Retrospective comparison of Cheson 2007 and Lugano classification criteria in independent review assessment of FDG-avid lymphomas.

e19015 Background: Revised Response Criteria in Malignant Lymphoma (Cheson 2007) and Lugano Classification are the most commonly used guidelines to assess response to treatment in lymphoma in clinical trials. While not drastically different from Cheson 2007, important clarifications and modifications were provided in Lugano Classification, specifically in the use of PET in response assessments. Methods: We retrospectively compared the blinded independent review of 25 subjects across multiple studies, assessed using Cheson 2007 and Lugano Classification on separate case report forms by the same reviewer per subject on 2 different dates. Focus was given on comparison of endpoint assessments of Progression-Free Survival (PFS), Duration of Complete Response (DOCR) and Duration of Response (DOR). Results: Assessments using Lugano Classification showed increased DOCR in 12% (3 out of 25), and DOR in 24% (6 out of 25) of the subjects. Cheson 2007 showed better DOR in 8% (2 out of 25) of the subjects. For PET positivity, Lugano Classification requires comparison with liver and mediastinal blood pool, whereas Cheson 2007 requires comparison to background or mediastinal blood pool. The results suggest that this difference in assessment of PET positivity (blood pool versus liver) leads to achieving Complete Response (CR) earlier, leading to longer DOCR and DOR when assessed using Lugano Classification compared to Cheson 2007. Lugano Classification also showed longer PFS in 16% (4 out of 25) of the subjects. When Progressive Disease (PD) was due to identification of new lesion(s), the two criteria showed similar PFS; however, when PD was due to lesion measurements and PET positivity assessment, Lugano Classification showed a longer PFS. Better PFS in Lugano Classification was observed because enlarging lymph nodes do not always show increased PET activity. Conclusions: In Independent review assessments for FDG avid lymphoma, using Lugano Classification showed better DOCR, DOR and PFS as compared to Cheson 2007. Further studies with increased number of subjects and intra-reader variability assessments are warranted to investigate the two criteria.

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High Dose Ifosfamide in Relapsed and Unresectable High-Grade Osteosarcoma Patients: A Retrospective Series

Cells ◽

10.3390/cells9112389 ◽

2020 ◽

Vol 9 (11) ◽

pp. 2389 ◽

Cited By ~ 2

Author(s):

Emanuela Palmerini ◽

Elisabetta Setola ◽

Giovanni Grignani ◽

Lorenzo D’Ambrosio ◽

Alessandro Comandone ◽

...

Keyword(s):

Gene Mutations ◽

Progression Free Survival ◽

Complete Response ◽

High Dose ◽

Free Survival ◽

Duration Of Response ◽

Or Gene ◽

High Grade Osteosarcoma ◽

And Control ◽

Generation Sequencing

Background: The evidence on high-dose ifosfamide (HD-IFO) use in patients with relapsed osteosarcoma is limited. We performed a retrospective study to analyze HD-IFO activity. Methods: Patients with osteosarcoma relapsed after standard treatment [methotrexate, doxorubicin, cisplatin +/− ifosfamide (MAP+/−I)] with measurable disease according to RECIST1.1 were eligible to ifosfamide (3 g/m2/day) continuous infusion (c.i.) days 1–5 q21d. RECIST1.1 overall response rate (ORR) (complete response (CR) + partial response (PR)), progression-free survival at 6-month (6m-PFS), duration of response (DOR), and 2-year overall survival (2y-OS) were assessed. PARP1 expression and gene mutations were tested by immunohistochemistry and next-generation sequencing. Results: 51 patients were included. ORR was 20% (1 CR + 9 PR). Median DOR was 5 months (95%CI 2–7). Median PFS, 6m-PFS, OS, and 2y-OS were 6 months (95%CI 4–9), 51%, 15 months (10–19), and 30%, respectively. A second surgical complete remission (CR2) was achieved in 26 (51%) patients. After multivariate analysis, previous use of ifosfamide (HR 2.007, p = 0.034) and CR2 (HR 0.126, p < 0.001) showed a significant correlation with PFS and OS, respectively. No significant correlation was found between outcomes and PARP1 or gene mutations. Conclusions: HD-IFO should be considered as the standard first-line treatment option in relapsed osteosarcoma and control arm of future trial in this setting.

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Vinorelbine Is an Effective and Safe Drug for AIDS-Related Kaposi’s Sarcoma: Results of a Phase II Study

Journal of Clinical Oncology ◽

10.1200/jco.2000.18.7.1550 ◽

2000 ◽

Vol 18 (7) ◽

pp. 1550-1557 ◽

Cited By ~ 40

Author(s):

Guglielmo Nasti ◽

Domenico Errante ◽

Renato Talamini ◽

Giuliano Rizzardini ◽

Marco Fasan ◽

...

Keyword(s):

Kaposi's Sarcoma ◽

Objective Response ◽

Kaposi’S Sarcoma ◽

Progression Free Survival ◽

Complete Response ◽

Free Survival ◽

Duration Of Response ◽

Previously Treated ◽

Chemotherapy Patients ◽

Dose Limiting Toxicity

PURPOSE: To assess the safety and efficacy of vinorelbine in patients with AIDS-related Kaposi’s sarcoma (KS). PATIENTS AND METHODS: From December 1994 to May 1997, within the Italian Cooperative Group on AIDS and Tumors, we enrolled 36 patients with AIDS-related KS who experienced disease progression after one or more regimens of systemic chemotherapy. Patients were treated with vinorelbine 30 mg/m2 every 2 weeks by intravenous bolus. RESULTS: Of 35 assessable patients, three (9%) had a clinical complete response and 12 (34%) had a partial remission, for an overall objective response rate of 43% (95% confidence interval, 26% to 61%). For the 15 patients with objective responses, the median duration of response from the beginning of therapy until the development of progression was 176 days, whereas the median progression-free survival and the median survival durations for 35 assessable patients were 151 days and 216 days, respectively. Vinorelbine also induced responses in patients who had become resistant to regimens that included other vinca alkaloids. Overall, vinorelbine was well tolerated. Toxicity, including neurologic toxicity, was mild and reversible. Neutropenia was the most frequent dose-limiting toxicity. CONCLUSION: Vinorelbine is safe and effective in the treatment of patients with advanced KS who have been previously treated with one or more chemotherapy regimens.

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Results of a phase 2 study of bortezomib in patients with relapsed or refractory indolent lymphoma

Blood ◽

10.1182/blood-2009-08-233155 ◽

2010 ◽

Vol 115 (3) ◽

pp. 475-480 ◽

Cited By ~ 61

Author(s):

Nicholas Di Bella ◽

Raymond Taetle ◽

Kathryn Kolibaba ◽

Thomas Boyd ◽

Robert Raju ◽

...

Keyword(s):

Median Time ◽

Single Agent ◽

Progression Free Survival ◽

B Cell Lymphoma ◽

Complete Response ◽

Low Grade ◽

Free Survival ◽

Ann Arbor ◽

Duration Of Response ◽

Unconfirmed Complete Response

Abstract This study evaluated the efficacy and safety of single-agent bortezomib in indolent B-cell lymphoma that had relapsed from or was refractory to rituximab. Sixty patients enrolled: 59 were treated with bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11 for up to eight 21-day cycles; responders could receive 4 additional cycles; maintenance was optional. Fifty-three evaluable patients completed more than 2 cycles. The median age was 70 years, 53% female, Ann Arbor stage III-IIIE (28%) and IV (65%); 43 patients (72%) had more than 2 prior regimens; and 6 patients went on to maintenance. Overall responses are as follows: 1 complete response (1.9%), 3 unconfirmed complete response (5.7%), 3 partial response (5.7%), 34 stable disease (64.2%), and 12 progressive disease (22.6%). Median time to response = 2.2 months (range, 1.2-5.3 months); duration of response = 7.9 months (2.8-21.3 months); 1-year survival was 73% and 2-year survival was 58%; median survival = 27.7 months (range, 1.4-30.9 months); median progression-free survival = 5.1 months (range, 0.2-27.7 months), median time to progression = 5.1 months (range, 0.2-27.7 months), and median event-free survival = 1.8 months (range, 0.2-27.7 months). Treatment-related grade 3 or 4 adverse events included: thrombocytopenia (20%), fatigue (10%), neutropenia (8.5%), and neuropathy and diarrhea (6.8% each). This study demonstrates that bortezomib has modest activity against marginal zone and follicular lymphoma; it has the potential for combination with other agents in low-grade lymphomas. Maintenance therapy should be explored further.

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The combination of intravenous bevacizumab and metronomic oral cyclophosphamide for recurrent platinum-resistant ovarian cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.5039 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. 5039-5039

Author(s):

Emma L. Barber ◽

Nikki Lynn Neubauer ◽

Emese Zsiros ◽

Julian C. Schink

Keyword(s):

Overall Survival ◽

Ovarian Carcinoma ◽

Single Agent ◽

Progression Free Survival ◽

Complete Response ◽

Response To Treatment ◽

Ca 125 ◽

Oral Cyclophosphamide ◽

Free Survival ◽

Platinum Resistant

5039 Background: This study was undertaken to determine the progression free survival and overall survival in heavily pre-treated patients with recurrent ovarian carcinoma treated with bevacizumab and metronomic oral cyclophosphamide. Methods: An IRB-approved retrospective review was performed for all patients with recurrent ovarian, fallopian tube or primary peritoneal carcinomas treated with intravenous bevacizumab 10mg/kg every 14 days and oral cyclophosphamide 50mg daily between January 2006 and December 2010. Response to treatment was determined by change in disease status according to RECIST criteria and/or CA-125 levels. Results: Sixty-six eligible patients were identified with a median age of 58 years. Fifty-five patients (83%) originally had optimal cytoreduction and all were platinum resistant. Median time from diagnosis to beginning bevacizumab and cyclophosphamide was 36 months. Median number of prior chemotherapy treatments was 7.5 (range 3-16). Eight patients (12.1%) had side effects which required discontinuing bevacizumab and cyclophosphamide, most common were hypertension, proteinuria, and fatigue. There was one bowel perforation (1.5%). A complete response was noted in 7 patients (10.6%), partial response was seen in 21 patients (31.8%) with an overall response rate of 42.4%. Fifteen patients (22.7%) had stable disease and 23 (34.8%) had disease progression. Median progression free survival (PFS) for responders was 5 months (range 2-14) and 11 months (range 4-14) for those with a complete response. Median overall survival (OS) from start of bevacizumab and cyclophosphamide for responders was 20 months (range 2-56) and 9 months (range 1-51) for nonresponders. Conclusions: Bevacizumab and cyclophosphamide is an effective, well-tolerated chemotherapy regimen in heavily pre-treated patients with recurrent ovarian carcinoma which significantly improves PFS and OS in responders. Response rates were significantly better than the rates we have reported in this same group of patients receiving topotecan (22%) or liposomal doxorubicin (25%) and were superior to reported rates for single agent bevacizumab (18%) in patients with only 2-3 prior regimens.

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Immunotherapy discontinuation and outcome: A multicenter real-life experience.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e14075 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e14075-e14075

Author(s):

Maria Bassanelli ◽

Diana Giannarelli ◽

Maria RITA Migliorino ◽

Marco Russano ◽

Alain Gelibter ◽

...

Keyword(s):

Advanced Cancer ◽

Progressive Disease ◽

Life Experience ◽

Checkpoint Inhibitors ◽

Real Life ◽

Progression Free Survival ◽

Complete Response ◽

Response To Treatment ◽

Best Response ◽

Programmed Death

e14075 Background: Unlike chemotherapy, the optimum treatment duration with Immune checkpoint inhibitors (ICIs) is not clearly established. The aim of this study was to assess the outcome of patients (pts) who discontinued immune-based therapies for any reason except progressive disease. Methods: We conducted an observational, retrospective analysis of 46 consecutive pts with advanced cancer who received ICIs as clinically indicated, at eight Italian institutions. Tumor response to treatment was defined according to RECIST. Median overall survival (OS) and the 95% confidence interval (CI) were estimated with the Kaplan -Meier method. Results: 46 pts (median age 68 years [range 41-86]; male: 65.2%) with advanced cancer (n.39 non-small-cell lung cancer, n.15 renal cell carcinoma and n.2 melanoma) were treated with ICIs: 44 pts received programmed death 1 (PD-1) inhibitors (n.31 nivolumab, n.13 pembrolizumab) and 2 pts programmed death ligand 1 (PD-L1) (n.1 durvalumab, n.1 atezolizumab). A median of 8 cycles were administered [range 1 to 52]. 36 pts discontinued ICIs due to toxicities (diarrhoea, pneumonitis, hepatotoxicity) and 10 pts for reasons non immune-related. The median progression free survival (PFS) from the beginning of ICIs was 12.4 months (mo) [95% CI: 8.2-16.6] and the median OS was 20.0 mo (95% CI: 11.8-28.2). Median PFS from discontinuation of therapy was 5.0 mo [95% CI: 2.7-7.3] and median OS was 16.1 mo (95% CI: 5.4-26.8). Best response achieved according RECIST criteria were: 1 complete response (CR), 18 partial response, 21 stable disease (SD), 2 progressive disease (PR) and 3 non evaluable (NE). During interruption of ICIs 1 pts achieved a PR. Conclusions: This study shows the activity of ICIs, in terms of outcome and durable immune-response, in pts with advanced cancer even after treatment discontinuation.

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Nivolumab (NIVO) + low-dose ipilimumab (IPI) as first-line (1L) therapy in microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): Two-year clinical update.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.4040 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. 4040-4040 ◽

Cited By ~ 5

Author(s):

Heinz-Josef Lenz ◽

Sara Lonardi ◽

Vittorina Zagonel ◽

Eric Van Cutsem ◽

M. Luisa Limon ◽

...

Keyword(s):

Clinical Benefit ◽

Low Dose ◽

Objective Response ◽

Progression Free Survival ◽

Complete Response ◽

Free Survival ◽

Duration Of Response ◽

Therapy Option ◽

Grade 3

4040 Background: In the phase 2 CheckMate 142 trial, NIVO + low-dose IPI had robust, durable clinical benefit and was well tolerated as 1L therapy for MSI-H/dMMR mCRC (median follow-up 13.8 months [mo; range, 9–19]; Lenz et al. Ann Oncol 2018;29:LBA18). Longer follow-up is presented here. Methods: Patients (pts) with MSI-H/dMMR mCRC and no prior treatment for metastatic disease received NIVO 3 mg/kg Q2W + low-dose IPI 1 mg/kg Q6W until disease progression or discontinuation. The primary endpoint was investigator-assessed (INV) objective response rate (ORR) per RECIST v1.1. Results: In 45 pts with median follow-up of 29.0 mo, ORR (95% CI) increased to 69% (53–82) (Table) from 60% (44.3–74.3); complete response (CR) rate increased to 13% from 7%. The concordance rate of INV and blinded independent central review was 89%. Median duration of response (DOR) was not reached (Table). Median progression-free survival (PFS) and overall survival (OS) were not reached, and 24-mo rates were 74% and 79%, respectively (Table). Nineteen pts discontinued study treatment without subsequent therapy. An analysis of tumor response post discontinuation will be presented. Ten (22%) pts had grade 3–4 treatment-related adverse events (TRAEs); 3 (7%) had grade 3–4 TRAEs leading to discontinuation. Conclusions: NIVO + low-dose IPI continued to show robust, durable clinical benefit with a deepening of response, and was well tolerated with no new safety signals identified with longer follow-up. NIVO + low-dose IPI may represent a new 1L therapy option for pts with MSI-H/dMMR mCRC. Clinical trial information: NTC02060188 . [Table: see text]

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SYST-04. TRAM-01: A PHASE 2 STUDY OF TRAMETINIB FOR PATIENTS WITH PEDIATRIC GLIOMA WITH ACTIVATION OF THE MAPK/ERK PATHWAY

Neuro-Oncology Advances ◽

10.1093/noajnl/vdab112.032 ◽

2021 ◽

Vol 3 (Supplement_4) ◽

pp. iv9-iv9

Author(s):

Sébastien Perreault ◽

Valérie Larouche ◽

Uri Tabori ◽

Cynthia Hawkins ◽

Sarah Lippé ◽

...

Keyword(s):

Progressive Disease ◽

Response Rate ◽

Progression Free Survival ◽

Low Grade ◽

Erk Pathway ◽

Minor Response ◽

Free Survival ◽

Overall Response ◽

Duration Of Response ◽

Braf Fusion

Abstract BACKGROUND Pediatric low-grade gliomas (PLGG) are the most frequent brain tumors in children. It is known that the majority of PLGG have activation of the MAPK/ERK pathway. METHODS This ongoing multicenter phase II trial includes three progressing/refractory PLGG groups: NF1 patients, KIAA1549-BRAF fusion patients and patients with other activation of the MAPK/ERK pathway (excluding V600E). The primary objective was to evaluate the overall response rate based on RANO criteria after daily oral trametinib administration for 18 cycles, lasting 28 days each. Secondary objectives include the assessment of progression-free survival, tolerability of trametinib, serum levels of trametinib and quality of life evaluation during treatment. RESULTS As of February 12 2021, 50 patients have been enrolled (NF1: n=10; KIAA1549-BRAF fusion: n=31; other: n=9 including 5 patients with FGFR1 alterations). Median age is 8.8 years (range 2.4-25.5). Median follow-up is 17.5 months (range 4.7-28.5). Forty-three patients are evaluable. The overall response includes: 4 partial response (PR) (9%), 18 minor response (MR) (42%), 17 stable disease (40%), 4 progressive disease (9%). Median time to response is 5.5 months (range 2.4-13.8). Median duration of response is 6.1 months (range 0.6-26.5). Progression free survival at 12 months is 79.9% (95% CI 68.5-93.6%) and median progression free survival has not yet been reached. Treatment was discontinued for 30 patients: 16 after completing 18 cycles as planned, 5 for progressive disease, 5 for adverse events, 4 for other reasons. A total of 8 patients progressed after discontinuation of treatment including 6 patients (37.5%) that completed 18 cycles. Five of these patients had achieved minor response prior to discontinuation. CONCLUSION Trametinib is a potentially effective targeted therapy for patients with recurrent/refractory PLGG. Treatment was overall well tolerated. This ongoing trial will continue to gather data on response rate, duration of response and safety of trametinib for PLGG.

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Resting palliative chemotherapy in patients with gastric cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.4_suppl.122 ◽

2013 ◽

Vol 31 (4_suppl) ◽

pp. 122-122

Author(s):

Hee Yeon Lee ◽

Young Seon Hong ◽

Hae Myung Jeon ◽

Cho Hyun Park ◽

Kyo Young Song ◽

...

Keyword(s):

Gastric Cancer ◽

Progressive Disease ◽

Palliative Chemotherapy ◽

Recurrent Disease ◽

Progression Free Survival ◽

Complete Response ◽

Palliative Surgery ◽

Free Survival ◽

Best Response ◽

Palliative Setting

122 Background: In gastric cancer, platinum and fluorouracil combination chemotherapy (CTx) is commonly used. But the optimal duration of CTx in palliative setting is not known. Thus, we reviewed the pts who rested CTx despite of persistent disease control. Methods: From Mar 2007 to Feb 2012 at Seoul St. Mary’s hospital, we retrospectively reviewed pts as follows; (1) had metastatic or recurrent gastric cancer, (2) received 9 cycles of FOLFOX as 1st-line, (3) had no progressive disease (PD) and rested after completion of 9th cycle. Results: Total 25 pts were reviewed. Median age was 54 (36~77) and 15 pts (60%) were male. 13 pts (52%) had recurrent disease and 12 metastatic initially. All pts were treated with oxaliplatin 100 mg/m2, leucovorin 400 mg/m2 on day 1 and 5-FU 1200 mg/m2 on day 1-2 every 2 weeks. All pts had metastasis; carcinomatosis peritonei (CP, 56%), lymph node (36%), liver (20%) and bone (8%). Nine pts (48%) had non-measurable lesions and 3 no evidence of disease (NED) on CT after palliative surgery. Response evaluation was done every 3 cycles. Among 22 pts with evaluable disease, 5 (20%) showed complete response (CR), 8 (32%) partial response (PR), 2 (8%) stable disease (SD) and 7 (28%) non-CR/non-PD as best response. Median progression free survival (PFS) was 14.2 m (95% CI, 6.6-21.9). The PFS in CP vs. non-CP was 9.9 vs. 21.5 m (log rank P = .037). And PFS according to best response were as follows; 25.5 m in CR + NED group, 15.7 PR, 13.4 non-CR/non-PD and 4.3 SD (log rank P = .014). Other factors did not seem to affect PFS. Conclusions: This study suggested that resting CTx in selected pts would be reasonable in gastric cancer. Especially the presence of CP and the grade of response seemed to be important in patient selection.

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Weekly topotecan and biweekly bevacizumab in recurrent and progressive ovarian carcinoma: A single institution experience for third-line or greater treatment.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.e16553 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. e16553-e16553

Author(s):

Kassondra S Grzankowski ◽

Shashikant B. Lele ◽

John Pietkiewicz

Keyword(s):

Ovarian Cancer ◽

Adverse Events ◽

Progressive Disease ◽

Progression Free Survival ◽

Complete Response ◽

Toxicity Profile ◽

Single Institution ◽

Free Survival ◽

Early Use ◽

Third Line

e16553 Background: The toxicity and efficacy of combined weekly topotecan and weekly bevacizumab in women with recurrent and progressive ovarian cancer. Methods: Reviewed data-base from 1/2003-present (1/2013) identified 15 patients who were treated with topotecan 4mg/m2 on days 1, 8, and 15 and bevacizumab 10mg/kg on days 1 and 15 of a 28-day cycle until progressive disease or excessive toxicity warranted discontinuation. The primary endpoint was progression-free survival. Results: Patients (n = 15) received a median of 4 treatment cycles. Mean number of previous chemotherapy regimens was 5 (range 2-9). Toxicity was generally mild, with neutropenia (20%), gastrointestinal toxicity (20%), pain (26%), anemia requiring transfusion (6%) being the most common adverse events. Two patients required dose adjustment secondary to neutropenia. Patients treated with 5 or more prior regimens had more adverse events, 66% vs. 33%, respectively. No febrile neutropenia or treatment-related deaths occurred. Median PFS and OS were 5.6 months and 5.9 months with 6 (40%) patients progression-free for ≥5 months. Two (13%) patients had complete response, 9 (60%) had stable disease or partial response and were still receiving the above mentioned treatment, and 4 (27%) had progressive disease. Conclusions: Treatment of recurrent and progressive ovarian cancer with weekly Topotecan and biweekly Bevacizumab demonstrates a viable efficacy with acceptable toxicity profile in women with previous multiple lines of treatment; as this becomes a more widely used regimen further investigation will be needed to determine early use of this well tolerated chemotherapy.

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First-line treatment of iNHL or MCL patients with BR or R-CHOP/R-CVP: Results of the BRIGHT 5-year follow-up study.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.7500 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 7500-7500 ◽

Cited By ~ 14

Author(s):

Ian Flinn ◽

Richard van der Jagt ◽

Julie E. Chang ◽

Peter Wood ◽

Tim E. Hawkins ◽

...

Keyword(s):

Progression Free Survival ◽

Complete Response ◽

Rank Test ◽

First Line ◽

Open Label ◽

Free Survival ◽

Non Hodgkin Lymphoma ◽

Duration Of Response ◽

Treatment Naïve

7500 Background: BRIGHT, a phase 3, open-label, noninferiority study comparing efficacy and safety of bendamustine plus rituximab (BR) vs rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) or rituximab with cyclophosphamide, vincristine and prednisone (R-CVP) in treatment-naive patients (pts) with indolent non-Hodgkin lymphoma (iNHL) or mantle cell lymphoma (MCL), showed that the complete response rate for first-line BR was statistically noninferior to R-CHOP/R-CVP ( Blood 2014). Pts were monitored for ≥5 years (yr) to assess the overall effect of BR or R-CHOP/R-CVP in a controlled clinical setting. This analysis reports the time-to-event variables of the 5-yr follow-up (FU) study. Methods: Pts with iNHL or MCL randomized to 6-8 cycles of BR or R-CHOP/R-CVP underwent complete assessments at end of treatment, then were monitored regularly. Progression-free survival (PFS), event-free survival (EFS), duration of response (DOR) and overall survival (OS) were compared using a stratified log-rank test. Results: Of 447 randomized pts, 224 received BR, 104 R-CHOP, and 119 R-CVP; 419 entered the FU. The median FU time was 65.0 and 64.1 months for BR and R-CHOP/R-CVP, respectively. The 5-yr PFS rate was 65.5% (95% CI 58.5-71.6) and 55.8% (48.4-62.5), and OS was 81.7% (75.7-86.3) and 85% (79.3-89.3) for BR and R-CHOP/R-CVP, respectively. The hazard ratio (95% CI) for PFS was 0.61 (0.45-0.85; P= .0025), EFS 0.63 (0.46-0.84; P= .0020), DOR 0.66 (0.47-0.92; P= .0134), and OS 1.15 (0.72-1.84; P= .5461) comparing BR vs R-CHOP/R-CVP. Similar results were found in iNHL [PFS 0.70 (0.49-1.01; P= .0582)] and MCL [PFS 0.40 (0.21-0.75; P= .0035)], with the strongest effect in MCL. Use of R maintenance was similar, 43% in BR and 45% in R-CHOP/R-CVP. B was included as second-line in 27 (36%) of the 75 pts requiring therapy who originally received R-CHOP/R-CVP. Comparable safety profiles with expected adverse events were observed in the FU study in BR vs R-CHOP/R-CVP. Conclusions: The long-term FU of the BRIGHT study has confirmed that PFS, EFS, and DOR were significantly better for BR, and OS was not statistically different between BR and R-CHOP/R-CVP. The safety profile was as previously reported. Clinical trial information: NCT00877006.

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