scholarly journals Prognostic value of baseline metabolic tumour volume in advanced-stage Hodgkin’s lymphoma

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Pierre Pinochet ◽  
Edgar Texte ◽  
Aspasia Stamatoullas-Bastard ◽  
Pierre Vera ◽  
Sorina-Dana Mihailescu ◽  
...  
Keyword(s):  
Prognostic Factor ◽  
Prognostic Value ◽  
Hodgkin’S Lymphoma ◽  
Multivariable Analysis ◽  
Progression Free Survival ◽  
Complete Response ◽  
Tumour Volume ◽  
Hodgkin's Lymphoma ◽  
Metabolic Tumour Volume ◽  
Advanced Stage

AbstractOur aim was to evaluate the prognostic value of initial total metabolic tumour volume (TMTV) in a population of patients with advanced-stage Hodgkin’s lymphoma (HL). We retrospectively included 179 patients with stage IIb-III-IV Hodgkin’s disease who received BEACOPP or ABVD as the first-line treatment. The initial TMTV was determined using a semi-automatic method for each patient. We analysed its prognostic value in terms of 5-year progression-free survival (PFS), overall survival, and positron emission tomography (PET) response after two courses of chemotherapy. Considering all the treatments and using a threshold of 217 cm3, TMTV was predictive of 5-year PFS and PET response after two courses of chemotherapy. In multivariable analysis involving TMTV, IPI score, and the first treatment received, TMTV remained a baseline prognostic factor for 5-year PFS. In the subgroup of patients treated with BEACOPP with a threshold of 331 cm3, TMTV was predictive of PET response, but not 5-year PFS (p = 0.087). The combined analysis of TMTV and PET response enabled the individualisation of a subgroup of patients (low TMTV and complete response on PET) with a very low risk of recurrence. Baseline TMTV appears to be a useful independent prognostic factor for predicting relapse in advanced-stage HL in ABVD subgroup, with a tendency of survival curves separation in BEACOPP subgroup.

Early Interim 18f-FDG PET In Hodgkin's Lymphoma: Evaluation on 304 Patients

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3879-3879
Author(s):  
Pier Luigi Zinzani ◽  
Luigi Rigacci ◽  
Vittorio Stefoni ◽  
Alessandro Broccoli ◽  
Benedetta Puccini ◽  
...  
Keyword(s):  
Hodgkin’S Lymphoma ◽  
Conflicts Of Interest ◽  
Early Recognition ◽  
Early Stage ◽  
Progression Free Survival ◽  
Complete Response ◽  
Hodgkin's Lymphoma ◽  
High Dose ◽  
Advanced Stage ◽  
Interim Pet

Abstract Abstract 3879 Purpose. The use of early (interim) positron emission tomography (PET) restaging during front-line therapy in Hodgkin's lymphoma (HL) has considerably increased in clinical practice as an early recognition of treatment failure allows patients to be addressed to more intensive treatment regimens. Patients and Methods. Between June 1997 and June 2009, 304 newly-diagnosed Hodgkin's lymphoma patients (147 early-stage and 157 advanced-stage) were treated with the ABVD regimen at two Italian institutions. Patients underwent to a PET staging and restaging at baseline, after 2 cycles of therapy and at the end of the treatment. Results. 53 patients showed a positive interim PET and only 13/53 (24.5%) achieved a complete response (CR), whereas 251 patients showed a negative PET and 231/251 (92%) remained in CR. Comparison between interim PET-positive and interim PET-negative patients indicated a significant association between PET findings and 9-year progression-free survival (p=0.0000) and 9-year overall survival (p=0.0000), with a median follow-up of 31 months. Among the early-stage patients, 19 had a positive interim PET and only 4 (21%) achieved a CR; among the 128 negative interim PET patients, 122 (97.6%) obtained a CR. In the advanced-stage subset, 34 patients showed a persistently positive PET (with only 9/34, 26.4% in CR), whereas 123 showed a negative interim PET, with 109 (88.6%) remaining in CR. Conclusions. Our results confirm the role of early PET as a significant step forward for the management of both early and advanced-stage HL patients, offering the potential for an immediate switch to high-dose treatments, if required. Disclosures: No relevant conflicts of interest to declare.

Multicenter Phase II Clinical Study of Iodine-131–Rituximab Radioimmunotherapy in Relapsed or Refractory Indolent Non-Hodgkin’s Lymphoma

2006 ◽  
Vol 24 (27) ◽  
pp. 4418-4425 ◽  
Author(s):  
Michael F. Leahy ◽  
John F. Seymour ◽  
Rodney J. Hicks ◽  
J. Harvey Turner
Keyword(s):  
Hodgkin’S Lymphoma ◽  
Progression Free Survival ◽  
Complete Response ◽  
Hodgkin's Lymphoma ◽  
Whole Body ◽  
Actuarial Survival ◽  
Entire Cohort ◽  
Non Hodgkin’S Lymphoma ◽  
Non Hodgkin's Lymphoma ◽  
Iodine 131

Purpose To evaluate efficacy and safety of iodine-131 (131I) –rituximab chimeric anti-CD20 antibody radioimmunotherapy in patients with relapsed or refractory indolent non-Hodgkin's lymphoma (NHL). Patients and Methods After a standard loading dose of rituximab 375 mg/m2, individualized dosimetry was performed by whole-body gamma imaging of a tracer activity of 131I-rituximab followed by administration of a therapeutic activity of 131I-rituximab to deliver an estimated whole-body radiation absorbed dose of 0.75 Gy. Results Ninety-one patients were entered onto the trial: 78 patients (86%) had follicular lymphoma, six patients (7%) had mucosa-associated lymphoid tissue/marginal zone lymphoma, and seven patients (8%) had small lymphocytic lymphoma. The objective overall response rate (ORR) was 76%, with 53% attaining a complete response (CR) or CR unconfirmed (CRu). Median duration of response for patients achieving CR/CRu was 20 v 7 months for those with a partial response (P = .0121). Median progression-free survival for the entire cohort was 13 months, with 14% remaining relapse free beyond 4 years. Median follow-up was 23 months, with a 4-year actuarial survival rate of 59% ± 10%. Toxicity was principally hematologic; grade 4 thrombocytopenia occurred in 4% and neutropenia occurred in 16% of patients, with nadirs at 6 to 7 weeks after treatment. Conclusion 131I-rituximab radioimmunotherapy of relapsed or refractory indolent NHL achieves high ORR and CR rates with minimal toxicity.

ABVD Versus Modified Stanford V Versus MOPPEBVCAD With Optional and Limited Radiotherapy in Intermediate- and Advanced-Stage Hodgkin's Lymphoma: Final Results of a Multicenter Randomized Trial by the Intergruppo Italiano Linfomi

2005 ◽  
Vol 23 (36) ◽  
pp. 9198-9207 ◽  
Author(s):  
Paolo G. Gobbi ◽  
Alessandro Levis ◽  
Teodoro Chisesi ◽  
Chiara Broglia ◽  
Umberto Vitolo ◽  
...  
Keyword(s):  
Adjuvant Radiotherapy ◽  
Hodgkin’S Lymphoma ◽  
Response Rate ◽  
Survival Rates ◽  
Progression Free Survival ◽  
Complete Response ◽  
Hodgkin's Lymphoma ◽  
Free Survival ◽  
Drug Doses ◽  
Advanced Hodgkin’S Lymphoma

Purpose In this multicenter, prospective, randomized clinical trial on advanced Hodgkin's lymphoma (HL), the efficacy and toxicity of two chemotherapy regimens, doxorubicin, vinblastine, mechlorethamine, vincristine, bleomycin, etoposide, and prednisone (Stanford V) and mechlorethamine, vincristine, procarbazine, prednisone, epidoxirubicin, bleomycin, vinblastine, lomustine, doxorubicin, and vindesine (MOPPEBVCAD), were compared with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) as standard therapy to select which regimen would best support a reduced radiotherapy program, which was limited to ≤ two sites of either previous bulky or partially remitting disease (a modification of the original Stanford program). Patients and Methods Three hundred fifty-five patients with stage IIB, III, or IV HL were randomly assigned. Three hundred thirty-four patients were assessable for the study and received six cycles of ABVD (n = 122), three cycles of Stanford V (n = 107), or six cycles of MOPPEBVCAD (n = 106); radiotherapy was administered to 76, 71, and 50 patients in these three arms, respectively. Results The complete response rates for ABVD, Stanford V, and MOPPEBVCAD were 89%, 76% and 94%, respectively; 5-year failure-free survival (FFS) and progression-free survival rates were 78%, 54%, 81% and 85%, 73%, and 94%, respectively (P < .01 for comparison of Stanford V with the other two regimens). Corresponding 5-year overall survival rates were 90%, 82%, and 89% for ABVD, Stanford V, and MOPPEBVCAD, respectively. Stanford V was more myelotoxic than ABVD but less myelotoxic than MOPPEBVCAD, which had larger reductions in the prescribed drug doses. Conclusion When associated with conditioned and limited (not adjuvant) radiotherapy, ABVD and MOPPEBVCAD were superior to Stanford V chemotherapy in terms of response rate and FFS and progression-free survival. Patients were irradiated less often after MOPPEBVCAD, but this regimen was more toxic. ABVD is still the best choice when it is combined with optional, limited irradiation.

Sintilimab for relapsed/refractory classical Hodgkin’s lymphoma: Extended follow-up on the multicenter, single-arm phase II ORIENT-1 study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 7533-7533
Author(s):  
Hang Su ◽  
Yongping Song ◽  
Wenqi Jiang ◽  
Xiuhua Sun ◽  
Wenbin Qian ◽  
...  
Keyword(s):  
Phase Ii ◽  
Hodgkin’S Lymphoma ◽  
Objective Response ◽  
Progression Free Survival ◽  
Complete Response ◽  
High Rate ◽  
Hodgkin's Lymphoma ◽  
Primary Analysis ◽  
Hematopoietic Stem

7533 Background: Classical Hodgkin’s lymphoma (cHL) is characterized by chromosome 9p24.1 alterations and PD-1 ligand overexpression. Sintilimab, a programmed death-1 checkpoint inhibitor, has demonstrated efficacy in relapsed/refractory cHL after the primary analysis of the ORIENT-1 study. Here, we report the updated safety and efficacy prolines after extended follow-up. Methods: ORIENT-1 is a multicenter, single-arm, phase II study in China. Classical Hodgkin’s lymphoma patients who had failed ≥2 lines of systemic therapy, including autologous hematopoietic stem cell transplantation (HSCT) were enrolled. Sintilimab, 200 mg IV was given every 3 weeks, until disease progression, death, unacceptable toxicity, or withdrawal from study. The primary endpoint was objective response rate (ORR) assessed by an independent radiological review committee (IRRC) according to 2007 IWG criteria. Results: 96 patients were treated. As of the data cutoff on 16 October, 2018 72.9% of patients were continuing treatment with a median follow-up of 14 months. Median number of treatment cycles was 20 (range: 1 to 26). ORR was 85.4% (82/96, 95%CI: 76.7 to 91.8) based on IRRC review. Twenty-eight patients (29.2%) achieved complete response (CR) by PET scan. At the time of analysis, 59 out of 82 patients who had achieved complete or partial response continued to have an on-going response. The median duration of response (DoR) and progression free survival (PFS) have not been reached. The most common treatment-related adverse event (TRAE) was pyrexia (40.6%, 39/96), 92.3% of which was grade 1 or 2. The most common grade 3 or 4 TRAEs were pyrexia (3.1%) and anemia (3.1%). One death occurred which was not considered treatment related. Conclusions: ORIENT-1 study has the largest cohort of cHL patients in China treated with a PD-1. In addition to a high rate of response, sintilimab also demonstrated durable efficacy and favorable long-term safety profile after extended follow-up. Clinical trial information: NCT03114683.

Eight Cycles of Escalated-Dose BEACOPP Compared With Four Cycles of Escalated-Dose BEACOPP Followed by Four Cycles of Baseline-Dose BEACOPP With or Without Radiotherapy in Patients With Advanced-Stage Hodgkin's Lymphoma: Final Analysis of the HD12 Trial of the German Hodgkin Study Group

2011 ◽  
Vol 29 (32) ◽  
pp. 4234-4242 ◽  
Author(s):  
Peter Borchmann ◽  
Heinz Haverkamp ◽  
Volker Diehl ◽  
Thomas Cerny ◽  
Jana Markova ◽  
...  
Keyword(s):  
Hodgkin’S Lymphoma ◽  
Residual Disease ◽  
Final Analysis ◽  
Residual Tumor ◽  
Complete Response ◽  
Hodgkin's Lymphoma ◽  
Study Group ◽  
Severe Toxicity ◽  
Advanced Stage ◽  
German Hodgkin Study Group

Purpose Eight cycles of BEACOPPescalated (escalated dose of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) followed by radiotherapy (RT) to initial bulk or residual tumor mass is the German Hodgkin Study Group standard of care for advanced-stage Hodgkin's lymphoma (HL). However, treatment-related toxicity is a concern, and the role of RT in this setting is unclear. The HD12 study thus aimed to reduce toxicity while maintaining efficacy. Patients and Methods In this prospectively randomized multicenter trial, eight cycles of BEACOPPescalated was compared with four cycles of BEACOPPescalated followed by four cycles of the baseline dose of BEACOPP (BEACOPPbaseline; 4 + 4), and RT with no RT in the case of initial bulk or residual disease. The study was designed to exclude a difference in 5-year freedom from treatment failure (FFTF) rate of 6%. Results Between January 1999 and January 2003, 1,670 patients age 16 to 65 years were enrolled onto the HD12 study. At 5 years, FFTF was 86.4% in the BEACOPPescalated arm and 84.8% in the 4 + 4 arm (difference, −1.6%; 95% CI, −5.2% to 1.9%), and overall survival was 92% versus 90.3% (difference, −1.7%; 95% CI, −4.6% to 1.1%). Deaths related to acute toxicity of chemotherapy were observed in 2.9% of patients (BEACOPPescalated, n = 19; 4 + 4, n = 27). FFTF was inferior without RT (90.4% v 87%; difference, −3.4%; 95% CI, −6.6% to −0.1%), particularly in patients who had residual disease after chemotherapy (difference, −5.8%; 95% CI, −10.7% to −1.0%), but not in patients with bulk in complete response after chemotherapy (difference, −1.1%; 95% CI, −6.2% to 4%). Conclusion The reduction of BEACOPP to the 4 + 4 regimen did not substantially reduce severe toxicity but might decrease efficacy. Our results do not support the omission of consolidation RT for patients with residual disease. Alternative strategies for improving the risk-to-benefit ratio for patients with advanced HL are needed.

scholarly journals Efficacy and safety of nivolumab in the treatment of relapsed/refractory classical Hodgkin’s lymphoma: Pavlov First Saint Petersburg State Medical University experience

2019 ◽  
Vol 13 (4) ◽  
pp. 17-26
Author(s):  
K. V. Lepik ◽  
N. V. Mikhailova ◽  
E. V. Kondakova ◽  
L. A. Tsvetkova ◽  
Yu. R. Zalyalov ◽  
...  
Keyword(s):  
Overall Survival ◽  
Adverse Events ◽  
Hodgkin’S Lymphoma ◽  
Therapy Response ◽  
Progression Free Survival ◽  
Complete Response ◽  
Hodgkin's Lymphoma ◽  
Treatment Results ◽  
Saint Petersburg ◽  
Medical University

Background . Using modern first-line chemotherapy more than 80 % of patients with classical Hodgkin’s lymphoma can be cured, however, in 15–20 % of cases there is a relapsed/refractory disease. The use of nivolumab in international clinical practice has significantly improved treatment results of patients with relapsed/refractory classical Hodgkin’s lymphoma.Objective of this study is to evaluate the results of therapy with nivolumab in the сlinic of Pavlov First Saint Petersburg State Medical University.Materials and methods . The retrospective analysis included treatment results of 101 patients with relapsed/refractory classical Hodgkin’s lymphoma who received nivolumab in Raisa Gorbacheva Memorial Research Institute of Children Oncology, Hematology and Transplantation from February 2016 to August 2018. The group included 90 patients who received nivolumab as part of an named patient program. Therapy response was assessed using CT/PET-CT in accordance with LYRIC criteria for response assessment of malignant lymphomas to immunotherapy. Safety and tolerability were assessed by registering adverse events in accordance with NCI CTCAE version 4.03 criteria. Results . Median follow-up was 25 months. The response was registered in 64 % of patients: in 32 (31.6 %) – complete response and in 33 (32.7 %) – partial response. Stabilization and progression as the best response were registered in 5 (4.9 %) and 10 (9.8 %) patients, respectively. Indeterminate response was observed in 21 (20.6 %) patients. The 2-year overall survival was 96 %; the median of overall survival was not achieved. Progression-free survival (PFS) in studied patients was 40.6 %. The median of PFS was 17.9 months. There were no significant differences in PFS between patients with a partial and indeterminate response. Adverse events were reported in 87.1 % of patients. Severe adverse events (III–IV grade) occur in 18.8 % of patients.Conclusion . The results of a retrospective study of nivolumab therapy in Russian patients with relapsed/refractory classical Hodgkin’s lymphoma are consistent with published international data. Nivolumab demonstrates high efficacy as a monotherapy for relapsed/refractory classical Hodgkin’s lymphoma, regardless of previous therapy type and duration with well tolerance. Pseudo-progression phenomena during immunotherapy require revision of the traditional Hodgkin’s lymphoma therapy response criteria.

Bendamustine in Patients With Rituximab-Refractory Indolent and Transformed Non-Hodgkin's Lymphoma: Results From a Phase II Multicenter, Single-Agent Study

2008 ◽  
Vol 26 (2) ◽  
pp. 204-210 ◽  
Author(s):  
Jonathan W. Friedberg ◽  
Philip Cohen ◽  
Ling Chen ◽  
K. Sue Robinson ◽  
Andres Forero-Torres ◽  
...  
Keyword(s):  
Phase Ii ◽  
Hodgkin’S Lymphoma ◽  
Single Agent ◽  
Progression Free Survival ◽  
Complete Response ◽  
Hodgkin's Lymphoma ◽  
Patients Âgés ◽  
Non Hodgkin’S Lymphoma ◽  
Non Hodgkin's Lymphoma ◽  
Duration Of Response

PurposeBendamustine hydrochloride is an alkylating agent with novel mechanisms of action. This phase II multicenter study evaluated the efficacy and toxicity of bendamustine in patients with B-cell non-Hodgkin's lymphoma (NHL) refractory to rituximab.Patients and MethodsPatients received bendamustine 120 mg/m2intravenously on days 1 and 2 of each 21-day cycle. Outcomes included response, duration of response, progression-free survival, and safety.ResultsSeventy-six patients, ages 38 to 84 years, with predominantly stage III/IV indolent (80%) or transformed (20%) disease were treated; 74 were assessable for response. Twenty-four (32%) were refractory to chemotherapy. Patients received a median of two prior unique regimens. An overall response rate of 77% (15% complete response, 19% unconfirmed complete response, and 43% partial) was observed. The median duration of response was 6.7 months (95% CI, 5.1 to 9.9 months), 9.0 months (95% CI, 5.8 to 16.7) for patients with indolent disease, and 2.3 months (95% CI, 1.7 to 5.1) for those with transformed disease. Thirty-six percent of these responses exceeded 1 year. The most frequent nonhematologic adverse events included nausea and vomiting, fatigue, constipation, anorexia, fever, cough, and diarrhea. Grade 3 or 4 reversible hematologic toxicities included neutropenia (54%), thrombocytopenia (25%), and anemia (12%).ConclusionSingle-agent bendamustine produced durable objective responses with acceptable toxicity in heavily pretreated patients with rituximab-refractory, indolent NHL. These findings are promising and will serve as a benchmark for future clinical trials in this novel patient population.

Treatment of Favorable, Limited-Stage Hodgkin's Lymphoma With Chemotherapy Without Consolidation by Radiation Therapy

2010 ◽  
Vol 28 (9) ◽  
pp. 1611-1615 ◽  
Author(s):  
George P. Canellos ◽  
Jeremy S. Abramson ◽  
David C. Fisher ◽  
Ann S. LaCasce
Keyword(s):  
Radiation Therapy ◽  
Hodgkin’S Lymphoma ◽  
Young Patients ◽  
Progression Free Survival ◽  
Complete Response ◽  
Primary Treatment ◽  
Hodgkin's Lymphoma ◽  
Radiation Toxicity ◽  
Limited Stage ◽  
The Impact

PurposeLimited-stage Hodgkin's lymphoma (HL) has been treated with radiation alone or radiation combined with chemotherapy. Although results in progression-free survival and overall survival have been excellent, the long-term, radiation-induced, toxic cardiac and secondary oncologic complications occurring in succeeding decades have compromised survival of young patients. This study examines the impact of chemotherapy alone in treatment of limited-stage, nonbulky HL, radiation therapy eliminated from primary treatment.Patients and MethodsFrom 1992 to May 2008, 71 patients with a median age of 29 years (range, 17-44 years) with stages I and II HL without bulky nodes were treated with six cycles of classic combination doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). Two patients received six cycles of ABVD-like modification. Two patients received four cycles of ABVD. The ABVD regimen was known to be curative in more advanced disease without radiation therapy.ResultsAll patients achieved a clinical complete response (CR) or CR unconfirmed. After a median follow-up of at least 60 months (range, at least 12 to at least 204 months), six patients experienced relapse at 6, 10, 11, 16, 20, and 58 months. All relapses occurred at site of presenting disease. No patients have died. Salvage therapy was successful with second-line chemotherapy/radiation and autologous stem-cell transplantation.ConclusionSix cycles of ABVD is an effective and safe treatment for limited-stage, nonbulky HL and would spare young patients radiation toxicity. Interim positron emission tomography/computed tomography scans in current and future trials may identify those patients who require less than six cycles of chemotherapy.

High Rates of Durable Responses With Anti-CD22 Fractionated Radioimmunotherapy: Results of a Multicenter, Phase I/II Study in Non-Hodgkin's Lymphoma

2010 ◽  
Vol 28 (23) ◽  
pp. 3709-3716 ◽  
Author(s):  
Franck Morschhauser ◽  
Françoise Kraeber-Bodéré ◽  
William A. Wegener ◽  
Jean-Luc Harousseau ◽  
Marie-Odile Petillon ◽  
...  
Keyword(s):  
Hodgkin’S Lymphoma ◽  
Bone Marrow Involvement ◽  
Progression Free Survival ◽  
Complete Response ◽  
Multicenter Trial ◽  
Hodgkin's Lymphoma ◽  
Bulky Disease ◽  
Non Hodgkin’S Lymphoma ◽  
Non Hodgkin's Lymphoma ◽  
Anti Cd20

Purpose Fractionated radioimmunotherapy targeting CD22 may substantially improve responses and outcome in non-Hodgkin's lymphoma (NHL). Patients and Methods A multicenter trial evaluated two or three weekly infusions of yttrium-90 (90Y) epratuzumab tetraxetan (humanized anti-CD22 antibody) in 64 patients with relapsed/refractory NHL, including 17 patients who underwent prior autologous stem-cell transplantation (ASCT). Objective (OR) and complete responses (CR/complete response unconfirmed [CRu]), as well as progression-free survival (PFS), were determined. Results At the maximum total 90Y dose of 45 mCi/m2 (1,665 MBq/m2), grade 3 to 4 hematologic toxicities were reversible to grade 1 in patients with less than 25% bone marrow involvement. The overall OR rate and median PFS for all 61 evaluable patients was 62% (CR/CRu, 48%) and 9.5 months, respectively. Patients without prior ASCT obtained high OR rates of 71% (CR/CRu, 55%) across all NHL subtypes and 90Y doses, even in poor-risk categories (refractory to last anti-CD20–containing regimen, 73% [CR/CRu, 60%]; bulky disease: 71% [CR/CRu, 43%]). Patients with prior ASCT received lower doses, but achieved an OR rate of 41% (CR/CRu, 29%). For patients with follicular lymphoma (FL), OR rates and median PFS increased with total 90Y-dose, reaching 100% (CR/CRu, 92%) and 24.6 months, respectively, at the highest dose levels (> 30 mCi/m2 total 90Y-dose [1,110 MBq/m2]). Further, patients with FL refractory to prior anti-CD20–containing regimens achieved 90% (nine of 10 patients) OR and CR/CRu rates and a median PFS of 21.5 months. Conclusion Fractionated anti-CD22 radioimmunotherapy provides high total doses of 90Y, yielding high rates of durable CR/CRus in relapsed/refractory NHL, resulting in 20 mCi/m2 × 2 weeks as the recommended dose for future studies.

Fludarabine-Based Regimens in the Treatment of Indolent Non-Hodgkin’s Lymphoma Patients: A Clinical Study of the Fludarabine Cooperation Group in 16 Hospitals in Eastern China.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 4753-4753
Author(s):  
Junmin Li
Keyword(s):  
Clinical Study ◽  
Hodgkin’S Lymphoma ◽  
Eastern China ◽  
Progression Free Survival ◽  
Complete Response ◽  
Lymphocytic Leukemia ◽  
Hodgkin's Lymphoma ◽  
Non Hodgkin’S Lymphoma ◽  
Non Hodgkin's Lymphoma ◽  
Multi Center Study

Abstract Objective: We performed this prospective, multi-center study to evaluate the efficacy and safety of fludarabine-based regimes in the treatment of previously untreated and refractory, or relapsed, indolent non-Hodgkin’s lymphoma (NHL). Methods: Two fludarabine-based regimens were used in the clinical study. The FC regimen which consisted of fludarabine 50 mg/day, and cyclophosphamide 200 mg/day, intravenously, for 3 consecutive days, was given to the previously untreated patients. The FMD regimen which consisted of fludarabine 50 mg/day, intravenously, for 3 consecutive days, mitoxantrone 10 mg/m2, intravenously, on the first day, and dexamethasone 20 mg/m2/day, intravenously, for 5 consecutive days, was given to the relapsed and refractory patients. Results: Forty-seven indolent NHL patients (29 male and 18 female) were enrolled in this study from February 2003 to May 2005. The main disease subtypes were: chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL; n = 25), follicular lymphoma (FL; n = 18), lymphoplasmic lymphoma (LPL; n = 3), marginal zone lymphoma (MZL; n =1). Overall response (OR) rate was 93.62%, and 44 of 47 patients achieved a response. The complete response (CR) rate was 63.83%, and 30 of 47 patients achieved a response. In the 16 previously untreated patients, the CR rate was 75.0% (n =12); the OR rate was 93.8% (n = 15). In the 31 relapsed and refractory patients, the CR rate was 61.3% (n =19) and OR rate was 93.5% (n =29). Median patient follow-up was 12 months (range, 1–27 months). The 12-month progression free survival (PFS) rates of previously untreated patients and relapsed or refractory patients were 93.3±6.4% and 91.04±6.1%, respectively; and the 18-month overall survival (OS) rates were 90.9±8.67% and 90.32±6.90%, respectively. Both regimens were well tolerated and the major toxicities were bone marrow suppression and gastrointestinal response. Conclusion: The FC and FMD regimens are effective and safe for indolent NHL patients.

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