bluuebunny/crossref_metadata_2025 huggingface dataset:
Risk assessment model for haematologic toxicity (HT) in patients with solid tumours (ST) during the first chemotherapy (CT) cycle
Authors: Casas A. M. , Rifà J. , González Larriba J. L. , Carrato A. , López Pousa A.
Published: April 2020

18516

Background: Bone marrow supression is the main type of CT dose-limiting toxicity. Specific studies on HT impact factors are key to help establish appropriate protocols in routine patient care. Objective: to identify significant factors among demographical and clinical variables for first-cycle CT-induced HT in patients (pts) with ST. Methods: Data was obtained from the Delfos Study, a multicentre prospective-cohort non-interventional study in Spain. To obtain a predictive model of logistic regression (LR), we followed the hierarchical principle as a way to ensure replication of results. This model was implemented for global HT, defined as compliance with at least one of the following criteria: anaemia grade (G) ≥2, thrombocytopenia G ≥2, neutropenia G ≥3, febrile neutropenia (FN, neutropenia G ≥3 and body Tª ≥38 Cº). A ROC curve was used to determine the best value for sensitivity and specificity of the model. Values were chosen so that both sensitivity and specificity resulted ≥70% and among the resulting possibilities, and due to study nature, the one providing higher specificity was taken. Results: A total of 1,194 pts with ST (breast, 37.9%; lung, 17.6%; colorectal, 15%; other, 29.5%) were included in 88 Spanish medical oncology health centres. Most pts were women (56%), mean age (SD) of 58(12) yrs. The LR model obtained predicted the global HT (pChi-sq < 0.0005), and includes the following factors: gender, tumour type, treatment intention, TNM-(T), TNM-(N), baseline haemoglobin (Hb), baseline lymphocyte count (LC), AST and the interaction gender-treatment intention. From those, five were statistically significant at the 0.05 level: baseline Hb (p < 0.0005, OR = 0.555), baseline LC (p = 0.026, OR = 0.8), type of treatment intention -neoadjuvant- (p = 0.013, OR = 0.265), TNM-(N) (p = 0.008, OR = 1.261), and interaction gender-treatment intention (p = 0.014). Inherent sensitivity and specificity of the equation were, respectively, 71.9% and 75.8%. Conclusions: A risk prediction model for global first-cycle CT-induced HT in pts with ST in Spain was implemented. Five prediction factors were identified. Baseline Hb and LC, as well as neoadjuvant intention, were inversely associated with HT. Toxicity increased with the number of affected lymph nodes.

No significant financial relationships to disclose.
The role of venography in the evaluation of malfunctioning central venous access ports (CVAPs)
Authors: Atallah E. , Salomon M. , Schiffer C. A. , El-Rayes B.
Published: April 2020

18535

Background: Malfunction of CVAPs is common in cancer patients receiving chemotherapy. We evaluated the role of venography as a means of assessing the cause of malfunction. Methods: We reviewed and analyzed data available from cancer patients who had a venogram for a malfunctioning CVAP between 1/03 to 3/05. All patients in our institution who have a malfunctioning CVAP receive a trial of intracatheter thrombolytics. If the malfunction persists, then a venogram is performed through the catheter. Results: Seventy-seven patients were studied. The indication for evaluation was inability to aspirate blood (54%), pain (18%), swelling at site of injection (10%), difficult aspiration and infusion (6.5%) and others (11.5%). Forty-four patients had chest ports (31% left and 26% right side), while 33 patients had the CVAP placed in the upper extremity (24% right and 18% left arm). Fibrin sheath or thrombus was the most common finding in 44% of patients, and 41% of venograms were normal. Only two patients had soft tissue extravasation of contrast. Sites of extravasation were in the chest at the catheter/port junction and in the supraclavicular area secondary to a catheter fracture. In patients with aspiration failure, 68% had either a fibrin sheath or thrombus at the catheter tip, 14% had CVAP malposition as the only abnormality, 14% were normal and one patient had extravasation. The CVAP tips were optimally positioned in 70% of patients (distal superior vena cava (SVC), venocava-atrial junction or atrium), while 30% were in a suboptimal position (proximal SVC, brachiocephalic, azygous, or internal jugular vein). Suboptimally positioned CVAPs had a higher incidence of an associated abnormality compared to optimally positioned CVAPs (58% vs. 4% P = 0.001). Only five CVAPs were removed, for extravasation (1), cellulitis (2), and malposition (2). Conclusion: Although the incidence of extravasation was low, venography evaluation could be considered in patients with malfunctioning catheters receiving a vesicant drug to help prevent a potentially significant complication. CVAPs with suboptimally positioned tips had a higher rate of associated abnormalities, emphasizing the importance of proper tip position.

No significant financial relationships to disclose.
Managing cutaneous side effects associated with erlotinib in head and neck cancer (HNC) and non-small cell lung cancer (NSCLC) patients (pts)
Authors: Oishi K. J. , Garey J. S. , Burke B. J. , Herbst R. S. , Kim E. S.
Published: April 2020

18538

Background: Erlotinib is an oral epidermal growth factor receptor (EGFR) targeted therapy. It is approved for therapy in NSCLC pts after failure of at least one prior chemotherapy regimen, and in combination with gemcitabine for pts with pancreatic cancer. It has also been studied in other tumors including HNC. Erlotinib has fewer side effects compared to standard chemotherapy. Cutaneous toxicities with erlotinib have been observed in approximately 70% of pts with most cases typically mild-to-moderate. The most common manifestations are an acneiform rash, pruritus, and dryness. As rash may be a marker of clinical benefit, continuing therapy through toxicities is important. Methods: We have described effective management of skin rash associated with erlotinib by using the proposed treatment algorithm in HNC pts enrolled in a phase II study in which they received erlotinib with chemotherapy. Pts were followed by physical exams and direct questionings about rash development and treatment response as they were treated based on the grade and characteristics (pruritic, macular, pustular, dryness, ulcerative) of rash. Results: Thus far, the HNC trial has enrolled 32 pts and 28 pts are evaluable for rash and treatment responses. 19 pts developed grade 1 rash, 8 pts grade 2, 1 pt grade 3, and none grade 4. Response to rash intervention (ie downgrading the rash) included 19/19 complete responses for grade 1, 6/8 partial responses for grade 2 (the non-responding patients were referred to dermatology and improved after several other treatments) and 1/1 partial response for grade 3 were noted. 4 pts experienced dose delay and/or dose modification. In addition, 33 NSCLC pts are also evaluable for toxicity. 25 pts developed grade 1 rash, 4 pts grade 2, 4 pts grade 3, and none grade 4. Response to rash intervention included 25/25 complete responses for grade 1, 4/4 complete/partial responses for grade 2 and 3. Four pts experienced dose delays and/or dose modifications. Conclusions: Successful management of rash associated with erlotinib can be achieved using the proposed treatment algorithm thus allowing pts to continue on treatment without delays or significant dosing changes.

[Table: see text]
Socio demographic correlates of pregnancy in cancer survivors using data from NHANES 1999–2002
Authors: Hammond C. , Moser R. , Jeffery D. , Harkins D.
Published: April 2020

18542

Background: Many cancer therapies can cause infertility and impaired fecundity. These are important long term outcomes of concern for survivors, which can affect their quality of life. Little is known about the socio-demographic correlates of impaired fecundity (inability to get pregnant or carry child to term) in cancer survivors. The purpose of this study is to assess socio demographic correlates of “ever pregnant” in the general American population of cancer survivors. Methods: Using data from adult (>20 years old) female cancer survivor participants of the 1999–2002 iterations of the population based cross sectional survey, National Health and Nutrition Examination Study (NHANES), we used logistic regression to examine the relationship between “ever” being pregnant and socio-demographic variables. Results: Complete data were available for 7558 females. Cancer survivors represented 8.2 % of that population. On univariate analysis, being married and having ≤ high school education were associated with a greater likelihood of “ever” pregnant compared to those unmarried and those with greater than high school education (p < .05). In cancer survivors of reproductive age (between the ages of 20 and 50) being Black or Hispanic was associated with a greater likelihood of “ever” pregnant compared to whites (p < .05). Interestingly, differences in race, income, health insurance status, and marital status were not significantly associated with “ever” pregnant on multivariate analysis of all female survivors older than 20. Conclusions: These results suggest there are differences in impaired fecundity between different groups of cancer survivors. However, questions in NHANES were not designed to explicitly examine fertility related outcomes. Additional studies that specifically examine measures of fertility in survivors are needed to understand the burden of this undesirable outcome in survivors.

No significant financial relationships to disclose.
Resource utilization by palliative surgery patients: results of the decision and outcomes in palliative surgery (DOPS) trial
Authors: Podnos Y. D. , Juarez G. , Pameijer C. , Uman G. , Ferrell B. R. , Wagman L. D.
Published: April 2020

18543

Background: The number of cancer patients is increasing. Though many cancer treatments are successful at improving survival, most tumors recur and become incurable. A spectrum of symptoms then manifest, many requiring operations. As this happens and the focus becomes symptom management, health system resources used often differ from other scenarios. This study seeks to define the type and breadth of perioperative resource utilization after palliative operations. Methods: Prospectively, patients with advanced malignancies getting palliative operations were followed 3 months postoperatively. In addition to demographics, all encounters with any medical personnel and healthcare resources used were captured by a thorough chart audit and entered into a database. Results: Of the 106 patients entering the study, 67 remained after 3 months. Patients suffered from a mean of 2 symptoms, pain being most common. Patients had a mean of 25.4 encounters (range 1–94). Most commonly, the encounters were with the departments of surgery, medical oncology, and radiation oncology. Half of the encounters were with physicians while 47% were with physician extenders and 3% with supportive staff. Eighty-seven percent of encounters were scheduled. Half occurred in the clinics, 21% in urgent care, and 29% by phone. Fifteen patients were readmitted, most often for symptom management (52%). The 54 patients receiving supportive care referrals had a mean of 2 different referrals per patient and were primarily social work, nutrition, and rehabilitation. Two pain management referrals were initiated. Conclusions: Patients undergoing palliative operations use no more resources than those having curative procedures. Because of disease persistence, the types of resources used differ. Defining these differences is important as health systems plan for the increase in aged with incurable cancers. Early referral to supportive care specialists, vital as symptoms worsen, remains underutilized. Without inclusion of these professions, patient quality of life and distress are not being helped as much as possible. Medical and surgical oncologists should aggressively assess and manage symptoms and consult colleagues to comprehensive symptom management.

No significant financial relationships to disclose.
Effectiveness of darbepoetin alfa 300 mcg every 3 weeks in patients with chemotherapy-induced anemia
Authors: Hernandez E. , Dibenedetto J. , Kotasek D. , Ganly P. , Silberstein P. , Tomita D. , Lillie T. , Boccia R. V.
Published: April 2020

18545

Background: Patients (pts) receiving chemotherapy (CTX) often experience anemia resulting in decreased quality of life. We performed a post hoc combined analysis of 2 clinical studies of darbepoetin alfa (DA) 300 mcg every 3 weeks (Q3W), allowing for comparison of larger treatment groups. Methods: Eligibility criteria of the 2 studies were similar: pts ≥ 18 yrs old with nonmyeloid malignancy, anemia (hemoglobin [Hb] < 11 g/dL), and receiving CTX. Study 1 (20030232) was a phase 3, randomized, placebo-controlled, double-blind, study involving 16 wks of treatment with end of treatment phase (EOTP) visit at wk 19. Study 2 (20030206) was a single-arm, open-label, phase 4 study involving 13-wks of treatment with EOTP visit at wk 16. Efficacy endpoints included: percentage of pts achieving target Hb (≥ 11 g/dL without RBC transfusion [TFN] within 28 days), pts requiring TFNs between wk 1 and EOTP, pts requiring TFNs between wk 5 and EOTP, pts with a ≥ 3-point change in FACT-F score, and pts achieving ≥ 1-g/dL increase in Hb after 4 wks of therapy. Results: In both studies, 61% of pts were women and 79% were white. The mean (SD) age was 64.5 years (12.1) for Study 1 and 62.6 years (13.3) for Study 2. The most common tumor type was breast (26% in Study 1; 29% in Study 2). Mean (SD) baseline (BL) Hb values were 10.1 (0.9) and 10.1 (0.7) g/dL for Study 1 and Study 2 respectively, and mean (SD) baseline FACT-F scores were 27.3 (12.8) and 27.9 (12.3) respectively. See Table for endpoints. Combined analysis showed that increasing Hb by ≥ 1 g/dL after 4 wks of therapy was a poor predictor of clinical outcomes (avoidance of TFN, sensitivity = 56.2%; achievement of Hb target, sensitivity = 57.8%). Safety outcomes were similar and expected for this population. DA appeared to be well-tolerated. No pts exhibited neutralizing antibodies to DA. Conclusions: This combined analysis provides further evidence of the effectiveness of DA Q3W dosing in this pt population. This dosing interval may facilitate the administration of DA in synchronization with Q3W CTX regimens.

[Table: see text]

[Table: see text]
A Phase III randomized study comparing the effects of oxandrolone (Ox) and megestrol acetate (Meg) on weight (wt), lean body mass (LBM) and quality of life (QOL) in solid tumor patients (pts) receiving chemotherapy (chemo)
Authors: Lesser G. J. , Case D. , Sharp S. , Choksi J. , Miller A. , Atkins J. N. , Shaw E.
Published: April 2020

18546

Background: Involuntary wt loss is a significant problem in pts with cancer and may lead to a decline in QOL, limit treatment options and reduce survival. Wt loss in these pts disproportionately represents a loss of muscle mass. Meg, a synthetic progesterone derivative, promotes wt gain mostly through an increase in adipose tissue rather than in LBM. Ox is a potent oral anabolic steroid with minimal androgenic activity which promotes wt gain primarily through increased LBM. Methods: Prospective, randomized phase III trial comparing the effects of Ox and Meg on wt, body composition and QOL in pts with solid tumors and wt loss receiving chemo. Body composition was serially assessed by Bioelectrical Impedance Analysis. QOL was evaluated with the FACT-G and the Anorexia/Cachexia subscale (FAACT). Eligibility: age ≥18; PS: 0–2; life expectancy ≥6 mos; near normal organ function; and progressive wt loss on chemo. Ineligibility: full dose anticoagulation; hormonally responsive or hematologic malignancies; and ongoing or planned treatment with corticosteroids (antiemetic use allowed), estrogens or progestins. The primary endpoint was LBM after 12 wks of drug therapy. Study design allowed 90% power for detecting a 1.5 kg difference between treatment groups using a 5% two-sided level of significance. A max of 155 pts were to be accrued. An interim analysis was planned after 62 pts had completed 12 wks on study. Results: As of 12/05, 74 pts have been accrued (72 eligible): median age 64 yrs, 42% females and 62% stage 4 disease. 25 pts (arm 1:8, arm 2:17) have completed 12 wks of therapy and 20 remain on study. 76 Grade 3/4 toxicities (arm 1:23, arm 2:53) and 1 grade 5 arrhythmia (arm 2) have been recorded. Accrual is ongoing and differing trends in wt gain and body composition between arms are emerging. Conclusions: This is the first and only trial comparing these two commonly utilized therapies for cancer-related anorexia/cachexia. Differences in efficacy, particularly effects on LBM, QOL and toxicity which emerge from this trial are likely to influence symptom management standards of care in the oncology community. Supported by Savient Pharmaceuticals and NCI grant 1 U10 CA81851.

No significant financial relationships to disclose.
Information needs of hematologic cancer survivors
Authors: Soloe C. , Bandel K. , Jarblum M. , Willacy E. , Squire S. , Driscoll D. , Kepner J. , Gansler T.
Published: April 2020

18547

Background: Little is known about how information needs of cancer survivors/patients (S/P), caregivers (CG), and non-caregiver relatives (NCG) evolve during the cancer experience. Methods: We conducted structured interviews of 21 leukemia, lymphoma, and multiple myeloma S/P, 13 CG, and 19 NCG, and asked them to prioritize information needs during the 4 cancer experience phases from a list of 13 topics. This research was supported by the Division of Cancer Prevention and Control of the Centers for Disease Control and Prevention. Results: Information preferences varied (Friedman’s test, P < 0.0001) by phase of the cancer experience. Topics ranked highest (median rank in parentheses) before treatment, during treatment, after treatment, and at relapse, respectively, were diagnostic tests (2), cancer/ cancer types (2.5), treatment options (3.4), hospitals/cancer centers (3.5), and insurance/financial issues (4); coping with treatment side effects (3), insurance/financial issues (4.5), treatment options (5), hospitals/cancer centers (5), and long term side effects (5); long term side effects (2), tests to detect recurrence (2), risk factors (3), diagnostic tests (4), and support groups (5); and tests to detect recurrence (3), insurance/financial issues (3), cancer/cancer types (4), diagnostic tests (5), and treatment options (5). Across the cancer experience, the highest priority topics for S/P, CG, and NCG, were cancer/ cancer types (4), treatment options (4), long term side effects (5), and risk factors (5); diagnostic tests (4.5), coping with side effects of treatment (5), and treatment options (5); and treatment options (3), diagnostic tests (4), and 5 other topics tied for 3rd place (6). In-depth, semi-structured interviews conducted with the surveys provided additional detail regarding responses collected in the prioritization exercise. Conclusions: Clinicians can help S/P, CG, and NCG by offering role- and cancer continuum-targeted information.

No significant financial relationships to disclose.
Prospective evaluation of epoetin-alfa (EA) vs epoetin-beta (EB) vs darbepoetin (DE) in anemic cancer patients (pts) receiving chemotherapy (CT): Early results of an independent observational survey by the Italian ReVERTO network
Authors: Pollera C. F. , Nelli F. , Gamucci T. , Sperduti I. , Giampaolo A. M. , Moscetti L. , Tonini G. , Mentuccia L. , Nardi M. , Cortesi E.
Published: April 2020

18548

Background: Direct comparison of EA vs EB vs DE has never been performed. In order to define the efficacy, impact on quality of life (QL) and pt’s preference, a prospective observational comparison of erythropoietic agents has been carried out. Methods: Anemic pts (hgb <11 gr/dL) scheduled to receive at least 3 cycles of CT were stratified according to 5 factors (platinum-based CT vs non-platinum; hgb ≤9,5 vs >9,5; PS ≤0–1 vs >1; previous CT vs upfront CT; and previous antianemic therapy vs not) and were autonomously assigned by 15 investigators to EA (3 times a week) or EB (3 times a week and only in pts receiving platinum-based CT) or DE (once a week) therapy. Efficacy by hgb level changes and transfusion needing was evaluated after each cycle of CT, QL by Fact-An questionnaire after 1 and 3 cycles of CT, and pt’s preference for standard vs weekly schedule at least once thereafter. Results: From 09/04 to 12/05 177 pts were recruited: 41%, 39% and 20% were assigned to DE, EA and EB, respectively. Severe anemia at baseline (≤9,5) was reported in 29% of pts, whereas 47% received platinum-based CT. Stratifying categories were well balanced among the treatment groups. Baseline mean hgb values were 9.7, 9.9, and 10 for DE, EA and EB, respectively. As of the general population, DE produced higher subsequent mean hgb increase in respect to EA and EB (Mean increase [gr/dL] for DE: 0.84, 1.58, 2.03; EA: 0.34, 0.84, 1.68; EB: 0.76, 1.54, 1.17). No difference was observed neither among pts receiving platinum-based CT, (mean increase: DE: 0.34, 1.76, 2.8; EA: 0.7, 1.27, 2.14; EB: 0.76, 1.54, 1.71) nor among pts with severe anemia at baseline (DE: 0.98, 2, 2.6; EA: 1.24, 1.94, 3.13; EB: 1.25, 2.25, 2.75). Transfusion needing ranged from 7% for DE to 3% for EB without any significant difference. To date 67% of pts completed at least one subsequent QL valuation, whereas 62% gave their preference for treatment schedule. Conclusions: Early results of our prospective analysis show that antianemic therapy with D is at least as effective as standard schedule of EA or EB. Efficacy of DE seems confirmed in pts with bad prognostic categories for anemia. Major data on QL and pt’s preference will be presented.

No significant financial relationships to disclose.
Hypogammaglobulinemia increases the risk of chemotherapy associated febrile neutropenia in patients with chronic lymphocytic leukemia
Authors: Huang C. , Taylor S. , Majhail N. S. , Pabla M. , Malani A. , Singh J.
Published: April 2020

18549

Background: Infections are the major cause of morbidity and mortality in patients with chronic lymphocytic leukemia (CLL). Hypogammaglobulinemia, in general, increases the susceptibility to infections in patients with CLL. We conducted a case-control study to investigate whether hypogammaglobulinemia (Immunoglobulin-G (IgG) level <600 mg/dL) increases the risk of febrile neutropenic episodes in CLL patients with chemotherapy associated neutropenia (absolute neutrophil count (ANC) <0.5 × 109/L). Methods: The source cohort consisted of all consecutive patients with CLL seen at our institution between Jan 2002 to June 2005.We identified 8 cases of chemotherapy associated febrile neutropenia; controls consisted of 18 patients, with neutropenia but no fever (n = 4) or no neutropenia (n = 14). Results: The two groups were comparable except for a higher proportion of patients with Rai stage-4 disease in the febrile neutropenia cohort (100% vs. 17%, p < 0.001). Eight of the 8 patients in febrile neutropenia group were found to be hypogammaglobulinemic as compared to 2 of 18 controls (100% vs 11%, P value < 0.001). The median IgG level was 400 mg/dL (range, 300–488 mg/dL) in the febrile neutropenia group compared to 820 mg/dL (range, 121–1700 mg/dL) in the control group (p = 0.003).The relative risk of developing chemotherapy associate febrile neutropenia in the presence of underlying hypogammaglobulinemia was 4.5 (95% confidence intervals, 1.9–10.7). Conclusions: Patients with CLL who are hypogammaglobulinemic are candidates for prophylactic administration of intravenous immune-globulin prior to initiation of myelosuppressive chemotherapy.

[Table: see text]

No significant financial relationships to disclose.
Providing end-of-life care to patients seeking hope for cure: Improving Mayo Clinic palliative care utilization
Authors: Swetz K. , Moynihan T. , Ruegg S. , Tan A. , Atherton P. J. , Sloan J.
Published: April 2020

18552

Background: We reviewed Palliative Care Consultation Service (PCCS) referrals to attempt to promote earlier referrals, and to improve overall patient care. Methods: Eligibility for PCCS referral is life expectancy of one year or less. Data was collected prospectively on the first 461 referrals (452 individual patients) over the initial 30-month period (January 1, 2003 to July 1, 2005). Additional factors were retrospectively abstracted from documentation. Kaplan-Meier survival analysis was then performed. Results: 452 patients were seen (mean age 71.9 years), and 387 (86%) have died. Median length of inpatient stay was 8 days, with PCCS consultation requested 3 days prior to discharge. 107 patients (24%) died prior to hospital discharge. 345 patients survived to discharge, 236 (68%) died within 3 months, and 262 (76%) died within 6 months. Median survival from consultation to death was 12 days and after hospital discharge was 6 days. Secondary analysis determined that patients with malignancy had longer median survival from discharge to death than those with other diagnoses (11 days versus 3 days, p = 0.025). Median survival was longer with referrals from general surgery and surgical specialties (37 days and 8 days, respectively), compared to hematology-oncology and critical care (2 days and 0 days, respectively). Conclusions: The primary goal of the PCCS is to provide symptom control and maximize quality of life at the end of life. These data suggest palliative care services are unnecessarily delayed until too late. Education is necessary to facilitate earlier PCCS intervention. Survival analysis suggests providers are more likely to consider PCCS involvement in patients with malignancy compared with other diseases. Critical care and hematology-oncology, showed the lowest median survivals. Education efforts must be focused on these areas. Programs are underway to identify eligible patients earlier in their disease process, and educate providers about key end-of-life services provided to patients and families.

No significant financial relationships to disclose.
Two studies from the JP Wilmot Cancer Center on the relationship of treatment, expectations, and race with post-treatment skin reactions reported by cancer patients
Authors: Ryan J. L. , Figueroa-Moseley C. , Bole C. , Hickok J. T. , Colman L. K. , Khanna R. C. , Lennon M. , Pentland A. P. , Morrow G. R.
Published: April 2020

18560

Background: Cancer patients may experience skin problems while undergoing treatment. Frequency of skin reactions may be influenced skin pigmentation and/or psychological factors. Methods: A Symptom Inventory (SI) completed by 411 cancer patients nationwide before and after treatment was analyzed to determine if treatment type, race (Black versus White), and pre-treatment expectations influenced post-treatment skin reactions. Subsequent analysis of a SI completed weekly for five weeks by 167 local patients receiving radiotherapy examined severity of reported skin reactions. Results: One-way between-group ANOVA, with Bonferroni correction, showed significantly more patients receiving radiotherapy had stronger expectations of skin problems (62%) compared to patients receiving chemotherapy (40%, p = 0.001) or chemotherapy plus radiotherapy (45%, p = 0.003). Overall, expectations did not correlate with patient reported skin problems post-treatment (Spearman’s rho = 0.02, p = 0.70). Likewise, a Kruskal Wallis test showed no significant difference in severity of skin reactions reported by patients receiving radiotherapy (n = 138) and/or chemotherapy (n = 273, p = 0.56). Severe skin problems were reported more frequently by 10/18 (56%) Blacks than 90/393 (23%) Whites (p = 0.001), although no significant difference was found between Blacks and Whites in their pre-treatment expectations of skin problems (p = 0.32). Further, pre-treatment expectations of skin problems did not influence post-treatment reporting of skin problems in Blacks (Spearman’s rho = −0.02, p = 0.93) or Whites (Spearman’s rho = 0.02, p = 0.65). Similarly, the local study showed that significantly more Blacks (38%) reported severe skin reactions at the treatment site than Whites (6%). Total radiation exposure was significantly related to the severity of skin problems reported by Blacks (Spearman’s rho = 0.90, p = 0.04), but not Whites (Spearman’s rho = −0.06 p = 0.52). Conclusions: Overall, Blacks reported more severe post-treatment skin problems than Whites. How this self-reported skin damage correlates with clinical findings remains to be determined. Supported by NCI PHS grants 1R25CA102618 and U10CA37420.

No significant financial relationships to disclose.
Evaluating if darbepoetin alfa efficacy and safety in patients with chemotherapy-induced anemia is affected by the disease stage of the patient
Authors: Schwartzberg L. S. , Glaspy J. , Tomita D. , Lillie T.
Published: April 2020

18568

Background: Cancer patients (pts) often develop chemotherapy-induced anemia (CIA), resulting in increased transfusion incidence and fatigue. Darbepoetin alfa (DA) is an erythropoiesis-stimulating agent that can reduce the incidence of transfusions, increase hemoglobin (Hb) levels to a range of 11 to 13 g/dL (as recommended by evidence-based guidelines), and decrease fatigue in pts with CIA. The 74-hour half-life of DA allows it to be effectively administered weekly (QW), every 2 weeks (Q2W), or every 3 weeks (Q3W). DA treatment can also be synchronized with chemotherapy (Glaspy et al., 2005). Here we examined if the efficacy and safety of DA for treating CIA is affected by the disease stage of the pt. Methods: Eight clinical trials (including single-arm, active-controlled, and placebo-controlled studies) were analyzed that described the administration of DA QW (2 studies), Q2W (3 studies), or Q3W (3 studies) to pts with CIA. Tumor-Nodes-Metastases (TNM) classification was used to define disease stage of I, II, III, or IV. A clinically meaningful endpoint evaluated was the proportion of pts achieving a target Hb of ≥ 11 g/dL. Other endpoints included incidence of transfusions, change in FACT-F score at end of study from baseline, and incidence of adverse events. Results: A high percentage of pts in all disease stages achieved a target Hb of ≥ 11 g/dL in response to DA treatment (see Table ). Early stage pts were seen to benefit at least as much as later stage pts. A similar trend was seen for the other efficacy and safety endpoints (data will be presented). Conclusions: The present analysis suggests that DA administered QW, Q2W, or Q3W can effectively correct anemia when administered to pts in either early or late disease stages. The potential to synchronize DA treatment and chemotherapy regardless of disease stage may increase pt convenience by reducing the number of clinic visits.

[Table: see text]

[Table: see text]
Colorectal cancer patients’ informational needs about sexuality related issues
Authors: Karagiannis S. , Heras P. , Hatzopoulos A. , Georgopoulou A. , Kritikos K.
Published: April 2020

18569

The aim of this study was to identify and describe the importance of information for patients about sexuality related issues during hospitalization. 112 patients (87 with colorectal cancer) completed the structural questionnaire. Most colorectal cancer patients (71%) reported that their disease or its treatment had affected their sexuality. Men reported slightly more adverse effects of disease or treatment on their sexuality than did women. Effects on sexuality were reported by 77% of men and 64% of women (p=0,041) having colorectal cancer. Among younger colorectal cancer patients reported more often effects of disease than did older colorectal cancer respondents. Over than half, 75% (n=84) of respondents under 40 and 67% (n= 75) of respondents over 50 years old complained effect on sexuality. Most colorectal cancer patients (72%) stated that it is necessary to discuss about the effect of the disease and of its treatment on sexuality during hospitalization. Most colorectal cancer patients (87%) wanted the health care personnel to take the initiative for the discussion of sexuality related issues. Only 12% expressed the wish that the initiative should come from the patient. It is important that health care professionals provide colorectal cancer patients with an opportunity to discuss sexuality related issues. The caring organization should develop, introduce and evaluate action models to facilitate especially opening discussion for these sensitive issues.

No significant financial relationships to disclose.
Erectile dysfunction (ED) in successfully treated lymphoma patients
Authors: Aksoy S. , Dinçer M. , Kilickap S. , Harputluoglu H. , Dizdar Ö. , Akdogan B. , Özen H. , Erman M. , Celik I.
Published: April 2020

18570

Background: Information on male potency in lymphoma survivors is insufficient. In this study, we assessed male sexual function in successfully treated lymphoma patients (pts). Methods: Fifty-nine pts treated for Hodgkin’s (HL) or non-Hodgkin’s lymphoma (NHL) with chemotherapy ± radiotherapy were recruited. Pts older than 55 years and those with a history of pelvic/inguinal radiotherapy or surgery were excluded. Study pts had to be disease-free and off-treatment for at least 6 months at the time of evaluation. Pts completed a survey questionnaire that consisted of demographic characteristics, risk factors for ED and the International Index of Erectile Function (IIEF) to assess their current level of sexual function. Serum luteinizing hormone (LH), follicle-stimulating hormone (FSH), and testosterone levels were also determined. Results: The mean age of the 59 pts was 40.2 ± 11.0 (range, 18–55 years). Thirty-eight (64.4%) had HL and 21 (35.6%) NHL. The mean interval between the end of active treatment and study evaluation was 7.7 years (range: 10 mths to 20 yrs). According to the IIEF score, 61.0% had some degree of ED (IIEF score <26): 33.9% had mild ED (IIEF score 17–25), 15.2% moderate ED (IIEF score 11–16) and 11.9% severe ED (IIEF score 6–10). Mean total scores of sexual desire, sexual satisfaction, orgasm and overall satisfaction domains of IIEF were significantly lower in pts with ED than those with normal ED (26.0 ± 1.8 and 39.0 ± 0.8, respectively; p < 0.001). Nine (18.4%) of 49 pts had an elevated FSH, 7 (14.2%) had elevated LH, and 3 (6.1%) had decreased testosterone levels. These hormonal disturbances did not affect the presence of ED and its severity. Six (10.2%) pts had hypertension and 3 (5.1%) had diabetes mellitus. Forty (57.6%) pts were ever-smokers, 29 (49.2%) were overweight or obese (BMI >25), but none had coronary artery disease. These risk factors did not statistically affect the presence of ED or its severity in our pts. Conclusions: These findings suggest that diagnosis and treatment of lymphoma may be a risk factor per se for the development of ED. Therefore, the underlying pathology, either organic or psychological, remains to be defined. Clinicians should be aware of this problem in lymphoma survivors and offer these pts adequate treatment options.

No significant financial relationships to disclose.
Pain on movement and pain at rest decrease after zoledronic acid infusion in patients with bone metastases due to breast or prostate cancer
Authors: Ripamonti C. , Fagnoni E. , Campa T. , Giardina V. , Brunelli C. , De Conno F.
Published: April 2020

18582

Background: There is no study on bisphosphonates assessing separately pain at rest and incident pain. Aim of the study was to evaluate the reduction in pain at rest and incident pain after treatment (up to 6 infusions) with 4 mg zoledronic acid (ZA) I.V. every 28 days in patients with bone metastases. Methods: All consecutive patients with bone metastases from breast or prostate cancer starting ZA treatment (August 2002 - May 2004) at NCI of Milan were enrolled in this observational prospective longitudinal study. Pain at rest and incident pain referred to the prior week were measured by a six level verbal scale (0–5 score) at baseline and on each infusion as well as at follow-up visit (2 weeks after every infusion). The two main endpoints (estimated reduction in pain at rest and incident pain) were defined as the difference between the baseline score and the average of all the post-treatment scores for each patient, and are presented with their respective 95% Confidence Interval. Positive values indicate reduction. Because of the potential confounding effect of analgesics intake, patients without any increase in analgesic consumption while on study were also analyzed as a separate subgroup. Results: 48 patients (mean age 66 years, 33 female), with breast (34) or prostate cancer (14) were enrolled. 30 patients underwent 4 to 6 infusions while 7 dropped out before the first follow-up visit. The analysis was performed on the 41 patients with at least one follow-up evaluation (average number of evaluations = 8.1 range = 1–13). The estimated reduction in pain at rest and incident pain was 0.55 (0.19–0.91) and 0.73 (0.31–1.14) respectively. In the 13 patients who did not report increased analgesic consumption, the estimated reduction was still substantial: 0.61 (0.25–0.97) 1.12 (0.41–1.83) respectively. Conclusions: This is the first study showing that in patients with painful multiple bone metastases, ZA reduces both pain at rest and incident pain in patients with painful bone metastases.

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Synthetic TGF-ß antagonist promotes healing of injured epithelial surfaces
Authors: Johnson F. E. , Wang Y. , Ling T. , Chuang S. , Huang S. S. , Huang J. S.
Published: April 2020

18586

Background: Cancer treatment often results in injury to epithelial surfaces. These injuries are often symptomatic and can delay or prevent further treatment. Since transforming growth factor-1 (TGF-ß) mediates inflammation, fibrosis, and epithelial mitogenesis, agents modulating TGF-ß may be useful in treating such wounds. We synthesized a dodecapeptide containing the active site of human TGF-ß. It is a TGF-ß antagonist in vitro. We investigated whether application to cutaneous wounds might promote epithelialization and decrease scarring by directly blocking local TGF-ß activity. Methods: We applied synthetic TGF-ß antagonist (1.5 mM in gel carrier, topically), with gel-only and no-treatment controls, to 6 standardized thermal burn wounds in each of 4 pigs. Wounds were measured and photographed for 41 d., then excised. Wound dimensions and percent epithelialization were calculated from photographs. Scar volume was estimated as surface area (photographs) x depth (microscopy). Statistical analysis employed student’s t-test. Additional experiments utilized skin excision wounds in rabbits and pigs. Recombinant TGF-ß and platelet-derived growth factor (PDGF) were applied to identical wounds in other pigs and rabbits in parallel experiments as additional controls. Results: In TGF-ß antagonist-treated pig burn wounds, epithelialization was complete on d. 26 ± 2 (mean ± SD); control wounds were 70 ± 10% re-epithelialized by d. 26 (p < 0.001). Contraction rate, collagen and fibronectin content, and scar volume were all significantly less in treated wounds. TGF- ß and PDGF each retarded wound epithelialization. Conclusions: Treatment of standard skin wounds with a synthetic TGF-ß antagonist promotes epithelialization in a whole-animal model. This agent may be useful in human epithelial injuries due to chemotherapy or radiation.

No significant financial relationships to disclose.
Topiramate (Top) in the treatment of neuropathic pain (Np) in cancer patients (pts)
Authors: Bendaly E. A. , Jordan C. A. , Staehler S. A. , Rushing D. A.
Published: April 2020

18589

Background: Top relieves Np by four direct and one indirect method, compared to most other anti-epileptics that relieve Np by one. Methods: Seventeen cancer pts treated with Top for Np were found on retrospective chart review of Palliative Care Clinics at Indiana University Hospital and Roudebush VA. Pain was assessed by physician serial follow-up. Results: Mean age was 53.8 years; 53.8 % were males. Four pts were not included in statistical analysis for efficacy, one for incomplete follow’up, and 3 had their pain decrease in frequency by 25 to 75 % but not in severity. Of the remaining 13 pts, 69% had previous gabapentin use, 85% had previous tricyclic use, and all were on opioids. Most common Np sites were extremity (53.8%), trunk (30.8%), and face (15.4%). Most common Np characteristics included burning (61.5%), pins and needles (30.8%), and sharp (15.4%). Np was related directly to active tumor in 38.5%, previous surgery in 43.8%, and chemotherapy in 11.7%. Mean duration of Top therapy was 6 months; mean total daily dose was 173 mg. 61.5% were current users. Pts had Np for 27.3 months on average prior to starting Top. All 13 pts were using Top as second-line therapy; 69.2% had tried another anticonvulsant, and 92.3% used antidepressants. 53.8% experienced Top-related adverse effects (AEs). These included change of taste (15.4%), dose-dependent, transient, memory loss (23.1%), depression (15.4%), nausea (7.7%), chest pain (7.7%), and fatigue (7.7%). 29.4% discontinued Top due to AEs. Using two-tailed paired testing, mean decrease in worst pain was from 8.7 to 5.6 (p < .001), in average pain from 6.4 to 2.4 (p = .0004), and in least pain from 4.4 to 1.5 (p < .03). Conclusions: Top was associated with improvements in Np in a high proportion of pts with refractory Np. Pts tolerated Top therapy well as indicated by the average duration of therapy. Further studies of Top in cancer-related Np are indicated, particularly as first-line therapy.

No significant financial relationships to disclose.
Information to cancer patients: A questionnaire survey in three different geographical areas in Italy
Authors: Piga A. , Zanon E. , Bracci R. , Barbieri V. , Puglisi F. , Aprile G. , Gesuita R. , Carle F. , Venuta S. , Cellerino R.
Published: April 2020

18593

Background: The way information to cancer patients is delivered widely varies among different countries. In Italy, as in other Mediterranean countries, the traditional approach has been of partial disclosure of the truth. Methods: We asked 200 cancer patients in 3 different Centres form Northern, Central and Southern Italy (Udine, Ancona, Catanzaro) to answer a 26-item questionnaire on communication aspects, in order to verify if information received was correct and adequate, and dependent on geographical variations. Statistics included univariate and multiple correspondence analysis, which studies relations between all variables, and provides a graphical representation in which associated variables tend to aggregate spatially. Results: Questionnaires were completed by 587 patients, of median age 60 yrs, 57% females, mainly with gastrointestinal (32%) or breast cancer (30%); 63% had active disease at time of interview. 77% of patients interviewed had a correct knowledge of their diagnosis, with no difference between different Centres. More informed were patients of female gender (p = 0.004), young age, better education, and with breast cancer (all p < 0.001). Patients appropriately informed on prognosis were 41%. More informed were those with good prognosis, breast cancer, and not receiving treatment; less informed patients from Southern Italy and those with advanced disease. Degree of information was not directly related to desire for information, which was more pronounced for patients from Central and Southern Italy. Satisfaction for information received was higher for patients from Northern Italy, not on treatment, with limited disease. Multiple correspondence analysis identified clusters of patients such as those of old age, lower education, male sex, advanced disease, preferred paternalistic approach, characterized by poor level of information; and young age, female sex, high scholarity, breast cancer, patient-centered relationship with their doctor, characterized by high level of information. Conclusions: The cultural attitude towards communication aspects in oncology is changing in Italy. There are still significant differences at different latitudes, but there is a general trend to improving awareness about cancer.

No significant financial relationships to disclose.
Necessity for including quality of life diagnostics and therapy in routine oncological care: Evaluation by methods of clinical guideline implementation
Authors: Klinkhammer-Schalke M. , Koller M. , Ehret C. , Steinger B. , Ernst B. , Hofstädter F. , Lorenz W.
Published: April 2020

18594

Background: Application of quality of life assessment has become an important topic in oncology. Current approaches, however, have focused on technical issues within single center settings overlooking the requirements of routine care. We report on implementing of structural elements of a quality of life diagnostics and therapy system (QoL system). It was designed as integral part of the health care program for breast cancer patients in a regional tumor center. Methods: The QoL system was implemented by a systematic approach (Med. Care, 39, Suppl.2, 2(2001). Its elements comprised (a) coordinating practitioners (CPs) who functioned as gate keepers for QoL related therapies, (b) experts in the QoL unit who provided QoL reports and specific therapeutic recommendations based on patients’ responses to the EORTC questionnaire, (c) professional health care providers in psychotherapy, pain therapy, social support, physiotherapy/lymph drainage, and fitness (nutrition, sports), (d) clinicians (gynecologists) for patient recruitment and (e) opinion leaders for educational influence on the CPs to keep the QoL system in daily practice. Success of implementation (as indicated by CPs’ QoL-related changes in knowledge, attitude and behavior) was evaluated in a prospective study with breast cancer patients. Results: The QoL system was applicable in all of 170 patients recruited between Dec. 2002-June 2004 (age 34–86yrs, UICC 0–4, breast conserving surgery 67%). From 75 CPs (mostly gynecologists) in the area only 39 fulfilled criteria for the QoL system, 1 refused to participate. 38 CPs showed knowledge about QoL following educational outreach visits. Concerning attitudes and behavior, 64% of CPs found the experts’ reports comprehensible, 56% followed their recommendations, 20% made additional actions. Follow-up 4 months after first QoL measurement revealed improvements in pain, body image and social life (p < .05). Conclusion: The study—in combining doctor’s approach and patient’s demands—showed success using methods of guideline implementation by improving QoL deficits within a routine oncological care. Effectiveness will be analyzed in an ongoing randomized trial.

No significant financial relationships to disclose.