bluuebunny/crossref_metadata_2025 huggingface dataset:
Survival of patients (pts) with advanced lung adenocarcinoma (ALA) treated in four hospitals from Bogotá D.C., Colombia, and report of a novel alteration in the epidermal growth factor receptor (EGFR) (ONCOLGroup study)
Authors: Otero J. M. , Cardona A. F. , Carrasco-Chaumel E. , Carranza H. , Vargas C. , Carlos C. , Diana T. , Ludovic R. , Reguart N. , Cuello M.
Published: August 2020

e19097

Background: This study included 147 ALA pts treated between 2000 and 2007. Overall response rates (ORR), clinical benefit (CB), time to progression (TTP) and overall survival (OS) were estimated. EGFR E19 deletions were studied by length analysis fluorescently and the exon 21 L858R mutation by PCR Taqman assay. Results: Mean age was 66±12.8 years. Seventy- eight pts were women, 40% had never been exposed to tobacco smoke and PS was ≥70% in 119 pts. The brain was the dominant site for metastasis (38%) followed by the lungs (38%). Sixty-nine percent of the pts received a platinum doublet as first-line intervention and 32 pts (21.8%) had received erlotinib (E) as part of their treatment. Response to first-line treatment was available in 110 pts; ORR was 28%, CB 39% and TTP 4.2 mo. (range, 0.2–11). Second-line therapy was administered to 46 pts; ORR was 8%, CB 25% and TTP 3.7 mo. (range, 0.4–12). Twenty pts received third-line therapy, with an ORR of 35%, CB 50% and a TTP 3.9 mo. (range, 1.0–5.7). Median OS was 10.1 mo. (range, 6.3–19) and the PS, absence of tobacco exposure, and administration of E, positively influenced this outcome. EGFR mutational profile was assessed in 6 pts; 3 pts presented mutations in E19, one a 5-nucleotide deletion (E746_A750) and 2 pts had a 3 serine-rich nucleotide insertion (L747_S75) which has not been previously reported. The first patient had a partial response, and the last two, had survival greater than 16-mo. Conclusions: Outcomes for pts suffering from ALA in Colombia are similar to those described in other Latin American countries. Three pts with EGFR alterations were identified in this cohort; two presented a non- described change in E19 which may have corresponded to a novel alteration in our region, with possible increased sensitivity to E.

No significant financial relationships to disclose.
Pemetrexed versus gefitinib versus erlotinib in previously treated non-small cell lung cancer by retrospective analysis
Authors: Cho E. , Hong J. , Kyung S. , Kim Y. , Shim S. , Park J. , Jung S. , Park J. , Shin D. , Lee J.
Published: August 2020

e19103

Background: The standards in 2nd-line therapy with advanced non-small cell lung cancer (NSCLC) were erlotinib or pemetrexed as well as docetaxel. To evaluate the efficacies and safeties of pemetrexed, gefitinib, and erlotinib in previously treated NSCLC we analyzed the datas retrospectively. Methods: Eligible patents were 1) histologically confirmed pretreated advanced (stage IIIB or IV) NSCLC, 2) with at least one measurable lesion, 3) age over 18 years, 4) performance status (PS) 0–2, and 5) should never experience other two drugs as previous therapy. Patients of pemetrexed group received IV infusion of 500mg/m2 pemetrexed mixed with normal saline every 3 weeks with vitamin B12 and folate supplementation. Patients of gefitinib group received gefitinib 250mg PO daily and of erlotinib took erlotinib 150mg PO daily. Cycles of IV pemetrexed or taking PO drugs were continued until disease progression or unacceptable toxicity. Results: we analyzed 57 patients (pemetrexed; 20, gefitnib; 20, and erlotinib; 17). The response rates were 5.3%, 25.0%, and 12.5% (P=0.22), and the disease control rate were 5.3%, 40.0%, and 50.0% respectively (P<0.01). Median progression-free survival (PFS) of pemetrexed, gefitinib, and erlotinib were 1.7, 3.5 and 4.4 months (P<0.01) and median overall survival (OS) were 5.6, 21.8 and 21.5 months respectively (P=0.04). In subgroup analysis, patients with non-squamous carcinoma, smokers and good PS (0 or 1) showed longer PFS and OS in gefitinib and erlotinib compared with in pemetrexed. All of these agents showed mild and tolerable toxicity. Conclusions: In retrospective analysis, the patients with gefitinib or erlotinib had longer PFS and OS than pemetrexed, eventhough there was no significant difference for response rate in three group. These results have to confirm by large randomized prospective study because the sample size was small and it was not randomized.

No significant financial relationships to disclose.
The use of single-fraction radiation therapy in cutaneous T-cell lymphoma
Authors: Babbo A. M. , Chokshi M. , Rademaker A. , Mittal B.
Published: August 2020

e19505

Background: Primary cutaneous lymphomas occur in 0.5 to 1 per 100,000 people every year in developed countries. Less than 1,000 cases of Mycosis Fungoides are diagnosed each year in the United States, with approximately 3 cases per 1,000,000 per year. Cutaneous T-cell lymphomas are responsive to radiation therapy, and local radiation therapy, total skin electron beam therapy, phototherapy (with UVB or PUVA), chemotherapy agents (nitrogen mustards, BCNU), retinoids, and steroids have all been used with varying degrees of success. Methods: This is a retrospective review of all cases of histology-proven cutaneous T-cell lymphoma treated with single-fraction radiation therapy at Northwestern Memorial Hospital in the Department of Radiation Oncology since 1990. We looked at response to treatment and local control. We reviewed the charts of 67 patients with cutaneous T-cell lymphoma, of which 40 patients and a total of 130 sites of disease received single-fraction radiation therapy and had available follow-up data. Results: Of the 130 lesions receiving a single-fraction of radiation, 86 (66%) received 800cGy in 1 fraction and 38 (29%) received 700cGy. 4 patients (3%) received 750cGy, 1 (<1%) received 550cGy and 1 (<1%) received 500cGy. Patients were treated with electron energies ranging from 6–18 MeV or photon energies ranging from 4–10 MV. Out of 130 lesions, 119 (92%) achieved a complete response (CR) to single-fraction radiation and 11 (8%) achieved a partial response (PR). There were 2 sites of relapse out of 130 treated sites, involving 2 patients. The median follow-up time was 4 months, mean follow-up time was 14 months, and 44% of patients had greater than 6 months of follow-up. Conclusions: This review of the experience at our institution since 1990 shows single-fraction radiation therapy to be an effective treatment for cutaneous T-cell lymphoma, with high response rates and very low relapse rates.

No significant financial relationships to disclose.
Natural history of multiple myeloma (MM) relapsing after autologous stem cell transplantation (ASCT)
Authors: Madan S. , Kumar S. , Lacy M. Q. , Dispenzieri A. , Hayman S. R. , Buadi F. K. , Dingli D. , Rajkumar S. V. , Gertz M. A.
Published: August 2020

e19513

Background: The outcome of patients with MM relapsing after ASCT used early in the disease course or after failure of initial therapy, is not well defined. We undertook this study to understand treatment approaches for patients relapsing after single ASCT. Methods: Patients relapsing after single ASCT were identified from a prospectively maintained database and relevant clinical data were extracted from medical records. Relapse and treatment responses were according to IMWG Uniform Response Criteria. Patients relapsing between Jan 2000 and 2008 were included in order to capture a recent cohort contemporaneous to availability of novel drugs. Results: We studied 487 patients who had relapsed following a single ASCT, of whom 351 (72%) had an early SCT (≤ 12 mos from diagnosis). The median estimated follow up for all patients was 27 mos, 50 mos and 69 mos from relapse, SCT and diagnosis respectively. The median overall survival (OS) from the time of relapse was 30 mos for the early SCT group and 21 months for the late SCT group. The median time to relapse following transplant was 15 mos (3–119) among early SCT group and 12 mos (3–76) among the late SCT group. Longer time to relapse as well as longer time from relapse to initiation of therapy were independent predictors of better outcome. Among the early group, nearly a third of the patients achieved a PR or better to first salvage therapy (Table), with another third achieving stable disease and 25% of patients did not have response data. The median progression free survival for the first salvage regimen was 8 mos; 18 mos for those with PR or better and 5 mos for those with SD as the best response. Data on the regimen 2, 3, 4, 5, and 6 were available for 211, 133, 84, 53 and 28 patients respectively. As expected, the response rates and the response duration decreased with increasing number of relapses. Conclusions: Patients relapsing after ASCT can obtain prolonged response duration with the currently available treatments. Those with a durable response to transplant and those not requiring initiation of therapy for long periods after disease relapse have favorable disease biology and have prolonged survival after relapse. The natural history of the disease provides a valuable benchmark for evaluation of newer treatment approaches.

No significant financial relationships to disclose.
DNA methylation status of Smurf2 promoter in patients with multiple myeloma
Authors: Hatzimichael E. , Dasoula A. , Stebbing J. , Dranitsaris G. , Crook T. , Bourantas K.
Published: August 2020

e19537

Background: Multiple myeloma (MM) is an incurable interleukin (IL)-6 dependent plasma-cell malignancy. Transforming growth factor-β (TGF-β) is the major inducer of IL-6 secretion by bone marrow stromal cells. The signaling responses to TGF-b are mediated by the Smad proteins. The Smurf2 gene (Smad ubiqitiniation regulatory factor 2) encodes a Smad-specific E3 ubiquitin ligase and targets Smad2 and Smad3 for proteasome-dependent degradation. Methods: Bone marrow samples from individuals with MM were obtained at diagnosis and in 5 cases at disease progression as well. Genomic DNA was isolated and bisulphite modification was performed using commercially available kits. The methylation-specific polymerase chain reaction was employed to study the methylation status of the CpG island. Logistic regression analysis was used to measure the association between gene methylation and the development of advanced disease (DS≥ II), extramedullary disease, bone disease, anemia (Hb 10 mg/dl), serum albumin and beta 2 microglobulin levels. Results: We analysed the methylation of Smurf2 in 45 cases of MM (24 male, 21 female, mean age 66.4 years). No sample from the control population was found methylated. The Smurf2 gene promoter was found to be methylated in 11/45 MM patients (24%). Interesting trends were noted where patients with methylated Smurf2 promoter had an increased risk of death (HR = 1.3; p = 0.68), anemia (OR=2.1, p=0.2) and advanced stage (OR=1.3, p=0.6) and a reduced risk of extramedullary disease (OR= 0.2, p=0.2). No association was found between Smurf2 methylation status and bone lytic lesions, serum albumin levels or beta-2 microglobulin levels. Conclusions: Interesting associations between Smurf2 methylation and some relevant clinical parameters in patients with MM were suggested by the data. These findings warrant further evaluation in a larger sample of patients in order to enhance our statistical power and better define the prognostic and clinical value of Smurf2 methylation in MM.

No significant financial relationships to disclose.
Neutrophil toxicity and primary prophylaxis in diffuse large B cell lymphoma treated with R-CHOP
Authors: Naqi N. , Khatak J.
Published: August 2020

e19548

Background: Three weekly R-CHOP therapy is regarded as standard treatment in advanced stage Diffuse Large B Cell Lymphoma (DLBCL) patients with low to intermediate-risk International prognostic index (IPI). This regimen is associated with intermediate risk (10–20%) of febrile neutropenia. Primary prophylaxis with colony-stimulating factor (CSFs) is therefore not recommended except in the presence of high risk factors as defined in the National Comprehensive Cancer Center Network guidelines for use of myeloid growth factors v.1.2008. It is however well realized that a significant number of good risk patients will still develop significant neutrophil toxicity. Methods: This observational study was conducted at Oncology department Combined Military Hospital, Rawalpindi, on fifty good risk patients of advanced stage DLBCL, treated with R-CHOP regimen without primary CSFs prophylaxis. NCI Common Toxicity Criteria version 3.0 was used for grading toxicity and significant neutrophil toxicity was defined as Grade 4 neutropenia between day 7 and 10 post therapy, febrile neutropenia and Grade 2 or more neutrophil toxicity persisting on day 1 of next cycle. Good risk patients were recruited by the following exclusion criteria: WHO Performance status scale 4, concurrent immunosuppressive drug therapy, abnormal hepatic or renal functions and inadequate hematological values. Results: 10(20%) patients, developed significant neutrophil toxicity. In this group 7(70%) had grade 4 neutropenia and 3(30%) patients developed febrile neutropenia. 8(80%) of these patients developing significant toxicity had WHO Performance scale ≥ 2. 2(20%) patients developing Grade 4 toxicity between days 7 and 10 post therapy had good performance status (0 or 1) and toxicity resolved by next cycle without getting complicated to febrile neutropenia. Conclusions: Performance status in terms of scale has not been defined in the high risk factors for developing febrile neutropenia in the NCCN guidelines on myeloid growth factors use. We observed that DLBCL patients with WHO performance status scale ≥ 2 treated with R-CHOP therapy at 3 weekly intervals are at greatest risk for developing significant neutrophil toxicity and febrile neutropenia.

No significant financial relationships to disclose.
A study of the prevalence and type of anemia in lymphoid malignancies
Authors: Ghosh J. , Kumar L. , Saxena R. , Raina V. , Sharma A. , Gupta R. , Vivekanandhan S. , Sreenivas V. , Verma R.
Published: August 2020

e19556

Background: Anemia is a common and serious problem in patients with lymphoid malignancy. Hence there was need to analyze the prevalence of anemia in our patient population and evaluate its cause for optimal management. Methods: Newly diagnosed patients of lymphoid malignancy- non Hodgkins lymphoma (NHL), Hodgkins lymphoma (HL), and chronic lymphocytic leukemia (CLL) aged more than 15 years without renal failure and who had not received blood transfusion, iron, folic acid or vitamin B complex in the last 2 weeks were analyzed. 316 patients were screened for the prevalence of anemia. Of the anemic patients (hemoglobin <11gm/dl), 46 were studied for the type of anemia. These patients underwent the following investigations -complete hemogram with RBC indices, hematocrit, reticulocyte count, peripheral blood smear (PBS) examination, direct Coombs test (DCT), bone marrow (BM) aspiration and biopsy, S. iron (SI), S. ferritin (SF), total iron binding capacity (TIBC), percentage saturation (psat), S. Vitamin B12 and Folic acid levels. Anemia was categorized as due to either autoimmune hemolytic anemia (AIHA)-DCT positive with evidence of hemolysis on PBS, B12 and folate deficiency (<200 pgm/ml and < 4ngm/ml respectively), iron deficiency anemia (IDA)- psat <20% and SF315μgm/dl, anemia of chronic disease (ACD)-psat200μgm/L, a combination of IDA and ACD -psat <20%, SF -30–200 with TIBC ≤315 μgm/dl. Results: The prevalence of anemia in patients with lymphoid malignancy was 42.41% (134 /316, 95% CI-36.96% -47.85%). It was multifactorial in 39.13% (18/46) patients. ACD was the most common cause of anemia present in 71.74% (33/46) patients. This was followed by nutritional anemia (iron,B12 and folate deficiency) in 47.83% (22/46) and AIHA in 10.87% (5/46) of patients. Conclusions: Although anemia of chronic disease is the most common cause of anemia in patients with lymphoid malignancy, it is multifactorial in a large number of patients and hence it is important to rule out other causes of anemia like nutritional and AIHA in these patients.

No significant financial relationships to disclose.
Ipilimumab in the common daily practice: Feasibility, safety, and efficacy in heavily pretreated metastatic melanoma patients
Authors: Di Giacomo A. , Danielli R. , Calabrò L. , Guidoboni M. , Miracco C. , Biagioli M. , Mazzei M. , Altomonte M. , Maio M.
Published: August 2020

e20002

Background: Effective anti-tumor responses are being observed in metastatic melanoma (MM) patients (pts) with the anti-CTLA-4 antibody Ipilimumab (Ipi) in clinical trials; however no data support the feasibility and clinical effectiveness of Ipi use in the daily practice. We report a single Institution experience utilizing Ipi within a compassionate program for MM pts. Methods: 27 stage III (2) or IV (25) pts (14 males, 13 females), median age 55 (23–77) years, ECOG performance status 0- 1, with MM (23 cutaneous, 3 uveal, 1 mucosal) progressing to 3 median (1–5) systemic therapies for metastatic disease received Ipi. Eight pts had evidence (6) or history (2) of brain metastases and 11 elevated (>1x upper limit of normal [ULN]) LDH. In the induction phase (IF) pts received Ipi (10 mg/kg i.v.) q3 weeks (wks) x 4 cycles; after a 12 wks rest treatment was repeated q12 wks in the maintenance phase (MF). Tumor assessment (TA) per modified World Health Organization criteria was performed at baseline, week (wk) 12 (±2) and wk 24, then every 12 wks. Adverse Events (AE) and immune related AE (irAE) were collected according to Common Terminology Criteria for Adverse Events version 3.0. Results: All pts received at least one Ipi dose, and 18/27 completed the IF. Of the remaining 9 pts, 4 are completing the IF and 5 were withdrawn for AE severity (3 pts) or disease progression (2 pts). Eight pts entered the MF. TA at wk 12 showed partial response (PR) in 1/18 or stable disease (SD) in 5/18 pts. TA at wk 24 showed PR and SD in 3/8 and 5/8 pts, respectively, with an ongoing clinical benefit (SD + PR + CR) of 34% (8/23 pts); these pts are still on treatment. Slow, steady declines in tumor volume and appearance of new lesions with subsequent shrinking of total tumor burden has been observed. One patient had Grade 3 AE (myocardial infarction) and 2 pts had Grade 3 irAE (diarrhoea). Excluding pts who are in IF, to date median overall survival is 27 wks (19–39). Conclusions: Ipi treatment is feasible, safe and clinically effective also in the common daily practice and in heavily pretreated, progressing, MM pts. A sizable proportion of these pts experiences durable clinical benefit.

No significant financial relationships to disclose.
Endostatin combined with chemotherapy as first-line therapy for stage IV melanoma patients: A phase II clinical study
Authors: Cui C. , Chi Z. , Yuan X. , Si L. , Sheng X. , Shen L. , Guo J.
Published: August 2020

e20003

Background: To observe the efficacy and safety of rh-endostatin injection (Endostar) combined with chemotherapy as first line therapy for stage IV melanoma patients. Methods: From March 2007-March 2008, 20 metastatic melanoma patients were enrolled. Endostar (15 mg d1–14) combined with dacarbazine (250 mg/m2 d1–5) or temozolomide (300 mg d 1–5) and fotemustine (100 mg/m2 d6) were given every 28days. Response, toxicity and progression free survival(PFS) were analyzed. Results: Among 20 evaluable cases, with mean cycle 2.7±0.80, four achieved partial response, six stable disease, with response rate 20.0% (4/20) and clinical benefit rate 50.0% (10/20). The median PFS reached 4.5 months (95% CI: 3.85–6.9 months), overall survival 8.5 months (95% CI: 5.62–8.54 months), with 6 months PFS rate 35% (7/20), and 6 months survival rate 65% (13/20). The Grade 3/4 toxicity was mainly myelosuppression, 40% (8/20). One patient ceased the treatment because of sinus bradycardia. Conclusions: Endostar combined with chemotherapy show its efficacy on melanoma patients and may prolong PFS.

No significant financial relationships to disclose.
Correlation between prior therapeutic dendritic cell vaccination and the outcome of patients with metastatic melanoma treated with ipilimumab
Authors: Pierret L. , Wilgenhof S. , Corthals J. , Roelandt T. , Thielemans K. , Neyns B.
Published: August 2020

e20006

Background: Ipilimumab (Ipi) is an anti-cytotoxic T lymphocyte associated antigen 4 (CTLA4) IgG1 monoclonal antibody active against metastatic melanoma. Ipi acts by reinforcement of CTL-activation trough B7/CD28 receptor stimulation. A pre- existing anti-tumor CTL repertoire, induced by dendritic cell (DC) vaccination, could influence the therapeutic effect of Ipi. The influence of prior DC-vaccination on the outcome of melanoma patients (pts) treated with Ipi at a single center was analyzed to evaluate this hypothesis. Methods: Data were obtained from the medical files of pts treated at the UZ Brussel with Ipi in protocols CA184–022, -025, and the BMS Ipi medical need program. Ipi (0.3, 3 or 10 mg/kg) was administered iv q3 wks x4 q12 wks thereafter. Results: 20 pts (10M/10F; med age 51y, range 28–72) were identified. Prior therapy: autologous DC-vaccine loaded with melanoma associated antigens (14 pts) ± IFN-a2b (9/14 pts), cytotoxic agents (17 pts). Baseline characteristics: AJCC st IV melanoma (20 pts); baseline LDH > ULN (16 pts). Ipi dose: 0.3 mg/kg (4 pts), 3 mg/kg (2 pts), 10 mg/kg (14 pts). Serial LDH measurements were available for 17 pts; 4 types of LDH-response following Ipi administration were observed: increase (11 pts), decrease (1 pt), fluctuation (4 pts), stable (1 pt). Objective response according to mWHO or irWHO: 3 PR, 1 SD, 16 PD. One pt received 0.3 mg/kg of Ipi (CA184–022) and had SD but no LDH response; at PD she received DC-vaccine and subsequently 10 mg/kg Ipi (medical need program) resulting in a fluctuating LDH-response and regression of an orbita-metastasis. Increasing LDH values following Ipi were less often observed in pts with prior DC-vaccination (5/6 pts (83%) without prior DC-vaccination had increasing LDH-values vs 6/12 pts (50%) with prior vaccination). DC- vaccination also correlated with regression of metastases and disease control (3/15 pts (20%) who were vaccinated had a PR/SD vs 1/6 (17%) PR for those who had not received prior DC-vaccinations). Conclusions: These data represent a small sample size from a single institution; however, our results suggests a potential correlation between prior therapeutic DC vaccination and outcomes in advanced melanoma patients treated with ipilimumab.

[Table: see text]
Paclitaxel plus carboplatin (PC) in patients with metastatic melanoma (MM): Experience in a single institution
Authors: Diaz Romero C. , Olvera N. , Martínez H. , Mtz Cedillo J. , Cuellar M. , Morales R. , Álvarez M. , Segura B. , De la Garza J. , Aguilar P
Published: August 2020

e20019

Background: The number of agents active in patients with metastatic melanoma is limited and cure is not an objective for treatment at this stage, so that clinical benefit in these patients is the most important. The aim of the study was to evaluate the efficacy and safety of combination regimen consisting of paclitaxel and carboplatin as second-line chemotherapy, in patients with MM. Based on reports of responses to PC, 17 patients with MM was treated at the National Cancer Institute of Mexico. Methods: We evaluated retrospectively the combination of PC in patients with MM. Data regarding patient characteristics and outcomes were abstracted from medical records of NCI of Mexico from 01/05 to 12/08. The regimen was weekly paclitaxel (at a dose of 80 mg/m2) received on days 1, 8, and 15 of a 21-day cycle and carboplatin (AUC 5) on day 1. Response evaluation was using RECIST and toxicity was according to National Cancer Institute Common Toxicity Criteria. This study was approved by the hospital ethics committee. Results: Seventeen patients with MM were treated with PC. All patients were previously treated (and failed) with dacarbazine (DTIC). Sixteen were assessable for response with three cycles of chemotherapy and seventeen for toxicity. One patient was deemed to be ineligible because they presented severe hypersensitivity reaction to paclitaxel at beginning. Objective partial response were obtained in 4 patients (25%); 8 stable disease (50%) at least four months. No patient had a complete response to therapy. Progression disease was in 4 patients (25%). In 12 (75%) we noted clinical benefit. The median time to disease progression for the entire group was 4.2 months (range, 1–11 mos), with a median overall survival of 8.1 months (range, 5.6–10.5 mos). The toxicity grade 3 reported was thrombocytopenic in 2 patients (11%) and anemia in one patient (6%). Additional patients had reversible toxicities grade 3 including alopecia, nausea and fatigue; 2 of them presented moderate hypersensitivity reactions to paclitaxel. No toxic death was noted. Conclusions: The PC combination appears to be safety and well tolerated in second line chemotherapy in MM, however we need more patients to demonstrate a true clinical benefit, we outcomes are according with other clinical reports.

No significant financial relationships to disclose.
Trends in pneumonia (PNA) hospitalization among patients (pts) with chronic lymphocytic leukemia (CLL)
Authors: Jones J. A. , Flynn J. , Moran M. , Lin T. , Byrd J.
Published: August 2020

e20500

Background: Despite recent therapeutic advances, PNA remains a significant source of morbidity and mortality among CLL pts. We determined population-level estimates for the incidence and outcome of PNA hospitalizations. We further investigated secular trends in care by comparing cohorts before (1994) and after (2004) the widespread use of multiagent chemoimmunotherapy. Methods: Using data from the U.S. Nationwide Inpatient Sample and ICD-9CM diagnosis codes, we identified all non-governmental hospitalizations of CLL pts for a primary dx of PNA in calendar years 1994 and 2004. Admissions were described by pt demographics (age, gender, race) and comorbidity (Charlson index, presence of chronic lung disease). Ten-year prevalence estimates for CLL were obtained from NCI SEER data and used as denominators in incidence calculations. Outcomes studied included need for intubation, in-hospital mortality, and length of stay (LOS). All analyses were sample weighted. Estimates and 95% confidence limits are reported. Results: PNA was the primary dx for 7316 (13.1%) and 7651 (11.2%) CLL pt admissions in 1994 and 2004, respectively. Incidence of PNA admission was similar in 1994 (140/per 1000 pts, 95%CI 130–151) and 2004 (129/per 1000 pts, 95%CI 119–138). CLL pts admitted in 2004 were older (75.7 v. 74.2 years, p<0.001) and more likely to have at least one Charlson comorbidity (67.6% v. 56.2%, p<0.001) or comorbid chronic lung disease (40.6% v. 28.3%, p<0.001) than pts in 1994. Intubation was rare in both cohorts (<1%) and did not significantly differ by year, but in-hospital mortality was significantly higher in 2004 (11.3% v. 8.2%, p=0.005). However, LOS decreased significantly between 1994 and 2004 (9.2 v. 6.4 days, p<0.001). Conclusions: PNA hospitalization rates for CLL pts have not significantly increased over the last decade despite more aggressive therapies, likely secondary to improved supportive care. However, CLL pts hospitalized for PNA are now older, increasingly likely to suffer from chronic medical illness, and significantly more likely to die while in hospital. Therapuetic strategies targeting older pts with significant comorbidities are needed.

No significant financial relationships to disclose.
Can prognostic factors identify women receiving anthracycline plus cyclophosphamide-based chemotherapy (MEC) who do not require an NK1 receptor antagonist?
Authors: Warr D. , Street J. C. , Carides A. D.
Published: August 2020

e20502

Background: Age, alcohol use, and history of sickness associated with pregnancy or motion have been identified as risk factors for chemotherapy-induced emesis. This post hoc analysis addressed two questions: 1) Can prognostic factors identify a low risk group for whom ondansetron (OND) plus dexamethasone [D] alone provide a high level of protection (≥80% no emesis)? 2) Does the NK1 receptor antagonist aprepitant improve antiemetic outcome regardless of emetic risk? Methods: The analysis was based upon outcomes in patients with breast cancer enrolled in a Phase III double-blind, placebo-controlled trial randomized to Day 1 OND 8 mg and D 20 mg before chemotherapy and OND 8 hours later and OND 8 mg bid Days 2–3 vs. Day 1 aprepitant 125 mg PO, OND 8 mg, and D 12 mg before chemotherapy and OND 8 mg 8 hours later and aprepitant 80 mg PO qd Days 2–3. Multivariate logistic regression models were used to assess the impact on emesis of the regimen with aprepitant, and previously reported risk factors, including age (<55 and ≥55 years), ethanol use (0–4 or ≥5 drinks/week), history of pregnancy-related morning sickness, and history of motion sickness, using a modified intent-to-treat approach. Results: 856 patients were assessed for efficacy. Treatment with aprepitant (p<0.0001), older age (p=0.006), ethanol use (p=0.0048), and no history of morning sickness (p=0.0007) were all significantly associated with reduced likelihood of emesis; motion sickness was not a risk factor. The Table below shows the probability of no emesis associated with the presence of 0, 1, 2, or all of these factors in the aprepitant and active control arms. Conclusions: 1) The low-risk group identified by this analysis is of questionable utility because it comprised less than 3% of patients. 2) We could not confirm that motion sickness was a significant risk factor. 3) Aprepitant improved the control of emesis irrespective of the number of risk factors for emesis.

[Table: see text]

[Table: see text]
Oral morphine gargles: A cost effective approach for pain relief in patients with chemoradiation induced acute oral mucositis in head and neck cancers
Authors: Haritha C. , Shankar V.
Published: August 2020

e20504

Background: Painful oral mucositis is the most significant dose-limiting toxicity in head & neck cancer patients treated with conc. CT-RT protocol. The purpose of this study is to evaluate the efficacy of oral morphine gargles in reducing the severity of chemoradiation induced mucositis pain & thus, its impact on nutrition, quality of life & cost of supportive care, during the treatment period. Methods: 106 consecutive patients, recruited between May 2006 through Dec. 2007, with adv. head and neck cancers (54 oropharynx, 42 hypopharynx & 10 nasopharynx) were included in the study. All patients underwent treatment under conc. CT-RT (Inj.CDDP 40mg/m2 weekly, RT: 66–70gy/33–35# @200cgy/# delivered by 3D- CRT). Patients who had painful mucositis (RTOG Grade 3 or more) not controlled with magic mouthwash, Tab. Acetaminophen 500mg qds or Tab.Tramdol 50–100 mg tds were randomized into 2 groups: morphine group (MOP) -53 patients & Control group (CON) - 53 patients. Patients in both groups received adjusted doses of oral steroids based on the severity of oral mucositis. While CON group patients were given adjusted doses of tramadol, MOP group patients were assigned to 15ml of 2% morphine gargles administered every 4th hourly. Patients were instructed not to swallow the rinses and to hold the solution in the mouth for 3mins duration. All patients underwent weekly recording of (1) response to pain rated on VAS (2) weight (3) morphine systemic side-effects (4) QOL Questionnaire. Mann-Whitney test and ’T’ Test are used for statistical analysis of the data. Results: Patients in the MOP group had significant lower pain intensity scores, better QOL scores & less weight loss compared to patients in the CON group. The duration of the severe pain was atleast 1 week shorter in the MOP group. Systemic side-effects secondary (nausea, vomiting, constipation) to opiod use were significantly lower in the MOP group. The Cost of supportive care for pain management was less in the MOP group, with greater compliance for the treatment. Conclusions: Morphine gargles, in our experience, is an effective approach for pain relief in patients with CT-RT induced acute mucositis in head and neck cancers thus leading to better nutrition & compliance in the treatment.

No significant financial relationships to disclose.
Chemotherapy-induced peripheral neuropathy as a predictor of neuropathic pain in breast cancer patients previously treated with paclitaxel
Authors: Reyes-Gibby C. C. , Morrow P.
Published: August 2020

e20505

Background: Neuropathic pain (NP) remains difficult to control for a significant proportion of patients with cancer. Chemotherapy induced peripheral neuropathy (CIPN) is postulated as an initial stage to the development of NP. Among breast cancer patients, taxanes, platinum agents, and vinca alkaloids are most likely to cause NP. The purpose of this study was to assess the extent to which those who experienced CIPN (NCI toxicity criteria ≥ grade 2 sensory neuropathy) during paclitaxel chemotherapy were at risk of developing chronic NP, controlling for disease- and treatment-related variables (e.g., stage of disease, location of tumor chemotherapy and other cancer therapies, dose of chemotherapy and duration of treatment), clinical health status (e.g., comorbid conditions), and sociodemographic characteristics (e.g., age, race). Methods: We conducted a follow-up survey of breast cancer patients who previously participated in clinical trials for paclitaxel. Patients were asked if they have ever been diagnosed by the physician or healthcare provider for NP during the survey. Clinical trial data (NCI Toxicity, cummulative dose) were abstracted from a clinical database. Results: Of the 430 potential respondents, 240 responded to the survey. Mean follow-up time was 9.5 years (SD=2.1). Sixty three percent of the respondents had grade 2 or greater sensory neuropathy during their previous treatment with paclitaxel. Follow-up data showed that 18% (43/240) were subsequently diagnosed by their physician to have NP. Logistic regression analysis showed that those with CIPN during the trial were 3 times more likely to having been diagnosed with NP (OR=3; 95%CI=1.2; 7.2; p<0.001), which persisted in the multivariable model. Other variables found to be associated with NP included cummulative dose of paclitaxel, and comorbid conditions such as diabetes and osteoarthritis. Patients with NP reported twice as many visits to their health care provider (p=0.028); had taken more prescription (50% versus 19%; p=0.0001) for pain relative to those without NP. Conclusions: We provide empirical evidence on the importance CIPN as a risk factor for NP in breast cancer patients.Prospective studies with larger cohorts are needed to validate our findings.

No significant financial relationships to disclose.
A randomized phase II trial of a new anticoagulant, apixaban, in metastatic cancer
Authors: Levine M. N. , Deitchman D. , Julian J. , Liebman H. , Escalante C. , O'Brien M. C. , Ramirez L. , Weise-Kelly L. , Solymoss S.
Published: August 2020

e20514

Background: Cancer patients receiving chemotherapy, biologic, and molecular targeted therapies are at increased risk of venous thromboembolism (VTE). Currently available anticoagulants (ACs) are not well suited to prevent VTE in such patients. Vitamin K antagonist oral ACs require frequent lab monitoring and low molecular weight heparins require daily subcutaneous injection. There is concern for bleeding with ACs. Apixaban (A) is a new antithrombotic agent which inhibits activated coagulation Factor X, is taken orally, and does not require lab monitoring. Trials to prevent post-operative VTE in orthopedic surgery showed that A was effective and safe. We wanted to assess the feasibility of A in cancer. Methods: In a randomized phase II trial, patients with metastatic cancer on 1st or 2nd line chemotherapy received study drug once daily for 12 weeks; either 5, 10 or 20 mg of A, or placebo. The primary outcome measure was the proportion of patients remaining free of major bleeding (MB), clinically relevant non-major bleeding (CRNMB), VTE, and grade ≥3 adverse events considered to be probably/definitely related to study drug (AE*). After 125 patients were recruited, the sponsor eliminated further randomization to the 10 and 20 mg arms, to add experience with the 5 mg dose currently under evaluation for VTE prevention in other conditions. Data on the first 125 patients are reported. Results: The study population was 50% male; 88% had ECOG performance status 0 or 1. The most common cancers were breast, colon, pancreas, and myeloma. 23% had liver metastases. Approximately 80% of A patients completed 12 weeks of treatment. The numbers of patients with events were: Conclusions: Apixiban was well tolerated in patients with advanced cancer on chemotherapy. Major bleeding, thrombosis, and drug-related SAEs were very low. These results support further study of A in phase III trials for VTE prevention in cancer patients.

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Acute palliative care unit in a comprehensive cancer center (CCC): Financial and clinical outcomes
Authors: Elsayem A. F. , Hui D. , Li Z. , Flores M. , Atkinson W. A. , Bruera E.
Published: August 2020

e20518

Background: Acute palliative care units (APCU) in CCCs improves symptom control for advanced cancer patients and supports their families. However, these services are not available in the majority of cancer centers. Concerns regarding financial reimbursements represent a major barrier for establishing APCUs. The purpose of this study is to report the clinical outcomes and compare the financial outcomes of our APCU as compared to other services at our CCC. Methods: We reviewed all admissions to the APCU over the last 5 fiscal years for demographic information, length of stay, discharges, survival, hospital billings and collection of charges, and compared these to the rest of the institution. Results: 2,510 unique patients were admitted to the APCU. Median age was 59 years (19–101) and 51% were female. The median length of stay in APCU was 8 days (Q1-Q3 6–10). Median survival of patients discharged home, to health care facilities and hospice were 53, 22, and 13 days, respectively (p<0.001, log rank test), with 6 month survival of 20%, 4%, and 2%, respectively. Professional collections ranged from 42–47% of charges for APCU, vs. 32–38% for rest of the CCC and were stable over the 5 year period. Hospital collections were 47–51% of charges for APCU, vs. 55–57% for the rest of the CCC. The payer mix included commercial 1155 (46%), Medicare 755 (30%), Medicaid 126 (5%), mixed 127 (5%), indigent 198 (8%), and others 149 (6%). Conclusions: The ACPU has reimbursement outcomes consistent with the American acute care model and comparable to the rest of the CCC for last 5 years. The APCU is as viable as any other clinical programs in our institution. Further research is needed to investigate possible reasons for lack of APCU in cancer centers.

No significant financial relationships to disclose.
Cognition and quality of life after chemotherapy plus radiotherapy (RT) vs. RT for pure and mixed anaplastic oligodendrogliomas: Radiation therapy oncology group trial 9402
Authors: Wang M. , Cairncross G. , Shaw E. , Jenkins R. , Scheithauer B. , Brachman D. , Buckner J. , Souhami L. , Laperriere N. , Mehta M. , Curran W.
Published: August 2020

e20519

Background: Radiation Therapy Oncology Group 9402 compared PCV chemotherapy plus radiation therapy (PCV+RT) versus RT alone for anaplastic oligodendroglioma. Here we report 1) longitudinal changes in cognition and quality of life, 2) effects of patient factors and treatments on cognition, quality of life and survival, and 3) prognostic implications of cognition and quality of life. Methods: Cognition was assessed by Mini Mental Status Examination (MMSE) and quality of life by Brain-Quality of Life (B-QOL) by repeat assessments. Scores were analyzed for survivors and within five years of death. Shared parameter models evaluated MMSE/B-QOL with survival. Results: For survivors, MMSE and B-QOL scores were similar longitudinally and between treatments. For those dying within 5 years, MMSE scores were stable initially, while B-QOL scores decreased; both declined rapidly in the last year of life and similarly between arms. In the aggregate, scores decreased over time (P=0.0413 for MMSE; P=0.0016 for B-QOL) and were superior with age < 50 years (P<0.001 for MMSE; P=0.0554 for B-QOL) and KPS 80–100 (P<0.001). Younger age and higher KPS were associated with longer survival. After adjusting for patient factors and drop-out, survival was longer after PCV+RT (HR=0.66, 95% CI=0.49–0.9, P=0.0084; HR=0.74, 95% CI=0.54–1.01, P=0.0592) in models with MMSE and B-QOL. There were no differences in MMSE and B-QOL scores between arms (P=0.4752 and P=0.2767, respectively); higher scores predicted longer survival. Conclusions: MMSE and B-QOL scores held steady in both arms for survivors. For those who died, B-QOL scores declined slowly until the last year of life, then rapidly. Younger, fitter patients had better MMSE and B-QOL scores and longer survival.

No significant financial relationships to disclose.
Comprehensive cancer cachexia staging and its impact in the outpatient oncology setting: A phase II study
Authors: Blum D. , Hess J. , Omlin A. , Jurt G. , Strasser ABHPM F.
Published: August 2020

e20530

Background: Symptom management in advanced cancer is based on appropriate and feasible syndrome staging. To test whether 1. various factors predict involuntary weight loss [WL], 2. patients [pts] attending a cachexia clinic [CC] improve nutritional intake [NI], and 3. eating-related distress [ERD] is a consequence of cachexia or psychological issues. Methods: The multidisciplinary CC (nurse, nutritionist, psycho-oncologist, palliative cancer care physician) applies standardized assessments (Symptom Visual Analogue Scales [VAS, 0=none, 10=severe], 2-day NI diary [% of calculated needs: calories, protein], secondary causes for impaired NI, weight history (2 months WL), Body Mass Index [BMI], C-reactive Protein [mg/dl, normal 8), ERD-VAS, Hospital Anxiety Depression Scale, spirituality [FICA]). Interventions include nutritional counseling, palliative cancer care and psychosocial supportive measures. Descriptive analysis, Spearman‘s Rank correlation and Factor analysis (Eigenvalue >1) were performed. Results: 58 pts (age 65 years [mean; range: 38, 85]; 28F/30M; cancer types: 24 GI, 13 GU, 12 lung/ENT, 9 other; survival 151 days [7, 776]) had 6.9% WL (-6, 22; 21%<2%), 21 kg/m2 BMI (15, 26), 52 CRP (1, 272; 32% normal), 5.6 anorexia, 1.6 anxiety, 6 HADS-A, 1.3 depression, 9 HADS-D, 68% of NI needs (1466kcal [400, 2700], 47g protein [15, 108]). WL correlated with NI kcal (r=-.29, p=.038) and protein (-.3,.035), not anorexia (.16), BMI (.032) or CRP (-.08); a 2 factor model (NI/anorexia/WL [.83/.79/.70], CRP/BMI [.86/.75] explains 67% variability. At second visit (21 days; 13, 64) 15/19 pts increased kcal (400kcal) and 15/16 protein (32g) NI, 6/17 weight. ERD correlated with anorexia (r=.56, p=.001) and depression (.48,.002), not anxiety (.23), WL (.038) or survival (-.15). A 3 factor model (ERD/anxiety/depression [.71/.85/.92], anorexia/survival [.82/.65], WL [.84]) explains 75% variability. Conclusions: A combination of clinical variables seems needed to characterize patients with involuntary WL. Most patients attending 2 consecutive cachexia clinic visits respond to multidimensional interventions. ERD seems to be associated both with loss of appetite and depression, not by WL or survival. Further testing of this intervention seems justified.

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Effect of bexarotene on platelet counts in patients undergoing cancer treatment: An analysis of clinical trials in lung cancer and leukemia
Authors: Tsai D. E. , Wang W. , Reshef R. , Vogl D. , Stadtmauer E. , Andreadis C. , Carlson A. , Luger S.
Published: August 2020

e20533

Background: Bexarotene (Bex) is an oral retinoid X receptor agonist with activity against cutaneous T cell lymphoma and currently under investigation for other malignancies. In patients receiving this agent for acute myeloid leukemia (AML), we noted increases in platelet counts. We therefore reviewed the available clinical trial data on Bex and its effects on platelet counts. Methods: We analyzed platelet count data from 3 Bex clinical trials encompassing non-small cell lung cancer (NSCLC) and AML. Results: In two phase III trials of Bex in NSCLC, patients underwent carboplatin + paclitaxel (CarP, n=587) or cisplatin + vinorelbine (CisV, n=613) and were randomized to receive concurrent Bex or placebo. More patients on Bex than on placebo had an increase in platelet count of at least 50 K/uL (55% vs. 27% for CarP, p<0.0001; 81% vs. 66% for CisV, p<0.0001) over pre-treatment baseline. The median increase in platelet count was higher on Bex than on placebo (69 vs 0 K/uL for CarP, p<0.0001; 168 vs. 95 K/uL for CisV, p<0.0001) and was maintained while on treatment. In both NSCLC trials, the median time to platelet increase >50 K/uL on Bex was 22 days. Similar findings were seen in a phase I monotherapy trial in AML where 5/18 (28%) patients achieved platelet transfusion independence with peak platelet counts of 40–91 K/uL. Conclusions: Clinically significant increases in platelet counts were seen in all 3 clinical trials examined. These data suggest that Bex improves platelet counts in patients with a variety of cancer types, both as monotherapy and with concurrent chemotherapy. Its effect on megakaryopoiesis and its potential role as a supportive care measure should be further evaluated.

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Confidence in knowledge discussing fertility changes with cancer treatment
Authors: Duffy C. M. , Allen S. M.
Published: August 2020

e20540

Purpose: Infertility can be a devastating side effect of cancer treatment in younger women, but approximately one third of young women fail to recall a discussion of such issues with their oncologist prior to cancer treatment. Oncologists may not discuss these issues because they lack confidence in their knowledge of treatment-associated fertility issues and fertility preserving options. We sought to determine oncologists’ confidence in their knowledge of fertility issues and the factors associated with greater confidence. Methods: A national sample of MedOnc, HemOnc, RadOnc, and GynOnc physicians was randomly drawn from the AMA Master File. Mailed recruitment letters provided a link to an on-line survey of fertility issues in cancer treatment. Only practicing oncologists who reported treating > 5 women/yr aged 21–45 were eligible to participate. Physicians were asked 8 questions regarding their confidence in knowledge of fertility changes with cancer treatments and fertility-sparing options. Responses on a 5pt likert scale ranged from 1=not at all confident to 5= very confident and a summary scale was created from participants’ answers. Multiple linear regression was conducted to determine the socio-demographic characteristics, practice settings and attitudes regarding discussing fertility issues that were associated with confidence in knowledge scores. Results: 336/1702 eligible participants responded (20%). Avg years in practice was 15.7, mean age was 48.5 and 75.2% were male. A majority were community-based (60%). Average score on confidence in knowledge scale was 2.9 (SD 0.80) with Cronbach α= 0.84. Higher confidence in knowledge scores were associated with Gyn-Onc sub-specialty, access to educational resources regarding fertility and cancer, and greater sense of responsibility to discuss fertility preservation options (p<.001). Age, sex, and practice setting were not associated with confidence in knowledge. Conclusions: This is the first nationally representative survey regarding confidence in knowledge among oncologists regarding fertility and female cancer treatments. Whether confidence in knowledge is a cause or result of resource access and sense of responsibility to discuss fertility issues should be explored in future research.

No significant financial relationships to disclose.