Pre- and Post-National Coverage Determination (NCD) Hematologic Outcomes and Blood Utilization in Cancer Patients with Chemotherapy-Induced Anemia (CIA): Results From a Multicenter Chart Review.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2491-2491
Author(s):  
David H. Henry ◽  
Corey J. Langer ◽  
R. Scott McKenzie ◽  
Catherine Tak Piech ◽  
Mekré Senbetta ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Research Funding ◽  
Chart Review ◽  
Negative Binomial ◽  
Performance Status ◽  
Cancer Type ◽  
Tumor Type ◽  
Ecog Performance Status ◽  
Ortho Biotech ◽  
Blood Utilization

Abstract Abstract 2491 Poster Board II-468 Introduction: In July 2007, the Centers for Medicare & Medicaid Services issued erythropoiesis-stimulating agent (ESA) coverage limitations for cancer patients with CIA through an NCD, which limits ESA utilization in patients with CIA to hemoglobin (Hb) levels of less than 10 g/dL at ESA initiation and after the initial 4 weeks of treatment. The primary objective of this study was to compare transfusion rates in patients with breast, colorectal or lung cancer who developed CIA before and after the NCD, regardless of treatment with ESAs. Patients and Methods: Chart data from adult cancer patients with Medicare as their primary payer and treated at community oncology clinics were abstracted for 12 weeks following the beginning of a CIA episode, provided that the entire episode occurred either before or after the change in policy. CIA was defined as Hb level < 11 g/dL, while receiving chemotherapy or within 8 weeks (60 days) of the last dose of chemotherapy. Logistic regression was used to calculate the odds of transfusion following the Hb < 11 g/dL index date. A negative binomial model was used to assess the change in units of blood transfused per patient. Multivariate models controlled for differences in age, gender, cancer type, line of therapy, ECOG performance status, history of antecedent transfusion and exposure to platinum, anthracyclines, antimetabolites and plant alkaloids. Results: 1794 patients were identified (800 Pre-NCD and 994 Post-NCD) from 49 sites. Patient groups were similar with respect to age, gender, race, weight, tumor type, line of treatment and recent exposure to radiation or surgery. As shown in the table below, there were significant differences in the chemotherapy class exposure in the Post- vs. Pre-NCD period. In addition, Hb levels were lower in the Post-NCD period, with a decrease in the proportion of ESA-treated patients and ESA treatment duration. The odds of receiving a transfusion were significantly higher Post-NCD (OR 1.41, 95% CI; 1.05 - 1.89; p=0.02) with an overall increase in adjusted units transfused of 53% (OR 1.53, 95% CI; 1.15 - 2.04; p=0.003). The table below summarizes patient characteristics and unadjusted Hb and transfusion outcomes. Conclusion: This large multicenter chart review reported decreased frequency and duration of ESA administration in CIA patients with Hb < 11 g/dL in the Post-NCD period compared to the Pre-NCD period. This was accompanied by a modest but statistically significant increase in blood utilization and decrease in Hb values. Further studies are warranted to assess other outcomes. Disclosures: McKenzie: Centocor Ortho Biotech Services, LLC: Employment. Piech:Centocor Ortho Biotech Services, LLC: Employment. Senbetta:Centocor Ortho Biotech Services, LLC: Employment. Schulman:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Stepanski:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding.

Blood and Resource Utilization in Cancer Patients with Chemotherapy-Induced Anemia (CIA) in the Pre- and Post-National Coverage Determination (NCD) Timeframes: Results From An Electronic Medical Record Study.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2472-2472
Author(s):  
Tanya Burton ◽  
Luke Boulanger ◽  
Kay Larholt ◽  
Chris L. Pashos ◽  
R. Scott McKenzie ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Resource Utilization ◽  
Research Funding ◽  
Treatment Patterns ◽  
Lower Proportion ◽  
Administrative Claims ◽  
Tumor Type ◽  
Ortho Biotech ◽  
Blood Utilization ◽  
The Impact

Abstract Abstract 2472 Poster Board II-449 Background: The Centers for Medicare & Medicaid Services issued erythropoiesis-stimulating agent (ESA) coverage limitations for cancer patients with CIA in July 2007 restricting ESA administration to those with hemoglobin (Hb) less than 10 g/dL and contingent on specific achieved Hb levels. Data assessing CIA patients regardless of ESA treatment pre- and post-NCD are scarce. This study evaluated Pre- and Post-NCD data in patients with CIA from a single oncology clinic in the northeastern United States to understand anemia treatment patterns, hematologic outcomes, and resource utilization. The oncology clinic, which is a part of a multi-specialty capitated integrated medical group, implemented the ESA NCD policy in September 2007. Methods: Medical, laboratory, and administrative claims data between 1/2005 and 4/2008 were retrospectively analyzed. Assessed patients had a diagnosis of malignant cancer (ICD-9-CM 140.XX-208.xx), received chemotherapy, and were anemic (Hb < 11 g/dL) during the chemotherapy treatment period. Patients diagnosed with myelodysplasia, acute leukemia, or chronic kidney disease who received dialysis, and those enrolled in ESA clinical trials were excluded. Data were categorized and analyzed in two time frames (Pre-NCD: 07/06-05/07, Post-NCD: 09/07-04/08). Baseline characteristics, ESA treatment patterns, hematologic outcomes (transfusion and available Hb levels), and resource utilization were assessed during the 20 week observation period following the index date of Hb < 11 g/dL. Results: 359 patients were identified (241 Pre-NCD; 118 Post-NCD). Baseline age, gender, race, weight, height, and distribution of tumor type were similar between groups. In the Post-NCD group, a significantly higher proportion of patients had comorbidities of congestive heart failure, coronary artery disease, and chronic obstructive pulmonary disease. The Post-NCD group had a significantly lower proportion of patients treated with ESAs (Pre-NCD 64%, Post-NCD 47%, p=0.0023). Among patients on ESA therapy (≥ 2 ESA injections), there was a trend toward shorter duration of ESA treatment in the Post-NCD arm [mean (SD): Pre-NCD 57.9 days (39.1), Post-NCD 47.3 days (38.1), p=0.08]. As noted in the table below, transfusion-independent Hb levels were lower in the Post-NCD group at baseline, Week 8, and Week 12. The proportion of patients transfused and blood utilization were similar in the Pre- and Post-NCD groups. The average number of oncology/hematology visits per patient was lower in the Post-NCD group [mean (SD): Pre-NCD 8.8 (5.9), Post-NCD 7.4 (6.5), p=0.01], however, a significantly higher proportion of patients in the Post-NCD period had a hospital admission (Pre-NCD 37.8%, Post-NCD 50.8%, p=0.02) or an emergency room (ER) visit (Pre-NCD 44.8%, Post-NCD 55.9%, p=0.048). Conclusion: Data from this single center observational study reported a lower proportion of patients initiated on ESAs, similar blood utilization, and an increased proportion of patients with hospitalization and ER visits in CIA patients with Hb < 11 g/dL in the Post-NCD as compared to the Pre-NCD time period. Further study assessing the impact of CIA NCD policy on healthcare resource utilization in multiple clinical centers is warranted. Disclosures: Burton: Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Boulanger:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Larholt:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Pashos:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. McKenzie:Centocor Ortho Biotech Services, LLC: Employment. Senbetta:Centocor Ortho Biotech Services, LLC: Employment. Lopez:Centocor Ortho Biotech Services, LLC: Employment. Sundaresan:Centocor Ortho Biotech Services, LLC: Consultancy. Preusse:Centocor Ortho Biotech Services, LLC: Consultancy. Seidler:Centocor Ortho Biotech Services, LLC: Consultancy.

Hematologic and Hospitalization Outcomes in Patients with Chemotherapy-Induced Anemia (CIA) Treated with Erythropoiesis-Stimulating Agents (ESAs) in the Pre- Vs Post-National Coverage Determination (NCD) Time Periods.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2482-2482
Author(s):  
Elizabeth Apgar ◽  
Tanya M. Burton ◽  
Kay Larholt ◽  
Chris L. Pashos ◽  
Lorie Ellis ◽  
...  
Keyword(s):  
Blood Transfusion ◽  
Cancer Patients ◽  
Research Funding ◽  
Study Patient ◽  
Patient Specific ◽  
Tumor Type ◽  
Ortho Biotech ◽  
Blood Utilization ◽  
Time Periods ◽  
Hospital Days

Abstract Abstract 2482 Poster Board II-459 Background: National coverage limitations for ESA treatment in cancer patients with CIA were established by the Centers for Medicare & Medicaid Services in July 2007. Clinical outcomes based on ESA dosing described in the NCD have not been reported in prospective observational or clinical trial data. To understand hematologic and hospitalization outcomes in CIA patients treated in Pre- and Post-NCD time periods, an analysis of data from the D.O.S.E. (Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies) registry, an ongoing prospective observational study, was conducted. Methods: ESA-treated cancer patients with CIA were selected if they initiated ESA treatment 12/01/2005-04/01/2007 (Pre-NCD) or 10/01/2007-02/01/2009 (Post-NCD), had ≥ 2 ESA administrations, and had both a baseline and ≥ 1 transfusion-independent post-ESA initiation hemoglobin (Hb) assessment. Assessed outcomes included proportion of patients receiving blood transfusion, number of units/study patient, Hb levels (at baseline and at weeks 4, 8, 12, 16) and hospitalization rates (admissions, number of hospital days) adjusted for ESA therapeutic duration (defined as time (days) from first to last ESA administration + patient-specific ESA treatment interval). Results: This analysis included 836 patients (Pre-NCD 585; Post-NCD 251) from 54 sites. Patients in the Pre-NCD and Post-NCD cohorts were similar in gender distribution and weight. The Post-NCD cohort was significantly older (64.7 yrs vs. 61.9 yrs; p<0.01). The groups also differed significantly in overall tumor type distribution (p<0.0001). The Post-NCD group had a lower proportion of patients with breast cancer and higher proportion of patients with lung cancer and gynecologic malignancies. ESA treatment duration was significantly shorter in the Post-NCD group (mean days ± SD: Post-NCD 55.5 ± 32.7, Pre-NCD 65.8 ± 33.8, p<0.0001). The proportion of patients receiving blood transfusion was significantly greater in the Post-NCD group (Post-NCD 26.7%, Pre-NCD 15.6%, p=0.0002) as was blood utilization (Units/study patient: Post-NCD 0.9, Pre-NCD 0.4, p=0.0001). As shown in the table, Hb levels were significantly lower at all time points in the Post-NCD group. The rate of hospital admissions was significantly greater in the Post-NCD group [Admissions/100-patient ESA therapeutic days (95% CI): Post-NCD 0.42 (0.34, 0.53), Pre-NCD 0.28 (0.24, 0.33)] as was the number of hospital days [Hospital days/100-patient ESA therapeutic days (95% CI): Post-NCD 2.3 (2.1, 2.5), Pre-NCD 1.3 (1.2, 1.4)]. Conclusions: Significantly greater blood utilization and lower Hb levels were observed in ESA-treated CIA patients in the Post-NCD period compared to the Pre-NCD period. Rates of hospitalizations and hospital length of stay were also significantly greater in the Post-NCD group. Study of comparative hematologic and resource utilization outcomes before and after the NCD is warranted in additional clinical centers. Disclosures: Apgar: Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Burton:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Larholt:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Pashos:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Ellis:Centocor Ortho Biotech Services, LLC: Employment. Senbetta:Centocor Ortho Biotech Services, LLC: Employment. McKenzie:Centocor Ortho Biotech Services, LLC: Employment.

The relationship between performance status and sleep quality in cancer patients.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20544-e20544
Author(s):  
Silviya Velinova ◽  
Rasa Kazlauskaite ◽  
Roxana Aguirre ◽  
Khosrow Zarei ◽  
Lily Parhad Hussein ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Cancer Patients ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Poor Sleep ◽  
Tumor Type ◽  
Quality Of Sleep ◽  
Ecog Performance Status ◽  
The Relationship

e20544 Background: Poor sleep is common, and is linked to impaired cognitive, psychological, and physical functioning and a lower quality of life. The purpose of this study is to measure quality of sleep in cancer patients and determine the relationship between quality of sleep and performance status. Methods: Patients with cancer (n=139) were recruited at the public hospital between November 2011 and January 2012 and asked to complete the Pittsburgh Sleep Quality Index (PSQI) and the Eastern Cooperative Oncology Group (ECOG) performance status (PS) questionnaires. Twenty patients repeated the questionnaires after 3 months. For the purpose of this study PSQI global score >5 was considered insomnia. PS score 0-1 was considered good, and PS 2-4 was considered poor. Results: The mean age of participants was 55±11 years, 56% were women, 78% were ethnic minority, 77% had advanced cancer, and 71% were undergoing cancer treatment. Among all patients, 73% reported good PS. Median PSQI score was 7 (IQR 4; 11) and 62% had insomnia. Sleep medication was used by 25%. Patients with poor PS had worse PSQI score (Mann-Whitney test, p< 0.0001), and 7.34 (95%CI 2.11-25.49) higher odds of insomnia (p=0.0002) compared to patients with good PS.(Table1) No significant correlation was found between insomnia and gender, ethnicity, primary tumor type, tumor stage, or treatment status. Conclusions: The incidence of insomnia among cancer patients is high. There is a higher incidence of sleep disturbance and worse sleep quality among patients with poorer performance status. [Table: see text]

Clinical impact of COVID-19 on patients with cancer: Data from the COVID-19 and Cancer Consortium (CCC19).

2020 ◽  
Vol 38 (18_suppl) ◽  
pp. LBA110-LBA110 ◽  
Author(s):  
Jeremy Lyle Warner ◽  
Sam Rubinstein ◽  
Petros Grivas ◽  
Toni K. Choueiri ◽  
Nicole Maria Kuderer ◽  
...  
Keyword(s):  
Performance Status ◽  
Severe Illness ◽  
Multivariable Logistic Regression Analysis ◽  
Cancer Type ◽  
Tumor Type ◽  
Cancer Treatments ◽  
Ecog Performance Status ◽  
Cancer Data ◽  
Patients With Cancer ◽  
The Impact

LBA110 Background: There are limited data on COVID-19 in patients with cancer. We characterize the outcomes of patients with cancer and COVID-19 and identify potential prognostic factors. Methods: The COVID-19 and Cancer Consortium (CCC19) cohort study includes patients with active or prior hematologic or invasive solid malignancies reported across academic and community sites. Results: We included 1,018 cases accrued March-April 2020. Median age was 66 years (range, 18-90). Breast (20%) and prostate (16%) cancers were most prevalent; 43% of patients were on active anti-cancer treatment. At time of data analysis, 106 patients (10.4%) have died and 26% met the composite outcome of death, severe illness requiring hospitalization, and/or mechanical ventilation. In multivariable logistic regression analysis, independent factors associated with increased 30-day mortality were age, male sex, former smoking, ECOG performance status (2 versus 0/1: partially adjusted odds ratio (pAOR) 2.74, 95% CI 1.31-5.7; 3/4 versus 0/1: pAOR 5.34, 95% CI 2.44-11.69), active malignancy (stable/responding, pAOR 1.93, 95% CI 1.06-3.5; progressing, pAOR 3.79, 95% CI 1.78-8.08), and receipt of azithromycin and hydroxychloroquine. Tumor type, race/ethnicity, obesity, number of comorbidities, recent surgery, and type of active cancer therapy were not significant factors for mortality. Conclusions: All-cause 30-day mortality and severe illness in this cohort were significantly higher than previously reported for the general population and were associated with general risk factors as well as those unique to patients with cancer. Cancer type and treatment were not independently associated with increased 30-day mortality. Longer follow-up is needed to better understand the impact of COVID-19 on outcomes in patients with cancer, including the ability to continue specific cancer treatments.

scholarly journals Palliative Care and COVID-19 Pandemic: Retrospective Study of Factors Associated With Infection and Death at an Oncological Palliative Care Reference Center

2021 ◽  
pp. 104990912098696
Author(s):  
Livia Costa de Oliveira ◽  
Karla Santos da Costa Rosa ◽  
Ana Luísa Durante ◽  
Luciana de Oliveira Ramadas Rodrigues ◽  
Daianny Arrais de Oliveira da Cunha ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Palliative Care ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Tumor Type ◽  
Advanced Cancer Patients ◽  
Factors Associated ◽  
Reactive Protein

Background: Advanced cancer patients are part of a group likely to be more susceptible to COVID-19. Aims: To describe the profile of advanced cancer inpatients to an exclusive Palliative Care Unit (PCU) with the diagnosis of COVID-19, and to evaluate the factors associated with death in these cases. Design: Retrospective cohort study with data from advanced cancer inpatients to an exclusive PCU, from March to July 2020, with severe acute respiratory syndrome. Diagnostic of COVID-19 and death were the dependent variables. Logistic regression analyses were performed, with the odds ratio (OR) and 95% confidence interval (CI). Results: One hundred fifty-five patients were selected. The mean age was 60.9 (±13.4) years old and the most prevalent tumor type was breast (30.3%). Eighty-three (53.5%) patients had a diagnostic confirmation of COVID-19. Having diabetes mellitus (OR: 2.2; 95% CI: 1.1-6.6) and having received chemotherapy in less than 30 days before admission (OR: 3.8; 95% CI: 1.2-12.2) were associated factors to diagnosis of COVID-19. Among those infected, 81.9% died and, patients with Karnofsky Performance Status (KPS) < 30% (OR: 14.8; 95% CI 2.7-21.6) and C-reactive protein (CRP) >21.6mg/L (OR: 9.3; 95% CI 1.1-27.8), had a greater chance of achieving this outcome. Conclusion: Advanced cancer patients who underwent chemotherapy in less than 30 days before admission and who had diabetes mellitus were more likely to develop Coronavirus 2019 disease. Among the confirmed cases, those hospitalized with worse KPS and bigger CRP were more likely to die.

Variation in Health-Related Quality of Life by ECOG Performance Status and Fatigue Among Patients with Chronic Lymphocytic Leukemia

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4591-4591 ◽  
Author(s):  
Chris L. Pashos ◽  
Christopher R Flowers ◽  
Mark Weiss ◽  
Nicole Lamanna ◽  
Charles M Farber ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Research Funding ◽  
Performance Status ◽  
Clinical Practices ◽  
Employment Equity ◽  
Ecog Performance Status ◽  
Advisory Committees ◽  
Equity Ownership ◽  
Ecog Ps ◽  
The Impact

Abstract Abstract 4591 Introduction: Clinicians and investigators appreciate the value of measuring HRQOL for monitoring CLL and the impact of treatments, and commonly use ECOG performance status (PS) and clinician-reported patient fatigue as surrogates for HRQOL in clinical practice. However, limited data exist on the relationships between PS, fatigue, and HRQOL in CLL patients (pts) undergoing treatment in clinical practices. We examined the associations between these measures and 3 psychometrically validated, patient-reported, HRQOL instruments: the Brief Fatigue Inventory (BFI), EQ-5D, and Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu). Methods: Data were collected as part of Connect CLL®, a prospective observational registry initiated in March 2010 involving US practices. Data on pt demographics and clinical characteristics were provided by clinicians. HRQOL was self-reported by pts at enrollment using the BFI, EQ-5D, and FACT-Leu. Mean BFI, EQ-5D and FACT-Leu scores were analyzed by ECOG PS and clinician-reported fatigue. Differences in HRQOL scores between sub-cohorts were assessed by ANOVA. Results: HRQOL data were reported by 604 pts enrolled from 10 academic, 148 community, and 3 government centers. Pts were predominantly male (62%) and white (90%); mean age was 70 (standard deviation 11) years. BFI data (scale: 0 [no fatigue] - 10 [worst fatigue]) indicated that on average pts report that global fatigue, fatigue severity and fatigue-related interference worsen by ECOG severity (Table 1) and are statistically associated with clinician-reported fatigue (Table 2). Mean EQ-5D overall HRQOL as measured by a Visual Analogue Scale (VAS) from 0 (worst) to 100 (best) worsens by ECOG severity and is significantly worse in pts with fatigue. Mean EQ-5D domain scores (scale: 1 [no problem], 2 [some problems], 3 [incapacity]) indicated that pain/discomfort, mobility and usual activities increase in severity as ECOG worsens and in pts with fatigue. FACT-Leu domains except social/family were statistically worse with worse ECOG PS and in pts with fatigue. Conclusions: Initial results from Connect CLL® indicate that HRQOL worsens with worsening ECOG PS, especially in physical / functioning domains, pain/discomfort, and mobility, and worsens across multiple domains among pts whose physicians reported fatigue. Future analyses should be conducted on how HRQOL, PS and fatigue may change over time with changes in CLL, and how they are influenced by therapies. These results may serve as baseline reference. Disclosures: Pashos: Celgene: Membership on an entity's Board of Directors or advisory committees. Flowers:Genentech/Roche (unpaid): Consultancy; Celgene: Consultancy; Millennium/Takeda: Research Funding; Wyeth: Research Funding; Novartis: Research Funding. Weiss:Celgene: Membership on an entity's Board of Directors or advisory committees. Lamanna:Celgene: Membership on an entity's Board of Directors or advisory committees. Farber:Celgene: Membership on an entity's Board of Directors or advisory committees. Kipps:Igenica: Equity Ownership, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Research Funding; Abbot Industries: Research Funding; Pharmacyclics: Membership on an entity's Board of Directors or advisory committees; Genentech: Research Funding; GSK: Research Funding; Gilead Sciences: Consultancy, Research Funding; Amgen: Research Funding. Lerner:Celgene: Membership on an entity's Board of Directors or advisory committees. Kay:Celgene: Membership on an entity's Board of Directors or advisory committees. Sharman:Celgene: Membership on an entity's Board of Directors or advisory committees. Grinblatt:Celgene: Membership on an entity's Board of Directors or advisory committees. Flinn:Celgene: Membership on an entity's Board of Directors or advisory committees. Kozloff:Celgene: Membership on an entity's Board of Directors or advisory committees. Swern:Celgene Corporation: Employment, Equity Ownership. Kahn:Celgene Corporation: Employment, Equity Ownership. Street:Celgene: Employment, Equity Ownership. Sullivan:Celgene: Employment, Equity Ownership. Keating:Celgene: Membership on an entity's Board of Directors or advisory committees.

Hematologic Response To Oral Azacitidine (CC-486) In Subjects With WHO-Defined RAEB-1 Or RAEB-2 Myelodysplastic Syndromes (MDS)

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1554-1554 ◽  
Author(s):  
Guillermo Garcia -Manero ◽  
Michael Savona ◽  
Steven D. Gore ◽  
Christopher R. Cogle ◽  
Paul Conkling ◽  
...  
Keyword(s):  
Phase I ◽  
Lower Risk ◽  
Research Funding ◽  
Performance Status ◽  
Phase Iii ◽  
Cell Transplant ◽  
Ecog Performance Status ◽  
Overall Response ◽  
Hematologic Response ◽  
Oncology Research

Abstract Background Subcutaneous (SC) azacitidine prolongs overall survival in subjects with higher-risk MDS (Fenaux, JCO, 2009). Previous Phase I and II studies have shown extended oral azacitidine dosing schedules to be safe and effective in subjects with IPSS-defined lower-risk MDS (Garcia-Manero et al, ASH 2010 and ASH 2012). Objective To assess the efficacy and safety of extended oral azacitidine dosing schedules in subjects with WHO-defined RAEB-1 or RAEB-2 MDS. Methods The subset of subjects with WHO-defined RAEB-1 or RAEB-2 MDS from two ongoing Phase I/II studies was included in this ad hoc analysis. Subjects received oral azacitidine 300mg QD or 200mg BID for 14 or 21 days of repeated 28-day cycles. For purposes of this analysis, subject data were analyzed collectively. Hematologic responses were defined by International Working Group (IWG) 2006 criteria. Overall Response was calculated as any response of complete or partial remission (CR or PR), RBC or platelet transfusion independence (TI), and/or any hematologic improvement (HI). Marrow complete remission (mCR) was not included in Overall Response. Serious treatment-emergent adverse events (STEAEs) that occurred in 2 or more subjects are reported. Results Of 23 subjects in all, 20 received 300mg QD oral azacitidine x 14 or 21 days/28-day cycle and 3 received oral azacitidine 200mg BID x 14 days/28-day cycle. Subjects had median age of 71 (range: 36 - 90) years and were predominantly male (61%). Fourteen subjects (61%) had a diagnosis of RAEB-1 and 9 (39%) had RAEB-2, median time from diagnosis was 2.1 (0.1 - 33.2) months, and ECOG performance status scores were 0 (n=4, 17%), 1 (n=15, 65%), or 2 (n=4, 17%). Five subjects had received prior MDS treatments (azacitidine injection; erythropoiesis stimulating agent [ESA]; thalidomide; azacitidine injection and decitabine; G-CSF, anti-thymocyte globulin, methylprednisolone, cyclosporine, and ESA). Median number of oral azacitidine treatment cycles was 3 (1 - 29). Overall Response was achieved by 11/22 subjects (50%) (Table). Four subjects achieved mCR only and are not included in the Overall Response category. RBC TI was achieved by 5/12 subjects (42%) and platelet TI was achieved by 2/5 subjects (40%). Two subjects were able to consolidate remission and proceed to allogeneic stem cell transplant and 1 subject progressed to AML on-study. Oral azacitidine was generally well tolerated. Three subjects discontinued treatment due to an AE. STEAEs were consistent with the known safety profile of SC azacitidine. Of 8 subjects who had an STEAE of febrile neutropenia, pneumonia, and/or septic shock, 3 were severely neutropenic (ANC <0.5 x 109/L) at baseline. Other STEAEs were diarrhea, nausea, and vomiting (n=2 subjects each). Conclusions This analysis in subjects with RAEB-1 and RAEB-2 is the first to assess extended oral azacitidine dosing schedules in higher-risk MDS. One-half of treated subjects achieved a hematologic response to oral azacitidine, which is easy to administer and was generally well-tolerated. Two Phase III studies of extended oral azacitidine dosing (in lower-risk MDS and as maintenance therapy in older patients with AML) are ongoing. Results of these large studies will better elucidate the use of extended oral azacitidine dosing schedules in treating hematologic malignancies. Disclosures: Gore: Celgene Corporation: Consultancy. Cogle:Celgene Corporation: Honoraria, Research Funding. Conkling:US Oncology: Research Funding. Beach:Celgene Corporation: Employment. Hetzer:Celgene Corporation: Employment. Dong:Celgene Corporation: Employment. Skikne:Celgene Corporation: Employment.

scholarly journals Photobiomodulation Therapy Prevents Dysgeusia Chemotherapy-Induced in Breast Cancer Women Treated with Doxorubicin Plus Cyclophosphamide: A Triple-Blinded, Randomized, Placebo-Controlled Clinical Trial

2021 ◽  
Author(s):  
Malta Cássia Emanuella Nóbrega ◽  
Anna Clara Aragão Matos Carlos ◽  
Manuele Carine Maciel de Alencar ◽  
Eveline Fernandes Alves e Silva ◽  
Victor Bruno Caitano Nogueira ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Placebo Group ◽  
Cancer Patients ◽  
Performance Status ◽  
Test Group ◽  
Controlled Clinical Trial ◽  
Breast Cancer Patients ◽  
Ecog Performance Status ◽  
Chi Square

Abstract Purpose To evaluate the effectiveness of photobiomodulation (PBMT) in preventing dysgeusia in breast cancer patients treated with doxorubicin-cyclophosphamide (AC). Methods This is a phase II, randomized, triple-blind, placebo-controlled clinical trial involving 112 breast cancer patients treated with AC. The patients were divided equally into two groups: a test group treated with 2 J red laser and 3 J infrared laser on 21 points that were symmetrically distributed on the tongue on day 0 of four cycles of AC, and an equal placebo group treated with simulated PBMT to blind the patient, evaluator, and statistician. The clinicopathological and sociodemographic data, results of the hematological tests, taste test, and subjective taste analysis, and the QoL, ECOG performance status, body mass index, and other side effects were recorded. The data were analyzed using ANOVA-RM/Bonferroni, Friedman/Dunn, and chi-square/Fisher's exact tests. Results PBMT patients showed less objective and subjective taste loss (p < 0.05). On the other hand, the placebo group showed a higher ECOG status (p = 0.037) and more significant weight loss (p < 0.001) after four cycles of AC. The QoL was significantly higherin the PBMT group (p < 0.05) at all assessment periods, and PBMT treatment also reduced the incidence of cachexia (p = 0.020), anorexia (p < 0.001), diarrhea (p = 0.040), oral mucositis (p = 0.020), and vomiting (p = 0.008). Conclusion PBMT reduced the taste loss and improved the overall health status and QoL of patients with breast cancer treated with AC. Trial registration : Brazilian Clinical Trials Registry (www.ensaiosclinicos.gov.br) approval numberRBR-9qnm34y, registered on 01/05/2021

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