bluuebunny/crossref_metadata_2025 huggingface dataset:
An attempt to correlate “comprehensive geriatric assessment” (CGA), treatment assignment and clinical outcome in elderly cancer patients: Preliminary results of a phase II open study
Authors: Mantovani G. , Astara G. , Massa E. , Madeddu C. , Tanca F. M. , Sanna E. , Spiga C. , Deiana L. , Saba F.
Published: April 2020

18599

Background: The aim of our study was to verify the feasibility of using the CGA as an effective instrumental tool for treatment assignment and verify its influence on clinical outcome in elderly cancer patients (pts). Methods: The study design was a prospective Phase II open study. Elderly (age ≥65 years) cancer pts were assigned to 3 different CGA categories (“Fit”, “Intermediate” and “Frail”): accordingly, an appropriate treatment was administered and the clinical outcome was assessed. “Fit” pts were assigned standard chemotherapy, “intermediate” pts tailored (chemo) therapy, “frail” pts monochemotherapy (as “supportive” therapy) or only “supportive” therapy. The primary endpoint of the study was to correlate CGA with treatment and clinical outcome which was based on: objective clinical response (RECIST), ECOG PS, toxicity (NCI CTC v.3), survival, quality of life. Patients who completed at least 3 months of treatment were evaluable. Results: At January 2006, 72 pts were enrolled (mean age 74.4 years, range 65–91, M/F 39/33), 35 of whom (34 stage IV) were evaluable: 5 were “fit”, 16 “intermediate” and 14 “frail”. At baseline no difference was found between the CGA categories in the clinical characteristics (M/F ratio, stage, tumor site) except for ECOG PS which was significantly higher in frail pts (ANOVA test). The objective clinical response to the assigned treatment was: 1 PR, 1 SD and 3 PD for “fit” pts; 1 PR, 9 SD and 6 PD for “intermediate” pts; 4 PR, 4 SD and 6 PD for “frail” pts. Comprehensively, the ORR was 17.1% and the median survival was 4.15 months; 25 out of 35 pts are alive. As for the correlation of CGA categories with treatment and clinical outcome, no difference was found in the clinical outcome variables after 3 months of treatment (ANOVA test). Our results are preliminary as the study is still in progress: the required accrual is at least 32 pts for each CGA category. Conclusions: The CGA assessment is strongly recommended as an essential component of the clinical evaluation of elderly pts. Large prospective clinical trials in this field are awaited. Work Supported by: MIUR, Rome, Italy: NRP No. 2004067078.

No significant financial relationships to disclose.
Complete rescue from established emesis by the NK-1 receptor antagonist, casopitant mesylate, in cisplatin-induced delayed emesis in the ferret
Authors: King A. G.
Published: April 2020

18601

Background: Postoperative and chemotherapy-induced nausea and vomiting (PONV, CINV) can be major complications in patients undergoing surgery or cancer treatment with emetogenic drugs. Nausea and vomiting may extend beyond the postoperative recovery period or in a delayed manner following chemotherapy. Prophylaxis with 5-HT3 receptor antagonists may fail in some patients, requiring the use of rescue medications. Selective NK-1 receptor antagonists provide incremental improvement in efficacy when used in combination with 5-HT3 antagonists and dexamethasone, both in preclinical animal models and in the clinical setting. Methods: The anti-emetic and anti-nausea properties of a potent and selective NK-1 receptor antagonist, casopitant mesylate ( GW679769 ), were evaluated in the ferret using single-dose rescue treatment in a cisplatin-based delayed emesis model. In the delayed model (72 hr), a single dose of saline, ondansetron, or casopitant mesylate was administered ip at 44.8 hrs post cisplatin (5 mg/kg, ip). This time corresponds to peak emetic frequency in this model. Results: Ondansetron (1 mg/kg) significantly delayed further emetic events for ∼8 hours post injection. Emetic frequency after this latency period then paralleled the saline treated group. In contrast, casopitant mesylate resulted in an immediate dose-dependent rescue from further emetic events, with minor effects on latency. Complete rescue from further emetic events were achieved at casopitant mesylate doses ≥0.5 mg/kg. Casopitant mesylate rescue treatment also reduced nausea-like behaviors in a dose-dependent manner; however, higher doses were required to achieve statistical significance. Conclusions: Single-dose ondansetron rescue treatment failed to reduce nausea-like behaviors. These unique results, along with previously described anti-emetic prophylactic activity, support the ongoing clinical evaluation of casopitant mesylate, which is currently in phase III trials for the prevention of PONV and CINV from moderately and highly emetogenic chemotherapy. It is also in clinical development for depression and anxiety.

[Table: see text]
Autologous tumor-derived HSPPC-96 vs. physician’s choice (PC) in a randomized phase III trial in stage IV melanoma
Authors: Richards J. , Testori A. , Whitman E. , Mann G. B. , Lutzky J. , Camacho L. , Parmiani G. , Hoos A. , Gupta R. , Srivastava P.
Published: April 2020

8002

Background: Vitespen (Oncophage; formerly HSPPC-96) is an autologous, tumor-derived, heat shock protein (gp96)-peptide complex vaccine that has shown signals of clinical activity in patients (pts) with metastatic melanoma, and colon and renal cancers. Methods: This phase 3 trial compares vitespen v. PC in AJCC stage IV melanoma. Pts had ECOG PS 0/1 and ≥7 g tumor tissue for vaccine production. Randomization was 2:1 favoring vitespen, and stratified by ECOG PS and AJCC substage (M1a, -b, -c). Vitespen was administered s.c. weekly for 4 weeks, then biweekly until vaccine depletion or disease progression (DP). PC treatment was any regimen including IL-2 and/or dacarbazine/temozolomide and/or tumor resection. Pts were evaluated every 3 months for 1st year, every 6 months for 2nd year, then annually until DP. Primary endpoint was overall survival (OS). OS data, based on ITT, were analyzed using 1-sided log-rank tests. Results: From Jan 2002-Sept 2004, 322 pts at 76 centers (US, Europe, Russia/Ukraine, Australia) were enrolled. 215 pts were randomized to vitespen, 107 pts to PC. Mean age was 55 y; 59% were male; ECOG was 0 in 71% of pts; 19% of pts were M1a, 24% M1b, 57% M1c. 62% of pts in vaccine arm received vitespen; median number of vaccines was 6 (range, 0–74). As of Sept 2005, 18 pts were in tumor evaluation phase, 53 in survival follow-up, 251 off-study (death, withdrew consent, lost to follow-up). Median follow-up time for vaccine and PC arms was 250 and 289 d, respectively. Estimated median survival for vaccine and PC arms was 281 and 322 d, respectively (P = .078). M1a pts in the vaccine arm survived longer than those in the PC arm (626 v. 383 d, P = .177). Survival was comparable in both arms for M1b pts (297 v. 320 d, P = .478), and longer in the PC arm for M1c pts (299 v. 226 d, P = .015). Impact of number of doses was examined using landmark analyses to correct potential biases. Pts who received ≥10 doses of vaccine survived longer than those who received PC (377 v. 478 d, P = .072). Conclusions: Vitespen confers qualitative survival benefit over PC for M1a melanoma pts. If 10 doses of vaccine can be administered, vitespen also appears to confer survival benefit over PC for M1b pts. A phase 3 trial evaluating vitespen in M1a and M1b pts is planned.

[Table: see text]
Methylation of circulating DNA in melanoma patients
Authors: Hengge U. R. , Marini A. , Mirmohammadsadegh A. , Nambiar S. , Gustrau A. , Ruzicka T.
Published: April 2020

8027

Background: DNA methylation is a well-known epigenetic phenomenon that occurs in higher order eukaryotes. Changes in the status of DNA methylation of tumor suppressor genes (TSG) is one of the common molecular alterations in many carcinomas. Methods: The purpose of this study was to investigate hypermethylation status of five different genes (TSG and cell cycle genes) involved in tumor suppression and DNA repair. Results: Serum before therapeutic intervention from 32 melanoma patients (stage I = 13; stage II = 9; stage III/IV = 10) was collected, cell-free DNA was isolated and sodium bisulfite conversion of genomic DNA was performed. The methylation status of CpG islands in the promotor region of SOCS1, SOCS2 (suppressors of cytokine signaling 1 and 2); RASSF1a (Ras-association domain family protein 1A); CDKN (D-type p16INK4a cyclin-dependent kinase inhibitor); and MGMT (O6-methylguanine DNA-methyltransferase) were analyzed using methylation specific-PCR (MSP). For comparison, sera from healthy controls (n = 20) and patients with other skin tumors (9 basal cell cancers, 5 Kaposi’s sarcoma) as well as different cancers (5 breast cancers, 5 colon cancers) were also analyzed. In addition, we examined if methylation was involved in silencing of these genes in 20 fresh melanoma specimens and we confirmed the hypermethylation status of SOCS2 using positional methylation analysis (pyrosequencing). Moreover, the expression of these genes was investigated cell lines (BLM, A375, MV3, and M13). Analysis of sera from cutaneous melanoma patients demonstrated circulating hypermethylated SOCS 1 in 59%, SOCS2 in 53%, RASSF1a in 53%, CDKN2a in 50%, while the MGMT did not show clear methylation pattern. Serum of healthy controls showed no methylation of any of the analyzed genes. The mRNA transcript of these genes showed a clear and significant downregulation, except for MGMT, for which an up regulation (7.3 times) was detected being consistent with the lack of promotor methylation. Detailed positional methylation analysis (pyrosequencing) has been performed for these genes and was found to correlate with mRNA expression in the tumor specimens in most cases. Conclusions: Analysis of positional methylation of circulating cell-free DNA seems to be a novel tool for molecular diagnosis in melanoma.

No significant financial relationships to disclose.
Cognitive impairment associated with chemotherapy for breast cancer: An exploratory case-control study
Authors: Booth C. M. , Vardy J. , Crawley A. , Rourke S. , Pond G. , Wagner L. , Tannock I. F.
Published: April 2020

8501

Background: There is evidence that some women suffer cognitive impairment after adjuvant chemotherapy (CT) for breast cancer and it may be sustained. We report a case-control study to explore underlying mechanisms with blood tests and functional imaging. Methods: Women diagnosed with breast cancer within 5 years were recruited to 3 groups of 20. Cases (group A) had received CT and self-reported cognitive dysfunction on a prototype FACT-COG questionnaire. There were 2 groups of controls: group B had received CT but did not report cognitive problems; group C had breast cancer but did not receive CT. Comprehensive tests of cognitive function (2.5 hr) were performed. Blood tests evaluated sex hormones, coagulation factors, 10 cytokines, and apolipoprotein genotype. Functional MRI (fMRI) scans were performed while subjects performed a mental task. Results: Currently, 60 women have completed FACT-COG, 39 have undergone neuropsychological assessment and 31 have completed fMRI; testing and analysis will be complete by May 2006. Median time from diagnosis was 2 years. There was increased self-report of cognitive impairment in CT vs non-CT patients (p<0.0001). Formal cognitive testing disclosed more impairment in group C (no CT) as compared to groups A and B: 29% vs 0% by classical tests (p=0.046), and 61% vs 47% and 25% (p=0.38) by computerized testing. This may be due to slight imbalance of demographic factors. Decreased activation in fMRI was seen in frontal areas and right parahippocampus of women who self-reported greater cognitive impairment (p<0.0005), while separate frontal areas show increased activity in women with greater objective cognitive impairment (p<0.0005). Patients who received CT reported more fatigue than non-CT patients (p=0.027). There was an association between fatigue and self-reported cognitive impairment (p=0.004) and anxiety and depression (General Health Questionnaire) (p=0.009), but not with objective cognitive testing. As yet there is no significant correlation between symptoms and cytokine levels. Conclusions: Self-reported cognitive impairment is associated with prior chemotherapy and changes in fMRI but not with formal cognitive testing. The larger sample size is required to confirm these changes and explore possible mechanisms.

No significant financial relationships to disclose.
Self-reported cognitive impairment in cancer patients: A URCC CCOP longitudinal study of 595 patients
Authors: Kohli S. , Griggs J. J. , Jean-Pierre P. , Mustian K. M. , Roscoe J. A. , Wade J. L. , Kuebler J. , Fishkin E. , Morrow G. R.
Published: April 2020

8502

Background: Patients undergoing cancer treatment often report cognitive impairment, manifested as problems with concentration and memory. Such cognitive problems may be noticed only by the patient. The purpose of this multicenter longitudinal study was to investigate the frequency and severity of self-reported problems with memory and concentration over time. Methods: Patients undergoing treatment for solid tumors self-rated problems with memory and concentration using an 11-point Likert Scale (0 = Not present to 10 = “As bad as you can imagine”) at baseline before treatment began (T1), at their worst during treatment (T2), and at 6 months following treatment (T3). Any symptom level ≥ 7 was classified as “severe.” T-tests, paired or independent as appropriate, were used to examine differences in symptoms over time and between patients treated with and without chemotherapy. Results: Of 595 participants, 356 (60%) received chemotherapy, with or without radiation and 239 (40%) radiation alone. Concentration problems were reported by 48% of all participants at T1 (5% severe), 67% at T2 (18% severe) and 58% (8% severe) at T3 (p < .001). Memory loss was reported by 53% at T1 (4% severe), 67% (18% severe) at T2 and 68% (11% severe) at T3 (p < .001). The average frequency and severity of both symptoms in patients receiving chemotherapy increased significantly between T1 and T2 (p<.001). Both symptoms were less severe in patients receiving radiation alone at all three measurements (all ps<.001). Symptoms at T3 were significantly higher than T1 for both groups (p<.001). Conclusion: Self-reported problems with memory and concentration are experienced by the majority of cancer patients who receive chemotherapy and radiation. The cognitive problems get worse during treatment and persist at least 6 months following. Controlled studies of interventions for problems of memory loss and concentration are warranted. Supported in part by a supplement from the Division of Cancer Control and Population Sciences, NCI, to Public Health Service grant U10 CA37420 and by NCI grant 1R25CA102618.

No significant financial relationships to disclose.
A randomized controlled pilot of home-based exercise (HBEX) versus standard care (SC) among breast (BC) and prostate cancer (PC) patients receiving radiation therapy (RTH)
Authors: Mustian K. M. , Morrow G. R. , Yates J. , Gillies L. , Boles C.
Published: April 2020

8504

Background: Cancer-related fatigue (CRF) is reported in up to 97% of cancer patients during RTH. 60% rate it as moderate to severe. Fatigue can significantly reduce functional capacity (FC), treatment compliance, and QOL. Although there is no standard treatment for CRF, aerobic exercise has demonstrated a positive influence on CRF and FC during RTH, but the influence of combined resistance and aerobic exercise is not clear. We explored the efficacy of a low to moderate home-based exercise intervention, including resistance and aerobic training, to SC on CRF and domains of FC (aerobic capacity and strength), in a sample of BC and PC patients during RTH. Methods: BC and PC patients (N=38; ξ age=56; 71% BC), beginning at least 28 sessions of RTH were randomized to a 4wk HBEX (7 days/wk) or SC condition, with CRF (FACT subscale), aerobic capacity (6-min. walk), and strength (handgrip dynamometry) assessments pre and post-intervention. Results: Change scores indicated improvements in the HBEX group (N=19) in CRF (ξ=3.6, SE=2.1) and aerobic capacity (ξ=43.6, SE=52.3), while the SC group declined in CRF (ξ=-1.1, SE=1.1) and aerobic capacity (ξ=-28.5 SE=71.6). Change scores revealed declines in strength among both groups, however the HBEX group showed smaller declines in strength (ξ=-.05, SE=0.7) compared to the SC group (ξ=-.80, SE=.91). T-tests using intent-to-treat indicated statistically significant between group differences on changes in CRF (ES=.63; p=.05) from pre to post-intervention, as well as significantly higher aerobic capacity (ES=1.3; p<.001) with a statistical trend toward lower CRF (ES=.51; p=.09) between groups post-intervention. Conclusions: HBEX improved CRF and aerobic capacity, while SC resulted in declines. HBEX reduced declines in strength compared to SC. Future phase III randomized controlled trials are needed with larger samples to fully investigate the influence of this HBEX intervention on CRF, aerobic capacity and strength. Funded by NCI grant 1R25CA102618.

No significant financial relationships to disclose.
Randomized trial of yoga in women with breast cancer undergoing radiation treatment
Authors: Cohen L. , Chandwani K. , Thornton B. , Perkins G. , Rivera E. , Arun B. , Raghuram N. , Nagendra H.
Published: April 2020

8505

Background: Yoga, an ancient Indian science, incorporates stress-reduction techniques that include regulated breathing, visual imagery, and meditation, as well as various postures that may be useful for cancer patients. Methods: A yoga program was developed that including loosening and breathing exercises, postures, alternate nostril breathing, a deep relaxation technique, and meditation for patients with breast cancer who were undergoing radiotherapy. Women participated in bi-weekly classes during their 6 weeks of radiation treatment. Sixty-one women with breast cancer were randomly assigned to either the yoga program or to a waitlist control group. Patients completed measures of intrusive thoughts and avoidance behaviors (Impact of Events Scale: IES), depressive symptoms (CES-D), sleep disturbances (Pittsburgh Sleep Quality Index), fatigue (BFI), and quality of life (SF-36) at baseline, 1 week, and 1 and 3 months after the last radiation therapy. We report on the outcomes 1 week after the end of radiotherapy. Results: The average age of the women was 52, 3% stage 0, 28% stage I, 43% stage II, and 26% stage III, 48% had undergone breast-conserving surgery, and 75% had received chemotherapy prior to starting radiotherapy. Analysis of covariance, controlling for baseline, revealed that the yoga group had significantly better SF-36 physical function scores (adjusted means: yoga 81.8 vs. control 68.6, P < 0.01), significantly higher SF-36 general health scores (adjusted means: yoga 78.3 vs. control 67.9, P < 0.03), marginally better SF-36 social functioning scores (adjusted means: yoga 85.3 vs. control 76.0, P > 0.1), significantly lower levels of sleep-related daytime dysfunction (adjusted means: yoga 0.5 vs. control 1.2, P < 0.04), and marginally lower levels of fatigue (adjusted means: yoga 1.9 vs. control 3.1, P < 0.06) than the control group. There were no other group differences on the SF-36 subscales or for the CES-D or IES scores. Conclusions: The results indicated that the yoga program was associated with statistically and clinical significant improvements in aspects of quality of life.

No significant financial relationships to disclose.
Osteonecrosis of the jaw in patients receiving intravenous bisphosphonate therapy
Authors: Hoff A. O. , Toth B. B. , Altundag K. , Guarneri V. , Adamus A. , Nooka A. K. , Sayegh G. G. , Johnson M. M. , Gagel R. F. , Hortobagyi G. N.
Published: April 2020

8528

There have been reports of osteonecrosis of the jaw (ONJ) in patients (pts) with metastatic bone disease (MBD) treated with IV bisphosphonates (IVBP). To estimate the frequency and identify risk factors for ONJ we performed a retrospective analysis of pts treated with IVBP. The cohort included 4019 patients identified through the MDACC pharmacy database (PD) treated with IVBP from 9/1996 to 2/2004, and 6 patients diagnosed with ONJ at the MDACC Dental Clinic. ONJ was defined as exposed non-healing bone of at least 3 months duration. Preliminary statistical analysis included 4000 patients. The most common diagnoses were breast cancer [BRCA] (1340), MM (550) and lung cancer (380).The indications for IVBP therapy included MBD (60%), hypercalcemia (25%), MM (14%) and osteoporosis (7%). We identified 34 patients with ONJ: 18 BRCA, 14 MM, 1 prostate cancer and 1 thyroid cancer. The frequency of ONJ was calculated by including patients from the PD only: 16/1338 (1.2 %) in BRCA and 14/448 (3.1%) in MM. Patients with ONJ received pamidronate [P] (6), zoledronate [Z] (10), combination of P and Z (15). The mean cumulative dose (MCD) of P was 2182 mg (720–4410) in MM and 2745mg (1980–3510) in BRCA. MCD of Z was 61 mg (24–152) in MM and 62 mg (28–110) in BRCA. The total doses of P and Z were significantly higher in the ONJ group VS NON-ONJ group (P<0.0001). Pts with ONJ had longer duration of disease and longer follow-up than NON-ONJ cases (P<0.0001). Univariate and multivariate logistic regression analyses (MLRA) revealed dental extractions (DE), ER positive tumors, and treatments with P and Z as significant factors associated with ONJ in BRCA pts. In MM, DE, periodontal disease and osteoporosis were significant factors. Further statistical analysis, including Cox regression analysis, is under way. ONJ pts were treated with aggressive oral hygiene, oral rinses, debridement of necrotic bone and antibiotics. 15 pts were followed at the dental clinic longer than 6 months. ONJ healed in 1, improved in 1, stable in 4 and progressed in 9 pts. In conclusion, ONJ is a significant but uncommon event. Higher doses of IVBP, longer treatment duration, DE, and periodontal disease are associated with a greater risk to develop ONJ. Good dental care and avoidance of dental interventions should be recommended to all patients treated with IVBP.

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A placebo-controlled trial of etanercept, a tumor necrosis factor (TNF) inhibitor, in patients with the cancer anorexia/weight loss syndrome. North Central Cancer Treatment Group (NCCTG) trial N00C1
Authors: Jatoi A. , Dakhil S. R. , Kugler J. W. , Rowland K. M. , Keit J. , Verdirame J. D. , Novotny P. J. , Sloan J. A. , Nguyen P. L. , Loprinzi C. L.
Published: April 2020

8534

Purpose: Tumor necrosis factor (TNF) is a putative mediator of the cancer anorexia/weight loss syndrome. This study was designed to determine if etanercept (a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton TNF receptor linked to the Fc portion of human IgG1) could palliate this syndrome. Methods: 63 evaluable patients were randomly assigned to etanercept 25 mg SQ twice/week versus a comparably-administered placebo, both of which were to be given for at least 12 weeks. All patients had an incurable malignancy, acknowledged loss of weight and/or appetite as a concern, and reported weight loss of > 5 pounds over 2 months and/or a daily intake of < 20 calories/kg body weight. The above sample size provided 81% power to detect a 24% difference in the percentage of patients who gained >/= 10% of baseline weight. Results: At baseline, groups were comparable on age, gender, tumor type, and degree of weight loss. Over time, weight gain was minimal in both groups; no patient gained >/= 10% baseline weight. Appetite questionnaires (the NCCTG Anorexia/Cachexia Questionnaire and FACT-AN) revealed negligible improvements in both groups. Median survival was comparable: 175 days versus 148 in etanercept-treated and placebo-exposed patients, respectively (p=0.82). Finally, preliminary data on adverse events showed that etanercept-treated patients had higher rates of neurotoxicity (29% versus 0%) but lower rates of anemia (0% versus 19%) and thrombocytopenia (0% versus 14%). Infection rates were negligible in both groups. Clinical correlative data on TNF genotyping will be available at the time of the meeting. Conclusion: This TNF inhibitor does not appear to palliate the cancer anorexia/weight loss syndrome. The study was supported by CA37404, the American Institute for Cancer Research, and Amgen.

No significant financial relationships to disclose.
Finding an appropriate dose of fentanyl effervescent buccal tablets for relief of cancer-related breakthrough pain
Authors: Weick J. K. , Tremmel L. , Messina J. , Portenoy R. K.
Published: April 2020

8564

Background: The recommended dose of a short-acting oral opioid used to treat cancer-related breakthrough pain (BTP) is 5%-15% of the equianalgesic around-the-clock (ATC) opioid dose used to control persistent pain; however, this dosing strategy may not be successful when oral transmucosal fentanyl citrate is used. The applicability of this strategy to fentanyl effervescent buccal tablets (FEBT) use was assessed as part of a multicenter study in opioid-treated patients with cancer BTP. Methods: This double-blind, randomized, placebo-controlled, crossover study required 63 evaluable patients for adequate statistical power. Eligible adults were to receive ≥60 mg/day morphine or equivalent for chronic cancer pain and to have experienced 1–4 BTP episodes daily. After open-label titration to an effective FEBT dose, patients were randomized to 1 of 18 predefined sequences of 10 tablets (7 FEBT, 3 placebo). Pain was assessed repeatedly after each dose; the primary efficacy variable was the sum of pain intensity differences at 30 minutes postdose (SPID30). Results: Of 123 enrolled patients, 77 found an effective FEBT dose (100–800 μg) and continued in the double-blind period; 72 were evaluable for efficacy. The SPID30 was 3.0±0.12 (mean±SE) for FEBT vs 1.8±0.18 for placebo (P<.0001). Ratios of the effective FEBT dose to ATC opioid or prior supplemental opioid dose showed no consistent trend (table). An effective FEBT dose showed no meaningful correlation with prior supplemental dose (r2=.094; Pearson’s coefficient=.3066), with ATC dose in patients using oral opioids (r2=.0609; Pearson’s coefficient=.2468), or with ATC dose in patients using transdermal fentanyl or combinations (r2=.1842; Pearson’s coefficient=.4292). Conclusions: There was no relationship between the effective FEBT dose and either ATC opioids or prior supplemental drugs. Therefore, titration, rather than use of a percentage of the ATC dose, is likely to be important in establishing an effective FEBT dose for each patient.

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[Table: see text]
Academic oncologists’ attitudes and practices regarding the care of cancer patients at the end of life
Authors: Dias L. , Lamont E.
Published: April 2020

8572

Background: Despite the fact that cancer is the second leading cause of death in the US and represents the most frequent diagnosis among hospice patients, little is known about the factors that influence oncologists in their decision making around end of life care. Methods: We surveyed all clinically active medical oncology attending and fellow physicians at two affiliated academic medical centers eliciting oncologists’ attitudes and practices regarding care of cancer patients at the end of life. Included in the survey were a series of randomized vignettes describing patients with advanced solid tumors. Oncologists were asked to describe their next treatment recommendations. Results: Of the 181 oncologists contacted for survey participation, 116 (64%) returned completed questionnaires. Sixty six percent (77/116) of respondents were attending physicians and 34% (39/116) were fellows. Sixty-five percent favored concurrent treatment with third-line chemotherapy and hospice if insurance would allow. Eighty percent (93/116) agreed that patients with advanced cancer should be able to receive hospice care even if they are receiving anti-tumor therapies. Results of randomized scenarios suggest that advanced patient age was positively associated with earlier referral to hospice care and that prior treatment on a clinical trial, although not statistically significant, was modestly associated with delayed referral to hospice (1.49, 95% CI 0.71–3.11). Conclusions: Among oncologists at two academic centers, chemotherapy is an important modality for management of advanced cancer patients at the end of life. Therefore, insurance policies that prohibit chemotherapy for hospice patients may constrain oncologists in their management of such patients.

No significant financial relationships to disclose.
Factors associated with fatigue in children with cancer at the end of life
Authors: Ullrich C. K. , Hilden J. M. , Sheaffer J. W. , Moore C. L. , Berde C. B. , Weeks J. C. , Wolfe J.
Published: April 2020

8574

Background: Fatigue is prevalent in children with cancer but is poorly understood. Improved understanding of this symptom will inform development of interventions aimed at alleviating it. Methods: Cross-sectional survey conducted between 1997–2001 of 144 parents of children who died of cancer cared for at Dana-Farber Cancer Institute/Children’s Hospital Boston and Children’s Hospital and Clinics, St Paul and Minneapolis (response rate 65%). Parents reported the child’s experience of symptoms in the last month of life and associated suffering, and patient characteristics. Determinants of suffering from, and treatment of fatigue were explored with univariate analyses adjusting for physician and time since death. A logistic regression model was built to determine factors associated with suffering from fatigue, with a threshold for entry of P<.05, and accounting for physician clustering. Results: Almost all children experienced fatigue and 50% suffered significantly from it (a great deal/a lot versus some/a little/none at all). Only 15% received treatment, and of them, 79% were not successfully treated. Univariate analyses revealed significant associations between suffering from fatigue and suffering from pain, dyspnea, anorexia, diarrhea, and nausea/vomiting, as well sadness, anemia and successful treatment of pain (P<.05). Treatment of fatigue was associated with side effects from treatment of pain (OR 3.9, P=.008) and treatment of dyspnea (OR 3.9, P=.02). In the multivariate analysis of suffering from fatigue, successful treatment of pain remained significant (OR 4.2, P=.009). Conclusions: Suffering from fatigue is common in children with cancer at the end of life and efforts to palliate it are limited. Significant fatigue is highly associated with other symptoms and their treatments. Increased attention to treatment-related fatigue and evaluation of interventions such as stimulants may be effective in ameliorating fatigue in children with advanced cancer.

No significant financial relationships to disclose.
Cancer outcomes at end-of-life in Michigan
Authors: Finn J. W. , Nelson P. , Yassine M. , Presby K. , Towns J. , Affholter S.
Published: April 2020

8575

Background: End-of-life care (EOLC) is an important focus of comprehensive cancer control, yet little data is formally collected and no central repository exists across all cancer sites. Collaboration by the MI Department of Community Health, the MI Public Health Institute, and the Institute for Public Policy and Social Responsibility (IPPSR) in 2004 produced an end-of-life module, which was added to a caregiver survey designed to track cancer screening already in use: the Michigan Special Cancer Behavioral Risk Factor Survey (MSCBRFS). Methods: A population-based sample of caregivers, age 40 and older, including minorities, were contacted by trained IPPSR staff (bilingual) using computer-assisted telephone interviews. Results: 761 respondents constituted the sample size of caregivers who reported having cared for a family member or friend who died of cancer in the preceding 5 years, including 196 African Americans, 92 American Indians, 51 Hispanic Americans, 49 Arab Americans and 73 Asian Americans. The average pain level in the final 3 months was severe to excruciating for 44.7%. Pain medications had been prescribed for 93.5%; however, not used as directed for 30.3%. The most frequent reason given for this was fear of addiction/side effects (32.7%). The proportion who died at home was 44.3%. In general terms, Caucasians tended to die outside the hospital, whereas African and Asian Americans tended to die in the hospital and Native and Hispanic Americans at home. 68.2% of cancer decedents died with the support of hospice care (no racial variance). The median length of stay on hospice was short, 17.5 days (2003 MHPCO data). The main reason given why hospice was not chosen was that death occured before hospice enrollment (55.2%). Conclusions: Cancer outcomes data at end-of-life is an important part of state-wide comprehensive cancer control. Specific progress markers are presently established for the Michigan Cancer Consortium. Baselines measurements include the prevalence of severe pain in the final 3 months (44.7%), proportion of those who died at home (44.3%), percent of those who used hospice services (68.2%) and median hospice length of stay (17.5 days). These outcome measures will be trended over the next five years for purposes of cancer care quality improvement, public and professional education and system change.

No significant financial relationships to disclose.
The assessment of randomized double blind clinical trial of Shugan-liangxue prescription used for the treatment of hot flashes in breast cancer patients
Authors: Li P.
Published: April 2020

8584

Background: Hot flashes are a common side effect for breast cancer (BC) pts with TAM treatment. Traditional Chinese medicine (TCM) is typically given to BC pts in China. This trial is to assess the effects of TCM for relieving hot flashes. TCM oral solution is prescribed for clearing heat and cooling blood. The compound was tested and contained no phytoestrogen. A randomized, double blind clinical trial was designed to examine the effects of TCM over a 3-week period. Methods: From October 2004 to October 2005, 49 BC pts undergoing treatment with TAM who having hot flashes at least 3 times a day involved the study. Daily average of hot flashes was recorded by the pts for a week as a baseline. TCM or placebo liquid (100 ml) was administered orally three times a day for 3 weeks by a randomized double-blind method. The number of hot flashes and quantity of sleep disturbance in the two groups were evaluated. Results: 45 pts were evaluated in TCM group (n = 22) and the placebo group (n = 23). The severity of the hot flash symptoms was evaluated according to the Kupperman menopausal index (KI). Pts were distributed approximately equally between the two groups. There were 31% (7/22) and 26% (6/23)pts with mild hot flashes in TCM and placebo groups, and 68% (15/22) and 73% (17/23) with severe hot flashes in TCM and placebo groups. Hot flash relief was described as either symptom disappearing, a decrease from severe to mild symptoms, or no change. In TCM group, 50% showed no change, 27% decrease and 23% symptoms disappearing. In the placebo group, 70% no change, 30% decrease and no pts reporting symptoms disappearing. A statistically significant difference exists between the two groups (P < 0.05). In TCM group, 73% of pts sleep improvement compared to 35% in the placebo group (P < 0.05). No adverse events or any side effects were reported. Conclusion: The oral solution of TCM is effective in alleviating tamoxifen-induced hot flashes and sleep disturbance. The study of the drug’s mechanism and an expanded clinical trial are underway.

No significant financial relationships to disclose.
Physical health and depression as predictors of fatigue in women with breast cancer undergoing chemotherapy
Authors: Shimabukuro K. A. , Clark K. L. , Bardwell W. A. , Mortimer J. E.
Published: April 2020

8591

Background: Fatigue is common in breast cancer patients undergoing systemic chemotherapy and is also linked with depression. We evaluated the importance of physical health and depression in the fatigue reported by women with early-stage breast cancer undergoing adjuvant chemotherapy. Methodology: 75 women treated for Stage I-II breast cancer were assessed within 1mo after initiating chemotherapy (‘baseline‘) and at 2, 6 and 12mo. Scales included the Profile of Mood States (POMS) & SF36 quality of life (QOL) survey. The POMS contains fatigue and depression subscales (higher scores, worse mood symptoms). The SF36 is comprised of 4 physical and 4 mental health subscales (higher scores, better QOL). Results: 26 Stage I (46.4%) and 30 (53.6%) Stage II breast cancer patients provided baseline data (median age 53yrs; range 28–82 yrs). Fatigue decreased significantly from baseline to 12mo (p<0.01). Using Pearson correlations, worse physical health summary scores (r= −0.55, p<0.01) and higher depression scores (r=0.55, p<0.01) were independently linked with fatigue at baseline. In partial correlations controlling for depression, the relationship between physical health and fatigue remained significant (p<0.01), but was reduced in strength by 27%, although, the influence of depression on fatigue diminished over time. Similar patterns were observed for 3 of the SF36 physical health subscales. However, the relationship between fatigue and bodily pain was unchanged when controlling for depression (p<0.01), suggesting a strong independent relationship. In linear regression models, depression predicted fatigue at all time points and was the strongest predictor at baseline and 2mo; however physical health subscales assumed increasing importance in accounting for fatigue at 6 and 12mo. Conclusion: Depression is the strongest predictor of fatigue during chemotherapy, however, over time physical health variables become increasingly important at predicting fatigue in women with early stage breast cancer. Conducted at Washington University, supported by NIH CA72554–02

No significant financial relationships to disclose.
Palonosetron (PALO) + dexamethasone (DEX) for prevention of chemotherapy (CT)-induced nausea and vomiting (CINV) in patients receiving multiple-day cisplatin CT for germ cell cancer
Authors: Brames M. J. , Roth B. J. , Dreicer R. , Bubalo J. , Nichols C. , Cullen M. T. , Degroot T. , Einhorn L. H.
Published: April 2020

8607

Background: Fractionated cisplatin is highly emetogenic; despite 5HT3 receptor antagonists + DEX, patients still experience acute and delayed CINV. PALO, a novel 5HT3 antagonist, is superior to conventional 5HT3 antagonists in protecting patients from emesis with a 0.25-mg IV dose prior to single-day CT. To assess the efficacy and safety of PALO in 40 patients with germ cell tumors receiving multiple-day cisplatin-based CT, a phase II multicenter study is being conducted. Methods: Adult men receiving 5-day cisplatin-based (20 mg/m2/d) CT received PALO 0.25 mg IV 30 min before CT on days 1, 3, and 5 and DEX 20 mg qd (po or IV 30 min before CT) on days 1–2; 8 mg po bid on days 6–7; and 4 mg po bid on day 8. Rescue medication was allowed at investigator discretion. Endpoints included emetic episodes (EE), nausea intensity, and rescue use, recorded in diaries for 9 consecutive 24-h periods. Interference with functioning due to nausea on a 4-point scale (none, a little bit, quite a bit, very much) was assessed with the validated Osoba nausea module on days 1, 5, and 10; safety was assessed at all follow-up encounters. Results: To date, 32 patients are evaluated, median age 35 years, 81% CT-naïve. Prior to CT, 97% of patients reported no more than a little interference with functioning from nausea. Most patients reported no significant interference with functioning due to nausea on days 1–4 of cisplatin (73% reported none/a little bit) and days 5–9 (87% none/a little bit). PALO + DEX was well tolerated; treatment-related adverse events were mild-moderate headache (18.8%), constipation (6.3%), and abdominal pain (3.1%), none serious. Conclusions: Three doses of PALO + 5 doses of DEX over an 8-day period effectively prevented both emesis and significant nausea in the majority of patients with germ cell tumors receiving multiple-day cisplatin-based CT. This regimen appears to be an improvement over historical CINV control. [Table: see text]

[Table: see text]
A phase II trial of olanzapine and palonosetron for the prevention of chemotherapy induced nausea and vomiting (CINV)
Authors: Navari R. M. , Einhorn L. H. , Loehrer P. J. , Passik S. D. , Vinson J. , McClean J. , Chowhan N. , Hanna N. , Calley C. , Yu M.
Published: April 2020

8608

Background: Olanzapine has been shown to be a safe and effective agent for the prevention of CINV in chemotherapy naïve cancer patients. Palonosetron has been approved for the prevention of acute CINV and for the prevention of delayed CINV in patients receiving moderately emetogenic chemotherapy (MEC). Methods: A phase II trial was performed for the prevention of CINV in chemotherapy naïve patients using the combination of olanzapine and palonosetron. The regimen was 10 mg of oral olanzapine, 0.25 mg of intravenous palonosetron, and dexamethasone (20 mg for highly emetogenic and 8 mg for moderately emetogenic chemotherapy) on the day of chemotherapy, day 1, and 10 mg/day of oral olanzapine alone on days 2–4 after chemotherapy. Forty patients (median age 60 yrs, range 38–84; 22 females; ECOG PS 0,1) consented to the protocol and all were evaluable. Results: The percentage of patients with a complete response (CR) (no emesis, no rescue) was 100% for the acute period (24 h post chemotherapy), 75% for the delayed period (days 2–5 post chemotherapy), and 75% for the overall period (0–120 h) for eight patients receiving highly emetogenic chemotherapy (HEC) (cisplatin > 70 mg/m2). CR was 97% for the acute period, 75% for the delayed period, and 72% for the overall period in 32 patients receiving MEC (doxorubicin, >50mg/m2). In the patients receiving HEC, the percentage of patients without nausea (0, scale 0–10, M. D. Anderson Symptom Inventory) was 100% in the acute period, 50% in the delayed period, and 50% in the overall period. In patients receiving MEC, the percentage without nausea was 100% in the acute period, 78% in the delayed period, and 78% in the overall period. There were no Grade 3 or 4 toxicities and no significant pain, fatigue, disturbed sleep, memory changes, dyspnea, lack of appetite, drowsiness, dry mouth, mood changes or restlessness experienced by the patients. CR and control of nausea in subsequent cycles of chemotherapy (35 patients, cycle 2; 31 patients cycle 3; 23 patients, cycle 4) were equal to or greater than cycle one. Conclusions: The combination of olanzapine and palonosetron with dexamethasone given only on the day of chemotherapy was safe and highly effective in controlling acute and delayed CINV in patients receiving HEC and MEC.

No significant financial relationships to disclose.
Effect of wheat grass juice in supportive care of terminally ill cancer patients— A tertiary cancer centre experience from India
Authors: Dey S. , Sarkar R. , Ghosh P. , Khatun R. , Ghorai K. , Choudhury R. , Ahmed R. , Gupta P. , Mukhopadhyay S. , Mukhopadhyay A.
Published: April 2020

8634

Background: The solid content of juice made from wheat grass is 70% chlorophyll. Chlorophyll is often referred to as “The blood of plant life” and has almost the same chemical structure as haemoglobin. Chlorophyll cleanses the blood by improving the supply of oxygen to the circulatory system. Wheat grass is also a complete protein with about 30 enzymes, vitamins & minerals. Wheat grass juice has been proven over many years to benefit people in numerous ways, building the blood, restoring balance in the body, removing toxic metals from the cells, nourishing the liver & kidneys and restoring vitality. The aim of our study was to see the effect of wheat grass juice in terminally ill cancer patients to improve the quality of life. Methods: During period from January 2003 to December 2005 we selected 400 solid organ cancer patients in our palliative care unit of Netaji Subhash Chandra Bose Cancer Research Institute to see the effect of wheat grass on improvement of haemoglobin level, serum protein & performance status on terminally ill cancer patients. The age range of the patients was 22 year to 87 year (median age 42 years). The different types of cancers were Lung (25%), Breast (20%), Oesophagaus (11%), Colon (9%), Ovary (8%), Hepatocellular carcinoma (6%), Stomach (6%) and others (15%) respectively. We cultivated wheat grass in our campus. When the grasses were 5 days old we took the fresh leaves including roots and made fresh juice out of that and had given 30ml of juice to all our 400 cancer patients for continuous 6 months. Result: The mean levels of haemoglobin, Serum total protein, albumin and performance status were 8gm%, 5.4gm%, 2.2gm% and 50%. Fifty patients required transfusion support & those patients were excluded from the study. Other 348 patients are evaluated 6 months after giving wheat grass juice. The mean values for haemoglobin, total protein & albumin were improved significantly (pvalue < .005) and were observed mean of 9.6gm%, 7.4gm% and 3.1gm%. White blood cell & platelet count were same in both the cases. The performance status was improved from 50% to 70% (Karnofsky) after wheat grass treatment. Conclusion: We concluded that wheat grass juice is an effective alternative of blood transfusion. Its use in terminally ill cancer patients should be encouraged.

No significant financial relationships to disclose.
Mobile Technologies and Cervical Cancer Screening in Low- and Middle-Income Countries: A Systematic Review
Authors: Zhang Dongyu , Advani Shailesh , Waller Jo , Cupertino Ana-Paula , Hurtado-de-Mendoza Alejandra , Chicaiza Anthony , Rohloff Peter J. , Akinyemiju Tomi F. , Gharzouzi Eduardo , Huchko Megan J. , Barnoya Joaquin , Braithwaite Dejana
Published: April 2020

PURPOSE

Cervical cancer screening is not well implemented in many low- and middle-income countries (LMICs). Mobile health (mHealth) refers to utilization of mobile technologies in health promotion and disease management. We aimed to qualitatively synthesize published articles reporting the impact of mHealth on cervical cancer screening–related health behaviors.

METHODS

Three reviewers independently reviewed articles with the following criteria: the exposure or intervention of interest was mHealth, including messages or educational information sent via mobile telephone or e-mail; the comparison was people not using mHealth technology to receive screening-related information, and studies comparing multiple different mHealth interventional strategies were also eligible; the primary outcome was cervical cancer screening uptake, and secondary outcomes included awareness, intention, and knowledge of screening; appropriate research designs included randomized controlled trials and quasi-experimental or observational research; and the study was conducted in an LMIC.

RESULTS

Of the 8 selected studies, 5 treated mobile telephone or message reminders as the exposure or intervention, and 3 compared the effects of different messages on screening uptake. The outcomes were diverse, including screening uptake (n = 4); health beliefs regarding the Papanicolaou (Pap) test (n = 1); knowledge of, attitude toward, and adherence to colpocytologic examination (n = 1); interest in receiving messages about Pap test results or appointment (n = 1); and return for Pap test reports (n = 1).

CONCLUSION

Overall, our systematic review suggests that mobile technologies, particularly telephone reminders or messages, lead to increased Pap test uptake; additional work is needed to unequivocally verify whether mhealth interventions can improve knowledge regarding cervical cancer. Our study will inform mHealth-based interventions for cervical cancer screening promotion in LMICs.