bluuebunny/crossref_metadata_2025_split huggingface dataset:
Fentanyl sublingual spray for breakthrough cancer pain in patients receiving transdermal fentanyl.
Authors: Alberts David S. , Rauck Richard L. , Parikh Neha , Forman Nicole 
Published: February 2017

175 Background: Sublingual fentanyl spray is indicated for the treatment of breakthrough cancer pain (BTCP) in opioid-tolerant patients receiving around-the-clock (ATC) opioids. This post hoc analysis characterized patients receiving ATC transdermal fentanyl patch (TFP) who also received fentanyl sublingual spray for BTCP during a phase 3, randomized, placebo-controlled trial. Methods: Opioid-tolerant adults (n=130) receiving ATC opioids for baseline pain, with 1 to 4 episodes/day of BTCP, were enrolled in a 26-day open-label titration period and received fentanyl sublingual spray. Patients who successfully titrated to a stable, effective dose (100-1,600 mcg) of fentanyl sublingual spray entered a 26-day double-blind period. Patient satisfaction was assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM). Adverse events (AEs) were monitored throughout the study. Results: Of the 50 patients (mean age, 50 years) who were on ATC TFP at baseline, most were male (58%) and white (90%) with a mean of 2.4 BTCP episodes/day. The most common types of cancer were reproductive (22%), head and neck (14%), and lung (8%). The percentage of patients in each cancer stage was 0/I (14%), II (10%), III/IV (48%), or unknown/not applicable (28%). Thirty-two of 50 patients (64%) achieved an effective dose of sublingual fentanyl spray and entered the double-blind period. In the 32 patients, the mean baseline TFP dose at the beginning of double-blind period was 81.4 mcg. The mean daily number of BTCP episodes during the 26-day double-blind period was 2.3 (range, 1-5). Mean TSQM scores at baseline and end of the titration period, respectively, were as follows: effectiveness, 49.0 vs 78.3; side effects, 65.0 vs 94.4; convenience, 61.6 vs 73.8; and global satisfaction, 49.3 vs 72.8. The effective dose of fentanyl sublingual spray only moderately correlated with the mean TFP dose (r=0.4; P=0.03). During the double-blind period, 19 of 32 patients (59%) reported AEs; the most common AEs were nausea (9%) and peripheral edema (9%). No opioid overdoses were reported. Conclusions: The findings support that fentanyl sublingual spray relieves BTCP and is well tolerated in most patients receiving ATC transdermal fentanyl. Clinical trial information: NCT00538850.
Supportive cancer care in-patient unit: A 3-year experience.
Authors: Scotte Florian , Legeay Karine , Maupoint de Vandeul Thyphaine , Leroy Pauline , Aubaret Christophe , Hans Stephane 
Published: February 2017

185 Background: An in-patient unit for supportive care in oncology (USSO) was created in 2011 in the Georges Pompidou European Hospital. Its primary objective is to improve patient care and manage the complications of cancer as well as their specific treatment. Patients are previously screened by a cross disciplinary team at an early stage before complication. Methods: A prospective observational study was performed through a yearly evaluation of the unit’s activity from January 1st, 2011 to December 31st, 2013. Results: 594 patients were admitted in the unit during the three years period of study. Most of them (64.3%) came directly from home, with an increase of this rate along this period (59.4% to 67.6%). The early screening thereby rendered emergency admission from 17.7% (2011) to 6.5% (2013). The predominant diseases observed were head and neck cancer (42.4%) and lung cancer (23%), followed by breast (7.2%) and ovarian cancer (7.2%). The main grounds for hospitalization were state of health impairment 32%, pain 12.8%, and invasive procedures 11.8%, increasing from 2011 to 2013. Therefore, an interdisciplinary approach is the cornerstone of the unit with the daily collaboration of dieticians (for 90% of inpatients), social workers, psychologists, physiotherapists and pain specialists (34%, 46%, 56% and 50% of inpatients respectively). The average length of stay decreased from 2011 (10.2 days) to 2013 (8.3 days) and 58.4% of the patients were home discharged. With the help of a social worker, 12% of the patients were transferred to a recovery unit and 9.7% to a palliative care unit while 9% died in the unit. Conclusions: With the opening of the in-patient USSO, and the development of its interdisciplinary strategy, most of the patients recover faster and regain better health. Preventive care can accommodate a majority of patients coming from home and allows for ambulatory secured discharge. These positive results conducted to enhance the USSO’s beds capacity and supportive care development in order to improve cancer care organisation in the hospital as well as patient’s quality of life.
The McGill University Health Centre interdisciplinary approach to cancer pain management: Description of treatments and outcomes.
Authors: Olivier Sara , Perez Jordi , Shir Yoram , Borod Manuel , O'Grady Rosemary 
Published: February 2017

190 Background: Cancer-related symptom management is best achieved by interdisciplinary teams. In 2011, the MUHC launched an interdisciplinary Cancer Pain Clinic including palliative care, anesthesia, radiation oncology and nursing with rapid access to physiotherapy, occupational therapy and psychosocial oncology. Methods: We retrospectively analysed all new outpatients completing two subsequent visits since March 2013. Variables included a) symptom severity with the Edmonton Symptom Assessment Scale (ESAS), b) pain with the Brief Pain Inventory (BPI) and c) treatment including medication (type, formulation, dose of opioids) of non-pharmacological approaches. Results: 71 patients were analysed. Symptom management: Severity of pain and other five symptoms decreased significantly at V2 or V3 (Table). Pain significantly decreased in all four BPI categories. One third of patients had ≥50% pain relief at V2 or V3. Number of severe pain cases decreased (45% at V1 to 18% at V3) in parallel to an increase of mild pain cases (11% at V1, 41% at V3). Treatments: Acetaminophen, anticonvulsants and NSAIDs were the most common non-opioid drugs. Opioid prescription remained constant at an 80% yet the ratio between short acting (SA) and long acting (LA) changed at V3 compared to V1 (V1: SA/LA=76/44; V3: SA/LA=48/58) and the morphine equivalent daily doses decreased (V1: 100±194 mg, V2: 84±158mg and V3: 65±80mg). Among non-pharmacological methods, 28% of patients received interventional procedures, 18% psychotherapy and 12% palliative radiotherapy. Conclusions: We believe that the pain and other symptom improvement observed after three visits along with a lower opioid consumption is a result of the interdisciplinary approach offered. [Table: see text]
Efficacy and tolerability of oxycodone for oxaliplatin-induced peripheral neuropathy and the extension of folfox therapy in colorectal cancer patients.
Authors: Nagashima Makoto , Ooshiro Mitsuru , Moriyama Ayako , Kadoya Kengo , Sato Ayami , Kitahara Tomoaki , Takagi Ryuichi , Urita Tasuku , Yoshida Yutaka , Tanaka Hiroshi , Oshiro Takashi , Okazumi Shinichi , Katoh Ryoji 
Published: February 2017

196 Background: The oxaliplatin-based regimen FOLFOX is widely used to treat patients with advanced colorectal cancer (CRC). However, dose-limiting toxicity after continuous oxaliplatin administration can lead to peripheral neuropathy. Several agents, including opioids, that have been employed to treat oxaliplatin-induced peripheral neuropathy (OIPN) have been examined in clinical settings regarding their protective and therapeutic effects. However, the pharmacotherapy of these agents has not yet been established. Therefore, we investigated the efficacy and tolerability of oxycodone for OIPN and subsequently with FOLFOX therapy in CRC patients. Methods: This was a single-center retrospective study of 64 CRC patients who underwent FOLFOX therapy at the Toho University Sakura Medical Center (Sakura, Japan). Controlled-release (CR) oxycodone was concomitantly administered to 29 patients (OXY group), whereas the additional 35 patients (non-OXY group) were not given oxycodone during the FOLFOX treatment course. The incidence and severity of OIPN and the number of FOLFOX cycles were measured and compared between the two groups. Neurological toxicities were assessed according to the Common Terminology Criteria for Advanced Events, version 3.0. Results: All study patients had OIPN. Most patients experienced grade 1 or 2 sensory neuropathy. Grade 3 sensory neuropathy was observed in two patients in the non-OXY group. All patients in the OXY group completed the scheduled FOLFOX therapy, whereas FOLFOX therapy was discontinued in ten patients in the non-OXY group due to severe peripheral neuropathy. The median numbers of FOLFOX cycles in the OXY and non-OXY groups were 13 (range, 6–46) and 7 (range, 2–18), respectively (P < 0.05). The median cumulative oxaliplatin doses were 1072.3 mg/m2 (range, 408.7–3385.3 mg/m2) in the OXY group and 483.0 mg/m2 (range 76.2–1414.1 mg/m2) in the non-OXY group (P < 0.05). Conclusions: Our findings indicate that CR oxycodone might attenuate the severity of OIPN and extend the use of FOLFOX therapy.
Is opioid-induced hyperalgesia a genuine issue for palliative care patients and clinicans?
Authors: Eastman Peter , Le Brian H. , Grant Ian , Berry Sue 
Published: February 2017

197 Background: Opioid-Induced Hyperalgesia (OIH) has been described as a paradoxical response whereby opioid administration induces an increase in pain sensitivity rather than an analgesic effect. It is proposed this results from increased pro-nociceptive sensitivity following changes in central and peripheral neural pathways. While there is basic science and pre-clinical evidence supporting OIH, debate remains about its clinical relevance or even existence. The existence or otherwise of OIH has relevance for palliative care as many patients are prescribed opioids and the standard management of unstable pain in palliative care may worsen symptoms in OIH. Therefore recognition of the concept would seem important for palliative care clinicians. Methods: An electronic survey of Australian and New Zealand palliative care clinicians was undertaken addressing awareness of OIH as well as approaches to recognising and managing it. The survey which contained single response, multiple-choice and open-ended questions was distributed through the Australian New Zealand Society of Palliative Medicine. Mixed-methods analysis was performed. Results: One hundred and twenty-three surveys were returned (response rate = 31%). The majority of respondents identified as palliative care specialists. More than 75% of respondents reported observing OIH in their clinical practice, often with malignant disease and with morphine, oxycodone and fentanyl identified as the commonest causal agents. The three features felt to be most suggestive of OIH were; escalating pain despite increasing opioids, demonstrable hyperalgesia or allodynia and a more diffuse pain distribution away from pre-existing pain sites. Most clinicians utilized more than one approach when OIH was encountered. The commonest of these were opioid reduction, opioid rotation and optimization of adjuvant analgesia. Conclusions: Our survey found a higher rate of reported observation of OIH amongst clinicians than might have been anticipated given debate about the existence of OIH in humans outside of a research environment. These results suggest that many palliative care clinicians perceive OIH to be a genuine issue for their patients.
Use of early radiation therapy in the palliative local treatment of stage IV esophageal cancer.
Authors: Hertan Lauren Michelle , Plastaras John Peter , Ben-Josef Edgar , Metz James M. , Jones Joshua Adam , Apisarnthanarax Smith 
Published: February 2017

198 Background: Palliating local symptoms in stage IV esophageal cancer remains a challenge with no clear optimal initial intervention. Therapeutic options include radiation therapy (RT), chemotherapy (chemo), stent, or a combination of these treatments. We hypothesized that early initial RT would result in the best palliation of local symptoms in stage IV esophageal cancer patients. Methods: The study cohort included 72 patients with locally symptomatic stage IV esophageal cancer treated at the University of Pennsylvania from 2006-2012 and was split into those who received RT as part of their initial treatment (n = 42) versus those who did not (n=30; chemo alone, n = 18; chemo and stent, n = 9; stent alone, n=3). Demographics, baseline disease characteristics, treatment details, and clinical outcomes were analyzed. Results: Patient demographics and baseline characteristics were well balanced between the groups, except the RT group was less likely to have liver metastases (p=0.001). The RT group included both concurrent chemoRT (n=31) and RT alone (n=11, with or without sequential chemo). Median RT dose was 50.4 Gy (range 21 – 70 Gy). Chemotherapy regimens included 5-FU based or Carboplatin/Paclitaxel. Presenting symptoms included dysphagia (n=69, median grade 2), odynophagia (n=3, median grade 1), bleeding (n=5, median grade 3), and chest pain (n=3, median grade 2). No difference was noted in symptom improvement (median grade improvement = 1; p=0.25) or ECOG status (median improvement = 0; p=0.24) between the groups. However, patients who received upfront RT were less likely to have local symptom progression (% not having symptom progression: 69.1% [RT] v 43.3% [no RT]; p=0.003) and less likely to need repeat local intervention (% not requiring repeat local intervention: 81.0% [RT] v 33.3% [no RT]; p<0.0001). There was no difference in median time to first progression (11 mo [RT] v 11 mo [no RT]) or median survival (9.8 mo [RT] v 10.7 mo [no RT]). Conclusions: Early use of RT in locally symptomatic stage IV esophageal cancer patients results in effective palliation of local symptoms that may be more sustained compared to chemo alone or stent placement.
The practice of early palliative care: A qualitative study of patient-clinician encounters.
Authors: Lim Christopher Taekyu , Tadmor Avia , Fujisawa Daisuke , MacDonald James John , Gallagher Emily R. , Temel Jennifer S. , Greer Joseph A. , Park Elyse R. 
Published: February 2017

2 Background: Studies have shown that palliative care (PC) integrated early in the course of metastatic cancer, shortly after diagnosis, leads to improved patient outcomes. Unlike PC in the inpatient setting, PC initiated early, in the ambulatory setting, had not been well studied. Our aim was to elucidate the practice of early PC through analysis of PC clinic visit transcripts. Methods: As part of an ongoing study of early PC in patients with advanced lung and gastrointestinal cancers at the Massachusetts General Hospital, we are audio-recording patients’ outpatient PC clinic visits. To capture the range of PC content, we randomly selected five patients and analyzed three clinic transcripts per patient: early, midway, and late in each patient’s clinical course. We performed thematic analysis on these clinic transcripts using NVivo 10. Results: Our analysis suggests that the elements of early PC that occur most frequently across the disease course are managing symptoms, facilitating coping, and developing the relationship with patients and their family caregivers. Elements that tend to occur during clinical transitions include advising treatment decision-making, facilitating medical understanding, and advance care planning. Our analysis also identifies four broad approaches to PC that are applied longitudinally, over the course of the patient-clinician relationship: 1) eliciting versus commenting on patients’ perspectives, 2) alluding to and preparing for the future, 3) transitioning between managing symptoms and facilitating coping, and 4) transitioning between developing the relationship and facilitating coping. Lastly, we observe three specific techniques applied by PC clinicians: 1) coordinating with oncologists, 2) providing referrals, and 3) addressing family dynamics. Conclusions: Our study identifies the predominant elements, four longitudinal approaches, and three specific techniques of early PC. These novel insights can be applied to care delivered by both PC and non-PC clinicians, well before patients approach the end of life. The longitudinal approaches in particular may help explain the significance of early integration of PC into cancer care.
Supportive care organization: Patients and oncologist national survey comparison.
Authors: Scotte Florian , Herve Christian , Tourani Jean Marc , Bugat Roland , Farsi Fadila , Jovenin Nicolas , Namer Moise , Tournigand Christophe , Leroy Pauline , Oudard Stephane , Krakowski Ivan 
Published: February 2017

202 Background: The medical doctor's (MD) perspective of supportive care in cancer (SCC) in France was previously assessed on a national survey. However, the opinion of patients (P) has never been evaluated nor compared to MD’s perception.Wepromoted and compared P and MD awareness via national surveys to monitor implementation and information delivered to patients on SCC. Methods: The French Speaking Association for SCC (AFSOS) conducted two observational studies, analyzed with a Chi2 test: S1: a 30 points questionnaire sent to 2,263 physicians caring for cancer P (oncologists, radiotherapists, haematologists, gastroenterologists); and S2: a 40 points questionnaire performed by physicians to P, using a face-to-face method. Results: 711 MDs returned S1 and S2 was conducted with 1,562 P. In S1, MDs declared relying on SCC organization (81%) but 19% of P declared they were offered to benefit from an organization called SCC (54% at diagnosis, 35% after complication). The name SCC was known by 34% of P, most frequently described as complementary care to specific treatments (55%). Palliative Care word had been previously heard by 80% P, mostly considered as care to improve quality of life during cancer treatment for 59%. In S2, professional resources identified outside the hospital were: general practitioners (84%), nurses (58%), pharmacists (52%). According to P, the top 3 supportive care consultations proposed were psychology (61%), nutrition (55%) and announcement organization (55%), while MDs mentioned palliative care (98%), psychological care (98%), social care (98%), S2 showed that supportive treatment was prescribed to 63% of P, mostly by their oncologist (74%), and 64% of those P received information on side-effects. Epoetin was prescribed to 25% and analgesics to 73%, with discussion on adverse events respectively for 38% and 53%. MDs declared delivering information on adverse events to 49% of P receiving epoetin and to 74% of P running for analgesic treatment. Conclusions: Oncologist is the cornerstone of SCC organization. Information as well as treatment must be developed to further enhance SCC and patient quality of care.
Long- and short-acting opioids in cancer pain management: What is the best ratio?
Authors: Wiesenthal Alison , Moryl Natalie , Glare Paul A. 
Published: February 2017

206 Background: Many cancer patients experience chronic and breakthrough pain necessitating the use of both immediate release (IR) and extended release (ER) opioids. The common strategy in treating chronic cancer pain is using ER opioids with the addition of IR opioids for breakthrough pain. The National Comprehensive Cancer Network recommends IR dosing at 0.1-0.2 times the daily ER dose as needed every 1 hour for breakthrough pain, though data is lacking to validate this recommendation. The aim of this exploratory study was to review the current practice in prescribing IR and ER opioids and the IR/ER ratio used in cancer pain management at one comprehensive cancer center (CCC). Methods: We performed a retrospective chart review of 54 consecutive patients at a CCC over a 6 month period. IR/ER doses, dose adjustments and satisfaction with analgesia were recorded. Adjustments in treatment plans were made based on patients' report of effectiveness and side effects associated with ER and IR opioids. Results: 19 of 54 (35%) patients reported adequate analgesia, with the average daily prescribed IR/ER ratio of 0.6 (range 0 to 3.75). In this group, IR opioids were unchanged during the clinic visit. The ER opioids, on average, were also unchanged, though decreased by 25% and increased by 50% in a few cases over serial clinic visits. Of those patients reporting suboptimal analgesia during the clinic visit (65%), 80% had their ER opioids increased, 6% had IR opioids increased, and 9% had both IR and ER increased. The ER opioids were increased by 40% on average and IR by 11% with the average IR/ER ratio changing from 0.5 (range 0-2) to 0.37 (range 0-1.13). Conclusions: These preliminary data highlight the great variability between patient preferences and clinician decisions in terms of IR/ER opioid ratios. In this retrospective study, analgesia was better in the group using higher IR doses with a higher IR/ER ratio. At the same time, patients with suboptimal analgesia had their ER opioids titrated faster and higher than the IR opioids. More studies are needed to determine best practice in the prescribing of long and short acting opioids for management of chronic cancer pain.
Usage of biosimilar filgrastim: A subanalysis of the next study.
Authors: Maloisel Frederic , Leprêtre Stephane , Kamioner Didier , Berthou Christian , Albrand Helene 
Published: February 2017

216 Background: Febrile neutropenia (FN), a major risk factor for morbidity/mortality, is associated with dose delays and/or reductions in potentially cytotoxic chemotherapy (CT) regimens. European recommend prophylactic use of granulocyte-colony stimulating factor (G-CSF) when using a CT regimen associated with a >20% risk of FN or in less intensive CT regimens if certain risk factors (eg >65 years, advanced disease) are present. Biosimilar filgrastim (Nivestim, Hospira Inc.) is a G-CSF licensed for the treatment of neutropenia and FN induced by myelosuppressive CT. As the NEXT (Nivestim safety profile in patients [pts] treated with cytotoxic CT in real-life clinical practice) study was conducted in France, the real-life usage of biosimilar filgrastim is compared with that recommended by current European guidelines. Methods: NEXT was a prospective, non-interventional, longitudinal, multicentre study conducted in France. Pts were undergoing CT for malignancies and receiving biosimilar filgrastim as prophylaxis or as curative treatment. This subanalysis included only pts receiving prophylactic biosimilar filgrastim. Individual FN risk factors were analysed. Results: Overall, 2102 pts were analysed in the study and 2065 pts received prophylactic biosimilar filgrastim. Of these, 19.4% received CT associated with a high risk of developing FN (intermediate risk 55.6%; low risk 25.0%). Of the pts receiving CT regimens associated with an intermediate or low risk of FN, 95.4% and 96.5%, respectively, had ≥1 risk factor for FN (Table). Of all pts analysed, 2.4% developed FN, 11.2% developed an infection and 2.4% were hospitalised for FN and/or infection after the first CT cycle. Median delay between the last CT dose and start of treatment was 2 days; mean ± SD duration of treatment was 6.0 ± 3.8 days. Conclusions: The majority of pts received prophylactic biosimilar filgrastim according to European guidelines (ie either had >20% risk of FN or had ≥1 FN risk factor). Clinical trial information: NCT01574235. [Table: see text]