bluuebunny/crossref_metadata_2025_split huggingface dataset:
Phase I trial of IL-2 plasmid DNA with electroporation in metastatic melanoma
Authors: Richards J. M. , Gonzalez R. , Schwarzenberger P. , Whitman E. , Stardal K. , Westhoff C. , Moss R. , Strause L. , Selk L. 
Published: March 2020

8578 Background: Significant toxicity limits the systemic delivery of high-dose recombinant Interleukin-2 (IL-2). An alternative method for extended dosing of IL-2 that may reduce toxicity is by intratumoral injection of IL-2 plasmid DNA (pDNA) with electroporation (EP). Methods: A phase I dose-escalation trial is ongoing in subjects with metastatic melanoma to evaluate the safety of intratumoral delivery of IL-2 pDNA (VCL-IM01, Vical Inc., San Diego, CA) followed by EP (MedPulser DNA EPT System, Inovio, San Diego, CA). Eligible subjects have recurrent metastatic melanoma; an injectable lesion = 1 cm2 and < 25 cm2; ECOG 0 or 1; LDH = 1.5 × ULN, and no brain or liver metastases. In the dose-escalation stage of the trial, 3 subjects in each dose cohort received up to 2 cycles of treatment, each consisting of 4 weekly injections followed by a 4-week observation period. Dose levels included 0.5, 1.5, 5.0 mg/tumor, and 15.0 mg (5 mg in each of 3 tumors). A safety assessment was conducted for each cohort prior to enrollment of the next cohort. In the 2nd trial stage, 17 subjects are to be enrolled at the maximum tolerated dose (MTD). The observation period is shortened to 2 weeks between cycles. For all subjects, safety is assessed at every visit. Results: 12 subjects (7 male, 5 female) were enrolled in the dose escalation stage, 3 subjects at each dose. Ages range from 38 to 86 years. No Grade 3 or 4 adverse events (AEs) were reported related to study drug or procedures. All related AEs (12 reported) were Grade 1: 5 related to study drug, 4 to the EP procedure, and 3 to both. Injection site pain was the most common AE. No dose-limiting toxicities occurred; thus the MTD was defined as the 15 mg dose (5 mg/tumor in 3 tumors). To date, 6/17 subjects in Stage 2 of the trial (5 mg/tumor, up to 3 tumors injected) have been enrolled with no Grade 3 or 4 AEs related to study drug or injection/EP procedures. Physicians have observed responses in treated and untreated lesions. Overall response data will be presented. Conclusions: Intratumoral administration of IL-2 pDNA with EP appears safe and well tolerated in 18 patients with metastatic melanoma when given up to a 15 mg dose (5 mg/tumor). Preliminary indications of decreased tumor size suggest local and systemic activity of IL-2 pDNA with EP. No significant financial relationships to disclose.
Donepezil for cancer-related fatigue: A double-blind, randomized, placebo-controlled study
Authors: Bruera E. , El Osta B. , Valero V. , Driver L. , Palmer J. , Pei B. , Shen L. , Poulter V. 
Published: March 2020

9003 Background: Fatigue is the most frequent symptom in advanced cancer. No standard treatment is available. We previously found that open-label donepezil significantly improved fatigue by day 3 and 7 in patients (pts) on opioids for cancer pain (Fisch et al, ASCO 2003). The purpose of this study was to compare donepezil (D) with placebo (P) for fatigue in pts with advanced cancer. Methods: In this randomized, double-blind, placebo-controlled trial, pts with fatigue score = 4 on a 0 to 10 scale (10 = worst fatigue) for > 1 week, hemoglobin = 10g/dl for = 4 weeks, and no major contraindication to D were randomized to receive D 5 mg or P orally every morning for 7 days. All pts were offered open-label D during week 2. Assessment included: research nurse daily phone call for fatigue and toxicity evaluation, Edmonton Symptom Assessment System (ESAS), Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F), Sleeping Pattern Assessment, and overall effectiveness of the treatment. The FACIT-F fatigue subscale score on day 8 was considered the primary endpoint. Results: 103 pts were evaluable for final analysis. Mean difference in scores for symptoms intensity between baseline and day 8 are shown in Table 1 . FACIT-F fatigue subscale score at day 8 decreased a mean of 6 (10.6 SD) in the D arm (p < 0.001) and 7.2 (9.5 SD) in the P arm (p < 0.001). There was no significant difference in fatigue improvement between both arms according to the FACIT-F subscale (p = 0.57) and ESAS fatigue (p = 0.18) scores, and no significant difference in sleep quality score between D and P. On day 15 of the open-label phase, mean fatigue intensity remained significantly improved as compared to baseline on FACIT-F fatigue subscale (p < 0.001) and ESAS fatigue (p < 0.001) scores. No significant toxicities were observed. Conclusions: Both donepezil and placebo resulted in significant fatigue improvement. Donepezil was not significantly superior to placebo after one week. Our pilot findings are probably due to placebo effect. No significant financial relationships to disclose. [Table: see text]
Prevalence and severity of sleep disturbance in 596 cancer patients: A URCC CCOP study
Authors: Palesh O. , Mustian K. , Roscoe J. , Morrow G. , Perlis M. L. , Issell B. , Banerjee T. K. , Delmore J. E. 
Published: March 2020

9016 Background: Sleep disturbance is a prevalent and, potentially, chronic problem among cancer patients, persisting for many months and years after treatments. As part of a multi-center longitudinal survey of patients beginning cancer treatments, we prospectively investigated the prevalence and severity of self-reported sleep disturbance. Methods: 596 Cancer patients (mean age=61; 66.4%=female) receiving chemotherapy and/or radiation (37.1%=chemotherapy, 40.1%=radiation therapy, 22.8%=both) from 17 NCI CCOPs reported whether they experienced any sleep disturbance using an 11-point Likert Scale (0 = “Not present” to 10 = “As bad as you can imagine”) prior to treatments, during treatments, and 6 months after finishing treatments. A side effect level 7 was considered “severe.” Results: Sleep disruption was reported by 31.9% (median=2; 10.6% severe) at baseline, 77.2% (median=4; 28.5% severe) during treatment and 65.1% (median=2; 15% severe) at 6 months post-treatment. Repeated-measures ANOVAs revealed statistically significant treatment group (chemotherapy, radiation, or both), age (< 61 or ≥ 61 yrs), and gender by time interactions (all p<0.05). Sleep disturbance was significantly higher among survivors in the two groups receiving chemotherapy, younger survivors, and women (all p<0.05). Sleep disruption increased from baseline to post-treatment and decreased from post-treatment to 6 months post-treatment (all p<0.05). There were no significant differences between baseline and 6 months post-treatment. Conclusions: These results show that difficulties with sleep increase during cancer treatment. Patients who are at higher risk for having sleep problems are women, younger patients, and patients undergoing chemotherapy. Supported by NCI Grants U10-CA37420 and R25-CA102618 No significant financial relationships to disclose.
Dental health of long-term survivors of childhood cancer: The childhood cancer survivor study (CCSS)
Authors: Kaste S. C. , Baker S. , Goodman P. , Leisenring W. , Stovall M. , Hayashi R. , Yeazel M. , Hudson M. M. , Sklar C. , Robison L. L. 
Published: March 2020

9017 Background: This study describes the frequencies of and risk factors for altered oral health and dental development in pediatric patients who have survived childhood cancer. Methods: We identified 8,522 participants and 2,831 siblings in the CCSS with information on dental health. Dental outcomes of treatment and socioeconomic-demographic (SED) data, were analyzed using univariate and multivariate logistic regression models to estimate odds ratios (OR). Results: Survivors included 4,249 females (49.9%), 7,367 white non-Hispanic (86.5%). Median age at cancer diagnosis, 6.8y (range, 0–20 y); time from diagnosis to interview, 31.4 y (range, 17–54 y). Overall, 30% of survivors self-reported ≥ 1 oral-dental abnormality: microdontia (10%), hypodontia (8%), > 5 caries (55%), root stunting (6%), enamel hypoplasia (13%), gingivitis (7%). Compared to siblings, survivors were at increased risk of ≥ 1 oral-dental abnormalities when adjusted for SED (OR = 2.0, p<0.001). Increased risk of abnormalities was associated with being female (p<0.001) or white non-Hispanic (p=0.001), having an income < $20K (p=0.001) or lower education (p=0.004), and lack of health insurance (p=0.02). Patients with central nervous system tumors, neuroblastoma and soft tissue sarcoma had highest risk of abnormality (all P-values < 0.001). In multivariate models adjusted for SED, radiation dose to jaw, and exposure to increasing doses of alkylating agents increased risk of oral-dental abnormalities (radiation dose = 20 Gy OR = 5.6, p < 0.001; alkylating agent score OR=1.6, p<0.0001). Conclusions: Childhood cancer therapy results in adverse long- term oral-dental sequelae and is associated with specific treatment factors. No significant financial relationships to disclose.
Communication and understanding of prognosis among stage IV lung and GI cancer patients
Authors: Lehmann L. , Shaykevich S. , Weeks J. C. 
Published: March 2020

9024 Background: Patients' understanding of prognosis is essential to informed decision making about treatment options. There is little data on what prognostic information oncologists communicate to patients and what patients actually understand about their prognosis. Methods: We audio taped consultations between 90 newly diagnosed stage IV non small cell lung cancer patients and stage IV GI cancer patients and medical oncologists at academic teaching hospitals. Interactions were audio taped until patients arrived at a treatment decision. Audiotapes were digitized, coded and analyzed using the RIAS system. All conversation relating to prognosis was blocked, coded and analyzed. After meeting with an oncologist patients were surveyed about their understanding of prognosis and desire for information about life expectancy. Results: 276 patients were contacted of whom 190 consented to participate. 87 patients were ineligible, 13 patients withdrew from the study, and complete data were obtained on 90 patients. The mean age of participants was 62 years (±11), 65% were women. Analysis of the audiotapes revealed that in 78% of cases oncologists told patients that their cancer was not curable. When patients were surveyed, however, only 32% of those who were told that their cancer was not curable actually understood that there was no cure for their cancer (CI 0.19–0.45). Patients’ age, gender, education, and marital status were not associated with an understanding of prognosis. Patient factors associated with understanding of prognosis included a desire for good and bad medical information (CI 0.75–0.99; p<0.0001), an interest in knowing the likelihood that treatment would cure their disease (CI 0.54–0.94; p<0.01), and a belief that information about life expectancy would influence their medical decisions (CI 0.56–0.94; p<0.01). Conclusion: In a majority of cases oncologists actually told patients that their cancer is not curable. Most patients, however, did not understand what was communicated. Patients’ understanding of prognosis is determined not only by what oncologists communicate, but also by patients’ desire for prognostic information. No significant financial relationships to disclose.
Long-term toxicity monitoring via electronic patient reported outcomes in end-stage chemotherapy patients
Authors: Basch E. M. , Iasonos A. , Barz A. , Culkin A. , Kris M. G. , Artz D. , Fearn P. , Speakman J. , Scher H. I. , Schrag D. 
Published: March 2020

9025 Background: In cancer trials, clinicians are required to report patient toxicity symptoms using the NCI's Common Terminology Criteria for Adverse Events (CTCAE). Alternatively, patients could provide this information directly as patient-reported outcomes (PROs). This strategy is advocated by the FDA and is standard in non-oncology trials. But it remains unclear if this approach is feasible over long periods, or in patients with high symptom burdens. Methods: Lung cancer patients starting chemotherapy were selected for this feasibility assessment because they are relatively older, sicker, and less web avid than other cancer populations. A patient adaptation of the CTCAE was uploaded to a web portal for self-reporting, including 15 items common in this population. Over 16-months, participants were encouraged but not required to login and complete an online questionnaire at clinic visits via a touchscreen computer. Optional home access was provided without reminders. Results: Beginning in June 2005, 125 patients were approached and 107 enrolled. Reasons for refusal included “too distressed” and “dislike computers.” Mean enrollment was 42 weeks (1–71), during which 35% of participants died. The average number of clinic visits was 12 (1–40). At each consecutive visit most patients (75–85%) logged in without significant attrition over time, even up to the 40th visit. Reasons for failure to login included “lack of reminder” and “inadequate time.” Prior computer experience was associated with greater adherence (p=0.017), but there was no relationship with sex, age, education, stage, or performance status. Most (90%) found the system useful and would recommend it to others, but only 77% felt it improved communication. Although 76% had access to home computers, only 15% voluntarily self-reported from home. Conclusions: Self-reporting is a feasible long-term strategy for toxicity symptom monitoring in most chemotherapy patients, including those with high symptom burdens. In future evaluations, adherence may be improved with more consistent personal encouragement to login in clinic, electronic reminders for home users, consistent staff response to patients’ symptom reports and alternative data collection methods for those who fail to report electronically. No significant financial relationships to disclose.
Family caregiver satisfaction with early palliative care for advanced non-small cell lung cancer (NSCLC)
Authors: Greer J. , Pirl W. , Lynch T. , Billings J. , Jackson V. , Temel J. 
Published: March 2020

9027 Background: Historically, there has been no established role for palliative care in treating ambulatory oncology patients who are not at the end of life, but still struggling with the physical, psychosocial and spiritual aspects of cancer. Integrating palliative care services earlier in oncology care may help alleviate the suffering of patients with advanced cancer and family caregivers. This single-arm pilot study examines caregiver satisfaction with early palliative care services in patients with advanced NSCLC. Methods: Sample included patients within 8 weeks of diagnosis of stage IIIb with effusions or IV NSCLC and their family caregivers. Patients met with the palliative care team at least monthly until the time of hospice referral or death, completing assessments of quality of life (FACT-L) and mood (HADS) at baseline, 3, and 6 months. Caregivers rated their satisfaction with palliative care services using the FAMCARE. To identify predictors of caregiver satisfaction with care, patient scores from the FACT-L and HADS were entered into a linear regression model. Results: Fifty-one patients were enrolled (31 female, mean age=64.5 years), with 73% (n=37) identifying a caregiver who consented to participate. Of the 32 caregivers who completed a follow-up assessment, 84% (n=27) reported average FAMCARE scores in the “very satisfied” to “satisfied” range. Patients with worse physical (β=−.49, p=.003) but better social wellbeing (β=.55, p=.001) on the FACT-L at baseline had caregivers who were more satisfied with palliative care services at follow-up. Patient mood symptoms on the HADS were not related to caregiver satisfaction with care. Conclusions: The majority of family caregivers reported being satisfied with oncology care that included early palliative care. Patients with greater physical disability had caregivers who were more satisfied with care, which may be due to increased contact with the palliative care team. Also, patients who felt more supported by their families at baseline had caregivers who were more satisfied with care. While these data are encouraging, controlled longitudinal studies are needed to determine if these findings are actually the result of early palliative care services. [Table: see text]
Benzydamine for prophylaxis of radiation induced oral mucositis in head and neck cancers: Double-blind clinical trial
Authors: Kamian S. 
Published: March 2020

9042 Background: Oral mucositis is one of the most common adverse effects of radiotherapy in head and neck tumors. We determined the efficacy of oral rinse benzydamine in prevention of radiation induced mucositis. Methods: Patients with head and neck cancers were enrolled in a randomize, placebo-controlled clinical trail to receive either benzydamine or placebo. All the cases received at least 50 Gy radiation to the oral cavity and oropharyngeal areas. The end points were comparison of highest grade of mucositis at the end of radiotherapy, frequency of grade 2 or more, the interval days to establishing grade 2 in the groups. Results: 100 patients with head and neck cancers were randomized in this trail. At the end of the study, 19 patients were excluded of the analysis due to minor side effects of drug, or stopping the radiotherapy. In 39 cases in the treated group, the frequency of mucositis grade 3 or more was 43.6% (17 cases) in contrast to 78.6% (33 cases) in 42 cases in the placebo group, which was significant (p=0.001). Mucositis grade 3 or more was 2.6 times frequent in placebo group (CI=95%, relative risk=1.38–5). At the end of RT, at least 42% of the treated group had mucositis grade 3 or more in contrast to at least 76% in the control group which was statistically significant. Intensity of mucositis was increased up to forth week of treatment in both groups to grade 2. In the treated group the grade of mucositis was approximately constant to the end of therapy; but in the control group it raised to grade 3 (p<0.001). The highest grade of mucositis during the treatment time was significantly different between two groups (p=0.049). The median interval days of establishing grade 2 mucositis was 3.6 days sooner in the placebo group (p=0.12). Conclusions: According to these results it seems that oral rinse benzydamine was effective, safe, and well tolerated for prophylactic treatment of radiation-induced oral mucositis in head and neck tumors. [Table: see text]
A case control study on risk factors of lymphedema after axillary lymph node dissection for breast cancer in Hong Kong
Authors: Mak S. , Yeo W. , Mo K. F. , Tse K. Y. , Lee Y. M. , Tse S. M. , Ho F. P. , Kwan W. H. 
Published: March 2020

9048 Background: Lymphedema is a relatively common occurrence after treatment for breast cancer. Some of the causes are well known such as axillary surgery and axillary radiation therapy. However, many of the potential modifiable factors such as weight-bearing exercises and airline travel have been inadequately studied. Methods: A matched case-control study was designed to evaluate potential factors associated with lymphedema for breast cancer patients. Subjects were 202 women undergoing a unilateral axillary dissection for breast cancer, consisting of 101 cases with lymphedema and 101 controls without lymphedema who were matched cases in terms of surgery date, having received axillary radiotherapy or not and stage of cancer. Potential risk factors were collected by using clinical data and questionnaire. Two-arm circumferences were measured to determine presence and severity of lymphedema. A multiple logistic regression was used to obtain the adjust odds ratios for potential risk factors. Results: Adjusted odds ratio (OR) for lymphedema were separately 3.80 (95% CI 1.84- 7.87) for previous inflammation-infection, and 1.06 (95% CI 1.02–1.10) for an increase in one year of age at axillary dissection. Adjusted ORs for moderate to severe degree of lymphedema were separately 4.49 (95% CI 2.16–9.30) for previous inflammation-infection, 2.97 (95% CI 1.46- 6.03) for operation on dominant arm, 1.11 (95% CI 1.01–1.21) for an increase in 1kg/m2 body mass index at recruitment, and 1.05 (95% CI 1.01–1.10) for an increase in one year of age at recruitment time. Leisure activities requiring walking once a week to twice a week was a protective factor with adjusted ORs of 0.23 (95% CI 0.08–0.66) for developing lymphedema and 0.19 (95% CI 0.05–0.69) for developing moderate to severe lymphedema. Hypertension and tumor location at upper-outer or outer quadrant in breast were not important factors. Conclusions: Previous inflammation-infection and older age at axillary dissection are risk factors for initiating lymphedema. Previous inflammation-infection, operation on the side of dominant hand, obesity and aging are risk factors for aggravating lymphedema. No significant financial relationships to disclose.
Frozen sock use in the prevention of docetaxel-induced nails and skin toxicities: Results of a case-control study
Authors: Scotte F. , Banu E. , Medioni J. , Levy E. , Ebenezer C. , Marsan S. , Banu A. , Andrieu J. M. , Oudard S. 
Published: March 2020

9059 Background: Nails and skin toxicities (NST) of the hand occur in about 50% of patients (pts) treated with docetaxel (D). No clinical data exists on specific NST of the foot after D treatment. We prospectively investigated the efficacy and safety of an Elasto-Gel (Akromed, France) flexible frozen sock (FS) for the prevention of D-induced NST according to the results of a precedent study on the hand toxicities (JCO 2005). Methods: Cancer pts receiving D at 75 to 100 mg/m2 (one hour infusion q3w) alone or in combination were eligible for this matched case-control study. Each patient wore a FS for a total of 90 minutes (min) on the right foot (15 min before to 15 min after D-infusion). The left foot acted as control was not protected by FS. NST were assessed at each cycle using NCI-CTC version 3 criteria and documented by digital photography. Comfort in socks wearing was assessed using an ad-hoc scale. Wilcoxon matched-pairs ranks test as a non-parametric method was used to determine the magnitude of the difference in terms of nails and skin toxicities between two matched groups. Results: Forty-nine pts were included: median age 64 years, M/F: 37/12, ECOG performance status 0/1/2 (%): 46/39/15, type of cancer (%): prostate: 53; breast: 20; lung: 18; others: 8. Nails toxicities were significantly lower in the FS-protected foot compared with the control foot (P=0.002, Wilcoxon test). Grade (G) of nails toxicities were (FS vs. control %): G0 100 vs. 80, G1–3; 0 vs. 20. Skin toxicity was not significantly different (P=0.18) with a low incidence of disorder (%) G0: 94 vs. 90, G1: 2 vs. 4, G2: 0 vs. 2 (missing data for 2 pts). Median time until nails toxicities occurrence was not significantly different between feet: 97 days with FS vs. 74 days in control foot. Skin toxicity occurred in both sides after a median of 96 days. FS comfort satisfied 74% of patients. Conclusions: Frozen sock significantly reduced nails toxicities of the foot associated with docetaxel treatment. No significant financial relationships to disclose.