scholarly journals Report on the Treatment of Hodgkin Lymphoma with ABVD Chemotherapy at Two Rural District Hospitals in Rwanda

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4053-4053
Author(s):  
Cyprien Shyirambere ◽  
Rebecca Deboer ◽  
Yvan Butera ◽  
Caitlin Driscoll ◽  
Jean Bosco Bigirimana ◽  
...  

Background: While Hodgkin lymphoma (HL) is highly curable with standard chemotherapy in high-resource settings, there are few reports of HL treatment in low-resource settings. In Rwanda, a treatment protocol using six cycles of ABVD chemotherapy (doxorubicin, bleomycin, vinblastine, dacarbazine) without radiotherapy has been implemented at two rural district hospitals. Here we report on the feasibility of this approach, our patient characteristics, and outcomes. Methods: We conducted a retrospective cohort study of all patients with biopsy-confirmed HL seen at Butaro and Rwinkwavu hospitals between October 2009 and June 2018. Data were extracted from clinical charts and analyzed using descriptive statistics and Kaplan-Meier logrank testing. Results: Ninety HL patients were seen at Butaro (n=85) and Rwinkwavu (n=5); 58% male, median age 16 (IQR 10.6-30.5) with 54% under age 18. Eleven (12%) were HIV positive. Mean duration of presenting symptoms at the time of intake was 54 weeks; 70% had B symptoms. Nodular sclerosis was the predominant histological subtype (47%) followed by mixed cellularity (28%). Of 24 biopsy specimens evaluated for EBV, 14 (58%) were positive, 10 (42%) negative. Most patients were staged with chest x-ray (81%); fewer had abdominal ultrasound (34%), CT (21%), or bone marrow biopsy (20%). Resulting Ann Arbor stages were I (17%), II (28%), III (32%), IV (20%), and undetermined (3%). Median time from initial biopsy to first dose of ABVD was 6.1 weeks (IQR 3.6-11.9). Of 76 patients who started ABVD, 56 (74%) completed all 6 cycles; the leading reasons for discontinuation were loss to follow up (n=9) and death (n=7). Median time to completion of the 24-week ABVD regimen was 26.1 weeks; 51 patients (67%) experienced at least one treatment delay. Neutropenia, social factors, and infection were the most common reasons for delays. Dose reductions were rare. Mean dose intensity over 6 cycles was 87.2% calculated per Owadally, et al. 2010; <86% in 40% of patients, 86-97% in 32%, and >97% in 28%. Of the 76 patients started on ABVD, 34 (45%) are in clinical remission, 21 (28%) are deceased, 2 (3%) referred to palliative care, and 19 (25%) are lost to follow up at a median interval of 48 months from intake. Univariate analysis demonstrates that stage III-IV (p=0.0000), ECOG performance status 2-4 (p=0.0004), hemoglobin <10.5 g/dL (p=0.01), WBC > 15,000 mm3 (p=0.05), B symptoms (p=0.004), and extranodal disease (0.0004) were associated with worse survival. Conclusions: We observed a strikingly younger age distribution in our cohort compared to the classic bimodal distribution reported in high income countries, suggesting biologic differences that warrant further investigation. Treating HL with standard chemotherapy in a low-resource setting through international partnership is feasible, and nearly half of patients who complete treatment may experience a clinically significant remission with this approach. Late presentation, treatment delays, and loss to follow up are among major reasons to explain the discrepancy in survival compared to high income countries. Further efforts should tackle these identified barriers to achieve better survival outcomes. Figure Disclosures No relevant conflicts of interest to declare.

2016 ◽  
Vol 2 (3_suppl) ◽  
pp. 67s-67s ◽  
Author(s):  
Rebecca J. DeBoer ◽  
Caitlin D. Driscoll ◽  
Yvan Butera ◽  
Jean Bosco Bigirimana ◽  
Clemence Muhayimana ◽  
...  

Abstract 34 Background: While Hodgkin lymphoma (HL) is highly curable with standard chemotherapy in high resource settings, there are few reports of HL treatment in low resource settings. In Rwanda, a treatment protocol using six cycles of ABVD chemotherapy (doxorubicin, bleomycin, vinblastine, dacarbazine) without radiotherapy has been implemented at two rural district hospitals. Here we report on the feasibility of this approach, our patient characteristics, and preliminary outcomes. Methods: We conducted a retrospective cohort study of all patients with biopsy confirmed HL seen at Butaro and Rwinkwavu hospitals between June 2012 and August 2015. Data was extracted from clinical charts and analyzed using descriptive statistics. Results: 43 HL patients were seen at Butaro (n=38) and Rwinkwavu (n=5); 58% male, median age 17 (range 4-54). Five (12%) were HIV positive. Of 22 patients with biopsy specimens evaluated for EBV, 12 (55%) were positive, 9 (41%) negative, and one indeterminate. Most patients were staged with chest x-ray (79%); fewer had liver ultrasound (33%) or CT (9%). With that, Ann Arbor stages were I (28%), II (23%), III (21%), IV (21%), and undetermined (7%). Of 39 patients who started ABVD, 25 (64%) completed all 6 cycles. Median time to completion of the 24 week ABVD regimen was 26.1 weeks (IQR 25-27); 26 patients (67%) experienced at least one treatment delay. Dose reductions were rare. At the time of data extraction, 5 (12%) were still on treatment, 18 (43%) in remission, 2 (5%) alive with relapse, 15 (35%) deceased, and 2 (5%) lost to follow up. Conclusions: Here we demonstrate the feasibility of treating HL with standard chemotherapy in a low resource setting through international partnership. Our preliminary results suggest that a majority of patients who complete treatment may experience a clinically significant remission with this approach. Further data analysis will identify areas for improvement with the hope of increasing sustained remissions. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST: No COIs from the authors.


Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 2137-2137
Author(s):  
Francois Guilhot ◽  

Abstract Imatinib (IM) and interferon alfa plus cytarabine (IFN+Ara-C) were compared in the phase 3 IRIS trial, which enrolled 1106 patients (pts) with newly diagnosed CML-CP. Pts were allowed to cross over to the alternative treatment arm provided intolerance to treatment was indicated and/or efficacy landmarks were not met. All crossover requests required approval by the Study Management Committee according to strict criteria. Reasons for crossover were amended during the trial to include reluctance to continue IFN+Ara-C. The status of the 553 pts randomly assigned to receive 1st-line IFN+Ara-C and the reasons for crossover to IM are summarized in Table 1. Table 1: Status of IFN + Ara-C pts* Randomly assigned to 1st-line IFN + Ara–C N = 553 * Analysis as of 31-Jan-06 On 1st-line IFN + Ara-C 16 (2.9%) Discontinued from the study 178 (32.2%) Crossed over to IM 359 (64.9%) – Intolerance of treatment 144 (26%) – No CHR at 6 or 12 mos 44 (8.0%) – No MCyR at 12 or 24 mos 53 (9.6%) – Reluctance to continue on IFN + Ara-C 41 (7.4%) – Progression 77 (13.9%) = Increase in WBC 25 (4.5%) = Loss of CHR 29 (5.2%) = Loss of MCyR 23 (4.2%) On 2nd-line IM at 60 mos 251 (45.4%) The median time on IFN+Ara-C treatment before crossover was 9 months (mos), the median time since diagnosis was 13 mos at start of 2nd-line IM. The median time on 2nd-line IM was 45 mos (average 40 mos), with a maximum of 63 mos as per data cutoff 31-Jan-06. About one third of pts discontinued 2nd-line therapy: reasons were unsatisfactory therapeutic effect (13%), adverse events (4%), death (1%) and others (12%) including withdrawal of consent, BMT, loss to follow-up. A total of 251 pts remain on 2nd-line IM. Among 359 pts treated with 2nd-line IM, the best observed CHR rate was 93%, the best observed MCyR rate was 86%, and the best observed CCyR rate was 80%. The CCyR rate was 95% in pts who were reluctant to continue on IFN+Ara-C arm, 82% in intolerant pts, 78% in pts with lack of response on IFN+AraC and 71% in pts who progressed on 1st-line IFN+Ara-C. After 18 mos of 2nd-line IM therapy, the estimated rate of freedom from progression to AP/BC was 94%, and the estimated overall survival rate was 97%. These data are consistent with a previous trial of IM in pts with CML-CP after failure of prior IFN in which an estimated 89% of pts were free from progression to AP/BC, and an estimated 95% were alive, after 18 mos (Kantarjian NEJM 2002). In this trial, median time from diagnosis and median duration of prior IFN therapy were 34 and 14 mos, respectively. Table 2 compares 1st-line and 2nd-line IM results in the IRIS trial. Table 2: Comparison of Long-Term Results at 48 mos* 1st-line IM (N= 553) % [CI] 2nd-line IM (N=359) % [CI] * Analysis as of 31-Jan-06 Estimated survival w/o progression to AP/BC 93.3 % [91, 96] 90.3% [86, 94] Estimated overall survival 90.4% [87, 93] 89.2% [85, 93] The 48-mos rates of freedom from progression to AP/BC (overall survival) were 97% (96%) in pts who were reluctant to continue on IFN+Ara-C arm, 93% (90%) in intolerant pts, 90% (88%) in pts with lack of response on IFN+Ara-C and 80% (85%) in pts who progressed 1st-line IFN+Ara-C. The adverse event profile was similar between 1st- and 2nd-line IM therapy. CML-CP pts treated with 2nd-line IM after IFN+Ara-C achieved high response rates that are durable; the vast majority of pts remain free from progression to AP/BC after median follow-up of nearly 4 years. However, the overall efficacy results were better for 1st-line IM pts in newly diagnosed CML-CP.


Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 4326-4326
Author(s):  
Malek Benakli ◽  
Redhouane Ahmed nacer ◽  
Amina Talbi ◽  
Rachida Belhadj ◽  
Farih Mehdid ◽  
...  

Abstract Abstract 4326 Background Patients (pts) with recurrent and refractory haematological lymphoid malignancy (HLM) have a very limited survival expectance. RIC allo-SCT has been proposed as a strategy for retaining the graft versus malignancy effect of allo-SCT while decreasing transplant related mortality (TRM). Here, we retrospectively studied a series of 32 pts treated by RIC allo-SCT. Patients and methods Between April 2001 and November 2007, 32 pts with HLM underwent RIC allo-SCT with an HLA-identical sibling donor. Fifteen pts with multiple myeloma, 7 pts with Non-Hodgkin lymphoma, 6 pts with Chronic lymphoid leukaemia, 3 pts with Hodgkin lymphoma and 1 pt with Waldenstrom disease. At time of allo-SCT, 10 pts were in complete remission (3 received prior autologous transplant) and 22 in refractory/progressive disease (6 received prior autologous transplant). Median age was 38 years (range, 28-60) and the sex-ratio (M/F) 2,2. Median time from diagnosis to RIC allo-SCT was 18 (range,6-76) months. The conditioning regimen included Fludarabine 150mg/m2 and Melphalan 140mg/m2. GVHD prophylaxis consisted of association cyclosporine (cSA) and mycophenolate (MMF). All pts received G-CSF mobilised peripheral blood stem cells, with a median CD34+ cell count: 6,2.106/kg (range, 1.9-13,6). Results Neutropenia occurred in all pts (100%) and the median duration of aplasia was 9 (range, 5-16) days. Only 10 pts (31 %) required red blood cells transfusions and 23 pts (71 %) needed platelets transfusions. Acute GVHD was observed in 15 cases (47 %) including 10 cases of grade II-IV. Fifteen pts (75 %) had chronic GVHD, of whom 9 with an extensive form. Four pts (12 %) had CMV reactivation at a median time 60 (range, 52-80) days after transplantation. Six pts (18 %) had late onset relapse at a median time of 13 (range, 4-45) months. TRM was 43 % at one year after RIC allo-SCT. With a median follow-up of 60 (range 18-97) months, 12 pts (37,5 %) are still alive in complete remission with full donor chimerism. Twenty pts (62,5 %) have died (5 early severe infections, 10 GVHD, 3 after relapse, one myocardial infarction, and one accident). Overall and progression-free survivals at 8 years are 31 % and 30 % respectively. Conclusion This study, after a large follow-up, suggests that RIC allo-SCT is a potential therapy for refractory or progressive HLM. However, TRM is still high likely due to the inclusion of refractory and heavily pretreated pts with many comorbid conditions. Disclosures: No relevant conflicts of interest to declare.


2011 ◽  
Vol 17 (1) ◽  
pp. 82-93 ◽  
Author(s):  
Amin S. Hassan ◽  
Katherine L. Fielding ◽  
Nahashon M. Thuo ◽  
Helen M. Nabwera ◽  
Eduard J. Sanders ◽  
...  

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 2845-2845
Author(s):  
Xin Li ◽  
Qian Cheng ◽  
Rui Liu ◽  
Liqing Kang ◽  
Nan Xu ◽  
...  

Abstract Background: CD20 antibody-based chemotherapy has been verified as a valid strategy and prolonged the overall survival (OS) of CD20(+) B-cell Non-Hodgkin Lymphoma (B-NHL) patients. However, over 40% of these patients finally would be relapsed or refractory(R/R) to CD20 antibody rituximab. Treatment of these R/R B-NHL patients has not been standardized yet. Furthermore, it is still a question that whether CD20-specific CAR T-cells could provide an alternative therapy in rituximab-relapsed/refractory B-NHL patients. Methods: Here, we conducted a prospective single-center study on patients with relapsed/refractory to CD20 antibody(No.ChiCTR2000036350). The aim of this study aims was to evaluate the efficacy and in vivo persistence of CART-20 cells in subjects with rituximab R/R CD20(+) B-NHL patients. Between October 2017 to December 2020, 15 patients with R/R B-NHL patients (including 14 DLBCL patents and 1 MCL patient) received anti-CD20 specific CAR T cell therapy. The efficacy of CAR T-cells therapy was evaluated at different assessment points by CT scan or 18FDG-PET. CAR-T expansion in blood was monitored regularly by real-time quantitative PCR (qPCR). Results: In this study, the clinical characteristic of these enrolled patients was a median age at 48 years (range 30 to 66), male n=7(47%). 10 (67%) patients were relapsed and 5 patients (33%) were refractory to rituximab-based chemotherapy.(Table 1) All of these patients were at advanced stage III/IV and 7 (47%) of them were diagnosed with bulky disease. The median time from latest rituximab utilization is 70 days (rang 31-471 days) before CAR T-20 cells infusion. The median number of lines of previous treatments was 4 (2-8). 14 patients (93%) received CAR T-20 with a dose of 1*10^7/kg, the median follow-up time for patients was 219 days (32 to 1231). CRS (100%) was observed in all 15 infusion patients: 11 patients grade I-II and 4 patients' grade ≥III. ICANS was recorded only in 1 patient (grade I). At 30 days after the infusion, the clinical response of all 15 infusion patients could be assessed: 4 (27%) CR, 11 (73%) PR, and ORR 100%.(Figure 1) 5 patients who were in PR at 30 days converted to CR, with a median time of 116 (6-858), and continued follow-up without relapse; 6 patients (40%) had relapse, with a median relapse time of 136 days (48- 1050), this might be related to the short time of rituximab before the CAR-T infusion.Although the cases are limited, we can still draw a preliminary conclusion that the use of rituximab within three months may not affect the efficacy of CD20-CAR-T, but may lead to early recurrence. Furthermore, the persistence time of CART-20 cells were comparably longer than that CART-19 cell infusions. Conclusions: In conclusion,these findings suggest that the use of CAR T-20 can be served as a salvage therapy in Rituximab-refractory CD20(+) B-cell Non-Hodgkin Lymphoma and raises the possibility of using CAR T-20 in an early disease stage. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.


Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 5506-5506
Author(s):  
Emilia Cocorocchio ◽  
Fedro Peccatori ◽  
Simona Bassi ◽  
Federica Gigli ◽  
Davide Radice ◽  
...  

Abstract We report retrospective data concerning 49 relapsed or refractory Hodgkin lymphoma pts, treated from 1995 in our institution with high dose chemotherapy (HDCT) with autologous peripheral blood stem cell (aPBSC) support. 41/49 had resistant disease, because presenting an early relapse (14/41), a late relapse (12/41) after CR induced by standard chemotherapy (CT) or persistence of disease (15/41) after initial CT. 8/49 had refractory disease, presenting stable or progressive disease within three months after the end of first line CT. Median age at transplantation time of 32 yrs (range 18–58 yrs). Before high dose chemotherapy, all pts received at least a standard chemotherapy (hybrid regimen for 4–6 cycles ± RT, according to the extension of disease). At the time of transplantation, 13 pts were in complete remission, 31 were in partial or very good partial remission and 5 were in stable /progressive disease. We used as myeloablative regimen mainly HDBEAM. Radiotherapy was performed in 9 pts after transplantation. In the subgroup of the 26 relapsed pts, 21 achieved a CR, 2 a PR and 3 a PD/SD; with a median follow up of 23 months from transplant (range 2 – 112 months), expected DFS and OS at 10 years are 90.5% and 76.9%, respectively. Analyzing separately early versus late relapsed patients, DFS expected at 10 years are 81.8% and 100%, respectively, and the OS expected are 71.4 and 83%, respectively. 11/15 pts with persistence of disease after initial CT achieved a CR, 2 PR, 2 presented SD/PD; with a median follow-up of 32 months from transplant (range 2 – 88 months), expected DFS and OS are 90.9% and 75%, respectively. Finally, 5/8 refractory pts achieved a CR (two of them progressed after transplant), 2 pts a PR (both progressed and died after transplant), 1 patient obtained a SD (progressed and died after transplant). No toxic deaths or second cancer or other severe late toxicity were recorded. Autologous transplantation is a safe procedure, considering the manageable early and late toxic effect; the clinical results achieved indicate that HDCT with aPBSC support is to be considered the first therapeutic option for those pts who present an early or late relapse after standard chemotherapy. The low number of refractory pts doesn’t allow any definitive conclusion about its role in this subgroup, but the relative high number of events observed seems to suggest that further analysis of biological features are warranted in order to better define the best therapeutic option.


Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 3646-3646
Author(s):  
Silvia Montoto ◽  
Kate Shaw ◽  
Jessica Okosun ◽  
Shreyans Gandhi ◽  
Paul Fields ◽  
...  

Abstract Abstract 3646 Background: The prognosis of patients with HIV and non-Hodgkin lymphoma (NHL) has improved considerably since the advent of HAART, approaching that of patients with NHL in the general population when treated with the same chemotherapy regimens. However, it is not clear whether the same holds true for patients with Hodgkin lymphoma (HL). Aim: To analyze the outcome of patients diagnosed with HL treated with ABVD in the HAART era according to HIV status. Patients: From 1997 to 2010, 237 patients (92 with HIV infection) were newly diagnosed with HL at 5 university hospitals in London and consecutively treated with ABVD chemotherapy. Patients with HIV were older (median age: 41 years vs 31, p<0.001) and more were men (88% vs 59%, p<0.001). The histology subtype was more frequently mixed cellularity in HIV patients (54%) than in non-HIV (19%, p<0.001). In addition, HIV positive patients had more advanced stage at diagnosis (stage III-IV: 80% vs 33%, p<0.001), B-symptoms (81% vs 36%, p<0.001), lower Hb level (<10.5g/dL: 46% vs 20%, p<0.001) and lower albumin level (<4g/dL: 76% vs 35%, p<0.001). Patients with HIV infection had more frequently high risk disease according to the International Prognostic Score than HIV negative patients (IPS>3: 71% vs 22%, p<0.001). Amongst HIV patients, the HIV viral load (VL) was undetectable at the time of HL diagnosis in 52 of 86 patients with available data. The median VL for the remainder was 4,563 (range: 3,060–6,066). Forty-seven patients (53%) had a CD4 count <200/mL. All patients were treated with 4–6 cycles of ABVD chemotherapy with or without radiotherapy to residual/bulky areas according to local policies. Ninety patients with HIV infection received HAART concomitantly during chemotherapy. Results: The complete response (CR) rate in HIV positive and negative patients was 74% and 81%, respectively (p=NS). Fifty-one patients (21%) received consolidation radiotherapy. After a median follow-up of 59 months (range: 8–172 months), 40 patients relapsed at a median time of 7 months (range: 1–106). The median duration of response for HIV positive and negative patients was 33 months and 48 months, respectively (p=NS). Thirty-three patients have died: in 25 cases of HL; 2 patients due to toxicity and 5 patients due to other causes. Five-year event-free survival (EFS) was 59% (95%CI: 46–69) for HIV patients and 65% (95%CI: 56–72) for the remainder (p=NS). Five-year overall survival (OS) was 79% (95%CI: 67–87) and 88% (95%CI: 80–92) for HIV positive and negative patients respectively (p=0.06). HIV status did not predict OS or EFS on multivariate analysis including all variables comprising the IPS and HIV status. Conclusions: This long follow-up study demonstrates that patients diagnosed with HL in the setting of HIV infection have a more extensive disease with adverse prognostic factors. However, when treated with ABVD chemotherapy HIV positive status does not adversely affect OS or EFS. Disclosures: Montoto: Roche: Honoraria; Genentech: Research Funding. Orkin:Janssen: Honoraria; Gilead: Honoraria; BMS: Honoraria; BI: Honoraria; MSD: Honoraria; GSK: Honoraria; Viiv: Honoraria. Gribben:Roche: Honoraria; Celgene: Honoraria; GSK: Honoraria; Mundipharma: Honoraria; Gilead: Honoraria; Pharmacyclics: Honoraria.


Heart ◽  
2018 ◽  
Vol 104 (20) ◽  
pp. 1707-1713 ◽  
Author(s):  
Emmanuel K Rusingiza ◽  
Ziad El-Khatib ◽  
Bethany Hedt-Gauthier ◽  
Gedeon Ngoga ◽  
Symaque Dusabeyezu ◽  
...  

BackgroundIn sub-Saharan Africa, continued clinical follow-up, after cardiac surgery, is only available at urban referral centres. We implemented a decentralised, integrated care model to provide longitudinal care for patients with advanced rheumatic heart disease (RHD) at district hospitals in rural Rwanda before and after heart surgery.MethodsWe collected data from charts at non-communicable disease (NCD) clinics at three rural district hospitals in Rwanda to describe the outcomes of 54 patients with RHD who received cardiac valve surgery during 2007–2015.ResultsThe majority of patients were adults (46/54; 85%), and 74% were females. The median age at the time of surgery was 22 years in adults and 11 years in children. Advanced symptoms—New York Heart Association class III or IV—were present in 83% before surgery and only 4% afterwards. The mitral valve was the most common valve requiring surgery. Valvular surgery consisted mostly of a single valve (56%) and double valve (41%). Patients were followed for a median of 3 years (range 0.2–7.9) during which 7.4% of them died; all deaths were patients who had undergone bioprosthetic valve replacement. For patients with mechanical valves, anticoagulation was checked at 96% of visits. There were no known bleeding or thrombotic events requiring hospitalisation.ConclusionOutcomes of postoperative patients with RHD tracked in rural Rwanda health facilities were generally good. With appropriate training and supervision, it is feasible to safely decentralise follow-up of patients with RHD to nurse-led specialised NCD clinics after cardiac surgery.


Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 4790-4790
Author(s):  
Anas Younes ◽  
Luis Fayad ◽  
Jorge E. Romaguera ◽  
Barbara Pro ◽  
Michael Wang

Abstract The safety and efficacy of pegfilgrastim (Neulasta) has been established in association with chemotherapeutic regimens that are repeated every 3 weeks. However, the long-term safety of pegfilgrastim in patients receiving chemotherapy regimens every 2 weeks remains under investigation. Of concern is the possibility of stem cell damage because of the long half-life that may overlap with subsequent courses of chemotherapy. ABVD chemotherapy is widely used for the treatment of patients with Hodgkin lymphoma (HL). Up to 65% of patients receiving ABVD will require growth factor support to maintain dose intensity, prevent neutropenic fever, and to prevent delays in chemotherapy administration. In this study, we used primary prophylaxis of 6 mg pegfilgrastim in first and subsequent cycles of ABVD. Patients were eligible if they were older than 16 years and had previously untreated HL patients who are scheduled to receive standard ABVD chemotherapy, adequate bone marrow reserve (ANC &gt; 1,000/uL, Platelet &gt; 100,000/uL, left ventricular ejection fraction &gt; 50%, serum creatinine &lt; 2 mg/dl, serum bilirubin &lt; 2 mg/dl. They were excluded if they had HIV infection, were pregnant women and women or child bearing age who are not practicing adequate contraception, had prior chemotherapy, severe pulmonary disease including COPD and asthma, or history of prior sensitivity to E. coli derived products. All patients received one fixed dose of 6 mg pegfilgrastim approximately 24 hours after ABVD therapy. CBC was performed on a weekly basis, until completion of therapy, and then was monitored every 3–4 months thereafter. Twenty-five patients are enrolled, all of whom are evaluable for efficacy and toxicity. Median age is 26 (range; 19 – 81 years). Men = 14, women = 11. Twenty three pts completed at least 3 full cycles (6 doses of ABVD), and thirteen Pts completed 6 cycles. A total of 225 doses of ABVD are administered. Day 14 ANC count below 1,000/uL occurred in only 5 doses of ABVD (2%). Non-neutropenic infection developed with 7 doses (3%) requiring delay in the subsequent dose of ABVD beyond day 14. Long-term safety is available on 11 pts who had a follow-up ANC counts beyond one year after completion of ABVD treatment. The median ANC after at least one year of follow up was 2,790/uL (range 1,350 to 7,060/uL). Five pts had a follow up beyond 18 months after completion of ABVD therapy, and their median ANC was 2,300/uL (range: 1,570 to 3,360/uL). Furthermore, PK data from 5 unselected patients were performed on day 14 following the first cycle of ABVD. In all 5 patients, serum pegfilgrastim levels were below clinically significant levels. Our data demonstrate the efficacy of single dose per cycle of pegfilgrastim in maintaining ABVD dose intensity, keeping therapy on schedule, and preventing neutropenic fever. Furthermore, our preliminary long-term follow up data demonstrate the safety of pegfilgrastim administration in conjunction with standard dose ABVD chemotherapy given every 2 weeks.


Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 5454-5454
Author(s):  
Stephen A. Strickland ◽  
Heidi Chen ◽  
Carole Hunt ◽  
Wichai Chinratanalab ◽  
Brian Engelhardt ◽  
...  

Abstract BACKGROUND: Auto-PBSC transplant has replaced auto-BMT. 10–30% of patients (pts) fail to mobilize adequate PBSCs. Previous studies have shown a correlation between infusion of marrow NC doses >2×108/kg recipient body weight and improved marrow engraftment as well as improved disease free survival (DFS). HYPOTHESIS: NC dose in auto-BMT following failed PBSC mobilization is not predictive of marrow engraftment. METHODS: Consecutive pts undergoing high-dose chemotherapy (HDC) and auto-BMT after failed PBSC mobilization were evaluated in this retrospective study. NC dose, CD34+ cell dose, time to neutrophil (ANC) engraftment, time to platelet (Plt) engraftment, and survival were reviewed. Spearman’s correlation was computed. Overall survival (OS) and progression free survival (PFS) were evaluated using Kaplan-Meier plots. RESULTS: 22 pts failed to mobilize PBSC and underwent bone marrow harvest followed by HDC and auto-BMT from 2001 to 2006. 3 pts failed G-CSF and 19 failed cyclophosphamide and G-CSF mobilization. The median age at transplant was 56 yrs (range, 9–69). The diagnoses included Non-Hodgkin lymphoma (NHL;14,64%), Hodgkin lymphoma (4,18%), acute myeloid leukemia (AML;3,14%), and multiple myeloma (MM;1,4%). The median number of salvage regimens prior to attempted PBSC mobilization was 1 (range, 0–4). The median NC and CD34+ cell doses of the marrow stem cell product infused were 3.7×108/kg (range, 1.4–6.8) and 1.0×106/kg (range, 0.3–3.0), respectively. All pts achieved ANC engraftment with G-CSF support at a median time of 20.5 days (range, 13–43). Only 55% (12/22) of the pts achieved Plt engraftment with a median time of 46.5 days (range, 23–92). The NC cell and CD34+ cell dose did not differ significantly in patients with ANC engraftment (≤20 days or >20 days), Plt engraftment (≤45 days or >45 days) or number of salvage regimens (≤1 or >1). There was no correlation between NC dose and time to either ANC engraftment (rho=−0.05, P=0.8) or Plt engraftment (rho=0.6, P=0.9). CD34+ cell dose did not correlate with time to ANC engraftment (rho=−0.2, P=0.4) or Plt engraftment (rho=−0.2, P=0.4). Median follow up was 322 days (range, 53 to 1700). Median overall survival (OS) was 1140 days and median PFS was 509 days (95% CI, 368 to 649). OS and PFS were not impacted by the number of salvage regimens prior to transplant. Overall mortality (OM) was 36% (8/22). Causes of death were progressive disease (6/8,75%) and treatment related mortality (2/8,25%). 10/22 (45%) pts are alive without post-transplant relapse (PTR) at a median follow-up time of 276 (range, 53 to 649). 6 of these 10 pts continue to have Plt counts <100×109/L. CONCLUSIONS: NC or CD34+ cell doses of auto-marrow graft do not correlate with engraftment in pts undergoing HDC and auto-BMT after failed PBSC mobilization. Caution should be exercised in interpreting marrow cell doses in this population. These pts have a high OM and should be appropriately counselled.


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