bluuebunny/crossref_metadata_2025 huggingface dataset:
Phase II study of oxaliplatin, docetaxel, and sargramostim (GM-CSF) in patients with previously treated advanced melanoma
Authors: Locke F. L. , Clark J. I. , Gajewski T. F.
Published: March 2020

8570

Background: Although much focus has been placed on immunotherapy for melanoma, further development of chemotherapy approaches is needed. Melanoma is responsive to platinum compounds and taxanes, but there is limited experience with combinations of these agents. Oxaliplatin has been reported to have detectable activity in melanoma, and a phase I study has identified a tolerable dose and schedule of oxaliplatin in combination with docetaxel and hematopoietic growth factor support. GM-CSF has a theoretical advantage of immune potentiation. These considerations supported study of oxaliplatin, docetaxel, and GM-CSF in patients with advanced melanoma. Methods: Eligibility included intact organ function, PS=2, at most one prior chemotherapy and one prior immunotherapy, no prior treatment with oxaliplatin or taxanes, and no chremophor allergy. After premedication, docetaxel was administered day 1 at 85 mg/m2, then oxaliplatin on day 2 at 85 mg/m2. GM-CSF (5 μg/kg) was administered s.c. days 3–12. Cycles were 21 days in length, and disease reevaluation was performed every 2 cycles by RECIST criteria. Results: 20 patients were enrolled, 13 with 1 prior therapy, 5 with 2 prior therapies, and 2 previously untreated. Six patients did not complete 2 cycles and were not formally evaluable for response. One patient who failed 2 prior treatment regimens experienced a minor response and received 10 cycles of therapy, and 4 patients had stable disease. The rest showed PD after 2 cycles. Notable toxicities included 7 cases of grade III/IV neutropenia and 2 hypersensitivity reactions. Conclusions: This combination of oxaliplatin, docetaxel, and GM-CSF has limited clinical activity in previously treated patients with advanced melanoma. Exploration in treatment-naive patients may still be warranted.

No significant financial relationships to disclose.
Clinical outcome of metastatic melanoma involving the CNS with or without (w/o) intracranial hemorrhage (IHC)
Authors: Cheng T. , Scott J. N. , Eigl B. , Corbett P. , McKinnon G.
Published: March 2020

8577

Background: Melanoma has a high rate of ICH associated with CNS metastasis (mets). There is no data on the clinical outcome of these patients (pts) in the literature. Methods: A retrospective review of 52 pts with melanoma CNS mets diagnosed from 11/2001 to 09/2006 at our institution. Two pts were excluded due to a second malignancy. The clinical, radiological, and pathological characteristics of these pts were reviewed. Results: 39 pts were diagnosed after onset of neurological symptoms and 11 were diagnosed during staging. Of these, 14 (28%) were solitary, 23 (46%) were = 4, and 13 (26%) were multiple brain mets. Mean age at brain mets diagnosis was 55 years (range 24–88). Mean follow-up was 25 months (mos) (range 3–61) and 64% were male. ICH was found in 22 pts (44%) with 13 pts (26%) having frank hemorrhage on cranial CT and/or MRI scan. ICH was less common (9%) in pts with brain mets diagnosed on staging. 11 pts (8 with ICH, 3 w/o ICH) underwent CNS mets resection through craniotomy followed by whole brain radiation (WBRT) and/or stereotactic radiotherapy (STR). 7 pts received best supportive care. The remaining pts received WBRT and/or STR. The median survival (MS) for the entire group from CNS mets diagnosis was 7.6 mos. For pts with ICH, overall MS was 9.6 mos with MS of 21.2 mos for pts who underwent craniotomy vs 2.9 mos for pts w/o craniotomy. One pt refused therapy and later died from frank ICH. For pts w/o ICH, overall MS was 6.0 mos with MS of 21.3 mos for pts who underwent craniotomy vs 4.2 mos for pts w/o craniotomy. Pts who underwent craniotomy followed by WBRT and/or STR fared the best with MS of 21.2 mos. Of these, 2 pts with solitary brain mets (1 with ICH, 1 w/o ICH) were alive with no relapse at 58 and 53 mos respectively. The cause of death was disease progression in almost all pts and 85% of pts died from CNS disease progression. One pt died from post-operative complications of craniotomy. Conclusions: ICH by itself is not associated with a negative clinical outcome with appropriate clinical management. Aggressive surgical resection followed by radiotherapy in selected pts improves clinical outcome with prolonged survival possible in a minority of pts.

No significant financial relationships to disclose.
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.
Osteonecrosis of the jaw: Long-term follow-up shows variable rate of healing
Authors: Hu M. I. , Hoff A. O. , Toth B. B. , Altundag K. , Guarneri V. , Cui J. , Hortobagyi G. N. , Gagel R. F.
Published: March 2020

9061

Background: Osteonecrosis of the jaw (ONJ) is a rare but clinically significant disorder recently reviewed in a large retrospective study (Hoff et al, 42nd ASCO Annual Meeting 2006, Abstract #8528). A subset of the ONJ patients from that study with breast cancer or multiple myeloma (MM) was followed at the University of Texas M.D. Anderson Cancer Center (UTMDACC) dental clinic. This analysis describes the natural history of ONJ in this subset. Methods: Thirteen of 29 ONJ patients treated with intravenous bisphosphonates (IVBP) at UTMDACC and 1 treated elsewhere were evaluated in the dental clinic for > 6 months (MM, n=7; breast cancer, n=7). The maximum length of exposed bone was measured at each visit. Patients received a standard regimen of conservative dental care with debridement when indicated. Results: All 14 patients received zoledronic acid (median cumulative dose 72 mg; range 24–152) and 10 also received pamidronate (median cumulative dose 1,710 mg; range 90–2,700). They were followed for a median duration of 17.1 months (range: 7.1–67.3). The mean length of exposed bone at initial evaluation was 11 mm (SD: 8.4). Each patient demonstrated fluctuating clinical courses. The lesion from baseline to the last visit progressed in 7 patients (median increase of 13 mm), remained stable in 2, regressed in 2 and resolved in 3. Persistent ONJ was seen if IVBP was stopped (n=8), decreased in frequency (n=1) or continued at the same dose/frequency (n=2). Complete resolution occurred in 3 MM patients, where IVBP was discontinued, decreased in frequency or replaced by weekly oral alendronate. Conclusions: Our experience shows that ONJ resolved in 21% but persisted in the majority of patients with a duration of up to 5 years with conservative dental care. Further studies are needed to evaluate the pathogenesis and healing process of ONJ.

No significant financial relationships to disclose.
Measures of aggressive care in advanced non-small cell lung cancer (NSCLC) patients
Authors: McCannon J. , Jackson V. A. , Billings J. A. , Pirl W. F. , Greer J. , Lynch T. J. , Temel J. S.
Published: March 2020

9063

Background: Data suggests that cancer care has become more aggressive over the last decade. Patients with advanced NSCLC have a short life expectancy and achieve only a modest survival benefit from chemotherapy. Investigating the aggressiveness of care during and at the end of life (EOL) is a key first step to better understanding quality of care in this patient population. Methods: This exploratory study uses previously defined measures of aggressive care (Earle, JCO 22(2), 2004) to evaluate a small cohort of patients with advanced NSCLC. We performed a pilot study of integrated palliative care in good performance status (PS) patients with newly diagnosed advanced NSCLC, which has been previously reported. This is a retrospective chart review of patients accrued at Massachusetts General Hospital (MGH) using the electronic medical record and case report forms for data collection. Results: 46 patients were enrolled from 10/03 to 6/05 (median age 65.5, 28 female). 43 (93%) patients had stage IV disease and the remainder had stage IIIB with effusions. 45 (98%) of patients had PS 0–1. 39 (85%) patients died at the time of chart review with a median follow up of 29.3 months. Using Earle's data as a benchmark more patients in this study received and began new chemotherapy at the EOL. Patients were also more likely to present to the emergency room (ER) and be admitted to the hospital. While more patients were admitted to hospice before death, the length of stay (LOS) in hospice was shorter and many patients still died in acute care hospitals. Conclusions: This study supports the finding that current cancer care is aggressive with many patients receiving chemotherapy at the EOL and having a short LOS in hospice.

[Table: see text]

No significant financial relationships to disclose.
The effect of methadone on the QTc interval in advanced cancer patients
Authors: Reddy S. , Dalal S. , Swafford J. , El Osta B. , Pei B. , Palmer J. , Bruera E.
Published: March 2020

9064

Background: Methadone (ME) has been used increasingly for pain control and for maintenance in drug addiction programs. Its use is increasing in cancer patients (pts), mainly as part of opioid rotation. Some recent reports suggest that ME may prolong QTc interval and cause torsade de pointes in pts on high dose ME. The purpose of our study was to determine the effect of initiation of ME on QTc interval in pts with cancer pain. Methods: We enrolled 101 pts in this prospective study. These pts had never been on ME before. Pts were followed clinically and electrocardiographically for QTc changes from baseline. EKG was obtained at baseline (QTc0), 2 (QTc2), 4 (QTc4), and 8 (QTc8) weeks. We recorded other contributing factors for QTc prolongation such as medication interactions with ME and electrolyte disturbances. QTc is prolongation is defined as > 430 ms in males and > 450 ms in females. In our study, significant QTc prolongation was defined as = 10% increase from baseline or QTc = 500 msec. Results: 74 pts (73%) had normal QTc (group A) and 27 pts (27%) had prolonged QTc (group B) at baseline. Significant increase in QTc in group A males occured in 1 of 16 (6%) at week 2, 2 of 10 (20%) at week 4, and 0 of 8 (0%) at week 8. Significant increase in QTc in group A females occured in 3 of 32 (10%) at week 2, 1 of 21 (5%) at week 4, and 0 of 12 (0%) at week 8. These pts had multiple contributing factors for QTc prolongation. QTc > reference for males occured in 6 of 16 (37%) at week 2, 4 of 10 (40%) at week 4, and 1 of 8 (12%) at week 8; in females, 1 of 32 (3%) at week 2, 3 of 21 (14%) at week 4, and 1 of 12 (8%) at week 8 ( Table 1 ). 2 of 27 pts (7%) from group B had a significant prolongation at week 2: one of them had an increase from 498 to 509 ms, then to 512 at week 4 and 486 at week 8. Conclusions: Baseline prolonged QTc is a common finding. QTc prolongation = 500 ms is rare in pts receiving ME for cancer pain. No data exists for other opioids. There was one case of temporary increase in QTc > 500 ms. There was no evidence of severe arrhythmias or torsade de pointes clinically or on EKG. ME dose was = 50 mg/day in the majority of these pts.

[Table: see text]

No significant financial relationships to disclose.
Pre-admission escalation rate of daily opioid consumption (PERDOC), and total morphine equivalent daily dose on the first complete day of admission (D1-MEDD) to a tertiary-level palliative care unit (TPCU): Correlates and predictors in patients with advan
Authors: Lawlor P. G. , Nekolaichuk C. L. , Lowe S. S. , Kelly A. , Fainsinger R. L. , Watanabe S. , Bruera E. D.
Published: March 2020

9065

Background: Although animal laboratory studies attest to opioid tolerance (OT), it can be difficult in clinical practice to determine whether substantive escalation in opioid dose (average of >5% per day between initial daily dose and maximum daily dose to date) is due to disease progression (DP) or decreased opioid responsiveness, which in turn may be due to OT or other factors. Our study aims were to determine (1) the frequency of PERDOC>5%, (2) the correlates and predictors of PERDOC>5% and D1-MEDD. Methods: We retrospectively examined TPCU patient database records for demographics, physician rating of PERDOC in the Edmonton Staging System (ESS) for cancer pain classification, Edmonton Symptom Assessment System (ESAS) scores, and D1-MEDD. Consecutive 1st admission data on patients surviving >3 days were included in the initial analysis. Using complete data, logistic regression and multiple regression models were created with PERDOC>5% and logn D1-MEDD, respectively, as dependent variables. Results: From 1,351 patients who met the initial descriptive analysis eligibility criteria, 1212 (90%) had an ESS rating for PERDOC. The prevalence of PERDOC>5% was 274/1212 (19.3%). Bivariate analysis (N=969, complete data) showed that PERDOC>5% was positively associated (p<0.05) with younger age, neuropathic pain component (NPC), a pathological level of psychological distress (PLPD), substance abuse, higher D1-MEDD, and higher ESAS pain score (ESAS-P). In the multivariate analysis, NPC (Odds ratio: 2.1, 95% confidence interval: 1.5–2.9), PLPD (1.7, 1.2–2.6), and higher D1-MEDD (2.2, 1.03–4.7) were the strongest independent positive predictors, and ESAS-P (1.01, 1.003–1.02) remained as a weaker predictor. In the D1-MEDD regression model, positive predictors (p<0.05) were younger age, NPC, incident pain, PERDOC>5%, PLPD, ESAS-P and ESAS anxiety scores. Conclusions: Aside from OT and DP, the multiple predictors identified for PERDOC>5% and D1-MEDD underscore the need for a systematic multidimensional assessment of cancer pain that incorporates psychological and physical characteristics.

No significant financial relationships to disclose.
End-of-life decisions by adults with cancer: Role of religious practices and spiritual beliefs
Authors: Navari R. M. , Buckingham L. M.
Published: March 2020

9067

Background: Religious practices and spiritual beliefs may affect end of life care decisions. Methods: Adult patients with advanced common cancers (Stages III, IV; lung, breast, prostate, colon) who were within one year of their diagnosis and were receiving active treatment in two community oncology practices, were interviewed (30 questions, 20–30 minutes) during an outpatient office visit to determine the major influences on end of life decisions. Specific attention was given to advance directives, influences on end of life decisions, discussions with family and physicians, and the role of religious practices and spiritual beliefs. 353 consecutive patients were invited to be interviewed and 339 patients (median age 66.2 yrs, 52.7% female, 57% married, 58% Caucasian, 30% African-American, 62% Christian, 61% high school education) completed the interview and were evaluable. Results: Fifty-one percent of the patients had an advance directive. The major influences on end of life decisions were family discussions (63%), quality of life (56%), personal experiences (50%), religious/spiritual beliefs (48%), financial burdens (41%), physician discussions (39%), and specific individuals (10%). Factors associated with having an advance directive were religious or spiritual affiliation, participating in regular religious or spiritual practices, and having discussed end of life decisions with their family or a physician. Patients had little knowledge of their religion's specific recommendations on end of life care and had few discussions with a religious professional on these issues. Conclusions: Health care providers need to recognize the influences on end of life decisions, as well as the role of patients’ religious practices and spiritual beliefs.

No significant financial relationships to disclose.
African-American and caucasian female cancer patients’ cancer and treatment information needs and preferred information sources
Authors: Matsuyama R. K. , Grange C. , Lyckholm L. J. , Smith T. J.
Published: March 2020

9073

Background: Patients need information to maximize access to appropriate care, make informed decisions about treatment and communicate with their physicians and other healthcare providers. This study examined information needs related to cancer care and preferred information sources across ethnicities. Methods: A cross-sectional telephone survey was conducted with a random sample of 107 African-American and Caucasian female cancer patients from a university-affiliated cancer clinic. Descriptive analyses characterize patient demographics and information preferences. Multiple logistic regression tested variations in preferences by ethnicity. Results: There were significant differences in what African-American and Caucasian cancer patients considered their primary sources of information about their cancer and treatment. More African-Americans (36%) than Caucasians (9%) said they go to healthcare providers other than their physicians (e.g., nurses, nursing assistants, p=0.002) and use the library (14% vs. 7%) for information about their disease and treatment (p=0.002). Caucasian patients more often said they go to physicians (61% vs. 40%, p<0.01) or the internet (23% vs. 10%, p=0.04) for their information. More African-Americans (84%) than Caucasians (59%) rated information about counseling for emotional support as extremely important (p<0.01) and rated information about issues such as transportation and legal advice as extremely important (75% vs. 55%, p=0.05). There were no differences between ethnicities in desire for information about disease, treatment, side effects, and chances of getting better. Conclusions: All patients desired accurate and comprehensive information about their disease, prognosis and treatment. Significant differences were found between African-Americans and Caucasians in type and means of information. African-American patients were more likely to obtain information from providers other than physicians, and Caucasians were more likely to use the internet. These findings have implications for training professionals and developing programs to provide information to patients about their cancer treatment.

No significant financial relationships to disclose.
Poverty is not the main obstacle for quality cancer care in diagnosed cases: Experience of 520 cases from Bangladesh
Authors: Hoque E. , Hossain M. , Karim S. , Begum R. , Rahman M.
Published: March 2020

9077

Background: Cancer management is expensive everywhere. In the developing countries poverty is always blamed for as to be the main obstacle for quality cancer care. According to WHO report (globocan) 1.295 to 1.36 million people in Bangladesh suffer from cancer. Our health care service is not extensive to diagnose all these cases. A number of diagnosed cases do not get standard specific treatment of cancer. The objective of the study is to find out the main possible reason behind it. Methods: We made a prospective analysis of pre-diagnosis and post-diagnosis expenses using hospital documents & taken interview with specific questionnaire form of 520 cases regardless of age, indication and management who are treated from January 2002 to December 2005 in NICRH, City General Hospital & Bangladesh Medical College Hospital. We calculated the total expenses incurred to each case before specific diagnosis (EBD). These include all investigations, and non-specific treatment costs from the onset of symptoms up to the specific diagnosis. We have estimated the total expenses after diagnosis (EAD). This includes planned specific cancer management according to diagnosis. We made a ratio in percent between them (EBD/EAD×100). Results: 219 cases (42%) spent = 100% of EAD before diagnosis. 94 cases (18%) spent = 200% of EAD before diagnosis. The more this ratio, less the quality of management they could afford. Among them 349 cases (67%) failed to complete planned management, 57 cases (11%) failed to receive any planned management. Only 114 cases (22%) completed their planned management. Queries revealed that 78% patients who failed to complete planned management is due to their financial exhaustion for high pre-diagnostic expenses. Conclusions: We conclude that poverty is not the main obstacle for quality cancer care in diagnosed cases of Bangladesh. High unnecessary pre-diagnostic expenses, which result in financial exhaustion, is one of the major obstacles for quality cancer care. Further study is required to determine how to reduce the redundant pre-diagnostic expenses & find out other removable factors for quality cancer care in developing countries like Bangladesh.

No significant financial relationships to disclose.
Preliminary effects of bright light on sleep in women with breast cancer
Authors: Ancoli-Israel S. , Rissling M. , Trofimenko V. , Parker B. A.
Published: March 2020

9094

Background: Studies have shown that women with breast cancer undergoing chemotherapy report disturbed sleep. Studies have also suggested that these women have very little bright light exposure, yet it is known that bright light may improve sleep. We present preliminary data from an on-going study that addresses whether bright light improves sleep in women with breast cancer undergoing chemotherapy. Methods: 11 women (mean age=50.3 yrs, SD=8.4, range: 35–70 yrs) diagnosed with stage I-III breast cancer, scheduled to receive at least 4 cycles of adjuvant anthracycline-based chemotherapy participated. Sleep quality was assessed with the Pittsburgh Sleep Quality Index (PSQI) and objective measures of sleep were assessed with 72-hours of actigraphy (Ambulatory Monitoring, Inc. and Respironics) at baseline (pre-chemotherapy) and during the last week of cycle 4 (C4). Participants were randomized into two treatment groups: bright white light (BWL; n=7) and dim red light (DRL; n=4). Both groups were instructed to self-administer light therapy for 30 minutes every morning throughout 4 cycles of chemotherapy. Results: In the BWL group, total sleep time (TST) increased by 41 min (SD=69), while wake time stayed approximately the same. In the DRL group TST decreased by 32 minutes (SD=30), while wake time increased by 27 minutes (SD=39). Subjectively, PSQI sleep latency subscale for BWL was reduced from 2.6 (SD=3.0, range=0–5) at baseline to 1.9 (SD=2.3, range=0–6) at C4, while for DRL, mean sleep latency increased from 2.7 (SD=2.5, range=0–5) at baseline to 3.0 (SD=3.0, range=0–6) at C4. PSQI total score for BWL decreased from 12.0 (SD=4.7, range=7–19) at baseline to 10.9 (SD=4.2, range=5–16) at C4 while for DRL it decreased from 8.3 (SD=3.1, range=5–11) at baseline to 7.7 (SD=5.1, range=2–12) at C4. Conclusions: Preliminary results suggest that bright white light may increase the number of hours of sleep in women undergoing chemotherapy, as well as decreasing sleep latency and improving sleep quality. As additional data are collected, we will be able to establish the significance of these effects. Supported by: CBCRP 11IB-0034, NCI CA112035, Litebook Company and the research service of the VASDHS.

No significant financial relationships to disclose.
Procollagen-I-propeptide and β-crosslaps are prognostic markers for pretherapeutic estimation of treatment success of combined radio- and bisphosphonate therapy in patients with bone metastases—A phase-II study
Authors: Wagner W. , Radmard A. , Bach M. , Loitsch C. , Krukemeyer M. G. , Wiedemann G. J.
Published: March 2020

9096

Background: Multiple painful bone metastases are a common problem in patients suffering from breast and prostate cancer. Side effects of morphines can impair quality of life. Pain reduction can also be achieved by radiotherapy combined with bisphosphonates; however, this treatment is not successful in all patients. Methods: 35 patients with breast and prostate cancer suffering from painful bone metastases (multiple metastases in 29 cases, solitary metastasis in 6 cases: were locally irradiated (30 - 40 Gy over 3 - 4 weeks, conventional dose fractionation). In addition they received a bisphosphonate therapy (zoledronate). Before and after radiotherapy procollagen-I- propeptide and β-crosslaps were measured as parameters for the intensity of bone metabolism. Results: 24 patients experienced complete pain relief, 10 patients partial pain relief and one patient noticed no effect of treatment. The values of procollagen-I-propeptide (normal range 19–102 μg/l) and β-crosslaps (normal range <= 1,0 μg/l) were correlated with treatment success. At pretherapeutical procollagen-I- propeptide levels above 190 μg/l, all patients became entirely free of pain. All patients with β-crosslaps values above 0.5 μg/l became equally free of pain, irrespective of the number of metastases and tumour entity. The mean levels of procollagen-I-propeptide as well as β-crosslaps correlate directly and without exception with analgesia, reduction of pain or persistency of pain as final results. No correlation concerning the values was found before and after therapy. Conclusion: Procollagen-I-propeptide as well as β-crosslaps measurements before the beginning of a radio- and bisphosphonate therapy due to painful bone metastases are an excellent prognostic parameter to predict the success of therapy. Where high initial values (procollagen-I-propeptide > 190 μg/l or β-crosslaps > 0.5 μg/l) were measured, complete analgesia was achieved through therapy. Despite this clinically clear statement, a statistical significance with a t-Test was not evaluable at the current collection of patient data. Therefore, 20 more patients were examined; the results are yet to come.

No significant financial relationships to disclose.