bluuebunny/crossref_metadata_2025 huggingface dataset:
High-dose bolus interleukin-2 in elderly patients (>60 years old) with metastatic melanoma or renal cell cancer
Authors: Homsi J. , Kim L. C. , Goetz D. , Chen D. , Fishman M. , Daud A.
Published: March 2020

19559

Background: Although durable complete responses have been reported from using high-dose bolus interleukin-2 (HDB IL-2) in a small number of patients with metastatic melanoma and renal cell cancer (RCC), IL-2 toxicity limits its use especially in the elderly. Methods: the medical records of patients older than 60 years old with melanoma or renal cell carcinoma who received HDB IL-2 at the Moffitt Cancer Center between 2000–2005 were reviewed. The effect of increased age, primary diagnosis, and the HDB IL-2 regimen used on the side effects, number of administered doses, and survival was analyzed. Results: 55 cycles were administered to 35 patients (23 RCC, 12 melanoma, 26 men). Median age was 67 years old (range: 61–77). 17 patients received a traditional regimen (one cycle: 600,000 IU/Kg intravenously every 8 hours for 14 doses repeated in 2 weeks, maximum of 28 doses) and 18 received a clinical trial regimen (one cycle: 600,000 IU/Kg intravenously every 8 hours for 5 doses repeated weekly, maximum of 20 doses). Median number of administered cycles was 1 (range 1–4) and median number of total doses was 24 (range 3–79). Increased age was not related to total number of administered doses. Median percentage of IL-2 administered in a cycle was 75% of planned (range 11%-100%). Reasons to discontinue therapy were: oliguria (35%), hypotension (25%), and arrhythmia (15%). Side effects in all cycles were: hypotension (71%), oliguria (67%), Arrhythmia (18%), Myocardial infarction (7%), pulmonary edema (7%), hypothyroidism (4%), confusion (4%), seizures (2%) and stroke (2%). Pressors were used in 58% of all cycles. 20 patients died within a year from starting treatment and 5 lived more than 2 years (4 had RCC). Conclusions: 1) HDB IL-2 has multiple and life-threatening side effects in the elderly and caution is needed when selecting these patients to such therapy 2) the number of doses administered is comparable to that general population 3) more studies are needed to identify the population that would mostly benefit from HDB IL2.

[Table: see text]

No significant financial relationships to disclose.
A case-control study examining the role of recent chemotherapy in causing Clostridium difficile infection among cancer patients
Authors: Thapaliya P. , Donato A. , Curl K.
Published: March 2020

19563

Background: Clostridium difficle infection is a major cause of morbidity and mortality in hospitalized patients. The recent use of cancer chemotherapy agents is a frequently cited risk factor but there is a paucity of evidence to this regard. Objective: To determine if an association exists between C. difficile infection requiring hospitalization and recent chemotherapy in patients with cancer. Design: A retrospective case control study. Setting: Community Teaching Hospital Participants: 357 cancer patients admitted with diarrhea or developed diarrhea during their hospital stay that were tested for C. difficile diarrhea via toxin assay over a 2 year period. Outcome Measurements: C. difficile infection using tests for toxin A and or B in stool. Results: Eighty-nine cases had stool positive for C. difficile toxin whereas 267 controls were negative. 30/89 (33%) cases and 90/268 (33%) controls were found to have chemotherapy in the six weeks before collection of stool for toxin assay (Odds Ratio (OR) 1.09, p=1.0 using Pearson Chi square). Factors associated with infection on logistic regression analysis included recent antibiotic usage (OR 1.99, 95% CI 1.01- 3.93),hospitalization in preceding 2 wks with OR 4.1 (95%CI 2.39–7.05) and institutionalization with OR 2.13 (95 % CI 1.03–4.39). Conclusions: C .difficile infection in cancer patients is more likely in recently institutionalized or hospitalized patients who have received recent antibiotics, but not patients with recent chemotherapy.

No significant financial relationships to disclose.
Prediction of short-term outcome in terminally ill cancer patients
Authors: Durand J. , Pourchet S. , Goldwasser F.
Published: March 2020

19572

Background: Oncologists tend to overestimate survival of advanced cancer patients (pts) emphasizing the need for objective prognostic models to prevent futility. Methods: From January 2004 to May 2006, a prospective unicenter study was done in terminally ill cancer pts referred to a palliative care unit. Evaluation at admission included physical examination and the following routine blood tests : total blood count, hemostasis (Prothrombin Time (PT), activated Partial Thromboplastin Time (aPTT)), inflammatory and nutritional proteins (fibrinogen, ferritin, PINI = [alpha-1 acid glycoprotein x C-reactive protein (CRP)] / [albumin x prealbumin]), serum lipids (total and HDL cholesterol), biochemistry (urea, serum creatinine, calcium, total bilirubin, B12 vitamin) and liver enzymes (AST, ALT, LDH). Fatal outcome within the first 48 hours and lack of blood tests were exclusion criteria. A multivariate analysis according to a logistic regression was used to estimate the probability of fatal outcome within 2 weeks (wks) based on baseline patients characteristics. Results: 285 consecutive pts were hospitalized; 246 were evaluable : 133 men and 113 women (median age : 64 years; range: 18–94). Primary tumor was gynecological (18.3%), gastro-intestinal (16.3%), pulmonary (13.4%), hepatic or biliary (13.8%), urological (11.8%), head and neck (9.3%), haematological (3.3%) or others (13.8%). In univariate analysis, survival ≤ 2 wks correlated with male gender (p<0.001), Karnofsky Index (KI) (p<0.001), leucocytes (WBC) (p<0.001), aPTT (p=0.04), Urea (p=0.011), Total bilirubin (p=0.004), AST (p<0.001), LDH (p=0.008), albumin (p=0.042), prealbumin (p=0.004), CRP (p=0.028), ferritin (p=0.007), B12 vitamin (p=0.042) and PINI (p=0.001). In multivariate analysis, male gender (p=0.034), cutaneous metastases (p=0.012), KI ≤ 20% (p=0.002), WBC > 7.5G/l (p=0.012), fibrinogen > 6.5 g/l (p=0.021), LDH > 2N (p=0.035) and PINI > 20 (p=0.007) were predictive. A mathematical model was built to estimate the probability of fatal outcome within 2 wks. Conclusions: We created a tool which may help physicians to better estimate survival of terminally ill cancer pts and to prevent unnecessary overtreatment. Our score needs prospective validation in a multicenter study.

No significant financial relationships to disclose.
Efficacy and compliance of small-bore chest tube insertion and pleurodesis protocols for the treatment of malignant pleural effusions
Authors: Goodwin R. A. , Reaume M. , Gallant V. , MacArtney G. , Maziak D. , Matzinger F. , Gertler S.
Published: March 2020

19575

Background: Small-bore chest tubes are now recognized as a safe and effective alternative to large-bore catheter chest tubes for the treatment of malignant pleural effusions (MPEs). The Ottawa Hospital (TOH) developed protocols for insertion and pleurodesis to maximize efficiency and minimize complications. Objective: To evaluate the efficacy and compliance of small-bore chest tube insertion and pleurodesis protocols for the treatment of MPEs. Methods: Retrospective chart review of TOH medical oncology inpatients treated for a MPE using our small-bore chest tube insertion and pleurodesis protocols from February 2003 to May 2004. Outcomes reviewed included deviations from protocol (major and minor), proportion of patients proceeding to pleurodesis and efficacy at six weeks, complications, as well as length of hospital stay. Results: One-hundred and fourteen potential cases were identified, of those 78 small-bore chest tubes were inserted into 72 patients. Major deviations from the chest tube protocol occurred in 21 patients (27%) who lacked microbiological analysis of their pleural fluid. Major complications of tube insertion occurred in ten patients (13%) who developed pulmonary infections and two patients (2.5%) who developed a significant pneumothorax. Of the 78 tube insertions, 24 cases went on to pleurodesis. Major deviations from our pleurodesis protocol occurred in five patients (2.1%) who failed to have a chest xray twenty-four hours prior to pleurodesis. The most common complication post pleurodesis was pain with seven of 24 patients (29%) rating their pain as severe. Fifteen of the 24 patients (63%) had fluid reaccumulation within six-weeks post pleurodesis. Median length of stay for patients without pleurodesis versus those with pleurodesis was 14.5 and 16.0 days, respectively. Conclusions: Our preliminary data suggests that chest tube insertion and pleurodesis protocols have good compliance rates with low rates of complications. Only a minority of patients were able to proceed to pleurodesis and long term control of effusion occurs in less than half of patients in this subgroup. As well, pain control at the time of pleurodesis was not adequate in one third of patients with the current protocol.

No significant financial relationships to disclose.
Efficacy and safety of echoguided catheterisation approach in oncological and hematological patients. Report on 843 consecutive patients
Authors: Lazzaro A. , Vallisa D. , Moroni C. F. , Bertè R. , Bernuzzi P. , Anselmi E. , Arcari A. , Bosi C. , Mordenti P. , Trabacchi E. , Cavanna L.
Published: March 2020

19581

Background: A central venous catheter (CVC) represents the most frequently adopted intravenous line for patients undergoing infusional chemotherapy, bone marrow transplantation (BMT) and parenteral nutrition. The aim of this study was to explore the feasibility and safety of CVC insertion under ultrasound (US) control. US offers the advantage of real-time, multiplanar imaging as well as Doppler analysis. Methods: The echoguided approach allowed us to insert CVC in right supraclavicular site nearby the clavicular head of sternocleidomastoid muscle. Using a 7.5-MHz probe we were able to perform a real time control of the hip of the needle while it was inserted in the last side of internal jugular vein. At the end of the procedure chest Rx was executed to evaluate CVC position and to detect pneumotorax. Mainly Sekalon Seldy, Becketon Dickinson was employed. For PBSC collection, 14-gauge Arrow double lumen revealed to be highly efficacious (46 PBSC collections, no one failure). Results: From November 1999 to December 2006 the echoguided CVC insertion method was applied 1003 times in 843 patients. The procedure was applied 288 times in haematological malignancies, in 698 solid tumors, in 3 neurological autoimmune diseases. Among solid tumors colon carcinoma was the first indication, while gastric carcinoma the second. Among haematological patients: non-Hodgkin lymphoma was the first indication, then acute leukemia. Ten patients underwent allogenic BMT and 92 autologous BMT. Nine in 1003 procedures failed (1%). Failures were caused by: arterial puncture in 3, CVC dislocation in 1, vein collapse in 3 and no efficacious “eco window” in 2. No pneumotorax was registered. The safety of this procedure was confirmed by 35 catheterisations obtained with platelets under 20000/μl, by 7 procedure with prothrombin activity under 50%. In 44 patients catheter was inserted with neutrophil count below 100/μl and in 66 below 500/μl without any increase in infections. Mean time of catheter permanence was 151 days with 1,7 infectious events every 1000 days of permanence. Symptomatic deep veins thrombotic complications were 9 (1%). Conclusions: This procedure is safe, cheap with high accuracy and success rate, and above all US-guidance avoids pneumothorax.

No significant financial relationships to disclose.
Additional binding mechanism of palonosetron to the 5-HT3 receptor versus first generation 5-HT3 receptor antagonists
Authors: Rojas C. , Stathis M. , Alt J. , Rubenstein E. , Cantoreggi S. , Sebastiani S. , Slusher B.
Published: March 2020

19583

Background: Palonosetron has a higher binding affinity and longer plasma half-life than first generation 5-HT3 receptor antagonists. Clinical trials have demonstrated that a single intravenous dose of palonosetron 0.25 mg provides better protection from chemotherapy-induced nausea and vomiting than other 5-HT3 receptor antagonists throughout the 5-day post-chemotherapy period. The purpose of this work is to determine differences in the molecular interactions of the antagonists with the receptor that could help explain the clinical efficacy differences. Methods: Molecular ligand-receptor relationships for commonly used 5-HT3 receptor antagonists were investigated. In particular, competitive vs. potential allosteric interactions between ondansetron, granisetron and palonosetron and the 5-HT3 receptor were examined. Binding experiments were carried out using each unlabeled antagonist in competition with [3H]-antagonist. Concentrations of [3H]-antagonists used in these experiments included the equilibrium dissociation constant (Ki) and several-fold Ki values in an effort to represent the probable concentrations of each antagonist at the receptor site in vivo. The inhibitory concentration of unlabeled antagonist needed to observe half maximal binding (IC50) as a function of [3H]-antagonist concentration was plotted for comparisons between ondansetron, granisetron and palonosetron. Results: A plot of the concentration of unlabeled antagonist needed to observe IC50 as a function of [3H]- antagonist concentration was linear when ondansetron and granisetron were in competition. On the other hand, when palonosetron was in competition with either granisetron or ondansetron the plot was curvilinear in each case. Conclusions: These results indicate that palonosetron exhibits both competitive and allosteric interactions with the 5-HT3 receptor, in contrast to ondansetron and granisetron which display strictly competitive antagonism. As allosteric interactions may induce changes in the receptor conformation, we can speculate that palonosetron's dual action on the 5-HT3-receptor could induce amplification of its inhibitory effect at the primary receptor binding site.

No significant financial relationships to disclose.
Effectiveness of epoetin beta 30,000 UI once weekly (QW) for treatment of anemia in solid tumor patients under chemotherapy
Authors: Spaeth D. , Hennequin C. , Salles G. , Facon T. , Cure H. , Ferrero J. , Avenin D. , Bergougnoux L. , Bleuzen P. , Jenabian A.
Published: March 2020

19588

Background: Anemia is the most frequent hematological complication of cancer. Epoetin beta (E), an effective treatment of anemia in patients with solid tumors (ST) was administered three-times weekly. However, the QW regimen used in patients with hematological malignancies would be more convenient and may improve patient compliance. The aim of our study was to evaluate efficacy and safety of E 30 000 IU QW in patients with ST. Methods: This study was an open-label, single-arm, multicenter trial carried out in 87 French centers between December 2003 and August 2005. Eligibility criteria were: informed consent, age =18 yrs, WHO performance status 0–2, malignant ST or non-myeloid hematological malignancy, on-going chemotherapy and anemia: hemoglobin (Hb) <12 g/dl. E 30 000 IU QW was administered SC for up to 16 weeks. Follow-up visits were scheduled after each chemotherapy cycle. Primary endpoint was Hb response defined as an Hb increase of =2 g/dl (whatever the baseline Hb level) and/or an achievement of Hb level of =12 g/dl or 13 g/dl (patients with Hb levels <11 g/dl or >11 g/dl at baseline respectively). Delay of Hb response, transfusion requirement, mood and cognitive functions were also assessed. Here we focus specifically on the subgroup of patients with ST. Results: In total, 365 patients with ST were included. The most frequent cancer sites were: lung (102 pts) and breast (86 pts). Median Hb level at baseline was 10.4 g/dl [7.9–12.3]. At endpoint, median Hb level increased to 12.5 g/dl [8.4–15.0]. Hb response rate (RR) was: 61% (IC95: 55–66%), 50% (IC95: 38–55%) in patients treated with platinum based regimen and 72% (IC95 : 62–76%) in patients treated without platinum. RR was 54% in lung (IC95: 44–64%), 76% in breast (IC95: 67- 85%). E treatment was well tolerated. Thromboembolic events occurred in 7% of patients, a rate consistent with information provided in the current label for E. Conclusion: Epoetin beta 30 000 IU once weekly is effective and well tolerated in anemic patients with solid tumor treated with chemotherapy. Once weekly treatment offers a convenient therapy which will improve patient compliance.

[Table: see text]
Evaluation of an instrument to assess the needs of cancer patients in an ambulatory chemotherapy unit
Authors: Bernal L. , Casas A. , Cayuela A. , Corral J. , Flor M. , Moreno J. , Iglesias L. , Puerto R. , Ramirez P. , Toscano F.
Published: March 2020

19593

Background: The physical deterioration, suffering and proximity of death associated with cancer dramatically affect the patient. Knowing about their perception of the circumstances that influence quality of life and adaptation to the disease, allows us to take appropriate medical action to satisfy their needs and improve the quality of patient care. Patients and Methods: The aim of this study was to evaluate treatment-related symptoms, information access, patient-doctor relationships, health service management, confidence, waiting time and financial needs of patients receiving ambulatory chemotherapy, through an “ad hoc” questionnaire. Different samples of patients were used to design the questionnaire: 141 patients for item identification, and completeness and acceptability evaluation; 47 patients for construct validity and prevalence of needs. The construct validity of the questionnaire was tested via analysis of the principal components, while reliability was evaluated in terms of the internal consistency of dimensions and test-retest scores. Results: The principal components found through factor analysis with Varimax rotation identified seven dimensions with Cronbrach′s a coefficients >0.70, which accounted for 64.3% of the variance. Internal consistency was high: Cronbrach′s a coefficients were 0.82. Test-retest reliability was acceptable with intraclass correlation coefficients ranging from 0.60 to 0.83. The most common needs were more information about diagnosis and prognosis (63%); over 50% of patients perceived shortcomings in communication with their doctors; 85% perceived sufficient intimacy in doctors‘ offices; 76% perceived that they had waited too long before being seen by doctors and given treatment. Conclusions: The validation analysis showed rather good reliability, structure validity and internal consistency. The needs expressed by patients are related to objective aspects of the disease, to time spent in contact with the service, to disease duration and to treatment lines. More vulnerable patients (elderly, low education level, more advanced treatment lines) express less needs, which is why they need an individualized analysis of their circumstances and greater attention from the professionals who take care of them.

No significant financial relationships to disclose.
Quality of life in colorectal cancer patients with hepatic arterial infusion (HAI) pumps
Authors: Sun V. C. , Nelson R. , Wagman B. , Carroll M. , Lee B. , Marx H. , Yen Y. , Wagman L. D.
Published: March 2020

19602

Background: More than half of patients diagnosed with colorectal cancer will develop hepatic metastases. Most patients with hepatic metastases will recur within two years after resection. Hepatic arterial infusion (HAI) pumps deliver regional treatment. However, very few studies quantitatively explore the patient's experience of living with an HAI pump and how this experience impacts HAI-related quality of life (QOL). This study explored the impact of HAI pump treatment on patient's overall QOL within the specific domains of physical, psychological, social, and functional well-being. Methods: Twenty-five colorectal cancer patients treated with HAI pumps completed an HAI pump- specific QOL assessment tool at one data collection time point. The QOL assessment tool items were derived from the investigator's previous QOL research with this patient population [Blair et al., 2002, Annals of Surgical Oncology]. Demographic, disease and QOL data were summarized using descriptive statistics. Results: Of the 25 patients accrued, 32% were receiving treatments through their HAI pump and 68% were not. There were no significant difference in QOL between treatment status, gender, and age (<65 or = 65). Currently treated pump patients experienced more appetite changes (p=0.03), sleep changes (p=0.08), and more restrictions in traveling (p=0.08). Male patients had more concerns with lifting heavy items (p=0.05), while female patients had more concerns with isolation (p=0.17) and changes in the type of clothing worn (p=0.16). Younger patients had more concerns with vigorous activity (p=0.01), bending (p=0.08), and were more self-conscious of their appearance with the pump (p=0.01). Conclusions: Overall, in this study, colorectal cancer patients with HAI pumps reported good QOL and were satisfied with their overall treatment experience. Although there was no comparative statistical analysis performed in this study, several QOL concerns remain worrisome for patients. Defining these specific QOL concerns in HAI patients will enhance clinical understanding of their unique experience with this treatment modality and impact patient management. This will enable further development of educational tools and research to test interventions to support HAI patients and sustain their QOL.

No significant financial relationships to disclose.
A feasibility study of an intensive combined modality smoking cessation program in the radiation oncology clinic
Authors: Hoopes D. J. , Hudson D. M. , Langer M. P. , Sinha B. , Pai H. , McDaniel A. M.
Published: March 2020

19604

Background: Radiotherapy (RT) patients present for daily treatment over many weeks, often accompanied by friends and family. This represents a unique opportunity for intensive smoking intervention concurrently with RT in both cancer patients and their companions. Methods: Eligible participants included smoking cancer patients scheduled to receive = 3 weeks of RT and their smoking family/friends. All participants received bupropion and 9 individualized behavioral interventions (BI) in the RT clinic with an addiction professional, followed by 9–12 scheduled intensive relapse prevention encounters (in person or by telephone). The primary endpoint was feasibility determined by accrual and program completion. Other endpoints included carbon-monoxide (CO) confirmed and participant-reported tobacco abstinence. During 4 months of enrollment, smoking and basic eligibility data were prospectively collected on consultations seen in clinic. Results: Over 8 months 20 cancer patients and 3 family members were enrolled. Based on our sampling, this represented greater than 40% of eligible smokers seen in clinic. Six cancer patients withdrew, all on or before the third BI. 13 participants completed all 9 BIs while 4 patients completed 7–8 BIs. 11 participants reported compliance with bupropion therapy. One participant discontinued bupropion citing increased depression. No other possible adverse events to bupropion or BI were discovered. At the completion of BI, 16 participants had exhaled CO concentrations < 10ppm and 14 participants self-reported tobacco abstinence. Of the 17 participants completing 7–9 behavioral interventions, the median number of relapse prevention sessions was 4 (range 0–8). With a median follow-up of 5.85 months, the 3-month crude self-reported abstinence rate was 41% (7/17). Conclusions: Tobacco cessation with bupropion and intensive BI for cancer patients and their companions during RT was feasible. A significant number of eligible smokers enrolled and completed BI during RT. However, few participants completed scheduled prevention encounters following RT.

No significant financial relationships to disclose.
Once-weekly epoetin beta treatment in anemic patients with breast cancer receiving chemotherapy: Interim analysis of a multicenter, single arm study
Authors: Del Mastro L. , Clavarezza M. , Amadori D. , Garrone O. , Mattioli R. , Ponchio L. , Latini L. , Saracchini S. , Fabi A. , Gamucci T.
Published: March 2020

19605

Background: Epoetin beta administered three times weekly is effective in the treatment of anemia in patients with malignancy. This study investigated the efficacy and safety of a more convenient and reduced frequency administration of epoetin beta 30,000 IU sc once weekly in anemic patients with early or metastatic breast cancer receiving chemotherapy (CT). Methods: Patients >18 years with early or metastatic breast cancer receiving CT with hemoglobin (Hb) <11 g/dL were enrolled in this open-label, single-arm, multicenter study. Patients received epoetin beta until Hb was = 12 g/dL. The primary endpoint was the proportion of patients with an Hb increase =2 g/dL from baseline or achievement of Hb =12 g/dL after 12 weeks of treatment in the absence of transfusion. Other endpoints included: median time to response, median change in Hb level after 12 weeks of treatment from baseline and proportion of patients with a Hb increase =1 g/dL at week 4. Adverse events (AEs), vital signs, and laboratory safety were recorded. Results: Interim data are presented for 101 patients (out of 200 patients enrolled) who had completed treatment to date. Patients’ characteristics were: median age 58 years (33–81), PS 0–1 88%, metastatic disease 49%, median baseline Hb 10.1 g/dL (7.8–11.7). Overall, 46% (95% CI: 35.5–57.6) of patients responded according to the primary end point, the median time to response was 42 days (95%CI: 15–103). Secondary objectives: median Hb increase after 12 weeks was 1.7 g/dL (CI95%: -1.6 to +5.4), at week 4 an Hb rise =1 g/dL was observed in 44% of patients (CI95%: 33.0–57.4). Overall, 13/101 (13%) patients required red blood transfusions, the median number of transfusion was 2. The incidence of treatment-related AEs (6.9%) was consistent with the current label for epoetin beta. Conclusions: These preliminary results indicate that Epoetin beta 30,000 IU once weekly is effective and well tolerated in patients with early or advanced breast cancer receiving CT.

[Table: see text]
Neutropenic complications in ovarian cancer patients receiving chemotherapy: Results of a prospective observational study
Authors: Myer B. S. , Cosler L. E. , Crawford J. , Dale D. C. , Selby C. , Wolff D. A. , Poniewierski M. S. , Culakova E. , Lyman G. H.
Published: March 2020

19610

Background: A nationwide, prospective cohort study of patients receiving cancer chemotherapy was undertaken to better define treatment-associated toxicities and delivered dose intensity. Methods: Following informed consent, 3,670 patients initiating a new chemotherapy regimen with lymphoma (n=547) or carcinomas of the colon (n=521), breast (n=1,473), lung (n=907) or ovary (n=312) were prospectively registered at 117 randomly selected US oncology practices between March 2002 and December 2005. Pretreatment characteristics including clinical and sociodemographic factors and practice setting associated with reductions in chemotherapy dose intensity over 4 cycles were evaluated. Results: Chemotherapy regimen standards and intended dose and schedule were defined in 97% and 93% of patients, respectively. Average initial (planned) relative dose intensity (RDI) was 90% while the mean RDI actually delivered over 4 cycles was 83%. Reductions in RDI =15% of standard were planned in 23% of patients and actually occurred over 4 cycles in 38%. Body surface area (BSA) calculated by the method of Mosteller exceeded the BSA utilized by the oncology practices in two-thirds of patients most often due to capping at 2 m2. Obese patients with a body mass index (BMI) =30 were more likely to receive planned RDI reductions =15% (30%) than patients with BMI <30 (21%) (P<.0001). Other factors associated with planned reductions in RDI in multivariate analysis included: older age, male gender, lower education, absence of myeloid growth factor prophylaxis and cancers of the lung or ovary as well as the practice setting, size and geographic location. Factors associated with unplanned (subsequent) reductions in RDI included: older age, male gender, poorer Charlson comorbidity index, prior chemotherapy, lung cancer, low baseline hematocrit, white blood or platelet count, poor renal or hepatic function and low serum albumin as well as smaller practice and rural setting. Conclusions: A substantial proportion of patients receiving cancer chemotherapy experience both planned and unplanned reductions in RDI. Further understanding of factors associated with such reductions may provide opportunities for improving the quality of cancer care and clinical outcomes.

[Table: see text]
Incidence of hepatitis virus infection and severe liver dysfunction in patients receiving chemotherapy for solid tumors
Authors: Alici S. , Alici O. , Izmirli M. , Tunahan H. , Gercik F. , Begenik H.
Published: March 2020

19611

Background: Hepatitis virus infection through virus reactivation has a high risk of mortality in patients with solid malignancies receiving chemotherapy. Methods: We examined the incidence of both hepatitis B virus (HBV) and hepatitis C virus (HCV) infection and severe liver dysfunction (alanine aminotransferase >ten times the normal upper limit and total bilirubin >5 mg/dl) during chemotherapy in 171 patients with solid tumor. Results: Six patients (3.5%) were infected with HCV and 17 patients (9.9%) were infected with HBV. One patients (0.5%) were infected with both HCV and HCV. There were severe liver dysfunction in 29 (16.9%) all patients. HCV- or HBV-infected patients showed severe liver dysfunction at a significantly higher incidence than non-infected patients (7/22 (31%) vs. 18/149 (12%), p<0.047). Furthermore, the incidence of severe liver dysfunction in HCV-infected patients was significantly higher than in HBV- infected patients (6/8 (75.0%) vs. 18/149 (18.2%), p<0.01). Three of eight HBV infected patients were initially negative for hepatitis B surface antigen (HBsAg) by latex agglutination and became positive for HBsAg during chemotherapy. Furthermore, all three patients developed severe liver dysfunction and two developed fatal fulminant hepatitis. From an examination of the original stock of serum samples before chemotherapy, two patients were found to be positive for HBV-DNA by polymerase chain reaction (PCR). Although post-transfusion HBV infection was suspected in the one remaining patient, the cause of HBV infection could not be clarified due to the impossibility of examination in blood donors. Conclusions: Since HBV-infected patients develop severe liver dysfunction at a higher incidence than either patients not infected with virus or HCV-infected patients before chemotherapy for hematological malignancies, it is recommended that HBV- DNA should be tested by PCR to detect HBV marker-negative carriers and liver function tests should be carefully monitored.

No significant financial relationships to disclose.
Protracted infusion of 5 fluorouracil and toxicity during CMF administration in adjuvant setting of breast cancer
Authors: Capoblanco A. , Capobianco A. , Ardito R. , Bochicchio A. , Coccaro M. , Di Leo P. , Romano C. , Tartarone A.
Published: March 2020

19618

Background: Protracted infusion of 5FU(PI) increases response rates and reduces toxicity when compared to bolus administration (BA): the mechanism of action of this drug appears to depend on the dose and the schedule of administration. In some trials 5FU was given as a BA: 30% incidence of severe mucositis or diarrhea was observed. These side effect decreased to less than 15% in trials in which 5FU was infused over 30 minutes and even less when the same dose of 5FU was given over 1 hour or over 2 hours. The CMF i.v. schedule with BA of all three drugs in the adjuvant setting of breast cancer has been shown to be associated with frequent gastrointestinal and mielo-toxicity. PI of 5FU in the CMF schedule can reduce toxicity and improve the quality of life. Methods and Results: From July 2003 to October 2006, 95 patients with breast cancer, mean age 56 years (range 40–75) were treated with adjuvant CMF (1, 8 every 28 days) with 5FU PI (1 hour). Toxicity and compliance were compared to those of 75 patients treated in our institution with CMF-5FU BA (10 min). Toxicity was coded by NCI-CTC. We observed that the patients treated with CMF-5FU PI compared to 5FU BA showed G2–3 nausea: 31.5% vs 46%, G2–3 emesis: 26.3% vs 34.6%, G2 diarrhea: 0% vs 2.6%,asthenia: 18.9% vs 33.3%, G2 neutropenia: 21.0% vs 30.6%, G3 neutropenia: 18.9% vs 20.0% ,G4 neutropenia: 9.4% vs 12%,G3–4 mucositis: 12.6% vs 18.6% and hand -foot syndrome 1.0% vs 0%. Compliance in CMF with 5FU PI compared to CMF with 5FU BA was: 6 cycles administered in 92.6% vs 88.0%, day 8 omitted in 11.5% vs 13.3%, dose reduction in 15.7% vs 17.3%. Conclusions: In our experience, 5 FU PI reduces the gastrointestinal toxicity, particularly nausea and emesis compared to BA.We suggest that less toxicity treatment schedule improves the quality of life and is mandatory mainly in frail and elderly patients.

No significant financial relationships to disclose.
Cancer survival: Which low molecular weight heparin (LMWH) is best?
Authors: Spahr J. E. , Akerley W. , Rodgers G. M.
Published: March 2020

19624

Background: The role of LMWH in cancer survival is controversial. There have been 6 randomized trials specifically evaluating cancer survival with LMWH. The objective of this study was to determine which LMWH is best for cancer survival, based on literature data. Methods: We performed a review of the literature for studies published from 1990 - 2007. Results: We identified 14 studies that included data on cancer survival and the use of LMWH, even if the primary endpoint was not cancer survival. We found studies for 5 LMWH products (See Table ). Conclusions: Based on our analysis, dalteparin is the most well studied LMWH in cancer. The 4 best designed trials looking at cancer survival were performed using dalteparin with over 1190 patients. The magnitude of benefit appears to be greatest in patients with better up-front estimated survival, and absence of metastatic disease. The estimated survival benefit was 25%. The second best studied LMWH appears to be nadroparin, with 5 trials with over 480 patients, including the MALT trial, and the most recently published Icli trial. Unfortunately, nadroparin is currently not available in the US. The studies of the other LMWH lack evidence to draw significant conclusions. The results of this study must be interpreted with caution. As there have been no randomized clinical trials comparing one LMWH against another in cancer survival, the studies we compared were not always similar in design or LMWH dosing, and cannot be compared head-to-head.

No significant financial relationships to disclose.

[Table: see text]
Epoetin-alfa initiation at Hb 10–11 or Hb <10 g/dL: Analysis of safety and efficacy
Authors: Szczudlo T. K. , Croot C. , McKenzie R. , Henry D.
Published: March 2020

19628

Background: Current guidelines recommend consideration of epoetin alfa (EPO) therapy for chemotherapy-induced anemia (CIA) either when Hb <11 g/dL (National Comprehensive Cancer Network) or when Hb < 10g/dL (ASCO/ASH 2002). The objective was to evaluate the safety and efficacy of EPO in patients (pts) with CIA when EPO was initiated at Hb 10–11 or at <10 g/dL. Methods: A post hoc analysis was performed on data from randomized, well-controlled trials conducted from 2002–2006. Trials in which EPO therapy was initiated at the approved dose of 40,000 Units weekly in male and female pts with Hb <11g/dL and =1 post-baseline Hb value were included. Two trials were identified, T1 and T2. Safety was assessed by the proportion of pts experiencing clinically relevant thrombovascular events (CR- TVEs) who received =1 dose of EPO. Efficacy was assessed by RBC transfusion requirements (Day 1 - end of treatment [EOT] and Day 29 - EOT) and achievement of durable Hb response (Hb =11 g/dL for =2 consecutive weeks). Results: Baseline (BL) characteristics (age, gender, platinum-based therapy, ECOG PS, and tumor type) were similar between the Hb 10–11 and <10 g/dL groups. BL Hb was 10.53 and 9.29 g/dL in T1 and 10.28 and 9.53 g/dL in T2 for the Hb 10–11 and Hb<10 g/dL subsets, respectively. Results are summarized below ( table ). Conclusions: These results show that patients treated with EPO at an Hb of 10–11 g/dL appear to have a lower incidence of CR-TVEs compared to patients treated at Hb <10 g/dL. In addition, patients who started EPO treatment at an Hb of 10–11 g/dL had fewer RBC transfusions and higher durable Hb response. Trial 1 - Waltzman et al. The Oncologist. 2005;10:642–650. Trial 2 - Henry et al. Curr Med Res Opin. 2006;22:1403–1413.

No significant financial relationships to disclose.

[Table: see text]
Exploration of pain management following implementation of WHO pain guidelines
Authors: Subongkot S. , Khounnikhom S. , Pratheepawanit Johns N. , Sookprasert A.
Published: March 2020

19646

Background: Pain is among the most common symptoms encountered in cancer patients and remains the first priority of care. Methods: This cross sectional study aimed to explore a pattern of pain management at KKU Hospital by utilizing a numeric rating scale (0–10). Cancer pain patients were categorized based on prior analgesic exposure into two groups; Naïve group, and Routine group. Treatments were defined according to WHO as 1) drug treatment relevant to pain severity, 2) analgesics being prescribed as around-the- clock and 3) analgesics used for break-through pain for patients receiving strong opioid. Results: From Dec 2005 to Jul 2006, 261 patients were enrolled. 93.1% (n=243) were in advanced stages and 88.5% (n=231) were in moderate to severe pain. This pain interfered with patient’s daily life activities mildly to moderately as each pain score increased (p-value<0.01). In Naive group (n=159), 32.7% (n=52) were given analgesics following the WHO on both days 1 and day 3 of admission whereas 40.2% (n=64) patients were not. A decreased pain score was greater (2.61, SD±1.5) in a group following the WHO on day 1. Additionally, a decreased pain score was greater (3.91, SD±1.8) in a group following the WHO on day 3 (p-value <0.0001). This pain score decreased was also clinically significant as pain score reduced more than 3 points. In Routine group (n=102), 32 (31.4%) were given analgesics following the WHO guideline on both day 1 and day 3 of admission. In contrast, 36 (35.3%) were not. A decreased pain score was greater (2.59, SD±1.8) in a routine group following the WHO on day 1. Moreover, a decreased pain score was greater (3.95, SD±1.8) in a group following the WHO on day 3. The clinical significance of pain score reduced was also found on day 3. Of the 261 evaluable patients, the pattern of analgesics usage following the WHO guideline was increased in both groups comparing to at the beginning of the study. Conclusions: The results demonstrated that patients who received pain management following the WHO guideline reported significantly lower pain intensity than those not following the WHO.

No significant financial relationships to disclose.
Reproductive health assessment in women with cancer: A pilot study
Authors: Sreedevi M. , Sutaria R. , Schoenhage M. , Patel A. R. , Radeke E. K. , Zaren H. A. , Patel A.
Published: March 2020

19660

Background: Many women in the reproductive age group are diagnosed with cancer. Reproductive health issues remain an important concern in caring for these women. Based on a case series in our institution and a review of the literature, we found a paucity of literature and clinical acumen regarding reproductive health issues. The purpose of this study was to pilot a survey instrument to develop descriptive data on the reproductive goals of reproductive aged women (15–44yrs) presenting with cancer. Methods: A cross- sectional pilot survey study of 20 selected women diagnosed with various types of cancers presenting to Hematology-Oncology clinic of John.H.Stroger Jr. Hospital of Cook County, Chicago, from January through July 2006. A survey instrument was developed and performed a reproductive health assessment. Patients were interviewed about their obstetric/menstrual history, contraceptive motivations and choices as well as future child bearing options. Results: Of the 20 patients with mean age of 36.6 years who were surveyed, 90 % had breast cancer. Child bearing was completed by 50%, 45% desired future childbearing, 5% were unsure. Contraception was used by 55 %( n=11) of patients out of which 55 %(n=6) were using abstinence, 45% denied the use of any contraception. Amongst the patients who received chemotherapy with radiation and chemotherapy without radiation, 75% and 72.7% respectively continued to menstruate. Ten percent would continue pregnancy, if they become pregnant while on treatment. Conclusions: The result of this pilot study demonstrates some insight into the reproductive health needs and concerns of women diagnosed with cancer. A reproductive health assessment should be performed on all cancer patients who are in the reproductive age group. We plan a large prospective study providing a larger database that may aid in developing treatment plan.

No significant financial relationships to disclose.
Amifostine pretreatment for patients with advanced colorectal cancer receiving folfox chemotherapy
Authors: Arena F. , Kurzyna-Solinas A. , Stark R. F. , Ohri A. , Schiffer C. , Sulzbach H. , Jemison D. , Dolat J.
Published: March 2020

19663

Background: Oxaliplatin plays a key role in the treatment of advanced colorectal cancer (CRC) but is associated with dose- limiting peripheral neuropathy (PN) in >20% of patients. We investigated the effects of amifostine, a cytoprotective agent, on the prevention of PN in patients receiving oxaliplatin in combination with 5-fluorouracil (5-FU) and leucovorin (LV) (FOLFOX) for the treatment of advanced (stage =III) CRC. Methods: In this ongoing prospective observational study, patients with stage =III CRC are assigned to receive FOLFOX alone (oxaliplatin 85 mg/m2, 5-FU 400 mg/m2 bolus, 5-FU 1.2 or 2.4 g/m2 continuous infusion over 46 h, LV 200 or 400 mg/m2) or FOLFOX plus 500 mg subcutaneous amifostine 30 minutes before chemotherapy. Some patients also receive bevacizumab and/or panitumumab. All patients receive Ca/Mg infusion (1 g each/100 mL normal saline) before and after oxaliplatin treatment. Incidence and degree of PN are assessed during biweekly patient interviews and graded using National Cancer Institute Common Toxicity Criteria Version 3. Results: Sixteen patients have enrolled to date (9 nonamifostine, 7 amifostine; mean age, 60.2 y [range, 33–81 y]; 81% men). Currently, data for 6 patients (3 per group) who have completed 12 cycles of therapy are available. Two of 3 patients in the nonamifostine group reported PN grade =2 during treatment; 1 of these patients required multiple treatment interruptions because of grade 3 PN. The third nonamifostine patient reported grade 1 PN on only 2 occasions during treatment but experienced grade 2 PN at 3-month follow-up. No patient in the amifostine group reported grade =2 PN during the treatment period. One amifostine patient required a reduction in oxaliplatin dose after 8 cycles because of neutropenia. At 3-month follow-up, 1 amifostine-treated patient reported grade 1 tingling in his hands and is currently receiving treatment with pregabalin. Conclusions: The use of amifostine for the prevention of oxaliplatin-induced PN is investigational. Patients with advanced CRC who received amifostine with FOLFOX chemotherapy had a decreased incidence and severity of PN compared with patients who did not receive amifostine. Updated data will be available at the time of presentation; study enrollment continues.

No significant financial relationships to disclose.
Patterns of hospitalization and toxicity among patients undergoing cancer chemotherapy in community-based oncology practice in Brazil
Authors: Pizao P. E. , Katayama L. M. , Sagarra A. J.
Published: March 2020

19678

Background: In Brazil, most cancer patients receive treatment outside the controlled clinical trial setting and at community- based clinics. In this scenario, data on treatment-related toxicity and its complications are seldom reported. Chemotherapy is frequently referred to as an excessively toxic treatment modality and this perception may have a negative impact on treatment decision-making. Methods: This is a single institution, prospective study. Eligible population consisted of all patients with solid tumors undergoing chemotherapy, between January/2005 and November/2006, at this community-based private oncology clinic with a multidisciplinary staff (physicians, nurses, pharmacists, nutrition and psycology experts). Treatment-related hospitalization (TRH) was defined as any hospitalization starting within 4 weeks after a chemotherapy session. Data concerning tumor-related symptoms and chemotherapy-induced toxicity were prospectively collected by a single physician. Results: A total of 59 patients were hospitalized during the study period. Median hospitalized patients′ age was 61 years and 58% were female. Most frequent tumor types were breast (36%), colorectal (14%), pancreatic (14%) and ovarian (9%) cancers. 34 (57%) of the 59 hospitalizations were classified as TRH. Febrile neutropenia (27%) and gastrointestinal complications (26%) were the main reasons for TRH. The median length of TRH was 4 days. 6/34 (17%) patients died during TRH: 5 died as a result of complications caused by disease progression (not chemotoxicity); 1 patient died as a consequence of chemotherapy-induced neutropenia and sepsis. TRH′s were associated to only 2% (34) of the 2203 chemotherapy sessions performed. Conclusions: Current evidence-based, consensus-guideline-oriented, cancer chemotherapy, administered by a multidisciplinary team of specialists, was associated to a low rate of treatment-related hospitalizations. Generally, chemotherapy-induced toxicity was reversible and manageable in the outpatient setting. The permanent monitoring and reporting of treatment-related toxicities is feasible in community-based clinical practice as part of a quality-assurance program.

No significant financial relationships to disclose.