ABSTRACT
BACKGROUND: Lenalidomide (R), bortezomib (V), and dexamethasone (d) is a standard-of-care regimen in newly diagnosed multiple myeloma (NDMM); however, characteristics and outcomes for nontransplanted patients receiving frontline RVd are not well understood. PATIENTS: The Connectâ MM Registry is a large, US, multicenter, prospective observational cohort study of NDMM patients. METHODS: This analysis investigated characteristics and outcomes of patients who received RVd alone or followed by Rd or R (RVd ± Rd/R) who did not undergo frontline autologous stem cell transplantation. RESULTS: As of August 2021, 314 of 1979 nontransplanted patients received RVd ± Rd/R as initial therapy. Of these, 135 were aged ≤ 65 years and 179 were > 65 years. 108 patients had time to relapse (TTR) of ≤ 12 months and 182 had TTR > 12 months. Baseline characteristics were comparable regardless of TTR and age group except renal function, which was more commonly impaired in older patients. Among patients aged ≤ 65 and > 65 years, median duration of first-line treatment was 6.3 and 9.0 months, median time to next line for those who received second-line therapy was 15.5 and 15.2 months, median progression-free survival (PFS) was 19.3 and 23.0 months, and median overall survival was 60.0 and 59.1 months, respectively. High-risk disease (per IMWG criteria) and high serum calcium were associated with higher hazard of progression or death; the adjusted PFS hazard ratio with respect to age (≤ 65 vs. > 65 years) based on multivariable analysis was 1.18 (0.89-1.57; P = .25). CONCLUSION: These results indicate RVd is active across age groups and provide a better understanding of outcomes with RVd in NDMM.
ABSTRACT
Over the course of the past two decades, attrition within the US governmental public health workforce has passed concerning and become dire. The practice sector has struggled to recruit and retain new talent, despite the infusion of considerable federal investment in workforce expansion initiatives. In 2020, Emory University's Rollins School of Public Health partnered with the Georgia Department of Public Health to establish the Rollins Epidemiology Fellowship Program. Initially created to recruit and place early-career master of public health-level epidemiologists into Georgia's public health system for COVID-19 pandemic response, the two-year service-learning program has evolved into an effective and replicable model of direct academic involvement in strengthening the governmental public health workforce. Here we describe the program's structure and early results, spotlighting it for consideration by the federal government and other jurisdictions interested in directly engaging academia in efforts to revitalize the public health workforce.
Subject(s)
COVID-19 , Fellowships and Scholarships , Humans , Georgia , COVID-19/epidemiology , Epidemiology/education , Public Health , Health Workforce , WorkforceABSTRACT
PURPOSE: Radiation therapy (RT) is an important treatment modality for patients with multiple myeloma (MM). Although patients are living longer with MM, they are more likely to have comorbidities related to treatment, such as bone pain; however, RT can provide symptom relief. To date, the characterization of patients who have received RT in the real-world setting has been limited. METHODS AND MATERIALS: The Connect® MM Registry is a large, US multicenter, prospective observational cohort study of adult patients with newly diagnosed MM from mostly community sites. RT utilization and outcomes were analyzed quarterly throughout treatment. Factors associated with RT use were identified via multivariable analysis. RESULTS: A total of 3011 patients were enrolled in the Connect MM Registry with 903 patients (30%) having received RT at any time. There was a significant difference (P < .05) in overall RT use among patients with an Eastern Cooperative Oncology Group performance status of 0 to 1 versus ≥2, International Staging System disease stage I/II versus III, a history of plasmacytoma or a novel agent in their first regimen, and any number of bone lesions or severe osteoporosis/fracture. RT use was associated with having bone lesions or severe osteoporosis (vs not having bone lesions). Additionally, RT use was associated with ethnicity (Hispanic vs not) and Connect MM Registry cohort (cohort 1 [enrolled 2009-2011] vs 2 [enrolled 2012-2016]). In the 6 months before death, increased RT use was associated with increasing number of treatment lines (P < .0001) and high- versus standard-risk disease (per International Myeloma Working Group criteria; P = .0028). CONCLUSIONS: Real-world results from the Connect MM Registry show RT is frequently used and is associated with clinical factors, including performance status and disease stage. Earlier in MM diagnosis, RT may be used as an adjunct to palliate symptoms or delay systemic therapy. Toward the end of life, RT is more frequently used for palliation when treatment options are often limited.
Subject(s)
Multiple Myeloma , Osteoporosis , Adult , Humans , Multiple Myeloma/radiotherapy , Prospective Studies , Ethnicity , RegistriesABSTRACT
BACKGROUND: Adults with triple-class refractory (TCR) multiple myeloma (MM) have limited treatment options and poor prognosis, but the burden of TCR MM has not been well characterized. This study evaluated treatment patterns, overall survival (OS), health-related quality of life (HRQoL), and healthcare resource use (HCRU) among patients with TCR MM in US clinical practice. PATIENTS AND METHODS: Patients with TCR MM in the Connect MM Registry (NCT01081028; a large, US, multicenter, prospective observational cohort study of patients with newly diagnosed MM) were included. Patient characteristics, treatment patterns, HRQoL, and HCRU were analyzed using descriptive statistics. OS was calculated using Kaplan-Meier methodology for the overall cohort and for patients with/without ≥1 post-TCR line of therapy (LOT). RESULTS: A total of 232 patients with TCR MM were included; 155 (67%) had ≥1 post-TCR LOT (post-TCR-Treated subgroup; median 9.9 months of follow-up). Most common post-TCR treatments were carfilzomib (47%), pomalidomide (40%), and daratumumab (26%); median treatment duration was 3.3 months. Median OS was 9.9 months in the overall population, 10.8 months in post-TCR-Treated patients, and 2.6 months for those with no new post-TCR LOT. HRQoL deteriorated and pain increased over 1 year of follow-up, with clinically meaningfully changes in EQ-5D (mean, -0.06 points) and FACT-G (mean, -9.9 points). 124 (53%) patients had ≥1 all-cause hospitalization and 58 (25%) had ≥1â¯MM-related hospitalization; median annualized length of stay was 35.3 and 42.9 days, respectively. CONCLUSION: The burden of TCR MM is substantial, emphasizing the need for more effective treatment options in the TCR setting.
Subject(s)
Multiple Myeloma , Adult , Humans , Multiple Myeloma/drug therapy , Prospective Studies , Quality of Life , Registries , Delivery of Health Care , Receptors, Antigen, T-Cell/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Dexamethasone/therapeutic useABSTRACT
Gay, bisexual, and other men who have sex with men (MSM) have been disproportionately affected during the 2022 U.S. monkeypox outbreak, with Black or African American (Black) MSM being the most affected demographic group (1). As of September 28, 2022, Georgia had reported 1,784 monkeypox cases; 98% of which occurred in males and 77% among Black persons (2). As of September 13, 2022, 60% of reported cases were among persons with HIV infection, and 50% of persons with monkeypox had a sexually transmitted infection within the past year (3). Because of racial disparities in the incidence of monkeypox cases and a large proportion of cases among MSM in Georgia, early vaccination beginning in July focused on improving equitable access by establishing new and leveraging existing partnerships with community-based organizations that serve affected populations, including persons with HIV infection. Despite these efforts, disparities persisted because of high demand and limited vaccine supply. The Georgia Department of Public Health (DPH) requested CDC support for a vaccine pilot and received an additional allocation of 5,500 doses of JYNNEOS vaccine for administration at events leading up to and throughout a Black gay Pride festival in Atlanta, a multiday event held Labor Day weekend (September 2-5, 2022). The event celebrates lesbian, gay, bisexual, transgender, queer or questioning, intersex, asexual, and other (LGBTQIA+) communities of color and hosts more than 125,000 attendees each year. Before the festival (as of August 24), 17,546 persons had been vaccinated in Georgia, of whom 96% were male, 34% aged 25-36 years, 44% Black, and 8% Hispanic or Latino (Hispanic) (4).
Subject(s)
HIV Infections , Health Equity , Mpox (monkeypox) , Sexual and Gender Minorities , Female , Male , Humans , Homosexuality, Male , HIV Infections/epidemiology , HIV Infections/prevention & control , Georgia/epidemiology , VaccinationABSTRACT
BACKGROUND: The t (11;14) (q13;32) translocation [t (11;14)] is present in â¼20% of patients with newly diagnosed multiple myeloma (NDMM), but studies examining its prognostic ability have yielded divergent results, and data are lacking on outcomes from first-line therapy. PATIENTS AND METHODS: Data from the Connect MM Registry, a large US, multicenter, prospective observational cohort study of patients with NDMM were used to examine the effect of t (11;14) status on first-line therapy outcomes in the Overall population (n = 1574) and race groups (African American [AA] vs. non-African American [NAA]). RESULTS: Baseline characteristics were generally similar between patients with (n = 378) and without (n = 1196) t (11;14). Prevalence of t (11;14) was similar by race (AA, 27%; NAA, 24%). In the overall population, regardless of first-line therapy, t (11;14) status did not affect progression-free survival (hazard ratio, 1.02; P = 0.7675) or overall survival (hazard ratio, 0.99; P = .9417). AA patients with t (11;14) had higher likelihood of death (Nominal Cox regression P = .0298) vs. patients without t (11;14). CONCLUSIONS: Acknowledging observational study and inferential limitations, this exploratory analysis of a predominantly community-based population suggests that t (11;14) is a neutral prognostic factor in the general MM population but may be a negative factor for overall survival in AA patients.
Subject(s)
Multiple Myeloma , Black or African American , Humans , Multiple Myeloma/diagnosis , Multiple Myeloma/drug therapy , Multiple Myeloma/genetics , Proportional Hazards Models , Prospective Studies , Registries , Retrospective StudiesABSTRACT
BACKGROUND: Reported coronavirus disease 2019 (COVID-19) cases underestimate true severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. Data on all infections, including asymptomatic infections, are needed. To minimize biases in estimates from reported cases and seroprevalence surveys, we conducted a household-based probability survey and estimated cumulative incidence of SARS-CoV-2 infections adjusted for antibody waning. METHODS: From August to December 2020, we mailed specimen collection kits (nasal swabs and blood spots) to a random sample of Georgia addresses. One household adult completed a survey and returned specimens for virus and antibody testing. We estimated cumulative incidence of SARS-CoV-2 infections adjusted for waning antibodies, reported fraction, and infection fatality ratio (IFR). Differences in seropositivity among demographic, geographic, and clinical subgroups were explored with weighted prevalence ratios (PR). RESULTS: Among 1370 participants, adjusted cumulative incidence of SARS-CoV-2 was 16.1% (95% credible interval [CrI], 13.5%-19.2%) as of 16 November 2020. The reported fraction was 26.6% and IFR was 0.78%. Non-Hispanic black (PR, 2.03; 95% confidence interval [CI], 1.0-4.1) and Hispanic adults (PR, 1.98; 95% CI, .74-5.31) were more likely than non-Hispanic white adults to be seropositive. CONCLUSIONS: As of mid-November 2020, 1 in 6 adults in Georgia had been infected with SARS-CoV-2. The COVID-19 epidemic in Georgia is likely substantially underestimated by reported cases.
Subject(s)
COVID-19 , Adult , Antibodies, Viral/blood , COVID-19/epidemiology , Georgia/epidemiology , Humans , Incidence , Seroepidemiologic StudiesABSTRACT
Although there have been several case reports and simulation models of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission associated with air travel, there are limited data to guide testing strategy to minimize the risk of SARS-CoV-2 exposure and transmission onboard commercial aircraft. Among 9853 passengers with a negative SARS-CoV-2 polymerase chain reaction test performed within 72 hours of departure from December 2020 through May 2021, five (0.05%) passengers with active SARS-CoV-2 infection were identified with rapid antigen tests and confirmed with rapid molecular test performed before and after an international flight from the United States to Italy. This translates to a case detection rate of 1 per 1970 travelers during a time of high prevalence of active infection in the United States. A negative molecular test for SARS-CoV-2 within 72 hours of international airline departure results in a low probability of active infection identified on antigen testing during commercial airline flight.
Subject(s)
Air Travel , COVID-19 Testing/standards , COVID-19/diagnosis , SARS-CoV-2/isolation & purification , COVID-19/transmission , COVID-19 Nucleic Acid Testing/standards , Humans , Italy , Risk Assessment , United StatesABSTRACT
Metaplastic breast cancer (MBC) is a rare and aggressive subtype of breast cancer. Tumor characteristics typically feature estrogen receptor, progesterone receptor, and HER2-negative, triple-negative breast cancer (TNBC), with a poorer prognosis relative to pure invasive ductal or lobular disease. Resistance to chemotherapy often leads to local recurrence and distant metastasis. Genomic profiling has identified multiple molecular abnormalities that may translate to targetable therapies in MBC. These tumors are known to display higher PD-L1 expressivity than other subtypes of breast cancer, and disease control with pembrolizumab and chemotherapy has been documented. We identify a patient with metastatic, metaplastic TNBC, with mesenchymal components and osseous differentiation, who completed 2 years of pembrolizumab treatment and has remained without evidence of disease after 32 months of observation, while maintaining good quality of life. Future efforts should focus on immunotherapy response with respect to the various subtypes of MBC, and treatment should continue to be incorporated in clinical trials to maximize disease response.
ABSTRACT
Although new multiple myeloma (MM) therapies are effective in alleviating some disease-associated symptoms (e.g. bone pain, fatigue, functional decline), they can result in additional toxicities, further impacting health-related quality of life (HRQoL). Here, we compared HRQoL and safety of lenalidomide-bortezomib-dexamethasone [RVd (n = 445)], bortezomib-melphalan-prednisone [VMP (n = 77)] and Vd or VMP (n = 588) in patients with newly diagnosed MM (NDMM) from the Connect® MM Registry, a large, USA, multicentre, prospective observational cohort study. Functional Assessment of Cancer Therapy-Multiple Myeloma subscale, EuroQol-5D overall score and Bone Pain Inventory HRQoL scores were significantly improved with RVd versus Vd/VMP. Serious adverse event rates were similar in all groups. Treatment with RVd maintained HRQoL in this real-world, largely community-based population of patients with NDMM.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/adverse effects , Multiple Myeloma/diagnosis , Multiple Myeloma/drug therapy , Multiple Myeloma/psychology , Adult , Aged , Aged, 80 and over , Angiogenesis Inhibitors/adverse effects , Angiogenesis Inhibitors/therapeutic use , Antineoplastic Agents/adverse effects , Antineoplastic Agents/therapeutic use , Antineoplastic Agents, Alkylating/adverse effects , Antineoplastic Agents, Alkylating/therapeutic use , Antineoplastic Agents, Hormonal/adverse effects , Antineoplastic Agents, Hormonal/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Bortezomib/adverse effects , Bortezomib/therapeutic use , Case-Control Studies , Dexamethasone/adverse effects , Dexamethasone/therapeutic use , Female , Humans , Lenalidomide/adverse effects , Lenalidomide/therapeutic use , Male , Melphalan/adverse effects , Melphalan/therapeutic use , Middle Aged , Multiple Myeloma/pathology , Prednisone/adverse effects , Prednisone/therapeutic use , Prospective Studies , Quality of Life/psychology , Registries , Safety , Stem Cell Transplantation/standardsABSTRACT
BACKGROUND: Studies have reported racial disparities in access to and use of multiple myeloma (MM) treatments between African American (AA) and White patients. Although AA patients demonstrate longer disease-specific survival, this has not uniformly translated into improved survival over time. The association between race and treatment patterns and survival outcomes was analyzed using data from the Connect MM Registry. METHODS: The Connect MM Registry is a large US, multicenter, prospective observational cohort study of patients with newly diagnosed MM. Patients who received first-line (1L) stem cell transplantation (SCT) or who did not receive SCT (non-SCT or non-stem cell transplantation [NSCT]) were grouped by raceEffects of race and transplantation status on the use of triplet treatment were estimated using logistic regression. RESULTS: Treatment patterns in 1L (types and duration of induction, posttransplantation maintenance) were similar between AA and White patients. SCT rates in 1L (32% vs 36%) and triplet treatment use (AA: 44% for NSCT patients and 72% for SCT patients; and White: 48% for NSCT patients and 72% for SCT patients) during first induction were similar. No significant effect of race or transplantation status on 1L triplet treatment use was observed. Race was not found to be associated with survival outcomes among patients who underwent NSCT; however, AA patients who received SCT had significantly longer overall survival compared with White patients who underwent SCT (not reached vs 88.2 months; hazard ratio, 0.56; 95% CI, 0.35-0.89 [P = .0141]). CONCLUSIONS: AA and White patients were found to have similar treatment patterns in the Connect MM Registry, suggesting that both groups had equal access to health care. In this real-world setting, AA patients received standard-of-care treatment, which might have contributed to better MM-specific survival compared with White patients.
Subject(s)
Multiple Myeloma/ethnology , Multiple Myeloma/mortality , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Prospective Studies , Racial Groups , Registries , Survival Analysis , United States , Young AdultSubject(s)
Immunologic Factors/administration & dosage , Multiple Myeloma , Proteasome Inhibitors/administration & dosage , Registries , Stem Cell Transplantation , Aged , Allografts , Disease-Free Survival , Female , Humans , Male , Middle Aged , Multiple Myeloma/diagnosis , Multiple Myeloma/mortality , Multiple Myeloma/therapy , Survival RateABSTRACT
BACKGROUND: The Surveillance, Epidemiology, and End Results (SEER) database and National Cancer Database (NCDB) show improved overall survival (OS) in patients with multiple myeloma (MM) over the last 15 years. This analysis evaluated the validity of the largely community-based Connect MM Registry as a national reference for MM. METHODS: Baseline disease characteristics and survival in US newly diagnosed MM patients were examined using the Connect MM Registry as well as SEER and NCDB databases. Baseline characteristics predictive of longer survival in Connect MM were also identified. RESULTS: As of February 2017, 3011 patients were enrolled in the Connect MM Registry; 2912 were treated. Median age at time of MM diagnosis and age range were numerically similar from 2010 to 2015 across all 3 registries; SEER had a higher representation of nonwhite racial groups than that in the other 2 registries. OS rates suggest proportionate improvement with year of diagnosis among the 3 registries. A Cox proportional hazards model suggests that younger age (<65 years) is associated with longer survival (vs ≥75; HR, 0.39; 95% confidence interval, 0.34-0.46) in the Connect MM Registry. However, sex (HR, 0.91; P = .15) and race (black vs white; HR, 0.88; P = .21) were not associated with longer OS. CONCLUSIONS: Data from the Connect MM Registry appear to be largely representative of national trends, comprehensive, and reliable representations of the national MM population. Baseline characteristics were comparable, and survival similarly improved over time among the 3 registries. CLINICALTRIALS. GOV, IDENTIFIER: NCT01081028.
Subject(s)
Databases, Factual/statistics & numerical data , Multiple Myeloma/mortality , Registries/statistics & numerical data , SEER Program/statistics & numerical data , Adult , Aged , Aged, 80 and over , Female , Follow-Up Studies , Humans , Male , Middle Aged , Proportional Hazards Models , Puerto Rico/epidemiology , Reproducibility of Results , Survival Rate , United States/epidemiology , Young AdultABSTRACT
Median overall survival (OS) has improved for patients with newly diagnosed multiple myeloma (NDMM), but prognosis varies depending on baseline patient characteristics. Current models use data from selected clinical trial populations, which prevent application to patients in an unselected community setting that reflects routine clinical practice. Using data from the Connect® MM Registry, a large, US, multicentre, prospective observational cohort study (Cohort 1: 2009-2011; Cohort 2: 2012-2016) of 3011 patients with NDMM, we identified prognostic variables for OS via the multivariable analysis of baseline patient characteristics in Cohort 1 (n = 1493) and developed a tool to examine individual outcomes. Factors associated with OS (n = 1450 treated patients; P < 0·05) were age, del(17p), triplet therapy use, EQ-5D mobility, International Staging System stage, solitary plasmacytoma, history of diabetes, platelet count, Eastern Cooperative Oncology Group performance status and serum creatinine, which were used to create survival matrices for 3- and 5-year OS. The model was internally and externally validated using Connect MM Cohort 2 (Harrell's concordance index, 0·698), MM-015 (0·649), and the phase 3 FIRST (0·647) clinical trials. This novel prognostic tool may help inform outcomes for NDMM in the era of triplet therapy use with novel agents.
Subject(s)
Multiple Myeloma/diagnosis , Multiple Myeloma/mortality , Adult , Age Factors , Aged , Aged, 80 and over , Chromosome Deletion , Chromosomes, Human, Pair 17 , Female , Humans , Male , Middle Aged , Multiple Myeloma/genetics , Multiple Myeloma/pathology , Neoplasm Staging , Prognosis , Proportional Hazards Models , Registries , Reproducibility of Results , Risk Assessment/methods , Smith-Magenis Syndrome/mortality , Survival Analysis , United States/epidemiology , Young AdultABSTRACT
In 2008, an outbreak of isoniazid-resistant tuberculosis was identified among residents of homeless shelters in Atlanta, Georgia, USA. When initial control efforts involving standard targeted testing failed, a comprehensive approach that involved all providers of services for the homeless successfully interrupted the outbreak.
Subject(s)
Antitubercular Agents/pharmacology , Ill-Housed Persons , Isoniazid/pharmacology , Mycobacterium tuberculosis/drug effects , Tuberculosis, Multidrug-Resistant/epidemiology , Tuberculosis, Multidrug-Resistant/microbiology , Antitubercular Agents/therapeutic use , Disease Outbreaks , Georgia/epidemiology , History, 21st Century , Humans , Incidence , Isoniazid/therapeutic use , Tuberculosis, Multidrug-Resistant/drug therapy , Tuberculosis, Multidrug-Resistant/historyABSTRACT
BACKGROUND: The Food and Drug Administration issued a drug safety alert highlighting the potential association of docetaxel infusion with signs and symptoms of alcohol intoxication. This concern is significant because patients treated with docetaxel often have comorbidities and are prescribed concomitant centrally active medications. As a result, these patients may be at risk for iatrogenic events. OBJECTIVE: The objective of this study was to identify a correlation with docetaxel infusion and saliva ethanol concentration using a point-of-care ethanol test. METHODS: In this pilot study, ethanol concentrations were measured using a validated saliva ethanol test in patients receiving intravenous docetaxel as part of their chemotherapy regimen. Both ethanol dose and infusion rate were calculated based on the amount of the specific docetaxel product administered. Saliva ethanol concentrations were measured at baseline, immediately after infusion completion, and at 30 and 60 min postinfusion. RESULTS: A total of 17 patients were included in the analysis. The mean ethanol dose administered was 2.6 ± 0.5 g of ethanol per infusion of docetaxel with a mean infusion rate of 3.2 ± 0.7 ml of ethanol per hour. At baseline, immediately after infusion, and 30 and 60 min postinfusion, all patients had a saliva ethanol test result of 0 mg/dl. CONCLUSION: Based on this small pilot study, the prediction of patients who will experience ethanol intoxication using a point-of-care saliva ethanol test based on the docetaxel dose administered is challenging. This observation requires confirmation in larger and more heterogeneous populations.
Subject(s)
Antineoplastic Agents/adverse effects , Docetaxel/adverse effects , Ethanol/analysis , Ethanol/poisoning , Point-of-Care Systems , Saliva/chemistry , Aged , Ethanol/administration & dosage , Female , Humans , Male , Middle Aged , Pilot ProjectsABSTRACT
PURPOSE: Maintenance therapy after autologous stem cell transplantation (ASCT) improves clinical outcomes in multiple myeloma (MM), but the effect of continued treatment with lenalidomide-only maintenance, or any maintenance, on health care resource utilization (HCRU) is largely unknown. METHODS: Here we present an analysis of HCRU and clinical outcomes in a cohort of patients from the Connect MM registry, the largest, ongoing, observational, prospective US registry of patients with symptomatic newly diagnosed MM. In this study, patients with newly diagnosed MM who completed induction and single ASCT without subsequent consolidation received lenalidomide-only maintenance (nâ¯=â¯180), any maintenance (nâ¯=â¯256), or no maintenance (nâ¯=â¯165). HCRU (hospitalization, surgery/procedures, and concurrent medications [growth factors, bisphosphonates, or neuropathic pain medication]) was assessed starting from 100 days post-ASCT for up to 2 years. FINDINGS: Although the rates of hospitalization per 100 person-years were similar across groups at the end of years 1 and 2, the median duration of hospitalization was numerically longer with no maintenance. The rates of use of growth factors, bisphosphonates, and neuropathic pain medication were generally similar in all 3 groups. The receipt of any maintenance was associated with significantly reduced use of neuropathic pain medications during year 1. Of note, lenalidomide-only maintenance was associated with significantly longer progression-free survival (54.5 vs 30.4 months; hazard ratio [HR]â¯=â¯0.58; 95% CI, 0.43-0.79; Pâ¯=â¯0.0005) and overall survival (OS) (median OS not reached in either group; HRâ¯=â¯0.45; 95% CI, 0.28-0.73; Pâ¯=â¯0.001) compared with no maintenance. Likewise, the group treated with any maintenance had significantly longer median progression-free survival (44.7 vs 30.4 months; HRâ¯=â¯0.62; 95% CI, 0.47-0.82; Pâ¯=â¯0.0008) and OS (median OS not reached in either group; HRâ¯=â¯0.50; 95% CI, 0.33-0.76; Pâ¯=â¯0.001) than did the group that did not receive maintenance. IMPLICATIONS: These findings suggest that in this largely community-based study population, post-ASCT maintenance therapy, including lenalidomide-only maintenance, improves clinical outcomes without negatively affecting HCRU. ClinicalTrials.gov identifier: NCT01081028.
Subject(s)
Hematopoietic Stem Cell Transplantation , Immunologic Factors/therapeutic use , Lenalidomide/therapeutic use , Multiple Myeloma/drug therapy , Adult , Aged , Disease Progression , Female , Health Resources , Humans , Male , Middle Aged , Registries , Transplantation, Autologous , Treatment Outcome , Young AdultABSTRACT
Maintenance therapy after autologous stem cell transplantation (ASCT) is recommended for use in multiple myeloma (MM); however, more data are needed on its impact on health-related quality of life (HRQoL). Presented here is an analysis of HRQoL in a Connect MM registry cohort of patients who received ASCT ± maintenance therapy. The Connect MM Registry is one of the earliest and largest, active, observational, prospective US registry of patients with symptomatic newly diagnosed MM. Patients completed the Functional Assessment of Cancer Therapy-MM (FACT-MM) version 4, EuroQol-5D (EQ-5D) questionnaire, and Brief Pain Inventory (BPI) at study entry and quarterly thereafter until death or study discontinuation. Patients in three groups were analyzed: any maintenance therapy (n = 244), lenalidomide-only maintenance therapy (n = 169), and no maintenance therapy (n = 137); any maintenance and lenalidomide-only maintenance groups were not mutually exclusive. There were no significant differences in change from pre-ASCT baseline between any maintenance (P = 0.60) and lenalidomide-only maintenance (P = 0.72) versus no maintenance for the FACT-MM total score. There were also no significant differences in change from pre-ASCT baseline between any maintenance and lenalidomide-only maintenance versus no maintenance for EQ-5D overall index, BPI, FACT-MM Trial Outcomes Index, and myeloma subscale scores. In all three groups, FACT-MM, EQ-5D Index, and BPI scores improved after ASCT; FACT-MM and BPI scores deteriorated at disease progression. These data suggest that post-ASCT any maintenance or lenalidomide-only maintenance does not negatively impact patients' HRQoL. Additional research is needed to verify these findings.
Subject(s)
Maintenance Chemotherapy , Multiple Myeloma/drug therapy , Quality of Life , Registries , Thalidomide/analogs & derivatives , Adult , Aged , Female , Follow-Up Studies , Humans , Lenalidomide , Male , Middle Aged , Prospective Studies , Thalidomide/administration & dosage , United StatesABSTRACT
Autologous stem cell transplantation (ASCT) followed by lenalidomide maintenance therapy is the standard of care for transplant-eligible patients with newly diagnosed multiple myeloma (NDMM). Clinical trials show progression-free survival (PFS) benefits, with some studies (Cancer and Leukemia Group [CALGB] trial and meta-analysis) also showing overall survival (OS) benefits, but applicability to real-world clinical settings is unclear. Using data from Connect MM, the largest US-based observational registry of NDMM patients, we analyzed effects of maintenance therapy on long-term outcomes in 1450 treated patients enrolled from 2009 to 2011. Patients who received induction therapy and ASCT (n = 432) were analyzed from 100 days post-ASCT (data cut 7 January 2016): 267 received maintenance (80% lenalidomide-based [of whom 88% received lenalidomide monotherapy]); 165 did not. Lenalidomide maintenance improved median PFS and 3-year PFS rate vs no maintenance (50.3 vs 30.8 months [hazard ratio (HR), 0.62; 95% confidence interval (CI), 0.46-0.82; P < .001] and 56% vs 42%, respectively). Improvements in median OS and 3-year OS rate were associated with lenalidomide maintenance vs no maintenance (not reached in either group [HR, 0.54; 95% CI, 0.36-0.83; P = .005] and 85% vs 70%, respectively). Five hematologic serious adverse events were reported with lenalidomide maintenance (pancytopenia [n = 2], febrile neutropenia, anemia, and thrombocytopenia [n = 1 each]) and 1 with no maintenance (thrombocytopenia). Second primary malignancies occurred at rates of 1.38 and 2.19 events per patient-year in lenalidomide maintenance and no maintenance groups, respectively. Survival benefits associated with lenalidomide maintenance previously demonstrated in clinical trials were observed in this community-based Connect MM Registry.