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.

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.

Waldeyer's Ring Marginal Zone B-Cell Lymphoma: Which Is Their Clinical and Prognostic Feature, Nodal or Extranodal?

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 5084-5084
Author(s):  
Sung Yong Oh ◽  
Won Seog Kim ◽  
Jin Seok Kim ◽  
Seok Jin Kim ◽  
Suee Lee ◽  
...  
Keyword(s):  
Conflicts Of Interest ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
Progression Free Survival ◽  
B Cell Lymphoma ◽  
Stage I ◽  
Female Ratio ◽  
Additional Information ◽  
Waldeyer’S Ring ◽  
Ann Arbor

Abstract Abstract 5084 Background: Waldeyer's ring (WR) is circular band of lymphoid tissue located at the opening of the respiratory and digestive tract. There is controversy as to whether WR should be considered as a nodal or extranodal site. In this study, we conducted retrospective analyses of WR involving MZLs (WR-MZLs) to identify their clinical features, treatment, prognosis- favor nodal or extranodal. And we want to get additional information about specific organ relationship between WR-MZL and other MALT sites. Patients and Methods: From 1987 to 2010, 124 patients who were histologically confirmed as a MZL arising from head and neck (H&N) area was including WR (47 patients) were reviewed. Primary orbit and ocular adnexa MZL patient was excluded this data collection. Results: The male/female ratio of the 47 patients was 23 to 24. The median age was 53 years (range, 17–77). The commonly involving sites were tonsil (53.2%) followed by nasopharyn (40.4%). Fourteen patients (29.7%) were accompanied with extra-WR area MALT site- gastrointestinal tract (14.9%), ocular and adnexa (12.8%). Ann Arbor stage I/II disease was present in 50% (23 out of 46). Thirty-nine patients were categorized into the low/low-intermediate risk group (84.8%) according to International Prognostic Index (IPI). Complete and partial remissions were achieved in 18 (78.3%) and 2 (8.7%) of the 23 stage I/II patients. In 23 patients with stage III/IV, CR and PR were achieved in 15 (65.2%) and 4 (17.4%), respectively. The median progression-free survival (PFS) was 3.6 years (95% CI, 2.4–4.8 years). The estimated 5-year overall survival (OS) was 88%. Compared with H&N MALT site MZLs, WR-MZLs were significantly poor in PFS and OS (P=0.005 and P=0.007). Conclusion: WR-MZLs were also an indolent disease like general MZL. But, WR-MZL patients presented with more advanced stage and poorer survivals than other site H&N MZL patients. Therefore, even though WR has been considered histologically extranodal MALT organ, clinically it is closer to nodal MZL. Disclosures: No relevant conflicts of interest to declare.

Combination of Rituximab, Bendamustine, and Cytarabine for Patients With Mantle-Cell Non-Hodgkin Lymphoma Ineligible for Intensive Regimens or Autologous Transplantation

2013 ◽  
Vol 31 (11) ◽  
pp. 1442-1449 ◽  
Author(s):  
Carlo Visco ◽  
Silvia Finotto ◽  
Renato Zambello ◽  
Rossella Paolini ◽  
Andrea Menin ◽  
...  
Keyword(s):  
International Prognostic Index ◽  
Autologous Transplantation ◽  
Prognostic Index ◽  
Progression Free Survival ◽  
Response Duration ◽  
Complete Response ◽  
Maximum Tolerated Dose ◽  
Non Hodgkin Lymphoma ◽  
Positron Emission ◽  
Mantle Cell

Purpose The combination of bendamustine (B) and rituximab (R) is efficacious, with favorable toxicity in mantle-cell lymphoma (MCL). In this phase II study, we combined cytarabine with R and B (R-BAC) in patients with MCL age ≥ 65 years who were previously untreated or relapsed or refractory (R/R) after one prior immunochemotherapy treatment. Patients and Methods In stage one, we established the maximum-tolerated dose (MTD) of cytarabine in R-BAC. In stage two, patients received R (375 mg/m2 intravenously [IV] on day 1), B (70 mg/m2 IV on days 2 and 3), and cytarabine (MTD IV on days 2 to 4) every 28 days for four to six cycles. The primary end point (overall response rate [ORR]) was evaluated by positron emission tomography. Secondary end points included safety, progression-free survival (PFS), response duration, and overall survival. Results Forty patients (median age, 70 years; 20 previously untreated patients) were enrolled; 93% had Ann Arbor stage III/IV disease; 49% had high Mantle Cell International Prognostic Index scores, with 15% blastoid histology. All R/R patients (35% refractory) had previously received R-containing regimens. The cytarabine MTD used in stage two was 800 mg/m2, and R-BAC was well tolerated, with an 85% treatment completion rate. The major toxicity was transient grades 3 to 4 thrombocytopenia (87% of patients); febrile neutropenia occurred in 12%. The ORR was 100% (95% complete response [CR]) for previously untreated and 80% (70% CR) for R/R patients. The 2-year PFS rate (± standard deviation) was 95% ± 5% for untreated and 70% ± 10% for R/R patients. Conclusion R-BAC is well tolerated and active against MCL.

scholarly journals End-of-treatment PET/CT predicts PFS and OS in DLBCL after first-line treatment: results from GOYA

2021 ◽  
Vol 5 (5) ◽  
pp. 1283-1290
Author(s):  
Lale Kostakoglu ◽  
Maurizio Martelli ◽  
Laurie H. Sehn ◽  
David Belada ◽  
Angelo-Michele Carella ◽  
...  
Keyword(s):  
International Prognostic Index ◽  
Prognostic Index ◽  
Progression Free Survival ◽  
B Cell Lymphoma ◽  
Complete Response ◽  
Published Data ◽  
Cell Of Origin ◽  
Term Survival ◽  
Entire Cohort ◽  
End Of Treatment

AbstractGOYA was a randomized phase 3 study comparing obinutuzumab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) vs standard-of-care rituximab plus CHOP in patients with previously untreated diffuse large B-cell lymphoma (DLBCL). This retrospective analysis of GOYA aimed to assess the association between progression-free survival (PFS) and overall survival (OS) with positron emission tomography (PET)–based complete response (CR) status. Overall, 1418 patients were randomly assigned to receive 8 21-day cycles of obinutuzumab (n = 706) or rituximab (n = 712) plus 6 or 8 cycles of CHOP. Patients received a mandatory fluoro-2-deoxy-d-glucose–PET/computed tomography scan at baseline and end of treatment. After a median follow-up of 29 months, the numbers of independent review committee–assessed PFS and OS events in the entire cohort were 416 (29.3%) and 252 (17.8%), respectively. End-of-treatment PET CR was highly prognostic for PFS and OS according to Lugano 2014 criteria (PFS: hazard ratio [HR], 0.26; 95% confidence interval [CI], 0.19-0.38; P < .0001; OS: HR, 0.12; 95% CI, 0.08-0.17; P < .0001), irrespective of international prognostic index score and cell of origin. In conclusion, the results from this prospectively acquired large cohort corroborated previously published data from smaller sample sizes showing that end-of-treatment PET CR is an independent predictor of PFS and OS and a promising prognostic marker in DLBCL. Long-term survival analysis confirmed the robustness of these data over time. Additional meta-analyses including other prospective studies are necessary to support the substitution of PET CR for PFS as an effective and practical surrogate end point. This trial was registered at www.clinicaltrials.gov as #NCT01287741.

Polatuzumab vedotin (Pola) + rituximab (R) + lenalidomide (Len) in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): Primary analysis of a phase 1b/2 trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 7512-7512
Author(s):  
Catherine S. Magid Diefenbach ◽  
Pau Abrisqueta ◽  
Eva Gonzalez-Barca ◽  
Carlos Panizo ◽  
Jose Maria Arguinano Perez ◽  
...  
Keyword(s):  
International Prognostic Index ◽  
Unmet Need ◽  
Prognostic Index ◽  
Progression Free Survival ◽  
B Cell Lymphoma ◽  
Complete Response ◽  
Primary Analysis ◽  
Phase 1B ◽  
The Impact ◽  
Cutoff Date

7512 Background: The combination of Pola-R-Len may enhance anti-tumor response in R/R DLBCL. We report the primary analysis of the R/R DLBCL cohort in a Phase 1b/2 study (GO29834; NCT02600897). Methods: Pts received induction with 6 x 28-Day (D) cycles (C) of: Pola 1.8mg/kg intravenous (IV; C1−6: D1); R 375mg/m2 IV (C1−6: D1) and oral Len 10–20mg (dose escalation) or recommended Phase 2 dose (RP2D) daily on D1–21. Pts with a response at end of induction (EOI) received 6 months (mo) consolidation with R 375mg/m2 (D1 every 2 mo) and Len 10mg (D1–21 monthly). Primary endpoints were safety/tolerability and positron emission tomography (PET)-complete response (CR) rate at EOI by independent review committee (IRC) by modified Lugano criteria. Results: At primary analysis (Sep 08, 2020), 57 pts were enrolled. Median age was 71 years (range 28–92); male (67%); Ann Arbor Stage III–IV (86%); International Prognostic Index 3–5 (60%); median 2 prior therapies; prior bone marrow transplant (11%); prior CAR-T therapy (5%); primary refractory (49%) and refractory to last therapy (65%). Grade 3–4 adverse events (AEs) were experienced by 75% of pts, most commonly, neutropenia (58%), thrombocytopenia (14%), infections (14%) and anemia (11%). AEs led to Len dose reduction in 25% and interruption in 63% of pts. One Grade 5 treatment-related AE (neutropenic sepsis) was reported. In total, 49 pts were treated at RP2D (Pola 1.8mg/kg + Len 20mg). IRC PET-CR rate at EOI was 29% (Table). A best overall response (BOR) assessed by investigator (INV) was seen in 36/49 (74%) pts with 17/49 (35%) pts achieving a CR; of these, 14/17 (82%) remain in remission at the cutoff date. Median duration of response (DOR) was 8.1 mo (95% confidence interval [CI]: 4.7–not evaluable [NE]). After a median follow-up of 9.7 mo, median progression-free survival (PFS) and overall survival (OS) were 6.3 mo (95% CI: 4.5–9.7) and 10.9 mo (95% CI: 7.4–NE), respectively. Conclusions: Our study of the novel triplet combination, Pola-R-Len, demonstrates a tolerable safety profile. This first efficacy report of Pola-R-Len shows promising activity in a difficult-to-treat R/R DLBCL population, particularly in pts achieving CR, a large proportion of whom remain in remission at the cutoff date. Further evaluation of Pola-R-Len and the impact of consolidation therapy is warranted to address the significant unmet need in this patient population. Clinical trial information: NCT02600897. [Table: see text]

Pooled Analysis of Aids-Malignancy Consortium (AMC) Trials Evaluating Rituximab Plus Either CHOP or Infusional EPOCH Chemotherapy In HIV-Associated Non-Hodgkin's Lymphoma

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 1797-1797
Author(s):  
Stefan K Barta ◽  
Jeannette Y Lee ◽  
Joseph A Sparano ◽  
Lawrence D Kaplan ◽  
Ariela Noy
Keyword(s):  
Conflicts Of Interest ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
B Cell Lymphoma ◽  
Complete Response ◽  
Pooled Analysis ◽  
Cd4 Count ◽  
Phase Iii ◽  
Increased Risk ◽  
Count Table

Abstract Abstract 1797 Background: Two consecutively performed randomized studies by the AMC evaluating chemoimmunotherapy for the treatment of HIV-associated NHL include AMC010 (Kaplan LD et al, Blood 2005: concurrent Rituximab [R] + CHOP vs. CHOP, N=150) and AMC034 (Sparano JA et al, Blood 2010: concurrent R+EPOCH vs. Sequential EPOCH → R; N=106). In AMC010, the addition of Rituximab to CHOP was associated with an increased risk of infectious death (15% vs. 2%, p=0.04) without a significant improvement in complete response (CR) rate (58% vs.47%; p=0.15), event free survival (EFS), or overall survival (OS). In AMC034, the CR rate met its primary efficacy endpoint in the concurrent arm (73%; 95% confidence intervals [CI] 58%, 85%) but not the sequential arm (55%; 95% CI 41%, 68%). Methods: We performed a pooled analysis of these two consecutive trials including patients treated with R-CHOP and concurrent R-EPOCH in order to determine the influence of the age-adjusted International Prognostic Index (aaIPI), CD4 count (< 100/uL vs. ≥ 100/uL), and treatment (CHOP vs. EPOCH) as variables on outcomes EFS, OS and CR. Results: The characteristics and outcomes of the study populations are shown in table 1. Patients treated with R-EPOCH tended to have better outcomes in both the low and high risk IPI groups. In a multivariate analysis that included pooled data from both consecutive studies, features that were significantly associated with improved EFS, OS, and CR rate included low aaIPI score and baseline CD4 count of at least 100/ul. Additionally patients treated with concurrent R-EPOCH exhibited improved EFS and OS even when adjusted for prognostic covariates including aaIPI score and CD4 count (table 2). Conclusions: These findings suggest that treatment outcomes may be superior with concurrent R-EPOCH compared with R-CHOP, and support the design of an ongoing phase III trial comparing concurrent R-EPOCH with R-CHOP in immunocompetent patients with diffuse, large B-cell lymphoma (NCT00118209). This analysis provides additional level 2 evidence supporting the use of concurrent R-EPOCH in patients with HIV-associated lymphoma. Acknowledgments: This study is presented on behalf of the AIDS Malignancy Consortium. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Does Neutrophil to Lymphocyte Ratio (NLR) Predict the Prognosis of Diffuse Large B-Cell Lymphoma?

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 5402-5402
Author(s):  
Aya Nakaya ◽  
Shinya Fujita ◽  
Atsushi Satake ◽  
Takahisa Nakanishi ◽  
Yoshiko Azuma ◽  
...  
Keyword(s):  
De Novo ◽  
Medical Center ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
Progression Free Survival ◽  
B Cell Lymphoma ◽  
University Hospital ◽  
Aggressive Lymphoma ◽  
Prognostic Impact ◽  
Medical University

Abstract Background: The international prognostic index(IPI) was widely used to predict aggressive lymphoma patients' outcome and to choose the best therapeutic treatment. However, this scale is unsatisfactory in identifying patients who would receive best benefit from rituximab containing regimens. Recently, NLR has been recognized as a poor prognostic indicator in various solid tumors. Here we quantify the prognostic impact of NLR in de novo DLBCL patients. However, various studies of the usefulness of the NLR have used different cut-off values, and the methods of selecting these NLR cut-offs were unclear. Therefore, we verify the adaptive cut-off value. Methods: We retrospectively analyzed 543 patients with de novo DLBCL who diagnosed at Kansai Medical University Hospital and Kansai Medical University Medical Center from January 2003 to December 2017. The prognostic value of NLR at diagnosis was assessed. We put the cut-off of NLR; 3, 4, 5, 6, and evaluate which the most predictive cut-off value is. Results: The median age was 69(20-95) years old, and male was 59%. The Ann Arbor stage III and IV was 60%. The proportion of patients with IPI, Low, Low-intermediate, High-intermediate, High was 36%, 19%, 21%, 24%, respectively. The optimal cutoff for NLR was 6. NLR(6) was associated with overall survival(OS)(HR 1.76, 95%CI: 1.23-2.51, p= 0.002) and progression free survival(PFS) (HR 2.66, 95%CI: 1.65-4.28, p<0.001), either. Multivariate analysis identified NLR(6) remained as a significant factor affecting PFS (hazard ratio: 1.53, 95%CI: 1.02-2.29, p=0.041). Conclusion: Our result revealed that the optimal cut-off for NLR was 6. NLR predicted both OS and PFS of the patients with de novo DLBCL. NLR is a simple and useful scale and it might be a useful marker for prediction of patients' survival or disease progression in patients with de novo DLBCL. Disclosures Ito: Mundipharma: Honoraria; Celgene: Honoraria; Bristol-Myers Squibb: Honoraria, Research Funding; Novartis Pharma: Honoraria; Takeda: Honoraria; Pfizer: Honoraria.

Retrospective Analysis of Intravascular Large B-Cell Lymphoma Treated With Rituximab-Containing Chemotherapy As Reported by the IVL Study Group in Japan

2008 ◽  
Vol 26 (19) ◽  
pp. 3189-3195 ◽  
Author(s):  
Kazuyuki Shimada ◽  
Kosei Matsue ◽  
Kazuhito Yamamoto ◽  
Takuhei Murase ◽  
Naoaki Ichikawa ◽  
...  
Keyword(s):  
B Cell ◽  
Cell Lymphoma ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
Progression Free Survival ◽  
B Cell Lymphoma ◽  
Complete Response ◽  
Chemotherapy Group ◽  
Large B Cell Lymphoma ◽  
Large B Cell

Purpose To evaluate the safety and efficacy of rituximab-containing chemotherapies for intravascular large B-cell lymphoma (IVLBCL). Patients and Methods We retrospectively analyzed 106 patients (59 men, 47 women) with IVLBCL who received chemotherapy either with rituximab (R-chemotherapy, n = 49) or without rituximab (chemotherapy, n = 57) between 1994 and 2007 in Japan. The median patient age was 67 years (range, 34 to 84 years). The International Prognostic Index was high-intermediate/high in 97% of patients. Results The complete response rate was higher for patients in the R-chemotherapy group (82%) than for those in the chemotherapy group (51%; P = .001). The median duration of follow-up for surviving patients was 18 months (range, 1 to 95 months). Progression-free survival (PFS) and overall survival (OS) rates at 2 years after diagnosis were significantly higher for patients in the R-chemotherapy group (PFS, 56%; OS, 66%) than for patients in the chemotherapy group (PFS, 27% with P = .001; OS, 46% with P = 0.01). Multivariate analysis revealed that the use of rituximab was favorably associated with PFS (hazard ratio [HR], 0.45; 95% CI, 0.25 to 0.80; P = .006) and OS (HR, 0.42; 95% CI, 0.21 to 0.85; P = .016). Treatment-related death was observed in three patients (6%) who received R-chemotherapy and in five patients (9%) who received chemotherapy. Conclusion Our data suggest improved clinical outcomes for patients with IVLBCL in the rituximab era. Future prospective studies of rituximab-containing chemotherapies are warranted.

scholarly journals Short regimen of rituximab plus lenalidomide in follicular lymphoma patients in need of first-line therapy

Blood ◽  
2019 ◽  
Vol 134 (4) ◽  
pp. 353-362 ◽  
Author(s):  
Emanuele Zucca ◽  
Stephanie Rondeau ◽  
Anna Vanazzi ◽  
Bjørn Østenstad ◽  
Ulrich J. M. Mey ◽  
...  
Keyword(s):  
Follicular Lymphoma ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
Progression Free Survival ◽  
Complete Response ◽  
Clinical Cancer Research ◽  
International Prognostic Index Score ◽  
First Line Therapy ◽  
Phase 2 Trial ◽  
Grade 3

Abstract The SAKK 35/10 phase 2 trial, developed by the Swiss Group for Clinical Cancer Research and the Nordic Lymphoma Group, compared the activity of rituximab vs rituximab plus lenalidomide in untreated follicular lymphoma patients in need of systemic therapy. Patients were randomized to rituximab (375 mg/m2 IV on day 1 of weeks 1-4 and repeated during weeks 12-15 in responding patients) or rituximab (same schedule) in combination with lenalidomide (15 mg orally daily for 18 weeks). Primary end point was complete response (CR)/unconfirmed CR (CRu) rate at 6 months. In total, 77 patients were allocated to rituximab monotherapy and 77 to the combination (47% poor-risk Follicular Lymphoma International Prognostic Index score in each arm). A significantly higher CR/CRu rate at 6 months was documented in the combination arm by the investigators (36%; 95% confidence interval [CI], 26%-48% vs 25%; 95% CI, 16%-36%) and confirmed by an independent response review of computed tomography scans only (61%; 95% CI, 49%-72% vs 36%; 95% CI, 26%-48%). After a median follow-up of 4 years, significantly higher 30-month CR/CRu rates and longer progression-free survival (PFS) and time to next treatment (TTNT) were observed for the combination. Overall survival (OS) rates were similar in both arms (≥90%). Toxicity grade ≥3 was more common in the combination arm (56% vs 22% of patients), mainly represented by neutropenia (23% vs 7%). Addition of lenalidomide to rituximab significantly improved CR/CRu rates, PFS, and TTNT, with expected higher, but manageable toxicity. The excellent OS in both arms suggests that chemotherapy-free strategies should be further explored. This trial was registered at www.clinicaltrials.gov as #NCT01307605.

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