bluuebunny/crossref_metadata_2025 huggingface dataset:
Clinical findings and interventions in cancer patients referred to a cachexia clinic (CC)
Authors: Nooruddin Z. , Hui D. , Dalal S. , Bruera E. , Del Fabbro E.
Published: August 2020

e20551

Background: The cancer-related anorexia/cachexia syndrome is primarily caused by an aberrant inflammatory response and neurohormonal dysfunction. Secondary causes that contribute to diminished nutrient intake include early satiety, constipation, nausea, vomiting, mood alterations, dysgeusia, and dysphagia. We determined the frequency and management of both secondary cachexia causes and metabolic/endocrine alterations in a new CC at a Comprehensive Cancer Center. Methods: We conducted a retrospective chart review of 159 consecutive patients who underwent structured assessments at the CC. Demographics, weight loss, secondary causes and specific treatments were analyzed. Results: The patients had the following characteristics: median age 59, females 39%, median body mass index 20.3, median weight loss over the preceding 3 months 7%, and hypoalbuminemia 76%. At consultation, 102 (64%) were on chemotherapy/radiation and 13 (8%) were on enteral or parenteral nutrition. Appetite stimulants prior to consult included megestrol (n=36, 22%), corticosteroids (n=21, 13%) and dronabinol (n=10, 6%). The median number of secondary causes was 3 (Q1-Q3 2–4), with a median of 2 (Q1-Q3 1–3) interventions per patient. 22 (14%), 105 (66%) and 32 (20%) patients had 0–1, 2–4 and 5–8 secondary cachexia causes, respectively. The table lists the significant findings and corresponding interventions. 52 (33%) were enrolled onto clinical trials for primary cachexia. Conclusions: A total of 411 treatable secondary cachexia causes and 89 endocrine/metabolic alterations were identified in our cohort. Low cost effective interventions were available for most of the common findings.

[Table: see text]

No significant financial relationships to disclose.
Media coverage of lung cancer
Authors: Blum D. , Boerckel W.
Published: August 2020

e20565

Background: In 2000, a survey was conducted to assess media coverage for the four major cancers (breast, prostate, lung, colorectal). A 2004 follow-up survey revealed there were more lung cancer articles conveying positive messages and greater celebrity involvement and coverage of new treatments. A 2008 follow up survey was commissioned to determine whether the trend of increased coverage and favorability of message had persisted. Methods: Research firm Carma International analyzed a systematic random sample of 600 stories from U.S. media, including print, broadcast and web based sources (August, 2007-July, 2008). Coverage was analyzed by volume, story type, topics, awareness events and celebrity outreach. Topics and messages from this period were matched to those used in previous periods (August 1999 - July 2000, August 2003 - July 2004). Project parameters were held consistent between time periods to enable an accurate comparison of each cancer over time. Results: Lung cancer coverage experienced an increase in volume, up 23% (116 to143 stories) from the previous period, while breast cancer coverage increased 21% (333 to 402 stories). Lung cancer coverage was less positive with a drop to a slightly favorable rating of 48; research references declined from 29 to 14 and lung cancer garnered the lowest percentage of stories discussing treatment (14%); while tobacco/smoking references were found in 44% of lung cancer stories, up 31% from the earlier period and was the leading negative message. Positive message penetration declined over time for lung cancer coverage with 36% of stories carrying at least one positive message in 1999–2000 but only 28% in 2007–2008. Conclusions: While the volume of lung cancer coverage has increased significantly from over time, the tone of coverage has become significantly less favorable and more negative. Such findings identify a clear need to encourage media to consider how they report on lung cancer, specifically the prominence of smoking as a risk factor in cancer related stories, and to encourage reporting more hopeful messages including survivor stories, and new developments in lung cancer research/treatment.

No significant financial relationships to disclose.
Use of the Prostate Cancer–specific Quality of Life Instrument (PROSQOLI) in clinical practice
Authors: Cescon D. W. , Canil C. , Le L. W. , Tannock I. F.
Published: August 2020

e20569

Background: Improvement of quality of life (QOL) is a major therapeutic goal for men with advanced prostate cancer (APC). The PROSQOLI consists of a series of 9 linear analog self-assessment (LASA) scales that evaluate pain, fatigue, appetite, constipation and other symptoms, and overall well-being; it was designed and validated for use in patients with APC. Here we evaluate the use of a computer-based version of the PROSQOLI in routine clinical practice for its ability to stimulate recognition of symptoms and for its impact on clinical decision-making. Methods: Consenting patients with APC completed a touch screen version of the PROSQOLI before seeing the doctor at visits to the outpatient clinic. In phase I of the study physicians did not have access to this information; in phase II physicians were provided with results of the PROSQOLI and its changes from previous visits. Physicians’ recognition of symptoms, and changes in management were extracted from transcribed clinical notes. Results: 36 men were recruited, and data collected from 120 clinic visits (85 phase I, 35 phase II). Normalized symptom scores (0=none; 100 =very severe) were highest for fatigue (median = 42), followed by urinary problems (27) and mood (27) with no differences between phases. Median normalized pain scores were 25 in phase I and 11 in phase II (p=0.03). Changes in management occurred in 41% of phase I, and 43% of phase II visits (NS). Comparison of patient-assessed and physician-described symptoms was limited by lack of documentation in transcribed notes: mention of PROSQOLI symptoms ranged from 75% of visits for pain to 2/120 visits for mood. Presence or absence of fatigue and urinary symptoms were described at 53% and 40% of visits respectively. Rates of documentation did not differ between study phases. Conclusions: No impact on patient care could be demonstrated as a result of computer-based self-assessment of changes in symptoms and QOL. Prostate cancer-specific symptoms were poorly documented in clinical notes; improved recording of symptoms might be facilitated by the use of a tool such as the electronic touch-screen PROSQOLI.

No significant financial relationships to disclose.
Do oncologists engage in bereavement practices? A survey of the Israeli Society of Clinical Oncology and Radiation Therapy (ISCORT)
Authors: Corn B. W. , Shabtai E. , Merimsky O. , Inbar M. , Rosenbaum E. , Meerovitz A. , Tamir R. , Wexler I.
Published: August 2020

e20588

Background: What happens to the patient-physician relationship after the patient succumbs to the illness? To begin answering this question, we determined the extent to which oncologists are involved in bereavement rituals for their patients. Methods: An e-mail survey was sent to ISCORT oncologists querying them as to their involvement in bereavement rituals including funerals, visitations (e.g., shiva), condolence phone calls, and condolence letters. Results were described using summary statistics, Wilcoxon, and Fisher's exact test. Results: The survey response rate was 69% (126/182). Median age of respondents was 49 y and the male:female ratio was 2:1. Generally, only 2% of oncologists attend funeral services and 1% visit the family. A higher number telephoned the surviving family members (27%) or sent written condolences (18%). When a ‘special bond‘ developed between doctor and patient, there was a significant increase in those who attended the funeral (8%), participated in a visitation (18%), or made phone calls (54%), p < .0001 for all three rituals. There was no higher likelihood to participate in bereavement practices as a function of subspecialty (Medical v. Radiation v. Surgical Oncologist), gender, religiosity, or personal death anxiety. The rank ordered reasons for not participating in bereavement activities are lack of time, fear of burnout, need to maintain boundaries, and death anxiety. Males, more often than females, indicated that time constraints were the most important factor in determining their participation (P = .025). There was a weakly significant association between the physician's spirituality and participation in specific bereavement rituals. Interestingly, 11% of oncologists indicated that they would participate in bereavement visits if compensated for their time. Conclusions: Most oncologists do not engage in bereavement rituals for their deceased patients. When they do, they are less likely to attend a funeral or visit the family, and more likely to send a condolence card or call.

No significant financial relationships to disclose.
Dyadic coping among breast cancer patients treated with radiotherapy
Authors: Pat-Horenczyk R. , Machyevsky D. , Brom D. , Schwartz I. , Inbar M. , Rice A. , Wexler I. , Corn B.
Published: August 2020

e20589

Background: Cancer poses a major stressor for patients and their partners. Understanding dyad coping is useful for determining if one partner's involvement is beneficial or harmful to the other. We sought to evaluate whether dyadic coping enhances resilience in the context of other risk and protective factors for coping with serious illness. Methods: An IRB-approved questionnaire was offered to breast cancer patients and their spouses. Consent was obtained from 21 dyads who were queried prior to initiation of breast irradiation and within 2 weeks of completing treatment. The nature of dyadic coping (positive or negative), level of posttraumatic stress, functional impairment, depression, and markers of resiliency were assessed for each partner at the beginning and conclusion of therapy. Results: Depression was significantly higher in patients than in their spouses (df = 1, 13; F = 6.13; p = 0.028). Over the course of the radiotherapy, partner's depression improved while the patient's depression worsened (df=1,13; F=5.46; p=0.030). The patient's negative dyadic coping assessment before radiation therapy was positively associated with depression (β = 0.78; df = 31.3; t = 2.15; p = 0.04), as well as the partner's depression (β = 0.92; df = 31.3; t = 2.52; p = 0.017) and posttraumatic stress (β = 0.74; df = 31.7; t = 2.10; p = 0.04). Patient's pre-radiation negative dyadic coping was negatively associated with the partner's flexibility (β = -.21; df = 19; t = -2.28; p = 0.03) and self efficacy (β = 0.46; df = 21.8; t = 2.96; p = 0.007) at completion of therapy. Positive dyadic coping assessment was not associated with negative coping behaviors on the part of either the patient or partner. Conclusions: The results of this pilot study support interventions incorporating dyadic support to enhance the resilience of patients and partners. Intervention should promote flexibility and self-efficacy while providing tools for altering negative dyadic coping patterns.

No significant financial relationships to disclose.
The era of oral drugs in oncology: What do patients think about their efectiveness?
Authors: Homet B. , Hitt R. , Ghanem I. , Malón D. , Cortés-Funes H.
Published: August 2020

e20600

Background: With the growing number of drugs available for the treatment of cancer, most of them of oral administration, some aspects of the everyday clinical practice are changing. Interesting is the opinion of the patients (pts) about oral therapy. Methods: We researched differences in preference, tolerance, effectiveness, and safety by means of the delivery of a survey to (pts) who had received oral and intravenous (IV) treatment. One hundred and ninety (pts) were enrolled from September to November 2008. Results: Seventy percent of the (pts) studied were women, the median age at diagnosis was 60 years (range, 28 - 91 years). Fifty percent had gynaecologic tumors; thirty percent digestive; eighteen percent lung cancer and two percent other tumors, with a median of 3 different lines of therapy (range, 1 to 9). Patients preferred the oral route over the IV (76% vs. 20% respectively; P<0.001) and four percent had no preference. Tolerance was better with oral therapy (64%) than with (IV) chemotherapy (CT) (36%; P<0.001). When the (pts) were asked for effectiveness, sixty percent of them considered the (IV) chemotherapy more effective, while eleven percent chose oral therapy and twenty-nine percent found both equally effective (p<0.001). Sixty one percent of the (pts) evaluated as more secure (IV) chemotherapy, while eight percent did so with oral therapy and thirty one percent did not think that differences existed with one or another route of administration (p< 0.001). Conclusions: The constant evolution in cancer therapy and the increasing participation of (pts) in therapeutic decisions makes it imperative to know the opinion of (pts) on these new treatments. When patients are asked for tolerance or preference, the majority of them choose the oral route. However, when asked about important issues such as effectiveness or safety that offers a treatment, most of them prefer the intravenous route.

No significant financial relationships to disclose.
Distal or proximal venous port device insertion: Results of a prospective randomized trial
Authors: Marcy P. , Chamorey E. , Macchiavello J. , Largillier R. , Peyrade F. , Ferrero J. , Hanoun-Levi J. , Poudenx M. , François E. , Frenay M.
Published: August 2020

e20605

Background: Open, nonblinded, prospective, randomized, controlled trial comparing two techniques of venous port device insertion: percutaneous distal (phlebography-guided arm port- study technique- 2) vs proximal surgical (cephalic vein cutdown- control technique- 1) placement -To determine whether technique 1 is superior to technique 2. Methods: 230 eligible patients beginning a course of i.v. chemotherapy via a port device catheter with an expected duration of treatment of 3 months or longer were randomized (written informed consent). Eligibility criteria included adult patients with solid tissue malignancy (neuro oncology, gynecology, lung, abdominal, head§neck) beginning a course of I.V.chemotherapy, normal hemostatic parameters, no organ failure, a life expectancy >3months, WHO status<3. Exclusion criteria included current anticoagulant therapy, previous ipsilateral venous catheter/pacewires/surgical axillary node dissection/radiodermatitis, local tumor growth/sepsis, symptomatic brain metastasis, psychosis. The silicone rubber 7F catheter was connected to a 11mm port reservoir, and implanted under local anesthesia using either technique 1 or 2 after randomization. Outcome measurements included technical feasibility/procedure duration, port complications, quality of life (EORTC) questionnaires. Results: Median study duration was 12.2 vs 11.9 months (p: 0.9), median chemotherapy cycles were 6.0 in both groups. Patients groups differed significantly in venous access side (left access in group 2) and sex ratio (p=0.028). In group 2, technical success rate was higher (99 vs 91%, p<0.02), procedure was shorter: 18.0min (10.0–90.0) vs 21min (15.0- 45.0)(p<0.008), but global complication rate was higher (p<0.05). Device complication related explantation rate was 11.9 vs 2.8% (p=0.022). Conclusions: Both techniques are safe and effective. Despite a higher technical success rate and a shorter procedure duration, arm port insertion has a lower complication-free duration. Distal (arm port) technique should be recommended in young female cancer patients (neckline cosmesis/discretion), head and neck cancer patients, obese patients (upright position) and in patients presenting with respiratory insufficiency or at high risk for pneumothorax.

No significant financial relationships to disclose.
Complementary and alternative medicine: What do oncology healthcare providers think?
Authors: Tung C. S. , Sun C. C. , Cohen L. , Frenkel M. , Ramondetta L. M. , Smith J. A. , Parker P. , Bodurka D. C.
Published: August 2020

e20614

Background: The use of complementary and alternative medicine (CAM) is growing as the oncology patient (pt) population increases. The purpose of this study was to assess current CAM practice patterns of oncology healthcare providers. Methods: We distributed a 20-page anonymous survey to all physicians (), mid-level practitioners, clinical pharmacists, and dietitians at a comprehensive cancer center. The survey examined factors influencing a provider's inquiry towards pt CAM use, as well as current perception and use of 15 different CAM modalities, such as meditation, acupuncture, chiropractic, and herbal therapy. Descriptive statistics, chi-square, and Student's t-test were used for analysis. Results: 671/1,601 (42%) surveys were returned with s comprising 50% of the responses. 83% of respondents believed CAM has a role in cancer care. Over 70% indicated that massage, meditation/prayer, relaxation techniques, and acupuncture have potential uses, primarily to relieve symptoms not controlled by conventional therapy (tx) (47%) and as psycho-social-spiritual support (47%). Respondents estimated 28% of pts utilize CAM; 25% of respondents and 19% of pts initiated CAM discussions during pt visits. Those in medicine-based fields were more likely to discuss pt CAM use compared to surgical specialities (30% vs. 19%, p<0.01), but there was no significant difference in comfort level to discuss CAM modalities. s were less likely to discuss CAM use compared to all other providers (21% vs. 31%, p<0.01). s were also less comfortable discussing herbs (37% vs. 51%, p<0.01), massage (73% vs. 82%, p<0.05), meditation/prayer (71% vs. 82%, p<0.05), and relaxation tx (67% vs. 77%, p<0.01) compared to all other providers but more comfortable discussing acupuncture (63% vs. 55%, p<0.05). Respondents cited lack of knowledge in CAM as the primary reason for not discussing CAM with pts. Conclusions: Past studies estimate that >50% of patients use at least one form of CAM. Our study suggests that oncology providers critically underestimate the number of patients incorporating CAM into their treatment. Improving provider education on CAM therapies is essential to improve patient-physician communication regarding potential risks and benefits of CAM with traditional cancer therapies.

No significant financial relationships to disclose.
Histological differentiation of skin toxicity between cetuximab, erlotinib and panitumumab (single ErbB1) and lapatinib (dual ErbB1/2) epidermal growth factor receptor inhibitors
Authors: Newman M. , Gerami P. , Guitart J. , Lertsburapa T. , West D. , Rosen S. , Cianfrocca M. , Lacouture M.
Published: August 2020

e20617

Background: Epidermal growth factor receptor inhibition by monoclonal antibodies and tyrosine kinase inhibitors has demonstrated activity in solid tumors. However, blockade of EGFR in skin results in disabling skin toxicity that may lead to therapeutic dose modification or interruption. This study compares cutaneous histological alterations among four EGFR inhibitors (EGFRIs): cetuximab (C), erlotinib (E), lapatinib (L) and panitumumab (P). Methods: Punch skin biopsies from patients with papulopustular rash were collected from 8 patients per each EGFRI (n=32). Two dermatopathologists performed independent blinded assessment of epidermis, dermis, follicle and inflammatory infiltrates. Histologic features were rated as 0 (absent) or 1 (present), with the exception of dyskeratosis, rated from 0 (absent) to 2 (severe) and infiltrate, rated from 0 (absent) to 3 (most prominent). Where variation occurred, scores were reconciled and combined for analysis. Results: Epidermal atrophy was observed for C, E, L and P (range 0–1, median 1, 1, 0, 0.5, respectively) and neutrophilic follicular infiltrate was observed for C, E, L and P (range 0–3, median 0.5, 3, 0, 3, respectively). Neutrophilic dermal infiltrate (range 0–3) and follicular neutrophilic pustules (range 0–1) were most prevalent in P (median 0.5), whereas the median for C, E and L was 0. A mononuclear dermal infiltrate (range 0–3) was least prevalent with C (median 0) while E, L and P had a median of 0.5. Concretions (range 0–1) were most prevalent for E (median 1), whereas the median for C, L and P was 0. Conclusions: Lapatinib, a dual ErbB1/2 inhibitor, induced the least structural disarray and inflammation in the skin as measured by median scores for epidermal atrophy, neutrophilic dermal and follicular infiltrates, neutrophilic pustules and lack of bacterial concretions. These histological data confirm a more benign pattern of rash with lapatinib compared to single ErbB1 inhibitors.

[Table: see text]
An observational study of the impact of ethnicity on patients treated for non-small cell lung cancer (NSCLC) in the second-line setting with pemetrexed: Preliminary results in African Americans
Authors: Girvan A. C. , Peltz G. , Pennella E. , Pohl G. , Faries D. , Marciniak M. D. , Obasaju C. K. , Stepanski E. J. , Schwartzberg L. S. , Adjei A. A.
Published: August 2020

e20624

Background: African-Americans are more likely to develop and die from lung cancer than persons of any other ethnic group. Historically, African-Americans have been under-represented in oncology clinical research. This prospective, single-arm, observational study evaluates the impact of ethnicity on disease control rate (DCR) (CR + PR + SD)) in patients (pts) with non-small lung cancer (NSCLC) being treated with pemetrexed (Pem) in the second-line setting. Methods: Eligibility criteria include stage IIIB or IV NSCLC pts receiving Pem for second-line therapy with no restrictions on performance status. An accrual of 200 African-Americans, 200 Hispanics, 200 Asian-Americans, and 400 Caucasians is planned to test the hypothesis that subjects from these minority populations with advanced NSCLC will have DCRs that are not inferior to Caucasian subjects during second-line treatment with Pem in routine clinical practice. This report describes observations from an early examination of the data of the Caucasian and African-American pts enrolled. Results: 293 pts have been enrolled in this study including 243 Caucasians and 34 African-Americans. Demographics of Caucasians: M/F (136:107); median age 66 (range 37–88); histology adenocarcinoma/squamous/other/unknown (141:67:33:2). Demographics of African-Americans: M/F (21:13); median age 64 (range 43–80); histology adenocarcinoma/squamous/other/unknown (22:9:3:0). DCR in Caucasians: 38% (CI= 28–47%: 3 CR, 8 PR, and 34 SD in 120 of the 243 pts). DCR in African-Americans: 61% (CI=36–86%: 0 CR, 0 PR, and 11 SD in 18 of the 34 pts). Updated safety and efficacy data will be available. Conclusions: Preliminary results based on limited data do not indicate an inferior response for African-American pts compared to Caucasian pts being treated with Pem for NSCLC in the second-line setting. Additional data are needed to establish a definitive conclusion.

[Table: see text]
Erythropoiesis stimulating agent (ESA) administration at Hb <10 g/dL for chemotherapy-induced anemia (CIA) following the National Coverage Decision (NCD)
Authors: Hulnick S. A. , Hess G. , Hill J. , Viswanathan H. N. , Nordyke R. J.
Published: August 2020

e20627

Background: Medicare coverage of ESA treatment for CIA was changed in 7/07 to a hemoglobin (Hb) < 10 g/dL prior to administration. We describe the proportion of ESA administrations at Hb < 10 g/dL over four quarters following the NCD. Methods: A retrospective analysis of ESA administrations from 7/07 - 6/08 using Varian and Impac electronic medical records for 304,654 cancer patients from 91 practice sites across 19 states. Episodes of ESA treatment were identified within chemotherapy episodes. A > 42 day gap in ESA use identified a completed ESA episode and a > 90 day gap in chemotherapy identified a chemotherapy episode. Hb ≤ 7 days prior to ESA administration date was identified for each ESA episode. The percent of ESA administrations at Hb < 10 g/dL was measured from Q3 07 to Q2 08 for darbepoetin alfa (DA) and epoetin alfa (EA) stratified by age. Results: For patients age ≥ 65, the percent of ESAs administered at Hb < 10 g/dL increased from Q3 07 to Q2 08 for initial and maintenance administrations. A less pronounced trend was observed in patients age < 65. Maintenance administrations at Hb < 10 g/dL in patients age < 65 were significantly lower for EA vs. DA. Conclusions: ESA administrations have been increasingly administered at Hb < 10 g/dL. A higher proportion of Medicare-eligible patients received maintenance ESA administrations at Hb < 10 g/dL.

[Table: see text]

[Table: see text]
Evaluation of the influence of physical problems, emotional problems, and extent of disease on the distress level (DL) in breast cancer (BC) women
Authors: Cedrych I. , Heyda A. , Lukaszczk-Widel B. , Lange B. , Syska-Bielak A. , Skladowski K.
Published: August 2020

e20628

Background: Despite recent treatment advances, BC diagnosis is still synonymous to death, and suffering and provides emotional impairment in most of patients. Thus the distress assessment and management is the essential component of comprehensive BC patient care.The aim of the study was to recognize DL in the group of BC patients (pts) at the different stages of the disease and treatment period and to evaluate the most important distress causes and sources. Methods: In 60 BC women (median age 58 years, range: 37–86) diagnosed within last two years, the measurement of distress level was performed using the Distress Thermometer scale with the problem list attached, according to NCCN practice quidelines recommendation for distress assessment. The median time from the diagnosis to the distress data collecting moment was 3.9 months. Most pts were postmenopausal (70%), have positive family cancer history (60%) and suffered from other diseases (75%); 45% of them presented stage III of BC (stage I - 26%, II - 23%, IV - 5%). Chemotherapy received 55% of pts, surgical treatment 65% and radiotherapy 46%. At the moment of DL evaluation 61% of pts were remained free from BC symptoms and 72% from strong stressful event during last year. Results: The median DL in the whole group was 5 (range 0–10) and in 76% of pts the level was 4 or higher. Problem-list evaluation revealed that 96% of pts had physical, 90% emotional, 38% practical and 20% family problems. Both univariate and multivariate analysis revealed the independent and positive correlation with DL for: physical problems (p=0.000009), peripheral blood granulocytes level (p=0.000024), strong-stressful event passed during the last year (p=0.005) sadness (p=0.01) The surgical cancer treatment was correlated with DL negatively (p=0.008). Conclusions: DL evaluation has shown that the DL was associated mostly with practical, emotional and physical problems and the history of personal stressful event in the near past. BC surgery is a strong source of anti-distress. These data indicate a need of DL assessment with not neglecting the individual medical and psychosocial history of each patient to provide best psychological support, expecially in women who are not qualified to, or are before surgery.

No significant financial relationships to disclose.
Fertility preservation and timing of cancer treatment
Authors: Kumar A. , Mhaskar A. , Vadaparampil S. , Djulbegovic B. , Quinn G. ,   The Moffitt Fertility Preservation Group
Published: August 2020

e20629

Background: Cancer survival rates have increased steadily over time and young cancer survivors desire quality of life, including the ability to have a family. Cancer treatments, due to its toxic nature, can permanently or temporarily affect fertility. However, advanced fertility preservation measures are available and should be pursued before toxic chemo or radiation therapy. Evidence from observational studies indicate patients want to be informed of the adverse effects of cancer treatments on their fertility. Despite conflicting evidence on the efficacy of early treatment, the urgency of starting treatment early for maximum benefit has been cited as the most common reason for not discussing fertility preservation with patients.Accordingly, we conducted a systematic review and meta-analysis to assess if early treatment leads to better outcomes. Methods: A comprehensive literature search was performed of MEDLINE and Cochrane databases from 1966–2008 for all phase III randomized controlled trials (RCT) comparing early versus late treatment in cancer patients as first line therapy. Data were extracted and pooled on benefits (overall survival) and harms (treatment related mortality). Results: Initial search yielded 570 trials, of which 8 RCTs met the inclusion criteria. 3 RCTs assessed the efficacy of early versus deferred treatment in prostate cancer, 3 in multiple myeloma, and 1 each in lung cancer and chronic lymphocytic leukemia (CLL). Overall, pooled data showed survival benefit with early treatment (Hazard ratio [HR]=1.16,95%CI 1.05–1.28). However, the benefit with early treatment was restricted to prostate cancer(HR=1.21,95%CI 1.09–1.35). There was no survival difference between early and deferred treatment in multiple myeloma (HR=1.11,95%CI 0.67–1.84), CLL (HR=0.89,95%CI 0.49–1.59) or lung cancer (HR=0.95,95%CI 0.72–1.24). Pooled results excluding prostate cancer RCTs did not show a survival benefit with early treatment (HR=0.97,95%CI 0.78–1.21). No trial reported data on harms. There was no significant heterogeneity among trials. Conclusions: The totality of the evidence shows except in prostate cancer, deferment of treatment does not lead to decreased survival, and provides a unique window to oncologists to address the issues related to fertility preservation if desired by patients.

No significant financial relationships to disclose.
Effect of interval between diagnosis of advanced cancer and cessation of active anti-cancer treatment on survival in terminally ill cancer patients
Authors: Kim Y. , Lee J. , Choi W. , Park J. , Kim H. , Lee S. , Kim D. , Lee J. , Bang Y. , Heo D. S.
Published: August 2020

e20630

Background: Although various prognostic factors have been proposed to predict survival in terminally ill cancer patients, accurate prognostication is still a challenging task for oncologists. The objective of this study was to evaluate whether the time interval between diagnosis of advanced cancer and cessation of active anti-cancer treatment (ATP; active treatment period) can predict survival in terminally ill cancer patients. Methods: We prospectively evaluated 79 patients with advanced (recurrent or metastatic) cancer who were determined as terminal stage, namely cessation of active anti-cancer treatment and transition to palliative care, by attending oncologists. ATP and other known prognostic factors including clinical symptoms and signs, performance status, laboratory tests, and clinical prediction of survival (CPS) were analyzed. Results: Of the 79 patients, 46 were male (58%) and 33 were female (42%) with a median age of 60 years (range, 21–82). Median overall survival after being diagnosed with advanced cancer was 11.6 months (95% confidence interval (CI), 8.02–15.18), and survival after being determined as terminal stage was 1.9 months (95% CI, 1.38–2.42). According to 3 ATP categories (< 3months, 3–12 months, and >12 months), terminal stage survival were 1.0 month, 1.8 months, and 3.6 months, respectively (p=0.002). On multivariate analysis, short ATP, non-colorectal cancer, fatigue, and Karnofsky performance status less than 50 were significantly associated with a poor prognosis. Conclusions: Our study suggests that ATP is an independent prognostic factor for survival in terminally ill cancer patients who cannot receive active anti-cancer treatment anymore. Future prognostic models should include ATP as a prognostic variable.

No significant financial relationships to disclose.
Phase II study of AVR118 in the management of cancer related anorexia/cachexia
Authors: D'Olimpio J. T. , Chasen M. R. , Sharma R. , Diego M. , Gullo V. , MacDonald N.
Published: August 2020

e20631

Background: AVR118 represents a new class of cytoprotective drugs in managing symptoms associated with anorexia\/ cachexia. In a previous study in patients with advanced HIV-AIDS, an improvement in appetite, strength and alertness was noted. The precise mechanism of action is not understood, but activity may be related to AVR118's adenosine based components. Other active components include guanosine and branched chain amino acids leucine and valine. Objective: To determine the effect of AVR118 on appetite, early satiety and nutritional intake in patients with advanced cancer. Secondary endpoints include changes in performance status, lean muscle mass and quality of Life (QOL). Methods: Eligible adult patients received 4.0 ml of AVR118 subcutaneous daily injections. Patients underwent bi-monthly evaluations during the 28 day initial treatment (phase A) Evaluations included Karnofsky performance status, Edmonton Symptoms Assessment Scale (ESAS), Patient Generated Subjective Global Assessment (PG-SGA), Simmonds Functional Assessment, Dyspepsia Symptom Severity Index, Weight, Lean Body Mass, skin fold thickness and grip strength. Patients who benefited from phase A could elect to continue with therapy (phase B). Results: Currently, of 16 enrolled patients 7 have completed phase A. All 7 patients chose to continue with AVR118 treatment (phase B). Improvements in anorexia and PG-SGA scores were seen in 7/7 and 6/7 patients respectively. Weight stabilization or gain was observed in 5/7 patients. All other parameters showed no significant difference. There was AVR118 has been well tolerated and no serious side effects have been reported. Conclusions: Based on these positive results, the primary endpoints have been achieved and the study will be expanded from 14 to 30 patients.

[Table: see text]
Incidence of chemotherapy-induced nausea and vomiting after highly and moderately emetogenic chemotherapy in the era of NK-1 receptor antagonists. Perception versus reality
Authors: Majem M. , Moreno E. , Perez J. , Calvo N. , Feliu A. , Gich I. , Tibau A. , Mangues M. A. , Barnadas A.
Published: August 2020

e20636

Background: Physicians and nurses had underestimated the incidence of chemotherapy-induced nausea and vomiting (CINV) after both high emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC) (Grumberg, Cancer 2004;100:2261–8; Erazo Valle, Curr Med Res Opin 2006;22:2403–10). We have assessed if physicians and nurses’ perception of CNIV in their own practices after the introduction of Aprepitant was closer to reality. Methods: A prospective, observational unicenter study of adult patients receiving their first chemotherapy cycle was performed. Medical oncologists and oncology nurses also estimated the incidence of acute (Day 1) and delayed (Days 2–5) CINV after first administration of HEC and MEC. Eligible patients completed a 6-day diary including emetic episodes, nausea assessment, and antiemetic medication use. Observed incidence rates of acute and delayed CINV were compared with physician/nurse predictions. Results: Twenty-nine physicians and nurses and 95 patients (86.3% receiving HEC and 13.7%MEC) were recruited. Acute nausea and emesis were observed in 14.3% and 2.4% respectively of HEC patients receiving Aprepitant, and delayed nausea and emesis were observed in 14.3% and 7.1% of these patients, respectively. Physicians and nurses accurately predicted the incidence of acute and delayed CINV after HEC patients receiving Aprepitant. Acute nausea and emesis were observed in 22.2% and 0% respectively of MEC patients and delayed nausea and emesis in 33.3% and 22.2% of MEC patients, respectively. All physicians and nurses underestimated the incidence of acute nausea and delayed nausea and emesis after MEC by 15, 28 and 18 percentage points, respectively. Conclusions: The addition of aprepitant in the prevention of CINV after HEC allows a better control of CINV that is perceived accurately by physicians and nurses. By contrary, physicians and nurses continue markedly underestimating the incidence of CINV after MEC. CINV still remain important targets for improved therapeutic intervention and physicians and nurses must be aware about the real incidence of CNIV.

No significant financial relationships to disclose.
Study of anxiety and depression in cervical cancer survivors
Authors: Kim S. , Nam J. , Park S. , Bae D. , Park C. , Cho C. , Lee J. , Yun Y.
Published: August 2020

e20644

Background: Cervical cancer is the second leading cause of cancer related deaths among women in Korea. However, few studies have been conducted to elucidate the psychological distress of this population. This study aimed to examine the prevalence of anxiety and depression among cervical cancer survivors, and to identify factors associated with such caseness. Methods: A total of 832 cervical cancer survivors recruited from six large hospitals in Korea completed a mailed survey, which included the Hospital Anxiety and Depression Scale (HADS), European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, and QLQ-CX24. Anxiety and depression were defined by a score of ≥ 8 on the HADS subscales. With a framework that included socio-demographic, clinical, and symptom characteristics, multivariate logistic regression models were used to identify factors associated with anxiety and depression. Results: Among cervical cancer survivors, 34.3% reported HADS-defined anxiety and 39.7% reported HADS-defined depression. Anxiety was associated with having a lower income (OR=1.95, p=.021), smoking (OR=2.42, p=.002), poor body image (OR=3.26, p<.001), peripheral neuropathy (OR=2.21, p=.002), menopausal symptoms (OR=2.02, p=.004), and sexual inactivity (OR=2.35, p=.001). Depression was associated with younger age (OR=1.75, p=.006), having a lower income (OR=2.14 p<.001), drinking (OR=1.56, p=.050), poor body image (OR=4.59, p<.001), peripheral neuropathy (OR=2.34, p<.001), and sexual inactivity (OR=2.68, p=.002). Both anxiety and depression were influenced by socio-demographic factors, health behaviors, and cervical cancer-specific symptom characteristics rather than cancer- or treatment-related factors. Conclusions: Anxiety and depression were highly prevalent among cervical cancer survivors in Korea. This examination of risk factors for anxiety and depression will be helpful for the development of clinical management strategies in cervical cancer survivors.

No significant financial relationships to disclose.
QTc interval in advanced cancer patients
Authors: Trivanovic D. , Dobrila-Dintinjana R. , Mavric Z. , Stimac D. , Petkovic M.
Published: August 2020

e20658

Background: The purpose is to identify prognostic factors that may have impact on survival in patients with advanced cancer. Methods: We retrospectively reviewed the data of patients who had biopsy proven advanced solid cancer disease in stage IV and no history or evidence of any prior cardiac disease. Univariate and multivariate stepwise Cox proportional hazard regression analysis were performed to identify independent predictors of one year survival. Results: Between 1/01 and 9/05, 143 patients (83 male and 60 female) with advanced cancers were evaluated in our institution. The primary site of disease was lung (28%), pancreas (19%), colon (15%), rectum (13%), breast (12%), and other (13%). The median follow-up was 12,5 months, median overall survival (OS) was 8.1 months, and 1-year OS rate was 62%. Median age was 65 years. OS was significantly related to the following pre-treatment prognostic factors: Age ≥65 (years), anaemia (hemoglobin level <13.2 g/dl), Eastern Cooperative Oncology Group performance status (ECOG PS) 0–1, and prolonged QTc interval in electrocardiogram (ECG). However, multivariate analysis revealed only prolonged QTc as independent prognostic parameter with 1-y survival status. Using 440 ms as the cut off value, the QTc interval was prolonged in 32 patients (22%) with median survival of 45 days and normal in 111 patients (78%) with median survival of 280 days. During the one-year 25 patients (78%) died in group with prolonged QTc interval while in group with normal QTc interval died 63 patients (57%). Conclusions: The results of our study indicate that a prolonged QTc interval (> 440 ms) is an adverse prognostic sign in patients with advanced cancer and without cardiac disease which correlates with increased mortality rates within one year after the diagnosis. Our findings suggest that QTc prolongation may be a good adjunct in risk stratification of patients with advanced cancer who are being considered for aggressive treatment regimens.

[Table: see text]

No significant financial relationships to disclose.
Clinical consequences of profound anemia
Authors: Devagiri M. , Ford P.
Published: August 2020

e20666

Background: Although there is an emerging trend to reduce blood transfusions, there is still very little randomized data outside of the critical care setting that identifies the risks and benefits of transfusion support. Many clinicians base the decision to transfuse primarily on the hemoglobin (Hb) level independent of symptoms. Little is known about the clinical consequences of profound anemia although there is concern that withholding transfusion will result in adverse outcomes in those with advanced age or underlying cardiovascular conditions. Methods: A retrospective chart review of 32 patients declining blood transfusions from January 2004 to June 2008 was performed to evaluate the clinical consequences of anemia. This population included a broad range of medical, surgical and obstetrical cases and their ages ranged from 84 to 28yrs (mean 53.03). The initial Hb ranged from 3.2 to 6.8 (mean 5.04).12 patients had Hb levels less than 4.9 and 3 patients had levels less than 4. Our non blood approach included simultaneous interventions to stimulate erythropoiesis, control bleeding, enhance hemostasis, minimize blood loss and maintain hemodynamic stability. Results: 6/32 patients (18.75%) had cardiac complications related to anemia like congestive heart failure, myocardial ischemia, and cardiac arrest. They occurred predominantly in patients with underlying cardiovascular disease (4/7) with increased tendency in patients with structural heart disease like Hypertrophic Obstructive Cardiomyopathy (HOCM) and critical Aortic stenosis (3/3) at Hb levels of 4.8 and 5.6. Patients without any pre-existing cardiovascular illness tolerated very low levels of Hb of 2.5 and 4 before they had cardiac arrest from anemia. 2 patients above the age of 70 tolerated the Hb levels of 2.7 and 3.3 without complications. 2 of 3 patients with Hb less than 3 had no complications.4 deaths are noted. Conclusions: This study illustrates that patients without cardiovascular co-morbidity tolerate levels of Hb as low as 3.3 without significant events. However patients with structural heart disease like Aortic stenosis and HOCM have shown the signs of decompensation at a lower degree of anemia which suggests that they need transfusion at lower degree of anemia.

No significant financial relationships to disclose.
Cardioprotective effect of telmisartan in cancer patients treated with epirubicin
Authors: Mantovani G. , Mercuro G. , Dessì M. , Madeddu C. , Serpe R. , Massa E. , Cadeddu C. , Piras A.
Published: August 2020

e20671

Background: We previously showed on 31 cancer patients (pts) that early cardiac abnormalities occurred at epirubicin (EPI) doses of 200 mg/m2 and persisted throughout subsequent EPI doses and even up to 18 months. Early contractility impairment, i.e. Strain rate (SR) reduction was detected by tissue doppler imaging (TDI) associated with high levels of inflammatory/oxidative stress markers. Renin-angiotensin system activation has been suggested to play an important role in the pathogenesis of Anthracycline-induced cardiotoxicity. Methods: A phase II placebo-controlled study was designed to investigate the possible role of telmisartan (an antagonist of angiotensine II type I receptor) in preventing both early preclinical and late myocardial damage induced by EPI. The correlation with changes of biochemical/inflammatory markers was also assessed. Planned sample size was 100 pts (50 pts per arm). Inclusion criteria: 18–70 y, histologically confirmed cancer, previously untreated and candidates for an EPI-based regimen; LVEF ≥55%; ECOG PS 0–2, no history of cardiac disease and previous mediastinal irradiation. Eligible pts were randomized to receive telmisartan 40 mg (1 tablet)/day or placebo starting 1 week before EPI until 6 months after the end of EPI administration. TDI as well as inflammatory/oxidative stress markers were assessed at baseline, 24 hours and 7 days at EPI doses of 100, 200, 300, and 400 mg/m2. Results: At December 2008 we enrolled 27 pts (M/F: 7/20, mean±SD age 58±14 years): 14 telmisartan and 13 placebo. 15 pts completed EPI treatment (8 telmisartan and 7 placebo). A significant reduction of SR peak was observed at 200mg/m2 of EPI in the placebo arm. Viceversa no significant TDI changes occurred in the treatment arm. Proinflammatory cytokines did not change in both arms whilst reactive oxygen species increased significantly in the placebo arm. Conclusions: The study is in progress.

No significant financial relationships to disclose.
Myelophthisis in solid tumors: Old aspects, new concepts (ONCOLGroup study)
Authors: Lujan M. , Cardona A. F. , Yepes A. , Carrasco-Chaumel E. , Reveiz L. , Otero J. M.
Published: August 2020

e20672

Background: Myelophthisis is a form of bone marrow failure due to replacement of hematopoietic tissue by abnormal tissue, most commonly metastatic carcinomas. This results in extramedullary hematopoiesis, typically in the spleen leading to premature release of hematopoietic cells into the circulation. Peripheral blood findings of myelophthisis may include nucleated red blood cells, tear drop forms, giant platelets, and immature leukocytes. Overall, this picture is usually called leukoerythroblastosis. Methods: This retrospective study included 89 patients (pts) with solid tumors and myelophtisis that had been treated from 1991 to 2006 in a single reference center in Bogotá. We made a detailed analysis of pts characteristics and outcomes. Results: Mean age was 47.5±17.2 years, there was homogeneous gender distribution (F46/M43) and 62% pts had a PS ≥60%. Twenty-seven pts (30%) had breast cancer, pathology followed by primary unknown tumours (21%), rabdomiosarcoma (10%), prostate adenocarcinoma (10%), gastric carcinoma (7%) and others (22%). At the time when myelophtisis was documented 72% and 50% of pts had osseous and visceral metastasis respectively; 81 pts presented anaemia (Hb 9.8 ± 1.2 gr/dl), mean platelet count was 174,000 and mean leukocyte count was 24,283 ± 5,447. Forty-three pts received chemotherapy following the diagnosis of medullar infiltration, and normal leukocyte count was being seen in 40% of them after such treatment. Nine episodes of febrile neutropenia were found; median overall survival (OS) following the diagnosis of neoplasia and myelophtisis were 13.8 months and 2.2 months respectively. The factors related to lower survival rate were the presence of Hb ≤8.5 gr/dl (HR: 0,54, CI95% 0,32–0,95; p = 0.04), >3 metastasis sites (HR: 0,67, CI95% 0,45–0,92; p = 0.03), visceral disease (HR: 0,72, CI95% 0,66–0,89; p = 0.04) and febrile neutropenia caused by chemotherapy (HR: 0,52, CI95% 0,37–0,60; p = 0.02). Conclusions: Myelophtisis is a serious condition modifying the OS of patients having solid tumours. Treatment for this subgroup should be selected bearing in mind its potential haematological toxicity.

No significant financial relationships to disclose.