bluuebunny/crossref_metadata_2025_split huggingface dataset:
Randomized trial to assess bone mineral density (BMD) effects of zoledronic acid (ZA) in postmenopausal women (PmW) with breast cancer
Authors: Tevaarwerk A. , Stewart J. A. , Love R. , Binkley N. C. , Black S. , Eickhoff J. , Mulkerin D. L. 
Published: March 2020

19558 Introduction: Osteoporotic fracture represents a major source of morbidity in PmW. Breast cancer patients can be at additional risk because of treatment related estrogen deprivation. The favorable effects of bisphosphonates in osteoporosis and potential reduction of metastases warrant evaluation of ZA in PmW at high risk for breast cancer relapse. We assessed whether ZA 4 mg IV every 12 weeks x 4 doses was associated with an increase in BMD. Secondary objectives included defining ZA’s toxicity profile in this setting, and assessing for differences in overall cancer relapse. Methods: PmW with node positive or stage III breast cancer diagnosed less than 5 years earlier were randomized to ZA or observation. BMD was assessed by dual energy xray absorptiometry (DXA) for all subjects at 0 and 12 months. A toxicity evaluation was performed pre- and post-treatment for patients receiving ZA. Study endpoint occurred when subjects completed the DXAs, had disease progression or declined further treatment. We calculated change in BMD between 0 and 12 months at the L1–4 spine and femur neck. Results: 66 women have enrolled since 2000; 49 women have completed DXAs at 0 and 12 months (observation 23, ZA 26). Median age was 52 (range 40–81 yr), median ECOG performance status was 0 (range 0–1), and most women received concurrent tamoxifen (observation 74%, ZA 61%). Over 12 months, L1–4 spine BMD decreased in the observation arm (-0.006 ± 0.034 g/cm2) and increased in the ZA arm (p<0.001; 0.050 ± 0.042 g/cm2). No significant BMD change occurred at the femur neck. Only three grade 3 events occurred (2 arthralgia, 1 myalgia). Side effects were mild and transient, but as frequent as 87% following dose 1. The most common side effects were fatigue, myalgia and arthralgia. No clinically significant changes in creatinine or calcium occurred. Osteonecrosis of the jaw was not observed. Of the 66 women enrolled, 7 have relapsed (observation 4, ZA 3) but time since diagnosis is less than 10 years for most patients. Conclusions: ZA administered every 12 weeks for 4 doses leads to a statistically and clinically significant change in BMD at the lumbar spine. Toxicity was mild but common. There are as yet no significant differences in cancer relapse. No significant financial relationships to disclose.
Patient and parent longitudinal reports of quality of life in children and adolescents with osteosarcoma
Authors: Hinds P. S. , Gattuso J. S. , Billups C. , Rivera C. , Quintana J. , Daw N. 
Published: March 2020

19562 Children and adolescents being treated for osteosarcoma are likely to experience physical, emotional, functional and possibly cognitive changes during the course of their treatment. The aims of this prospective study were to assess the effect of treatment on patients’ quality of life (QoL) at diagnosis and during therapy, compare patient and parent QoL reports, and examine relationships between patient QoL and tumor histologic response to preoperative chemotherapy and event-free survival (EFS) in children and adolescents in treatment for osteosarcoma. Newly diagnosed patients with localized disease completed three established patient reports (Symptom Distress Scale, and PedsQL v.3 and v.4). Parents completed two parent reports (PedsQL v.3 and v.4). QoL evaluations were done at diagnosis, prior to definitive surgery (Week 12), and postoperatively during treatment (Week 23). Sixty-two of 72 eligible patients and their parents completed QoL measures. Symptom distress (SD) decreased in 85% of patients from baseline to Week 12 (with 8/10 symptoms significantly improved) and from baseline to Week 23 in 74% of patients. Improvements in most domains of the PedsQL v. 3 were noted by patient and parent reports from baseline to Weeks 12 and 23 except for the nausea domain. Patient and parent reports differed, with parents reporting lower QoL scores on v. 3 than did patients, particularly in the domains of treatment anxiety, cognitive problems, and communication. QoL scores did not differ by patient gender but did by age in certain domains. Patients reported significant improvements in physical and emotional functioning from baseline to Weeks 12 and 23 using the PedsQL v.4. Parents reported significant improvements in emotional functioning from baseline to Weeks 12 and 23 using the PedsQL v.4. QoL scores were not associated with tumor histologic response or EFS. Significant improvements in QoL domains and in symptoms from diagnosis to Week 12 and to Week 23 were documented in both patient and parent reports. Treatment contributed to improvements in physical and emotional functioning and in symptoms except for nausea. QoL was not related to histologic response or EFS. No significant financial relationships to disclose.
Is there a benefit to having a clinical oncology pharmacist on staff at a community oncology clinic?
Authors: Ruder A. D. , Smith D. L. , Madsen M. T. , Kass F. H. 
Published: March 2020

19570 Background: The John Marsh Cancer Center is an ambulatory oncology clinic located in Hagerstown, MD. In 2004, an on-site clinical oncology pharmacist was hired to help manage therapies and control cost. The objective was to evaluate the clinical interventions and assess the impact of consultations by the clinical oncology pharmacist to patients during therapy. Methods: This was a retrospective descriptive analysis of previous clinical interventions by the clinical oncology pharmacist from September 4, 2004 to October 27, 2006. This study involved a diverse patient population with different tumor types and/or disease states. The evaluation comprised two different categories: drug related problems (DRPs) and consultations, with several sub-categories. The DRPs included medication reconciliation, dosing, and adverse effect management and prevention. Consultations incorporated drug information questions, patient visits, and patient education sessions. The information was extracted from an online documentation program linked to medical charts and analyzed to determine the impact of a clinical oncology pharmacist on staff at the cancer center. Results: A diverse population of 199 patients was identified. Diagnoses included solid tumors 89%, hematological malignancies (3%), and miscellaneous diseases (8%). The 583 clinical interventions documented totaled 5,705 minutes, at an average of 10 minutes per intervention. Of the 583 interventions, 205 were DRPs, including 22 dosing, 52 medication reconciliations, and 131 adverse events. A total of 378 consultation interventions were documented, including 25 drug information questions, 124 patient visits, 143 patient education sessions, and 86 patient follow-ups. The on-site clinical oncology pharmacist saved $210,000 by admixing chemotherapy. Implementation of a carboplatin skin-testing protocol saved over $3,000 by preventing hypersensitivity reactions. Patient and colleague satisfaction surveys found the pharmacist to be a valuable asset with overall positive ratings of 95% and 98%, respectively. Conclusion: Analysis of clinical interventions, cost-savings, and feedback from patients and colleagues confirmed beneficial services provided by a clinical pharmacist in an outpatient oncology center. No significant financial relationships to disclose.
Differences in lung cancer symptom severity by tertiary cancer center vs. centers treating underserved patients
Authors: Palos G. R. , Shi Q. C. , Mendoza T. , Mobley G. , Zhang Y. , Valero V. , Hurley J. , Wang X. S. , Cleeland C. S. 
Published: March 2020

19577 Background: Understanding how differences in treatment site and ethnic/racial background affect the severity and outcomes of symptoms related to advanced lung cancer is critical to providing optimal symptom management. This analysis investigated the differences in the severity of symptoms among patients receiving treatment for advanced non-small cell lung cancer (NSCLC) at three different treatment centers. Methods: We compared changes in ratings of 139 patients diagnosed with NSCLC over the course of their chemotherapy regimen for symptoms and their interference on daily activities. Eligible patients had to be diagnosed with Stage III or IV NSCLC and treated at Jackson Memorial - Dade County, LBJ - Harris County or The University of Texas M. D. Anderson Cancer Center. Data were collected using telephone and pen-paper versions of the M. D. Anderson Symptom Inventory Lung Chemotherapy Module. Mixed modeling analysis was used to examine the differences in self-reported symptom severity between black, non-Hispanic, Latino/Hispanic and white, non-Hispanic patients. Results: A total of 56 patients from all sites, matched by age and gender, were included in this sub-analysis. Because this was a relatively small sample, we combined the non-Hispanic, black (27%) and Latino/Hispanic (14%) groups to form the minority group vs. the majority group (59%). Median follow-up was 24 weeks. Inclusion of the treatment site in the model resulted in losing the effect for ethnicity for the majority of symptoms. Significant higher ratings were found for fatigue and drowsiness in white, non-Hispanic patients when compared to the minority group. We found that treatment site (tertiary vs. center treating underserved) was a significant predictor for differences in symptom severity scores. Greater symptom severity ratings were found in patients seen at centers treating the underserved for pain, sleep, fatigue, nausea, shortness of breath, appetite, drowsy, dry mouth, and numbness. Conclusions: These findings suggest that receiving treatment at a center caring for the medically underserved is associated with greater symptom burden in patients with advanced lung cancer. These results underscore the need for additional studies. No significant financial relationships to disclose.
Epoetin beta treatment of chemotherapy induced anemia in cancer patients: Results of a large prospective cohort study
Authors: Ray-Coquard I. , Tourani J. , Facon T. , Haïoun C. , Audhuy B. , Mathoulin-Pelissier S. , Ollivier C. , Barbaza M. , Bergougnoux L. , Jenabian A. 
Published: March 2020

19582 Background: The efficacy of epoetin beta (E) is well documented in clinical trials in anemic cancer patients (pts). This study was conducted to assess E use, efficacy, safety and effect on quality of life in cancer pts, in usual practice. Methods: This prospective, multicenter, longitudinal, observational French study assessed a 4-month follow-up of informed consent cancer pts (including both solid tumors (ST) and hematological malignancies (H)) treated with E for chemotherapy-related anemia. Data were collected between January 2005 and March 2006. Results: Among 3100 pts enrolled by 423 specialists, 2810 were analysed. Pts’ characteristics were: mean age 63±13 yrs, male 50%, performance status 0 (13%), 1 (46%), =2 (41%). 74% of pts suffered from a ST and 26% from a H. The most frequent cancer types were lung (22%), breast (15%), non-Hodgkin lymphoma (12%), colon (9%), multiple myeloma (7%), ovary (7%), prostate (3%), head and neck (3%) and chronic lymphocytic leukemia (3%). The mean time from diagnosis to inclusion was 2 yrs. 52% of pts received their first line of chemotherapy, 25% their second one. 55% and 10% of ST and H pts received platinum based regimen, respectively. At inclusion, hemoglobin levels were distributed as follows: < 9 g/dl (ST 14%, H 32%), [9–11 [g/dl (ST 70%, H 56%), [11–13 [g/dl (ST 16%, H 11%). Regarding pre-treatment biological tests, endogenous erythropoietin rate was controlled for only 3% of pts (ST 1% and H 7%, median 37 IU/ml [0; 388]), ferritin was available for 15% of pts (ST 11% and H 28%), transferrin saturation for 12% of pts (ST 10% and H 17%) and reticulocytes for 11% of pts (ST 7% and H 24%). At initiation, pts received a median dose of 30000 U/week of E on a once weekly regimen schedule for 98% of pts. E was associated with iron supplementation in 49% and 13% of ST and H pts, and with blood transfusion in 5% and 15% of ST and H pts. Conclusion: These preliminary results describe baseline characteristics of cancer patients treated with epoetin beta. The study suggests very few biological controls before initiation of E in routine practice. Final analyses of hemoglobin evolution and quality of life will be presented. [Table: see text]
How much cost can one patient bear? The influence of income and education on drug purchasing decisions in Hong Kong Chinese cancer patients
Authors: Chan T. , Chan S. , Poon Y. , Fok J. , Epstein J. , Mak J. , Epstein R. 
Published: March 2020

19584 Background: Inflation of anticancer drug prices is a growing problem worldwide. This problem is especially challenging in Asia, where rising healthcare expectations clash with low incomes and weak insurance. To clarify the factors influencing drug purchasing decisions in this context, we conducted a survey of Hong Kong oncology patients. Methods: A questionnaire was designed to assess the effect of cost on purchasing decisions relating to drug variables such as (1) efficacy, (2) tolerability, (3) convenience, (4) safety, (5) novelty and (6) reliability. Validation of the original 33-part survey resulted in a final set of 21 questions that was administered to 51 oncology patients. These respondents were characterised in terms of age, household income, insurance, educational level, family circumstances, occupation, ethnicity, religious beliefs, prognosis, and co-morbidity. Results: Most respondents were Hong Kong (68.8%), mainland Chinese (18.8%) or Caucasian (10.4%). There was a strong correlation between household income and education. Patients from middle-income (US$7,000–14,000 per month) households were most influenced in their decisions by costs and insurance rebates, whereas those from low-income households (less than US$3,000 per month) were keenest to purchase expensive medications, whether Western or traditional Chinese remedies. Demand for drug safety was cost-inelastic across all income groups, independent of gains in efficacy. Even when free treatment was offered, therapeutic uncertainties (e.g., early-phase drugs or randomization) proved unpopular with all income groups. Only the most affluent and well-educated patients valued overall survival above disease-free survival in making decisions, suggesting that less educated cohorts did not understand these concepts. Conclusion: These data suggest that low-income cancer patients and their families may have unrealistic expectations of high-priced medications, based either on misunderstanding or cultural pressures. Greater educational efforts targeting this large population sector may be needed to avoid worsening dissatisfaction and social unrest in the future. No significant financial relationships to disclose.
Initiating epoetin-alpha (EPO) 120,000 units (U) every three weeks (Q3W) in patients with chemotherapy (CT)-induced anemia (CIA) and a hemoglobin (Hb) of <11 g/dL
Authors: Wilhelm F. E. , Charu V. , Glaspy J. , Moyo V. , Kamin M. 
Published: March 2020

19589 Background: Reported here are the final Hb results for the group of patients enrolled under an amendment to a larger study that was the first to compare early vs standard intervention with EPO 120,000 U Q3W in patients with CIA and Hb of 11 to 12 g/dL. The amendment allowed for treatment of patients who had a Hb value <11g/dL at screening. Methods: The larger study was a 16-week open-label randomized study that enrolled patients with non-myeloid malignancy, baseline (BL) Hb =11.0 and =12.0 g/dL, and CT planned for =9 weeks. Patients were randomized (1:1) to receive EPO 120,000 U subcutaneously Q3W immediately (early intervention group, EIG) or when their Hb fell to <11.0 g/dL (standard intervention group, SIG). If, at any dosing visit after the first EPO dose, Hb decreased to <10.0 g/dL, patients were switched to EPO 40,000 U weekly (QW). An amendment was added to the larger study to allow similar patients whose Hb was <11 g/dL at screening to be treated with EPO 120,000 U Q3W. EPO was withheld for Hb >13.0 g/dL at any dosing visit; dose was reduced for Hb >12.0 g/dL or Hb increase >1.5 g/dL in a 3-week period (current prescribing information recommends target Hb not to exceed 12 g/dL). Hb response was analyzed using an observed case approach and Hb data following switch to 40,000 U QW were censored. Results: Fifty patients were enrolled under the amendment. BL characteristics were: mean age, 62.0 years; 67% female; mean Hb 10.1 g/dL. Mean Hb changes over time from BL for patients receiving Q3W dosing are shown in the table . PRBC transfusion rate after 4 weeks on treatment was 24.5%. 18.0% of patients had at least one dose withheld and 22.0% had at least one dose reduction. Five deaths and 6 clinically relevant TVEs were reported. Conclusions: This study shows that EPO is effective in raising Hb when initiated in patients with CIA and a Hb of <11 g/dL at 120,000 U every 3 weeks. Further studies are warranted. No significant financial relationships to disclose. [Table: see text]
An attempt to correlate “comprehensive geriatric assessment” (CGA), treatment assignment and clinical outcome in elderly cancer patients: Results of a phase II open study
Authors: Mantovani G. , Massa E. , Astara G. , Madeddu C. , Tanca F. M. , Sanna E. , Spiga C. , Deiana L. 
Published: March 2020

19592 Background and Methods: The design was a prospective Phase II open study. Elderly (age =65 years) cancer patients (pts) of different sites were assigned to 3 different CGA categories: “fit”, “intermediate” and “frail”. Therefore, an appropriate treatment was administered and the clinical outcome was assessed. “Fit” pts were assigned standard chemotherapy, “intermediate” pts tailored (chemo-) therapy, “frail” pts monochemotherapy (as “supportive” therapy) or only “supportive care”. The primary endpoint of the study was to correlate CGA with treatment and clinical outcome which was based on: objective clinical response (RECIST), ECOG PS, toxicity (NCI CTC v.3), survival. Patients who completed at least 3 months of treatment were evaluable. At December 2006, 136 pts were enrolled; 114 (mean age 73.6 years) 104 of whom stage IV were evaluable: 36 “fit”, 36 “intermediate” and 42 “frail”. At baseline no difference was found between the CGA categories as for clinical characteristics (M/F ratio, stage, tumor site) except for ECOG PS which was significantly higher in frail pts (ANOVA test). Results: At 3 months the objective clinical response to the assigned treatment was: 9 CR, 9 PR, 13 SD and 5 PD for “fit” pts; 9 PR, 14 SD and 13 PD for “intermediate” pts; 6 PR, 11 SD and 25 PD for “frail” pts. As for the correlation of CGA categories with treatment and clinical outcome: a significantly higher OR, particularly CR, in favor of fit pts was observed, ECOG PS was maintained significantly higher in frail pts, toxicity was the highest in intermediate pts, the dose intensity was highest in fit pts. At the multivariate regression analisys the independent predictive factors for the clinical response were initial CGA and dose intensity. Conclusions: The study confirms: 1) Fit pts should be treated with the most active regimens not differently from adult pts; 2) the “intermediate” group should be probably better assessed as for inclusion criteria; 3) frail pts need a more exhaustive assessment of the quality of life currently not included in the CGA. In conclusion, the CGA assessment is strongly recommended as an essential tool for the clinical evaluation of elderly pts. Large prospective clinical trials in this field are awaited. No significant financial relationships to disclose.
Mitomycin C in combination with capecitabine (Mi-Cap) as chemotherapy in breast cancer patients with extensive liver metastases and impaired hepatic function: A non-randomized multicentre phase II study
Authors: Loibl S. , Schmidt M. , Marquardt F. , Huober J. , Bischoff J. , von Minckwitz G. , Mehta K. M. , Kaufmann M. 
Published: March 2020

19597 Background: Breast cancer patients with an impaired liver function due to liver metastases have very limited, evidence based treatment options. Based on our experience with mitomycin C, 5Fu and folinate (Loibl et al. 2004), we wanted to improve this schedule by including the oral antimetabolite capecitabine. Methods: Breast cancer patients (pts) with liver metastases and elevated liver enzymes defined as AST/ALT = 3×UNL (group A) or liver enzymes = 1.5×UNL and AP = 3×UNL (group B) were enrolled. Further inclusion criteria were as follows: bidimensionally measurable disease, normal hematological values (WBCs = 3×109/L; platelets = 100×109/L; hemoglobin = 10 g/dL), normal renal function. A three weekly cycle with Mitomycin C 8 mg/m2 i.v. on day 1, capecitabine 2,000 mg/m2 day 1–14 and prednison 5 mg day 1–5 orally was given. Primary endpoint is the progression free survival (PFS) measured from the planned 44 eligible patients who received at least one cycle of Mi-Cap. Results: Between April 2004 and December 2006, 35 patients with a median age of 57.1 years (range, 39–76) were enrolled. 29 pts. received an adjuvant or neoadjuvant chemotherapy of whom 20 received anthracyclines and 6 a taxane containing regimen. 9 pts. had no chemotherapy for metastatic disease and 9 pts. had 3 or more chemotherapies for metastatic disease. At the start of chemotherapy 24 pts belonged to group A and 11 to group B and 12 pts had hyperbilirubinemia. 20 pts had liver involvement only. So far 109 cycles had been given. 29 pts. received more than one cycle, 6 pts. received the 6 preplanned cycles so far. Myelosuppression and hand foot syndrome are the most frequent toxicities. 4 patients had a documented partial remission, 18 patients had stable disease or are still under treatment, and 13 patients progressed during treatment. The median time to progression is 6.4 months in all patients who received at least one cycle. The median overall survival for the total population was 8.3 months. Conclusion: Mi-Cap can be safely given. Initial observations show that pts with a decrease in liver enzymes or bilirubin in the first two cycles had a longer PFS. No significant financial relationships to disclose.