bluuebunny/crossref_metadata_2025 huggingface dataset:
Vulvar melanoma: A monocentric retrospective study on 29 cases.
Authors: Tosti Giulio , Botteri Edoardo , Spadola Giuseppe , Baldini Federica , Mosconi Massimo , Ferrucci Pier Francesco , Gandini Sara , Pennacchioli Elisabetta , Zampino M. Giulia , Cocorocchio Emilia , Verrecchia Francesco , Cataldo Francesco , Buffon Rosana , Sideri Mario , Maggioni Angelo , Testori Alessandro
Published: March 2020

e19036

Background: Vulvar melanoma (VM) represents 3-7% of melanoma in women. The 5-year survival rate ranges from 8 to 55%. Surgical excision represents the best definitive therapy but surgical radicality does not impact on recurrence or survival. Methods: Thirty women with histologically confirmed VM diagnosed between 1993 and 2009 were selected for this monocentric retrospective study. One patient with metastases at time of diagnosis was excluded from the statistical analysis. Clinical, pathological and follow-up data were collected. Cumulative incidences of events were calculated and compared across subgroups by means of the Gray test. Results: Average age at diagnosis was 62 years. Average Breslow thickness was 4.91 mm. Ulceration was present in 11 cases and was unknown in 5. One case of VM was multifocal at presentation. Eleven patients underwent a wide local excision, 11 a hemivulvectomy and 7 a radical vulvectomy Sentinel node biopsy was performed in 23 patients and at least one positive sentinel node was found in 8 cases. Eight patients received adjuvant therapy. Ten patients had a second tumor (other than melanoma); of these, a breast cancer was recorded in 5 cases. Four patients had a second primary melanoma: of the vulva (n=2), vagina (n=1), and urethra (n=1). Median follow-up among ongoing survivors was 79 months and median overall survival was 69 months. The 5-year overall survival was 55.4%. Median event free survival 34 months. Positive lymph nodal status was associated with an increased risk of loco-regional recurrences (P=0.04). Positive lymph nodal status (P=0.06), Breslow thickness > 2mm (P=0.05) and number of mitoses > 10/mm2 (P=0.04) increased the risk of distant metastases. Age, ulceration and type of surgery were not significantly associated with any type of event. Conclusions: Lymph node involvement, elevated depth of invasion and a high number of mitoses were the most important prognostic factors for locoregional recurrence and distant metastases. The same trends were observed for the overall survival, but results were not statistically significant. Conservative surgery in the form of wide local excision with adequate margins may replace vulvectomy. Sentinel node biopsy is feasible and its role in VM should be further investigated.
Ipilimumab in metastatic malignant melanoma: The Irish experience.
Authors: Donnellan Paul P. , Bambury Richard , Battley Jodie E , Power Derek Gerard , O'Byrne Kenneth John , Crown John , Breathnach Oscar S. , Teo MinYuen , Jamaluddin Muhammad Faisal , Boychak Oleksandr Volodymyrovych , Lyons Tomas , Greene John , Jayaram Anuradha ,   ICORG Melanoma Group
Published: March 2020

e19059

Background: Ipilimumab (Ipi) is a potent anti CLA-4 immunotherapy recently shown to improve overall survival (OS) in a phase III study in patients (pts) with previously-treated, unresectable or metastatic malignant melanoma. Ipilimumab (3 mg/kg) has been available on compassionate grounds to pts in Ireland since June 2010. Methods: In this retrospective observational study we examine the Irish experience with ipilimumab specifically regarding patient-factors, treatment toxicity, and outcomes including response rate and survival. Results: Between June 2010 and December 2011, a total of 93 patients received ipilimumab. Data available for analyses was conducted in 46patients. Median age of patients was 56 yrs (ranging 28 – 84). M1c disease was identified in 40 patients (83.3%). Median number of prior lines of chemotherapy is 1 (ranging from 1-4). 22 (47.8%) patients received all four planned induction doses of ipilimumab. All patients received full doses of treatment and on schedule. There are no grade 4 toxicities reported and 13% (n= 6) had grade 3 adverse events. This included renal autoimmune toxicity (n=3), diarrhoea (n=1) elevated AST/ALT (n=1), ocular toxicity (n=1) and skin (n=1). Grade 3 adverse events occurred in 3 patients who received all 4 cycles of Ipilimumab. No intestinal perforations or hypophysitis were noted. There were no drug-related deaths. From available survival follow-up data there are 22 reported deaths. Due to paucity of the data, surrogate marker for response of treatment was expressed as absence of disease progression at the time of assessment. Among the 11 (23.9%) patients who responded to treatment, 45.5% of these patients received 4 cycles of ipilimumab. Conclusions: Ipilimumab was well tolerated with a manageable side effect profile. Response rates to ipilimumab in metastatic melanoma in an Irish population are in keeping with internationally reported figures. Comprehensive survival data will be reported as well as correlation of response with hematologic and biochemical blood tests.
A psychosocial and pshycoeducational intervention for cancer patients integrated into routine care: A study from India.
Authors: Chandra Anita
Published: March 2020

e19518

Background: Patients with cancer experience significant distress and access to effective psychosocial care is limited by lack of systematic approach. This paper presents results of a study to evaluate the effectiveness of a brief tailored psychosocial intervention delivered by health professionals in cancer care in developing countries. Methods: Health professionals deliver the multicomponent, psychoeducational and psychosocial intervention focusing on core concepts of quality of life, supportive-expressive, cognitive, social functioning, symptom scale and dignity-conserving care. A total of 100 patients recruited across all tumour sites, from July 2011 to December 2011, in a University Hospital in India. Eligible patients received 2 sessions, each for 30 minutes in length, delivered face-to-face at baseline and 12 week follow-up. Results: Quality of life was measured by using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire .In this study the functional scales were high, whereas in the symptom scales fatigue (48.9%) and financial difficulties (45.53%) were noted. Percentages of families who evaluated by the palliative care team voted as useful or very useful were: 80% (symptom control), 85% (emotional support), 86% (family support), and 87% (care coordination). Compared with participants receiving usual oncology care, those receiving a palliative care-focused intervention addressing psychosocial care provided concurrently with oncology care had higher scores for quality of life and mood. Conclusions: This study will provide important information about the effectiveness of a brief tailored psychological intervention for patients with cancer in a developing country. This model of care should be a systematic implementation in routine clinical practice cancer settings in resource restraints countries. [Table: see text]
Phase II study of caphosol oral rinse for prevention of oral mucositis (OM) in sarcoma patients (pts) receiving multicycle doxorubicin-based chemotherapy (CT): Randomized study with cross-over to palifermin for severe OM.
Authors: Vadhan-Raj Saroj , Araujo Dejka M. , Trent Jonathan C. , Zhou Xiao , Ludwig Joseph A. , Ravi Vinod , Chambers Mark Steven , Patel Shreyaskumar , Benjamin Robert S.
Published: March 2020

e19520

Background: Mucositis is a common complication in cancer pts receiving CT. We have shown that palifermin (recombinant Keratinocyte Growth Factor), administered as single dose prior to CT, alleviated severe mucositis in pts receiving doxorubicin-based CT (Ann Int Med 2010). Caphosol is a supersaturated electrolyte solution of calcium phosphate that has been indicated as oral rinse for xerostomia and as an adjunct to treat OM induced by radiation or high-dose CT. Purpose of the study was to evaluate the preliminary efficacy of Caphosol in pts receiving CT. Methods: Pts were randomized 1:1 to Caphosol vs. baking soda (control) as an oral rinse five times daily from initiation of CT. All pts received doxorubicin (75 or 90 mg/m2 by continuous infusion over 3 days) with ifosfamide (10 gm/m2) or cisplatin (120 mg/m2). Pts that experienced Grade (Gr) > 3 mucositis received palifermin (180 mcg/kg) iv 3 days before CT in subsequent cycles. Results: 28 of 30 pts received treatment and were evaluble; 15 men and 13 women, with median age 51 (range, 20-65 yrs). Incidence of Gr > 2 OM was 57% (8 of 14 pts) for Caphosol vs. 86% (12 of 14) for control (P=0.21). Incidence of Gr > 3 OM was 29% (4/14) for Caphosol vs. 43% (6/14) for control (P=0.43). However, the benefit was limited to oral but not other GI mucosal sites. Of 10 pts (Caphosol: 4, BS: 6,) with Gr > 3 OM, 6 crossed over to palifermin (Caphosol: 3, BS: 3); the other 4 pts (Caphosol: 1, BS: 3) came off the study. All 6 pts, that received palifermin, avoided severe OM in the next cycle. The median duration of Gr > 2 OM in the cycle before cross-over was 8 days (range: 5-12) vs. 0 days (0-3) in palifermin cycle (p=0.0032) and Gr > 3 OM was 5 days (2-7) vs. 0 days (p=0.0015). Oral assessment and the pts-reported outcome were in substantial agreement for the OM grading (weighted kappa, 0.78, 95% CI: 0.44-0.87, p<0.0001). No serious adverse event related to the study drug was observed. Conclusions: There was a trend for less severe OM with Caphosol vs. control. Secondary prophylaxis with palifermin alleviated severe mucositis in all pts who previously experienced severe mucositis during multi-cycle CT.
An evaluation of the drug interaction potential of netupitant with palonosetron, dexamethasone, and oral contraceptives.
Authors: Vouis Jan , Henriksson Anders , Timmer Wolfgang , Calcagnile Selma , Rossi Giorgia
Published: March 2020

e19532

Background: Netupitant (NETU) is a highly selective neurokinin 1 receptor antagonist (NK1 RA) developed to provide protection from nausea and vomiting in patients undergoing emetogenic chemotherapy. Three individual studies were aimed at determining NETU effect on the metabolism of the new generation 5-HT3 RA palonosetron (PALO), dexamethasone (DEX) and oral contraceptives which may be coadministered in clinical practice. Methods: Two 3-way crossover studies to determine the interaction between NETU (450 mg, day 1) and PALO (0.75 mg PO, day 1), and between NETU (100 mg, 300 mg or 450 mg PO, day 1) and DEX (20 mg PO, day 1; 8 mg BID PO, days 2-4), were performed in 18 and 25 healthy subjects, respectively. The study investigating the effect of NETU/PALO (300 mg/0.5 mg PO) as a fixed dose combination on the PK of oral contraceptives ethinylestradiol and levonorgestrel (60 μg/300 μg) was a 2-way crossover trial of 24 healthy women. Serial blood samples were collected over the course of the three studies and pharmacokinetic parameters were determined for all analytes. Results: There were no significant pharmacokinetic interactions between NETU and PALO. DEX mean AUC and Cmax increased respectively, by 1.7 and 1.1 fold on day 1 and by 2.4 and 1.7 fold on day 4 when coadministered with NETU. NETU was shown to increase exposure to DEX in a dose-dependent manner. The combination of NETU/PALO did not significantly affect exposure to ethinylestradiol; systemic exposure to levonorgestrel increased by 40%, a level that is not considered clinically relevant. Conclusions: A relevant drug interaction was seen between NETU and DEX and therefore dose reductions are recommended for DEX when administered with NETU. This drug interaction is likely due to inhibition of CYP3A4 by NETU. No interaction was clinically relevant between NETU and PALO, or between NETU/PALO and ethinylestradiol and levonorgestrel. Treatments were well-tolerated in all studies.
Efficacy of palonosetron-based antiemetic prophylaxis in breast cancer patients receiving anthracycline-containing adjuvant chemotherapy: A survey in 41 German gyneco-oncology practices.
Authors: Schilling Joerg Peter , Klare Peter , Wetzel Antje , Kittel Kornelia , Hindenburg Hans-Joachim , Gazawi Nidal , Jungberg Peter , Guth Dagmar , Busch Steffi , Geberth Matthias , Konias Marina , Ortner Petra Angelika , Feyer Petra C.
Published: March 2020

e19540

Background: The emesis risk in young breast cancer (BC) patients (pts) receiving adjuvant anthracyclines (A) plus cyclophosphamide (C), taxanes or other cytotoxics is higher than anticipated earlier. Furthermore, antiemetic control seems to decline in subsequent cycles of chemotherapy (CT). The ASCO has classified AC to be highly emetogenic (HEC) in their antiemetic guidelines 2011. Palonosetron (P) is a 5-HT3-receptor-antagonist (5-HT3-RA) with higher receptor affinity and longer biological half-life than older compounds. Data suggest that Palonosetron is clinically more effective in the acute phase and that in contrast to the older 5-HT3-RA it is also effective in the delayed phase. P also showed to maintain its efficacy in subsequent cycles. Current antiemetic guidelines list palonosetron as preferred 5-HT3-RA in moderate emetogenic chemotherapy (MEC). Methods: To evaluate the efficacy of palonosetron after 4 cycles of A containing chemotherapy in BC patients, we have conducted a survey in 41 practices of the BNGO in Germany. Between Nov 2007 and Jan 2012 1299 patients have been documented. Median age was 55 years. Severity, frequency, duration and onset of N/V were recorded in a patient diary. Efficacy criteria were complete control CC (no V, no rescue, mild N); complete response (CR: no V, no rescue) and rescue medication. Results: At the beginning P was used as single agent (56%). Following the MASCC 2010 guidelines P was used in combination with dexamethasone (PDex, 15%) or plus dex and NK1-RA (PNDex, 23%), 16% of pts received additional medication. Efficacy after 4 cycles of CT: Overall (5 days): Complete control CC: (no V, no rescue, mild N) 63,3% of pts, complete response (CR: no V, no rescue) 73,7%; Rescue Medication was needed in 15,6% of pts. PDex CC 48,7%, CR 69,8 %, PNDex: CC 76,3%, CR % 83,33. N was also very well controlled: Overall (5 days) 56% of pts no nausea, 15% moderate N 3% severe N. Conclusions: Palonosetron in combination with dex and NK1-RA is very effective to control nausea and vomiting in A-based adjuvant chemotherapy in young breast cancer patients after 4 cycles of chemotherapy.
Factors predicting local recurrence in phyllodes tumor of the breast.
Authors: Ramakant Pooja , Cherian Anish Jacob , Abraham Deepak T , Paul MJ
Published: March 2020

e19562

Background: Phyllodes tumor of the breast (PT) has local recurrences resulting in higher morbidity and disfiguring reoperations. Aim to find factors predicting local recurrences in PT. Methods: Retrospective data analyzed with SPSS v.17 (Pearson Chi square test, Logistic regression test for multivariate analysis) done on patients with PT managed during 2000-2010. Results: In total 141 patients with PT, mean age was 40.44 years (+0.98) and mean tumor size 11.07 cm (+0.57). Preoperatively cytology done in 96 % and was suggestive of PT in 59%; core biopsy done in 58 % and was suggestive of PT in 93% Imaging done in 65%. The mean duration of lump- 2.2 years (+0.23). Thirty two patients (23%) presented with recurrence post lumpectomy done elsewhere. Adjuvant radiotherapy was given in 28% patients. In multivariate analysis, high stromal cellularity ( p 0.002), surgery type (p= 0.000) and recurrent status (p=0.05) at first time presentation showed statistically significant p values for odd’s ratios. Conclusions: Tumor size, margins, surgery type, histological features of high stromal hypercellularity, necrosis with high mitotic rates predicted recurrence in PT. Core biopsy is more accurate than fine needle biopsy in diagnosis and recommended in suspected cases to permit the correct initial surgery. [Table: see text]
Risk factors for oral mucositis (OM) in multiple myeloma (MM) patients receiving high-dose melphalan (Mel) prior to autologous stem cell transplantation (SCT).
Authors: Bhatnagar Bhavana , Goloubeva Olga G. , Gilmore Steven , Hoffman Arnold , Ruehle Kathleen , Akpek Gorgun , Rapoport Aaron , Yanovich Saul , Badros Ashraf Z.
Published: March 2020

e19565

Background: OM is a common complication of high-dose melphalan in MM patients (pts). Proposed risk factors for OM in SCT include: low albumin and high serum creatinine (Cr) levels, both were evaluated in MM patients undergoing Mel/ASCT. (Grazziutti, ML, Bone Marrow Transplant 2006). Methods: This is a single center retrospective chart review of 214 sequentially treated MM pts who received Mel 200mg/m2 conditioning prior to SCT between January 2005-September 2011. Data collected included: demographics, Hgb, Cr, C-reactive protein and albumin on the day of SCT, length of hospital stay. OM assessment was graded as follows: Grade 1, no OM; Grade 2, mild OM; the pts maintained adequate oral intake; Grade 3, decreased oral intake and/or use of oral narcotics; Grade 4, severe OM needing intravenous narcotics. Results: The table below describes pt characteristics grouped by OM grade. Overall, 56 pts (27%) had grade 3/4 OM. Multivariate analysis of variance revealed no statistically significant correlation between OM grade and Hgb, Cr, albumin, CRP; the overall test’s p value = 0.55. There were no racial or gender differences with regard to grade of mucositis, the p-values range are 0.75 and 0.31, respectively (likelihood ratio chi-square test). Most interestingly, OM did not impact length of hospital stay. Conclusions: We did not establish any predictive risk factors for OM as previously described. Analysis of the impact of OM on MM response and event and overall survival will be presented. Studies of Mel pharmacogenetics may provide insight to patients' predisposition to OM. [Table: see text]
Iron-deficiency anemia and cardio-renal toxicity of doxorubicin in hypertensive rats.
Authors: Toblli Jorge E , Rivas Carlos , Cao Gabriel , Giani Jorge , Dominici Fernando
Published: March 2020

e19569

Background: Hypertension and anemia are common in patients with neoplasm and may increase the toxicity of anti-cancer drugs. This study evaluated cardio-renaltoxicity of doxorubicin (DOX) in combination with iron deficiency anemia (IDA) in Spontaneously Hypertensive Stroke Prone (SHRSP) rats. Methods: SHRSP rats were randomized into six groups (A-F; n=8 each). IDA was induced in groups A-D by 12 weeks low iron diet; groups E and F had normal diet. After 6 weekly DOX or control treatments (0.9% saline), echocardiography was performed and blood analyzed for hemoglobin (Hb) and transferrin saturation (% TSAT). Tissue sections and homogenates from heart and kidney samples were analyzed for markers of oxidative-nitrosative stress and inflammation. Results: IDA plus DOX was associated with significantly lower cardiac performance (% FS) and kidney function (CrCl) and a higher degree of cardio-renal oxidative-nitrosative stress and inflammation (Table). Conclusions: The results show that IDA can aggravate dose dependent DOX-induced cardio-renal toxicity in hypertensive rats and confirm that IDA significantly induces oxidative-nitrosative stress and inflammation. [Table: see text]
Cancer patients’ information needs in Nigeria.
Authors: Nwankwo Kenneth Chima , Ezeome Emmanuel
Published: March 2020

e19572

Background: The attitudes of Nigerian cancer patients on cancer diagnosis and prognosis were studied to ascertain what diagnostic and prognostic information were disclosed to them by their physicians, and what they wanted to know about their cancer diagnosis and prognosis. Methods: Structured questionnaires were administered on all consenting cancer patients that were managed at the University of Nigeria Teaching Hospital Enugu (UNTH-E) between July and October 2011. The data collected were analyzed with Statistical Package for Social Sciences (SPSS) software version 18. Results: Two hundred and forty four (244) patients participated in the study. While 95% of the participants wanted to know the nature of their diagnosis, only76.7% admitted to being informed of the diagnosis by their doctors. Nearly 54% of participants will like to be informed of a bad prognosis when death is imminent. The word “cancer” was used to disclose the diagnosis to 69.4% of the patients. Hundred and eight (44.3%) of the patients did not have any idea what “cancer” meant or did not know how to explain it while 39.8% knew it as a deadly, incurable or a painful disease and 8.6% described it as a tumour or abnormal growth. The nature of the disease was explained to 155(66.0%) of the patients among whom 114(76%) felt they received adequate or more than adequate explanation of their cancer to enable them undergo treatment. Patient factors that significantly improved the disclosure of diagnostic information were education (p=0.044) and site of the cancer (p=0.043). There was no statistically significant association between the desire for diagnostic and prognostic information and the patients’ age, gender, educational attainment or site of the cancer. Conclusions: Most of the surveyed cancer patients in Nigeria desire to know the truth about the diagnosis of their disease and more than 50% of them desire to know when the cancer stage becomes terminal and death imminent. Physicians in Nigeria should consider the information needs of the individual patients and satisfy them.
Interactive voice response system compliance in chronic myeloid leukemiapopulation.
Authors: Garcia-Gonzalez Araceli , Ault Patricia , Williams Loretta A. , Williams Janet L. , Cleeland Charles S. , Cortes Jorge E.
Published: March 2020

e19589

Background: Recent advances in telecommunication technology have created sophisticated systems to support and evaluate chronic disease. The telephone-based interactive voice response system (IVRS) is a simple method of delivering specific health information to patients and allowing them to interact with care providers. The IVRS has been used to monitor chronic conditions such as cancer, diabetes, asthma, hypertension, and psychiatric disorders. Our study aimed to evaluate patient adherence to routine IVRS symptom assessment in chronic myeloid leukemia (CML). Methods: We conducted a longitudinal study in patients with a diagnosis of Philadelphia chromosome-positive CML treated at a tertiary cancer center. We collected IVRS data every 2 weeks for 6 months. Upon recruitment, patients were trained to use the IVRS and selected preferred days and times to receive IVRS calls. The IVRS asked patients to rate symptoms using the M. D. Anderson Symptom Inventory CML module (MDASI-CML), which assesses 20 symptom items and 6 interference items on a 0-10 scale (0 = not present and 10 = symptom as bad as you can imagine or complete intereference). Compliance equaled the number of answered IVRS calls divided by total calls for that patient. Univariate analysis examined associations between IVRS compliance and various demographic, clinical, and treatment variables. Results: Of 160 patients enrolled in the study, 12 withdrew and were excluded from analysis. Mean age of the sample was 51 years (SD 13.7); most were female (54%) and white non-Hispanic (74%). We collected 1,197 MDASI-CML assessments overall and found a 66% compliance rate. Almost one-third (29.7%) of the patients had 100% compliance; 10% answered no IVRS calls. IVRS compliance was statistically significantly associated with marital status (p=.016) and ethnic group (p=.045). Patients who were married or white were more likely to answer IVRS calls. Conclusions: 66% of our sample answered every IVRS call. The IVRS could be extremely useful for population survey research. It should be especially useful for assessing symptoms in chronic disease over time. More studies are needed to evaluate the utility of capturing symptom clinical trials status via the IVRS in the cancer population.
How are cared surviving cancer patients? Results of an Italian national survey to medical oncologists (MO) about clinical and organizational features of follow-up (FU).
Authors: Numico Gianmauro , Pinto Carmine , Ucci Giovanni , Gori Stefania , Di Maio Massimo , Cancian Maurizio , De Lorenzo Francesco , Venturini Marco ,   Associazione Italiana di Oncologia Medica (AIOM)
Published: March 2020

e19592

Background: The growing demand and the resources shortage are pushing toward more efficient models of survivorship care delivery. The interface between the MO, the specialists involved in FU and Primary Care Physicians (PCP) should be optimized. While the “oncology centered” model seems hardly sustainable, a “sequential” model (PCP FU after an arbitrarily defined period of specialist FU) is gaining acceptance. A proposed alternative is a “shared-cares” model that promotes the interaction between MO and PCP throughout the whole clinical history. AIOM established a working group with the aim of promoting improvements at the national level. A survey aimed at assessing attitudes and feelings of MO was considered preliminary to any further initiative. Methods: A 25-item questionnaire was sent to the mailing list of the Society, in a 2-months period during 2011. One MO per institution was asked to answer to the questions. The sections of the survey were the following: 1) organizational features of FU; 2) clinical features involving breast (BC) and colorectal cancer (CRC) FU; 3) feelings of MO about the different meanings of FU. Results: 91 MO of 160 institutions (57%) answered. A shared organization between specialists is reported in 71% for BC and 53% for CRC. However, a shared medical record is used in only 19% and 11% respectively. The ordinary communication between MO and PCP consists in the medical report released to the pt in 87% and in other instruments in 8%. 55% and 30% of the MO follow BC and CRC pts indefinitely. In case of discharge, a conclusive letter is sent to the PCP in 74%, while a survivorship care plan is delivered in only 9%. Only 6% and 14% of the MO feel that FU has an important role in reducing mortality or in improving recurrence detection in BC. These figures grow to 31% and 47% for CRC. The educational role of FU is considered important in 36% and 32% while the psychological role in 44% and 37% for BC and CRC respectively. Conclusions: Although efforts are made to include other specialists and PCP into survivorship care, MO tend to privilege the “oncology centered” model. National efforts are being encouraged to promote the diffusion of a “shared-cares” model.
Would warning of osteonecrosis of the jaw (ONJ) have induced a change in the administration schedule of zoledronic acid (ZA)? A report from Toledo, Spain.
Authors: Rubio Salvador Ana Rosa , Chacon Jose Ignacio , Munoz Platon Enriqueta , Martinez Carrasco Begona , Cordero Franco Nazaret , Martinez Sesmero Jose Manuel , Diaz Paniagua Laura , Alonso Soler Sonia , San Juan del Moral Alberto , Fernandez Franco Lourdes , Esteban Esteban Carmen , Moya Gomez Paloma , Cruz Mora Miguel Angel
Published: March 2020

e19596

Background: ZA therapy has been associated with the development of ONJ. In Nov 8th, 2005, osteonecrosis of the jaw was elevated to a safety warning by Spanish Drug Agency (SDA). The aim of this study was to investigate if that warning has had any effect in the pattern of ZA administration in a general hospital. Methods: We retrospectively analysed database using pharmacy, medical and nurse claims data from the Oncobass integrated claims database for all pts diagnosed with cancer who had received treatment with ZA between Jan 1, 2002, and Dec 31, 2011. Delivered doses of ZA were stratified in 2 groups: used before the SDA warning and after the SDA warning. Main variable: time between two consecutive doses (TTCD). Secondary variables: age, sex and diagnosis. Descriptive statistical analysis were applied for both groups. Comparisons of means of TTCD before and after the warning were performed with Student’s test, or the Mann-Whitney test, as necessary. Statistic significance: p value < 0.05. Results: We identified 761 patients (374 (49.2%) male; 387 (50.8%) female), median age 64 y (25 – 92) who were delivered 7301 doses [mean: 9.6 doses/patient (d/p)]: 2,353 (32.2%) before the SDA warning and 4948 (67.8%) after. Pathologies: breast cancer (BC) 257 patients (pts) (33,77%), 2,918 doses (40%), mean 11.4 d/p; multiple myeloma (MM) 167 pts (21.94%), 2001 doses (27%), 12 d/p; prostate adenocarcinoma (PA) 129 pts (16.95%), 1,510 doses (20.7%), 11.7 d/p; lung cancer (LC), 112 pts (14.72%), mean 4.2 d/p, 465 doses (6.4%); other 96 pts (12.61%), 407 doses (5,5%), 4.2 d/p. 3,126 (43%) doses were delivered to male and 4,149 (57%) to female. TTCD was significantly increased after ths SDA warning [32.12 vs 33.87 days (d); p< 0.001; CI 95% (-0.79)- (-0.90)]. By pathologies, differences were significant only for MM [35.8 vs 44.4 d; p<0.001; CI 95% (-10.19)-(-6.99)] and for PA [28.67 vs 32.03; p < 0.001; CI 95% (-5.08)-(-1.63)], but not for the other pathologies. Median d/p was unchanged before and after warnings for all pathologies except for MM (13 d/p vs 8.3 d/p). Conclusions: In our environment, ONJ warnings have not changed substantially the ZA schedule pattern, except for MM.
Measuring the functional decline of people with advanced-stage non-small cell lung cancer (NSCLC).
Authors: Denehy Linda , Murnane Andrew , Krishnasamy Meinir , Gough Karla , Granger Catherine , Mileshkin Linda R.
Published: March 2020

e19605

Background: People affected by lung cancer maybe highly symptomatic. This study aimed to quantify changes in physical function and health-related quality of life (HRQoL) in patients with advanced NSCLC. Methods: A prospective cohort study was performed. Patients with stage III and IV NSCLC were recruited within one month of starting treatment and assessed at baseline, 2, 4 and 6 months or until they became too unwell. HRQoL and functional status were measured using the EORTC QLQ-C30, the 6-minute walk test (6MWT) and timed up and go test (TUG). Comparisons between baseline and follow-up assessments were carried out by fitting linear mixed models to each outcome separately. Results: 39 patients (21 male) were included in the analysis; median age of 63 (range 40-80). 59% were receiving treatment with curative intent. 28% had stage 4 disease with 26% deceased by 4 months. Response rates at 2 and 4 months were 71.8% and 53.8% for 6MWT and TUG and 87.2% and 64.1% for EORTC. The mean 6MWT at baseline was significantly lower than predicted for the age, sex and height of the cohort (417.9 versus 550.4 metres, p<0.0005). Significant decline in mean 6MWT distance was seen at 2 (decrease of 42.4m, 95%CI -59.0, -25.7, p<0.0005) and 4 month follow-ups (decrease of 63.6m, 95%CI -85.6, -41.5, p<0.0005) compared to baseline. Significant increases in time taken to complete the TUG were also seen at 2 (increase of 0.76 sec, 95%CI 0.54 – 0.98, p<0.0005) and 4 month follow-ups (increase of 1.01 sec, 95%CI 0.76 – 1.27, p<0.0005) compared with baseline. In contrast, global health status and physical functioning as assessed by the QLQ-C30 showed small but significant decreases at the 2 month follow-up compared to baseline (decrease of 8.04, p=0.01 and decrease of 7.67, p=0.024 respectively), but no significant differences between baseline and the 4 month follow-up. Conclusions: Patients with advanced NSCLC show clinically and statistically significant decrements in physical function at commencement of treatment. This continues to decline rapidly and significantly over time, despite small changes in self-reported HRQoL. The 6MWT demonstrated clinically relevant changes in physical function. Interventions to address this problem are urgently needed.
Concurrent stereotactic robotic radiosurgery and hyperthermia for palliation of pain in recurrent advanced malignancies.
Authors: Papaiah Susheela Sridhar , Govindarajan Mallarajapatna , Rajan Sudhan , Bilimaga Ramesh s , Anchineyan Pichandi , Amalraj Jerrin , Gupta Monica , D Madhusudan , Pundalika Mohan , Ajaikumar Basavalinga S.
Published: March 2020

e19619

Background: The management of advanced recurrent malignancy after definitive treatment is challenging. Palliation of pain in these cases by medication alone may not be sufficient. The role of Radiotherapy and hyperthermia were tried in the past with little benefit but side effects of radiation were considerably high due to large volume of disease. This study aims at Concurrent Robotic radiosurgery with hyperthermia for large volume disease for palliation of pain in recurrent advanced malignancy. Methods: Ten cases of recurrent advanced malignancy with Visual analog pain scale (VAS) score of > 8 were treated by concurrent stereotactic robotic radiosurgery and hyperthermia between July 2010 to Jan 2012. All patients underwent PET CT based radiosurgery planning,Sterotactic Robotic Radiosurgery was delivered to Gross Tumor Volume (GTV) to dose of 30Gy in 3-5 fractions using fiducial tracking method.Hyperthermia was delivered using Celsius 42 locoregional hyperthermia device for an hour after stereotactic robotic radiosurgery on alternate day for 3-5 sessions. All patients received premedication and pain medications during treatment. All patients were analyzed for tolerance of treatment, acute toxicity and pain control. Pain control was assessed at the end of treatment and 6 weeks. Results: Among 10 patients 7 were female and 3 were male, age ranged from 40 to 72 years. 4 patients were carcinoma cervix, 2 were carcinoma rectum, 1 cholangiosarcoma, 1 carcinoma pancreas, 1 carcinoma esophagus with supraclavicular lymphnode, 1 mucoepidermoid ca of maxilla. All patients completed the planned treatment of concurrent Sterotactic Robotic Radiosurgery and Hyperthermia without any acute toxicity. At the end of treatment all patients had reduction in the pain. 7 patients had more than 60% reduction. At the end of 6 weeks 8 patients had >80% reduction and off the analgesics. Conclusions: Concurrent Sterotactic Robotic Radiosurgery and hyperthermia is well tolerated and may gives good palliation of pain with improved quality of life in recurrent advanced malignancy. However randomized trial in this regard will be required.
Efficacy, safety, and cost-effectiveness (CE) analysis of pegfilgrastim (P) and lenograstim (L) in patients (pts) with nonmetastatic breast cancer (nmBC) receiving myelosuppressive chemotherapy (mCT).
Authors: Papa Anselmo , Rossi Luigi , Tomao Federica , Ricci Fabio , Giordani Erika , Spinelli Gian Paolo , Lo Russo Giuseppe , Basso Enrico , Verrico Monica , Zaccarelli Eleonora , Rinaldi Giulia , Stati Valeria , Pasciuti Giulia , Strudel Martina , Zoratto Federica , Tomao Silverio
Published: March 2020

e19620

Background: Neutropenia (N) is common in pts who receive mCT. This retrospective study was conducted to determine efficacy, safety and cost of single injection of P (6 mg) compared with daily L (263 μg), in primary prophilaxis of N in pts affected by nmBC, who received mCT. Methods: 50 women (median age 54 years) underwent to median 6 (range 4–8) CT doses with antracyclines +/- taxanes. At every cycle, 28 pts received daily L (median 5 injections from day 5 to 9), while 22 pts received one dose of P on day 2. Absolute neutrophil count, incidence of G3/G4-N, bone pain (BP: Numerical Rate Scale >7) and CE analysis were evaluated. Results: In overall population (OP) incidence of G3-N and G4-N was 25% and 68%, respectively in L vs 22.7% and 41%, respectively in P; two cases (7%) of febrile N (FN) occurred in pts treated with L and three cases (13.6%) of FN in P. In 19 pts treated with FEC100 (10 pts L vs 9 pts P) we observed 0% of G3-N and 30% of G4-N in L while 33% of G3-N and 44% of G4-N in P. 31 pts received TAC/AC+T (18 pts L vs 13 pts P) with G3-N and G4-N 38.8% and 66.6%, respectively in L vs 15.3% and 30.7%, respectively in P. 18.2% of pts, who received P, had BP vs 35.7% in L. Reduction of CT doses was observed in 35.7% in L vs 41% in P. In Italy the cost of 1 injection of P was about 1489,00 euro compared with about 655,00 euro for 5 injections of L. Conclusions: In our experience, 1 injection of P was more effective and expensive than 5 daily administration of L to control N in OP and in particular in TAC/AC+T, while in FEC100, L was satisfactory with good CE profile. No difference about incidence of NF. Safety of P and L were similar with a lower incidence of BP in P.
Using practice algorithms to deliver cancer survivorship care.
Authors: Palos Guadalupe R. , Zandstra Fran , Russell Ludivine , Flores Jacklyn J , DeJesus Yvette , Foxhall Lewis E , Rodriguez Maria Alma
Published: March 2020

e19625

Background: Clinical practice algorithms provide a framework to guide providers’ practice in delivering care to long-term cancer survivors. Here we describe how algorithms were developed in a comprehensive cancer center and types of metrics used to evaluate their feasibility. Methods: Survivorship practice algorithms were based on a multidisciplinary care approach successfully used to build screening and treatment algorithms. This model consisted of four phases: development, adoption, implementation, and evaluation of algorithms. Phase 1, expert clinicians and researchers identified and agreed upon a specific cancer site. Group-consensus and literature reviews/syntheses were used to determine eligibility criteria to transition patients to survivorship care. Phase 2, reviews and approval processes were conducted by credentialing and regulatory committees to ensure adoption of the algorithms into clinical practice. Phase 3, pilot programs were conducted to implement the algorithm(s) in disease-specific survivorship clinics. Phase 4, metrics to evaluate progress included the number of algorithms and providers’ use of and adherence to the algorithms. Results: Between 09/2008 – 12/2011, nine multidisciplinary disease-specific survivorship clinics were operationalized. Thirty-seven practice algorithms were developed to provide survivorship care based on each survivor’s specific needs. The algorithms’ framework included: 1) surveillance for recurrent or new primary malignancies; 2) primary and secondary cancer prevention recommendations; 3) management of toxicities and latent treatment effects; and 4) assessment of psychosocial functioning. Conclusions: Practice algorithms provide an organized plan to deliver comprehensive and holistic care to long-term survivors. Given the projected increase in cancer survivors, further research is needed to determine how practice algorithms impact providers’ practice and survivors’ outcomes.
Validation of the patient-generated part of the PG-SGA against the malnutrition screening tool (MST).
Authors: Swinton Nelda , Kasymjanova Goulnar , Grossman Mary , Cohen Victor , Pepe Carmela , Agulnik Jason Scott , Small David
Published: March 2020

e19626

Background: It is important to identify cancer patients (pts) who are at risk for malnutrition as many pts experience an array of nutritional problems which can impact upon their treatment plan and quality of life. This requires using an easy and reliable screening tool such as the MST or the scored PG-SGA. The scored PG-SGA is a more extensive tool consisting of a patient (pt) - generated section identifying symptoms that can impact on nutritional status. It also includes a second part consisting a pt’s physical examination. Both sections are summed to give an overall PG-SGA score. We hypothesized that the PG-SGA‘s pt-generated part alone, could be a comparable screening tool to the MST. Methods: We performed a prospective analysis from our out-patient pulmonary oncology clinic between July 1, 2010 to January 1, 2012 on non-small cell lung cancer (NSCLC) pts at various times in their cancer trajectory and used the MST as the gold standard. Pts were asked the MST’s questions by an oncology dietitian and completed the pt - generated part of the PG-SGA. Cut off points of ≥ 2 for the MST and ≥ 4 for the PG-SGA ( pt-generated part) were used to identify pts at risk for malnutrition. Results: 144 pts with NSCLC (72 male, 72 female, aged 67 ± 11 years) completed the questionnaires. Sixty-nine percent (99/144) had advanced disease. Fifty-six percent (81/144) of pts had a score ≥ 2 on the MST and 70 % (101/144) pts had a score ≥ 4 on the PG-SGA ( pt generated part). In 114 cases, the MST and PG-SGA scores were congruent: 76 were true positive and 38 were true negative. And in 30 cases the scores were discordant: 25 were false positive and 5 were false negative. The PG-SGA had a sensitivity of 94 % and a specificity of 60% in comparison to the MST. Conclusions: The pt-generated part of the PG-SGA alone had a sensitivity of 94% when compared to the MST. This tool could be used to screen for malnutrition risk in NSCLC pts attending an out-patient oncology clinic.
Multidisciplinary care clinics: A model to deliver personalized survivorship care.
Authors: Zandstra Fran , Palos Guadalupe R. , Russell Ludivine , Flores Jacklyn J , DeJesus Yvette , Foxhall Lewis E , Rodriguez Maria Alma
Published: March 2020

e19629

Background: Multidisciplinary care models provide a comprehensive approach to improve the care of long-term cancer survivors as recommended by the Institute of Medicine report.. Here we describe a Multidisciplinary Survivorship Care Model and the metrics used to evaluate the delivery of personalized care to long-term survivors. Methods: Critical components used to develop survivorship services included: 1) engaging clinical and administrative leadership; 2) conducting extensive reviews/syntheses of published literature including health promotion, prevention and risk reduction, late treatment effects, and rehabilitative services for each disease-site; 3) determining eligibility criteria to transition patients from active-disease care to survivorship care; 4) developing, implementing, and evaluating algorithms by involving a multidisciplinary team expert-consensus; 5) obtaining approval for integration of algorithms into practice by institutional credentialing and regulatory committees; 6) identifying appropriate survivorship clinics to pilot the feasibility of algorithms in routine clinical operations; 7) performing improvement checks of the clinic operations; and 8) revising operations and scheduling as needed. Metrics used to evaluate the progress of the clinical activity of each multidisciplinary survivorship care clinic (MSCC) included number of unique patients transitioned, number seen, number of arrived appointments, number of summary care plans issued, and survivors’ satisfaction. Results: The MSCCs included gynecology, thyroid, genitourinary, stem cell transplant, breast, head and neck, colorectal, lymphoma, and melanoma, with varied launch dates for each clinic. Between 09/01/2008 and 12/31/2011, there were a total of 7396 unique survivors, 12,741 arrived appointments, and 10,016 summary care plans completed within 30 days from appointment. Conclusions: Dedicated multidisciplinary survivorship care models are a comprehensive approach to deliver long-term survivorship care. Comparative effectiveness and other health outcomes research examining the feasibility, usability, acceptance, and effectiveness of the MSCC by providers and survivors is warranted.
Krill oil to improve blood lipids status in advanced cancer patient with cachexia.
Authors: Serpe Roberto , Madeddu Clelia , Panzone Filomena , Antoni Giorgia , Cau Maria Chiara , Macciò Antonio , Mantovani Giovanni , Banni Sebastiano
Published: March 2020

e19634

Background: Cancer patients with cachexia symptoms often show a lipid profile disorder, consisting in severe hypertriglyceridemia due to increased circulating free fatty acids and variable total cholesterol levels, decreased activity of lipoprotein lipase and increased lipolysis, which is correlated with proinflammatory cytokines levels, particularly IL-6 and TNFα. Recent evidence further confirms impairment of adipose tissue metabolism in inflammatory condition like cancer cachexia. The aim of this study was to assess the effect of nutritional supplementation with Omega 3 fatty acids (EPA and DHA) in the form of Krill Oil, on main parameters of blood lipid profile and on IL-6 and TNFα blood levels. Methods: In 2011, 34 IV stage cachectic patients (M/F 20/14; age range 55-85 y) with cancer at different sites were enrolled. 21 healthy subjects were studied as controls. All patients had high blood tryglicerides, low total cholesterol levels , high levels of blood IL-6 and TNFα compared to controls. Patients received 3 capsules (3 g/day) of krill oil (Superba™ Krill Oil, Aker Biomarine, Norway), which is an oil extract from the crustacean krill (Euphausia Superba) which contains Omega-3 series unsaturated fatty acids in phospholipidic form, of which 98 % are EPA and DHA mainly in phospholipid form. Treatment duration was 2 months. Results: A significant reduction of tryglicerides blood levels (148.23 ± 88.06 vs 114 ± 55.8 mg/dl) and a significant improvement of HDL cholesterol (42.5 ± 15.6 vs 60.9 ± 12.3 mg/dl) and Total Cholesterol (135.6 ± 46.3 vs 159 ± 41.1 mg/dl) was observed after treatment. Cytokines Il-6 and TNFα blood levels did not change significantly after treatment Conclusions: Nutritional supplementation with krill oil showed a positive activity in the regulation of blood lipid profile, involving different metabolic and inflammatory pathways, probably mainly affecting hormone-sensitive lipase activity. Our data suggest that krill oil could be useful in multi-targeted combined pharmaco-nutritional approaches to treat cancer-cachexia. Additional phase III clinical studies are warranted.
Supportive care in cancer organization in France: State of the art.
Authors: Scotte Florian , Herve Christian , Bugat Roland , Farsi Fadila , Namer Moise , Tourani Jean-Marc , Tournigand Christophe , Yazbek Gabriel , Richard Sandrine , Oudard Stephane , Krakowski Ivan ,   Association Francophone pour les Soins Oncologiques de Support
Published: March 2020

e19640

Background: Second Cancer Act was defined in France in December 2009 including enhancement of supportive care in Cancer (SCC). How are supportive care organized in France? Are patients informed about supportive treatment side effects? Methods: The AFSOS (French Speaking Association for Supportive Care in Cancer) conducted this observational study to evaluate practices, organizations and informations given to patients (pts) about SCC. Among 1621 french medical doctors (MD) caring cancer pts who were sent an adhoc questionnaire, 20% (330 MD including 44% medical oncologists) answered. Results: Three different organizations were described: Single MD, transversal team and specific structure specialized in global care (specifically developed in comprehensive cancer centers-CCC). Psycho-oncology, palliative care, nutrition and pain care were the four main items considered as supportive care. During their disease, 68% of pts are receiving SCC, presented by their MD (88%) or nurse devoted to announcement of disease and SCC information (57%). Supportive care is more dispensed during palliative period (90%) than at diagnosis (44%). Patients information is rather supplied during palliative care (85%) than at diagnosis (52%) using a specific questionnaire for outpatient (20%) or specific supportive care session (17%). 71% of cancer department have a cross team to provide supportive care, with specific SCC team particularly in CCC (62%; p=0.01)). 37% have inpatient specific units. Only 40% have a specific organization in home care connection, more in CCC than in public or private centers (respectively 69%, 45%, 20%; p=0.01). 73% use specific financial valorization of CSC activity. Adverse events information is dispensed to 54% of the pts for erythropoiesis stimulating agents (ASE), 74% for biphosphonates and 94% for opioids treatments, rather by medical oncologist than other specialists (p=0.01). Conclusions: Specific organization developed especially in comprehensive cancer centers seems to facilitate SCC organization and information to pts. In the mean time, recommendations include this information, involvement in supportive care team and methods have to be enhanced. Further results compared with patient point of views are expected.