bluuebunny/crossref_metadata_2025 huggingface dataset:
Safety and tolerability of 1-hour intravenous infusion of tremelimumab (CP-675,206) in patients with surgically incurable stage III or IV melanoma
Authors: Chesney J. , Ribas A. , Gonzalez R. , Gordon M. , Gomez-Navarro J. , Marshall M. A. , Huang B. , Hsyu P. , Gernhardt D.
Published: August 2020

e20016

Background: In previous tremelimumab clinical trials, monoclonal antibody was infused over 3–5 hours. Shorter infusion times would be more convenient. Therefore, this study assessed safety and tolerability of tremelimumab 1-hr infusion. Methods: This ongoing study is an open-label, multicenter, phase I clinical trial evaluating safety and tolerability of tremelimumab (15 mg/kg 1-hr infusion every 90 days for up to 4 doses) in patients with surgically incurable stage III or IV melanoma. Primary endpoint was any tremelimumab-related adverse events (AEs) that occur from start of infusion to 1 hr post-end of infusion of Dose 1 and either prevented full dose from being administered or were ≥ grade 3. Results: Forty-five patients (71% male; median age, 59 years) were enrolled and received ≥ 1 dose of tremelimumab. Patients experienced no AEs during first infusion that met criteria for the primary endpoint. With a 1-sided exact binomial test at 10% significance level (α=0.10), p value was 0.099 (<0.10). Therefore, the null hypothesis (H0: infusion-related reaction rate ≥ 5%) was rejected. Four (9%) patients reported a mild to moderate AE during or within 1 hr after first infusion. These included 1 patient each who experienced grade 2 hypertension (considered unrelated to tremelimumab by the investigator), grade 1 hypotension, grade 2 hypersensitivity, and grade 1 transient flushing. Mean (SD) Cmax (n=32) was 325 (66) μg/mL, mean (SD) AUC (N=16) was 102,000 (35,000) μg×h/mL, and mean half-life was 20 days. These single-dose PK results were similar to those from previous studies using 3- to 5-hr infusion times, suggesting that 1-hr infusion of tremelimumab did not significantly alter PK. No human-anti-human antibodies were detected in any patients. Conclusions: In patients with advanced melanoma, 1-hr infusion of tremelimumab resulted in a safety profile during infusion that was consistent with tremelimumab studies using longer infusion times, and single-dose PK analysis did not reveal any perturbations in tremelimumab distribution or clearance. Therefore, a more convenient 1-hr infusion is a reasonable option for administration of tremelimumab.

[Table: see text]
A pilot study comparing objective physical activity to the physical component of the Eastern Cooperative Oncology Group (ECOG) performance status scale
Authors: Walsh J. , Hussey J. , O'Donnell D.
Published: August 2020

e20501

Background: The ECOG performance status (PS) scale is widely used in oncology for clinical decision-making, being a good predictor of survival, prognosis, and treatment response. It has never been formally compared to objective measures of physical activity (PA). Accelerometers are now established as detailed valid measures of PA. The aim of this study was to compare the ECOG PS scale to objectively measured PA. Methods: Accelerometer data (RT3) as well as self-report (International Physical Activity Questionnaire (IPAQ)) was collected for at least 3 days immediately before cancer outpatient assessment on 15 patients (6 males, 9 females) with a mean age of 65 years (range 47–51), all with solid tumours. RT3 and self-report data were compared to the ECOG PS score assigned by the treating physician. Time ‘up and about’ is all activity, however minimal, detected by the RT3, except lying flat. Institutional ethics committee approval was gained. Results: Most subjects were assigned an ECOG score of 1. In all subjects, the score assigned over-estimated PA levels ( Table ). Spearman's rank correlation coefficient showed poor correlation between percentage waking time ‘up and about’ and the ECOG PS score assigned (p = -0.1), and between the IPAQ and ECOG scores (p = 0.1). Conclusions: Although ECOG PS is recognized as a good predictor of clinical outcome, a poor correlation was found between ECOG PS assigned, objective PA, and self-report. Subjects were far more sedentary than estimated using physician-assigned ECOG PS. A large study to investigate these relationships further is ongoing.

[Table: see text]

No significant financial relationships to disclose.
Pain and analgesic use in men with metastatic prostate cancer
Authors: Basch E. M. , Sit L. , Fruscione M. , Burke L. , Kane R. , George D. , Carducci M. A. , Matthew P. , Beer T. M. , Scher H. I.
Published: August 2020

e20515

Background: Pain is an important endpoint in metastatic prostate cancer and was the basis for the 1996 FDA approval of mitoxantrone. Standards for pain assessment have evolved, and a 2006 draft FDA guidance provides new recommendations for patient- reported outcomes. Contemporary palliation models generally require pain reduction starting from baseline worst pain scores of ≥4/10, and progression models require a sufficient proportion of patients’ pain scores to worsen in order to assure an adequate effect size. The prevalence and distribution of pain severity at specific points in the prostate cancer disease continuum are not well defined. Consequently, it is unclear if sufficient numbers of patients are available to conduct prospective studies using pain palliation or prevention as primary endpoints. Methods: A questionnaire that includes the Brief Pain Inventory and additional pain/analgesia items was developed as a collaboration between the DOD/PCF-supported Prostate Cancer Clinical Trials Consortium (PCCTC) and FDA Study Endpoints and Labeling Design (SEALD) team. IRB waivers were obtained for anonymous administration at 5 PCCTC institutions (Sloan-Kettering, Duke, Johns Hopkins, Anderson, OHSU). Administration is ongoing. Results: Between August-December 2008, 325 men with prostate cancers representing different disease states being seen in outpatient clinics of participating centers were each queried once. Median age was 70 (range 49–87). More than half (n=175) self-reported metastatic disease, including 129 with bone metastases. Among those with bone metastases, 76 (59%) reported experiencing any level of pain in the last week; 49 (38%) reported a worst pain score ≥4/10 of which 38 (78%) used analgesics over the past week and 31 (63%) used daily analgesia. In addition, 70 of the 76 (92%) noted that their pain interfered with work, sleep, or enjoyment of life, with 25 (33%) noting severe interference. Among the 49 patients with pain scores ≥4/10, current or past docetaxel use was reported by 32 (65%), androgen deprivation therapy by 47 (96%), and 28 (57%) had been or were currently enrolled in a clinical trial. Conclusions: Pain is sufficiently prevalent in men with metastatic prostate cancer to enable prospective assessment of palliation endpoints in clinical trials.

No significant financial relationships to disclose.
Metoclopramide versus setrons in delayed emesis in moderate emetogenic chemotherapy: A meta-analysis
Authors: Jordan K. , Mueller F. , Hinke A. , Behlendorf T. , Feyer P. , Roila F. , Schmoll H. J.
Published: August 2020

e20538

Background: In the actual antiemetic ASCO and MASCC guidelines 5-HT3-RAs but not metoclopramide (MCP) are recommended as prophylaxis option for delayed emesis (DE) in moderate emetogenic chemotherapy (MEC). However, MCP was part of the former guidelines in this setting. As there are no clear study results showing a consistent advantage of 5-HT3-RAs over MCP in delayed emesis a metaanalysis would give more conclusive informations. Methods: In a Medline search 15 potential studies comparing a 5-HT3-RA vs. MCP in DE in patients receiving MEC were identified. Efficacy was classified as complete delayed response (no vomiting 24h-120h after chemotherapy). In 4 studies insufficient data for discrimination of acute and delayed emesis were given and in 5 studies additional antiemetics in one arm or MCP/ 5-HT3-RA were administerd only on demand. For each indivudual study odds ratio was calculated. Combined odds ratios were generated according to the methods developed by the Peto group. Results: Six studies (N=700) could be included in the final analysis. The comparison of 5-HT3-RAs and MCP revealed similar efficacy in the prevention of DE in patients receiving MEC (OR fixed 1.01, 95% CI: 0.75, 1.36, OR random 1.26, 95% CI: 0.64, 2.46). A second analysis (N=895) including the study with additional dexamethasone application in the DE phase confirms no advantage of one drug over the another (OR fixed 1.02, 95% CI: 0.79, 1.22, OR random 1.19, 95% CI: 0.70, 2.04). Conclusions: This is the first meta-analysis of all available randomized trials comparing 5-HT3-RAs and MCP in the delayed phase of MEC demonstrating no apparent difference in efficacy. MCP is a less expensive alternative to setrons in this setting. However, the results of this meta-analysis have to be interpreted with cautious due to the potential carry over effect from the acute phase and heterogeneity of the included studies. Despite these limitations, it should be discussed to recommend MCP again for the propyhlaxis of delayed emesis for MEC when preparing the new antiemetic guidelines.

No significant financial relationships to disclose.
Human immunodeficiency virus/acquired immunodeficiency syndrome–related cancer in the pre- and post-highly active antiretroviral therapy era in a national cancer center of a resource-limited country: 1988 to 2007
Authors: Cuéllar Ponce de León L. E. , Miranda Rosales L. M. , Biminchumo Zagástegui C. , Rosales Cusichaqui R. , Flores C. , Mas López L. , León Chong J.
Published: August 2020

e20550

Background: The introduction of the highly active antiretroviral therapy (HAART) has changed the clinical course of acquired immune deficiency syndrome (AIDS) related to cancer. The goals were to describe the the characteristics of AIDS related to cancer before and after HAART in patients in a Hospital of a resource-limited country. Methods: This was an observational, retrospective and cross sectional study. Comparisons analyzed with X2 test. Survival estimated with Kaplan-Meier estimates. Results: The population included 426 (52.2%) patients. The mean age was 39 y.o. The main group was heterosexual 51.1%. The number of invasive cervical cancer (CC) and AIDS-related lymphomas (ARLs) increased in the Post HAART era; the number on non-HIV/AIDS related to cancer has decreased. During the first period none of patients had antiretroviral therapy, living patients was 62% in the Post HAART era (p< 0.01). Conclusions: The introduction of HAART has reduced the number of non-VIH/AIDS related cancer, but have increased the CC and LNH and improved the survival of patients.

[Table: see text]

No significant financial relationships to disclose.
Association of cytokines with quality of life among breast cancer survivors: A randomized pilot study exploring the effect of Tai Chi Chuan
Authors: Darling T. V. , Mustian K. M. , Heckler C. E. , Peppone L. J. , Janelsins M. C. , Morrow G. R.
Published: August 2020

e20556

Background: While advances in cancer treatment can increase breast cancer (BC) survival, cancer treatment side effects can decrease quality of life (QOL). Cancer cardiotoxicity is a major side effect of chemotherapy and radiotherapy that leads to cardiovascular disease (CVD). The combined burden of cancer and cancer cardiotoxicity drastically affects QOL. Cytokine-mediated inflammatory profiles are dysregulated by cancer treatments and are implicated in the pathogenesis of CVD. Tai Chi Chuan (TCC), an exercise mode with an energy expenditure equivalent to brisk walking, has been shown to improve cardiovascular function and QOL among BC survivors. The purpose of this pilot study was to explore how TCC affects cytokines and how cytokine changes are related to QOL changes among BC survivors. Methods: This pilot study compared the effects of 12 weeks (3, 60 min. sessions/week) of TCC with support therapy on IL-2 and IL-8 and on QOL among 21 BC survivors (mean age=51; range 33–78). Cytokine responses were obtained via serum ELISA and QOL were assessed via the FACIT measurement system pre- and post-intervention. Results: Mean levels of IL-2 decreased in the TCC group (CS=-8.82) but increased in the control group (CS=4.60). Mean levels of IL-8 increased in the TCC group (CS=0.32) but decreased in the control group (CS=-3.82). ANCOVA, controlling for baseline, revealed no treatment effect for IL-2 but there was a statistical trend suggesting a possible treatment effect and baseline interaction for IL-8 (p=0.1). Bivariate analyses revealed a negative association between overall QOL and IL-8 (p=0.07), functional QOL (e.g. ability to work) and IL-8 (p=0.03), as well as physical QOL (e.g. energy level) and IL-8 (p=0.01) in the TCC group. Correlations also showed a negative association between overall QOL and IL-2 (p=0.05) and between functional QOL and IL-2 (p=0.005) among the control group. Conclusions: These findings suggest that TCC-induced changes in cytokines may be associated with changes in QOL, specifically in the physical and functional domains. Future research is needed to verify these pilot study findings and should focus on cardiotoxic effects associated with physical and functional QOL. NCI grant 1R25-CA102618 and Sally Schindel Cone.

No significant financial relationships to disclose.
Efficacy and safety of routine intravenous iron replacement therapy for chemotherapy-induced anemia in the community setting
Authors: Sen K. , Taylor W. C. , Shea T. C. , Peterson J. L. , Logue-Hunter J.
Published: August 2020

e20563

Background: Anemia occurs frequently during cancer chemotherapy and contributes to the development of fatigue. Erythropoiesis-stimulating agents (ESAs) are successfully utilized in this setting but recent studies have raised concerns regarding their potentially harmful effects. Iron deficiency, real or functional is a common problem among cancer patients. In addition to bleeding and poor oral intake new studies have hypothesized that cancers as well as chemotherapy can lead to overproduction of the hormone hepcidin that shifts usable iron to the storage pool. We hypothesized that chemotherapy induced anemia (CIN) could be reversed simply by increasing the supply of usable iron by intravenous iron infusion and adopted this practice empirically at our UNC affiliated community practice. Methods: We conducted a retrospective chart review of 50 patients with documented CIN. Each received treatment with intravenous iron preparations to provide between 1,000–4,000 mg of elemental iron over a period of 1–4 weeks based on serum iron and % saturation. The goal was to identify the frequency of transfusion, ESA use, adverse events and overall cost effectiveness of this approach. Results: Intravenous iron therapy (IIT) led to an average 3g/dL increase of hemoglobin in 80% of all patients with a hemoglobin level at or below 10g/dL during chemotherapy. Transfusion could be avoided in 95% cases. Total usage of ESAs to maintain the target hemoglobin level above 10g/dL during chemotherapy was reduced by 50% of the standard recommended dose. Total cost of infusing 1,000 mg of IIT was roughly 60% of a single 40,000 unit dose of erythropoietin. We recorded a 4% incidence of grade I-II and 2% incidence of grade III-IV adverse events but no fatalities. Adverse events were significantly more frequent among young females and Hispanics. Conclusions: A prospective study should be designed to confirm the encouraging result of this review. IIT may become a standard component of anemia management during chemotherapy. It appears to be safe and cost effective, can be given alone or in combination with ESAs and we found it suitable for routine use in community cancer clinics.

No significant financial relationships to disclose.
Use of percutaneous kyphoplasty to treat painful vertebral compression fractures (VCF) in solid tumors
Authors: Elrafei T. N. , Hazza M. , Tindel N.
Published: August 2020

e20568

Background: Vertebral compression fractures are a major source of morbidity in metastatic carcinoma. Kyphoplasty involves inflation of a balloon for painful kyphotic deformity restoring the vertebral body to its original height and creating a cavity for percutaneous injection of polymethylmethacrylate (PMMA). Contraindications include epidural spinal cord compression. Although it is FDA approved for cancer-associated VCF most of the data is in the myeloma population. Methods: We retrospectively assessed by electronic medical records the safety and efficacy of kyphoplasties performed by the orthopedic spine service in a single institution between 12/03 and 2/08. We identified those patients who had kyphoplasty as the only spine procedure and excluded those patients with incomplete documentation of pain scores. Comparison was made between patients selected for pathologic compression fractures and benign compression fractures secondary to trauma or osteoporosis. Results: Review of 447 consecutive orthopedic spine cases identified 40 kyphoplasty patients, 30 of which met the inclusion criteria - 21 with benign compression fractures secondary to osteoporosis/trauma and 9 with malignant disease (3 breast CA, 2 lung, 1 cervix, 1 RCC, 2 myeloma). 49 kyphoplasties and 23 concurrent spine biopsies were performed in this group. Median age was in the cancer group was 55 (37–81) vs. 68(41–93) in benign group. One patient had prior radiation in the cancer group. The average preoperative visual analog pain score was 7 (range 3–9) and postoperative pain score was 2.0 (0–9) in the cancer group. The average preoperative visual analog pain score 6.8 (0–9) and post-operative score was 0.8 (0–4) in the benign group. Most procedures did not require general anesthesia. There were no reported PMMA extravasations, and no hematologic or neurologic complications in either group. Conclusions: Kyphoplasty provided marked pain relief in patients with VCF secondary to solid tumors and myeloma. The results are comparable to non-cancer population in safety and efficacy, and are feasible in selected cancer patients with pain due to pathologic compression fractures.

[Table: see text]
A longitudinal evaluation of oral mucositis in patients receiving radiation therapy (IMRT) with/without chemotherapy (CTX)
Authors: Dodd M. J. , Cho M. , Miaskowski C. , Quivey J.
Published: August 2020

e20572

Background: Oral mucositis is a major side effect of RT ± CTX to the head and neck. A variety of instruments and techniques have been used to quantify oral cavity changes during treatment. Few studies have reported on the evaluation of oral mucositis using both subjective and objective methods. A secondary aim in our study testing an innovative mouthwash is to increase our understanding of using subjective and objective methods for measuring oral mucositis, functional status, and weight changes over time. Methods: Patients reported functional status, pain and investigators measured oral mucositis and weight at four times (beginning of RT [T1], onset of mucositis [T2], end of RT [T3], and healing of mucositis [T4]) over a 10 - 15 week period, using the Karnofsky Performance Status [KPS]) and the Oral Mucositis Assessment Scale (OMAS). The OMAS measures researcher-evaluated ulceration/pseudomembrane formation and erythema in specific sites in the mouth, and self-report by patients, rating severity of mouth pain, ability to swallow and chew. Results: Of 51 head and neck cancer patients enrolled, 3 never developed mucositis. Mean days to onset of mucositis was 15.58 (SD 6.85), and mean days to healing of mucositis was 77.86 (SD 40.1). Mucositis pain scores (possible range 0–45) were moderate at T2 (x=6.25, SD 3.5) and T3 (x=12, SD 5.0). Subjective pain, chewing, and swallowing scores were positively correlated with each other (r= .31 - .73, p<.05) and objective oral mucositis scores were positively correlated with each other (r= .49 - .77, p<.01), however, no significant correlations were obtained between the subjective and objective scores. In both the RT-only group as well as the RT+CTX group, weight significantly decreased from T1 to T4, and KPS significantly decreased from T1 to T3. RT+CTX patients showed lower KPS and greater weight loss from T1 to T4 (X=10lbs) compared to the RT-only group (X=3 lbs), but neither was significantly different. Conclusions: During RT+CTX, patients need more supportive care to maintain functional status and avoid weight loss. Lack of correlations between the subjective and objective scores is interesting in that they are measuring something quite different, which may provide some insight into underlying mechanisms.

No significant financial relationships to disclose.
Renal function evolution in cancer patients. Results of the IRMA-2 study
Authors: Oudard S. , Janus N. , Gligorov J. , Beuzeboc P. , Ray I. , Morere J. , Spano J. , Pourrat X. , Deray G. , Launay- Vacher V.
Published: August 2020

e20574

Background: In 2007, the IRMA-1 study reported the high prevalence of renal insufficiency (RI) in cancer patients. Because of this high frequency, the IRMA-2 study started to investigate the evolution of renal function in cancer patients. Methods: Data were collected for cancer patients presenting at one of the 19 IRMA-2 centers in March 2005. Data included: sex, age, weight, serum creatinine (SCR), haemoglobinemia, type of tumour, metastasis (bone and/or visceral) anticancer drugs. Dialysis, myeloma and lymphoma patients were not included. Glomerular filtration rate was estimated with the abbreviated RD (aRD) formula at the inclusion. Patients were retrospectively followed during 2 years after the inclusion, every 6 months, from March 2005 (T0) to March 2007 (T24). Results: 4945 cancer patients (breast 1816, colorectal 747, lung 463, ovarian 294, prostate 251) were included in 19 cancer centre in France. Median age 60.0, mean weight 66.2, 62.8% were women. Mean GFR decreased from 90.8 ml/min/1.73m2 to 83.7 over the two years (table). Meanwhile, the prevalence of RI increased, reaching 62.9% and 17.5% for a GFR<90 and <60, respectively at T24 (table). Among the 4945 patients, 193 (7.6% of the 2525 patients who were alive at the end of the study) had a SCR determination at each time point. Among the 641 patients with a SCR at T0 and at T24, 41.6% of those with a GFR>=90 at T0 had a GFR<90 at T24. Furthermore, 17.7% of patients with mild renal insufficiency (60 to 90) at T0 had a GFR<60 at T24. Conclusions: IRMA-2 shows that renal function decreases rapidly in cancer patients with a loss in GFR of more than 3.5 mL/min/1.73m2 per year. This suggests that cancer patients are more exposed to a deterioration of renal function and that it should be closely monitored with at least a regular estimation of renal function, for instance every 6 months. So far, such a follow-up is not performed in clinical practice. Furthermore, drug therapy should be reevaluated, dosages adjusted when necessary, and some potentially nephrotoxic drugs changed for less or non-nephrotoxic drugs if possible.

No significant financial relationships to disclose.
Integrative medicine consultation with cancer patients: Does it affect patients concerns and well-being?
Authors: Frenkel M. , Peterson N. , Swint K. , Cohen L.
Published: August 2020

e20581

Background: Increased numbers of cancer patients are searching for additional options outside of their conventional medical care to improve their clinical outcome, quality of life, and overall wellbeing. Complementary and integrative medicine (CIM)) is one of the main options that patients are incorporating. The objectives of this study were to assess the outcome and value of an integrative medicine clinical consultation. Methods: Patients attending academic integrative medicine clinic evaluated their concerns and wellbeing using the Measure Yourself Concerns and Wellbeing (MYCaW) scale, a validated tool assessing outcome of complementary consultation for cancer patients. Prior to each visit patients completed the MYCaW and listed their two main concerns, the severity of the concern (0 = does not bother me at all to 6 = bothers me greatly), and their wellbeing (0 = as good as can be to 6 = as bad as can be). All patients met with a physician who provided an integrative consultation that included discussion of nutrition, supplements, exercise, useful complementary therapies, and the mind-body-spirit connection. At the follow up visit (usually 2–3 months later) patients completed the MYCaW to evaluate if the initial concerns were met. Results: Oncologists in the cancer center referred 197 patients for consultation about the integration of complementary medicine to their care. The majority of the participants were female (n=121), mean age was 56, range 21–90. Patients had been using a large range of CIM therapies including nutritional supplements (n=144), dietary changes (n=36), and acupuncture (n=33). The leading diagnosis was breast cancer followed by prostate cancer, but all major cancer diagnoses were represented. The leading concerns were related to “What else can I do?” and “How can I better cope?” From pre to post there was a reduction in severity of the concerns scores in 79% of patients, no change for 8%, and an increase for 13% (mean pre = 4.6; mean post = 2.6). For the question of Well being there was a reduction for 49%, no change for 32%, and an increase for 18% of the patients (mean pre = 2.5; mean post = 1.82). Conclusions: Integrative medicine consultations for cancer patients appear to be a valuable service that addresses patients’ main concerns and improves well being.

No significant financial relationships to disclose.
Zoledronic acid and atrial fibrillation in cancer patients with bone metastases
Authors: Aksoy S. , Dizdar Ö. , Turgut D. , Sener Dede D. , Arslan Ç. , Harputluoglu H. , Altundag K.
Published: August 2020

e20591

Background: Treatment with a bisphosphonate was linked with a significantly increased risk for atrial fibrillation (AF) in a few studies. Once-yearly infusions of intravenous zoledronic acid (ZA) was also significantly increased serious AF in postmenopausal women with osteoporosis. This study was conducted to determine the frequency of atrial fibrillation among cancer patients receiving the standard treatment of ZA. Methods: One hundred and twenty-four cancer patients who had bone metastasis receiving ZA were included in this study. All patients have been receiving 4 mg ZA at 4-week intervals; with each dose administered over 15 minutes. Patients who presented outpatient clinic for any reason (routine control, chemotherapy, ZA administration) a short survey completed and standard 12-lead ECG recordings were obtained. Results: One hundred and twenty-four cancer patients with documented bone metastases were evaluated. Mean age of the patients was 55 ± 13.0 years, 60% of the patients were female. Forty-one percent of the patients had breast cancer and 17% non-small cell lung cancer and the remainder had other solid tumors. Mean duration of ZA administration was 13.4 ± 15.0 months/patients. Mean total cumulative dose was 54 ± 15.0 mg per patients. 60 (48%) of the patients were treated with antracycline including regimens, and 37 (30%) were treated with mediastinal radiotherapy that might effect the heart. Twenty-three percent of the patients had hypertension, 10% diabetes mellitus, 7% currently smoker and 32% exsmoker, 3.7% myocardial infarction history, 1.9% congestive heart failure, and 1% valvular disease. On ECG evaluation; we observed sinus rhythm in 58%, sinus tachycardia in 15%, sinus bradicardia in 3.2%, ventricular exracystole in 5.7% of the patients. There were no AF. Conclusions: Although most of the patients were also having potentially cardiotoxic treatment, there was no increase in AF frequency in cancer patients who were treated with intravenous ZA. We believe that the risk of AF is small and may increase with age and comorbidity.

No significant financial relationships to disclose.
Predictive value for thrombosis of pre-chemotherapy D-Dimer in ambulatory cancer patients
Authors: Vicente E. , Gonzalez-Billalabeitia E. , Zafra M. , García-Martinez E. , Roldan V. , García T. , Lopez-Oliva J. , Macias J. , Vicente V. , Ayala F.
Published: August 2020

e20601

Background: Elevated D-Dimer (DD) is related with activated coagulation system. We pretended to assess if high DD is predictive of thrombosis in ambulatory cancer patients. Methods: We prospectively determined DD in plasma specimens from ambulatory cancer patients, without previous thromboembolic events (TE), before chemotherapy initiation. DD was determined with an immunological test in an automated coagulometer (IL D-Dimer test, Instrumentations laboratory). The selected cut-off point for DD was 1.5 x UNL, as it was the nearest point to the median DD. All thromboembolic events were recorded. Results: Between June 2007 and December 2008 eighty four patients were included, 66% with advanced and 34% with early disease. The most frequent tumours were colorectal 31%, breast 27% and genitourinary cancers 30% (12% HR prostate and 28% non prostate cancers). Antiangiogenic drugs were included in 24% of treatments (16% Bevacizumab and 8% Sunitinib). Median ECOG was 1. With a median follow-up of 6.5 months, 12 thromboembolic events were observed (5 PE, 3 DVT and 4 Arterial thrombosis). The following variables were included in the univariate analysis: high DD (>1.5 x UNL), low haemoglobin (Hb <10 mg/dL), high leukocyte, high platelet, high BMI and tumour location. High DD (HR = 6,25, 95% CI: 1,34–29,25; p= 0,02) and low Hb (HR= 6,17, 95% CI: 1,77- 21,53; p=0,004) were associated with increased TE. The high risk group in the Khorana index was also significant (p=0.02). In multivariate analysis both high DD (HR= 5,06, 95%CI: 1,05–24,48; p=0,044) and low Hb (HR=3,77, 95%CI: 1,02–13,97; p=0,047) remained significant. Conclusions: High pre-chemotherapy DD is associated with increased risk of thrombosis in ambulatory cancer patients.

No significant financial relationships to disclose.
Patient preferences for chemoradiation-related side effects
Authors: Sun C. C. , Ramondetta L. M. , Jhingran A. , Eifel P. J. , Crane C. , Phan A. T. , Frumovitz M. M. , Elting L. S. , Bodurka D. C.
Published: August 2020

e20604

Background: Patients (pts) undergoing chemoradiation (CRT) face intense treatment (tx) schedules and adverse tx- related side-effects (SEs). We conducted this study to determine whether pts’ preferences (PREFs) for CRT-related SEs changed over tx duration. Methods: We used the visual analog scale (VAS) and modified time trade-off (TTO) to assess PREFs of newly diagnosed pts with gynecologic (GYN) and gastrointestinal (GI) cancers scheduled to receive CRT. Pts evaluated 16 SE health state scenarios during interviews conducted at 3 points in time: T1=prior to starting CRT; T2=2–3 weeks after starting CRT; and T3=4–6 weeks after completing CRT. Using the VAS, pts ranked SEs on a scale of 0=worst to 100=best. The TTO asked pts whether they would accept a hypothetical tx for a specified time with the SE in question or a tx for a shorter length of time that involved a worse SE profile. PREF scores were converted to 0.0=least preferred to 1.0=most preferred. Mann-Whitney and Kruskal-Wallis tests were used to analyze data. P- values were adjusted for multiple comparisons. Results: PREFs were collected from 93 pts (GYN=43; GI=50). 46/93 pts were female (3 women were GI pts). Median age was 53.7 yrs. Pts received a median of 5 chemo cycles (31/50 GI and all GYN pts received platinum) and 5.4 wks of external beam radiation. Median time between T1-T2 was 2.6 wks and T2-T3 was 9.1 wks. TTO PREFs were stable over time regardless of disease group or tx regimen. VAS scores for 7 SEs worsened significantly after initiation of CRT and remained low despite completion of CRT ( table ). Pts gave low baseline PREF scores for diarrhea, fatigue, and loss of appetite; these did not change significantly over time. Conclusions: Pts receiving CRT were willing to accept tx of longer duration with less severe SEs instead of shorter tx with more severe SEs. Relative to other SEs, pts rated GI-associated SEs lower after initiation of CRT. Ratings remained low 4–6 weeks after tx completion. Further studies are needed to determine whether pts’ experiences with and perceptions of SEs influence tx compliance.

[Table: see text]

[Table: see text]
Oxaliplatin for colorectal cancer: Prevalence of delayed nausea and/or vomiting
Authors: Fleishman S. B. , Gorospe V. E. , Rosenwald V.
Published: August 2020

e20610

Background: Delayed nausea and vomiting (N&V) have been associated with cisplatin and carboplatin. Its prevalence with third-generation oxaliplatin was examined in patients (pts) receiving oxaliplatin-based regimens. Methods: 64 pts (53% male, 47% female) signed IRB-approved informed consent and were enrolled on day 1 of cycle 1. 53 (83%) pts had colon cancer, and received 85mg/kg of oxaliplatin, while 11 (17%) had rectal cancer, and received 65mg/kg. Age ranged from 29 to 84 years, with 65% between 50 and 69. Data was collected on the first chemotherapy cycle of 24 pts and the first and second cycles of 40 pts, for a total of 104 cycles. Baseline demographic data were collected by chart review and interview. Maximum grade of N&V for each cycle was assessed by the Functional Living Index - Emesis (FLIE). Pts also maintained a daily diary of nausea, vomiting, and anti-emetic usage for 7 days after each infusion. Results: 7 pts (11%) reported a history of motion sickness. History of morning sickness was reported by 13 (43%) of the 30 female pts. All pts received anti-emetics and steroids on day 1 of each cycle. 75% of pts received 5HT3 inhibitors only, 22% received 5HT3 + an oral NK-1 receptor antagonist, and 3% received an NK-1 receptor antagonist alone. Among 40 pts for whom data were collected on both first and second cycles, the occurrence of nausea was the same during cycle 1 and cycle 2: Grade 0 - 60% and 62% respectively; Grade 1 - 20% and 21%, Grade 2 - 20% and 21%. 41% of pts used rescue antiemetics (prochlorperazine, metoclopramide, or lorazepam) in cycle 1 and 43% in cycle 2. Men experienced no nausea 69% of the time, while women had no nausea in 41% of cycles. In 57% of cycles, no nausea was reported. In 88% of cycles there was no reported vomiting. Conclusions: Oxaliplatin-based regimens (65–85 mg/kg) caused minimal nausea and negligible vomiting, with a satisfactory response to 5HT3-inhibitor antiemetics and corticosteroids.

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Evaluation of AMG 531 in chemotherapy-induced thrombocytopenia (CIT): Results of a phase I/II study
Authors: Vadhan-Raj S. , Trent J. , Araujo D. M. , Patel S. , Zhou X. , Benjamin R. S.
Published: August 2020

e20616

Background: AMG 531 is a Fc-peptide fusion protein (peptibody) that increases platelet production by stimulating thrombopoietin (TPO) receptors. Prior studies have shown the importance of schedule of recombinant TPO to overcome cumulative thrombocytopenia (TCP) caused by high-dose chemotherapy with carboplatin (C), a late-nadir regimen, and doxorubicin and/or ifosfamide (AI), early-nadir regimen. Methods: The objectives of this study were to evaluate the safety and biologic activity of AMG 531 in CIT. Pts receiving high dose C (AUC=11) or AI received CT alone in the study cycle-1 and CT + AMG 531 in the study cycle-2 and subsequent cycles. At least 6 pts were enrolled at each dose level of AMG 531 (1, 3, and 10 mcg/kg). AMG 531 was administered SC as 2 doses given 2 days apart, starting from the day after CT (post-dosing schedule). An additional cohort of 6 pts received AMG 531 (10 mcg/kg) 2 doses administered as predose (day -5) and postdose given on day after CT (pre-/postdosing schedule). Results: Twenty-four of the 27 pts enrolled received the study drug and are evaluable. Treatment with AMG 531 was well tolerated; one pt experienced pulmonary embolism during cycle-6. In the 4 pts that received C with AMG 531 (1 mcg/kg) by post-dosing schedule, there was a reduction in duration of TCP (days < 100,000/mm3; 10 vs 7, p = 0.023, and days < 50,000mm3; 6 vs 2, p = 0.001, in cycles 1 and 2, respectively) and the PLT nadir count was stable (2 pts), increased < 2-fold (1 pt) or > 2-fold (1 pt) in C-2 as compared to C-1. In pts that received AI with AMG 531, there was a trend for increase in PLT nadir count with pre/post dosing schedule with a regimen known to cause cumulative thrombocytopenia from C-1 to C-2 ( Table ). Conclusions: AMG 531 is well tolerated and shows biologic activity in pts receiving CT. These findings suggest that postdosing may be effective with late-nadir regimen such as C. Ongoing study will determine if pre-/postdosing may be more effective with early-nadir regimens such as AI.

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Caspofungin for invasive aspergillosis: A single-centre prospective study
Authors: Bonini A. , Tieghi A. , Gamberi B. , Imovilli A. , Carbonelli C. , Spaggiari L. , Gugliotta L.
Published: August 2020

e20618

Background: Infections are the main complication for neutropenic patients (pts).Fungal infections represent a frequent cause of death. Caspofungin (Caspo) is the first drug able to inhibit the growth of the fungal cell wall. Methods: Since 2004 we began a prospective study with the administration of Caspo as first line therapy in 63 consecutive adult neutropenic pts. With persistent fever despite antibiotics,a chest CT-scan and galactomannan test were performed. In case of probable or proven infection Caspo was administered at the dose of 70 mg on the first day followed by 50 mg daily. They were 35 males and 28 females; the mean age was 56 yrs. The diagnoses were: leukemia 44, myeloma 3, lymphoma 16; the disease's phases were: new onset 24, remission 16, relapse 23. 12 pts received an allogeneic and 6 an autologous transplant; the others received conventional chemotherapy. Results: Fungal infections were proven in 12 and probable in 51 cases.The first site of infection was the lung in 62 pts. CT scan was positive(halo sign or air-crescent sign)in all the pts with a lung localization. BAL was performed in 37 pts.The mean time of treatment was 18 days. Caspo was well tolerated and not discontinued for adverse events. Among pts submitted to an allogeneic HSCT the concomitant therapy with Cyclosporin A was not influenced by Caspo. No adverse events during the infusion were seen, and it was not necessary to administer any premedication. The global (partial and complete) response was 50/63 (79%); 13 pts died for fungal infection. The responses were generally similar for probable and proven infections. No breakthrough infections were seen. All surviving patients, upon discharge from the hospital, received oral treatment with voriconazole. For all the cured pts, there was a concomitant recovery of neutrophils and this seems crucial for the resolution of the infection. Among the 50 responsive patients, 25 died later: 23 for hematologic disease and 2 for sepsis during recurrence of the malignant disease. In 2 pts there was the recurrence of the fungal infection. Conclusions: The resolution rate of the infections is very high; Caspo seems safe, it does not preclude any other treatment, it is well tolerated and the cost is lower than other antifungal treatments.

No significant financial relationships to disclose.
Corrleation of health-related quality of life (HRQL) of cancer patients and the mental component parameters of their family members
Authors: Vrettos I. , Papadopoulos A. , Kamposioras K. , Charitos D. , Giannopoulos G. , Pectasides D. , Niakas D. , Economopoulos T.
Published: August 2020

e20619

Background: It is widely experienced that health-related quality of life (HRQL) is greatly influenced in the family members of cancer patients. The aim of this study was to find the correlation of the HRQL parameters in cancer patients with the main mental component parameters of patients’ relatives. Methods: 122 cancer patients undergoing chemotherapy in our department (49 men and 73 women) of mean age 56.6 ±15.4 1SD and their 122 relatives that accompanied them (45 men and 77 women) of mean age 48.3 ±14.5 completed the validated SF-36 health survey by personal interview. The SF-36 health survey summarizes the functional health status and general health into eight scales with higher scores (0–100 range) reflecting better-perceived health. In this study, physical functioning (PF), role physical (RP), bodily pain (BP), general health perception (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH) of the patients were correlated with the SF, RE, MH of their family members using the Spearman's test. Data analysis was performed with SPSS version 13.0 and correlations were considered statistically significant when p<0.05. Results: Table 1 summarizes the results of our study. Social Functioning and Mental Health of family members are highly correlated with the HRQL parameters of cancer patients. The RE does not seem to be affected. Conclusions: HRQL of cancer patients undergoing chemotherapy is highly correlated with the SF and the MH of their relatives. This observation highlights the need to develop more oriented supportive programs for both the patients and their family memebers. Abbreviations: PF = Physical Functioning, RP = Role Physical, BP = Bodily Pain, GH = General Health, VT = Vitality, SF = Social Functioning, RE = Role Emotional, MH = Mental Health; NS=Not Significant. * = 0.05. ** = 0.01.

[Table: see text]

No significant financial relationships to disclose.
Chemotherapy in very elderly cancer patients (85 years and over): A retrospective study
Authors: Bascioni R. , Giorgi F. , Safi M. , Giustini L. , De Signoribus G. , Silva R.
Published: August 2020

e20632

Background: Elderly cancer patients (pts) population is expanding due to demographic changes. Currently 2.4 % of Italian population is older than 85, with this group accounting ∼8 % of all cancer pts in our geographic area. Since very elderly (85 years and over) cancer pts are generally excluded from clinical trials, few data are available about tolerability of chemotherapy in this population. Methods: We conducted a retrospective analysis of cancer pts aged 85 years and over receiving chemotherapy for advanced disease in the years 2005–2007 in three Oncology Unit of the Regione Marche, Italy. Results: We identified 50 patients (26 males, 24 females) with a mean age of 86.4 (range 85–95), ECOG PS 0 (4 pts) 1 (25 pts) 2 (13 pts) 3 (8 pts). Type of cancer (pts): NSCLC (13), colorectal (11), breast (5), prostate (4), gastric (3), NHL (3), bladder (2), head-neck (2), ovarian (2), vulvar (1), skin (1), pancreas (1), GIST (1), UPT (1). Main co-morbidities included hypertension (18 pts), COPD (8 pts) and heart disease (6 pts). The median number of cycles in first line chemotherapy were 6 (1–44); 20 pts received 2 or more lines of chemotherapy (range 2–5). Dose reductions were planned in all pts: in 26 dose reduction was 30 %, in 22 was 50%, in 2 > 50 %. Most used drugs were: vinorelbine os or iv (14 pts), capecitabine (9 pts), gemcitabine (7 pts). Target agents were used in 7 pts (5 erlotinib, 2 gefitinib, 2 rituximab, 1 sunitinib). Ten partial responses were observed; main toxicities were: grade 3–4 neutropenia (10 %), grade 3 diarrhea (5 %), and 1 pts had grade 3 hand-foot syndrome. No treatment related deaths were observed. Conclusions: Very elderly cancer pts (85 years and over) in good PS and few co-morbid conditions receiving dose reduced chemotherapy experienced acceptable toxic effects; a partial response was documented in 10 out of 50 pts. The expanding use of chemotherapy and target therapy in this clinical setting has profound influence on health care management and costs. Prospective studies specifically designed for this pts population could clarify the benefit, in terms of quality of life and survival, of an interventionist instead of a supportive care only approach.

No significant financial relationships to disclose.
Factors affecting type of surgical treatment in patients with breast cancer
Authors: Garip M. , Gumus M. , Dane F. , Seker M. , Bilici A. , Ustaalioglu B. O. , Salman T. , Sönmez B. , Salepci T. , Yaylaci M.
Published: August 2020

e20633

Background: Many prospective randomized studies have shown that modified radical mastectomy (MRM) and breast conserving surgery (BCS) are equivalent in terms of overall survival. Patients’ social and cultural features and clinicopathological characteristics of the tumors generally influence the decision of selecting surgical type. Here, we aimed to evaluate the variables that affect the type of surgical resection in our patients’ population. Methods: One hundred patients undergone breast surgery with the diagnosis of breast cancer from December 2007 to March 2008 were included in the study. After detailed history taking and physical examination, all patients were given questionnaire evaluating sociodemographical data and parameters influencing their decision in choosing type of breast surgery. Results: Overall, 100 patients (80 MRM, 20 BCS) were evaluated in this study. Age was statistically significant predictive indicator in choosing BCS (p: 0.025). Nulliparous women were more likely to select BCS than multiparous (p:0,004). Patients who have the experience of breastfeeding less likely preferred BCS (p: 0.007). Having taken second opinion from a different breast surgeon about type of surgery during evaluation made patients select more BCS (p: 0.023). Although not statistically significant patients who had family history of breast cancer had selected MRM more than BCS (p: 0.088). Marital status, life assurance, age at first birth, and education status were not associated with the decision of selecting type of surgery. Conclusions: We concluded that cosmetic concern and risk of relapse affect the decision of surgical type in breast cancer patients. Broader efforts should be made to inform our patients about the results of BCS.

No significant financial relationships to disclose.
A systematic review of the impact of comorbidity on chemotherapy utilization and outcomes in solid tumors
Authors: Lee L. M. , Cheung W. Y. , Krzyzanowska M. K.
Published: August 2020

e20646

Background: The management of cancer patients (pts) with comorbidities can be challenging as these individuals are underrepresented in oncology clinical trials. We conducted a systematic literature review to determine the impact of comorbidity on utilization, tolerability, and efficacy of chemotherapy among pts with solid tumors. Methods: Using MEDLINE and EMBASE databases, all English-language articles published from 1990–2008 that explored the association between comorbidity and chemotherapy were identified. MeSH and keyword search terms included “comorbidity,” “chemotherapy” and “cancer.” All abstracts were manually reviewed for eligibility based on inclusion and exclusion criteria. Two reviewers independently abstracted data on the design and results of each eligible study, and rated the quality of the article using the STROBE checklist. Results: Of 1,031 citations retrieved by the search, 29 articles met inclusion criteria. Study designs were too heterogeneous to permit a quantitative summary and the overall quality of articles was poor. Comorbidity was investigated most frequently among pts with lung (41%), breast (17%), or colon cancers (17%). Most studies were retrospective (72%), based on cancer registry data (48%), and assessed the effect of cumulative comorbidity based on an index score (76%). Fourteen studies (41%) investigated access and 26 (90%) addressed survival. For pts with comorbidities, the majority reported decreased access (50%) and inferior survival (65%). Of the 12 articles that included both parameters, 6 showed that comorbidity was independently associated with worse survival while 4 demonstrated that impaired access to treatment, not comorbidity, was the stronger predictor of inferior outcomes. Few studies addressed toxicity (24%), ability to complete chemotherapy (7%) or response rates (7%). Among them, no differences based on comorbidity were noted. Conclusions: The evidence regarding the impact of comorbidity on chemotherapy utilization and outcomes among cancer pts is limited and of poor quality. Further better-designed studies are warranted to determine the relationship between decreased access and inferior outcomes and to better define the tolerability and efficacy of chemotherapy in pts with comorbidities.

No significant financial relationships to disclose.