bluuebunny/crossref_metadata_2025_split huggingface dataset:
Multivitamins do not improve radiation therapy related fatigue: Results of a double-blind randomized cross-over trial
Authors: Kaliks-Guendelmann R. , Oliveira Campos M. P. , Souza Fêde Â. B. , Bensi C. G. , Trufelli D. C. , Pecoroni P. G. , Ranzatti R. P. , del Giglio A. 
Published: March 2020

9103 Background: Fatigue is a common symptom in cancer patients including those receiving radiation therapy. Multivitamins are broadly used by cancer patients to improve overall health and energy. Methods: We conducted a double blind randomized cross- over trial of multivitamins versus placebo in patients with breast cancer (BC) undergoing radiation therapy (Rxt) in order to evaluate if multivitamins would affect fatigue and quality of life. We randomized patients at the beginning of Rxt treatment to either placebo or Centrum Silver (Wyeth-Whitehall laboratory). At the middle of the radiation treatments patients were switched from placebo to multivitamins and vice versa. Patients answered to the EORTC QLQ C-30 quality of life (QOL) and Chalder fatigue questionnaires at the beginning, the time of switching and at the end of Rxt. Results: We randomized forty patients to either placebo or Centrum Silver. At the middle of the radiation treatments patients were switched from placebo to MVi and vice versa. Patients answered the EORTC QLQ C-30 quality of life (QOL) and Chalder fatigue questionnaires at the beginning, the middle and at the end of Rxt. Both groups experienced decreases in general (p = 0.009; p = 0.001) and physical fatigue scores (p = 0.031; p = 0.029) at the end of the course of placebo compared to the assessment prior to this treatment. We also observed significant improvements in functional (p = 0.026) and symptoms (p = 0.016) score scales of the QOL questionnaire in the patients on placebo. No significant changes were elicited with the use of MVi. We also observed significantly lower rates of fatigue in the patients who had just finished a course of placebo as compared to patients finishinga course of MVi (0 vs 25% p = 0.035). Conclusions: MVi do not improve radiation related fatigue in patients with BC. No significant financial relationships to disclose.
Prophylaxis of chemotherapy-induced neutropenia: Patterns of care in U.S. community oncology practices
Authors: Naeim A. , Friedman L. , Pasta D. J. , Elkin E. P. , Malin J. , Viswanathan H. , Ozer H. 
Published: March 2020

9123 Background: Adherence to neutropenia guidelines may improve patient outcomes and decrease costs associated with febrile neutropenia (FN). This analysis presents baseline data on patterns of colony-stimulating factor (CSF) use among community-based oncology practices prior to an educational intervention targeted to health care providers to improve adherence to CSF guidelines from the National Oncology Alliance (NOA). Methods: Medical records were identified from 47 participating sites. Abstractors collected data from a sequential sample of adult cancer patients receiving chemotherapy during the year prior to site randomization to an educational intervention (June and August 2006). A complex algorithm was developed to identify patients for whom the NOA guidelines recommend primary prophylaxis with a CSF including (1) patients receiving a chemotherapy regimen with a >20% expected risk of FN and (2) patients receiving chemotherapy with a 10–20% risk of FN and who have one of the following risk factors present: diminished performance status or non-Hodgkin's lymphoma with low serum albumin or high serum LDH or spread to bone marrow. Results: 2594 patients were evaluated for this analysis. Most were female (66%) and the mean age was 61.7 years (± 13.1). During this period (2005–06), 423 (16%) patients received chemotherapy regimens with an FN risk >20% and 143 (6%) received chemotherapy regimens with an FN risk of 10–20% and had a risk factor. Of patients receiving chemotherapy with a >20% risk of FN, 176 (42%) received CSF primary prophylaxis. Of patients receiving chemotherapy with a 10–20% risk FN with a risk factor present, 40 (28%) received CSF primary prophylaxis. Conclusions: Many patients for whom guidelines recommend treatment did not receive CSF primary prophylaxis. After the year-long educational intervention, we will re-evaluate CSF patterns of care and assess whether adherence to guidelines improved patient outcomes. No significant financial relationships to disclose.
Influence of skin color in the development of erlotinib-induced rash: A report from the SERIES clinic
Authors: Lai S. E. , Minnelly L. , O'Keeffe P. , Rademaker A. , Patel J. , Bennett C. L. , Lacouture M. E. 
Published: March 2020

9127 Background: A papulopustular reaction occurs in 68–75% of patients undergoing treatment with the epidermal growth factor receptor (EGFR) inhibitor erlotinib, necessitating dose modification or interruption in 14% and 12% of patients, respectively. Based on preclinical data showing that EGFR inhibition in the skin may potentiate the harmful effects of ultraviolet radiation (UVR) exposure, sun protection is generally advocated. Because the level of melanin, a biological pigment in the epidermis, correlates with increased intrinsic protection against the harmful effects of UVR, we hypothesized that lower levels of skin pigmentation would be associated with higher frequency and severity of erlotinib rash. Methods: We conducted a retrospective chart review of 42 patients undergoing erlotinib therapy to characterize the relationship between skin sensitivity to UVR and severity of EGFR inhibitor rash. Skin sensitivity to UVR was categorized using the Fitzpatrick skin phototype (SPT) classification scheme, and individuals were grouped in phototypes I/II, III/IV, and V/VI. Grading of rash was performed using the NCI-CTC criteria version 2.0 and 3.0. Results: Patients with SPT I/II developed rash grades 0 (6%), 1/2 (31%), and 3/4 (63%), whereas patients with skin phototype III/IV had rash grade 0 (26%), 1/2 (68%), and 3/4 (5%). Patients with SPT V/VI had rash grade 0 (43%), 1/2 (57%), and 3/4 (0%). Lower skin phototypes had higher grade rash (p=0.0006 by Fisher's exact test). Conclusions: Management of cutaneous side effects from EGFR inhibitors is important in order to achieve maximal patient compliance and anti-cancer therapeutic benefit, and the correlation between rash and survival underscores maintaining patients on therapy. The results of this study suggest that SPT may be an independent predictive factor for EGFR inhibitor-induced skin toxicities, thus impacting pre-therapy counseling and early intervention. [Table: see text]
Factors associated with depressive symptoms in patients with metastases from prostate cancer
Authors: Domont J. , Fizazi K. , Zesnasni F. , Plantade A. , Massard C. , Escudier B. , Chauchereau A. , Dauchy S. 
Published: March 2020

9131 Background: The purpose of this study was to identify predictive factors of depression in patients with metastases from prostate cancer. Methods: Patients with evidence of metastases from prostate cancer were prospectively screened for depression. Depressive symptoms were defined by the Beck Depression Inventory-Short Form (BDI-SF) with a low cut-off score of 4 to optimize sensitivity as a screening test (Lowe AW, 2004). Self-report questionnaires including BDI-SF were sent to pts through the mail and then given back to the oncologist. In case of a BDI-SF > 4, a consultation with a psychiatrist was proposed, so that the diagnosis of depression could be made and treatment be started. Characteristics including marital status, spiritual well-being, educational level, ongoing treatment for prostate cancer, and the presence of pain requiring analgesic therapy were registered. Results: 92 patients were prospectively enrolled of whom 54 (60%) completed the self-report questionnaires. Median age was 69 years (range: 50–84). 31 pts (54%) had castration-refractory disease, of whom 30 were receiving chemotherapy: docetaxel (n=22), carboplatin-etoposide (n=6) and doxorubicin (n=2). Eighteen patients (33%) had a BDI-SF score > 4, of whom 10 (18%) had a major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria. Logistic regression analysis showed that pain requiring analgesic therapy was the only predictive factor of depressive symptoms (OR=3.75; 95% confidence interval 1.1–12.4). In patients with pain requiring treatment, the incidence of depressive symptoms and MDD was 53% and 32%, respectively. In contrast to female with advanced breast cancer (Conforti R, 2004), marital status and belief in god were not predictive factors of depressive symptoms in this population of males. Conclusions: Pain requiring analgesic treatment was the only factor significantly associated with depressive symptoms in this sample of 54 patients with metastatic prostate cancer. A screening for depression should be systematically implemented at least in this subgroup of patients. No significant financial relationships to disclose.
Anti-GD2 monoclonal antibody 3F8 plus granulocyte-macrophage colony-stimulating factor (GM-CSF) for primary refractory neuroblastoma (NB) in bone marrow (BM)
Authors: Kushner B. H. , Kramer K. , Modak S. , Cheung N. V. 
Published: March 2020

9502 Background: Despite high-dose chemotherapy, NB in BM often persists and forebodes death. Methods: 3F8/GM- CSF was used in 63 patients (pts) with NB in BM by morphology and/or metaiodobenzylguanidine (MIBG) scan, no prior progressive disease or immunotherapy, and no soft tissue NB; 35 (56%) of the pts had received second-line therapy and 24 (38%) were post-transplant. Treatment was repeated if human anti-mouse antibody (HAMA) titer was low. Results: Of 30 pts with NB in BM but normal MIBG scans (Group 1), 25 (83%) had complete response (CR) after cycle 1 (n=17), cycle 2 (n=5), or cycle 3, 6, or 7 (one pt each), including 13/16 post-transplant pts. Among 15 pts with NB in BM and abnormal MIBG scans (Group 2), 12 (80%) had CR in BM after cycle 1 (n=5), cycle 2 (n=4), cycle 4 (n=2), or cycle 9 (n=1); MIBG scans normalized in 5/11 pts who had multiple abnormal MIBG(+) sites and in 4/4 pts who had one abnormal MIBG(+) site (irradiated in three pts). Of 18 pts who had abnormal MIBG scans but no NB seen in BM tests (Group 3), 14 (78%) had CR or near CR, including eight whose MIBG(+) sites were irradiated. Early HAMA limited treatment in 19 pts, but was prevented by high-dose cyclophosphamide. CR continues in 12 pts (five never transplanted) with long follow-up (20+ -to- 146+ months) and in 10 pts with short follow-up. The only common toxicities of this outpatient treatment were pain and hives; there were no long-term toxicities. Conclusions: 3F8/GM-CSF is well tolerated, achieves a high CR rate against primary refractory NB in BM (including post-transplant), and may prolong disease control in non- transplanted pts. Further experience will show whether it ought to be used for consolidative therapy in place of myeloablative cytoreduction. No significant financial relationships to disclose.
A phase III trial of biologically-based therapy reduction for intermediate risk neuroblastoma
Authors: Baker D. L. , Schmidt M. , Cohn S. , London W. B. , Buxten A. , Sandler A. , Shimada H. , Matthay K. 
Published: March 2020

9504 Background: Infants with advanced neuroblastoma (stage 3 and 4) and children >1 year with favorable biology stage 3 disease have had a survival exceeding 80% with aggressive chemotherapy. The primary objective of Childrens Oncology Group A3961 was to maintain a 3-year event-free and overall survival rate above 90% for intermediate risk (IR) neuroblastoma with a reduction in therapy compared to historical trials for similarly defined risk patients. Methods: IR patients were defined by selected clinical (age, INSS stage, histopathology) and biologic (MYCN status and DNA index) factors. All eligible IR patients were MYCN non-amplified and were divided into subcategories defined as favorable or unfavorable biology. Therapy consisted of 2 to 3 agent combinations of carboplatin, etoposide, cyclophosphamide and doxorubicin given every 3 weeks for a total of 4 cycles (favorable biology) or 8 cycles (unfavorable biology). Patients with favorable biology failing to achieve CR/VGPR after 4 cycles and surgery, received 8 cycles. All patients were required to enter a companion neuroblastoma biology study and to enroll on A3961 within 28 days of diagnosis. Results: Between March 1997 and May 2005, 467 eligible patients were enrolled on study. These included 261 stage 3 (105 children; 156 infants), 174 stage 4 infants, and 32 stage 4s infants. 362 (78%) were less than 12 months of age at diagnosis. 330 (71%) patients had favorable and 137 (29%) unfavorable biology. There were 40 (12.1%) of 330 favorable biology patients who went onto cycles 5–8. There were 52 events in 467 cases including 15 deaths and two secondary AML. Conclusions: The primary hypothesis of this study was confirmed and survival rates greater than 90% were maintained for IR neuroblastoma with reduced therapy compared to historical trials. The successor trial will prescribe duration of therapy based, in part, on loss of heterozygosity states at 1p36 and 11q23 as well as initial response to treatment in an endeavor to further reduce therapy for this group of patients. [Table: see text] No significant financial relationships to disclose.
Comparison of intermittent versus continuous methotrexate plus 6-mp in maintenance regimen for standard risk acute lymphoblastic leukemia in children (GBTLI ALL-99)
Authors: Brandalise S. R. 
Published: March 2020

9512 Objectives: To compare by randomization the conventional use of 6-MP (50 mg/m2 daily) / MTX (25 mg/m2/wk) regimen with the intermittent use of MTX (200 mg/m2/IV 6 h infusion each 21 days)/ 6-MP (100 mg/m2/day × 10) in maintenance therapy. Methods: Newly diagnosed ALL children up to 18 yrs of age registered in the GBTLI ALL-99 Protocol. The eligibility criteria for standard-risk group were age >1 <9 years and WBC count at diagnosis <50,000/mm3 and good responders at D7/D14. Randomization was made after the late consolidation phase (week 42) prior to the maintenance treatment. Treatment Schedule: Induction: [DX(Pred), DNM, VCR, L-ASP, CICLO, Ara-C, 6-MP], Intensification: (MTX 2 g/m2 6 h inf. × 4, 6-MP) Late Consolidation: (DX, VCR, DOXO, L-ASP, CICLO, ARA-C, 6-TG) plus prolonged triple intratecal therapy, were done previously to maintenance therapy. Total treatment duration was two years. No CNS radiation was done. Toxicities were defined according to NCI-version 2001 criteria. Results: 560 pts were enrolled in the study. 22 slow responders pts (4.1%) moved to high risk group. The total number of analyzed pts was 512. Two hundred and thirty pts entered group 1 [continuous (conventional) 6MP-MTX] and 230 pts entered group 2 (Intermittent MTX/6-MP). Remission rate was 95.3%. 439 pts (87.9%) are in CCR. The mean follow up period is 2.2 years. The estimated 5 years OS rate for both groups is 88.1% ± 2.1%. The estimated 5 years EFS for both groups is 80% ± 2.9%. According to maintenance regimen, the 5 years EFS rate is 80.2% ± 4.5% and 88.3% ± 3.7% for group 1 and group 2, respectively (p=0.048). Grade 3 and 4 hepatic toxicities were 254 episodes for group 1 and 144 episodes for group 2 (p=0.019). Grade 3 CNS toxicities were 13 episodes (group 1) and 5 in group 2. Grade 4 hematological toxicities were 254 episodes for group 1 and 144 episodes for group 2 (p=0.003). Conclusions: Despite the short mean time follow-up (2.2 years) the patients with the intermittent regimen (Group 2) had better EFS rate (p = 0.048) and less hematological, CNS and hepatic toxicities, comparing with patients that received conventional maintenance treatment (group 1). No significant financial relationships to disclose.
Chemoimmunotherapy reinduction with epratuzumab in children with ALL with marrow relapse: A Children's Oncology Group (COG) pilot study (ADVL04P2)
Authors: Raetz E. A. , Cairo M. S. , Borowitz M. J. , Blaney S. M. , Krailo M. D. , Leil T. A. , Goldenberg D. M. , Wegener W. A. , Carroll W. L. , Adamson P. C. 
Published: March 2020

9513 Background: CD22, a 135kd protein restricted to B-cells, is expressed in > 90% of childhood B-precursor acute lymphoblastic leukemia (ALL). We conducted a feasibility/phase 2 study of epratuzumab, a humanized monoclonal antibody against CD22, with reinduction chemotherapy in children with relapsed CD22+ ALL. Methods: The feasibility portion (n=12) of the study is reported here. Patients with first or later ALL marrow relapse at any time following diagnosis, ± extramedullary disease, with = 25% blasts expressing CD22 and a presenting white blood cell count (WBC) of = 50,000/μl, were eligible. Therapy consisted of a 14-day single agent phase (epratuzumab 360 mg/m2 /dose IV twice weekly × 4 doses), followed by 4 weekly doses of epratuzumab in combination with standard reinduction chemotherapy (vincristine, prednisone, PEG-asparaginase, doxorubicin). Remission induction rates and minimal residual disease (MRD) by flow cytometry were determined at the end of this 6-week period. PK studies were performed by ELISA based immunoassay (prior + 30 minutes after infusions). Results: 12 evaluable patients, median age 10 years (range 3 - 18), were accrued. 9 pts were in 1st (n=5 early; n=4 late), and 3 pts in 2nd or later marrow relapse. The mean (±SD) trough epratuzumab concentration increased from 69±23 to 232±74 μg/ml during the initial 14 days. Surface CD22 was not detected by flow cytometry on peripheral blood leukemic blasts within 24 hours of drug administration in all but one patient, indicating effective targeting of leukemic cells by epratuzumab. The most frequent toxicities were grade 1–2 infusion reactions (n=9). Two dose limiting toxicities occurred: one patient had a Grade 4 seizure of unclear etiology and one patient had asymptomatic Grade 3 ALT elevation. 9 patients achieved a complete remission following chemoimmunotherapy, of whom 7 were MRD-negative. Conclusions: Treatment with epratuzumab plus standard reinduction chemotherapy is feasible and well tolerated in children with relapsed ALL, producing favorable early responses in the majority of patients. The phase II portion of the study is ongoing. [Table: see text]
Hematopoietic stem cell transplant (HSCT) versus intensive chemotherapy in infant acute lymphoblastic leukemia (ALL)
Authors: Dreyer Z. E. , Dinndorf P. , Sather H. , Hilden J. M. , Devidas M. , Heerema N. A. , Smith F. O. , Carroll W. , Reaman G. , Camitta B. M. 
Published: March 2020

9514 Background: Infants (<366 days) with ALL and an MLL rearrangement (MLL-R), have a dismal prognosis. Early relapse is common and event free survival (EFS) is poor. The Children's Oncology Group (COG) parallel pilot trials, 1953 and 9407, were designed to prospectively compare early HSCT to intensified chemotherapy in infants with MLL-R ALL. This is the largest prospective trial investigating the role of HSCT in such patients (pts) in first remission (CR-1). Methods: From 1997–2000, 186 pts were registered (132 MLL-R). Both trials were identical through Induction, Induction Intensification and Re-Induction (Re-I), then diverged. Pts with MLL-R ALL with matched/one antigen mismatched - related/unrelated donors were to undergo HSCT (mandated on 1953/optional on 9407) at completion of Re-I. The HSCT regimen was ara-c, cyclophosphamide, steroid and total body irradiation; graft vs. host prophylaxis was cyclosporine. Results: Compliance with protocol mandated conditioning for HSCT was poor and 28/53 HSCT pts received non-protocol preparative regimens. By life table comparisons, the 5 year HSCT EFS was 50.9% (SE=9.9%, RHR 1.13) vs. 48.7% (SE=10.1%) p=0.68 in 47 control pts (chemotherapy-treated, MLL-R), who survived 143 days (median time to HSCT = 143 days). By statistical regression analysis the RHR for HSCT was 1.454 (90% CI 0.911, 2.318), p-value = 0.19, showing a trend in favor of chemotherapy alone. Neither donor source nor preparative regimen affected HSCT outcome. Chemotherapy outcomes were similar on 1953 and 9407. Events for HSCT pts were most common in the first 6 months: 20 events (11 HSCT related deaths/9 relapses). In the control group, 7/9 events in this time period were due to relapse. Conclusion: These results show no advantage for HSCT in CR1 in infants with MLL-R ALL. These data do not support the routine use of HSCT in CR1 in MLL-R infants. No significant financial relationships to disclose.
Obesity in adult survivors of childhood acute lymphoblastic leukemia: A follow-up report from the Childhood Cancer Survivor Study
Authors: Garmey E. G. , Liu Q. , Sklar C. A. , Meacham L. R. , Stovall M. , Yasui Y. , Robison L. L. , Oeffinger K. C. 
Published: March 2020

9518 Background: We previously reported an association between ≥ 20 Gy cranial radiotherapy (CRT) and obesity in adult survivors of childhood ALL. This follow-up study aimed to determine if, with time, (1) the prevalence of obesity and (2) the rate of BMI change were increased in ALL survivors in comparison with sibling controls. Methods: A longitudinal cohort comparing 1,451 adult survivors of childhood ALL (mean age 32.3 years) to 2,167 siblings of childhood cancer survivors (mean age 35.9 years). BMI was calculated from self- reported heights and weights and used to determine the prevalence of being overweight (25.0 ≤ BMI < 30.0) or obese (BMI ≥ 30.0). Polytomous logistic regression was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for being overweight or obese among ALL survivors compared to sibling controls. BMIs at baseline and follow-up (with a mean interval of 7.8 years) were used to calculate mean BMI increases per year occurring between these timepoints. Results: Age- and race-adjusted ORs for obesity among survivors compared with siblings are shown in the table . Notably, 10–19 Gy CRT was associated with an increased likelihood of being obese in comparison with siblings. In longitudinal analysis, survivors who were treated with CRT had a significantly greater net increase in BMI/year in comparison with siblings. At follow-up, 69.7% of females treated with ≥ 20 Gy CRT prior to the age of 10 were overweight (31.1%) or obese (38.6%). Conclusion: Cranial radiotherapy ≥ 10 Gy employed in the treatment of childhood ALL is strongly associated among both male and female survivors with increases in the prevalence of obesity and average BMI gains over time. Female survivors who received CRT ≥ 20 Gy, particularly those treated at a younger age, were most affected. [Table: see text] No significant financial relationships to disclose.