bluuebunny/crossref_metadata_2025_split huggingface dataset:
Elderly patients with advanced non-small cell lung cancer (nsclc). Results of chemotherapy and comparison with younger patients
Authors: Rubio I. , Martínez-Bueno A. , López-Vivanco G. , Fuente N. , Barceló R. , Gil-Negrete A. , Carrera S. , López-Argumedo G. , Fernández R. , Muñoz A. 
Published: April 2020

18505 Background: Lung cancer is increasingly diagnosed in elderly patients and is the first cause of cancer death. Treatment of this subset represents a challenge to medical oncologists. Methods: We retrospectively reviewed clinical characteristics, co-morbidity (Charlson Index), toxicity and results of all patients ≥ 65 years (y) old, diagnosed of advanced NSCLC. We compared these results with younger patients’. Results: From January-95 to June-02, we treated 477 patients (pt), 176 ≥ 65 years, 301 < 65 y. Treatment: 177 pt, MIC (mitomycine + ifosfamide + cisplatin), 60 ≥ 65 y and 117 < 65 y; 156, CG (Cisplatin + Gemcitabine), 52 > 65 y and 104 < 65 y; 144, CP (Cisplatin + Paclitaxel), 64 ≥ 65 y and 120 < 65 y. Characteristics: median age 60 (31–78); 428 male, 49 female; ECOG 0/1/2/3: 83/312/71/5, Stage IIIA, IIIB and IV: 72/199/206, Histology: squamous carcinoma 215, adenocarcinoma 190, large cell 19, bronchioloalveolar 7, undifferentiated 45 pt. No significant differences between the two groups. Overall response rate: 39% (CR, 32.9%, PR, 6.1%), Stable disease 26.4% and Progressive disease, 26.4%. Patients ≥ 65 y: CR 5.7%, PR 45.5%, SD 23.3% and PD 18.2%. Patients < 65 y: CR 6.3% PR 25.6%, SD 28.2% and PD 31.2%. Predictive factors for response: ECOG and stage. Response rate was superior in patients ≥ 65 y and in patients ≥ 70 y. Overall survival: 38.29 weeks (w): < 65 y, 38.57 w; 65–70 y, 37.71 w and ≥ 70 y, 37 w. Multivariate analysis: ECOG, stage and sex were prognostic factors; age, histology, Charlson index and schedule treatment were not significant. Grade 3/4 episodes of toxicity: ≥ 65 y, 184/17, and < 65 y, 232/8. Treatment delays: ≥ 65 y, 115 and < 65 y, 100. Hospitalization due to toxicity: >≥ 65 y, 34 and < 65 y, 23. Treatment was stopped in 13 pt >≥ 65 y and in 7 pt < 65 y. Conclusions: Age is not a predictive factor for response to chemotherapy, neither a prognostic factor for survival. Charlson index does not seem to be useful for these patients. Although toxicity is superior, cisplatin-based schedules are safe and active. No significant financial relationships to disclose.
Regional cooling significantly reduces liposomal doxorubicin-induced palmar-plantar erythrodysesthesias (PPE) in patients with recurrent ovarian cancer
Authors: Sayer R. A. , Apte S. , Tedjarati S. S. 
Published: April 2020

18507 Objective: To evaluate the effect of regional cooling on the incidence and severity of liposomal doxorubicin-induced PPE in patients with recurrent ovarian cancer. Methods: Following IRB-approval, a retrospective chart review identified all patients treated with liposomal doxorubicin for recurrent ovarian cancer from 7/00 through 7/05. It was then determined whether patients received a regional cooling protocol, which involved placing hands and feet in ice water during chemotherapy infusion. Information was collected including patient demographics, prior chemotherapy, and grade and severity of PPE. Results: 73 women were treated for recurrent ovarian cancer with liposomal doxorubicin over the 5-year period. The median age was 58 years (range 24 to 82). The number of cycles ranged from 2 to 27 (median of 5). Liposomal doxorubicin dosages were available for 69 patients. Of the 69 patients, 4 patients were treated at 30 mg/m2, 64 patients were treated at 40mg/m2, and 1 patient was treated at 50mg/m2. The number of prior chemotherapy regimens ranged from 1 to 6 (median of 2.4) and the total number of all prior cycles ranged from 6 to 57 (median of 10). 25 of 73 patients (34%) were treated using the regional cooling protocol, while 48 of 73 (66%) were not. All incidences of PPE occurred in patients treated at the 40mg/m2 dosing. The overall incidence of PPE in the regional cooling group was 24% compared to 54% in the non-regional cooling group (p = 0.0067). In the regional cooling group, 12% had grade 1 PPE, 8% had grade 2 PPE, 4% had grade 3, and none developed grade 4 PPE. Of the 48 patients without regional cooling, 19% had grade 1 PPE, 15% had grade 2 PPE, 15% had grade 3, and 2 of 4% had grade 4 PPE. Of the 25 patients receiving regional cooling, 1 patient (4%) required discontinuation of liposomal doxorubicin due to grade 3 PPE while 11 patients of the 48 patients who did not receive regional cooling (23%) required discontinuation due to PPE (p = 0.048). The incidence of PPE was not associated with age at diagnosis or total number of previous chemotherapy cycles. Conclusions: Regional cooling is effective in significantly reducing the incidence and severity of liposomal doxorubicin-induced PPE in patients with recurrent ovarian cancer. No significant financial relationships to disclose.
Darbepoetin alfa administered at varying intervals compared with weekly epoetin alfa for treating chemotherapy-induced anemia: A pooled analysis of 20 clinical trials
Authors: Glaspy J. , Henry D. , Canon J. L. , Lam H. , Lillie T. 
Published: April 2020

18508 Background: Cancer patients (pts) often develop chemotherapy-induced anemia (CIA), resulting in an increased risk for transfusions and fatigue. The erythropoiesis-stimulating agents (ESAs) epoetin alfa (EA) and darbepoetin alfa (DA) can reduce transfusion requirements, raise hemoglobin (Hb) levels, and decrease fatigue in pts with CIA. The 74-hour half-life of DA allows for flexible dosing with weekly (QW), every-2-week (Q2W), or every-3-week (Q3W) administration. This study evaluated if the dosing interval used to administer DA affected its efficacy. Methods: Data from 20 clinical trials in the CIA setting were pooled, including single-arm, active-controlled, and placebo-controlled trials (a full description of these studies will be presented). Six studies contributed data for DA QW, 7 studies for DA Q2W, and 5 studies for DA Q3W. Controlled studies used either a placebo or EA as the comparator. Logistic regression with treatment as a random effect was used to analyze the clinical trials. Endpoints included the percentage of pts requiring transfusions (from week 1 to end of the treatment period [EOTP] and from week 5 to EOTP), reaching a target Hb of ≥ 11 g/dL, and achieving ≥ 3 point change in FACT-F score from baseline (BL). Percentages were adjusted for BL Hb levels (< 10 vs ≥ 10 g/dL), whether pts received platinum chemotherapy (no vs yes), and for dosage adjustments. Results: The type of ESA used (EA or DA) did not appear to affect the percentage of study pts who achieved clinically meaningful endpoints (see Table ). The results from these analyses also suggest that the dosing interval at which DA was administered did not affect its efficacy in study pts (see Table ). Conclusions: DA administered at dosing intervals of QW, Q2W, or Q3W has comparable efficacy to EA QW. This flexibility allows DA administration to be synchronized with common chemotherapy schedules, which may increase pt convenience by reducing the number of clinic visits. [Table: see text] [Table: see text]
Toxicity in elderly breast cancer patients treated by a taxane based chemotherapy as adjuvant or neoadjuvant therapy for primary breast cancer
Authors: Loibl S. , Von Minckwitz G. , Elling D. , Janni W. , Kaufmann M. , Vescia S. , Eggemann H. , Harbeck N. , Nekljudova V. , Kuemmel S. 
Published: April 2020

18509 Background: Elderly patients (pts) are more likely to develop haematological toxicity with anthracycline based regimen. There are no sufficient data available on toxicities especially in elderly pts who are treated by taxane containing regimen. Methods: Four prospective randomised trials in the treatment of primary breast cancer have been combined retrospectively to evaluate the toxicity in pts ≥ 60 treated by a taxane. Pts received either 1: docetaxel/adriamycin/cyclophosphamide (TAC 75/50/600 mg/m2), 2: adriamycin(epirubicin)/cyclophosphamide (A(E)/C: 60(90)/600 mgm2) followed by docetaxel (T: 100 mg/m2) or paclitaxel (P: 175mg/m2), or 3: dose-dense adriamycin/docetaxel (AT dd: 50/75 mg/m2) or 4: epirubicin-paclitaxel in sequence (E-P dd: 90–175 mg/m2). A descriptive analysis was performed in regards to pts and per cycles. In the sequential regimen cycles without taxanes were not considered evaluable. Results: 917 pts median age of 64 (range 60–80) years were included in this pooled analysis. 59 were older than 70 years. In total 3852 cycles of a taxane containing chemotherapy were administered. 378 pts (41.2%) received therapy 1, 332 (36.2%) therapy 2, 121 (13.2%) therapy 3, and 86 (9.4%) therapy 4. A total of 16 % of the pts did not complete treatment. Grade 3–4 neutropenia occurred in 46.2% and febrile neutropenia in 6.1% of the pts, severe anemia (0.8%) and thrombopenia (1.1%) was infrequent. Main non hematological toxicities were (% pts with grade I-IV): fatigue 86; loss of appetite 74; nausea and vomiting 68; mucositis 60; sensory neuropathy; conjunctivitis 45; skin 38; nail 39; fluid retention 36; dyspnea 32. Conclusion: Toxicity of taxanes in pts older than 60 years does not significantly differ from younger pts. Therefore, taxanes as adjuvant or neoadjuvant treatment for primary breast cancer could also be considered in otherwise fit pts in the age group of 60–70. [Table: see text]
The effectiveness of darbepoetin alfa administered at 300 mcg every 3 weeks on clinical outcomes in elderly patients with chemotherapy-induced anemia
Authors: Boccia R. V. , Silberstein P. , Tchekmedyian S. , Tomita D. , Lillie T. , Otterson G. 
Published: April 2020

18511 Background: Chemotherapy-induced anemia (CIA) is common in patients (pts) receiving chemotherapy, and reduces health-related quality of life. The primary objective of this exploratory analysis was to describe the effectiveness of darbepoetin alfa administered at 300 mcg every 3 weeks (Q3W) in elderly (≥ 65 years old) and younger pts (< 65 years old) with CIA. Methods: We analyzed data on 1493 pts, enrolled in a multicenter, open-label, 16-week study and who received ≥ 1 dose of darbepoetin alfa. Eligible pts were ≥ 18 years old, had a non-myeloid malignancy, and were anemic (hemoglobin [Hb] < 11 g/dL). Pts were analyzed stratified by age (≥ 65 and < 65 years old) and baseline (BL) Hb (< 10 or ≥ 10 g/dL). Hb-based endpoints were analyzed using 2 approaches: the last value carried forward (LVCF) method, where missing Hb values or values within 28 days of a red blood cell (RBC) transfusion were imputed, or an available data approach, where missing Hb values were not imputed. Pt-reported outcomes were assessed using the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) scale. Results: Pt demographics and disease characteristics varied between the age strata: in the ≥ 65-stratum (mean age = 73.7, n = 724), 52% of pts were women and the most common cancer was gastrointestinal (27%); in the < 65-stratum (mean age = 52.1, n = 769), 69% of pts were women and the most common cancer was breast (41%). Mean (SD) BL FACT-F scores for pts ≥ 65 and < 65 were 27.5 (12.8) vs 27.2 (12.1) for the < 10-g/dL strata and 29.0 (12.5) vs 27.5 (12.0) for the ≥ 10-g/dL strata. Study endpoints are shown in the table. The safety profile was as expected for each age group. Conclusions: Darbepoetin alfa 300 mcg Q3W appears to be as effective in achieving and maintaining Hb between 11 to 13 g/dL in elderly pts as in younger pts with CIA. Since chemotherapy is often administered Q3W, synchronizing darbepoetin alfa treatment with pts’ chemotherapy schedules may simplify the treatment of CIA in this pt population. [Table: see text] [Table: see text]
The economical impact of subcutaneous amifostine in the Kaiser Permanente health care system
Authors: Wang R. , Hastings J. , Tome M. A. 
Published: April 2020

18526 Background: We have previously shown that Subcutaneous amifostine (SQ A) was safe and effective in decreasing the early and late complications of patients (PTS) treated with radiotherapy (RT) or chemoradiotherapy (CRT) for head and neck cancer (HNC). We have further observed that the QOL is better for many PTS treated with SQ A compared with historical controls (HC). Although we believe we cannot put a price on QOL, we hypothesized that the use of SQ A could result in cost savings to our institution because of the observed decrease in treatment-related complications. Methods: From May 2001 to October 2004, we treated 52 consecutive HNC PTS with RT or CRT and daily SQ A. PTS treated in our SQ A protocol received 500 mg of SQ A at least 30 minutes prior to daily RT. In order to be included in our present study, SQ A PTS had to have completed at least 80% of the prescribed SQ A dose. These PTS were then matched with HC based on age, sex, stage, primary site, smoking status, co-morbidiites, and treatment (RT or CRT). Fourteen PTS treated with SQ A (SQ A Group) were successfully matched with HC (Control Group). The entire costs of these 28 PTS to our institution (including the cost of SQ A) was obtained using our Management Accounting and Analysis database. Cost data was obtained at 6 months and 12 months after the completion of treatment. The median follow-up is 18 months (range 12–31). The economical impact of SQ A on xerostomia and dental care were not addressed in this study. Results: Ten PTS received RT and 18 received CRT. At 6 months of follow-up, the total cost for the Control Group was $196,789 versus $211,711 for the SQ A Group (p= 0.59). At 12 months, the total cost in the Control Group and SQ A Group were $287,594 and $275,654 respectively (p = 0.51). Within the SQ A Group, the cost was lowest in PTS who had never smoked or had a remote (>5 years) smoking history (p < 0.01). Conclusions: This study primarily addresses one of SQ A’s cytoprotective properties, mucositis. Our analysis suggests that we were able to offset the cost of SQ A in most PTS because of fewer complications observed in this group. The cost benefit of SQ A appears to be greater at 12 months vs. 6 months after treatment, suggesting continued cytoprotection. QOL is better in the SQ A Group. We plan to continue to follow these PTS and accrue new ones in a prospective fashion. [Table: see text]
Spirituality, quality of life, and locus of control in a palliative care setting
Authors: Thaker P. H. , Sun C. , Bodurka D. C. , Palmer J. , Pei B. , Willey J. , Bruera E. , Ramondetta L. 
Published: April 2020

18529 Background: A patient’s spirituality/religious beliefs have a profound role on how one copes with disease & on quality of life (QOL). Perceptions of control play an important role in coping not only with stressful experiences, but also in health outcomes. Therefore, the primary objective was to determine whether patients’ spirituality/ religiosity correlates with quality of life and locus of control. Methods: As part of a pilot study, pts presenting for initial outpatient evaluation in the Department of Symptom Control & Palliative Care were enrolled and completed self-report measures: Functional Assessment of Chronic Illness Therapy-General (FACT-G), FACT-Spiritual Well-Being Scale (FACT-Sp), Duke University Religion Index (DUREL), Locus of Control (LOC), Herth Hope Scale (HHS), Predestination (PDQ), and Hospital Anxiety & Depression Scale (HADS). LOC contained 3 subscales: perceived occurrence of chance, dependence on powerful others, and internal control. Pearson correlation coefficients were calculated to explore the relationship between measures. The Mann-Whitney t-test was used to compare patient scores. Results: One hundred patients (48 men & 52 women) completed the surveys & 90% reported a Christian affiliation. QOL was positively correlated with FACT-Sp (p ≤ 0.001, r = .614) and the DUREL which measures both external/internal religiosity (p ≤ .01, r = .291). Interestingly, there was no gender difference in spirituality as measured by FACT-Sp; however, by the DUREL women engaged more frequently in private religious activity when compared with men (p < 0.001). Men had more perceived internal control with less emphasis on the occurrence of chance events or dependence on powerful others on LOC (p = 0.07), as well as a positive correlation with controlling of one’s own fate as measured by the PDQ (p = 0.1). Conclusions: As oncologists committed to providing comprehensive care, we need to be receptive to the spiritual needs of our patients since it augments their QOL and to empower them to have a sense of control. Future studies need to further define these complex relationships and to recognize possible gender differences. No significant financial relationships to disclose.
Effect of zoledronic acid (Zol) compared with placebo on overall disease and bone lesion progression in patients (pts) with bone metastases from certain solid tumors: Stratification by baseline characteristics
Authors: Ucar K. , Tchekmedyian N. S. , Shrina N. , Chen Y. , Xie T. , Hei Y. 
Published: April 2020

18541 Background: Zol has been shown to significantly reduce the risk of skeletal complications compared with placebo in pts with bone metastases from a wide range of solid tumors including a delay of bone lesion progression in pts with renal cancer. To assess whether Zol may reduce the risk of overall disease or bone lesion progression in pts with solid tumors other than breast, non-small cell lung, and prostate cancers, we conducted a retrospective analysis of pts enrolled in a large, randomized, controlled trial. Methods: Pts treated with Zol or placebo were retrospectively stratified by baseline characteristics, including Brief Pain Inventory (BPI) composite pain score, time from initial cancer diagnosis to development of bone metastases, and duration of cancer. The relative risk (RR) of disease progression during 25 months on study was analyzed using the Cox proportional hazards model (stratified log rank). Results: Median baseline BPI pain score was 2.75, median time with cancer was 15 months, and median time to development of bone metastases was 8.5 months. In pts with a baseline BPI score ≥ 2.75 (n = 236), Zol treatment significantly reduced the RR of disease progression by 34% (hazard ratio [HR] = 0.657; P = .014) and the RR of bone lesion progression by 32% (HR = 0.680; P = .028) compared with placebo. Additionally, in pts with cancer duration <15 months (n = 193), Zol treatment reduced the RR of disease progression by 45% (HR = 0.547; P = .002) and the RR of bone lesion progression by 40% (HR = 0.605; P = .016) compared with placebo. Similarly, among pts who developed bone metastases < 8.5 months from initial diagnosis of cancer (n = 193), Zol treatment significantly reduced the RR of disease progression by 39% and the RR of bone lesion progression by 48% compared with placebo (HR = 0.611; P = .009 and HR = 0.519; P = .004, respectively). Conclusions: This exploratory analysis suggests that Zol has potential antitumor effects that may reduce the risk of overall disease and bone lesion progression in pts who have higher pain scores and shorter time to development of bone metastases. Prospective studies are needed to confirm this result. [Table: see text]
Patient burden, resource utilization, and treatment outcomes of grade 3/4 chimeric or humanized monoclonal antibody-associated infusion reactions
Authors: Fortner B. V. , Zhu L. , Tsong W. , Burns C. , Schwartzberg L. S. 
Published: April 2020

18544 Background: Treatment with chimeric and humanized monoclonal antibodies (MAb) is associated with infusion reactions that may limit their usage. Despite growing use and importance of MAb regimens, there is a dearth of information describing MAb-associated infusion reactions (MAb-IRs) outside of clinical trials. The purpose of this study is to describe the patient burden, resource utilization, and treatment outcomes of grade 3 and 4 chimeric or humanized MAb-IRs in a community sample. Methods: We obtained a convenience sample of charts from 8 US outpatient oncology practices for patients who were treated between Feb 2004 to Dec 2005 with bevacizumab, cetuximab, or rituximab and experienced a grade 3 or 4 MAb-IR during their treatment. Results: Data were abstracted for 30 (n = 3 bevacizumab, 4 cetuximab, 23 rituximab) adult cancer patients who experienced a grade 3 (26, 87%) or grade 4 (4, 13%) MAb-IR. Of these, 63% (19) of patients were male; the mean age was 62 yrs. Twenty (67%) of these patients received premedication before experiencing their grade 3/4 MAb-IR. Twenty (67%) MAb-IRs occurred during the first cycle, 6 (20%) occurred at or beyond cycle 4. The most common MAb-IRs were rigors/chills (13, 43%), bronchospasms (5, 17%), and dyspnea (6, 20%). Grade 4 MAb-IRs were sinus bradycardia (2), severe pain (1), and apnea, seizure, ventricular arrhythmia (1). The consequences of MAb-IRs required increased utilization of resources as shown in the table . Additionally, 9 (30%) required antihistamines, 19 (63%) corticosteroids, 1 (3.3%) an H2 blocker, 3 (10%) an H3 blocker, 4 (13%) epinephrine, 14 (47%) intravenous fluids, 4 (13%) antiemetics, 10 (33%) narcotics, and 17 (57%) oxygen. Conclusions: Grade 3 and 4 chimeric or humanized MAb-IRs result in substantial patient symptom burden, numerous clinical interventions, and changes to subsequent MAb treatment. Further analyses will be required to estimate the direct medical costs and long term consequences of MAb-IRs, and the impact of less severe infusion reactions. [Table: see text] [Table: see text]
Presentation of non-small cell lung cancer (NSCLC) in octogenarians
Authors: Velcheti V. , Viswanathan A. , Sainani N. , Grove L. , Suresh R. , Baggstrom M. Q. , Govindan R. 
Published: April 2020

18555 Background: Lung cancer is the most common cause of cancer related death in the United States. Non-small cell lung cancer (NSCLC) accounts for over 80% of all new cases of lung cancer. Lung cancer is a disease of the elderly. There are only limited data available on NSCLC in octogenarians. Methods: From our institutional tumor registry, we identified all patients with NSCLC from 1995 to 2002 who were 80 years or older at the time of initial presentation. Data regarding overall stage, histology, date and extent of surgery, and co-morbidities were analyzed. Co-morbidity determination was based on the Adult Co-morbidity Evaluation (ACE-27) test, which ranges from 0 to 3 depending on severity of co-existing conditions. Results: At the time of initial presentation with NSCLC, 236 pts were 80 years or older. The distribution of stages were: stage I in 93 pts (39.5%), stage II in 15 pts (6.5%), stage III in 66 pts (28%) and stage IV in 62 pts (26%). Of the 236 patients the co-morbidity score was known for 223 pts. The distribution of the known scores was: 0, 39 pts (17.5%); 1, 79 pts (35%); 2, 68 pts (30.5%); and 3, 37 pts (17%). Only 35 patients in this cohort underwent surgery. Conclusions: 1. Despite a high proportion (46%) of early stage NSCLC, only a few elderly patients 80 years or older undergo surgical resection, likely because of co-morbid conditions. 2. Innovative non-surgical local modalities of therapy need to be studied in this population. No significant financial relationships to disclose.