bluuebunny/crossref_metadata_2025_split huggingface dataset:
Lines of systemic therapy in patients with metastatic melanoma in the United States.
Authors: Zhao Zhongyun , Wang Song , Barber Beth , Wagner Volker Jean 
Published: March 2020

e19043 Background: To describe treatment patterns by lines of systemic (drug) therapy in patients with metastatic melanoma in the U.S. Methods: Using a large U.S. medical claims database, patients were identified between 2005 and 2010 using ≥2 melanoma diagnoses (ICD-9-CM: 172.xx, V10.82) and ≥2 diagnoses for metastasis (ICD-9-CM: 197.xx, 198.xx). Patients were followed from the metastatic diagnosis date to death, disenrollment, or end of study period (6/30/2010), whichever occurred first. Lines of systemic therapy were identified based on the temporal order, gaps, and changes in the drug regimens. Systemic therapies and the duration of therapy in each line were examined. Results: A total of 2,546 patients with metastatic melanoma were included and 985 (38.7%) received systemic therapy. As the first documented therapy after diagnosis, 82.4% of patients received mono-therapy (38.5% temozolomide, 14.3% interleukin-2, 11.4% interferon alfa-2b, 8.2% dacarbazine, 2.9% paclitaxel, 2.5% GM-CSF) and 9.4% received carboplatin plus paclitaxel. Mean duration of mono-therapy was 60 days, ranging from 32 days on interleukin-2 to 124 days on GM-CSF. Of 287 patients (29.1% of previously treated) received subsequent therapy, 68.0% received mono-therapy (26.8% temozolomide, 11.9% interleukin-2, 10.5% dacarbazine, 8.4% paclitaxel, 3.1% interferon alfa-2b, 1.7% GM-CSF), 16.7% carboplatin plus paclitaxel, and 7.3% dacarbazine-containing therapies. Mean duration of mono-therapy was 67 days, ranging from 30 days on interleukin-2 to 238 days on GM-CSF. Among 71 patients who further received additional therapy, mono-therapy was still the dominant regimen (63.4%) with 21.1% temozolomide, 18.3% paclitaxel, 8.5% interleukin-2, 5.6% dacarbazine, 4.2% GM-CSF, and 1.4% interferon alfa-2b. Carboplatin plus paclitaxel was given to 19.7% of patients. Mean duration of mono-therapy was 63 days, ranging from 7 days on interferon alfa-2b to 90 days on temozolomide. Conclusions: The majority of patients with advanced melanoma didn’t receive systemic therapy as captured in the claims database; among those who received systemic therapy, mono-therapy was most common.
Acral melanoma among the minority population in Hawaii and the Pacific basin: Analysis of downstream effectors within the PI3K pathway.
Authors: Morita Shane Young , Lum Christopher A. , Davis James W. 
Published: March 2020

e19051 Background: Acral melanoma (AM) has been described as a distinct entity in the molecular classification of melanoma. The minority population tends to be more commonly afflicted by AM. Recent studies have profiled the importance of the PI3K (phosphatidylinositol 3-kinase) cascade in melanoma biology and therapy. Both mTOR (mammalian target of rapamycin) and S6K (S6 kinase) are involved in translational control and protein synthesis. However, characterization of this pathway focusing on these pivotal components in a multi-ethnic AM population has not been reported. We elected to determine the frequency of PI3K involvement of the critical downstream effectors, mTOR and S6K. Methods: IRB approval was obtained. From 1992 to 2011, 24 non-Caucasian patients histologically confirmed to have AM were evaluated at a tertiary institution. Data including age, gender, tumor location, Breslow thickness, Clark level, ulceration and mitoses per mm squared were compiled. Immunohistochemical expression for both phosphorylated mTOR and S6K was performed on archived biospecimens (primary lesions). Both mTOR and S6K expression were graded on a scale from 0 (absent) to 2 (high). Results: Our findings demonstrated that mTOR 12/24 (50%) and S6K 20/24 (84%) were highly expressed. Demographics of the non-Caucasian cohort (17 Filipino and 7 Pacific Islanders) included mean age of 67.2 years old (range 44-89) and male gender 12/24 (50%). Tumor location principally involved the foot 20/24 (83%); mean Breslow thickness was 5.0 mm (range 1.6-11.0), Clark IV or higher 18/24 (75%), ulceration 18/24 (75%) and mean mitoses per mm squared was 8.9 (range 1-30). Conclusions: A high proportion of minority patients with AM displayed evidence of an activated PI3K pathway. Over half of our cohort had thick primary lesions with a high propensity for ulceration. This is the first study to our knowledge that has examined the downstream effectors, mTOR and S6K within the PI3K pathway in a minority population of AM patients. This is compelling data that may be applied to the metastatic phenotype in future trials and help stratify which patients will benefit from rapalogs.
Clinical and dermoscopic features of keratinizing skin tumors in BRAFi-treated patients.
Authors: Rosen Alyx C. , Jaimes Natalia , Marghoob Ashfaq A. , Halpern Allan C. , Myskowski Patricia L. , Lacouture Mario E. 
Published: March 2020

e19052 Background: Development of keratinizing skin tumors (KST), including squamous cell carcinomas (SCC), keratoacanthomas (KA) and verrucae (warts), are common in patients receiving BRAF inhibitors (BRAFi), including vemurafenib (V), XL281 (X) and GSK211846 (G). Dermoscopy is a specialized technique for examining skin lesions. While the clinical characteristics of these lesions are well known, the dermoscopic morphology remains to be elucidated. Methods: Patients on V, X or G who developed biopsy-proven KSTs were included in the study. Clinical and dermoscopic images of the KSTs were evaluated to determine the clinical and dermoscopic features. Frequent and reproducible structures were identified. P values were calculated based on Fisher's exact test. Results: 44 lesions (8 SCC/KAs, 36 verrucae) were identified in 21 patients. Clinically, SCC/KAs presented as scaly papules (75%) or plaques (25%) with a central scale/crust (63%), erythematous halo (63%) and/or scaly rim (63%). Verrucae presented as papules (97%) with an erythematous halo (50%). Dermoscopically, keratinizing pearls were exclusive to the SCC/KAs and keratin “petals”, “domes” or horns were seen exclusively in verrucae (Table). In the verrucae, thrombosed vessels were often observed within keratin structures; vs. vessels seen in the SCC/KAs, which were mainly located outside the keratin, around the center or in the base of the tumor. Conclusions: Although KSTs secondary to BRAFi do not result in drug discontinuation, they can affect dosing and quality of life. The dermoscopic features described herein may aid in the differentiation of benign vs. malignant lesions, with keratinizing pearls appearing to be unique to SCC/KAs. Management strategies for BRAFi KSTs may be tailored based on dermoscopic findings, with more conservative treatment for verrucae vs. SCC/KAs, which may decrease morbidity and cost. [Table: see text]
Conditional survival (CS) in patients with stage II melanoma.
Authors: Gamerman Victoria , Karakousis Giorgos Constantine , Guerry DuPont , Gimotty Phyllis A. 
Published: March 2020

e19054 Background: While sentinel lymph node biopsy is recommended for those presenting with clinical stage II melanoma, it is not always performed. Future survival beyond the time already survived is captured by CS and is relevant to patient counseling and guiding follow up. We sought to investigate patterns of CS in patients with clinical (no nodal biopsy) or pathological stage II melanomas controlling for ulceration. Methods: The study included 5,370 patients diagnosed with primary cutaneous melanoma in 2004-2008 from the Surveillance, Epidemiology, and End Results (SEER) data. Three-year CS probabilities were estimated from the Kaplan-Meier survival curves (time to melanoma-specific death) at 6, 12, and 18 months from diagnosis. Newly developed biostatistical methods were used to evaluate the statistical significance of changes in CS as the time survived increased for four groups of patients: those clinically and pathologically staged with and without ulceration. Results: With increasing time survived up to 18 months, there was no significant change in the 3-year CS estimates for the cohort of pathologically-staged patients with non-ulcerated lesions (n=1702). For pathologically-staged patients with ulcerated lesions (n=1915), 3-year CS increased significantly only after having survived 1 year (86% to 87% p=0.001). A similar pattern was seen for the cohort of clinically-staged patients with non-ulcerated lesions (n=801), (85% to 87% p<0.001). For clinically-staged patients with ulcerated lesions (n=952), the 3-year CS estimates for those who had survived 6, 12, or 18 months were 74%, 78%, and 82%. After the initial 6 months of survival, there was a significant change in 3-year CS having survived 6 versus 12 months (p=0.002), as well as having survived 12 versus 18 months (p<0.001). Among patients with ulcerated lesions, CS for those clinically staged begins to change after 6 months whereas for those pathologically staged change occurs only after a year. Conclusions: CS provides up-to-date prognostic information to patients, their physicians and clinical trialists. Formal statistical methods, as illustrated here, identify when clinically meaningful CS estimates change in statistically significant ways.
Biomarkers of treatment effect in a phase II trial of velimogene aliplasmid in patients with metastatic melanoma.
Authors: Wloch Mary K , Kharkevitch Dmitri D. , Chu Alice , Schulte John , Smith Larry R , Kenney Richard T. , Rolland Alain 
Published: March 2020

e19058 Background: Velimogene aliplasmid (Allovectin, A) is a plasmid-based immunotherapeutic that encodes human leukocyte antigen-B7 and β-2 microglobulin. A is designed to induce allogeneic and tumor-antigen-specific T-cell responses against tumor cells. In a phase II trial, 127 patients with stage III or IV recurrent metastatic melanoma were treated in cycles of 6 weekly intralesional injections of 2 mg/dose. Complete (CR) or partial responses (PR) were observed in 15 patients (11.9%, 95% CI: 6.2-17.4), stable disease (SD) in 32 (25.2%), and progressive disease (PD) in 80 (63.0%). Methods: Serum collected before treatment and 3 weeks after each cycle from 29 patients who showed clinical benefit (CB: 15 CR or PR patients and 14 patients with SD for >4 months) and 62 with PD (progressed by the end of the first cycle) were evaluated for 45 inflammation biomarkers in a quantitative multiplex immunoassay. Changes in analyte concentrations relative to baseline were evaluated by paired t-test or Wilcoxon signed-rank test. Results: Overall, 52% of patients had decreases in serum IL-10 after treatment; however, decreases were more prevalent in CB patients (71.4% for CB, 44.4% for PD; p=0.036; Chi-square test). At week 8, mean serum IL-10 concentration within a group was reduced relative to baseline in CB (p=0.008) but not PD patients suggesting greater treatment effect in CB patients. In CB patients, IL-10 remained at lower levels relative to baseline through week 26. CCL-3 decreased in CB patients by week 26 (p=0.021) and von Willebrand factor (a biomarker of vascular endothelium dysfunction) was increased at week 26 (p=0.007). In PD patients, by week 8, several biomarkers associated with metastatic melanoma (TIMP-1, VCAM-1, and TNF-R2) or inflammation (haptoglobin) increased (p=0.001, 0.022, <0.001, 0.004, respectively) consistent with tumor progression, whereas others (IL-8 and stem cell factor) decreased (p=0.007, 0.013, respectively). Conclusions: Consistent with A’s proposed mechanism of action, treatment was associated with a decrease in the production of the T-cell suppressive cytokine, IL-10. Furthermore, biomarker profiles in the two groups were markedly different and analogous with treatment outcomes.
Do patients with thin melanomas benefit from sentinel lymph node biopsy with selective lymph node dissection?
Authors: Krishnamurthy Vikram , Hieken Tina J. 
Published: March 2020

e19061 Background: Sentinel lymph node (SLN) biopsy for thin melanoma remains controversial. While most patients diagnosed with thin melanoma have an excellent prognosis, ~5% will die of their disease. With the growing number of thin melanomas, nearly 25% of all melanoma-related deaths now result from thin primary tumors. Yet these patients are unlikely to have LN disease at presentation and when SLN disease is identified, it is often minimal. It remains unclear whether SLN biopsy with selective LN dissection (LND) represents an opportunity to cure patients with high-risk thin melanoma or whether they are a subgroup with disease likely confined to the SLN(s) or of unclear clinical significance. We undertook this study to examine outcomes in patients with thin melanomas (<1.0mm on biopsy) who underwent SLN biopsy. Methods: From our Melanoma Registry, we identified 338 consecutive thin melanoma cases in 300 patients. Data were verified by pathology and record review. Median patient follow up was 61 months. SAS software was used for statistical analysis. Results: 36 of 300 patients (12%) underwent SLN biopsy. Patients selected for SLN biopsy were younger (median 58 v 69 yrs, p=0.03), their melanomas were thicker (median 0.9 v 0.25 mm), more often level IV/V (44 v 5%), ulcerated (11 v 0.3%) and 53 v 22% had ≥1 mitoses/mm2, all p<0.001. Two (5.5%) were SLN+, one with isolated tumor cells in a solitary SLN, the other with 2.0 and 0.2 mm foci in 2 of 2 SLNs. Neither had additional disease identified after LND. Recurrent disease developed in 6/36 SLN patients (16.7%) and in 20/264 non-SLN patients (6.6%), after a median 32 of months. Isolated regional recurrence as site of first relapse occurred in 9/264 non-SLN patients (3.4%) and in no patients after SLN biopsy, p<0.001. Disease-free and overall survival were governed by tumor thickness. Conclusions: SLN biopsy with selective LND provides excellent regional control and prognostic information for selected patients with thin cutaneous melanoma, and may alter treatment and improve outcome for patients who harbor LN disease. Pending ongoing randomized controlled trial results, selective completion LND for patients with thin melanoma and evidence of SLN metastases appears warranted.
Cancer survivors’ perspectives on the U.S. generic drug shortage.
Authors: Nutt Stephanie , Rechis Ruth , Shulman Lawrence N. , Hayes-Lattin Brandon M. 
Published: March 2020

e19503 Background: Approximately 1.6 million new cancer cases are expected to be diagnosed in 2012 in the United States, making the need for generic cancer treatment drugs widespread. Methods: In late 2011, LIVESTRONG fielded the Drug Shortage Survey, which mirrored the questions from the American Hospital Association drug shortage survey for providers reworded for a patient audience. The primary goals of the brief survey were to 1) assess if survivors were aware of a generic drug shortage in the U.S. and 2) gauge the impact that the drug shortage has had on people affected by cancer. Individuals were asked to participate in this online survey through a number of means (including the LIVESTRONG Blog). Results: Between October 31, 2011 and January 30, 2012, 114 individuals completed the drug shortage survey, including 54 individuals who have been personally diagnosed with cancer. A little under half of the respondents (47%) felt they or a loved one had been impacted by the drug shortage, while an additional 30% were not sure if they had been impacted. Of the individuals impacted, the most commonly reported adverse effects of the drug shortage were not receiving medications needed for cancer treatment (40%) and receiving different medications (36%). The table highlights the reported effects. Conclusions: Results from this survey indicate that for cancer survivors who chose to participate in this survey who had been impacted by the drug shortage, the impact has been very significant. Additionally, results indicate that more information may need to be disseminated to the patient population about the drug shortage. [Table: see text]
A phase II study of loratidine (L) and naproxen (N) to prevent pegfilgrastim-induced pain (PIP).
Authors: Kirshner Jeffrey J. , Heckler Charles E , Reichel Carol , Morrow Gary R. 
Published: March 2020

e19510 Background: We have previously demonstrated the efficacy of N in terms of preventing the incidence, severity and duration of PIP (ASCO 2010; JCO, in press). Last year at ASCO, we reported the results of a pilot study of L, using similar methodology. The present pilot study was designed to determine the safety and efficacy of the combination of N + L , used to prevent PIP. Methods: Using identical eligibility criteria to the aforementioned studies, 41 pts were treated with N 500 mg po bid and L 10 mg po qd beginning on the morning of their initial dose of P and continuing for 5-8 days. Pain at any time was recorded by pts in diaries using a 0-10 scale. Unexpected adverse events were promptly reported. Similar methodology and statistical analyses were used, with the primary endpoint being AUC for the severity and duration of pain. Results: Six pts either did not take the pills or return questionnaires. 35 evaluable pts were treated (27F;8M). Cancers included 24 breast, 7 lung and 4 others. AUC was 7.10. At any time during the 5 days after administration of P, 10 pts experienced no pain, 17 had some mild pain and 8 had some severe pain. No unexpected adverse events were reported. Comparison to our prior studies is tabulated (see table below). Conclusions: The combination of N + L does not appear to be unsafe when used to prevent PIP, but in these small pilot studies, the regimen does not appear to be any more efficacious than either drug when used alone. A larger study is needed to specifically evaluate efficacy and toxicity. [Table: see text]
ASCO's international cancer corps: Oncology nursing education in Honduras.
Authors: Sheldon Lisa Kennedy , Carlson Julie R. , Sanchez Jose Angel 
Published: March 2020

e19515 Background: Developing countries face a heavy cancer burden. Nurses in oncology care are challenged by lack of resources and training to care for these patients. Volunteer nurses from other nations have been used as clinician/educators on service trips organized by ASCO’s International Cancer Corps and Health Volunteers Overseas. In 2011, a team of four oncology providers, two gynecologic oncologists and two oncology nurses, traveled to Tegucigalpa, Honduras, to improve cancer care through education/training and professional development. Methods: The team explored cancer care and oncology nursing in outpatient and inpatient settings, provided training to residents and medical students, and presented the first ever cancer nursing conference in this country. The two-day conference, with over 100 participants from different cities and insitutions, included cancer registry data, treatments such as chemotherapy, radiotherapy and surgery, symptom management, palliative care and psychosocial concerns. It concluded with a roundtable discussion for future directions. A survey was piloted with conference participants to assess needs for continuing education and professional development. Data were collected from 61 nurses (age, gender, education/training, years in oncology, work settings, access to educational resources, and educational needs). Results: The majority of the nurses (59.7%) learned about cancer care during patient care with <4% having formal training/coursework. The most common cancers were leukemias, breast, cervical, and stomach. The nurses wanted more education about chemotherapy (medications, administration, management of side effects), pain management, palliative care and emotional support. Conclusions: Volunteer oncology providers can improve cancer care in developing countries. Meeting the educational needs requires site-specific exploration of training and resources, and the goals of providers, hospitals, and healthcare organizations in the host country. The survey could be replicated prior to travel to assess the needs of oncology nurses in other developing countries and plan appropriate training programs.
Assessment of cancer patients of the local patient’s support organizations and the available sources of the patient’s health education: Local perspectives from Saudi Arabia.
Authors: Kandasamy Ravichandran , Al-Dalee Abdelmuniem , Aljubran Ali Husain 
Published: March 2020

e19526 Background: Few Local patients’ support organizations are available for cancer patients in Saudi Arabia. These non governmental organizations NGOs were recently founded to provide social, financial, logistic and educational support to cancer patients. Their role and participation to the cancer patient’s care is not well estimated. On the other hand, Health education is imperative. However, there is yet no clear estimation of the adequacy and quality of the available local sources for cancer health education. This study was intended to show the cancer patient’s assessment of the available resources of support and health education to cancer patients. Methods: The subjects were adult cancer patients who attended the outpatient clinics at King Faisal cancer center in Riyadh, Saudi Arabia. They completed a validated questionnaire of six sections. In this abstract, we only present the data of the fifth and sixth sections. The fifth is regarding patient’s impression about the support provided by the family and society. The sixth is about the patient’s sources of information and education about their diseases. Results: 234 patients participated. Age range: 15-86, median: 40.5 y. Males: 61.5%. 12.4% from suburban areas. 41.5% had higher than high school education, and 76% had annual income <$32,000. 90% of the participating patients evaluated the family support as full support. However, 92% did not receive any support from the NGOs, and 54% were not aware that such organizations exist. Only 20% of those who suffered psychological/ psychiatric changes actually did ask for help. Regarding the patient’s use of the available sources of health education, 77% received education other than that provided directly by physicians. 45% had more information about their conditions from educational brochures and health magazines and only 33% sought more information from the internet. Conclusions: The cancer patient’s assessment of the role and participation of the NGOs is generally poor. Majority of patients were able to have more information about their conditions through different means. The use of internet is relatively inadequate.
Level of scientific evidence underlying palliative care recommendations arising from the National Comprehensive Cancer Network (NCCN) clinical practice guidelines.
Authors: Cruz Felipe Melo , Prearo Fernando Mauro Lima , Cubero Daniel Iracema , Del Giglio Auro 
Published: March 2020

e19537 Background: The palliative care NCCN recommendations are classified according to the level of scientific evidence in four groups: category I, high level of evidence with uniform consensus; category IIA, lower level of evidence with uniform consensus; category IIB, lower level of evidence without a uniform consensus but with no major disagreement; and category III, any level of evidence but with major disagreement. Palliative care guidelines have not yet been judged as to the relative content of each of the aforementioned types of recommendations. Methods: We analyzed the distribution of categories of evidence cited in the 10 supportive care NCCN guidelines, version 2.2011. Results: Of the 2,537 recommendations found in the 10 guidelines, the proportion of category I, IIA and IIB recommendations were 2.9%, 95.7%, 1.4%, respectively. There wasn’t any category III recommendation (table 1). The fields with a higher rate of category I recommendations were fatigue (14.3%) and chemotherapy induced nausea and vomiting (12.7%). No category I recommendations were found on Senior Adult Oncology, Cancer and Chemotherapy induced Anemia and Adult Cancer Pain. Conclusions: : Palliative care NCCN recommendations are largely based on lower level of evidence, but with uniform expert opinion. This data show the urgent need to expand palliative care research in oncology. [Table: see text]