bluuebunny/crossref_metadata_2025_split huggingface dataset:
A phase 2 study to evaluate the efficacy of darbepoetin-alfa administered using an extended dose schedule versus weekly dosing in cancer patients with chemotherapy-induced anemia
Authors: Rearden T. , Schwartzberg L. , Yee L. , Mirtsching B. , Charu V. , Lam H. , Lillie T. , Burkes R. , Silberstein P. 
Published: March 2020

19501 Background: Chemotherapy-induced anemia (CIA) can be effectively treated with darbepoetin alfa (DA) using different dosing schedules. Since chemotherapy (CTX) regimens involve various dosing schedules, the ability to synchronize DA dose with CTX could be beneficial. Methods: This phase 2, 25-week (wk), randomized, open-label study compares the efficacy and safety of DA administered using an extended dose schedule (EDS) (every 2 wks [Q2W] or every 3 wks [Q3W]) vs weekly (QW) dosing in patients (pts) with CIA. Pts were randomly assigned to receive DA EDS (either 300 mcg Q2W [with CTX QW, Q2W, or Q4W] or 500 mcg Q3W [with CTX Q3W]) vs 150 mcg DA QW (with CTX QW, Q2W, Q3W, or Q4W). Randomization was stratified by length of CTX cycle, screening hemoglobin (Hb) (< 10 vs = 10 g/dL), and type of cancer (lung/gynecological vs other cancers). The primary endpoint was the change in Hb from baseline (BL) to wk 13; other endpoints included the change in Hb from BL to end of study (EOS), percentage of pts with = 1 transfusion (TFN) from BL to wk 13 and EOS, and safety. Results: Final data for the total 25-wk study period will be presented. Results from a planned interim analysis for all pts who were enrolled in the study and received = 1 dose of DA (n = 752) are shown for wk 13 endpoints (Table). The groups had similar mean change in Hb from BL to wk 13, with a difference (QW minus EDS) (95% CL) of 0.2 (-0.1, 0.4) g/dL. The % pts who achieved target Hb were also similar (difference [95% CL] = 0 [-7, 6]). At the time of the interim analysis, the incidence and types of adverse events were similar between the groups. Ten (3%) EDS and 15 (4%) QW pts had thromboembolic events, 5 (1%) EDS and 2 (1%) QW pts had cerebrovascular accidents, and 19 (5%) EDS and 22 (6%) QW pts had died. Conclusions: This is the first trial synchronizing DA dosing (Q2W and Q3W) with CTX schedules. The interim results suggest that DA administered once per CTX cycle is well-tolerated and efficacious in these patients. [Table: see text] No significant financial relationships to disclose.
Potential of COX-2 inhibitors in lowering chemotherapy-induced neutropenia: Results from a randomized trial
Authors: Chow L. W. , Yip A. Y. , Lam C. , Toi M. 
Published: March 2020

19509 Background: This study was to evaluate the effect of celecoxib on the regimen 5-fluorouracil, epirubicin, and cyclophosphamide (FEC) combination, followed by docetaxel in neoadjuvant setting. Patients and Methods: Twenty-three female patients with operable breast cancer were randomized into two groups: group A (n=12), four cycles of FEC (500 mg/m2, 100 mg/m2, 500 mg/m2) followed by four cycles of docetaxel (100 mg/m2) with concurrent celecoxib (400 mg twice daily); group B (n=11), same chemotherapy regimen but without concurrent celecoxib. These combined chemotherapies were administered 3-weekly. Results: 22 (96%) patients completed all cycles except that one (4%) omitted the fourth cycle of FEC owing to repeated incidences of febrile neutropenia. Received dose intensity (RDI) of group A and B for FEC (90% vs. 80%, p=0.035) and docetaxel (93% vs. 96%, p=0.414) showed significant difference in first four cycles of FEC between groups. Limiting hematological toxicity, severe neutropenia including febrile neutropenia, was significantly different between group A and B (33.3% vs 90.9%, p=0.005) during the first four cycles of FEC. Other toxicities commonly observed in chemotherapy receiving patients were manageable. Conclusion: Neoadjuvant use of FEC followed by docetaxel with concurrent celecoxib is safe for treatment of operable invasive breast cancer. COX-2 inhibitor likely lowers the incidence of chemotherapy-induced neutropenia. We believe that further investigation might provide more evidence on the use of COX-2 inhibitors in breast cancer. No significant financial relationships to disclose.
XELOX regimen in elderly patients with metastatic colorectal cancer (MCRC), a FNCLCC French Collaborative Group GERICO 02 phase II study
Authors: Viret F. , Bugat R. , Ducreux M. , Cvitkovic F. , Carola E. , Gisselbrecht M. , Esterni B. , Gouttenoire F. , Rousseau F. 
Published: March 2020

19513 Background: Xelox regimen is an active combination in 1st line MCRC. In elderly patients, independence measured by the 6-items Activity of Daily Living Katz scale (ADL) determines whether an elderly can eventually live alone. We wanted to evaluate, the impact of Xelox regimen on independence of elderly patients measured by ADL after 3 and 6 cycles (CY), the response rate and safety profile. Methods: Elderly patients above 70 with histological proven MCRC were treated with an adapted XELOX regimen capecitabine (CPT) 750 mg/m2 orally bid d1–14 + oxaliplatin (OXP) 90 mg/m2 iv d1,q3w). After 3 CY with no significant toxicity, OXP and CPT were increased to 120 mg/m2 iv d1 and 1,000 mg/m2 bid d1–14 respectively. Results: 60 patients were enrolled at 6 centers over 36 months, of the 53 analyzed to date: M/F, 30/23, median age 78 years, Karnofsky index 80, 88.68% patients had comorbidity. Metastatic sites were liver (70.59%), lung (43.14%) and bone (9.8%). 39 % of patients (20) stopped treatment prematurely: progressive disease (6), toxicity (11), patients wish (3). Median ADL baseline was high (5.5; 1.5–6). Primary endpoint was achieved: after 3 CY 32/35 (91%) had no ADL decrease (median 6; 3.5–6) and unilateral Wilcoxon tested on paired data showed ADL improvement (p=0.0001). After 6 CY, 96% of patients had no ADL decrease. Median number of CY administered was 6 (1–6) with 88.24% of patients received ≥ 3 cycles. The dose of chemotherapy OXP and/or CPT was increased in 31.6 % of the elderly patients. Efficacy analysis: 1 patient achieved CR, 19 PR, 11 SD, 11 PD, 9 NE. Toxicity was moderated: diarrhea (g3/4: 13%), neurotoxicity (g1/2: 67%, g3/4: 2%), hand-foot syndrome (g1/2:19%, g3/4: 0%) and haematological (g3/4: 12%). Conclusions: This study shows that Xelox regimen does not impair independence measured by ADL in MCRC elderly patients. It is also a safe, well tolerated (in 1st line treatment) and active regimen in this population of patients. [Table: see text]
Chemotherapy administration associated errors before and after use of electronic order entry and decision support
Authors: Kirlin D. L. , DeVoe M. G. , Brennan L. V. , Drosick D. R. , Essell J. H. , Hawley D. K. , Bowman R. M. , Heaton D. , Neuss M. N. , Guo J. J. 
Published: March 2020

19528 Chemotherapy Administration Associated Errors Before and After Use of Electronic Order Entry and Decision Support Background: Chemotherapy administration is an important part of oncology practice and as treatment plans have evolved, their complexity has increased. Our practice has developed a software program that incorporates decision support and safety checks. Here we report the errors we have noted before and after utilization of this system. Methods: Drug administration errors are tracked through a mandatory “incident report” process that requires staff to report whenever an error is recognized. All reports from 2003 (the year before utilization of the chemotherapy software) and 2006 were reviewed. We compared the number and type of errors from the two time periods. Results: • Statistically significant *increase or † decrease at alpha level 0.05. • 1rate is expressed per 100,000 treatments • 2 “Other” errors are those which could not be classified otherwise and had no impact on the patient Conclusions: The frequency of recognized errors associated with chemotherapy administration is very low (0.03%) and while still unacceptable, much lower than the 5% reported for medication administration in general. (Kaushal, Arch Int Med 163:1409 2003) A computerized software support system did not make a statistically significant change in the total frequency of administration errors but did significantly decrease wrong drug errors even as the complexity of treatment protocols increased. A class of error “Planned Drug Missed” was recognized because of a formal declaration of treatment plan. There may be significant reporting bias consequent to increased recognition and subsequent reporting of errors when a computerized system and formal declaration of treatment plan is in place. However, no matter the system, the human/computer interface remains a potential source of error. [Table: see text] No significant financial relationships to disclose.
Patients with breast cancer feel empowered by their participation in online support groups
Authors: Smit W. M. , van Uden-Kraan C. F. , Drossaert C. H. , Seydel E. R. , Taal E. , van de Laar M. A. 
Published: March 2020

19544 Background: People often join support groups when they find themselves in stressful circumstances such as serious health conditions. With the increase in the availability and popularity of the Internet, the opportunity to join support groups online has arisen. Ever since the rise of online support groups, much is expected of the potential empowering effect of taking part in these groups for patients. However, thus far, there is no direct evidence. Therefore the purpose of this study was to explore if and how people with breast cancer feel empowered by their participation in online support groups and which processes that take place in online support groups contribute to these outcomes. Methods: We have sent a posting with a link to an online survey to 7 online support groups for patients with breast cancer. In total 214 participants responded to the request to fill in the survey. Results: The majority of the respondents were women (n=211). The mean age of the respondents was 46 years (SD 8.9 years). The respondents were diagnosed 3 years ago on average, with a range of 0 to 15 years. The respondents felt empowered in several ways by their participation. First of all, most respondents (74%) felt better informed. They indicated that as a result of their participation, they had received adequate information to deal with their disease (60%). Additionally, most participants felt more confident in the relation with their physician. The participants indicated that they knew better which questions to ask their physician (69%) and that they felt better prepared for a consult with their physician (61%). For some of the respondents, participation in an online support group enabled easier acceptation of the disease (48%) and helped them to “open up” about their disease (49%). The main processes that contributed to these outcomes were: exchanging information, comparing with other participants and encountering social support. Conclusions: This study suggests that participation in online support groups can make a valuable contribution to the emergence of empowered patients, who set their own health agendas and who take control of their own health status, as is deemed necessary in the current transformation towards a modern health care consumer model. No significant financial relationships to disclose.
Relationship between fatigue and cytokine levels in patients age 50+ with acute myeloid leukemia (AML)
Authors: Panju A. , Kelvin D. , Minden M. D. , Alibhai S. M. 
Published: March 2020

19566 Background: Fatigue is the most common and disabling symptom affecting patients with AML; effective prevention or treatment measures have yet to be found. Cytokines, biological markers of inflammation, may represent a major cause of fatigue, but published data are limited. Methods: Patients age 50 or older with AML were recruited between May and September 2006. All patients were fluent in English, within one year of diagnosis, and free of any other active malignancy. Fatigue was measured using the Functional Assessment of Cancer Therapy (FACT) Fatigue subscale, a single-item global fatigue scale, and the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30. Blood was simultaneously drawn for quantitative measurement of a panel of 13 cytokines. Repeat measurements were done 4–6 weeks later. Correlational analysis was used to examine relationships between individual cytokines and fatigue scores. Changes in fatigue scores between time points were correlated with changes in cytokine levels. Results: 34 patients (23 men; 11 women) were enrolled (mean age 67 y; range 52–84). 27% had not started chemotherapy or were receiving best supportive care, while the rest were undergoing active chemotherapy. At baseline, a weak correlation (r=0.332, p=0.059) was seen with interleukin (IL)-6 and at least one fatigue measure. No correlations (r<0.30) were observed with any of the other cytokines (interferon (IFN)-?, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, IP-10, MCP-1, MiG, and tumor necrosis factor-a) and any fatigue measure. Follow-up data were available for 29 patients. A statistically significant correlation with fatigue was seen with IL-2 (r=0.407, p=0.032), and clinically-important correlations that did not achieve conventional statistical significance were seen with IFN-? (r=0.331, p=0.085), IL-5 (r=0.344, p=0.073), and IL-10 (r=0.326, p=0.091). Conclusions: Based on these data, the most promising cytokine-fatigue relationship was noted with IL-2. However, IFN-?, IL-5, IL-6, and IL-10 also showed potentially important relationships with fatigue. Given our small sample size and patient enrolment at differing time points during their treatment course, further controlled studies are warranted. No significant financial relationships to disclose.
Chemotherapy in non-selected elderly patients: Factors influencing dose-intensity and toxicity
Authors: Lemare F. , Mateus C. , Camps S. , Montheil V. , Henguelle E. , Cacheux W. , Bezian E. , Di Loreto R. , Dauphin A. , Goldwasser F. 
Published: March 2020

19585 Background: Chemotherapy (CT) is the treatment of choice for most metastatic cancers. Frequent functional impairment and comorbidities in the elderly increase the risk of chemotherapy-related acute complications. The applicability of clinical trials data to the elderly population is exposed to multiple bias. Informations extracted from non-selected treated patients (pts) may be useful. Methods: A serie of consecutive elderly cancer pts (>73 years) treated over 3 years in the oncology outpatient unit, and receiving CT were included for analysis and assessed using prechemotherapy evaluation of cancer in the elderly (including performance status, comorbidities, glomerular filtration rate, liver tests, hemogram, nutritional status, inflammation tests). Relationship between preCT evaluation and acute complications, unscheduled hospitalisation, mortality were investigated by univariate analyses. Comparison between planned and realised dose- intensity of CT protocols could be extracted for the CT prescription software. Results: 108 pts with a median age of 78 years (73- 89; 44% over 80) were identified. Characteristics included performance status (PS) ≥ 2 (44%), chronic renal insufficiency (47%) ; ≥2 comorbidities (75%). Primary tumour was urologic (31%), gastro-intestinal (29%), mammary and gynaecologic (20%); pulmonary (16%) or other (4%). Disease stage was metastatic for 82% of pts. Most CT regimens contained a platinum derivative (55%), gemcitabine (25%), 5-FU (20%), taxanes (17%), vinorelbine (15%). Transfusion requirements were higher in PS≥2 pts (p<0.0001). Febrile neutropenia correlated with PS, lymphocytopenia and PINI =(CRP×AAG)/(albumin×pre-albumin)>10 (p<0. 05). Unscheduled hospitalisation correlated with PS, lymphocytopenia, PINI, more than 2 co-morbidities, more than 4 co-medications. Oxaliplatin- and paclitaxel-containing CT protocols were associated with significant reduction of dose-intensity because of reduced number of cycles due to neurosensory toxicity (p=0.01). Conclusions: Lymphocytopenia, PS, and PINI were the most relevant prognosticators of short-term CT outcome. Elderly pts characteristics are associated with higher risk of acute toxicity and increased sensitivity to neurosensory cumulative toxicity. No significant financial relationships to disclose.
Comparison between gemcitabine-based combination (G) and single-agent chemotherapy (S) for elderly patients (EP) with advanced non-small cell lung cancer (NSCLC): A literature-based meta-analysis
Authors: Carreca I. , Bellomo F. , Bronte G. , Burgio M. , Carreca A. , Piazza D. , Rizzo S. , Russo S. , Balducci L. 
Published: March 2020

19586 Background: It was estimated that a quarter of all patients who have a diagnosis of NSCLC worldwide are more than 70 years old. This meta-analysis tries to shed light on the controversial results of phase III trials evaluating in NSCLC EP doublets against third generation S. Methods: We performed a literature search using MEDLINE and Cochrane Library. We selected only clinical trials responding to the question of our meta-analysis. Outcomes recorded were 1-year survival rate (1-y SR), overall response rate (ORR) and haematological toxicity (HT). Fixed-effects and random-effects models were used to calculate pooled odds ratios (OR). An OR greater than 1 indicates that doublet is more effective for 1-y SR and ORR and more toxic for HT. Results: Three published randomized controlled phase III trials (SICOG 9909; MILES; AISCAP-SICOG) were selected yielding a total of 1082 patients (G: 426; S: 655) clustered in seven comparisons. Drugs delivered to randomized patients included gemcitabine, vinorelbine and paclitaxel. EP treated with doublets showed respect to control patients a pooled estimate for 1-y SR advantage of 36%, not statistically significant (OR=1.356; 95% CI=0.925–1.990; p>0.05). The pooled estimate for ORR advantage was 57% and statistically significant (OR=1.559; 95% CI=1.220–2.015; p<0.05). However G showed not significant difference for HT (OR=1.168; 95% CI=0.685–1.992; p>0.05). Conclusions: These data confirm in EP superior efficacy and equal tolerability of G in comparison with S previously demonstrated for adult patients. Anyway G seems to not change prognosis of NSCLC EP. It is worthy to note that all the trials analysed showed some biases: early closure of the study, second-line therapy or crossover, lower dosage of drugs in combination regimen, inclusion of unfit or strongly comorbid patients. This meta-analysis doesn’t solve troubles in decision-making of treatment for EP, but suggest to design a better phase III trial including more patients and improving accrual criteria for reducing biases. An indication of a potentially active combination regimen (gemcitabine + paclitaxel) is suggested in SICOG 9909 trial. No significant financial relationships to disclose.
Polymicrobial bloodstream infections (PBI): An under-realized complication in patients with cancer (2005–2006)
Authors: Safdar A. , Rodriguez G. H. , Raval D. S. , Bodey G. P. , Rolston K. V. 
Published: March 2020

19590 Background: Little attention has been directed to PBI in cancer patients. Methods: Fifty-four PBI episodes were evaluated retrospectively in 51 patients after obtaining IRB approval. PBI was defined as ≥ 2 organisms isolated from a single blood culture or sample(s) obtained within 72 hrs after the initial positive culture. All values are given as median ± s.d. Results: The age was 57 ± 16 years. Thirty-four patients had hematologic malignancy of whom, 73% had acute leukemia. Nearly half (47%) of the patients had refractory or relapsed cancer. Thirty-two (63%) were neutropenic (ANC 0 ± 144 cells/UL) and 31 patients (61%) had lymphocytopenia (ALC 0 ± 86 cells/UL). At the time of infection diagnosis, APACHE II score was 16 ± 5 and 5 (10%) patients were receiving systemic corticosteroids (> 600 mg prednisone equivalent dose). Thirty-one PBI episodes (57%) occurred while patients were receiving systemic antimicrobial agents for prophylaxis or treatment. In 83% of PBI episodes, positive specimens were collected from central venous catheter (CVC). Catheter-related infection necessitating CVC removal occurred in nearly half of these cases (24/45). Twenty-two (41%) PBI episodes were associated with high bacterial load (> 100 CFU/ml). The overall response to treatment was 86%. In 39 of 42 episodes (77%) treated with concordant antimicrobial therapy infection resolved. Whereas, in only 5 episodes (9%) treated with discordant antimicrobial therapy, infection resolution occurred (P = 0.07). There were no differences in PBI outcomes in patients with hematologic malignancies vs. solid-organ cancers, patients > 50 years vs. < 50 years of age or among neutropenic patients who had recovery of neutropenia during infection episode vs. patients in whom neutropenia persisted. Conclusions: The overall high response of concordant antimicrobial therapy for even high-risk cancer patients with PBI looks encouraging. No significant financial relationships to disclose. [Table: see text]
Quality of life: An independent prognostic variable in a general population of cancer patients receiving chemotherapy
Authors: Grutsch J. F. , Gupta D. , Granick J. , Wodek T. , Lis C. G. 
Published: March 2020

19596 Background: It is uncertain whether the current Quality of Life (QL) instruments can facilitate clinical decision-making in oncology. Since the most important outcome in oncology is survival, we investigated QL domains from 2 contrasting QL instruments, EORTC QLQ-C30 and the Quality of Life Index (QLI) to determine if these instruments can partition a heterogeneous population of cancer patients into distinct prognostic groupings. Methods: 1,200 patients consented to participate in Cancer Treatment Center of America's QL program between Mar ‘01 and May ’05. We identified 494 deaths in this group. Most common tumors were breast (n=319), colon (n=159), and lung (n=209). Among 434 patients undergoing definitive treatment 159 had stage 4 and 49 had stage 3 disease, the other patients had failed definitive therapy. The median survival was 39 weeks for newly diagnosed patients and 29.9 weeks for patients with recurrent disease. We used cutpoint analysis using statistical strength of association with QL scores to determine the association between QL score and survival. This information was then used in a recursive partitioning analysis to group our cancer patient population into mutually exclusive prognostic groups. Results: We found several QL domains had a non-linear relationship with survival, which indicates that a relatively small change in QL score could result in a large change in survival. QLI Health/Functioning domain, had the strongest association with survival. Subsequent iterations of the recursive partitioning found that a combination of clinical and QL domain scores partitioned the patient population into distinct groups, whose median survival ranged from 13–100 weeks. Patients with the best prognosis had high QLI health satisfaction scores health and had hormonally dependent tumors. The patients with the poorest survival had intermediate QLI health satisfaction scores, poor appetite, and poor emotional function. Conclusion: This retrospective analysis found specific combination of QL domains and scores that partitioned patients with advanced cancer into distinct prognostic groupings. This analysis indicates that our current instruments have the potential to be developed into tools that could facilitate clinical decision-making. No significant financial relationships to disclose.