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  • 1
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    Long Term Survival After High-Dose Chemotherapy with Autologous Hematopoietic Cell Transplantation in Metastatic Breast Cancer.
    American Society of Hematology ; 2012
    In:  Blood Vol. 120, No. 21 ( 2012-11-16), p. 3072-3072
    Details
    In: Blood, American Society of Hematology, Vol. 120, No. 21 ( 2012-11-16), p. 3072-3072
    Abstract: Abstract 3072 In the 1990s, the most common indication for high dose chemotherapy (HDC) and autologous hematopoietic cell transplantation (AHCT) was breast cancer. Several randomized controlled trials for metastatic breast cancer (MBC), performed to address the role of HDC and AHCT, found no survival benefit over conventional therapy. A recently published meta-analysis confirmed a lack of significant survival benefit and failed to identify any subset of patients that benefited from this approach. Many trials of HDC for MBC, however, demonstrate better than expected 10–15 year progression free and overall survival occurring in 5–15% of patients. These data prompted us to evaluate the long term results of treatment with HDC and AHCT in MBC at our institution. Two-hundred eighty five patients underwent HDC followed by AHCT for metastatic breast cancer from 1984–2000. Preparative regimens included STAMP V (cyclophosphamide [Cy], carboplatin, thiotepa [TT] ), n=98; CBT (Cy, carmustine, TT), n=79; busulfan and Cy, n=54; TT, n=27; STAMP I (Cisplatin, Cy, BCNU), n=26; and BCNU, n=1. With a median follow up of 169 months (range 77–283 months) in survivors, 34 (12%) of these patients remain alive. Of the 251 patients who died, 218 (87%) died of relapsed/metastatic disease. Other causes of death included infectious or cardiopulmonary etiologies. Incidence of death from secondary malignancies was less than 1%. Her2 status was unavailable in the majority of the patients, but comparison by age ( 〈 50 and 〉 50) and hormonal status did not demonstrate any significant differences in relapse (p=0.33 and p=0.32 respectively) or survival (p=0.13 and p=0.42). Using Cox analysis, we identified three prognostic factors for survival in multivariable analysis: number of prior chemotherapy regimens (HR 1.48 per 1 regimen increase, p 〈 0.001); disease status, (HR 1.34, p=0.029 for partial response and HR 2.66, p=0.008 for relapsed/refractory disease); and source of hematopoietic cells (HR 2.45, p=0.012 for bone marrow compared to peripheral stem cells). Data regarding number and type of metastatic sites was not available for the entire cohort. Of the 34 long term survivors identified, sufficient data was available on 28 patients. In this cohort, 10 patients had metastatic disease at presentation while 18 patients had recurrent metastatic disease. Of the 10 patients with primary metastatic disease, 4 patients had oligometastatic involvement of the ipsilateral supraclavicular lymph node which would now be classified as stage IIIC disease by current AJCC staging guidelines. Three patients had limited bone disease and 3 had oligometastatic disease that had been resected. Of the 18 patients with recurrent metastatic disease, 9 had local recurrence at the site of the incision or chest wall, and 6 had a single site of recurrence primarily in the lung or loco-regional lymph nodes, also classified as primarily oligometastatic disease. Most of these lesions were surgically resected. Of the remaining patients, one had recurrent lesions in the liver, one had bilateral breast recurrence, and one had recurrence in the lung with additional possible bone involvement. This retrospective evaluation of patients who underwent HDC and AHCT for metastatic breast cancer demonstrates long term survival in a small subset of MBC patients, primarily those with primary or recurrent oligometastatic disease. Previous studies have suggested that oligometastatic breast cancer is a distinct subgroup with long-term prognosis that is superior to MBC. While the use of HDC and AHCT has largely been abandoned in the United States, several recent long term follow up studies such as this one questions its role for select populations. The use of HDC in subsets such as oligometastatic breast cancer may be beneficial, and may warrant further study; however, overall there remains no demonstrable benefit to HDC and long term survival is rare in the population of patients with metastatic disease. Disclosures: No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V120.21.3072.3072
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2012
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  • 2
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    Prognostic Factors for Late Mortality Among Day 100 Survivors after Allogeneic Hematopoietic Cell Transplantation (HCT)
    American Society of Hematology ; 2016
    In:  Blood Vol. 128, No. 22 ( 2016-12-02), p. 4666-4666
    Details
    In: Blood, American Society of Hematology, Vol. 128, No. 22 ( 2016-12-02), p. 4666-4666
    Abstract: Allogeneic HCT is a potentially curative but high risk therapy for patients with hematologic malignancies. HCT recipients are typically followed closely by their transplant center within the first 100 days, and with advances in supportive care, day 100 survival has continued to improve significantly over time. Longer term survival, however, remains a challenge and the factors that predict for later mortality are not well understood. We thus undertook this retrospective analysis to identify prognostic factors for 1-and 2-year survival among day 100 survivors. Of 413 patients that underwent a first allogeneic HCT from 2006 to 2014, 355 survived 〉 100 days post-transplant. Diagnoses included acute myeloid leukemia (N=163), myelodysplastic syndrome (N=89), acute lymphoblastic leukemia (N=62), chronic myeloid leukemia (N=34), or undifferentiated/biphenotypic leukemia (N=7). 34% of patients had high risk, 18% intermediate, and 48% low risk disease by American Society for Blood and Marrow Transplantation (ASBMT) RFI risk category. Median age at transplant was 50 years (range, 18-73). The majority of patients were Caucasian (89.6%). Median household income was $49,980 (range 13,316-112,530) and median distance from transplant center was 46 miles (range, 1-1055). 40% patients had a high HCT co-morbidity index, 32% intermediate and 28% low. 152 (43%) patients underwent a matched related donor, 148 (42%) matched unrelated donor, 36 (10%) umbilical cord blood (UCB), 13 (3%) haplo-identical, and 6 (2%) mismatched unrelated donor transplants. The majority of patients (75%) underwent a myeloablative transplant and bone marrow (BM) (53%) was the primary graft source. Cox proportional hazards was used to identify prognostic variables for 1- and 2-year mortality in the 355 surviving patients using baseline characteristics and factors evaluated at day 100. Baseline characteristics as described above included patient, disease, transplant, and socioeconomic/psychosocial factors. Additional variables evaluated at day 100 included number of readmissions, days hospitalized, GVHD rates, infections, relapse within the first 100 days of transplant, and QOL measures as assessed by the Functional Assessment of Cancer Therapy Bone Marrow Transplantation (FACT-BMT), scored at baseline and day 100. 1- and 2-year mortality was 71%, and 54%, respectively, compared to a day 100 mortality of 86%. Among day 100 survivors, the most common causes of death within the first 2 years were relapse (N=78, 54%), followed by infection (N=24, 17%), pulmonary or other organ failure (N=23, 16%), and GVHD (N=16, 11%). In multivariable analysis evaluating risk factors for mortality among the day 100 survivors, lower income (HR 1.25, P=0.013), high risk ASBMT RFI (HR 1.75, P=0.03), relapse (HR 7.84, P 〈 0.001), and more days hospitalized within the first 100 days (HR 1.19, P=0.003), were associated with increased mortality at 1 year (Table). Similar risk factors were identified for 2-year mortality, however, patients receiving BM and UCB grafts had lower mortality long-term as well. In summary, although relapse remains the biggest cause of treatment failure and mortality after allogeneic HCT, we also highlight findings that increased hospitalization within the first 100 days and low socioeconomic status is associated with worse long-term survival. While early post-transplant care is typically well-coordinated through the transplant center, our findings suggest that patients who may have had complications within the first 100 days and survivors with lower socioeconomic status and potential poor access to healthcare may be at higher risk for longer term complications. Further studies are needed to identify these at-risk, resource limited patients that may benefit from longer and closer follow up or additional interventions to improve long-term post-HCT care and non-relapse mortality. Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V128.22.4666.4666
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2016
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  • 3
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    Comparative Effectiveness of Busulfan/Cyclophosphamide Versus Busulfan/Fludarabine Myeloablative Conditioning for Allogeneic Hematopoietic Cell Transplantation in Acute Myeloid Leukemia
    American Society of Hematology ; 2018
    In:  Blood Vol. 132, No. Supplement 1 ( 2018-11-29), p. 3365-3365
    Details
    In: Blood, American Society of Hematology, Vol. 132, No. Supplement 1 ( 2018-11-29), p. 3365-3365
    Abstract: Background Myeloablative conditioning (MAC) is a standard approach for allogeneic hematopoietic cell transplantation (alloHCT), but is associated with risks of morbidity and mortality. As regimen intensity affects post-transplant outcomes, assessment of pre-transplant cytogenetics and somatic mutations may refine which acute myeloid leukemia (AML) patients benefit the most. We compared the effectiveness of two approaches: busulfan/cyclophosphamide (Bu/Cy) and the MAC, but reduced toxicity regimen busulfan/fludarabine (Bu/Flu). Moreover, it is unclear whether somatic mutations in AML may differentially affect post-transplant outcomes between these regimens. We hypothesized that despite relative differences with these regimens, they may result in comparable outcomes. Methods We conducted a single center, retrospective analysis of adult AML patients in CR1 or CR2 who underwent a first T-cell replete HLA-8/8 matched related or unrelated donor alloHCT. Patients received either parenteral Bu (12.8 mg/kg total over 4 days) with Cy (120 mg/kg total over 2 days) or parenteral Bu (400 mg/m2 total over 4 days) with Flu (160 mg/m2 total over 4 days). Bu dose adjustment was not used in either cohort. In addition to cytogenetic risk group stratification by European LeukemiaNet criteria (Döhner H, et al, Blood 2016), a subset of patients had a 36-gene somatic mutation panel assessed prior to alloHCT by next-generation sequencing. Pre-transplant characteristics were compared between regimens with Chi-square, Fisher's exact, or Wilcoxon rank sum tests. Differing characteristics were included in a multivariable Fine and Gray regression model with results as hazard ratios (HR) and 95% confidence intervals (CI). Results From 2008 - 2017, 76 AML patients receiving Bu/Cy and 50 receiving Bu/Flu were identified meeting inclusion criteria (Bu/Flu used starting in 2010). Median age at transplant was 51 (21-61) years for Bu/Cy vs. 64 (34-74) for Bu/Flu (P 〈 0.001). The cohorts were otherwise comparable in regards to gender, race, performance status, HCT-CI, and disease status at alloHCT. Bu/Cy vs. Bu/Flu patients had 16% vs. 10% favorable, 66% vs. 50% intermediate, and 18% vs. 40% adverse-risk cytogenetics (P=0.033). The most common somatic mutations in the Bu/Cy cohort were FLT3 (20%), NPM1 (18%), DNMT3A (16%), TET2 (9%), CEBPA (5%), and IDH1 (5%). In the Bu/Flu cohort, these were FLT3 (20%), NPM1 (18%), NRAS (12%), TET2 (12%), and DNMT3A (10%). There were no significant differences in somatic mutations between the cohorts, except for a higher incidence of NRAS in the Bu/Flu cohort (12% vs. 4%, P=0.029). Bu/Flu patients were more likely to have an unrelated donor (70% vs. 47%, P=0.012) and receive a peripheral blood stem cell (PBSC) graft (94% vs. 17%, P 〈 0.001). As such, Bu/Flu patients had more rapid neutrophil (median 13 vs. 14 days, P=0.009) and platelet (median 15 vs. 20 days, P 〈 0.001) recovery and a shorter length of hospital stay (LOS) (median 22 vs. 27 days, P 〈 0.001). In multivariable analysis, Bu/Flu patients trended towards more chronic graft-versus-host-disease (GvHD; any stage) (HR 0.42, CI 0.16-1.11, P=0.08), but there were no other differences in CMV infections, other infections, acute GvHD, relapse, relapse mortality (RM), non-relapse mortality (NRM), relapse-free (RFS), and overall survival (OS). 58% of Bu/Cy and 56% of Bu/Flu patients remain alive with median follow-up of 59 and 22 months, respectively (P=0.003). The most common causes of death for these respective cohorts were relapse (50% vs. 41%) and infection (16% vs. 27%). Conclusion Bu/Cy and Bu/Flu in alloHCT for AML results in comparable incidences of infection, GvHD, RM, NRM, RFS, and OS. This was despite Bu/Flu patients being older and more likely to have adverse cytogenetics and an unrelated donor. Bu/Flu is better tolerated with less toxicity. Faster hematopoietic recovery and shorter LOS with Bu/Flu reflects PBSC graft use and has implications for health care resource utilization. Future prospective studies with larger cohorts and cost-effectiveness analyses comparing these conditioning strategies are warranted. In this analysis, no mutations appeared to be sensitive to use of the more intensive regimen, Bu/Cy. Further investigation of pre-transplant or post-transplant persistence of somatic mutations may risk stratify those who may benefit from more intensive or innovative approaches to prevent relapse after transplant. Disclosures Gerds: Apexx Oncology: Consultancy; Celgene: Consultancy; CTI Biopharma: Consultancy; Incyte: Consultancy. Majhail:Incyte: Honoraria; Atara: Honoraria; Anthem, Inc.: Consultancy.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood-2018-99-113871
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2018
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  • 4
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    Randomized Trial of Tacrolimus and Methotrexate Versus Tacrolimus, Reduced Dose Methotrexate, and Mycophenolate Mofetil for Prevention of Graft-Versus-Host Disease after Myeloablative Related and Unrelated Donor Allogeneic Hematopoietic Cell Transplantation
    American Society of Hematology ; 2021
    In:  Blood Vol. 138, No. Supplement 1 ( 2021-11-05), p. 99-99
    Details
    In: Blood, American Society of Hematology, Vol. 138, No. Supplement 1 ( 2021-11-05), p. 99-99
    Abstract: Background: Graft-versus-host disease (GVHD) remains a major cause of morbidity and mortality after allogeneic hematopoietic cell transplantation (HCT). The combination of tacrolimus (Tac) and methotrexate (MTX) is a standard regimen for GVHD prophylaxis; however, it is associated with several toxicities and patients are often not able to complete the full MTX regimen. The combination of Tac, reduced dose ("mini")-MTX, and mycophenolate mofetil (MMF) has been investigated with a well-tolerated toxicity profile and low incidence of GVHD, although comparison with standard dose MTX has not been done. We performed a randomized non-inferiority trial comparing Tac/MTX (Full-MTX) to Tac/mini-MTX/MMF (Mini-MTX) for prevention of GVHD after myeloablative related and unrelated donor HCT. Methods: Patients & lt;70 years in age receiving first myeloablative allogeneic HCT using 8/8 HLA-matched related or unrelated donor were eligible; all diagnoses and both bone marrow and peripheral blood stem cell grafts were allowed. Full-MTX patients received MTX dose of 15 mg/m 2 day +1, and 10 mg/m 2 days +3, +6, and +11. Mini-MTX patients received doses of 5 mg/m 2 on days +1, +3, and +6 plus MMF 1000 mg BID. MTX and MMF doses were adjusted for body weight in pediatric recipients. Primary endpoints were incidence of acute GVHD, mucositis, and hematopoietic engraftment. Secondary endpoints included incidence of chronic GVHD, organ toxicity, infection, relapse, non-relapse mortality (NRM), and overall survival (OS). Based on our local incidence rates, 45 patients/arm were needed to detect a hazard ratio of at most 1.7 for acute GVHD (no difference between two arms) using a one-sided non-inferiority log-rank test with 5% significance and 80% power. Results: We enrolled 101 patients; 5 were excluded due to change in eligibility or withdrawal of consent prior to HCT. Analysis is based on 96 patients who were randomized to receive Full-MTX (N=49) or Mini-MTX (N=47). Patient characteristics are described in the Table, and were generally balanced between the two groups . All patients in the Mini-MTX arm received their 3 planned doses of MTX; in the Full-MTX arm, 71% received all 4 doses, 26% received 3 doses, and 1 patient received 2 doses of MTX. There was no significant difference in cumulative incidence of grade 2-4 acute GVHD by day 100 between arms (28% Mini-MTX vs 27% Full-MTX, P=0.41) (Figure 1); however, there was a trend toward higher grade 3-4 acute GVHD in Mini-MTX arm (13% vs 4%, P=0.07). Mini-MTX recipients had lower incidence of severe WHO grade 3-4 mucositis (57% vs 82%, P=0.010), shorter duration of mucositis (median 11 vs 18 days, P & lt;0.001), and had faster engraftment of both neutrophils (median 15 vs 17 days, P & lt;0.001) and platelets (median 23 vs 27 days, P=0.023), with resultant shorter hospital stay (median 27 vs 31 days, P & lt;0.001). There were no significant differences between the two arms in any grade of chronic GVHD (36% vs 25%, P=0.09) or moderate-severe chronic GVHD at 1 year (23% vs 20%, P=0.14). There were also no differences in bacterial (P=0.18), viral (P=0.52) or fungal (P=0.74) infections. There were no significant differences in hepatotoxicity, but lower proportion of patients receiving Mini-MTX experienced nephrotoxicity (creatinine ≥3X upper limit of normal: 2% vs 26%, P & lt;0.001). Mini-MTX recipients also had less respiratory failure in the first 6 months (6% versus 22%, P=0.026). There was no difference in relapse between arms (2-year incidence 22% vs 21%, P=0.89), although Mini-MTX was associated with lower NRM (11% vs 25% at 2 years) (Figure 2), and non-significant but higher OS (70% vs 52% at 2 years; P=0.06). Conclusions: Compared to Full-MTX, a Mini-MTX regimen that incorporates MMF was associated with no difference in acute or chronic GVHD incidence and a more favorable toxicity profile, with faster engraftment, less mucositis, less organ toxicity, and lower NRM. The combination of Tac/mini-MTX/MMF is an acceptable alternative to Tac/MTX after myeloablative related and unrelated donor HCT. Figure 1 Figure 1. Disclosures Hamilton: Syndax: Membership on an entity's Board of Directors or advisory committees; Equilium: Membership on an entity's Board of Directors or advisory committees. Gerds: Imago: Research Funding; AbbVie: Consultancy; Constellation: Consultancy; Brystol Myers Squibb: Consultancy; Sierra Oncology: Consultancy; Incyte: Research Funding; PharmaEssentia: Consultancy; Novartis: Consultancy; Constellation: Research Funding; Krtos: Research Funding; CTI Biopharma: Research Funding; Accutate: Research Funding. Hill: Gentenech: Consultancy, Honoraria, Research Funding; AstraZenica: Consultancy, Honoraria; Novartis: Consultancy, Honoraria, Research Funding; Celgene (BMS): Consultancy, Honoraria, Research Funding; Epizyme: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria, Research Funding; Karyopharm: Consultancy, Honoraria, Research Funding; Beigene: Consultancy, Honoraria, Research Funding; Pfizer: Consultancy, Honoraria; Incyte/Morphysis: Consultancy, Honoraria, Research Funding; Kite, a Gilead Company: Consultancy, Honoraria, Other: Travel Support, Research Funding. Copelan: Amgen: Consultancy. Majhail: Anthem, Inc: Consultancy; Incyte Corporation: Consultancy.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood-2021-149686
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2021
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  • 5
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    Long-term survival after high-dose chemotherapy with autologous hematopoietic cell transplantation in metastatic breast cancer
    King Faisal Specialist Hospital and Research Centre - DIGITAL COMMONS JOURNALS ; 2015
    In:  Hematology/Oncology and Stem Cell Therapy Vol. 8, No. 3 ( 2015-09), p. 115-124
    Details
    In: Hematology/Oncology and Stem Cell Therapy, King Faisal Specialist Hospital and Research Centre - DIGITAL COMMONS JOURNALS, Vol. 8, No. 3 ( 2015-09), p. 115-124
    Type of Medium: Online Resource
    ISSN: 1658-3876
    URL: Article
    DOI: 10.1016/j.hemonc.2015.06.005
    Language: English
    Publisher: King Faisal Specialist Hospital and Research Centre - DIGITAL COMMONS JOURNALS
    Publication Date: 2015
    detail.hit.zdb_id: 2576566-8
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  • 6
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    Bortezomib-Based Induction Therapy PRIOR to High Dose Melphalan and Autologous Hematopoietic CELL Transplantation in Primary Amyloidosis
    Elsevier BV ; 2015
    In:  Biology of Blood and Marrow Transplantation Vol. 21, No. 2 ( 2015-02), p. S133-S134
    Details
    In: Biology of Blood and Marrow Transplantation, Elsevier BV, Vol. 21, No. 2 ( 2015-02), p. S133-S134
    Type of Medium: Online Resource
    ISSN: 1083-8791
    URL: Article
    DOI: 10.1016/j.bbmt.2014.11.182
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2015
    detail.hit.zdb_id: 3056525-X
    detail.hit.zdb_id: 2057605-5
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  • 7
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    Impact of MHC Class I Chain-Related Gene a (MICA) Mismatch on Umbilical Cord Blood Hematopoietic Cell Transplantation
    Elsevier BV ; 2018
    In:  Biology of Blood and Marrow Transplantation Vol. 24, No. 3 ( 2018-03), p. S190-
    Details
    In: Biology of Blood and Marrow Transplantation, Elsevier BV, Vol. 24, No. 3 ( 2018-03), p. S190-
    Type of Medium: Online Resource
    ISSN: 1083-8791
    URL: Article
    DOI: 10.1016/j.bbmt.2017.12.300
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2018
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  • 8
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    Prognostic Factors for Mortality among Day +100 Survivors after Allogeneic Hematopoietic Cell Transplantation
    Elsevier BV ; 2018
    In:  Biology of Blood and Marrow Transplantation Vol. 24, No. 5 ( 2018-05), p. 1029-1034
    Details
    In: Biology of Blood and Marrow Transplantation, Elsevier BV, Vol. 24, No. 5 ( 2018-05), p. 1029-1034
    Type of Medium: Online Resource
    ISSN: 1083-8791
    URL: Article
    DOI: 10.1016/j.bbmt.2018.01.016
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2018
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  • 9
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    Comparative Effectiveness of Busulfan and Fludarabine versus Fludarabine and 400 cGy Total Body Irradiation Conditioning Regimens for Acute Myeloid Leukemia/Myelodysplastic Syndrome
    Elsevier BV ; 2017
    In:  Biology of Blood and Marrow Transplantation Vol. 23, No. 5 ( 2017-05), p. 776-781
    Details
    In: Biology of Blood and Marrow Transplantation, Elsevier BV, Vol. 23, No. 5 ( 2017-05), p. 776-781
    Type of Medium: Online Resource
    ISSN: 1083-8791
    URL: Article
    DOI: 10.1016/j.bbmt.2017.01.077
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2017
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  • 10
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    Single Nucleotide Gene Polymorphisms (SNP) in the Gamma Block of the Major Histocompatibility Complex (MHC) Are Independent Risk Factors for Severe Acute Graft Versus Host Disease (GVHD) in Unrelated Donor Hematopoietic Cell Transplantation (HCT)
    Elsevier BV ; 2015
    In:  Biology of Blood and Marrow Transplantation Vol. 21, No. 2 ( 2015-02), p. S326-S327
    Details
    In: Biology of Blood and Marrow Transplantation, Elsevier BV, Vol. 21, No. 2 ( 2015-02), p. S326-S327
    Type of Medium: Online Resource
    ISSN: 1083-8791
    URL: Article
    DOI: 10.1016/j.bbmt.2014.11.519
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2015
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    detail.hit.zdb_id: 2057605-5
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