bluuebunny/crossref_metadata_2025 huggingface dataset:
Palonosetron compared to ondansetron in the prevention of chemotherapy-induced nausea and vomiting: Activity, safety, and cost-effectiveness evaluation
Authors: Bernardo G. , Palumbo R. , Frascaroli M. , Bernardo A. , Losurdo A. , Poggi G. , Teragni C. , Albanese D. , Amatu A. , Strada M. R.
Published: August 2020

e20573

Background: Chemotherapy(CT)-induced nausea and vomiting (CINV) are common adverse effects in cancer patients. The control of CINV is a relevant objective for the patient's quality of life and also aims to optimize cancer treatment. 5-HT3- receptor antagonists (RAs) are commonly used to prevent CINV. Palonosetron, the only second generation 5-HT3-RA, has a significantly longer half-life and a higher binding activity than the first generation of 5-HT3RAs. Methods: To evaluate the activity, safety and farmacoeconomic profile of palonosetron compared to ondansetron as antiemetic prophylaxis for highly (HEC) or moderately (MEC) emetogenic chemotherapy, 235 consecutive chemo-naïve patients (pts) were assigned (1:1) to receive palonosetron 250 mcg i.v. plus dexamethasone 8 mg i.v. 30 min before CT on day 1 (Group A) or ondansetron 8 mg i.v. plus dexamethasone 8 mg i.v. on day 1, followed by 8 mg os twice daily over 3 days (Group B). Results: The 2 treatment groups were comparable with respect to tumour type (breast 52%, lung 20%, colorectal cancer 11%, ovarian 8%, head & neck 5%, other 4%) and emetogenic potential of CT (HEC in 78 pts, AC-based chemotherapy in 123, MEC in 35). FLIE questionnaires were completed on days 2–5. Complete response (CR) rate for the acute period was 82% in pts given HEC in group A versus 63.2% in group B, 93.4 % versus 80.6% in pts given AC and 100% versus 94.4% in pts given MEC. For the delayed period: 74.4% in group A versus 63.2% in group B for pts receiving HEC, 90.2% versus 71% in pts given AC and 94% versus 88.9% in pts given MEC. FLIE analysis showed a reduced impact of CINV on daily life in group A (p<0.05). The pharmacoeconomic evaluation showed favourable cost effectiveness profiles for palonosetron, with a saving of about 50% per cycle/per patient over ondansetron. A not significant reduced incidence of headache and constipation was observed in group A. Conclusions: Palonosetron was effective in preventing CINV following HEC, AC and MEC in both acute and delayed phases, as well as being cost effective. The CR rates were maintained throughout subsequent cycles of CT, with a significant positive impact on daily functioning and quality of life.

No significant financial relationships to disclose.
Abnormal physical performance and frailty in older men with biochemical recurrence of prostate cancer (PCa) on androgen deprivation therapy (ADT)
Authors: Bylow K. A. , Hemmerich J. , Mohile S. , Stadler W. , Dale W.
Published: August 2020

e20578

Background: ADT has recognized toxicities including osteoporosis, muscle weakness and wasting, anemia, and fatigue. ADT is increasingly being used in men with biochemical recurrence (BCR) despite the fact that earlier initiation has not been shown to improve overall survival in this setting. Little is known about the impact of ADT on physical performance or the development of frailty in older patients. Methods: A case-control study (n=119) of men age 65+ with BCR on ADT ≥ 6 months with stable PSA (n=56) compared to controls with history of PCa status post radiation or surgery with no evidence of recurrence (n=63) was conducted. Frailty prevalence per Fried's criteria (validated measures of weight loss, exhaustion, grip strength, walking speed, and physical activity), Short Physical Performance Battery scores (SPPB: validated measure of balance, walking speed and timed chair stands) and falls were compared between groups. Exploratory analyses of proposed biomarkers of frailty (CRP, ESR, hemoglobin, albumin, and total cholesterol) were conducted. Results: Age, ethnicity and socioeconomic status were not different between groups. Total score on the SPPB was significantly lower in the ADT group (9.1 vs. 10.2, p = .01), indicating higher risk of incident morbidity and mortality. 7.2% of men in ADT group met Fried's criteria for frailty compared to 3.2% in control group and 58.9% met criteria for “prefrail” in ADT group compared to 41.9% controls (p=0.03 for trend). Quadriceps strength, as measured by chair stands in SPPB, was significantly worse for ADT group (p<.01). Incident falls were higher in ADT group (14.3% vs. 3.2%, p=.05). With the exception of hemoglobin (12.7 vs 14.4 g/dl, p< .01), putative frailty biomarkers were not significantly different between groups. Conclusions: Men with BCR of PCa on ADT have worse physical performance, are more frail, and have a higher incidence of falls than controls, but biomarkers suggest that mechanism of frailty is different than in the geriatric syndrome. A prospective trial is needed to establish a temporal link between initiation of ADT and frailty.

No significant financial relationships to disclose.
An exploration of Pap smear history and behavior of patients with newly diagnosed cervical cancer in Taiwan
Authors: Cheng H. , Chao A. , Huang H. , Chou H. , Chang T. , Liao M. , Lai C.
Published: August 2020

e20582

Background: The national health insurance policy has provided a yearly Pap smear for women >= 30 years old since 1994 in Taiwan, yet the coverage rate is still unsatisfactory. The purpose of this study is (1) to investigate the Pap smear screening history of women newly diagnosed with cervical cancer and (2) to examine factors that influence participation in Pap smear screening program in these women. Methods: Patients primarily treated for cervical cancer at Chang Gung Memorial Hospital between November 2006 and June 2007 were enrolled into this prospective study. Questionnaires included (1) socio-demographic data, and (2) knowledge on Pap smear and cervical cancer. Results: Two hundred sixty-nine patients were eligible for analysis. The median age was 51 years old (range, 25–83). Of the 269 patients, 147 (54.6%) had never had a Pap smear before diagnosis, and 35 (13.0%) did not know about Pap smear. Socio-demographic factors that significantly influenced number of previous Pap smear screening (0 vs >=1) were education level, income less than 600 U.S. dollars per month, menopaused, multiple sexual partners, and increase number of sexual partners of the male consort. Of the 147 never received Pap women, the most common reasons were thought that Pap smear screening was not necessary (46.3%), embarrassment (42.0%), busy (43.5%), and worry about the screening findings (20.4%). Of the 122 patients who have received Pap smear, 56.6% patients thought that Pap smear screening was necessary, 35.2% patients worried about the disease, 24.6% were alert on their check-ups, and 20.5% did the screening for the convenience to nearby clinics. Conclusions: Public health organizations in Taiwan should put more efforts to provide women in low education level, low income and multiple sexual partners with information on Pap smear.

No significant financial relationships to disclose.
To analyze efficacy and safety of pegfilgrastim versus filgrastim in patients with breast cancer
Authors: Satheesh C. T. , Tejinder S. , Ankit J. , Sajeevan K. V. , Lakshmaiah K. C. , Lokanatha D. , Govind Babu K. , Suresh T. M.
Published: August 2020

e20587

Background: We evaluated the safety and efficacy of a single fixed 6 mg dose of pegfilgrastim (a pegylated version of filgrastim) per cycle of chemotherapy, compared with daily administration of filgrastim, in the provision of neutrophil support. Methods: Patients with carcinoma of breast, less than 65 yrs with ECOG performance status 0 or 1 treated at our institution were randomized to receive either a single 6 mg subcutaneous (s.c.) injection of pegfilgrastim or daily 5 mg/kg s.c. injections of filgrastim, after adjuvant or neoadjuvant chemotherapy with doxorubicin, cyclophosphamide and docetaxel (60 mg/m, 600 mg/m2 and 75 mg/m2, respectively)q3 wk. Duration of grade 4 neutropenia (DSN), incidence of febrile neutropenia (FN), grade 4 neutropenia (SN), IV anti-infective use (IV), hospitalization and adverse events like bony pain (BP), anemia & thrombocytopenias were assessed as safety endpoints. Results: 71 patients were analyzed from Aug 2007 to Dec 2008. The median age in pegfilgrastim group is 58 years and filgrastim is 57 years respectively. Results are shown ( Table ). The mean duration of grade 4 neutropenia (DSN) in cycle 1 was 2.0 and 1.7 days for the pegfilgrastim and filgrastim groups, respectively. Results for all efficacy end points in cycles 2–6 were consistent with the results from cycle 1. A trend towards a lower incidence of febrile neutropenia was noted across all cycles with pegfilgrastim compared with filgrastim (10.7% versus 18.6%, respectively). Conclusions: A single fixed dose of pegfilgrastim administered once per cycle of chemotherapy was comparable to multiple daily injections of filgrastim.

[Table: see text]

No significant financial relationships to disclose.
Clinical trials networks and enrollment of historically underrepresented populations in medical oncology trials
Authors: Berkowitz J. L. , Fernandez A. , Dichmann R. A. , Kennedy K. A. , DiCarlo B.
Published: August 2020

e20598

Background: Oncology research is limited by the very low number of patients accrued into clinical trials. Clinical trials networks may help to overcome this limitation by allowing investigations designed through academic centers to be available to patients seen in community practices that are far from these centers. This allows for increased accrual and access for these patients while potentially increasing the pace of progress in clinical oncology research. Methods: In this study, we attempted to determine the effect that clinical trials networks can have on the accrual of cancer patients into clinical investigations. We retrospectively analyzed the records from 2002–2008 of a private practice located over 150 miles from an academic center for accrual into trials. This practice is a member of a clinical trials network affiliated with a major academic cancer center. Accrued patients were divided into subgroups based upon type of malignancy, ethnicity and whether or not they were elderly. In addition, from 2007–2008, the percentage of patients accrued into trials relative to the total number treated onsite was calculated and compared to national averages. Results: In this period, a total of 139 patients at this practice were accrued into clinical trials. By malignancy, they were as follows: breast 36%, colorectal 22%, lung 13%, prostate 8.4%, gastric and lymphoma each 3.0%, pancreatic 1.8%, melanoma 1.2% and ovarian 0.6%. The other 18 patients were in trials for either chemotherapy related anemia 7.8% or bony metastases 3.0%. Of the 139 patients, 45% were elderly and 16% were Hispanic, both markedly higher than national averages. For 2007–2008, 12% of patients that received on site treatment were accrued on to trials. For lung, colorectal, and breast cancer, the number of patients on trial as a percentage of all treated onsite were also higher than the national averages. Conclusions: Clinical trial networks allow a higher percentage of total patients to be accrued than the national average and greatly enhance the potential for both minority and elderly enrollment, two populations that have been historically underrepresented in major clinical trials. It may also help to accelerate the progress of medical oncology research towards better treatments for all patients.

No significant financial relationships to disclose.
Estimating the need for palliative external beam radiotherapy in adult cancer patients
Authors: Nieder C. , Pawinski A. , Haukland E. , Dokmo R. , Philippi I. , Dalhaug A.
Published: August 2020

e20599

Background: Older benchmark data suggest that 46–53% of all radiotherapy (RT) courses were administered with palliative intent. In the most comprehensive analysis from Sweden, 87 annual palliative RT courses per 100,000 inhabitants were registered in 2001, mainly for the treatment of bone and brain mets (95% CI 84–91). Despite an increase from Swedish data collected in 1992, continuous underuse could not be ruled out. Newer data accounting for the increasing life expectancy of patients with metastatic cancer are lacking. Methods: Prospective collection of data on palliative RT in adult cancer patients during a 12 months period in 2007/2008 in a well defined region of Norway. All patients (median age 70 years, 26% lung, 23% prostate, 11% breast, 7% bladder cancer, 33% others) were treated in one federal state with ∼234,000 inhabitants and had unlimited access to RT (no economical barriers, waiting time 0–14 days). Efforts were made to account for potential overuse, e.g., registration of patients who died within 2 weeks from the first RT fraction. Results: In the study population, 134 annual treatments per 100,000 inhabitants were registered (after correction for overuse, but not accounting for emerging treatment options, e.g., stereotactic RT for lung metastases; 95% CI 112–159). As some patients received simultaneous treatment to different target volumes, the annual number of target volumes amounted to 160.8 per 100,000 inhabitants (95% CI 137–188). Of these, 115.2 were related to skeletal lesions, 12.3 to thoracic tumors and 11.4 to brain mets. Due to the differences in fractionation and treatment technique from country to country and even between institutions in the same country, no data on number of fractions or fields were collected. However, each institution can easily calculate their own figures on the basis of the new data. Conclusions: To the authors’ best knowledge, this is the first patterns of care study in the last 5 years. The data derived from a region where underuse is not an issue anymore suggest that previous estimates were incorrect. If confirmed in other databases, resources for palliative RT need to be adjusted. In regions with significantly different cancer incidence, age structure and other socioeconomic factors then northern Europe, separate analyses need to be conducted.

No significant financial relationships to disclose.
Changes in arm morbidities and health-related quality of life after breast cancer surgery: A five-year follow-up study
Authors: Sagen Å. , Kåresen R. , Sandvik L. , Risberg M.
Published: August 2020

e20602

Background: Many breast cancer survivors (BCS) suffer from longterm upper limb morbidities after axillary node dissection. The purpose of this five-year follow-up study was to describe changes in long-term upper limb morbidities, physical activity level, and Health-Related Quality of Life (HRQoL) and to find factors that predict HRQoL five years after surgery. Methods: This study included 204 women aged 55 ± 9 years who had primary breast cancer surgery with axillary node dissection. The subjects were examined for arm volumes and arm lymphedema, arm pain, sensation of heaviness, shoulder function, physical activity level, and HRQoL, prior to surgery, and six months and five years after surgery. The statistical analyses used included ANOVA for repeated measures and multivariate linear regression. Results: ALE (12%), pain (36%), and sensation of heaviness (32%) in the upper limbs were still present five years after surgery. ALE was the only morbidity that continued to increase over time. The HRQoL temporarily declined after surgery, but improved in the period from six months to five years after surgery. The significant predictive factors of HRQoL five years after surgery included HRQoL prior to surgery, physical activity level at leisure time (both prior to and at six months after surgery), and duration of sick leave after surgery (in weeks). Conclusions: The HRQoL improved from six months to five years, despite the chronic arm pain and increase in ALE. Three independent predictive factors of HRQoL were identified.

No significant financial relationships to disclose.
Association between ECOG PS, age, and components of the Comprehensive Geriatric Assessment (CGA) in an elderly colorectal cancer (CRC) cohort
Authors: Polite B. N. , Bylow K. A. , Hemmerich J. , Martens C. , Karr E. , Rosenbaum C. , Holmstrom C. , Kindler H. L. , Dale W.
Published: August 2020

e20603

Background: 75% of CRC patients (pts) are age 65 and older. The ability of ECOG PS and age to predict underlying frailty in older pts has been questioned. This prospective multi-center observational study explores the association between EGOG PS, age and a comprehensive geriatric assessment (CGA) in older CRC pts. Methods: CRC pts aged 65 and older who were eligible for chemotherapy based on disease characteristics are being prospectively enrolled. ECOG PS and CGA measures, including functional status, cognition, comorbidity, and affect, were obtained prior to initiation of chemotherapy using validated, standardized measures. Results: 35 elderly CRC pts enrolled between March 2006 and December 2008. Age: 65–69 46%, 70–74 23%, 75–79 11%, >80 20%; gender: female 65%; race: Caucasian 52%, African-American 46%; stage IV disease: 80%. Baseline ECOG PS: 0 60%, 1 32%, 2 8%. Age did not correlate with any components of the CGA except for dependence in any ADLs (rho 0.4, p=0.03). Associations between the components of the CGA and ECOG PS are shown in the table . Conclusions: Neither biologic age nor ECOG PS were robust proxies for rigorously measured functional status in this elderly CRC cohort. This was especially true for the ECOG 0 and 1 pts where, for example, 80% of the ECOG 0 pts had impaired performance on the Short Physical Performance Battery. Work on this expanding cohort is ongoing to determine correlations with these assessments and the ability to tolerate and complete prescribed chemotherapy regimens. If predictive, the CGA could help better target established geriatric interventions to those elderly pts at greatest risk regardless of their age or performance status.

[Table: see text]

No significant financial relationships to disclose.
Functional outcome of malignant spinal cord compression treated with radiotherapy alone: A prospective analysis
Authors: Spensley S. , Gilmore J. A. , Kenny J. , Dunne M. , Clayton-Lea A. , Thirion P. G.
Published: August 2020

e20623

Background: Malignant spinal cord compression (MSCC) is a major oncological complication. The management of Impending Malignant Spinal Cord Compression (IMSCC) remains unclear. Radiotherapy (RT) is often the sole management of both entities. Our aim was to prospectively evaluate the functional outcome of MSCC and IMSCC. Methods: All pts with MSCC and IMSCC treated by RT in our institution were screened for 2 national trials (ICORG 05–03/07–11). Non-eligible pts were prospectively evaluated and followed with assessment of mobility (modified Tomita scale) and sphincter function (continence/ incontinence/catheter) at baseline and 5 weeks posttreatment. Results: From 08/07 to 11/08, 54 pts [23 IMSCC, 31 MSCC] were followed. 31 pts were male. The median age was 60.5 y (30–86). The primary tumours were haematological [13 pts], lung [10], prostate [8], renal cell [6] and breast [5]. 51 pts had diagnostic MRI. The compression level was cervical in 6 pts, thoracic in 27, lumbosacral in 16, and 5 had multiple levels. 2D RT was used with varying radiation schedules: 20Gy/5fractions (f) [32 pts], 30Gy/10f [12] and other [10]. At baseline, normal mobility was found in 29 pts, mildly impaired mobility in 15 and immobility in 10. 7 pts had sphincter dysfunction. At 5 weeks, 38 pts (16 IMSCC, 22 MSCC) were evaluable (37 for mobility score, 38 for sphincter function). 10 pts had died and 6 were lost to follow up. Overall mobility was stable, improved or worse in 28 pts, 3 pts and 6 pts respectively. The mobility score was worse in 4 pts with IMSCC and 2 pts with MSCC. Improvement of mobility score was seen in 2 pts with MSCC. Among the 7 pts with baseline sphincter dysfunction, 2 pts improved. New sphincter dysfunction after RT was seen in 2 pts with IMSCC. Conclusions: The functional outcome of MSCC treated by RT alone remains poor, with minimal mobility and sphincter improvement. Functional outcome of pts with IMSCC is worrying with a worsening of mobility and/or occurrence of sphincter dysfunction in a large number of patients.

No significant financial relationships to disclose.
Prediction of treatment response in anemic patients with cancer using darbepoetin alfa (DARB)
Authors: Camara O. , Hartmann M. , Egbe A. , Koch I. , Runnebaum I.
Published: August 2020

e20643

Background: Malignant diseases along with chemotherapy or radiotherapy often result in anemia. Anemia is adversely correlated with the patient quality of life. Darbepoetin alfa (DARB) is an erythropoietic protein that works in a similary way as the body´s natural erythropoietin. The aim of this prospective study is to assess factors that are predicitive of treatment response under DARB. Methods: Between November 2002 and November 2007 overall 116 patients out of 120 projected were included in this trial. Patients with breast cancer, ovarian cancer or cervical cancer who were treated with chemotherapy, chemoradiation entered in the study. The initial hemoglobin level had to be less than 6.8 mmol/l. The primary endpoints were the evaulation of the effect of DARB(2.25 ug/kg/week) on erythropoietin level,on the hemoglobin level, on the transferrin receptor, on ferritin and creatinine. Secundary endpoints were the number of non responders and the effect of iv. iron. Patients were considered responders if hemoglobin increased by greater than 1.24 mmol/l or up to 7.44 mmol/l without red blood cells transfusion during a four week treatment. Results: 116 patients were recruited. The median age was 61(range 28–79). 44% were breast cancer patients, 39% suffered from ovarian cancer and 17% had cervical cancer. Overall 46% had adjuvant treatment. The median duration of DARB treatment was 6.1 weeks(range 0.1–37.6). 47% of the patients responded. Hemoglobin level increase more than 1.24 mmol/l was detected in 9 patients. 6 patients meet the criteria hemoglobin level more than 7.44 mmol/l. Both criteria had 29 patients.The median hemoglobin increase was 1.8 mmol/l(range 0.8–4) in responders and 0.5 mmol/l(-0.9–2.1) in non responders. Responders had significantly lower serum creatinin levels as non responders(p= 0.037). Hemoglobin increase was within the first 3 weeks significantly faster in responders as in non responders(p=0.0020). The transferrin receptor increase was also significant faster in responders(p=0.0036). Conclusions: An early hemoglobin increase was the most predictive factor for response to DARB.

[Table: see text]
Evaluation of supportive care needs: Comparison between patients and physicians’ perception
Authors: Vignot S. , Delgado M. , Levy-Soussan M. , Taillade L. , Rocher M. , Lopez S. , Lassauniere J. , Spano J. , Khayat D.
Published: August 2020

e20649

Background: In order to optimize supportive care for cancer patients, we proposed them to fill a short questionnaire evaluating their potential complaints and we evaluated the concordance of their answers with the perception of their referent physician. Methods: Patients seen in consultation in an oncology unit were proposed to answer anonymously to 7 questions designed to identify potential social, psychological, nutritional problems or uncontrolled pain. Their physician answered to a similar questionnaire. Physicians were blinded to patients’ answers. Results: 155 patients accepted to complete the questionnaire. Median age was 60 yrs [21–85], 45% of patients were in metastatic setting. 70% of patients reported at least one problem, especially in the field of potential social problems (35%) or sleep disorders (25%). Concordance between patients and physicians was high for psychological support need (81%) or nutritional problems (87%) but was lower for social problems (62%) or uncontrolled pain (69%). Physicians tended to underestimate patients’ problems and missed social issues for 30% of patients or sleep disorders for 18% of patients. On the contrary and surprisingly, physicians overestimate patients’ complaints about uncontrolled pain (underestimation in 9% of cases but overestimation in 20% of cases for the item). Conclusions: Discordance between physicians and patients’ perception of supportive care needs emphasizes the importance of extending the use of screening tolls in daily practice.

No significant financial relationships to disclose.
Incidence of chemotherapy-induced nausea and vomiting in 2008
Authors: Martin I. , Montheil V. , Ropert S. , Alexandre J. , Goldwasser F. , Durand J. P.
Published: August 2020

e20660

Background: The authors determined the incidence of acute and delayed chemotherapy-induced nausea and vomiting (CINV) among new patients (pts) receiving chemotherapy with modern antiemetic prophylaxis in 2008. Methods: A prospective observational study of adult cancer pts receiving, for the first time, moderately or highly emetogenic chemotherapy (MEC or HEC) was performed. Study participants were called on day 2 and day 8, after first and second cycle, to evaluate acute and delayed emesis according a 10-item questionnaire. All patients received, before and after their chemotherapy, the optimal antiemetic prophylaxis according to the 2006 Update of ASCO Guideline for Antiemetics. Results: 131 consecutive pts were enrolled between January and June 2008. At cycle 1, on 124 assessable pts for acute emesis: 68 pts received MEC and 18, HEC. 5.6% developed acute vomiting (5.9% for MEC and 5.6% for HEC) and 33.1%, acute nausea (39.7% for MEC and 44.4% for HEC). At cycle 1, on 101 assessable pts for delayed emesis: 5% experienced delayed vomiting (5.1% for MEC and 6.3% for HEC) and 17.8%, delayed nausea (18.6% for MEC and 31.3% for HEC). At cycle 2, on 121 assessable pts for acute emesis: 62 pts received MEC and 18, HEC. 8.3% developed acute vomiting (6.5% for MEC and 16.3% for HEC) and 31.4%, acute nausea (35.5% for MEC and 44.4% for HEC). At cycle 2, on 96 assessable pts for delayed emesis: 5.2% experienced delayed vomiting (3.3% for MEC and 9.1% for HEC) and 19.8%, delayed nausea (23% for MEC and 27.3% for HEC). Conclusions: Though the application of the last antiemetic recommendations, CINV, especially nausea, remained a substantial toxicity for patients receiving chemotherapy, pointing out the need for improved therapeutic intervention.

[Table: see text]
Incidence of febrile neutropenia (FN) with pegfilgrastim (PF) on day of chemotherapy (D1) versus 24–72 hrs later (D2)
Authors: Kumar P. , Ingle A. M. , Miller S. , Woods M. , Thomas S. P.
Published: August 2020

e20664

Background: Docetaxel, doxorubicin hydrochloride, and cyclophosphamide (TAC) is a commonly used adjuvant chemotherapy (C) regimen in patients (pts) with high risk breast cancer (BC). Pegfilgrastim (PF) is a long acting G-CSF known to decrease the risk of FN. It is typically given the day after C. Illinois CancerCare (ILCC) is a large oncology practice that provides cancer care to many communities in Illinois. For patients with limited access to medical care, in past PF has been given on same day as C. In this study we have compared the incidence of FN in pts who received PF on the same day as TAC (D1) versus those who received it 24–72 hrs after C (D2). Methods: All pts treated for BC at ILCC between 09/2004 and 08/2008, and received TAC and PF were deemed eligible. Logistic regression was used to analyze the association between incidence of FN and type of regimens. Results: Of the 56 eligible pts (55 females), mean age 52.9 yrs (range 27.8–84.8 yrs), 43 patients received PF on D1 and 13 pts received PF on D2. 7 of 43 pts that received PF on D1 developed FN as compared to 1 of 13 pts that received PF on D2. There was a 2.1 times greater probability of developing FN in pts that received PF on D1 versus the pts who received it on D2; 95% CI (0.28–15.6). We did not observe a statistical significance for the above association in univariate analyses or after adjusting for age, stage of disease and receptor status (p>0.05). The lack of significance could be due to small patient population. Conclusions: The odds of developing FN in patients who received PF on the same day as TAC was 2.1 as compared to pts who received it on D2, this difference was statistically not significant.

[Table: see text]
Comorbidities, concominant medications, and clinical guidelines/algorithms in treating elderley patients with hormone receptor positive early breast cancer
Authors: Robinson A.
Published: August 2020

e20680

Background: Guidelines and algorithms have been published for aspects of BC care such as adjuvant hormonal therapy, f/up testing, and mgmt of hormonal S/Es. This study examined how CPG's for BC address comorbidity in older patients, and applicability to frail elderly. Patterns on the use of adj hormonal therapy in patients > 60, number of comorbidities, and concurrent medications was assessed at a single institution. Methods: Guidelines were obtained by searching the National Guideline Clearinghouse, as well as Pubmed. Guidelines on adjuvant anti-estrogen use for women with BC, follow-up, the use of bisphosphonates, and management of arthralgia in endocrine therapy treated patients were assessed. For the chart review, 290 consecutive patients over the age of sixty were reviewed for medication use, comorbid medical conditions, and anti-estrogen use. Results: The examined clinical guidelines and algorithms did not discuss the applicability of recommendations for older patients or those with multiple comorbidities. Fifty percent of patients in our sample had conditions where NSAID/COX2 use would be contraindicated. The median number of concurrent medicines at initial consult was 4. Patients >70 were significantly more likely to not receive adjuvant hormonal therapy (21% vs. 10%, p=0.025). Conclusions: CPG's do not address the applicability of treatments in patients with multiple comorbidities or the frail elderly. Older patients may be significantly less likely to receive adjuvant hormonal therapies. A significant proportion of patients in our sample had risks for SAE's from the use of NSAIDs, which are commonly recommended to manage arthralgias associated with hormonal therapies. Assessing commonly used hormonal treatment and side-effect management drugs for potential interactions with concurrent medications is an important clinical step in personalized therapy.

No significant financial relationships to disclose.
Palliative care (PC) education for medical students: An unresolved need
Authors: Sala R. A. , Zanini K. , Juarez S. , Rapelli C. , Pendido A. , Aronna A. , Fein L. E.
Published: August 2020

e20704

Background: Chapters contained in subjects other than PC lack the specificity and the integration of concepts to impact quality of care. Since 2005 an elective subject is part of the undergraduate curriculum of the medical school of the UNR. Teaching is case based in large groups with elective rotations to an acute care hospital PC team. Methods: To evaluate if this subject, as it is outlined, produces sensitization about PC, results of initial surveys (IS) (358) and final surveys (FS) (292) performed each year were compared and changes over time evaluated. Summary measures were calculated and hypothesis tests were done. Results: Students average age: 23 years. Female sex: 75.8%. Global answer rate of IS: 86.77% (range: 76.2% to 96%) and of FS: 76.65% (range: 68% to 85.9%). Composition of courses according to year of study. Quantity of IS and FS/ year. Differences in identification of the objectives of PC between IS and FS was statistically significant (p = 0.002) only in 2005. In 2006 (p = 0.195), 2007 (p = 0.318), and 2008 (p = 0.10) there was not statistical significance. Average 97.3% (range: 93% to 100%) of students considered the contents of the subject will impact in their practice and 95,75% (range: 91.5% to 98.5%) found them useful. 87% (range: 87.3% to 94.1%) positively changed their vision of interdisciplinary team work. Conclusions: Few students have a correct knowledge of PC at the beginning of the course; this knowledge is increased at the end of each course without reaching statistical significance except in 2005 (p = 0.002), when all the students were in the third year of study.

[Table: see text]

No significant financial relationships to disclose.
Dyspnea in oncologic patients as an important cause of attendance in emergency room
Authors: Serrano S. , Tobeña M. , Vidal M. , Ferrer A. , Millastre E. , Ruiz Echarri M. , Pajares I. , Lopez D. , Tres A. , Lambea J.
Published: August 2020

e20705

Background: Attending oncologic patients in emergency room because of a large variety of symptoms due to treatments or tumor complications is very common. Our objective is to estimate the prevalence of dyspnea in oncologic patients and its etiology. Methods: From October 2007 to October 2008 we recollected 560 oncologic patients who were seen on Emergency room. It was revised cause of consultation, tumors´ location and stage, active or palliative care, diagnosis and treatment. Results: 71 of the 560 patients (12.7%) related dyspnea as cause of consultation, being the third cause of attendance in Emergency room after pain (126 patients, 22.5%) and fever (98 patients, 17.5%). The most common tumor´s location was lung in 38 of the 71 patients (53.52%), followed by colorectal cancer (11.3%) and breast (9.9%). 76.8% were advanced oncologic patients (stage IV). Diagnosis was respiratory infection in 19 patients (26.8 %) followed by malignant pleural bleeding (10 patients, 14.1%), disease progression (9 patients, 12.7%) and pulmonary embolism (5 patients, 7%). Dyspnea was a multifactorial symptom in 21 of the 71 patients (29.6%) without an etiological diagnosis. In 47 patients (66.2%) was required admission with a mortal evolution in more than 50%. Conclusions: In oncologic patients dyspnea is a frequent cause of consultation in Emergency room with high rates of morbility and mortality. It affects to patients´quality of life. When etiology is diagnosed the most common is respiratory infection. We should make an effort to offer the best supportive care.

No significant financial relationships to disclose.
The effects of a brief relaxation program on heart rate variability in cancer patients
Authors: Asher A.
Published: August 2020

e20713

Background: Objectives were: (1) To characterize the physiologic changes of the autonomic nervous system, demonstrated by heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program for cancer patients. (2) To assess whether changes of HRV correlate with subjective feeling for anxiety, based on the Edmonton Symptom Assessment Scale (ESAS), and the summed ESAS score. Methods: 20 patients with any cancer diagnosis and normal cognition were recruited for the study. The ECG electrodes were attached and a 5-minute period of heart rate variability was recorded (HRVbefore) after 15 minutes of supine resting. The patient then began the brief relaxation program via recorded audio. Another 5 minute period of HRV was then recorded (HRVafter). The ESAS was completed before and immediately after the relaxation program. Parasympathetic activity assessed by heart rate variability, as measured by high frequency spectral analysis, was the primary outcome measure. The differences between the pre and post values of low and high frequency HRV, of the ESAS anxiety score, and of the summed ESAS score were compared using a Wilcoxan signed rank test. Results: No statistically significant differences were found in HF HRV power between the pre and post relaxation program. However, the summed ESAS scores were significantly lower after the relaxation program (p <0.001). There was also a trend of decrease in the ESAS anxiety score (p = 0.086). There was no correlation between the change in HRV HF and change in the ESAS anxiety score. Conclusions: A brief guided relaxation program can significantly improve symptoms as measured by ESAS, but not HF HRV power.

No significant financial relationships to disclose.
Pretreatment correlation between hemoglobin, unintentional weight loss, and inflammatory status in patient with advanced non-small cell lung cancer (NSCLC)
Authors: Capuano G. , Pavese I. , Satta F. , Burattini E. , Tosti M. , Palladino A. , Di Palma M.
Published: August 2020

e20718

Background: Anemia, defined as a hemoglobin level < 12 g/dL, is frequent in cancer and affect quality of life and performance status. Of all the pretreatment possible causes of cancer-related anemia, unintentional weight loss, early indicator of malnutrition, is often underestimated or completely ignored. The aim of this study is to evaluate the possible pretreatment correlation between hemoglobin level, recent unintentional weight loss (≥ 5% in the last three months) and inflammatory status (C-reactive protein ≥ 10 mg/dL) in NSCLC. Methods: 56 consecutive outpatients with NSCLC (IIIB - IV stage), 68% males, 32% females, were enrolled. Criteria for eligibility included absence of comorbidity (diabetes, hepatic or renal failure) and not previous oncological treatment All patients were evaluated for hemoglobin level (Hb), percentage of involuntary weight loss (WL) and C- reactive protein (CRP) before chemotherapy. Results: 25% of patients had a Hb level < 12 g/dL, 38% referred a recent WL ≥ 5% and 54% had a CRP ≥ 10 mg/dL. Hb was WL-related (p = 0.001) and not CRP-related (p = 0.160), WL was CRP-related (p = 0.022). In the subgroup of patients, the differences of haemoglobin concentrations were minimal, but stastically significant only when inflammatory status was associated with WL. On Table we reported the mean concentrations of haemoglobin as measured in the subgroups of patients. Conclusions: Our data suggest that an early and intensive management of weight loss might prevent or reduce anemia in NSCLC before treatment.

[Table: see text]

No significant financial relationships to disclose.
Acute allergic reactions to infusion chemotherapy in outpatient office practice
Authors: Mundia M. , Ali S. , Ali M. F. , Devlin D. , Nezhat F. , Mundia A. G.
Published: August 2020

e20722

Background: Outpatient chemotherapy/biotherapy in oncologist's offices are being utilized in greater numbers, increasing the risks of acute allergic reactions. Methods: The clinical charts of patients receieving prolonged infusion chemotherapy/biotherapy treatments (1–3 hours of infusion) in a community oncologist's office setting were reviewed to determine the rate(risk), management and outcome of severe acute allergic reactions. Results: From January 2007 to December 2008, there were 1453 patient infusions conducted. 653 infusions in 2007 and 800 in 2008. All patients were premedicated with antiemetics, H2 blockers if indicated and dexamethasone. In addition starting 2008 patients also recieved diphenhydramine 25mg. There were total of 15 aute allergic reactions. 10 patients with respiratory symptoms(cough/dysponea/wheezing), 3 patients developed anaphylactic reactions, and 2 patients developed rash. Chemotherapy infusions were promptly discontinued and appropriate resusitative measures instituted. The drugs to which reactions occured included 6 to docetaxel, 3 paclitaxel, 3 carboplatin. and 3 oxaliplatin. All patients responded to resusitative measures which included IV fluids, oxygen, subcutaneous epinephrine, IV dexamethasone, and IV diphenhydramine. None required assisted ventilation or cardio version. All patients were discharged home after 1 to 3 hours of observation. Conclusions: Acute allergic reactions to anticancer therapy must be anticipated in all cases. Appropraite preventive protocols and prompt response will minimize the morbidity and eliminate mortality.

No significant financial relationships to disclose.
Evaluation of nausea, vomiting, and diarrhea in oncologic patients at the emergency department
Authors: Ferrer Perez A. I. , Vidal Losada M. J. , Serrano Solares S. , Tobeña Puyal M. , Pajares Bernad I. , Lopez Sanchez D. , Ruiz-Echarri Rueda M. , Millastre Bocos E. , Lambea Sorrosal J. , Tres Sanchez A.
Published: August 2020

e20727

Background: Nausea, vomiting, and diarrhea are very common in cancer patients under palliative treatment. These usually can be controlled on an outpatient basis, although they can become extremely debilitating for the patient. It is not uncommon that patients come to the emergency department because of the rebelliousness of these symptoms. The aim of this study is to describe cancer patient population which consults for nausea, vomiting, or diarrhea in the Emergency Department (ED) of a tertiary hospital, their causes and clinical management. Methods: From October 2007 to October 2008, all cancer patients attended at the Emergency Department of our hospital were prospectively collected. The reasons for consultation, diagnosis and clinical management in the SE are described Results: Of 560 patients enrolled, 440 patients were stage IV disease. 54.8% of them ( 307 patients) were under palliative chemotherapy treatment at the time of consultation. 5.9% consulted for nausea or vomiting (33 patients), 3.6% (20 patients) consulted for diarrhea, 0.7% (4 patients) consulted for both. 57.5% of patients (19 patients) with nausea or vomiting, 90% (18 patients) with diarrhea and 100% (4 patients) with both symptoms were receiving chemotherapy at that moment. The most frequent causes of these symptoms were chemotherapy toxicity (52.6%) and acute abdominal pathology (15.8%). 24 patients (72.7%%) who consulted for nausea or vomiting, 12 patients (60%) who consulted for diarrhea and 3 patients (75%) who consulted for vomiting and diarrhea required at least 24 hours of hospitalization. Conclusions: Vomiting and diarrhea are very prevalent symptoms in oncology patients, but they are not frequent causes of demanding emergency attention. The most important etiology of these situations is the chemotherapy toxicity, followed by acute abdominal pathology. Most patients attended in ED because of these symptoms require hospitalization.

No significant financial relationships to disclose.
End-of-life care: Empowering cancer patients with information and choices
Authors: Tucker K.
Published: August 2020

e20739

Background: Terminally ill patients want information and choices, including aid in dying, as they confront death due to cancer and other terminal illnesses. Physicians treating such patients want to feel safe in having candid conversations with patients about their wishes and to provide aid in dying when appropriate. Methods: Review the law governing end of life decision making, including aid in dying. Review the data from Oregon, which has more than 10 years experience with a regulated practice. Review what has been learned in OR, and how that is transferring to other states making aid in dying an end of life option. Results: Oregon's experience shows that when aid in dying is a legal option for mentally competent terminally ill patients overall end of life care improves. Conversations between physicians and patients are more open and candid; Referrals to hospice increase and occur earlier; clinician enrollment in CE for pain and symptom management increase; rx of strong pain medication increase; more patients die at home; patients are comforted to have aid in dying as an option; there is no negative impact on the practice of medicine. Conclusions: Terminally ill patients should be able to recieve comprehensive counseling about all end of life options. There is a growing trend of support for expanding end of life options to include aid in dying for mentally competent terminally ill patients who find themselves trapped in an unbearable dying process.

No significant financial relationships to disclose.
The use of cannabinoids (CBs) for the treatment of chemotherapy-induced peripheral neuropathy (CIPN): A retrospective review
Authors: Gingerich J. , Wadhwa D. , Lemanski L. , Krahn M. , Daeninck P. J.
Published: August 2020

e20743

Background: CIPN is a common toxicity associated with the use of chemotherapy (CT) agents such as platinums, taxanes and vinca alkaloids. Patients (pts) may suffer from pain that adversely affects their quality of life, regardless of their disease trajectory. Preclinical research has shown CBs to be effective in preventing CIPN. CBs can be beneficial for cancer pain, although their specific benefit in pts with CIPN remains unknown. Methods: A retrospective chart review was conducted to identify all pts with CIPN treated with CBs at our institution between 7/07–10/08. Results: Eight pts were identified; 6 were male. Six pts had received platinum-based CT. Four had colon cancer. Four pts had metastatic disease. The median time to CIPN treatment (post-chemotherapy) was 4 months (0–84 months). All pts had 2+ neuropathy based on the NCI-CTC for Adverse Events. Pain improved in 7/8 pts with CB treatment. In those who responded, the improvement was as much as 7 points on an 11 point VAS. Two pts who transiently stopped treatment noted increased CIPN symptoms. Three pts eventually stopped treatment (1 due to side effects). Conclusions: Treatment with CBs appears to benefit some pts with CIPN. Further research is needed to explore the optimal use of CBs in pts with CIPN.

No significant financial relationships to disclose.
Systematic review of response evaluation in gastrointestinal stromal tumors
Authors: Verma S. , Macdonald B.
Published: August 2020

e21500

Background: Our purpose was to conduct an evidence-based systematic review of the literature on the accuracy of 18FDG PET - CT(PET) and contrast enhanced computer tomography (CT) in assessment of response to imatinib therapy in advanced gastrointestinal stromal tumor (GIST) Methods: A systematic review of the literature between January 2000 and December 2008 was performed on Medline and EMBASE. Inclusion criteria included prognostic studies or diagnostic studies using CT or PET to determine response to imatinib. Only articles with Level 1B or higher were included. The following variables were extracted: imaging modality (PET, In-line PET/CT, CT), response criteria used EORTC,RECIST criteria, or novel criteria), and the clinical outcome (time-to-treatment failure (TTF), time to progression (TTP), progression free survival (PFS), disease specific survival (DSS), and/or overall survival). The number of responders and non-responders was extracted from the data, and the reported log rank statistics for the Kaplan Meier curves were used to determine the strength of correlation between the responders and the clinical outcomes. Results: Five articles met the strict criteria for Level 1B evidence. Four articles met the inclusion criteria for In-line PET/CT. In these four articles the log rank correlation between In-line PET/CT response criteria described by the EORTC and the outcome measure of TTF ranged between. p=0.002 -0.04, a very high degree of positive correlation. A subset of four articles met the strict methodological inclusion criteria for CT using RECIST criteria. The log rank correlation for RECIST ranged from p=0.100 - 0.74, no significant correlation. Only one of the articles met the criteria for prospectively applying novel CHOI criteria with CT in a validating cohort. The log rank correlation with the TTF was p=0.0002, a very high degree of positive correlation. Conclusions: In-line PET/CT using EORTC criteria accurately predicts the response to imatinib in terms of TTF or PFS across four Level 1B studies. CT using RECIST criteria has a poor correlation with TTF in well designed studies and is not a useful predictor of response; consistently poor across four Level 1B studies. CT using CHOI criteria shows promise in a single Level 1B study

No significant financial relationships to disclose.