First-MIND: A phase Ib, open-label, randomized study to assess safety of tafasitamab (tafa) or tafa + lenalidomide (LEN) in addition to R-CHOP in patients with newly diagnosed DLBCL.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 7540-7540
Author(s):  
David Belada ◽  
Katerina Kopeckova ◽  
Juan Miguel Bergua ◽  
Marc André ◽  
Ernesto Perez Persona ◽  
...  
Keyword(s):  
Performance Status ◽  
Randomized Study ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
Dose Intensity ◽  
Newly Diagnosed ◽  
Open Label ◽  
Bulky Disease ◽  
Phase Ib ◽  
Ecog Ps

7540 Background: Tafasitamab is a humanized, Fc-modified anti-CD19 monoclonal antibody that enhances antibody-dependent cellular cytotoxicity and phagocytosis. It is FDA-approved with LEN for adult patients (pts) with relapsed/refractory (R/R) DLBCL ineligible for autologous stem cell transplantation. First-MIND (NCT04134936) is a Phase Ib, open-label, randomized study of tafa + R-CHOP or tafa + LEN + R-CHOP in newly diagnosed DLBCL. Methods: Eligible pts were ≥18 years, treatment-naïve, with histologically confirmed DLBCL not otherwise specified, international prognostic index (IPI) 2–5 and ECOG performance status (PS) 0–2. Pts with known double- or triple-hit and transformed lymphoma were excluded. Treatment (Tx) comprised six 21-day cycles of tafa (12 mg/kg IV, Day [D] 1, 8, 15) + R-CHOP (arm A) or tafa (12 mg/kg IV, D1, 8, 15) + LEN (25 mg orally, D1–10) + R-CHOP (arm B). G-CSF and VTE prophylaxis was mandatory. Primary objective is safety; secondary objectives are ORR, PET-CR rate at end of Tx, PFS, long-term safety, pharmacokinetics, immunogenicity. Results: From Dec 2019 to Aug 2020, 83 pts were screened in Europe and the US; 66 were randomized (33 per arm). Data cut-off for this analysis: 9 Dec 2020; study is ongoing. Median age was 64.5 years (range 20–86). Overall, 30% (20/66) of pts were ≥70 years and many had high-risk disease: IPI 2 29%, IPI 3 46%, IPI 4 26%. ECOG PS: 47% of pts were ECOG PS 0, 44% PS 1, 9% PS 2. Most pts had stage III/IV disease (92%); 46% had bulky disease. All pts experienced a treatment-emergent adverse event (TEAE). Grade ≥3 neutropenia and thrombocytopenia occurred in 54.5% and 12.1% (arm A) and 66.7% and 30.3% (arm B) of pts, respectively (Table). Serious TEAEs occurred in 42.4% (arm A) and 51.5% (arm B) of pts. There were three deaths, unrelated to tafa and/or LEN (sepsis, urosepsis, and COVID-19 pneumonia). R-CHOP dose intensity was maintained in both arms. Among 60 pts who completed tumor assessments after cycle 3, ORR was 89.7% (arm A) and 93.5% (arm B). Conclusions: These data suggest R-CHOP + tafa or tafa + LEN is tolerable in pts with Tx-naïve DLBCL and that R-CHOP dosing is not affected. Toxicities are similar to those expected with R-CHOP or R-CHOP + LEN. Updated safety and early efficacy data will be presented at the conference. Clinical trial information: NCT04134936. [Table: see text]

Treatment Outcome of Aggressive Lymphoma with CyclOBEAP (CHOP-Like + Etoposide and Bleomycin): Results of Multicenter Trial.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 3303-3303
Author(s):  
Masataka Okamoto ◽  
Nozomi Niitsu ◽  
Sadao Aoki ◽  
Yasunobu Kuraishi ◽  
Hirokazu Okumura ◽  
...  
Keyword(s):  
Treatment Outcome ◽  
Liver Damage ◽  
Performance Status ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
Dose Intensity ◽  
Aggressive Lymphoma ◽  
Who Grade ◽  
Bulky Disease ◽  
Total Period

Abstract Introduction: To improve treatment outcome in aggressive lymphoma, a CHOP-like regimen with added etoposide and bleomycin was studied. Patients and Methods: Between April 1997 and March 2003, 126 consecutive patients (pts) with aggressive lymphoma of low-intermediate to high risk disease according to the age adjusted International Prognostic Index (IPI), age<61 years, and performance status(ECOG)<3 were treated with CyclOBEAP. MCL and ATL/L were excluded from this study. CyclOBEAP was a weekly protocol for a total period of 12 weeks. It consisted of doxorubicin 50mg/m2 given every 2 weeks in combination with either cyclophosphamide 1,000mg/m2 (weeks 1, 5, 9) or etoposide 70mg/m2 qd x4 (weeks 3, 7, 11). During the alternative weeks non-myelosuppressive vincristine 1.4mg/m2 (max. 2.0mg/body) was given either with bleomycin 10mg/m2 (weeks 2, 6, 10) or alone (weeks 4,8,12). Prednisolone 40mg/m2 was administered daily for 14 days during weeks 1–2, 5–6, and 9–10. Protocol dose intensity relative to that of CHOP was 1.5 for DXR, VCR and 1.0 for CPA. G-CSF was prophylactically used. Pts who had had a bulky disease at presentation received 40Gy of local irradiation after chemotherapy. Results: One hundred twenty-six pts were enrolled and 5 were excluded from analysis; 3 due to change of diagnosis ( ATL/L, Hodgkin lymphoma, germ cell tumor), 1 due to PS4 and the other due to drop out. In 121 eligible pts (DLBCL 94, PTCL 11, ALCL 7, nasal NK/T 4, others 5), 7 pts did not complete the full course of the treatment because of pneumonia (3), liver damage (1), intrathoracic hemorrhage (1), and PD response at 8th week (2). Relative given dose intensity was 0.94 for DXR, 0.95 for CPA, 0.86 for VCR, 0.94 for VP16, and 0.96 for BLM. All pts were evaluated. CR (including cCR) was obtained in 106 (88%), PR in 11 and NC/PD in 4. No treatment related death was observed. With a median follow-up of 56 months, 5yr overall survival (OS) rate is 72% and progression-free survival (PFS) rate is 62%. The 5yr OS and PFS within the subgroups defined by IPI and in pts with DLBCL and PTCL are not significantly different (data shown in the table). WHO grade 4 neutropenia was observed in 91 pts and thrombocytepenia in 13 pts. 66 pts required 2 or more units of red cell transfusions (2 – 66 units). Liver damage of grade 3 to 4 was seen in 3 pts. Conclusions: Addition of etoposide and bleomycin to CHOP drugs may enhance the effect of CHOP for aggressive lymphoma, encouraging comparative study between the two treatments. n CR (%) 5yr OS 5yr PFS *OS:Log-Rank 0.578; Wilcoxson 0.616 *PFS:Log-Rank 0.552; Wilcoxson 0.573 #OS:Log-Rank 0.049; Wilcoxson 0.059 #PFS:Log-Rank 0.122; Wilcoxson 0.146 All 121 106 ( 88) 72 % 62 % IPI: L-I* 41 37 ( 90) 69 65 IPI: H-I* 62 56 ( 90) 71 55 IPI: H* 18 13 ( 72) 82 43 DLBCL# 94 82 ( 87) 70 58 PTCL# 11 11 (100) 100 82

Real-world (RW) treatment (tx) patterns and outcomes of 3,455 previously untreated mantle cell lymphoma (MCL) patients (pts) in U.S. routine clinical practice.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 7504-7504
Author(s):  
Peter Martin ◽  
Michael Wang ◽  
Anita Kumar ◽  
Keqin Qi ◽  
Katherine Daly ◽  
...  
Keyword(s):  
High Risk ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
Community Setting ◽  
Cell Transplant ◽  
Bulky Disease ◽  
Non Hodgkin Lymphoma ◽  
Community Oncology ◽  
Mantle Cell ◽  
Ecog Ps

7504 Background: MCL is a non-Hodgkin lymphoma with heterogeneous biology and outcomes. We characterized RW tx patterns and outcomes of MCL pts to identify factors associated with outcomes in the US. Methods: This retrospective study included adult MCL pts diagnosed Jan 2011-Nov 2020 in the nationwide Flatiron Health EHR-derived deidentified database. Pt characteristics, tx patterns, time to next tx (rwTTNT, defined as start of first-line [1L] tx to subsequent tx or death) and rwOS were evaluated. Results: 3455 pts were included, 85.3% from a community oncology setting. In 2946 (85.2%) pts with documented 1L MCL tx, median age was 69.5 y (range 27.7-85.3); 9.5% had blastoid/pleomorphic MCL. 262 (39.6%) and 235 (35.6%) of 661 pts with available MCL international prognostic index (MIPI) had intermediate and high risk, respectively. 150/1253 pts (12.0%) with available ECOG PS had PS ≥ 2. Chemoimmunotherapy was the most common 1L tx, including BR in 1223 (41.5%), R-CHOP in 512 (17.4%) and cytarabine (ara-C)-containing tx in 414 (14.1%). 667 pts received R maintenance (MR). In 1036 pts < 65 y, 243 pts received 1L stem cell transplant (SCT), mainly autologous. In 1L-treated pts, with median follow-up of survivors of 45.3 mos (range 0.03-117.2), median rwTTNT was 24 mos; 36-mo rwOS was 67%. The Table shows tx received and outcomes by age and SCT status. MVA analyses showed age ≥ 65 y, ECOG PS ≥ 2, LDH/ULN ≥ 1, WBC ≥ 10 × 109/L, bulky disease (≥ 5 cm) and blastoid/pleomorphic morphology were associated with shorter rwTTNT and rwOS; MR was independently associated with longer rwTTNT and rwOS. In pts < 65 y who were alive and did not initiate subsequent tx within 6 mos of 1L tx (“SCT-eligible”), 36-mo rwTTNT and rwOS were similar between pts treated with vs without SCT: 65% vs 59% and 86% vs 85%, respectively. Conclusions: In this large RW cohort of primarily community-based US practices, median 1L rwTTNT for MCL pts was ̃ 2 y. BR was the most commonly used 1L tx. SCT was uncommon even in pts < 65 y, suggesting RW considerations may influence SCT eligibility and availability. Also, SCT was not clearly associated with rwOS. As with other reports, older age and high-risk disease features were predictive of worse outcome in RW, while MR appeared to be associated with better outcomes. Outcomes across the board appear worse than prospective trials, suggesting a need to focus on developing tx that can be delivered effectively in the community setting.[Table: see text]

The MYOCAN Study. A Phase II Study of Cyclophosphamide, Oncovin, Myocet™, and Prednisone Plus Rituximab (R-COMP) in the Treatment of Elderly Patients with Diffuse Large B-Cell Non-Hodgkin Lymphoma (DLBCL).

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 4586-4586 ◽  
Author(s):  
Massimo Federico ◽  
Martin J.S. Dyer ◽  
Maria Dolores Caballero ◽  
Claire Reilly ◽  
Eckhard Thiel
Keyword(s):  
Elderly Patients ◽  
Phase Ii ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
Pegylated Liposomal Doxorubicin ◽  
Dose Intensity ◽  
Complete Response ◽  
Open Label ◽  
Dlbcl Patient ◽  
Grade 3

Abstract BACKGROUND: For more than 20 years, CHOP has been the gold standard treatment for patients with aggressive NHL. The addition of rituximab to this regimen has been shown to improve outcomes in elderly patients with advanced (Coiffier et al NEJM2002; 346:235–42). However, CHOP is often poorly tolerated by elderly patients resulting in dose reductions and consequently lower response and cure rates compared to younger patients. Myocet™ (non-pegylated liposomal doxorubicin) has an improved pharmacokinetic profile with less myelosuppression and GI toxicity and has a reduced risk of cardiotoxicity at dose levels equivalent to standard formulations of doxorubicin. METHODS: In this phase II, open label, 2-stage study, we replaced the conventional doxorubicin with Myocet™ to evaluate the response rate and safety of the R-COMP regimen (rituximab, cyclophosphamide, vincristine, Myocet™, prednisone). Previously untreated, elderly patients (≥60 yrs) with CD20+ newly diagnosed, advanced DLBCL were treated every 3 weeks with: Myocet™ 50mg/m2, cyclophosphamide 750mg/m2, vincristine 1.4 mg/m2 (max. 2mg), rituximab 375 mg/m2 (day 3 on cycle 1, day 1 thereafter) and prednisone 100mg/d d1–5 for 8 cycles. Response was assessed after 3 and 8 cycles. RESULTS: Thirty patients were enrolled in stage 1 of the study with a median age of 72 (range 61–82). At baseline 17 (56%) patients had stage III–IV disease; 60% had an intermediate or high risk (2+) International Prognostic Index score and the median LVEF was 59% (range 50–75). A total of 198 cycles of chemotherapy were given, with a median of 8 cycles (range 1–8). Of the 198 cycles administered 15 (8%) were delayed by haematological or hepatic toxicity for a median of 7 days (range 0 to 25). The relative dose intensity for the regimen was 87%, for Myocet™ it was 84%. Toxicity was mainly haematological with grade 3 or 4 neutropenia in 29% of cycles and febrile neutropenia in 4%. There was no grade 3 or 4 vomiting and a low incidence of grade 1 or 2 vomiting (3%). At the last observation the median LVEF was 55% (range 40–76), 16 patients had no change or an improved LVEF and 13 patients had a reduced LVEF. In the cohort of 24 patients evaluable for response, 15 (63%) had a complete response and an additional 7 (29%) achieved a partial response. CONCLUSIONS: These interim results suggest R-COMP is a well tolerated regimen with promising response rates in elderly patients with advanced DLBCL. Patient recruitment continues in stage 2 of the study with the aim of enrolling a total of 75 patients with a 2-year follow-up.

IPI and R-IPI in Korean DLBCL Patients Treated with R-CHOP.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4481-4481
Author(s):  
Sung-Hwa Bae ◽  
Hun-Mo Ryoo ◽  
Min Kyoung Kim ◽  
Kyung Hee Lee ◽  
Myung Soo Hyun ◽  
...  
Keyword(s):  
International Prognostic Index ◽  
Prognostic Index ◽  
B Cell Lymphoma ◽  
P Value ◽  
Newly Diagnosed ◽  
Chop Chemotherapy ◽  
Large B Cell Lymphoma ◽  
Estimated Risk ◽  
Extranodal Disease ◽  
Ecog Ps

Abstract Background: The addition of rituximab to CHOP chemotherapy (R-CHOP) has resulted in a marked improvement in outcome for patients with diffuse large B cell lymphoma (DLBCL). The previously estimated risk factors needed to be re-evaluated in immunochemotherapy era. Shen et al. (Blood109:1857–61, 2007) reported that a revised (R) international prognostic index (IPI) provided a more clinically relevant prediction of outcome than IPI. To assess the applicability of IPI and R-IPI in unselected Korean DLBCL patients, we conducted this study. Methods: We performed a retrospective analysis of patients with newly diagnosed DLBCL treated with R-CHOP to assess the value of the IPI and R-IPI. Results: From January 2004 to July 2006, 113 newly diagnosed DLBCL patients from four Korean institutes were included. Patients characteristics were: median age 54 y (range: 14–83), male 62.8%, extranodal disease 54.9%, age greater than 60y 40.7%, ECOG PS greater than 2 10.6%, elevated LDH 46.9%, more than 1 extranodal sites 17.7%, stage III/IV 40.7%. The 3 year EFS rate was 60.2% and the 3 year OS rate was 66.7%. Estimated 3 year EFS and OS according to IPI were described in the table. Conclusions: The IPI score as well as R-IPI was an important prognostic parameter in unselected Korean DLBCL patients treated with R-CHOP. No of Pt 3 year EFS (%) p-value 3 year OS (%) p-value No of IPI <0.001 0.001 0 22 78.6 83.3 1 40 71.8 81.9 2 28 59.3 61.8 3 16 36.5 42.4 4 6 16.7 22.8 5 1 0 0 IPI <0.001 <0.001 Low 62 74.7 82.8 Low intermediate 28 79.3 61.8 High intermediate 16 36.5 42.4 High 7 14.3 16.7 R-IPI <0.001 0.008 Very good 22 78.6 83.3 Good 68 65.8 71.6 Poor 23 28.1 34.9

scholarly journals Phase IB/II Randomized Study of FOLFIRINOX Plus Pegylated Recombinant Human Hyaluronidase Versus FOLFIRINOX Alone in Patients With Metastatic Pancreatic Adenocarcinoma: SWOG S1313

2019 ◽  
Vol 37 (13) ◽  
pp. 1062-1069 ◽  
Author(s):  
Ramesh K. Ramanathan ◽  
Shannon L. McDonough ◽  
Philip A. Philip ◽  
Sunil R. Hingorani ◽  
Jill Lacy ◽  
...  
Keyword(s):  
Phase Ii ◽  
Performance Status ◽  
Randomized Study ◽  
Dose Finding ◽  
Open Label ◽  
Phase Ib ◽  
Metastatic Pancreatic Adenocarcinoma ◽  
Finding Study ◽  
Grade 3 ◽  
Recombinant Human Hyaluronidase

PURPOSE Pegylated recombinant human hyaluronidase (PEGPH20) degrades hyaluronan (HA) and, in combination with chemotherapy, prolongs survival in preclinical models. The activity of PEGPH20 with modified fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFIRINOX) was evaluated in patients with metastatic pancreatic cancer (mPC). MATERIALS AND METHODS Patients had untreated mPC, a performance status of 0 to 1, and adequate organ function. Tumor HA status was not required for eligibility. After a phase Ib dose-finding study of mFOLFIRINOX plus PEGPH20, the phase II open-label study randomly assigned patients (1:1) to the combination arm or to mFOLFIRINOX alone (n = 138). The primary end point was overall survival (OS). RESULTS PEGPH20 dosages of 3 µg/kg every 2 weeks were more tolerable than twice-weekly dosages used in the phase I study, so 3 µg/kg every 2 weeks was the phase II dosage. An amendment instituted enoxaparin prophylaxis in the PEGPH20 combination arm as a result of increased thromboembolic (TE) events. The planned interim futility analysis when 35 deaths (of 103 analyzable patients) occurred resulted in an OS hazard ratio (HR) of 2.07 that favored the control arm, and the study was closed to accrual. The treatment-related grade 3 to 4 toxicity was significantly increased in the PEGPH20 combination arm relative to control (odds ratio, 2.7; 95% CI, 1.1 to 7.1). The median OS in the mFOLFIRINOX arm was 14.4 months (95% CI, 10.1 to 15.7 months) versus 7.7 months (95% CI, 4.6 to 9.3 months) in the PEGPH20 combination arm. CONCLUSION Addition of PEGPH20 to mFOLFIRINOX seems to be detrimental in patients unselected for tumor HA status. This combination caused increased toxicity (mostly GI and TE events) and resulted in decreased treatment duration compared with mFOLFIRINOX alone. The median OS in the mFOLFIRINOX control arm (14.4 months) is, to our knowledge, the longest yet reported and can be considered for patients with good PS.

A phase Ib dose-escalation study of eribulin mesylate in combination with capecitabine in patients with advanced/metastatic cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 2552-2552 ◽  
Author(s):  
Muhammad Yaser Nasim ◽  
Ruth Plummer ◽  
T.R. Jeffry Evans ◽  
Rosemary Morrison ◽  
David Alan Anthoney ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Dose Escalation ◽  
Metastatic Cancer ◽  
Performance Status ◽  
Metastatic Breast ◽  
Dose Intensity ◽  
Open Label ◽  
Eribulin Mesylate ◽  
Dose Escalation Study ◽  
Phase Ib

2552 Background: Eribulin mesylate is a microtubule dynamics inhibitor approved by FDA for patients (pts) with metastatic breast cancer after treatment with at least two prior chemotherapeutic regimens. This Phase Ib, open-label dose-escalation study determined the maximum tolerated dose (MTD) of eribulin in combination with capecitabine. Methods: Pts with advanced solid malignancies refractory to standard therapies, adequate organ function and ECOG performance status ≤2 received eribulin mesylate (2–5-min IV) by Schedule 1 (1.2, 1.6 or 2.0 mg/m2 on Day 1) or Schedule 2 (0.7, 1.1 or 1.4 mg/m2 on Days 1 and 8), in combination with twice-daily oral capecitabine 1000 mg/m2 Days 1-14 every 21 days. The MTD was defined as the highest dose in each schedule where ≤1/6 pts experienced dose-limiting toxicity (DLT). Safety and pharmacokinetics (PK) were assessed. Results: Of the 34 pts recruited, 19 (53% male; median age 62 years; 42% ECOG 0, 58% ECOG 1) and 15 (33% male; median age 61 years; 33% ECOG 0, 60% ECOG 1, 7% ECOG 2) were enrolled in Schedules 1 and 2, respectively. Most common tumor types were large intestine (20.6%), lung/bronchus (17.7%) and breast (14.7%). DLTs are shown in the table; there were no unexpected toxicities with the combination. The MTD for eribulin mesylate was 1.6 and 1.4 mg/m2 for Schedules 1 and 2, respectively, in combination with capecitabine 1000 mg/m2 twice-daily. Eribulin PK were dose proportional and independent of schedule or capecitabine co-administration. Combination with eribulin had no effect on the disposition of capecitabine and its metabolites. Although sample size was small, preliminary signs of efficacy were observed. Conclusions: The combination of eribulin and capecitabine was well tolerated with no unexpected safety findings. Schedule 2 MTD (1.4 mg/m2 Days 1 and 8) delivered a higher dose intensity of eribulin than Schedule 1 and was selected for evaluation in an ongoing Phase II breast cancer study. [Table: see text]

scholarly journals Clinical characteristics and outcomes of primary versus secondary gastrointestinal mantle cell lymphoma

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Alessia Castellino ◽  
Aung M. Tun ◽  
Yucai Wang ◽  
Thomas M. Habermann ◽  
Rebecca L. King ◽  
...  
Keyword(s):  
Mantle Cell Lymphoma ◽  
Cell Lymphoma ◽  
Performance Status ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
Local Therapy ◽  
Progression Free Survival ◽  
Cell Transplant ◽  
Multiple Lesions ◽  
Mantle Cell

AbstractPrimary gastrointestinal (GI) mantle cell lymphoma (MCL) is rare and the optimal management is unknown. We reviewed 800 newly diagnosed MCL cases and found 22 primary (2.8%) and 79 (9.9%) secondary GI MCL cases. Age, sex, and performance status were similar between primary and secondary cases. Secondary cases had more elevations in lactate dehydrogenase (28% vs 0%, P = 0.03) and a trend for a higher MCL international prognostic index (P = 0.07). Observation or local therapy was more common for primary GI MCL (29% vs 8%, P < 0.01), and autologous stem-cell transplant was more common for secondary GI MCL (35% vs 14%, P < 0.05). The median follow-up was 85 months. Primary and secondary GI MCL had similar 5-year progression-free survival (PFS) (30% vs 28%, P = 0.59) and overall survival (OS) (65% vs 66%, P = 0.83). The extent of GI involvement in primary GI MCL affected treatment selection but not outcome, with a 5-year PFS of 43% vs 14% vs 31% (P = 0.48) and OS of 57% vs 71% vs 69% (P = 0.54) in cases with single lesion vs multiple lesions in 1 organ vs multiple lesions in ≥2 organs. Less aggressive frontline treatment for primary GI MCL is reasonable. It is unknown whether more aggressive treatment can result in improved outcomes.

Randomized Comparison of ACVBP and m-BACOD in the Treatment of Patients With Low-Risk Aggressive Lymphoma: The LNH87-1 Study

2000 ◽  
Vol 18 (6) ◽  
pp. 1309-1315 ◽  
Author(s):  
Hervé Tilly ◽  
Nicolas Mounier ◽  
Pierre Lederlin ◽  
Josette Brière ◽  
Brigitte Dupriez ◽  
...  
Keyword(s):  
Group Performance ◽  
Remission Rate ◽  
Performance Status ◽  
International Prognostic Index ◽  
Eastern Cooperative Oncology Group ◽  
Prognostic Index ◽  
Tumor Burden ◽  
Low Risk ◽  
Aggressive Lymphoma ◽  
Standard Regimen

PURPOSE: To compare a short intensified regimen followed by sequential consolidation therapy (doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone [ACVBP]) to the standard regimen of methotrexate, bleomycin, cyclophosphamide, and etoposide (m-BACOD) in patients with low-risk aggressive lymphoma. PATIENTS AND METHODS: A total of 752 patients with intermediate- or high-grade lymphoma and no adverse prognostic factors (Eastern Cooperative Oncology Group performance status of 2 to 4, ≥ two extranodal sites of disease, tumor burden ≥ 10 cm in largest dimension, bone marrow or CNS involvement, Burkitt’s or lymphoblastic subtypes) were registered. Of 673 eligible patients, 332 received ACVBP and 341 received m-BACOD. RESULTS: The complete remission rate was identical (86%) in the two groups. With a median follow-up duration of 7 years, the 5-year failure-free survival (FFS) rate was 65% in the ACVBP group and 61% in the m-BACOD group (P = .16). The 5-year overall survival rate was 75% in the ACVBP group and 73% in the m-BACOD group (P = .47). ACVBP was responsible for more severe and life-threatening infections (P < .01), but m-BACOD caused more pulmonary toxicity (P < .001). The number of treatment-related deaths did not differ between the two regimens. A multivariate analysis indicated that ACVBP was associated with a longer FFS in patients with two or three risk factors of the International Prognostic Index. CONCLUSION: In this population of patients with low-risk aggressive lymphoma, toxicities of the regimens are different, but the rates of response and survival are identical. The survival advantage of ACVBP over standard regimen in patients with advanced disease is suggested by this analysis but remains to be assessed in prospective studies specifically designed for this purpose.

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