusion: Very elderly DLBCL patients may differ from elderly patients in ECOG PS, comorbidity profile and chemotherapy regimen. These patients were less likely to complete the course of chemotherapy and fewer achieved complete response compared to the elderly group. There were no statistically significant differences in outcomes between the two groups. Disclosures No relevant conflicts of interest to declare.

Autologous Stem Cell Transplantation (ASCT) as Consolidation Therapy for Patients with Low-Intermediate (LI) Risk Diffuse Large B-Cell Lymphoma (DLBCL) and Overexpression of Bcl2 Protein. Results of the First Interim Analysis of the GELA Trial LNH98-B2.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 2928-2928 ◽  
Author(s):  
Pierre Morel ◽  
Nicolas Mounier ◽  
Josette Briere ◽  
Christophe Ferme ◽  
Bertrand Coiffier ◽  
...  
Keyword(s):  
Stem Cell ◽  
Treatment Failure ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
B Cell Lymphoma ◽  
Complete Response ◽  
Consolidation Therapy ◽  
Apoptotic Protein ◽  
Bcl2 Protein ◽  
Bcl2 Expression

Abstract The anti-apoptotic protein bcl2 expression is associated with treatment failure in elderly patients (pts) with DLBCL (Blood 101:4279,2003). The ACVBP regimen with conventional consolidation therapy (JCO 18:3025,2000) yield a 2-year (yr) EFS at 71% in DLBCL pts aged 60 yrs or less with only 1 adverse age-adjusted International-Prognostic-Index factor (LI risk pts). To assess if ASCT reduces treatment failure in these pts, we initiated a trial stratified by bcl2 expression. Centralized staining for bcl2 was prospectively performed within 6 weeks after inclusion. Induction regimen consisted of 4 courses of ACVBP given every 2 weeks. In case of response, bcl2 negative pts received the conventional consolidation regimen, whereas bcl2 positive pts underwent peripheral blood stem cell collection after the 4th cycle, and ASCT (mitoxantrone 45 mg/m2, cyclophosphamide 1.5 g/m2 x 4d, etoposide 250 mg/m2 x 4d and carmustine 300 mg/m2) between d80 and d90. From 1999 to 2002, 272 LI-risk pts aged 18 to 59 (median 46, M/F=1.4) presented with bcl2 overexpression (151) or without (121). There was no difference in initial characteristics, toxicity of induction and complete response (CR+CRu) rates between bcl2 positive and bcl2 negative pts (78% and 82%, respectively, p = 0.38). ASCT was not performed in 35 pts, mainly because of early failure (37%). Although bcl2 negative pts retained a better 2-yr survival than bcl2 positive pts (95% vs. 86%, p=0.01) with a median follow-up of 21 months, 2-yr EFS and 2-yr DFS did not differ significantly (84% vs. 79%, p=0.33, and 89% vs. 87%, p=0.94 respectively). This analysis demonstrates the feasibility of taking bcl2 expression into account for the design of multicentre protocol. The lack of difference in EFS and DFS between bcl2 positive pts who received ASCT and bcl2 negative pts treated with conventional consolidation suggested that ASCT may overcome the adverse prognostic value of bcl2 expression in LI-risk pts who achieve CR or Cru.

Prognostic Impact of Mid-Treatment PET in Patients with Diffuse Large B-Cell Lymphoma Who Achieved Metabolic CR at Post-Treatment PET

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 3949-3949 ◽  
Author(s):  
Changhoon Yoo ◽  
Jeong-Eun Kim ◽  
Byeong Seok Sohn ◽  
Dok Hyun Yoon ◽  
Shin Kim ◽  
...  
Keyword(s):  
Conflicts Of Interest ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
Progression Free Survival ◽  
B Cell Lymphoma ◽  
Complete Response ◽  
Post Treatment ◽  
Prognostic Impact ◽  
Positron Emission ◽  
Age Range

Abstract Abstract 3949 Poster Board III-885 Background Mid-treatment positron emission tomography (PET) has been found to predict clinical outcomes in patients with aggressive non-Hodgkin's lymphoma. Currently, risk-adapted therapy based on mid-treatment PET has been widely evaluated. This study was intended to assess the prognostic value of mid-treatment PET in patients who achieved metabolic complete response (mCR) at post-treatment PET. Methods From February 2002 to March 2009, total 130 patients in whom post-treatment PET showed mCR were included in this study. We performed retrospective analysis of progression-free survival (PFS) and overall survival (OS) according to the results of mid-treatment PET. Results Median age (range) was 51 (16-85) years old, and 70 (54%) patients were male. International Prognostic Index (IPI) was low (0-2) in 91 (70%) patients and high (3-5) in 39 (30%) patients. As a front-line chemotherapy, most frequently administered regimen was R-CHOP (76%). Eighty-seven (67%) patients were mCR, and 43 (33%) patients were metabolic partial response (mPR) in mid-treatment PET. With 24 months of median follow-up, 3 year-rates of PFS and OS in overall patients were 74% and 87%, respectively. Differences of survival outcomes between patients with mCR and mPR at mid-treatment PET were not statistically significant in terms of PFS (p=0.13) and OS (p=0.76). Conclusions In patients with metabolic CR at post-treatment PET, survival outcome was not influenced by the results of mid-treatment PET. Therefore, risk-adapted therapy solely based on mid-treatment PET might be inappropriate in the management of newly diagnosed DLBCL. Disclosures: No relevant conflicts of interest to declare.

What Is the Appropriate Dose Attenuation System of RCHOP for Elderly DLBCL Patients? - A Single Institutional Analysis in 115 Cosecutive Patients From Japan -

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3639-3639
Author(s):  
Akira Tanimura ◽  
Risen Hirai ◽  
Atsushi Sato ◽  
Miki Nakamura ◽  
Masataka Takeshita ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Prognostic Factors ◽  
Elderly Patients ◽  
Conflicts Of Interest ◽  
Univariate Analysis ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
B Cell Lymphoma ◽  
Age Related

Abstract Abstract 3639 Background: The combination therapy of RCHOP [rituximab (R), cyclophosphamide (CY), doxorubicin (DOX), vincristine (VCR), and prednisone (PSL)] is a standardized treatment for diffuse large B-cell lymphoma (DLBCL). However, its clinical outcome is worse in elderly patients because of comorbidities, age-related decrease in organ function, and impaired drug metabolism. If possible, the dose of RCHOP in elderly patients and patients with comorbidities should be adjusted appropriately. Since 2005, we have used a unified dose attenuation system for RCHOP according to the age and comorbidities of patients. This study retrospectively verified this system. Patients/Methods: We analyzed 115 consecutive DLBCL patients treated at our institute from September 2001, when rituximab was approved in Japan, to December 2010. From September 2001 to August 2005, 33 patients received dose adjustment of RCHOP according to the physician's discretion (PHY group). From September 2005, 82 patients received RCHOP according to the unified dose attenuation system (UNI group). In the UNI group, patients younger than 60 years received the standard RCHOP dose [R, 375 mg/m2; CY, 750 mg/m2; DOX, 50 mg/m2; VCR, 1.4 mg/m2 (max 2.0 mg/body); PSL, 100 mg/m2]. In patients older than 60 years, the doses of CY, DOX, VCR, PSL, and R were attenuated as shown in Table 1. In addition to age, the doses of CY, DOX, and VCR were adjusted according to organ functions (Table 2). The two groups were compared statistically. Results: The median age of patients was 70 years (range, 38–91), with 70.4% of patients classified as stage III or IV DLBCL, 40.4% with an international prognostic index (IPI) score of 0–2, and 70.2% with a ECOG performance status (PS) of 0 or 1. Low serum albumin levels (under normal range) were observed in 50.5% patients, and a high Charlson comorbidity index (CCI) score of >1 was found in 58.3%. The characteristics of the patients in the two groups were almost similar. The UNI system was completed in 94% of patients. The complete response (CR) rate was 63% in all patients (UNI group, 73%; PHY group, 39%; P = 0.0006). Univariate analysis revealed that better prognostic factors for CR were a low IPI score, better PS, and the UNI group. In the multivariate analysis, only the UNI group was a significantly better prognostic factor for CR. With a median follow-up of 26 months, the 5-year event-free survival (EFS) and overall survival (OS) were 39.3% and 68% in all patients, 43% and 72% in the UNI group, and 27% and 59% (5-year EFS; P = 0.0083, 5-year OS; P = 0.16) in the PHY group, respectively. Multivariate analysis showed that better prognostic factors for EFS were a low IPI score, a low CCI score, and the UNI group, and that for OS were low IPI and low CCI scores. In elderly patients aged >70 years (N = 59), the CR rates were 81% and 13% in the UNI and PHY groups, respectively (P = 0.0004), with OS in the UNI group being longer than that in the PHY group (72% vs. 59%; P = 0.02; Fig.1). In the UNI group, patient age did not affect the CR rate (<70, 71% vs. 70–79, 83% vs. >79, 79%; P = 0.56) or 5-year OS (<70, 76% vs. 70–79, 70% vs. >79, 66%; P = 0.58). The actual dose of CY, DOX, and VCR compared with the standard RCHOP dose was 64% and 26%, 63% and 16%, and 63% and 21% in the UNI and PHY groups, respectively. Disease progression during treatment, discontinuation of therapy, and death during treatment were observed in 10% and 15%, 5% and 24%, and 5% and 3% in the UNI and PHY groups, respectively. Nineteen patients (23%) from the UNI group died over a median follow-up of 15 months, while 15 patients (45%) of the PHY group died over a median follow-up period of 29 months. Lymphoma-related deaths were 12 (14%) in the UNI group and 8 (24%) in the PHY group. Five secondary primary malignancies (SPM) were observed (1 colon cancer and 1 breast cancer in the PHY group, and 1 lung cancer and 2 myelodysplastic syndrome in the UNI group). Four deaths were related to SPM. Conclusion: The unified dose attenuation system determined by the patients' age and comorbidities may achieve an effective dose level and better prognosis in elderly DLBCL patients. Disclosures: No relevant conflicts of interest to declare.

Multicenter Phase II Trial of Immunotherapy With the Humanized Anti-CD22 Antibody, Epratuzumab, in Combination With Rituximab, in Refractory or Recurrent Non-Hodgkin's Lymphoma

2006 ◽  
Vol 24 (24) ◽  
pp. 3880-3886 ◽  
Author(s):  
Sandra J. Strauss ◽  
Frank Morschhauser ◽  
Juergen Rech ◽  
Roland Repp ◽  
Philippe Solal-Celigny ◽  
...  
Keyword(s):  
Follicular Lymphoma ◽  
Hodgkin’S Lymphoma ◽  
International Prognostic Index ◽  
Objective Response ◽  
Prognostic Index ◽  
B Cell Lymphoma ◽  
Complete Response ◽  
Hodgkin's Lymphoma ◽  
Non Hodgkin’S Lymphoma ◽  
Non Hodgkin's Lymphoma

Purpose A multicenter, single-arm study examining efficacy and toxicity of epratuzumab combined with rituximab was conducted in patients with recurrent or refractory non-Hodgkin's lymphoma. Patients and Methods Sixty-five patients were enrolled; 34 patients with follicular lymphoma (FL), 15 patients with diffuse large B-cell lymphoma (DLBCL), and 16 patients with other lymphomas. The patients had received a median of two prior therapies (range, 1 to 4); 23% had received rituximab. Epratuzumab was given at 360 mg/m2 intravenously over 60 minutes followed by infusion of 375 mg/m2 rituximab, weekly for 4 consecutive weeks. Results Combination therapy was well tolerated without greater toxicity than rituximab alone. The objective response (OR) rate was 47% (30 of 64) in assessable patients (46%; 30 of 65 in all patients), being highest in FL (64%; 21 of 33) and DLBCL (47%; seven of 15), and with 24% (eight of 33) and 33% (five of 15) achieving complete response (CR) or complete response unconfirmed (CRu) in these two groups, respectively. Two of six patients with marginal zone lymphoma responded to treatment (one CR). There was a trend for the response rates to be higher in patients with low prognostic index scores (statistically significant with respect to the Follicular Lymphoma International Prognostic Index score in FL patients), with 12 FL patients and three DLBCL patients in groups 0 to 1 having OR (CR/CRu) rates of 83% (33%) and 100% (100%), respectively. The median duration of response was 16 months for FL, with five patients currently progression free for 18 months to 30 months, and 6 months for DLBCL, with two patients currently progression free for 12 months and 18 months. Conclusion Epratuzumab combined with rituximab was well tolerated, demonstrating promising antilymphoma activity that warrants additional study.

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