First-Line Radio-Immunotherapy of Newly Diagnosed, Advanced Follicular Non-Hodgkin Lymphoma with 131I-Rituximab: The INITIAL Study,

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 3719-3719 ◽  
Author(s):  
Andrew D McQuillan ◽  
William BG Macdonald ◽  
Michael F Leahy ◽  
J Harvey Turner
Keyword(s):  
Hodgkin Lymphoma ◽  
Combination Chemotherapy ◽  
Post Treatment ◽  
Whole Body ◽  
Chimeric Antibody ◽  
Newly Diagnosed ◽  
First Line ◽  
Non Hodgkin Lymphoma ◽  
One Year

Abstract Abstract 3719 Introduction: Radio-immunotherapy (RIT) with 131I-rituximab has demonstrated efficacy in relapsed and refractory non-Hodgkin lymphoma (NHL). 131I-tositumomab has been shown to be an effective first-line agent in follicular NHL with durable response. We aimed to evaluate the efficacy and safety of first-line 131I-rituximab RIT and the duration of response in previously untreated patients with follicular NHL, given that this radiolabeled chimeric antibody treatment can be repeated upon relapse. Methods: Fifty consecutive patients with newly diagnosed, symptomatic, advanced follicular NHL received a prescribed therapy activity of 131I-rituximab predicated upon a fixed, whole-body radiation dose of 0.75 Gy. All patients were treated as outpatients. All patients received a standard four-week course of rituximab at a dose of 375 mg/m2 in conjunction with the radionuclide therapy, and subsequent rituximab maintenance at 3-monthly intervals for one year. Response was determined by 18F-FDG PET/CT scans at baseline, and at 3 and 12 months post-treatment. Results: Overall response rate (ORR) at 3 months was 98%, with complete response (CR) seen in 38 patients (76%) and partial response (PR) in 11 patients (22%). Four patients (36%) assessed as having PR at 3 months converted to CR in the year following treatment, so that 84% of patients were in CR at one year. During median follow-up of 33 months (range 12–61 months) only one patient (2.6%) among those who had achieved CR has relapsed, while progressive disease has been seen in seven patients (64%) of those with PR at first post-treatment assessment. Only three of the seven patients with PD have so far required further treatment; one with local radiotherapy and two who have received combination chemotherapy. Median progression-free survival (PFS) has not yet been reached. Toxicity was limited to hematological Grade 4 neutropenia in 5 patients (10%) and thrombocytopenia in 5 patients (10%). One patient received a single platelet transfusion. There were no episodes of bleeding or infection. Three patients have died; one from transformed, aggressive NHL (the only non-responder) and the other two from non-hematological malignancies not apparent at study entry. Conclusion: First-line 131I-rituximab RIT of advanced follicular NHL is effective and safe. Early response rates are similar to those observed with combination chemotherapy and rituximab regimens. Durable CR is present in 82% of patients over a median follow-up of 33 months and median PFS has not yet been reached. Of those with documented PR at 3 months, approximately one-third subsequently converted to CR, while the remaining two-thirds developed PD. Disclosures: Off Label Use: radiolabelled rituximab.

The Frequency, Manifestations and Duration of Prolonged Cytopenias after First Line Fludarabine-Combination Chemotherapy for Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3176-3176 ◽  
Author(s):  
Saar I. Gill ◽  
Dennis Carney ◽  
David S. Ritchie ◽  
Max Wolf ◽  
David Westerman ◽  
...  
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Hodgkin Lymphoma ◽  
Combination Chemotherapy ◽  
Residual Disease ◽  
Post Treatment ◽  
Lymphocytic Leukemia ◽  
Cytotoxic Agents ◽  
First Line ◽  
Bone Marrow Biopsies ◽  
Non Hodgkin Lymphoma

Abstract The combination of fludarabine with other cytotoxic agents or rituximab is established in the treatment of lymphoid malignancies, with well-recognised efficacy and short-term toxicity. However, the presence and significance of prolonged cytopenias after completion of treatment have not been thoroughly described. In addition, recent guidelines on the management of chronic lymphocytic leukemia (CLL) highlight the importance of delineating the cause of post-treatment cytopenias. In order to address this important and under-reported aspect of treatment outcome, we evaluated 61 patients with indolent non-Hodgkin lymphoma or chronic lymphocytic leukemia treated in our institution with fludarabine with or without other agents as their first-line cytotoxic therapy. Post-treatment cytopenias (defined as hemoglobin < 130 g/L, neutrophils < 2.0 × 109/L or platelets < 140 × 109/L) persisting longer than 3 months were found in 43% of patients. Increasing patient age was found to be the only predictive factor (p= 0.02), whereas the presence of pre-treatment cytopenias, dose delivered, and requirement for dose delay during treatment were not. Patients failing to achieve complete count recovery by 3 months were more likely to experience post-treatment complications (infection, transfusion requirement, and bleeding) (p=0.03). The median time to resolution of anaemia, neutropenia and thrombocytopenia was 7, 9, and 10 months respectively, and the median hemoglobin, neutrophil count and platelet count were 94 g/L, 0.94 × 109/L and 86 × 109/L, respectively. Persistent cytopenias at 3 months did not impact on overall survival at 36 months. Bone marrow biopsies revealed residual disease infiltration and autoimmune aetiology in only 4% and 11% of patients, respectively, and there was no typical morphological appearance in the remaining 85%. After the completion of first-line fludarabine-based combination therapy for CLL and NHL, persistent cytopenias are frequent and clinically significant. Although cytopenias tend to resolve over time, treating physicians should be aware of these factors when considering fludarabine combination chemotherapy and when documenting post-treatment response status in CLL.

FDG PET in the follow-up management of patients with newly diagnosed Hodgkin and non-Hodgkin lymphoma after first-line chemotherapy

2003 ◽  
Vol 57 (2) ◽  
pp. 307-315 ◽  
Author(s):  
William C Lavely ◽  
Dominique Delbeke ◽  
John P Greer ◽  
David S Morgan ◽  
Daniel W Byrne ◽  
...  
Keyword(s):  
Hodgkin Lymphoma ◽  
Fdg Pet ◽  
Newly Diagnosed ◽  
First Line ◽  
Non Hodgkin Lymphoma ◽  
Line Chemotherapy

Risk-adapted therapy utilizing upfront brentuximab vedotin (Bv) and rituximab (R) with reduced toxicity chemotherapy in children, adolescents, and young adults with Hodgkin lymphoma.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 10532-10532
Author(s):  
Jessica Hochberg ◽  
Liana Klejmont ◽  
Lauren Harrison ◽  
Allyson Flower ◽  
Quihu Shi ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
High Risk ◽  
Hodgkin Lymphoma ◽  
Combination Chemotherapy ◽  
Early Response ◽  
Brentuximab Vedotin ◽  
Response To Therapy ◽  
Newly Diagnosed ◽  
Risk Patients

10532 Background: Cure rates for CAYA patients with Hodgkin Lymphoma remain high, however are limited by significant toxicity of chemoradiotherapy. Brentuximab Vedotin and Rituximab have shown efficacy in relapsed HL. We hypothesize that the addition of both to combination chemotherapy will be safe in newly diagnosed HL preserving current EFS with elimination of more toxic chemoradiotherapy. Objective: To evaluate the safety and overall response and EFS of Brentuximab and Rituximab in combination with risk adapted chemotherapy in CAYA with newly diagnosed HL. Methods: Age 1-30 yrs with newly diagnosed classical HL given 3 to 6 cycles of chemoimmunotherapy: Brentuximab vedotin with Doxorubicin, Vincristine, Prednisone and Darcarbazine (Bv-AVPD) for Low risk patients or Doxorubicin, Vinblastine, Darcarbazine and Rituximab (Bv-AVD-R) for Intermediate/High risk. Early response measured by PET/CT scan following 2 cycles. Slow responders received an additional 2 cycles of Bv-AVD-R for Intermediate Risk or Ifosfamide/Vinorelbine for High Risk patients. Radiation therapy was given ONLY to those patients not in CR. Results: Total = 19 patients. Median age = 15yr (range 4-23yr). Risk = 2 low, 13 intermediate, 4 high. Toxcity = 1 episode of GrIII mucositis, 1 episode of GrIII infusion reaction to Brentuximab. 17 patients have completed therapy. All 17 patients achieved a complete response to therapy for a CR = 100%. Eleven (58%) have achieved a rapid early response. No patient has required radiation therapy. For 17 patients who have completed therapy, the EFS and OS is 100% with a median follow up time of 915 days (30 months). Conclusions: The addition of Brentuximab vedotin and Rituximab to combination chemotherapy for newly diagnosed Hodgkin Lymphoma appears to be safe. Our early results show significant promise with a CR rate of 100% and 58% rapid early response. We have successfully deleted toxic alkylator, topoisomerase inhibitor, bleomycin and radiation from this treatment regimen. The EFS/OS to date is 100% with a median follow up time of 2.5 years. Further follow up and a larger cohort is needed to determine long term outcomes of this approach. Clinical trial information: NCT02398240.

Cyclophosphamide, Vincristine, Myocet and Prednisone ± Rituximab (COMP±R) Regimen Is Safe and Effective as First Line or Salvage Therapy in Elderly Non Hodgkin Lymphoma (NHL): Preliminary Data of Single Centre Experience.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 3747-3747
Author(s):  
Elsa Pennese ◽  
Claudio Cristofalo ◽  
Michelina Dargenio ◽  
Maria Rosaria De Paolis ◽  
Pasquale Forese ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Hodgkin Lymphoma ◽  
Preliminary Data ◽  
Salvage Therapy ◽  
First Line ◽  
Who Grade ◽  
Early Stage Disease ◽  
Non Hodgkin Lymphoma ◽  
Co Morbidity

Abstract Abstract 3747 Poster Board III-683 Background despite the prognosis of aggressive non-Hodgkin Lymphoma has considerably improved over the past decades, the treatment of elderly patients with NHL is still a difficult challenge for the clinician. A retrospective EORTC study conducted in patients with aggressive NHL and age above 70 years showed that about half of patients received an aggressive treatment and that only 15% of investigators employed full-dose regimens from the first cycle. We here present the preliminary data of CHOP-like regimen delivered as first-line or salvage therapy to elderly or young patients with NHL and not eligible for more aggressive therapy. Patients and methods from July 2006 to January 2009, 27 pts (M/F:11/16) with a median age of 71 years (range: 53-84) were included in the study. Twenty-four pts (88%) were more than 65 yo, 18 (66%) had high-grade and 9 (34%) an indolent lymphoma. Stage III-IV disease according to Ann Arbor staging occurred in 18 pts (66%) whereas aaIPI, evaluated only for pts with aggressive NHL, was 3 2 in 9 pts (18%). ENS involvement ≥ 1 was present in 11 (41%) and BM involvement in 13 pts (48%). Most of pts (60%) had ECOG PS ≥ 1. Twenty out of 27 pts (74%) received COMP±R as first-line treatment and 7 (26%) as salvage therapy; all but one of pre-treated pts had received more than 1 line of chemotherapy (range 2-4). Twenty-five (92%) pts had co-morbidity with more than 1 disease in 44% of cases. Median LVEF was 59% (range: 35-80%). COMP±R regimen consisted of cyclophosphamide 750 mg/m2 IV d1, vincristine 1.4 mg/m2 IV d1 (capped at 2mg), liposome-encapsulated doxorubicin (MyocetÒ) at the dose of 50 mg/m2 IV d1 and Prednisone 100 mg/die PO d 1-5 with or without Rituximab at dose of 375 mg/m2 d8 at first course and at d1 of subsequent courses according to B or T-cell lymphoma phenotype respectively. To pts with early stage disease were planned 4 courses of COMP±R±IF-RT while those with advanced stage of disease received six courses of chemotherapy delivered every 3 weeks. Median number of cycles delivered was 5.6 (range: 4-8). All patients completed the planned treatment and most of them (92%) received G-CSF at dose of 300 mg/die as primary (67%) or secondary (25%) prophylaxis. ESA support was need in 8 pts (30%). Results complete response (CR) was achieved in 21 (78%) and partial response (PR) in 3 (11%) of pts with an ORR of 89%; three pts had stable (n=2) or progressive disease (n=1). The regimen was safe and well tolerated with dose reduction occurring in 9 pts (34%). None of pts developed cardiac toxicity. The mainly adverse events recorded was neutropenia occurring in 15% of pts and febrile neutropenia in 6 pts (23%). Extra-haematological toxicity was mild (WHO grade 1-2) and recorded in 18% of pts. There was no treatment-related fatal toxicity. With a median follow-up of 15 months (range 6-33) the OS and EFS was 93% and 89% respectively. Conclusion COMP±R regimen shows to be safe and effective in a group of elderly patients both as first line or salvage therapy. However more patients and longer follow-up is required to assess definitively the role of this regimen in elderly patients with untreated aggressive NHL. A prospective phase II trial is ongoing at our Institution. Disclosures: No relevant conflicts of interest to declare.

scholarly journals ASCO 2017 meeting summary: updates to practice-changing studies in untreated non-Hodgkin lymphoma

2017 ◽  
Vol 24 (4) ◽  
pp. 262
Author(s):  
P. Laneuville ◽  
J.F. Larouche ◽  
A. Tosikyan ◽  
A. Christofides
Keyword(s):  
Hodgkin Lymphoma ◽  
Meeting Report ◽  
Line Treatment ◽  
Efficacy And Safety ◽  
First Line ◽  
Non Hodgkin Lymphoma ◽  
American Society ◽  
Oral Presentations ◽  
First Line Treatment

The 2017 annual meeting of the American Society of Clinical Oncology took place in Chicago, Illinois, 2–6 June. At the meeting, results from key studies in the first-line treatment of indolent non-Hodgkin lymphoma (inhl) were presented. Of those studies, two were selected for oral presentations: 9-year follow-up data from the stil nhl1 trial, which compared the efficacy and safety of bendamustine plus rituximab (br) with those of rituximab plus cyclophosphamide–vincristine–prednisone–doxorubicin (r-chop); and 5-year follow-up data from the bright study, which compared br with r-chop and r-cvp (rituximab plus cyclophosphamide–vincristine–prednisone) combined. Our meeting report describes the foregoing studies and includes interviews with key investigators, plus commentaries from three Quebec hematologists on the potential effects for Canadian practice.

Real-world incidence and costs of serious infections and cardiovascular complications among patients with indolent non-Hodgkin lymphoma treated with first-line ibrutinib or bendamustine/rituximab.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e19528-e19528
Author(s):  
Debra E. Irwin ◽  
Stephen Thompson ◽  
Rinat Ribalov ◽  
Azhar Choudhry
Keyword(s):  
Hodgkin Lymphoma ◽  
Real World ◽  
Index Date ◽  
Cardiovascular Complications ◽  
Hospitalized Patients ◽  
First Line ◽  
Real World Data ◽  
Non Hodgkin Lymphoma ◽  
Serious Infections

e19528 Background: Patients with Indolent non-Hodgkin lymphoma (iNHL) have shown positive outcomes with ibrutinib monotherapy (IM) as well as bendamustine/rituximab combination (BR) therapy, but no studies have reported on patient outcomes using real-world data. The current analysis evaluated serious infections and cardiovascular complications in iNHL patients treated with first-line IM or BR therapy using US real-world data. Methods: Administrative claims from the MarketScan® Research Databases were used to identify adult patients enrolled in commercial or Medicare supplemental insurance plans based on a first prescription fill of IM or BR therapy (the index date) from 2/1/14 to 9/1/19. Patients included in the study were diagnosed with iNHL, were treatment naïve, and were continuously enrolled for ≥12 months both prior to and following the index date. Serious infections and cardiovascular complications requiring hospitalization (diagnosis code in any position) and associated inpatient costs were evaluated during a fixed 12-month follow-up period. Statistical differences in outcome distributions and costs (reported per patient per month [PPPM]) between the groups were tested. Results: Of 1,948 iNHL patients, 147 had IM and 1,058 had BR as index therapy with ≥12 months of follow-up data. Patients receiving IM were older, more often male, and more likely to have had a lower respiratory tract infection (LRTI) or atrial fibrillation (AF) during baseline compared to BR patients, otherwise the groups had similar baseline characteristics. Hospitalization for serious infections was similar for IM and BR patients during the follow-up period (17.0% vs. 14.4%; p = 0.397); among hospitalized patients, the IM and BR groups incurred similar PPPM inpatient costs ($2,839 vs. $3,954; p = 0.188). Specifically, 7.5% of IM patients had a bacterial infection hospitalization and incurred $2,561 PPPM vs 7.6% of BR patients who incurred $3,975 PPPM (both p > 0.05); 8.8% of IM patients had a LRTI hospitalization and incurred $3,629 PPPM vs 6.1% of BR patients who incurred $4,980 PPPM (both p > 0.05). Hospitalization for cardiovascular complications was similar during follow-up for IM and BR patients (15.6% vs. 12.2%; p = 0.237); among hospitalized patients, the IM and BR groups incurred similar PPPM costs ($3,777 vs. $3,862; p = 0.948). Specifically, 7.5% of IM patients had a hospitalization for AF and incurred $4,481 PPPM vs 3.6% of BR patients who incurred $4,860 PPPM (p = 0.025 and p = 0.875, respectively). Conclusions: In a real-world setting, serious infections and cardiovascular complications requiring hospitalization, including associated costs, were similar among iNHL patients treated with first-line IM or BR over 12 months, although IM patients were more likely to have an AF-related complication.

Optimizing Follow up Schedule for Non Hodgkin Lymphoma' Patients by Multi-Objective Analysis.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 3945-3945
Author(s):  
Matteo Pelosini ◽  
Flavio Baronti ◽  
Francesco Caracciolo ◽  
Sara Galimberti ◽  
Edoardo Benedetti ◽  
...  
Keyword(s):  
Hodgkin Lymphoma ◽  
Imaging Techniques ◽  
Objective Analysis ◽  
Whole Body ◽  
High Grade ◽  
Multi Objective ◽  
Non Hodgkin Lymphoma ◽  
The Cost ◽  
Second Period

Abstract Abstract 3945 Poster Board III-881 Introduction Non Hodgkin Lymphoma could be clinically divided as low grade/indolent NHL (LG NHL) and high grade/aggressive NHL (HG NHL). These diseases are chemo and radio-sensitive and improvements have been achieved by immunotherapeutic approaches. However some patients will relapse and a follow up strategy has to be planned in order to detect and treat them. Several aspects should be considered in planning a follow up including safety, specificity, sensitivity, costs and impact on the patient's psychology: an optimal follow up should mediate between these ones. The more diffuse follow up have been planned years before the introduction of innovative methods and imaging techniques, suggesting the opportunity to revise these programs. Methods We collected data about 418 NHL patients -both low and high grade- treated at our institution from 1990 to 2005 who achieved a complete remission according to Cheson criteria and who entered a follow up program which schedule is planned for 5 years divided in two periods: first two years evaluation every 3 months and in the following three years every sixth month. At each visit physical examinations, blood testing (blood count, chemistry) are performed; for imaging techniques we alternate a whole body CT scans to ultrasounds and chest X-ray coupled. Analyzing time to relapse (TTR), we tried to optimize our follow up schedule trough a computation application known as multi-objective analysis. The first step of this method has been to choose and try to quantify the costs of a follow up which reflect its effectiveness. We considered as costs the expected time between relapse and its detection (Ca) and the expected number of performed examinations before failure or censoring occurs (Cb). The total follow up costs could be summarized in a vector Cref: (Ca,Cb). After doing that we described survival analysis, relapse rate and their onset time in order to be suitable for the informatic analysis. We used a log logistic parametric model to do that. Next we shaped our ideal follow up as a structure based one, which is currently the most used in medical practice: a first period where examinations are more tightly spaced, followed by a second period where they are performed further apart. We describe such follow-up schedule “S” as (d1, k, d2) : d1 is the time between the first k examinations; d2 is the time between the remaining examinations. Applying the log-logistic model we calculated the Cref and schedule for our follow up: Cref was (Ca,Cb)=(8.5,6.2); this means that, on average, every patient entering the follow-up will perform 6.2 examinations, and among those who incur in a relapse, the relapse will be detected 8.5 units of time (eg. weeks) after its onset. The follow up structure was (13,8,26). We then calculated all the possible combination of (d1, k, d2) values from 1 to d1 = 25, k= 24 and d2 = 60. Results 360000 follow up schedules had been detected after searching all the possible combinations for d1, k and d2. For each one Ca e Cb costs have been calculated and than compared by multi-objective analysis to those of the current schedule, We look for both follow up structured and “free” follow up, where “free” means that intervals between examination is continuously variable. When comparing follow-up schedules, we apply the rule of Pareto-dominance: the schedule S1 is superior to the S2 schedule if and only if the cost values for S1 are both lower than the cost values for S2. The method then takes into account only those schedules which improve the current one, with respect to both the Ca and the Cb costs. After multi-objective analysis six follow up were detected. These were as following: (16,10,22), (15,8,20), (15,6,19), (16,8,19), (16,5,18), (16,4,18) and are shown in Fig. 1. Conclusions no differences in follow up schedules emerged when we considered separately LG and HG lymphoma patients. Maximum improving of our follow was just 4% and all the new schedules had wide time frequency visit in the first period and a narrow one in the second period: this was a consequence of the higher relapse distribution in the first period and this follow up organization lead to a lower total number of visit without risk of lose any relapse. This is the first application of this analysis to hematological patients confirming the validity of a follow up schedule should be shaped in two different period. Disclosures: No relevant conflicts of interest to declare.

Semen quality in non-Hodgkin lymphoma survivors: a monocentric retrospective study

2020 ◽  
Author(s):  
Francesco Pallotti ◽  
Marianna Pelloni ◽  
Fabiana Faja ◽  
Silvia Di Chiano ◽  
Alice Di Rocco ◽  
...  
Keyword(s):  
Hodgkin Lymphoma ◽  
Post Treatment ◽  
Reproductive Age ◽  
Haematopoietic Stem Cell ◽  
Semen Parameters ◽  
Cell Transplant ◽  
Sperm Number ◽  
Sperm Cryopreservation ◽  
First Line

Abstract STUDY QUESTION How is semen quality affected by treatment in survivors of non-Hodgkin lymphoma (NHL)? SUMMARY ANSWER Before cancer treatment, most NHL subjects were normozoospermic and, while standard first-line treatments seemed compatible with post-treatment recovery after 18 months, salvage therapy followed by haematopoietic stem cell transplant caused permanent damage to spermatogenesis in many cases, with 66% azoospermic subjects in the long term. WHAT IS KNOWN ALREADY Testicular function has been widely investigated in relation to the most common malignancies in men of reproductive age, such as testicular cancer and Hodgkin lymphoma, but NHL has been somewhat under-investigated. The available reports generally show a post-treatment worsening of semen parameters in NHL survivors, but they involved small caseloads or a subgroup of broader caseloads, and their results are not comparable. STUDY DESIGN, SIZE, DURATION We conducted a retrospective analysis of 222 subjects who attended our University Hospital Sperm Bank between 2002 and 2017 for sperm cryopreservation after a diagnosis of NHL. PARTICIPANTS/MATERIALS, SETTING, METHODS The study included 222 patients with NHL who underwent sperm cryopreservation before any antineoplastic treatment. Subjects with any comorbidity and/or other conditions interfering with sperm parameters were excluded. All patients underwent a careful medical history and physical examination at the time of sperm cryopreservation (T0) and had at least one follow-up visit at 6 (T6), 12 (T12), 18 (T18) and/or 24 months (T24) or more than 24 months (T > 24), with a median follow-up of 47.5 months (range 28–140 months). Fertility information was collected through the administration of a questionnaire. MAIN RESULTS AND THE ROLE OF CHANCE Pre-treatment, more than 80% of NHL patients were normozoospermic and in 15.9% of cases had already fathered a child. Aggressive lymphomas were associated with worse baseline semen volume and total sperm number compared to indolent subtypes (P < 0.05). Post-treatment analyses showed that standard first-line treatments alone had a more favourable outcome than intensified regimens for semen parameters, with total sperm number returning to near-baseline values at 18 months (T0: 195.0 ± 189.8 versus T18: 113.4 ± 103.1, P = 0.278), and a 7.7% prevalence of azoospermia at 2 years. In this subgroup receiving standard first-line treatments, radiotherapy of the pelvis versus other ‘high’ sites (mediastinum, latero-cervical and axillary lymph nodes, etc.) was associated with an increased risk of developing post-treatment azoospermia (odds ratio 4.29, 95% CI 1.81–10.14; P = 0.001). Two-thirds of subjects who had relapsed or had disease progression after first-line treatment and then underwent salvage treatment ± haematopoietic stem cell transplant became azoospermic. Fertility data were available for 176 patients: 15.9% already had at least one child prior to the NHL diagnosis and 12.5% (22 patients) desired children after treatment. Fourteen patients achieved fatherhood: 12 through natural conception and two following ART. LIMITATIONS, REASONS FOR CAUTION The main limitations of the study are the lack of data on blood hormones for evaluation of testicular function as a whole and the non-compliance of several patients in attending follow-up visits at all time points, resulting in a reduced sample size for the treatment subgroup analyses. Furthermore, despite a good fertility questionnaire response rate (>80%), the low number of NHL survivors actively seeking fatherhood limits the generalization of results. WIDER IMPLICATIONS OF THE FINDINGS The increased survival of NHL patients of reproductive age makes it essential to focus on the testicular toxicity of the treatment. Sperm cryopreservation must be suggested before any treatment. Two years after first-line treatments, sperm number showed signs of recovery: this finding is of the utmost importance for oncofertility counselling, as it indicates that only a standard first-line chemotherapy in many patients may be compatible with at least a partial spermatogenesis recovery in the long term. Nonetheless, it is expected that up to 30% of subjects will require treatment intensification, which could result in permanent testicular damage; in such cases the use of banked semen might represent the patient’s best chance for future fertility. STUDY FUNDING/COMPETING INTEREST(S) This work was supported by a grant from the Italian Ministry of Education and Research (MIUR-PRIN 2015-2015XSNA83-002) and the ‘Sapienza’ University of Rome, Faculty of Medicine. The authors report no conflicts of interest. TRIAL REGISTRATION NUMBER N/A.

Rituximab monoclonal antibody as initial systemic therapy for patients with low-grade non-Hodgkin lymphoma

Blood ◽  
2000 ◽  
Vol 95 (10) ◽  
pp. 3052-3056 ◽  
Author(s):  
John D. Hainsworth ◽  
Howard A. Burris ◽  
Lisa H. Morrissey ◽  
Sharlene Litchy ◽  
Daniel C. Scullin ◽  
...  
Keyword(s):  
Hodgkin Lymphoma ◽  
Stable Disease ◽  
Systemic Therapy ◽  
Response Rate ◽  
Objective Response ◽  
Chimeric Antibody ◽  
Low Grade ◽  
Current Response ◽  
Non Hodgkin Lymphoma

Abstract Rituximab, a chimeric antibody that targets CD20+ B cells, produces a 48% response rate in patients with refractory low-grade non-Hodgkin lymphoma. In this phase II trial, patients with low-grade non-Hodgkin lymphoma who had previously received no systemic therapy were treated with rituximab, 375 mg/m2, administered by IV infusion for 4 consecutive weeks. Patients with objective response or stable disease received repeat 4-week courses of rituximab at 6-month intervals. At the time of initial reevaluation at 6 weeks, 21 of 39 patients (54%) had objective response to treatment, and an additional 14 patients (36%) had stable disease or minor response. Response rates were similar in patients with follicular and small lymphocytic (CLL-type) lymphoma (52% versus 57%, respectively). At present, follow-up is short and only 13 patients have undergone a second course of rituximab treatment. However, 4 additional responses were documented either prior to the second course of rituximab (2 patients) or following the second course (2 patients) and 4 patients improved from partial to complete response. The current response rate is 64%, with 6 complete responses (15%). Treatment with rituximab was well tolerated, with only 1 patient experiencing grade 3/4 infusion-related toxicity. Rituximab is well tolerated and highly active in patients with low-grade non-Hodgkin lymphoma previously untreated with systemic therapy. Although further follow-up is required, the demonstration of minimal toxicity and considerable activity of this new biologic agent represents an important beginning of more specific, less toxic treatment for this important group of cancer patients.

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