Disease Characteristics and Patterns of Care In Elderly Patients (80+ years) with Follicular Lymphoma (FL) In the United States (US); Are Older Patients Treated Differently? Report From the National LymphoCare Study (NLCS)

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 4152-4152
Author(s):  
Chadi Nabhan ◽  
Michelle Byrtek ◽  
Michael Taylor ◽  
Jill Tydell ◽  
Jamie H. Hirata ◽  
...  
Keyword(s):  
Older Patients ◽  
Research Funding ◽  
Age Groups ◽  
Treatment Patterns ◽  
Disease Stage ◽  
Younger Patients ◽  
Disease Characteristics ◽  
Significant Difference ◽  
The Difference ◽  
Grade 3

Abstract Abstract 4152 Background: While FL is the most common low-grade lymphoma in the US, median age was less than 60 in patients enrolled on pivotal studies that led to our understanding of disease biology and optimal therapy. It remains unclear whether similar disease characteristics, presentation, prognostic factors, treatment patterns, and outcomes pertain to older patients with FL. No clear guidelines exist on how older patients should be treated and data is lacking as to whether current practice patterns affect their survival and progression. Previous reports on FL in the elderly have been retrospective and single center-based. Methods: The NLCS is a prospective, longitudinal multicenter, observational study that enrolled consecutive newly diagnosed FL patients from 3/2004 through 3/2007 collecting data on disease and patients' characteristics, treatment patterns, and outcome. Using the NLCS data we analyzed information on disease stage, grade, FL International Prognostic Index (FLIPI), B symptoms, and treatment choice for patients <60 years, 60–69 years, 70–79 years, and 80+ years. Either Chi-square or Fisher's exact comparison was used to assess the correlations depending on the sample size of the test. Results: A total of 2,736 pts were enrolled, of which 1,215 (44%) were < 60, 708 (25%) were between 60–69, 549 (20%) were between 70–79, and 264 (9%) were >80. There was a significant difference in grade distribution across the different age groups (p < 0.0001), with 22% of pts 80+ having grade 3 FL vs 17% pts <60. No significant differences across age groups in B symptoms, extra nodal sites, or LDH values were observed. A significant difference in FLIPI score was seen across the age groups (p < 0.0001) where high-score FLIPI was present in 48% of pts 80+ as opposed to 16% of pts <60, although calculating FLIPI might be confounded by the fact that older patients were more likely to not have received a bone marrow (BM) exam with 66% of pts 80+ not having BM exam vs. only 40% of those <60 (p < 0.0001). The difference in FLIPI was mainly due to lower Hgb values as older patients were more likely to have had Hgb < 12 g/dL than younger patients (31% of pts 80+ vs. 15% of pts <60) and to age being a component of the FLIPI index. The difference in FLIPI score across age groups was also observed in patients with grade 3 FL where 53% of pts 80+ had poor FLIPI vs. 15% of pts <60 (p < 0.0001). A statistically significant difference in treatment patterns was found across age groups (p <0.0001). When treatment was implemented, older patients were more likely to have received rituximab (R) monotherapy (37% of 80+ vs. 12% of <60) and less likely to have received R+Chemotherapy (40% of pts 80+ vs. 64% of pts<60). In addition, more pts 80+ were observed compared to those <60 (23% vs. 16%). These differences persisted even in those with advanced stage (III/IV), grade 3 disease, region of diagnosis, and in poor-risk FLIPI. When chemotherapy was used, older patients were less likely than younger patients to receive anthracyclines (p < 0.0001) (31% of pts 80+ vs. 69% of pts<60). Anthracycline use remained significantly different regardless of disease stage, grade, or FLIPI score. Conclusions: To our knowledge, this is the largest prospective data collection available for FL pts 80+ years of age. We demonstrate that these pts have higher FLIPI score and grade 3 disease. When treatment is initiated, these patients receive R monotherapy more often than their younger counterpart. Anthracycline use in this population is also less common regardless of disease stage, grade, or risk profile. Whether these baseline differences translate into different outcomes remains to be seen. Disclosures: Nabhan: genentech: Research Funding, Speakers Bureau. Byrtek:Genentech: Employment. Taylor:Genentech: Employment. Hirata:Genentech: Employment. Flowers:Genentech/Biogen-Idec (unpaid): Consultancy; Celgene, Intellikine: Consultancy; Millennium: Research Funding.

scholarly journals Bosutinib or Imatinib in Older Vs Younger Patients with Newly Diagnosed Chronic Myeloid Leukemia in the Phase 3 BFORE Trial

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 1734-1734 ◽  
Author(s):  
Michael W. Deininger ◽  
Vamsi Kota ◽  
Jeff H. Lipton ◽  
Dragana Milojkovic ◽  
Valentín García Gutiérrez ◽  
...  
Keyword(s):  
Older Patients ◽  
Myeloid Leukemia ◽  
Research Funding ◽  
Age Groups ◽  
Newly Diagnosed ◽  
Phase 3 ◽  
Younger Patients ◽  
Equity Ownership ◽  
The Difference ◽  
Grade 3

Abstract Introduction: Bosutinib is approved for newly diagnosed chronic phase (CP) chronic myeloid leukemia (CML) and CML resistant or intolerant to prior therapy. Efficacy and safety of first-line bosutinib and imatinib were assessed in older vs younger patients in the ongoing phase 3 BFORE trial (NCT02130557). Methods: In all, 536 patients were randomized 1:1 to receive bosutinib or imatinib (400 mg once daily). We compared outcomes in patients aged ≥65 years (older group) vs <65 years (younger group) after 24 months of follow-up. Efficacy (excluding complete cytogenetic response [CCyR]) was assessed in the intent-to-treat (ITT) population (Philadelphia chromosome-positive [Ph+] and negative patients) of both age groups and safety in patients who received ≥1 dose of study drug. CCyR was assessed in the modified ITT population (Ph+ patients with e13a2/e14a2 transcripts [N=487]). Results: In the bosutinib arm (n=268), 53 were older and 215 were younger patients. In the imatinib arm (n=268; 3 untreated), 48 (2 untreated) were older and 220 (1 untreated) were younger patients. Sokal risk scores were balanced between treatment arms but higher in the overall older (8.9% low, 70.3% intermediate, 20.8% high) vs younger (44.1% low, 34.7% intermediate, 21.1% high) populations, reflecting that age is part of the score. Bosutinib was discontinued in 32.1% of older and 28.4% of younger patients; the most common primary reason was treatment-related adverse events (AEs; 18.9% and 15.3%, respectively). Imatinib was discontinued in 32.6% of older and 33.8% of younger patients, most frequently due to suboptimal response or treatment failure (13.0% and 13.2%, respectively). The percentage of patients who discontinued treatment due to treatment-emergent AEs (TEAEs) was similar in the older vs younger group in both arms (bosutinib: 22.6% vs 19.1%; imatinib: 8.7% vs 12.3%). In older vs younger patients, median (range) duration of treatment was similar: 24.8 months (0.3-33.3) vs 24.9 months (0.3-33.5) for bosutinib and 25.6 months (2.9-33.1) vs 24.5 months (0.7-33.4) for imatinib. Median relative dose intensity was slightly lower in older vs younger patients in the bosutinib arm (92.8% vs 99.3%) but was 100% in both age groups in the imatinib arm. The difference in rates of major molecular response (MMR) at 12 months (primary endpoint) with bosutinib vs imatinib was consistent across age groups (older: 43.4% vs 35.4%; younger: 47.4% vs 36.4%; P=0.7879 for test of interaction), as was the difference in rates of CCyR by 12 months (older: 68.8% vs 69.0%; younger: 79.3% vs 65.8%; P=0.1689). MR rates at 24 months (and MR1 at 3 months) were generally similar in older vs younger patients within each arm and higher with bosutinib than with imatinib (Table 1). Time to achieve MMR on bosutinib was not different in older vs younger patients (hazard ratio: 1.227; P=0.2380, after adjustment for baseline and time-dependent covariates in a multivariable proportional subdistribution hazards model). Rates of common TEAEs in each treatment arm were similar (<10% difference) between age groups, except for higher rates of anemia, rash, and decreased appetite in older patients in the bosutinib arm; higher rate of pruritus in older patients in both arms; and higher rate of peripheral edema and lower rate of neutropenia in older patients in the imatinib arm (Table 2). In older vs younger patients in the bosutinib arm, there were higher rates of grade 3/4 TEAEs (75.5% vs 61.4%), serious TEAEs (39.6% vs 23.3%), and dose delays (69.8% vs 58.1%) and reductions (52.8% vs 37.2%) due to TEAEs. In older vs younger patients in the imatinib arm, rates of grade 3/4 TEAEs (43.5% vs 47.9%), and dose delays (39.1% vs 38.8%) and reductions (23.9% vs 21.5%) due to TEAEs were similar, but the rate of serious TEAEs was higher (28.3% vs 16.9%). Conclusions: In the phase 3 BFORE trial, bosutinib showed clinical activity in older and younger patients with newly diagnosed CP CML. Difference in rates of MMR at 12 months for bosutinib vs imatinib was consistent in older and younger patients. MR rates at 24 months were similar in older and younger patients and higher with bosutinib than with imatinib. Although the incidence of grade 3/4 TEAEs, serious TEAEs, and dose modifications due to TEAEs were higher in older vs younger bosutinib-treated patients, treatment discontinuation rates were similar between age groups, suggesting that, regardless of patient age, TEAEs were manageable with bosutinib. Disclosures Deininger: Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees; Blueprint: Consultancy. Kota:Pfizer: Honoraria; Xcenda: Honoraria; Novartis: Honoraria; Incyte: Honoraria; BMS: Honoraria. Lipton:Pfizer: Consultancy, Honoraria, Research Funding; Novartis: Consultancy, Honoraria, Research Funding; Takeda: Consultancy, Honoraria, Research Funding; BMS: Consultancy, Honoraria, Research Funding. Milojkovic:Incyte: Honoraria, Speakers Bureau; Novartis: Honoraria, Speakers Bureau; BMS: Honoraria, Speakers Bureau; Pfizer: Honoraria, Speakers Bureau. García Gutiérrez:Incyte: Honoraria, Research Funding; Pfizer: Honoraria, Research Funding; BMS: Honoraria, Research Funding; Novartis: Honoraria, Research Funding. Leip:Pfizer: Employment, Equity Ownership. Nick:Pfizer: Employment, Equity Ownership. Hochhaus:Takeda: Research Funding; Bristol-Myers Squibb: Research Funding; Novartis: Research Funding; Pfizer: Research Funding; Incyte: Research Funding. Gambacorti-Passerini:BMS: Consultancy; Pfizer: Consultancy, Honoraria, Research Funding. Cortes:Astellas Pharma: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding; Daiichi Sankyo: Consultancy, Research Funding; Arog: Research Funding. Brummendorf:Merck: Consultancy; Pfizer: Consultancy, Research Funding; Janssen: Consultancy; Takeda: Consultancy; Novartis: Consultancy, Research Funding.

scholarly journals Comparison of Peripheral Blood Stem Cell Mobilization for Multiple Myeloma Patients over 70 Years of Age with Younger Patients

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4554-4554
Author(s):  
Ning Dong ◽  
David S Siegel ◽  
Phyllis McKiernan ◽  
Noa Biran ◽  
Alan P Skarbnik ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Older Patients ◽  
Research Funding ◽  
Age Groups ◽  
Disease Status ◽  
Cell Yield ◽  
Disease Stage ◽  
Age Group ◽  
Advisory Committees ◽  
Younger Patients

Abstract Background: Autologous stem cell transplantation (ASCT) is increasingly offered to older patients with multiple myeloma (MM) based on clinical trials demonstrating improved outcome. Inherently, successful mobilization and collection of peripheral blood stem cells (PBSC) is necessary for ASCT. A direct comparison of the efficacy of mobilization between elderly and younger patients has not been reported. Retrospective studies demonstrated that older patients had lower CD34+ cell yield and a higher incidence of mobilization failure (Lee et al 2014, Muchtar et al 2016). In this retrospective study, we compared two age groups (>/=70 years and <70 years) in MM patients who received ASCT at the John Theurer Cancer Center. We compared the outcomes of PBSC mobilization and transplantation between the two groups. Methods: MM patients who received a single ASCT at our institution between 2005 and 2016 were included. More than 95% of patients received either cyclophosphamide-based chemotherapy with GCSF (CY-GCSF) or plerixafor with GCSF (Pleri-GCSF) and were included in the analysis. We identified 111 patients aged >/= 70 years and 315 patients <70 years. The total CD34+ cell yield, number of apheresis sessions and CD34+ yield per session were compared by age group and mobilization regimen using the student's t-test. Multivariate analysis was performed using the general linear model with age group, mobilization regimen, age and mobilization agent interaction, Durie-Salmon (DS) stage, disease status at mobilization, and mobilization within 12 months of diagnosis as covariates. Progression-free survival (PFS) and overall survival (OS) were compared using Cox proportional hazard model with the above-mentioned covariates. All analyses were done using SAS 9.4. Results: Patient characteristics and CD34+ cell yield by age group are summarized in Table 1. The majority of patients in both groups underwent mobilization within one year of diagnosis. Older patients were less likely to receive CY-GCSF and more likely to receive Pleri-GCSF compared to younger patients (p<0.001). Disease status at mobilization, time from diagnosis to mobilization and DS stage were not associated with choice of mobilization regimens (p>0.05 for all). The two groups had similar number of apheresis sessions regardless of mobilization regimen. When receiving Pleri-GCSF, the two age groups had similar CD34+ yield per apheresis (4.4x10e6 /kg and 3.9x10e6 /kg for age>/=70 and age<70, respectively, p=0.49). However when receiving CY-GCSF, the older patients had lower CD34+ yield per apheresis compared to the younger patients (5.4 x10e6 /kg and 7.5 x10e6 /kg, respectively, p=0.004). When comparing the CD34+ yield per session within the older cohort, the yields with CY-GCSF and Pleri-GCSF were similar (p=0.16). In the multivariate analysis including all patients, time from diagnosis to mobilization, disease stage and disease status at mobilization were not associated with CD34+ yield per session or total CD34+ yield. Neither age nor mobilization regimen was associated with PFS or OS, after adjusting for disease stage and disease status at ASCT (Table 2, Figure 1, Figure 2). Conclusions: CD34+ yield was comparable between younger patients and older patients receiving plerixafor + GCSF. In contrast, the CD34+ yield was lower in the older patients receiving cyclophosphamide + GCSF. The cause of the difference is not clear and warrants further study. The PFS and OS were comparable between the two groups after ASCT. The choice of mobilization regimen did not affect survival. We have previously advocated cyclophosphamide mobilization in most patients because of the higher CD34+ yield and lower cost compared to plerixafor + GCSF (Panchal et al., ASH 2017). However this study showed that the CD34+ yield was not significantly different for patients aged 70 years or older in response to the different mobilization regimens. It is reasonable to consider plerixafor + GCSF in the elderly when chemotherapy toxicity is of concern. Disclosures Siegel: Karyopharm: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Research Funding, Speakers Bureau; Merck: Consultancy, Honoraria, Speakers Bureau; Janssen: Consultancy, Honoraria, Speakers Bureau; Amgen: Consultancy, Honoraria, Speakers Bureau; Novartis: Honoraria, Speakers Bureau; Takeda: Consultancy, Honoraria, Speakers Bureau; BMS: Consultancy, Honoraria, Speakers Bureau. Biran:Amgen: Consultancy, Speakers Bureau; Merck: Research Funding; Celgene: Consultancy, Honoraria, Speakers Bureau; BMS: Research Funding; Takeda: Consultancy, Speakers Bureau. Skarbnik:Gilead Sciences: Honoraria, Speakers Bureau; Abbvie: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Genentech: Honoraria, Speakers Bureau; Pharmacyclics: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Jazz Pharmaceuticals: Honoraria, Speakers Bureau; Seattle Genetics: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Novartis: Honoraria, Speakers Bureau.

scholarly journals Older Patients Are Less Affected by Radiochemotherapeutic Treatment than Younger

2018 ◽  
Vol 2018 ◽  
pp. 1-8
Author(s):  
Max J. Weiling ◽  
Wencke Losensky ◽  
Katharina Wächter ◽  
Teresa Schilling ◽  
Fabian Frank ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Elderly Patients ◽  
Cancer Patients ◽  
Older Patients ◽  
Normative Data ◽  
Age Groups ◽  
German Population ◽  
Younger Patients ◽  
Significant Difference

Purpose. The general assumption is that cancer therapy impairs the quality of life in elderly patients more than in younger ones. We were interested in the effects of radiochemotherapeutic treatment on the quality of life of elderly patients compared to younger patients and compared to normative data of a general German population. Methods and Materials. A total of 465 patients completed the EORTC QLQ-C30 questionnaire. Repetitive completion of the questionnaire over time led to 1407 datasets. Our patient cohort contained 197 (42.4%) patients with colorectal cancer followed by 109 (23.4%) patients with head and neck cancer, 43 (9.2%) patients with lung cancer, and 116 (25%) with other types of cancer. Patients were categorized into five age groups, the respective cut-offs being 40, 50, 60, and 70 years. Normative data were drawn from a population study of a general German population. Results. Functional scores and symptom scores were approximately stable between the different age groups. Our data does not suggest a significant difference between the investigated age groups. Advancing age evened out the differences between the normative data of the general German population and the cancer patients in 11 of 15 scores. Conclusions. The general belief about younger patients having fewer physical and psychological problems related to radiochemotherapy needs to be reconsidered. Overall resilience of older patients is apparently underestimated.

Unrelated Cord Blood Transplantation Using Myeloablative Regimen for Acute Leukemia Patients Aged between 50 and 55 Years: Single Institutional Retrospective Comparison with Patients Less Than 50 Years of Age.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 2013-2013
Author(s):  
Takaaki Konuma ◽  
Satoshi Takahashi ◽  
Jun Ooi ◽  
Akira Tomonari ◽  
Nobuhiro Tsukada ◽  
...  
Keyword(s):  
Acute Leukemia ◽  
Cord Blood ◽  
Older Patients ◽  
Acute Gvhd ◽  
Cord Blood Transplantation ◽  
Chronic Gvhd ◽  
Age Groups ◽  
Younger Patients ◽  
Cell Dose ◽  
Significant Difference

Abstract Background: Increasing age has been well-known as an obvious risk factor for graft-versus-host disease (GVHD) and transplant-related mortality (TRM) resulting negative impact on allogeneic transplantation including cord blood transplant (CBT). The incidence of sever GVHD after CBT, on the other hand, is lower than that after transplants using graft from adult cells, so we have expected the better results of CBT in older patients. Objectives and Methods: This study aimed to evaluate safety and efficacy of CBT using myeloablative regimen for older patients with acute leukemia. Patients and Methods: We retrospectively compared outcomes of older patients with acute leukemia with younger adults in our institute. Nineteen elderly patients (median age 52, range 50–55) and 81 young patients (median 49, range 16–49) received myeloablative conditioning regimen including 12 Gy of total body irradiation. GVHD prophylaxis comprised cyclosporine with (N=96) or without (N=4) methotrexate. Results: Comparisons of characteristics in the 2 age groups showed similar distributions for weight, gender ratio, diagnosis [de novo acute myeloid leukemia (AML), myelodysplastic syndrome related secondary AML, or acute lymphoblastic leukemia], disease status at transplantation, total nucleated cell dose and CD34+ cell dose in the graft before cryopreservation and proportions of HLA and sex compatibility between donors and recipients. The median period of follow-up for survivors after CBT was 730 days for older group and 1331 days for younger group, respectively. Grade II to IV acute GVHD occurred in 10 of 17 evaluable older patients and 49 of 75 evaluable younger patients (P = 0.61), while no older patients, but 6 younger patients developed grade III to IV acute GVHD. Extensive-type chronic GVHD occurred in 4 of 15 evaluable older patients and 18 of 69 evaluable younger patients (P = 0.96), respectively. The cumulative incidence of TRM at 100 days was 5% versus 6% (P = 0.70), and of relapse at 3 years was 29% versus 20% (P = 0.33) and the estimated disease-free survival at 3 years was 67% and 71% (P = 0.53) for older or younger patients, respectively. There was no significant difference in GVHD, TRM, relapse, and DFS between 2 age groups. Conclusion: The use of cord blood as a stem cell source might contribute to be decreased in the incidence of acute and chronic GVHD resulting in decreased TRM in older patients. Our results suggest that myeloablative CBT might be as safe and effective in patients with acute leukemia aged between 50 and 55 years as in younger patients.

Barriers to Clinical Trial Participation by Older Women With Breast Cancer

2003 ◽  
Vol 21 (12) ◽  
pp. 2268-2275 ◽  
Author(s):  
M. Margaret Kemeny ◽  
Bercedis L. Peterson ◽  
Alice B. Kornblith ◽  
Hyman B. Muss ◽  
Judith Wheeler ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Older Women ◽  
Cancer Patients ◽  
Older Patients ◽  
Disease Stage ◽  
Trial Participation ◽  
Breast Cancer Patients ◽  
Retrospective Case ◽  
Younger Patients ◽  
Significant Difference

Purpose: Although 48% of breast cancer patients are 65 years old or older, these older patients are severely underrepresented in breast cancer clinical trials. This study tested whether older patients were offered trials significantly less often than younger patients and whether older patients who were offered trials were more likely to refuse participation than younger patients. Patients and Methods: In 10 Cancer and Leukemia Group B institutions, using a retrospective case-control design, breast cancer patients eligible for an open treatment trial were paired: less than 65 years old and ≥ 65 years old. Each of the 77 pairs were matched by disease stage and treating physician. Patients were interviewed as to their reasons for participating or refusing to participate in a trial. The treating physicians were also given questionnaires about their reasons for offering or not offering a trial. Results: Sixty-eight percent of younger stage II patients were offered a trial compared with 34% of the older patients (P = .0004). In multivariate analyses, disease stage and age remained highly significant in predicting trial offering (P = .0008), when controlling for physical functioning and comorbidity. Of those offered a trial, there was no significant difference in participation between younger (56%) and older (50%) patients (P = .67). Conclusion: In a multivariate analysis including comorbid conditions, age and stage were the only predictors of whether a patient was offered a trial. The greatest impediment to enrolling older women onto trials in the setting of this study was the physicians’ perceptions about age and tolerance of toxicity.

Comparison of Outcomes of Haploidentical Peripheral Blood Stem Cell Transplantation with Post-Transplant Cyclophosphamide in Older Versus Younger Patients

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 27-27
Author(s):  
Giacomo Adoncecchi ◽  
Ambuj Kumar ◽  
Rawan Faramand ◽  
Hien D. Liu ◽  
Farhad Khimani ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Older Patients ◽  
Research Funding ◽  
Chronic Gvhd ◽  
Age Groups ◽  
Group Versus ◽  
Survival Outcomes ◽  
Advisory Committees ◽  
Younger Patients ◽  
Two Age Groups

Introduction: Previous studies have demonstrated that allogeneic haploidentical (haplo) peripheral blood stem cell transplantation (PBSCT) with post-transplant cyclophosphamide (PTCy) yields improved progression free survival (PFS) when compared to haplo bone marrow transplant (BMT) with PTCy, attributable to lower relapse without an increase in non-relapse mortality (NRM) (Bashey, et al. JCO. 2017). However, haplo PBSCT results in higher rates of graft-versus-host disease (GVHD) which may negate these benefits in older patients who are more susceptible to transplant related toxicity. Thus, evaluation of the outcomes of haplo PBSCT with PTCy in older patients is warranted. Methods: We retrospectively evaluated 121 adult patients with hematologic malignancies treated at the Moffitt Cancer Center with allogeneic T-cell replete PBSCT from a haplo donor followed by PTCy-based GVHD prophylaxis. Data were extracted from the Moffitt BMT Research & Analysis Information Network (BRAIN) database. Myeloablative (n=70, 58%) and reduced intensity (n=51, 42%) conditioning regimens were included. Transplant related outcomes were compared between two age groups: &lt;60 years (n=66) versus &gt;60 years (n=55). Associations with transplant related survival outcomes were assessed using univariate and multivariate Cox proportional hazard survival models. Fine and Gray regression models were used to assess associations of transplant related endpoints with competing risks. Kaplan-Meier curves and cumulative incidence function curves were also plotted. Results: The median age at the time of transplant was 42 years (range: 20-59) for the younger group and 66 years (range: 61-75) for the older group. The median follow-up was 17 months (range: 2-53) for the entire cohort. Younger patients were more likely to receive myeloablative conditioning (83% versus 27%, p&lt;0.001). Baseline characteristics were otherwise similar. Neutrophil engraftment (&gt;500/uL) by day 30 did not differ significantly between the younger and older group (98% versus 93%, p=0.26). However, the median time to neutrophil engraftment was faster in the younger group versus the older group (16 versus 21 days, p&lt;0.001). Platelet engraftment (&gt;20,000/uL) by day 90 was achieved in 92% in the younger group versus 76% in the older group (p=0.03). The time to platelet engraftment was faster in the younger group: 28 days versus 36 days (p=0.006). At day 100, the cumulative incidence (CuI) of grade II-IV acute GVHD in younger patients was 42% (95% CI 29-61%) and for older patients was 35% (95% CI 22-55%, p=0.82). The CuI for grade III-IV acute GVHD for the younger and the older groups were 8% (95% CI 4-25%) and 15% (95% CI 7-38%, p=0.23), respectively. At 2 years, the CuI of chronic GVHD was 67% (95% CI 55-82%) for younger patients versus 56% (95% CI 38-82%) for older patients (p=0.20). NRM for the younger group and the older group, respectively, was 6% (95% CI 2-16%) versus 19% (95% CI 11-34%) at 100 days and 14% (95% CI 6-30%) versus 22% (95% CI 13-37%) at 2 years (p=0.17). The CuI of relapse at 2 years was not significantly different between the two age groups, with the younger recipients having a CuI of 42% (95% CI 20-60%) and the older group 31% (95% CI 17-56%, p=0.70). The 2-year DFS was similar between the younger and older group, respectively: 51% (95% CI 36-66%) and 53% (95% CI 37-70%, p=0.72). Similarly 2-year overall survival (OS) for the younger group was 59% (95% CI 44-74%), while the older group was 66% (95% CI 52-80%, p=0.92). In multivariate analysis, NRM was superior in the younger group (HR=0.31, 95% 0.12-0.82, p=0.02). Otherwise, age was not associated with engraftment, risk of acute or chronic GVHD, relapse, DFS, or OS. Conclusion: Our results demonstrate that outcomes following allogeneic haplo PBSCT with PTCy in patients &gt;60 years approximate outcomes in patients &lt;60 years. While NRM was inferior in the older patient group, this difference did not result in significant differences in long term OS or DFS. Instead, other variables such as the hematopoietic comorbidity index and the disease risk index were better indicators of survival outcomes. Additionally, these survival outcomes with haplo PBSCT with PTCy appear to be similar to prior published data with haplo BMT with PTCy in older patients (Kasamon, et al. JCO. 2015). Based on this study, haplo PBSCT with PTCy is an appropriate transplant platform for elderly patients. Disclosures Khimani: Bristol Myers Squibb-Moffitt-Alliance: Research Funding. Nishihori:Novartis: Other: Research support to institution; Karyopharm: Other: Research support to institution. Pidala:Syndax: Consultancy, Membership on an entity's Board of Directors or advisory committees; CTI Biopharma: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Research Funding; Takeda: Research Funding; Janssen: Research Funding; Johnson and Johnson: Research Funding; Pharmacyclics: Research Funding; Abbvie: Research Funding; BMS: Research Funding. Bejanyan:Kiadis Pharma: Membership on an entity's Board of Directors or advisory committees.

Age Differences in Disease Characteristics, Patterns of Care, and Outcomes of Follicular Lymphoma (FL) in the United States (US): Report From the National Lymphocare Study (NLCS)

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3708-3708
Author(s):  
Chadi Nabhan ◽  
Michelle Byrtek ◽  
Shadi Latta ◽  
Keith L Dawson ◽  
Xiaolei Zhou ◽  
...  
Keyword(s):  
Research Funding ◽  
Age Groups ◽  
Age Group ◽  
Employment Equity ◽  
Disease Characteristics ◽  
Baseline Factors ◽  
Equity Ownership ◽  
Grade 3 ◽  
The Impact ◽  
To Receive

Abstract Abstract 3708 Background: There are few prospective studies on disease characteristics, patterns of care, response, and outcomes in elderly FL patients (pts) in the US. The NLCS is a Genentech-sponsored prospective multicenter registry study that collects this information without study-specific treatment. We utilized the NLCS database to better understand the impact of age on FL outcome. Patients and Methods: All evaluable pts with FL histology in the NLCS were included except pts with FL plus other lymphoma histology or pts who progressed before first treatment or before being assigned to watchful waiting (WW). Using Pearson Chi-Square tests, associations of age groups (≤60, 61–70, >70) with disease characteristics and overall response (ORR) were examined. Median PFS and OS by treatment regimen were estimated using Kaplan-Meier methods for each age group. Cox proportional hazards regression adjusted for baseline factors (grade, number of nodal sites, LDH, Hgb, stage, performance status (PS), bone marrow (BM) involvement, race, and treatment center type) were used to assess treatment differences in PFS and OS and the significance of age by treatment interactions. Results: Of 2,647 pts, 47% (n=1,254) were ≤60 yrs, 25% (n=666) were 61–70 yrs, and 27% (n=727) were >70 yrs (min age of 22; max of 97). Compared with pts ≤60 yrs, pts 61–70 and >70 were more likely to be white (93% >70, 92% 61–70, and 88% ≤60, P=.02 and .02 respectively), have stage I/II disease (37% >70, 36% 61–70, and 29% ≤60, P=.0008 and .0003), have <5 nodal sites (73% >70, 69% 61–70, and 61% ≤60, P=.001 and <.0001), and have poor-risk FLIPI (53% >70, 51% 61–70, and 15% ≤60, P<.0001 and <.0001). Compared with pts ≤60, elderly pts (>70) were more likely to have FL grade 3 (24% vs 18%, P=.01). While there were no differences in geographic distribution by age, elderly pts were more likely to receive therapy at community practices (86%) versus academic institutions than pts ≤60 (77%, P<.0001) or 61–70 (81%, P=.004). Treatments varied significantly by age (P<.0001). More elderly pts were observed compared to pts ≤60 (23% vs19%). When treated, elderly pts (22%) were more likely to receive rituximab (R) monotherapy compared with patients aged 61–70 (12%) or ≤60 (10%). When chemotherapy alone or plus R was given, elderly pts were less likely to receive anthracyclines (45% vs 65% (61–70) and 68% (≤60)). Among all variables, only grade 3 histology predicted anthracycline use in all age groups. Lack of BM involvement predicted anthracycline use for younger pts (≤60 and 61–70). Of those ≤60, white pts were more likely to receive anthracyclines, and of those 61–70, those with ≥5 nodal sites were more likely to receive anthracyclines. ORRs were similar across age groups receiving similar regimens with R plus chemo providing the highest ORR. Adjusting for baseline factors, treatment (WW, R, R-Chemo, or other) benefit varied for each age group in terms of PFS (P=.02), with treatment outcomes being most differentiated among younger pts (Table). PFS appeared shorter in elderly pts regardless of the treatment received. No significant interaction between age and efficacy of anthracycline in terms of PFS or OS was observed (P-values >.65), but the overall effect of anthracycline for all pts was beneficial for PFS (HR=0.80, P=.02) and OS (HR=0.67, P=.003). Median OS was 8 years for elderly and not reached for others. After adjusting for baseline factors, no significant differences in treatment impact by age on OS were seen. Elevated LDH, reduced Hgb, stage III/IV, PS ≥1, and BM involvement were all significantly associated with shortened OS. These factors were also significantly associated with treatment choice, as worse-prognosis elderly pts were more likely to receive either R or R+chemo than WW or other treatment. Conclusions: FL pts >70 yrs more commonly received R alone and less commonly received anthracyclines when treated with chemotherapy. The impact of anthracyclines on PFS did not vary by age, but differences in PFS for other treatment regimens showed a stronger association among younger pts Disclosures: Nabhan: Genentech: Research Funding, Speakers Bureau. Byrtek:Genentech, Inc., a member of the Riche Group: Employment, Equity Ownership. Dawson:Genentech, Inc., a member of the Riche Group: Employment, Equity Ownership. Link:Genentech, Inc., a member of the Riche Group: Consultancy; Celgene: Consultancy; Spectrum: Consultancy. Friedberg:Genentech: Consultancy. Cerhan:Genentech: National LymphoCare Scientific Advisory Board Other. Flowers:Celgene: Consultancy; Prescription Solutions: Consultancy; Seattle Genetics: Consultancy; Millennium: Consultancy, Research Funding; Genentech: Consultancy; GIlead: Research Funding; Spectrum: Research Funding; Janssen: Research Funding; Lymphoma Research Foundation: Membership on an entity's Board of Directors or advisory committees.

Allogeneic Stem Cell Transplantation in Patients ≥70 Years Old

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 2309-2309
Author(s):  
Christopher C Walling ◽  
Pamela A Shaw ◽  
Noelle V Frey ◽  
Saar I Gill ◽  
Elizabeth O. Hexner ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Older Patients ◽  
Research Funding ◽  
Age Groups ◽  
Hematopoietic Stem ◽  
Younger Patients ◽  
Allogeneic Hsct

Abstract Background: While reduced intensity conditioning has allowed older patients to undergo allogeneic hematopoietic stem cell transplantation (HSCT) for a variety of hematologic malignancies, age is still viewed as a relative contraindication. In particular, only limited and conflicting data are available on outcomes of patients ≥ 70 years old. Methods: To determine outcomes and utility or futility of transplant for "older" patients, we conducted a retrospective study of all patients 65 and older who underwent allogeneic SCT at our institution between March 2002 and March 2015. 33 patients age 70-75 (median 71 years) were compared to 95 concurrent allogeneic HSCT recipients age 65-69 (median 67). Results: The two groups (70-75 and 65-69) were similar in terms of donor type (70% URD 30% MRD vs. 67% URD 27% MRD 3% cord blood, p=0.86), conditioning regimen (75% flu/bu vs. 65% flu/bu, p =0.26), HCT-CI scores (mean 2.7 vs 2.9, p=0.29), disease phase (9% vs. 15% with primary refractory/active disease, p=0.651) and disease distribution (AML/MDS in 76% and 80%, p=0.7). The OS for all patients was 51% at 1 year and 38% at 2 years, with a median follow up of 13.1 mo and no differences between age groups (fig 1, p=0.70). The median survival was 12.5 months in the 70-75 group vs. 13.7 months in the 65-69 group. As seen in Table 1, transplant was well tolerated and outcomes similar between both age groups with minimal 30 day mortality. Comparing patients age 70-75 to those 65-69, there was no difference in OS at 100d, 1 year or 2 years. There was no difference in grade II-IV acute GVHD (p=0.50). The cause of death was similar in both groups; of the patients who died, death was treatment-related in 45% and 40% of 70+ versus younger patients respectively, largely due to GVHD and infection. Relapse accounted for death in 55% and 57% of older versus younger patients who died. Conclusions: These data suggest that at least selected patients ≥70 years old can tolerate allogeneic HSCT similar to patients ages 65-69. Outcomes in both age groups remain limited by a high risk of relapse highlighting that better methods for tumor control are needed such as post-transplant maintenance or novel disease-specific strategies that minimize GVHD but allow for enhanced GVL induction. However age ≥70 should not be an absolute contraindication for transplant. Figure 1 Figure 1. Disclosures Shaw: Vitality Institute: Research Funding; Novartis: Research Funding. Frey:Servier: Consultancy; Amgen: Consultancy; Novartis: Research Funding. Gill:Novartis: Patents & Royalties, Research Funding. Luger:Astellas: Honoraria; Dava Oncology: Honoraria; Pfizer: Consultancy; Onconova: Other: Clinical Trial --Institutional PI; Seattle Genetics: Other: Clinical Trial--Institutional PI; Ariad: Other: Clinical Trial--Institutional PI; Celgene: Other: Clinical Trial--Institutional PI; Cyclacel: Other: Clinical Trial, Institutional PI. . Mangan:Novartis: Research Funding; Incyte: Other: Advisory Board. Stadtmauer:Celgene: Consultancy; Takeda: Consultancy; Teva: Consultancy; Janssen: Consultancy; Novartis: Consultancy; Amgen: Consultancy. Porter:Genentech: Other: Spouse Employment; Novartis: Patents & Royalties, Research Funding.

Delivery and Toxicity of Fludarabine-Based Combination Chemotherapy Regimens in Older Patients.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 3329-3329
Author(s):  
Mark N. Polizzotto ◽  
Constantine S. Tam ◽  
Henry Januszewicz ◽  
Miles Prince ◽  
Max Wolf ◽  
...  
Keyword(s):  
Combination Chemotherapy ◽  
Older Patients ◽  
Age Groups ◽  
Infectious Complications ◽  
P Values ◽  
Younger Patients ◽  
Severe Infections ◽  
The Difference ◽  
Treatment Related Mortality ◽  
Related Mortality

Abstract Fludarabine (F)-based combination chemotherapy regimens are highly effective in a range of indolent lymphoproliferative disorders. Despite the prevalence of such disorders in older patients, the deliverability of these regimes in patients aged &gt;= 60 has not been assessed. We analysed the delivery and toxicity of three F-based regimens, all using F 25 mg/m2/dx3 q28d, in 82 adults aged &gt;= 60 years, and compared this with the same regimens in 99 adults aged &lt; 60. The sample comprised 66 patients (32 &gt;= 60) treated with F and cyclophosphamide (C; 250 mg/m2/dx3); 29 with F and mitoxantrone (M; 10 mg/m2 x1; 12 &gt;= 60); and 86 with FC and rituximab (R; 375 mg/m2 x1; 38 &gt;= 60). 349 cycles in older patients were compared with 393 cycles in younger patients for haematologic nadirs, infectious complications and organ toxicity. Both groups received a median of 4 cycles, although older patients were more likely to require dose reduction (4.3% of cycles versus 1.2%, P &lt; 0.001) and growth factor support (3.8% versus 1.8%, P=0.01). The cohorts were well matched for baseline characteristics other than age. Overall, older patients had a slightly higher rate of infections (18%/cycle versus 15%/cycle), though this was not statistically significant (P = 0.28). For severe (grade &gt;=3) infections the difference was minimal: 6% versus 7% (P&lt; 0.5). The rates of neutropenia &lt; 1.0 and 0.5 were 13% and 22% versus 11% and 20% for older and younger patients, respectively (all P values&gt;0.1). The rates of thrombocytopenia &lt; 100 and &lt; 50 were 21% and 5% versus 16% and 5% for older and younger cohorts (all P values &lt; 0.1). Other organ toxicities were uncommon, and showed no difference between age groups. Treatment-related mortality in both cohorts was &lt;1% (P &gt; 0.5). Comparison within the cohort aged over 60 showed that those aged 70 and over were at higher risk of haematological and infectious toxicity. 82 cycles delivered to 23 patients aged &gt;= 70 were compared with 267 cycles delivered to 61 patients aged 60 to 69. The rate of infection for those over 70 was 25% versus 16% in those aged 60 to 69, though this was not statistically significant (P=0.07). For severe infections (grade &gt;=3), the rates were 13% versus 6% (P=0.03), while rates of neutropenia &lt; 0.5 and thrombocytopenia &lt; 50 were 32% and 15% versus 8% and 3% for those &gt;= 70 and 60 to 69 respectively (all P values &gt; 0.001). These results demonstrate that F-based regimens are well tolerated and can safely be delivered to most older patients, with a modestly increased rate of infectious morbidity, but no increased treatment-related mortality. However, for patients aged &gt;=70 the increased rate of toxicity mandates careful patient selection and monitoring.

Therapy with Imatinib In Elderly CML Patients (>65years): Results of the German CML-Study IV.

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3411-3411
Author(s):  
Susanne Saussele ◽  
Nadine Pletsch ◽  
Michael Lauseker ◽  
Armin Leitner ◽  
Susanne Jung-Munkwitz ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Older Patients ◽  
Research Funding ◽  
Gastrointestinal Symptoms ◽  
Chronic Phase ◽  
The Elderly ◽  
Interferon Α ◽  
Younger Patients ◽  
Treatment Groups ◽  
Grade 3

Abstract Abstract 3411 Background: Dose of therapy and time to response may be different in the elderly as compared to younger patients with CML. This has been reported previously for interferon α (Berger et al., Leukemia 2003). For imatinib, contradictory results have been presented (Rosti et al. Haematologica 2007, Guliotta et al. Blood 2009). Aims: An analysis comparing dose-response relationship in patients more or less than 65 years (y) of age is warranted. Methods: We analysed the German CML-Study IV, a randomized 5-arm trial to optimize imatinib therapy by combination, dose escalation and transplantation. Patients older and younger than 65y randomized to imatinib 400 mg (IM400) or 800 mg (IM800) were compared with regard to time to hematologic, cytogenetic and molecular remissions, imatinib dose, adverse events (AEs) and overall survival (OS). Results: From July 2002 to April 2009, 1311 patients with Ph+ CML in chronic phase were randomized, 623 patients were evaluable, 311 patients for treatment with IM400 and 312 for IM800. 84 (27%) and 66 (21%), respectively, were older than 65 years. All patients were evaluable for hematologic, 578 (140 >65y and 438 <65y) for cytogenetic, and 600 (143 and 457, respectively) for molecular responses. Median age was 70y vs. 49y for IM400 and 69y vs. 46y for IM800. The median dose per day was lower for elderly patients with IM800 (517mg vs. 666mg) and the same with IM400 (400mg each). Patients' characteristics at baseline were evenly distributed in all groups regarding gender, follow-up, hemoglobin, platelet count and spleen size. Leukocyte counts were significantly lower in elderly patients (IM400: 50/nl vs. 78/nl, IM800: 36/nl vs. 94/nl). EURO score was different due to age in elderly patients (low risk: IM400: 11% vs. 43%, IM800: 14% vs. 42%; intermediate risk: IM400: 79% vs. 44% and IM800: 73% and 43%). There was no difference in cytogenetic and molecular analyses between treatment groups. With regard to efficacy, there was no difference for older patients in achieving a complete cytogenetic remission (CCR) and major molecular remission (MMR) if IM400 and IM800 were compared together. If treatment groups were analyzed separately, older patients treated with IM400 reached CCR and MMR statistically significant slower than younger patients (CCR: median 14.2 months vs. 12.1 months, p=0.019; MMR: median 18.7 months vs. 17.5 months, p=0.006). There was no difference with IM800 (CCR: median 7.7 months vs. 8.9 months, MMR: median 9.9 months vs. 10.0 months). 3y-OS for older patients >65y was 94.7% and for patients <65y was 96.1%. Some differences were observed in the safety analyses. 530 patients (IM400: 278, IM800: 252) were evaluated on common toxicity criteria (WHO). Some hematologic AEs were documented slightly more often in the elderly than in the younger patients: for IM400 anemia grade 1–2 (60 vs. 42%) and leukopenia grade 3–4 (5.6 vs. 1.4%) and for IM800 anemia grade 1–4 (64 vs.47% and 7.2 vs. 5.7%) and thrombocytopenia grade 3–4 (9.3 vs. 7.1%). Non hematologic AEs were more prominent in IM800 and were mainly gastrointestinal symptoms (IM400: 33 vs. 31%, IM800: 48 and 44%) and edema (IM400: 28 vs. 29%, IM800: 35 vs. 50%). There was no difference for grade 3/4 non-hematological AEs in older patients in both groups. Conclusions: Imatinib 400 mg and 800 mg are well tolerated also in the elderly. The IM800 dosage was more tolerability-adapted for the elderly, but there was no difference in reaching a CCR and MMR in contrast to the IM400 where a significantly slower response was detected in the elderly. Whether this difference is clinically relevant has yet to be determined. Updated results will be presented. Disclosures: Haferlach: MLL Munich Leukemia Laboratory: Employment, Equity Ownership, Research Funding. German CML-Study Group:Deutsche Krebshilfe: Research Funding; Novartis: Research Funding; Roche: Research Funding; BMBF: Research Funding; Essex: Research Funding.

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