Efficacy Of Helicobacter Pylori Eradication For The First Line Treatment Of Immune Thrombocytopenia Patients With Moderate Thrombocytopenia

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2324-2324
Author(s):  
Hyo Jung Kim ◽  
Won Sik Lee ◽  
Hawk Kim ◽  
Jung-Hee Lee ◽  
Sang Min Lee ◽  
...  
Keyword(s):  
Platelet Count ◽  
Immune Thrombocytopenia ◽  
Base Line ◽  
Line Treatment ◽  
First Line ◽  
Platelet Counts ◽  
Chronic Itp ◽  
Significant Difference ◽  
H Pylori ◽  
First Line Treatment

Abstract Background Since the first case report of Gimaz et al., several investigators have reported that the secondary immune thrombocytopenia (ITP) can occur in patients with Helicobactor pylori (H. pylori) infection. Eradication of H. pylori has been shown to result in improvement in thrombocytopenia. In one systematic review of 696 patients with H. pylori infection it showed 50.3% overall response (platelet count >= 30 X 109/L and at least a doubling of the base line count) after H. pylori eradication. Under these results, ASH 2011 guidelines for ITP recommended that eradication therapy be administered in adult patients who are found to have H. pylori infection (grade 1b). But also they recommended that treatment be administered for newly diagnosed patients with a platelet count < 30 X 109/L. To the best of our knowledge, there was no prospective study to evaluate the efficacy of H. pylori eradication for ITP patient with moderate thrombocytopenia and positive H. pylori. In Korea, the prevalence of H. pylori was reported as high as 60 – 65% in general adult population. The response rate and price of 1st line triple regimen for H. pylori eradication were known to be 70 - 80% and around 100 US dollars in Korea. With these circumstances, tolerable treatment like H. pylori eradication for ITP patients with platelet count >=30 X 109/L is challengeable. Thus, we performed the prospective multicenter phase II study to evaluate the efficacy of H. pylori eradication for the 1st line treatment of persistent or chronic ITP patients with moderate thrombocytopenia. Methods We enrolled patients with persistent (3 to 12 months from diagnosis) or chronic (lasting for more than 12 months) ITP defined by international working group. The platelet counts of patients were between 30 X 109/L and 70 X 109/L. And all patients had positive result of C13-urea breath test (UBT) and had never been treated for ITP or H. pylori. Patients with other secondary ITP could not be enrolled. Patients received lansoprazole 30mg twice daily, amoxicillin 1000mg twice daily and clarithromycin 500mg, twice daily for one week. Eradication of H. pylori was evaluated at eighth week after treatment by UBT. Platelet counts were monitored at 2 weeks and after then at every month for a year. Complete response (CR) was defined as a platelet count >= 100 X 109/L. Partial response (PR) was defined as a platelet increase of >= 30 X 109/L and at least a doubling of the base line count. The primary endpoint was CR rate at 3 months after treatment. All patients provided written informed consents and this trial was registered at www.ClinicalTrials.gov (NCT01255332). Results Twenty-six patients were enrolled between November 2010 and May 2013 from 6 medical centers in Korea. Two patients with HCV infection and one patient with more than 70 X 109/L of platelet counts were excluded from analysis. The mean initial platelet counts of 23 patients (7 males, 16 females, median age 43 years and range 19 - 58 years) was 52.7 ± 9.5 X 109/L (range 39 – 68 X 109/L). All patients except one checked UBT after treatment and H. pylori eradication was achieved in 86.3% (19/22) of patients. CR was obtained in 13 of 23 patients (56.5%) within 3 months after treatment. And no PR was found until this time point. The median time to CR after initiating treatment was 4 weeks (range 2 – 8 weeks). CR rate of the patients who achieved H. pylori eradication was 63.2% (12/19). Unlike other reports, there was no significant difference on initial platelet counts among CR group and non-responder group and no significant correlation on the platelet levels between baseline and initial 3 months (Fig 1). Only 2 of 26 patients could not continue medication due to nausea and diarrhea, respectively. There was no other significant adverse event. Conclusion The eradication of H. pylori is an effective first line treatment for persistent or chronic ITP with moderate thrombocytopenia with high CR rate and rapid onset. And it has acceptable toxicity and relatively low cost. This study supports routine detection and eradication of H. pylori infection in ITP patients especially in populations with a high prevalence of this infection. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Effect of Helicobacter pylori infection on the first-line treatment outcomes in patients with immune thrombocytopenic purpura

2021 ◽  
Author(s):  
Ali Dogan ◽  
Omer Ekinci ◽  
Senar Ebinc
Keyword(s):  
Helicobacter Pylori ◽  
Platelet Count ◽  
Immune Thrombocytopenic Purpura ◽  
Eradication Therapy ◽  
Line Treatment ◽  
First Line ◽  
Thrombocytopenic Purpura ◽  
Significant Difference ◽  
H Pylori ◽  
First Line Treatment

Background: Helicobacter pylori (H. pylori) eradication therapy is known to increase the platelet count, but in immune thrombocytopenic purpura (ITP), the effect of H. pylori infection on the response to treatment is not clear. This study aims to determine whether the response to the first–line treatment is affected by the states of H. pylori–positivity and –negativity in ITP patients. Methods: Adult newly diagnosed or chronic ITP patients who had not received eradication therapy for H. pylori infection were included. Characteristics of the patients, presence and severity of bleeding, initial platelet count, administered treatments, and treatment response rates were inspected. Results: Of 119 total patients, 32 (26.9%) were H. pylori–positive, 87 (73.1%) were H. pylori–negative. The most common treatment was standard–dose steroid in both groups (62.5% vs 68.9%, p=0.524). Rates of complete response, partial response, no response were comparable for the two groups (respectively, 75% vs 73.6%, and 18.8% vs 19.5%, and 6.2% vs 6.9%), and there was no significant difference between the groups (p=0.283). Conclusion: It can be stated according to the present study that; in ITP patients in whom treatment is indicated, the response to the first–line treatment without the administration of H. pylori eradication therapy is comparable between H. pylori–positive and H. pylori–negative patients. Keywords: Helicobacter pylori, immune thrombocytopenic purpura, first-line treatment

Eltrombopag and High-Dose Dexamethasone As First Line Treatment For ITP

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 3544-3544
Author(s):  
David Gomez-Almaguer ◽  
Miguel Angel Herrera-Rojas ◽  
Andres Gomez-de Leon ◽  
Olga Graciela Cantú-Rodríguez ◽  
Cesar H Gutiérrez-Aguirre ◽  
...  
Keyword(s):  
Platelet Count ◽  
Immune Thrombocytopenia ◽  
High Dose ◽  
Line Treatment ◽  
Front Line ◽  
First Line ◽  
High Dose Dexamethasone ◽  
Line Therapy ◽  
First Line Treatment

Abstract Introduction Primary immune thrombocytopenia (ITP) is an acquired autoimmune disorder that involves antibody and cell mediated destruction of platelets as well as suppression of their production. Prednisone is the initial standard therapy in adults1. High-dose dexamethasone as front-line therapy given as pulses of 40 mg per day for 4 consecutive days, was effective in 85% of patients, nevertheless, 50% relapsed within six months2. The prices of ITP drugs for 1 month of treatment in an adult range from prednisone; $16, eltrombopag; $5,934, intravenous immune globulin (IVIG) (80 g); $9,648, to rituximab (2 g); $15,5963. Only prednisone/dexamethasone and eltrombopag are available in oral presentation, for this reason, ambulatory treatment is an alternative for these patients. The trombopoietin receptor agonists are effective for the treatment of patients with chronic ITP, although response is dependent on continued administration. Eltrombopag is a small molecule agonist of the c-mpl (TpoR) receptor, which is the physiological target of thrombopoietin. This drug effectively raises the platelet count in adult patients (aged 18 years and over) as second/third line therapy, that is for patients refractory to corticosteroids and IVIG who have had their spleen removed or when splenectomy is not an option4. Our group, as well as others, has previously sought to improve response rates in these patients, particularly with the use of rituximab5, 6. To our knowledge neither eltrombopag nor romiplostim have been used as front line therapy in ITP, therefore the purpose of this study was to assess the efficacy of eltrombopag and dexamethasone in this setting. Patients and Methods This was a prospective, phase 2 study, using the combination of eltrombopag (50 mg PO once a day for 4 weeks) and high-dose dexamethasone (40 mg PO days 1,2,3,4) in untreated adult patients with immune thrombocytopenia or in patients with less than 7 days of treatment with corticosteroids. Complete response (CR) was defined as an increase in platelet count >100×109/L. Partial response (PR) was defined as an increase in the platelet count greater to 30 ×109/L according to standard criteria. Duration of response was considered from the day of initial administration to the first time of relapse (platelet count <30×109/L). Results Twelve consecutive patients were enrolled from June 2012 to June 2013, 6 women and 6 men. The median age at diagnosis was 50 years (range, 20 - 80 years). The median platelet count at diagnosis was 7 x 109/L (range, 2 - 29 x 109/L). Patients were followed for a median of 2.5 months (range 1.1 - 13). After steroid treatment at day +5, ten patients had responded (83.3%), five had achieved CR (41.7%), and five PR. After completing treatment with eltrombopag at day +34, all patients responded (100%), nine patients achieved CR (75%) and three PR (25%). Two patients relapsed in a median time of 39.5 days (range, 30.1 - 49), both regaining CR after treatment with another high-dose dexamethasone course and low-dose rituximab (4 doses of 100 mg every week). At 3 months follow-up 66.7% remained in CR and 33.3% in PR (n=6). At 6 months follow-up two patients remained in CR and two in PR (n=4). Time to best response achieved was 34 days from diagnosis (range, 19 – 64.1). At the end of follow-up 9 patients (75%) remained in CR and 3 patients in PR (25%). Total treatment cost per patient was $1,640 approximately. Conclusion Currently the initial treatment of ITP patients is based on prednisone or high dose dexamethasone with or without IVIG. This approach is associated with high cost and high relapse rate. The results from our pilot study suggest that high dose dexamethasone and eltrombopag are very effective as first line treatment for acute ITP in adults. This treatment is ambulatory, affordable and well tolerated; however, we still don't know if this approach will have a favorable impact on the relapse rate of this disease. Disclosures: Off Label Use: Eltrombopag as first line treatment for ITP.

scholarly journals Romiplostim Treatment Pattern of Adult Chronic Immune Thrombocytopenia in Routine Clinical Care in Three Nordic Countries

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4998-4998
Author(s):  
Mette Nørgaard ◽  
Nickolaj Risbo Kristensen ◽  
Henrik Frederiksen ◽  
Shahram Bahmanyar ◽  
Waleed Ghanima ◽  
...  
Keyword(s):  
Platelet Count ◽  
Research Funding ◽  
Clinical Care ◽  
Previous Treatment ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Platelet Counts ◽  
Clinically Significant ◽  
First Line Treatment

Abstract Introduction Romiplostim was approved in 2009 in Europe for treatment of adult chronic immune thrombocytopenia (cITP) in splenectomized patients, refractory to other ITP treatments, and as second-line treatment for adult non-splenectomized patients. In 2016 the indication was extended to second-line treatment in all cITP patients. Few data exist on how romiplostim is used in routine clinical care. Methods To examine romiplostim treatment patterns we used the Nordic Country Patient Registry for romiplostim (NCPRR). NCPRR was established in 2009 and includes all adult (≥18 years) patients in Denmark, Sweden and Norway with a confirmed cITP (ITP lasting >6 months) diagnosis requiring hospital contact. The cohort is based on data from national health registries and enriched by medical record review. All patients diagnosed with cITP from April 1, 2009 to December 31, 2016 (data cut-off) are included. We describe age, comorbidity, previous treatment, platelet level, and both romiplostim dose and duration in patients who started romiplostim after date of their cITP diagnosis by line of treatment. Results Among 2895 patients diagnosed with cITP: 103 patients started romiplostim treatment before the data cut-off. Of these, 40% were aged 18- 50 years old, 30% were 35-70 years old, and 30% were ≥71 years. A total of 76% had no recorded comorbidity. Romiplostim was first-line treatment in 8 cITP patients of whom one had been splenectomized. In the month before romiplostim start, six of these patients (75%) had platelet count <50x109/L, but only one patient had experienced clinically significant bleeding (see Table). Twenty cITP patients started romiplostim as second-line treatment: duration of non-romiplostim first-line treatment had been <3 months in 50%, 3-12 months in 25%, and ≥12 months in 25%. Fourteen (70%) second-line romiplostim patients had obtained a platelet count of >150x109/L during their first-line treatment. In the month prior to romiplostim initiation, 3 (15%) patients experienced a bleeding event, while median latest platelet count was 10 x109/L (inter quartile range, IQR :10, 38). Romiplostim was third-line treatment in 44 patients: in the month prior to initiation, median latest platelet count was 15 x109/L (IQR: 10-32), and 20 (46%) patients experienced clinically significant bleeding events. Duration of non-romiplostim second-line treatment was ≤1 month in 33 patients (75%) and between 1-6 months in 20%. During their second-line treatment, 17 (39%) patients did not reach a platelet count of >50x109/L and 15 (34%) had a highest platelet count of 50 to 150x109/L. In the remaining 31 romiplostim-treated patients, it was used as fourth or later treatment line: median latest platelet count in the month preceding initiation was 14 x109/L (IQR: 5-27), with 7 (22.6%) patients experiencing clinically important bleeding during this time. Duration of the previous treatment in these patients had been ≤1 month in 16 (52%) and 1- 3 months in 12 (39%) patients. During their previous line of treatment 14 (45%) patients did not reach a platelet count of >50x109/L and an additional 9 (29%) had a highest platelet count of 50 to 150x109/L. In patients initiating romiplostim at first-line, median maximum platelet count while on therapy was 147x109/L (IQR: 109-237): this value was 299x109/L (IQR: 187,752), 295x109/L (IQR: 107,454), and 132x109/L (IQR: 52-305) for second, third, and fourth-or-later lines respectively. Median duration of romiplostim therapy was shortest at first-line (37 days, IQR: 21-180), and longest at second-line (91 days, IQR: 21, 169). Two patients on second-line, and 8 patients on third-line eltrombopag, switched to romiplostim. Conclusion Approximately 4% of cITP patients were treated with romiplostim, predominantly at third or later treatment lines: median platelet counts were seen to improve from <20 x109/L prior to romiplostim initiation to >100x109/L while on therapy across all lines. Romiplostim treatment had a relatively short duration. However, romiplostim-treated patients were characterized by a short duration on their previous non-romiplostim treatment line, and a high proportion had low platelet counts during this prior treatment. These data indicate that romiplostim is effective at increasing platelet counts in cITP patients with varying clinical history. Larger studies are needed to confirm these results and investigate drivers at different lines of therapy. Disclosures Bahmanyar: Amgen: Research Funding. Ghanima:GlaxoSmithKline and Pfizer: Other: Personal Fees; Roche, Amgen, Novartis, Bayer, BMS: Other: Personal Fees, Research Funding. Alam:Amgen: Employment, Equity Ownership. Christiansen:Amgen: Research Funding.

Hydroxychloroquine for the Treatment of Immune Thrombocytopenia Associated with Antinuclear Antibody in Patients Refractory to First-Line treatments .

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2414-2414
Author(s):  
Amélie Chabrol ◽  
Matthieu Mahévas ◽  
Nicolas Limal ◽  
Medhi Khellaf ◽  
Philippe Bierling ◽  
...  
Keyword(s):  
Platelet Count ◽  
Immune Thrombocytopenia ◽  
Response Rate ◽  
Oral Prednisone ◽  
Line Treatment ◽  
Definite Diagnosis ◽  
Systemic Lupus ◽  
First Line ◽  
First Line Treatment

Abstract Abstract 2414 Poster Board II-391 Background and objective: Although, corticosteroids (CS) are commonly used as the first-line treatment for lupus-associated immune thrombocytopenia (ITP), few patients fail to respond to CS and a majority of the responders relapse when CS are withdrawn. Hydroxychloroquine (HCQ) is commonly used in both cutaneous and systemic lupus due to its immunomodulatory properties. In a previous report on lupus-associated immune thrombocytopenia (ITP), it has been suggested that HCQ could have an effect on the platelet count in this setting (Arnal C et al. J Rheumatol 2002). The objective of the study was to better assess the efficacy of HCQ as a treatment of ITP associated with positive antnuclear antibody (ANA) in patients who failed to achieve a durable response after a first-line treatment. Patients and Methods: This single centre retrospective study was conducted at the French national referral center for adult's immune cytopenias. To be included in the study, all patients had to fulfil the following criteria: 1) Definite diagnosis of ITP with a platelet count < 50 × 109/l at diagnosis 2) Positive ANA at a significant titer (i.e ≥ 1/160 on Hep2 cells), with or without a definite diagnosis of systemic lupus erythematosus (SLE) according to the ACR-revised criteria and 3) No response or incomplete response to at least one previous treatment-line. Response to HCQ was considered when the platelet count was persistently (at least for 3 consecutive months) maintained above 150×109/l (complete response: CR), and when the platelet count increased and persisted above 30 × 109/l with at least a doubling of the baseline count (partial response: PR). Results: The data from 40 patients (32 F, 8 M) with a median age of 35 yrs (range: 15-75) were analyzed. The median platelet count at ITP diagnosis was 13×109/l (range: 1-46). Twelve (30%) patients had a SLE-associated ITP (4 or more SLE ACR-criteria) whereas 28 patients (70%) had positive ANA without definite SLE. The median HCQ dose was 200 mg bid (200 to 600 mg/d) and the median time between ANA-associated-ITP diagnosis and HCQ first administration was 4 months (range: 1-120). HCQ was given after failure of a median of 2 treatment-lines [1 to 5 including oral prednisone (n=39), IVIg (n=15), danazol (n=5), dapsone (n=2), splenectomy (n=2), anti-D (n=1) and immunosuppressive agents (n=2)]. HCQ was given in combination with other treatments in 36 patients (90%) including oral prednisone (n=36) (median initial dose: 50 mg/day, range: 30 to 65 mg/day), dapsone (n=8), danazol (n=5). The median duration of HCQ treatment was 5 years (range: 0.4 to 12 yrs). The overall response rate for was 60% (24/40), with 18 CR and 6 PR. All the responses were sustained with a median follow-up of 64 months (range: 6 to 146 mths). At the end of the follow-up period, all concomitant therapies could be either stopped (n = 29 patients) or tapered [n = 7 patient left on low dose of prednisone (less than 10 mg/d)]. The response rate was significantly higher in the SLE group (83%; 10/12) when compared to the ANA-positive group (50%; 14/28) (p <0.05). The overall safety of HCQ was good and none of the patients stopped the treatment because of a side-effect. Blood HCQ concentration was checked in 2 non-responding patients and was found below therapeutic range in both cases. Conclusion: This retrospective study strongly suggests that HCQ is a safe, and effective treatment for ITP patients with high titer of ANA who failed to achieve a lasting response after a first-line treatment and mainly after CS. HCQ appears particularly attractive in the subgroup of patients who fulfil the SLE ACR-revised criteria. This costless treatment should therefore be systematically considered in this setting regardless SLE-activity. Moreover, it is likely that HCQ may also be helpful as a corticosteroid-sparing strategy in patients with chronic ITP and positive ANA but this observation needs further confirmation throughout a prospective analysis. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Postinfectious Olfactory Dysfunction: Oral Steroids and Olfactory Training versus Olfactory Training Alone: Is There any Benefit from Steroids?

ORL ◽  
2021 ◽  
pp. 1-8
Author(s):  
Sotiria Genetzaki ◽  
Evangelia Tsakiropoulou ◽  
Vasilios Nikolaidis ◽  
Konstantinos Markou ◽  
Iordanis Konstantinidis
Keyword(s):  
Olfactory Dysfunction ◽  
Olfactory Function ◽  
Line Treatment ◽  
First Line ◽  
Olfactory Testing ◽  
Significant Difference ◽  
Oral Steroids ◽  
Group A ◽  
Olfactory Training ◽  
First Line Treatment

<b><i>Introduction:</i></b> There are limited treatment options for postinfectious olfactory dysfunction (PIOD). Olfactory training has recently been used in clinical practice, but no medical treatment is widely accepted. Although there is weak evidence for their value, some physicians use oral corticosteroids as first-line treatment. The aim of this study was to compare combined oral methylprednisolone and olfactory training with olfactory training alone in the management of PIOD. <b><i>Methods:</i></b> This prospective cohort study included 131 patients with PIOD over a 2-year period before the COVID-19 pandemic. Seventy-eight patients who were treated with oral methylprednisolone and olfactory training (group A) were compared with 53 patients who were treated with olfactory training only (group B). Olfactory function was evaluated with “Sniffin’ Sticks” at baseline and 2, 8, and 16 weeks after initial assessment. Patients who improved after steroid treatment underwent magnetic resonance imaging of the paranasal sinuses, skin prick tests, lung spirometry, and sputum eosinophil assessment. <b><i>Results:</i></b> Oral steroids improved 19.23% of patients (<i>n</i> = 15) of group A. History, clinical evaluation, imaging, and laboratory tests identified an inflammatory background in half of them (<i>n</i> = 8). The remaining 7 had no findings of nasal inflammation, and all had a short history of olfactory dysfunction. Both groups significantly improved in olfactory testing results at the end of the olfactory training scheme without significant difference between them. <b><i>Conclusions:</i></b> The percentage of improved patients after oral methylprednisolone was relatively low to suggest it as first-line treatment. Half of the improved patients had an underlying upper airway inflammatory condition not related to the infection that caused the acute loss of olfactory function.

Clinical Features and Effects of Eradication on Helicobacter Pylori Positive 207 ITP Cases in Japan.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 2071-2071
Author(s):  
Kingo Fujimura ◽  
Masataka Kuwana ◽  
Yoshiyuki Kurata ◽  
Masahiro Imamura ◽  
Hiroshi Harada ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Platelet Count ◽  
Eradication Therapy ◽  
The Other ◽  
First Line ◽  
Platelet Counts ◽  
Count Response ◽  
Successful Group ◽  
H Pylori ◽  
Over 40 Years

Abstract In 1998, Gasbarrini et al reported that in ITP cases with Helicobacter pylori (H.pylori) infection, elevation of platelet counts was observed by eradication of this bacterium. Since then, several reports from Italy and Japan confirmed the elevation of platelet counts after eradication. However, the characteristic background in the H.pylori positive ITP and eradication effects on platelet counts is unclear. On the other hand, reports from Spain, North Europe and USA could not show the evidence that eradication is effective on elevating platelet counts in H.pylori positive ITP. Therefore, we designed a nationwide retrospective study in Japan to evaluate the incidence of H.pylori positive ITP cases and the effects of eradication on platelet counts and to clear above problems. Four hundred and thirty-five ITP cases were enrolled over a period of one and half years (2002. 7~2003.12) from 12 hospitals. H. pylori infection was found in 300 cases(65%), who were significantly (P<0.005) older and showed hyperplastic megakaryocyte in bone marrow (P=0.011) comparison with negative cases. Eradication to H. pylori was performed in 207 H. pylori positive ITP cases and as a whole, the platelet count response was observed in 63% of eradication succeeded group. In the successful group, CR and PR rate were 23% and 42% respectively at 12 months after eradication. The platelet count response was significant in the successfully eradicated group (P<0.005) and the increased platelet count was maintained without ITP treatment for over 12 months. In conclusion, H. pylori infection was involved in most ITP patients over 40 years old in Japan and eradication therapy proved effective for increasing platelet counts even in splenectomy non-responsive cases and the platelet count response appeared one month after eradication. This evidence suggests that eradication therapy is the first line of treatment in H. pylori positive ITP patients.

Rituximab (Mabthera) Improves the Treatment Results of DHAP-VIM-DHAP and ASCT in Relapsed/Progressive Aggressive CD20+ NHL. A Prospective Randomized HOVON Trial.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 328-328 ◽  
Author(s):  
Edo Vellenga ◽  
Annelise Notenboom ◽  
Mars van ‘t Veer ◽  
Josée Zijlstra ◽  
Willem E. Fibbe ◽  
...  
Keyword(s):  
Disease Free Survival ◽  
Response Duration ◽  
Rank Test ◽  
P Value ◽  
Line Treatment ◽  
First Line ◽  
Post Transplantation ◽  
Free Survival ◽  
Significant Difference ◽  
First Line Treatment

Abstract A total of 239 patients with relapsed/progressive aggressive CD20+ NHL after/during adriamycin containing regimens, were recruited to the randomized HOVON-44 trial comparing DHAP-VIM-DHAP followed by BEAM and autologous stem cell re-infusion (ASCT)(“DHAP-arm”) with DHAP-VIM-DHAP in conjunction with Rituximab (375 mg/m2) and ASCT (“R-DHAP arm”). Of the included patients, 202 were evaluable and randomized to the DHAP arm (n=101) or R-DHAP arm (n=101). Only patients with CR/PR after two courses of intensive chemotherapy were eligible for ASCT. Patients were well balanced for risk factors. In both arms the majority of patients had not been exposed to Rituximab during first line treatment. As of July 2006, median follow-up of all patients still alive is 24.5 months. After two courses of chemotherapy PR/CR was obtained in 49 % of the patients in the DHAP arm and 77% in the R-DHAP arm (p=<.01;intention to treat analysis). Post-transplantation PR/CR was obtained in 41% and 58% of the patients respectively (p=.40). A significant difference between both arms was observed for failure free survival (FFS), disease free survival (DFS) and overall survival (OS) in favor of the Rituximab arm (p<.05, table 1). The less pronounced difference in OS between both arms is most likely due to the fact that non-responding or relapsing patients in the DHAP arm received salvage treatment with a Rituximab containing regimen. Additionally, a subgroup analysis was performed according to type of response to first-line treatment:1) Response duration more than 3 months (n=138); 2) Progression or response duration less than 3 months (n=64). Within both subgroups, the hazard ratio’s for the endpoints were of equal magnitude (.40–.60), indicating that the beneficial effect of Rituximab existed in both subgroups. In conclusion these results demonstrate that the addition of Rituximab to second line of chemotherapy followed by ASCT results in a significant improved FFS, DFS, and OS in patients with relapsed/progressive aggressive CD20+ NHL. Table 1 FFS DFS OS *: 2 years estimate DHAP-arm* 21% 46% 48% R-DHAP arm* 52% 82% 62% Hazard ratio .40 .32 .61 p-value log rank test <0.001 0.003 0.03

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