bluuebunny/crossref_metadata_2025_split huggingface dataset:
Incidence of pediatric melanoma in Texas: A report from the Texas Cancer Registry, 1995–2003
Authors: Spelman A. R. , Okcu M. F. , Bondy M. , Pappo A. 
Published: March 2020

8564 Background: Although melanoma is rare in the pediatric population, a sizable increase in the incidence of this disease has been previously reported in the pediatric population (J Clin Oncol 23:4735, 2005). In this study, we describe the incidence of pediatric melanoma in Texas in an effort to determine whether there has been a similar increase in Texas. Methods: Between 1995 and 2003, we identified 197 cases of melanoma (ICD codes 8720–8780) in children < 20 years of age. Baseline characteristics were compared by chi-square analysis and age-adjusted incidence rates were calculated based on the US 2000 standard population. Results: Between 1995 and 2003, the incidence of pediatric melanoma in Texas increased by 57.2% (95% CI 42.4 to 72) per year of age. There was an 18.1% (95% CI 9.8 to 26.4) increased incidence per year for Texas in contrast to the 12% (95% CI 5.2 to 18.8) national increase (SEER). Fifty-three of 254 counties (20.9%) reported cases during this time period. Cases were diagnosed at a median age of 16 years (range 0–19). The majority of cases were non-Hispanic white (91.7%). Over half the cases (54.3%) were diagnosed at Stage I and the lesions were largely distributed between the extremities (39.1%), torso (28.9%) and head, face and neck (27.4%). Older individuals (10–19 years of age) were more likely to be female (p=0.024), non-Hispanic white (p<0.001) and diagnosed at an earlier stage (p=0.023) than younger individuals (<10 years of age). The incidence in older individuals was over 6 times that in the younger individuals (IRR=6.32, 95% CI 4.19–9.87) Conclusions: The incidence of pediatric melanoma in Texas has rapidly increased over that past 10 years. This increase emphasizes the need for public awareness, primary and secondary prevention campaigns and prospective studies to identify risk factors. No significant financial relationships to disclose.
Survival and treatment morbidity with therapeutic lymphadenectomy for regional nodal metastases from melanoma
Authors: Agrawal S. , Kraybill W. G. , Albini P. , Tan W. , Wilding G. E. , Kane J. 
Published: March 2020

8571 Background: Therapeutic lymphadenectomy (TL) is potentially curative therapy for clinically palpable nodal metastatic melanoma. However, TL is associated with significant morbidity and a dismal prognosis. Methods: Review of the melanoma database identified 275 patients who underwent TL. Patient, tumor, and treatment-related variables associated with recurrence and overall survival were analyzed. Results: The study group comprised of 63% males with a nodal basin distribution of 47% axilla, 35% groin and 18% neck. Median age, number of positive lymph nodes and size of the largest lymph node were 51 years 2 nodes and 2.5 cm respectively. Median survival was 27.4 months (77%, 55% and 34% at 1, 2 and 5-years respectively). Regional recurrence at the lymphadenectomy site occurred in 76 (28%) patients. Distant metastases developed in 67 (88%) patients with and 126 (63%) without regional recurrence. On multivariate analysis, the most powerful predictor of both survival and regional recurrence was lymph node ratio (LNR- number of positive nodes/total dissected nodes). Median survival for LNR <0.13 was 39 months versus 19 months for ≥0.13 (p = 0.005). Older age and male sex were also predictive of a decreased survival. Treatment-related morbidity was rare and included lymphedema (12%), wound complications (3%) and nerve injury (1%). Conclusion: The overall survival and acceptable morbidity justifies TL for clinically positive nodal metastatic melanoma. LNR is predictive of survival and regional recurrence following TL. Due to significant distant and regional failure rates, in addition to systemic adjuvant therapy these patients may benefit from radiation therapy. No significant financial relationships to disclose.
Temozolomide (TMZ) and cisplatin (CDDP) combination in naïve patients with stage IV melanoma. Definitive results of a phase II multicenter trial
Authors: Tourani J. , Wiersbicka E. , Mourey L. , Guillot B. , Sassolas B. , Bedane C. 
Published: March 2020

8572 Background: TMZ, an imidazol derivative, is a second-generation alkylating agent. TMZ has shown some efficacy in metastatic melanoma and recently received extended approval to treat brain tumours. The purpose of this study was to test the efficacy and safety of combination therapy with TMZ plus CDDP in patients with metastatic melanoma. Methods: Patients with stage IV melanoma were required to have histologically proven measurable metastasis. Patients received as a first-line therapy a combined treatment with TMZ (200 mg/m2/day), days 1–5 and CDDP (75 mg/m2/day) on day 1.The treatment was given every 28 days, maximum 6 cycles. The primary end point was an overall response rate. Secondary end points were: tolerance, progression free survival (PFS) and OS. Results: Thirty patients (pts) were enrolled from 09–2003 to 11–2005: 17 males and 13 females. Median age was 59 years (min: 26; max: 83). Initial performances status was 0 (22 pts) and 1 (8 pts). A total of 126 cycles of chemotherapy were administered. Clinical toxicity was mild and no toxic death occurred. Dose modifications for TMZ were required in 40% of pts and for CDDP in 13.3% of pts. 21 cycles of chemotherapy (21/126) had to be delayed due to toxicity. Grade 3 and 4 toxicity was observed in 12 pts (40 %). 16 pts withdrew because of tumor progression, 4 were removed because of adverse events including neutropenia (3 pts) and medullar aplasia and sepsis (1 pt). No complete response was observed among the 28 evaluable pts. Five pts (17.8%) achieved a partial response. An additional 6 pts (21.4%) showed disease stabilization & 17 pts (60.7%) revealed progressive disease. So the overall response rate was 17.8%. Median PFS of 29 evaluable pts was 111 days (min: 28; max: 808). Median response duration was 216 days. Conclusions: This combination therapy with TMZ and CDDP according to this schedule had an acceptable tolerance but gave a poor response rate comparatively to those reported previously by Tas and al (30%). Definitive data will be produced in June 2007. No significant financial relationships to disclose.
Routine PET and PET-CT scans in melanoma patients with positive sentinel node biopsy is of limited benefit
Authors: Constantinidou A. , Hofman M. , O'Doherty M. , Acland K. , Healy C. , Harries M. 
Published: March 2020

8582 Background: Positron emission tomography (PET) scanning is increasingly used for the staging and management of malignant melanoma. The role of PET as a routine procedure in patients with positive sentinel node biopsy (SNB) is not yet established. We report in the series with longest follow up outcomes of PET scans performed in patients with subclinical lymph node disease. Methods: Case notes of 29 sequential patients with melanoma of Breslow thickness greater than 1mm who had PET scans within 130 days after a positive SNB were reviewed. Four patients had a PET after the lymph node dissection (LND). Results: 2 patients (6%) had a positive PET scan neither of which was melanoma related. The first patient had a thyroid tumour confirmed with fine needle aspiration biopsy and the second patient had increased uptake in the chest wall which on verification with bone scan proved to be old trauma. 28 patients (96%) had a LND and this was positive in 5 cases (17%). With a median follow up of 23 months 21 patients remained disease free. Out of the 8 patients (27%) who presented with recurrence 2 (25%) were successfully treated with further surgery and remained in remission, 4 (50%) died, 1 (12.5%) was lost from follow-up and 1 (12.5%) is followed up in another hospital. In none of the 29 cases did the early PET scan after a positive SNB alter subsequent melanoma management. Conclusions: The role of PET scanning soon after a positive sentinel node biopsy appears to be of uncertain benefit. It is questionable whether any imaging is beneficial at this stage. The results of this review suggest that PET scanning might not be indicated for this group of patients but larger prospective studies are required to confirm this. Patients Characteristics No % Male 15 (51) Female 14 (49) Melanoma Type: Nodular 8 (27) Superficial spreading 15 (51) Other 2 (6) Unknown 4 (13) Breslow thickness: 1.0–1.9 13 (44) 2.00–3.9 14 (49) ○= 4.0 2 (6) Ulceration: Yes 3 (10) No 25 (86) Unknown 1 (3) Age Median 56 No significant financial relationships to disclose.
A pilot, multi-dose, placebo-controlled evaluation of american ginseng (panax quinquefolius) to improve cancer-related fatigue: NCCTG trial N03CA
Authors: Barton D. L. , Soori G. S. , Bauer B. , Sloan J. , Johnson P. A. , Figueras C. , Duane S. , Dakhil S. , Liu H. , Loprinzi C. L. 
Published: March 2020

9001 Background: Fatigue is one of the most common symptoms in people diagnosed with cancer. Ginseng is a popular herb for treatment of this. It has been termed an “adaptogen”, felt to be able to restore balance to the body; its potential anti-fatigue efficacy is supported by animal data. The purpose of this pilot trial was to evaluate three doses of American Ginseng versus placebo for cancer-related fatigue. Methods: Patients with a life expectancy = 6 months and a history of cancer-related fatigue who had been experiencing fatigue = 1 month were eligible. Exclusion criteria included prior use of ginseng, chronic systemic steroids and brain malignancies. Other etiologies for fatigue, such as pain, were also excluded. Participants were randomized to receive, in a double blind manner, placebo, 750 mg/d, 1,000 mg/d or 2,000 mg/d of American Ginseng in BID dosing for 8 weeks. Endpoints included The Brief Fatigue Inventory (BFI), the Vitality Subscale of the SF-36 and several numeric analogue questions of perceived benefit; endpoints were measured at baseline, 4 weeks and 8 weeks. Area under the curve (AUC) and change from baseline were calculated. Results: Two hundred eighty two patients (69–72 per arm) were enrolled from 10/21/2005 to 07/05/2006. Available 8-week data are provided in the table below; higher numbers are better. There were no statistically significant differences in any grade of toxicity between active and placebo arms, and an equivalent number of patients discontinued the study due to adverse events in each arm. Conclusion: This randomized pilot trial provided data to suggest that American Ginseng doses of 1000–2000 mg/d may be effective for alleviating cancer related fatigue. Therefore, further study of American Ginseng in cancer survivors appears warranted. No significant financial relationships to disclose. [Table: see text]
A placebo-controlled trial of Sertraline's effects on symptoms, well-being and survival in advanced cancer: The ZEST Trial
Authors: Wilcken N. R. , Goldstein D. , Nowak A. K. , Beale P. J. , Jefford M. , Dhillon H. , O'Connell R. , Heritier S. , Simes R. J. , Stockler M. 
Published: March 2020

9002 Background: Depression, anxiety, fatigue and impaired well-being are common, important and closely related in advanced cancer. We sought to determine the effects of sertraline (a well-tolerated, SSRI antidepressant) on these symptoms and survival in a broad cross-section of people with advanced cancer but without major depression. Methods: 189 participants (pts) were randomly allocated to sertraline 50 mg daily or placebo. Assessments were at baseline; months 1, 2, 4, 6, 9, 12; and, then 3-monthly. Outcome measures rated by pts included the: Centre for Epidemiologic Studies Depression scale (CES-D); Hospital Anxiety and Depression Scale (HADS-A, HADS-D); and the Functional Assessment of Cancer Therapy General and Fatigue scales (FACT-G and FACT-F). Clinicians completed Spitzer's Quality of Life Index (SQLI). Outcomes on all scales are expressed from 0 (worst) to 100 (best). The primary analyses of sertraline's effects on quality of life were based on scores at 4 and 8 weeks adjusted for baseline scores using generalised estimating equations. Efficacy analyses are by intention to treat; toxicity analyses by treatment received. P-values and 95% confidence intervals (CI) are 2-sided. Results: Recruitment was stopped after the first planned interim analysis of 150 pts showed a trend in overall survival favouring placebo (univariable logrank p=0.04; multivariable Cox model hazard ratio 1.61, CI 1.1 to 2.5, p=0.02). This trend was weaker at the final analysis including all 189 patients and longer follow-up (univariable logrank p=0.09); and, after accounting for baseline factors (multivariable Cox model hazard ratio 1.27, CI 0.87 to 1.8, p=0.2). Sertraline had no significant effects (scale: benefit over placebo, 95% CI) on depression (CES-D: 0.4, −2.6 to 3.4), anxiety (HADS-A: 2.0, −1.5 to 5.5), fatigue (FACT-F: 0.3, −4.3 to 4.9), overall quality of life (FACT-G: 1.7, −1.3 to 4.7) or clinicians’ ratings (SQLI: 2.0, −2.5 to 6.5). Subgroup and sensitivity analyses also excluded significant benefits. Sertraline was discontinued more often and earlier than placebo (logrank p = 0.03). The trial was closed for lack of benefit. Conclusions: Sertraline did not improve symptoms, well-being or survival and should be reserved for those with a proven indication. No significant financial relationships to disclose.
Gabapentin for hot flashes in men: NCCTG trial N00CB
Authors: Loprinzi C. L. , Khoyratty B. S. , Dueck A. , Barton D. L. , Jafar S. , Rowland K. M. , Atherton P. J. , Marsa G. W. , Krook J. , Kottschade L. 
Published: March 2020

9005 Background: Hot flashes can be a major problem in men with prostate cancer; effective non-hormonal options are needed. Methods: A four-arm, double-blinded, placebo-controlled randomized trial was developed to evaluate gabapentin for hot flashes. Men with bothersome hot flashes (at least 14/week) related to androgen deprivation therapy were randomized to receive either a placebo or gabapentin doses of 300 mg qd, 300 mg bid or 300 mg tid; men were treated for 4 weeks. Hot flashes numbers and scores (hot flash number times mean severity) were measured using a validated daily hot flashes diary. A one-week baseline period preceded initiation of study tablets. The primary endpoint was the average intrapatient difference in hot flash score between baseline and treatment termination. With the planned sample size of 50 evaluable patients per arm, the study provided 80% power to detect a difference in change from baseline at 4 weeks between each gabapentin arm and the placebo arm of 1.3 hot flashes per day or 3.3 points in hot flash score. Results: 223 patients were randomized between 12/21/2001 and 11/10/2006. The study arms were well balanced. The following table illustrates the percentage of baseline hot flash scores and frequencies during the fourth treatment week, compared to the baseline week for 179 eligible patients, utilizing the data available at time of this abstract preparation. Patients receiving 900 mg/d dose of gabapentin also reported significantly less hot flash distress and more hot flash control satisfaction than did the placebo group. The gabapentin was remarkably well tolerated, without any statistically significantly worse patient-reported side effects on the gabapentin arms. Conclusion: Gabapentin at the 900 mg/d dose can reduce hot flashes, in men receiving androgen deprivation therapy for prostate cancer. No significant financial relationships to disclose. [Table: see text]
How durable are behavioral changes? Results from FRESH START: A randomized controlled trial to improve diet and exercise behaviors in breast and prostate cancer survivors
Authors: Demark-Wahnefried W. , Clipp E. C. , Lipkus I. M. , Lobach D. , Peterson B. , Snyder D. C. , Sloane R. , Kraus W. E. 
Published: March 2020

9019 Background: A healthy diet and regular exercise may improve the health, well-being and ultimate survival of cancer survivors. Last year, results of the FRESH START trial (n=543) were presented at ASCO; significant improvements in diet and exercise behaviors of breast and prostate cancer survivors were observed with two 10-month mailed print interventions - one that was sequentially- tailored and another using non-tailored print materials in the public domain (attention control). While both arms achieved significant improvements, those receiving the tailored intervention reported significantly greater changes (all p-values <.05). The durability of these changes, however, is not known. Methods: At 2-year follow-up, and after a 12-month wash-out, telephone surveys that were conducted at baseline and post-intervention (Diet History Questionnaire and 7-Day Physical Activity Recall) were repeated. Results: Ordinary Least Square analysis suggest that changes from baseline largely remain significant at 2-year follow-up for both interventions (see table ). Moreover, significant differences between arms are observed for dietary fat restriction and the practice of more lifestyle behaviors at goal level [i.e., consumption of ≥ 5 servings/day of fruits & vegetables (F&V), < 30% kcal from fat, and >150 min/week of exercise], with the tailored intervention arm achieving levels superior to those achieved in the attention control arm. Conclusions: Tailored and untailored interventions delivered over a 10-month period to cancer survivors exert durable effects on several lifestyle behaviors. However, the effects of the tailored intervention were initially more powerful and largely sustained over time (especially, with regard dietary fat restriction). No significant financial relationships to disclose. [Table: see text]
Does NSCLC patient-rated performance status predict survival more accurately than physician ratings?
Authors: Dajczman E. , Kasymjanova G. , Swinton N. , St-Pierre D. , Swanson T. , Kreisman H. , Agulnik J. S. , Cohen V. , MacDonald N. , Small D. 
Published: March 2020

9022 Background: The Eastern Cooperative Oncology Group (ECOG) score is a well known predictor of survival, which impacts on treatment decisions. Patient (pt) rated activity level, using the Patient Generated Subjective Global Assessment (PG-SGA) scale, is identical in criteria to the ECOG scale used by physicians. We compared the patient rated activity level (Pt-PS) to physician rated PS (MD-PS), at baseline, and evaluated survival with respect to the 2 PS ratings. Methods: Pts with newly diagnosed advanced NSCLC (stages 3–4) completed a PG-SGA self rated questionnaire, which was then compared to the physician-generated ECOG score recorded prior to any treatment using a Wilcoxon signed rank test. Pts were treated with standard chemotherapy. Survival analysis was performed using a Kaplan Meier analysis and Cox regression. Results: 92 pts (M: F-48:44) with a mean age of 65 years (39–83) were included. 67 (73%) presented with stage 4 disease. 62 (67%) had an MD-PS of 0–1, whereas only 51 (55%) had a Pt-PS of 0 -1. MD-PS 3–4 was seen in 9 (10%), compared to 28 (30%) by Pt-PS. Pt-PS was significantly different from MD-PS in 48% of scores (p=0.003). When scores were not congruent, 29/44 (66%) pts evaluated themselves as having a worse PS than the physician. Survival analysis demonstrated that stage and functional status irrespective of method of reporting was predictive of survival (p=0.01 for MD-PS and p=0.001 for Pt-PS). However, when comparing median survival by method of performance status evaluation, Pt-PS was associated with superior stratification of survival than MD-PS ( table 1 ). Conclusions: Pt-PS and MD-PS are not congruent almost 50% of the time. Pt-PS allows for better stratification of survival and should be further evaluated in prospective trials. No significant financial relationships to disclose. [Table: see text]
Open-label safety and efficacy pilot trial of intraperitoneal bevacizumab as palliative treatment in refractory malignant ascites
Authors: El-Shami K. , Elsaid A. , El-Kerm Y. 
Published: March 2020

9043 Background: One of the most burdensome complications of advanced cancer is the development of malignant ascites, impacting quality of life (QoL), gastrointestinal function, survival, and overall management costs. Recent studies have shown that malignant effusions arise in part from increased production and activity of vascular endothelial growth factors (VEGFs). VEGFs increase vascular permeability and establish an ideal environment for accumulation of malignant effusions. Methods: A pilot trial evaluating safety and efficacy of intraperitoneal administration of bevacizumab at 5 mg/kg monthly for as long as no disease progression or unacceptable toxicities are encountered. Patients with cytologically documented malignant ascites from any primary tumor refractory to standard therapy of diuretics, repeated paracentesis, and/or intraperitoneal chemotherapy were eligible. Patients were either off systemic therapy or had not had any changes in their systemic therapy for at least 4 weeks at the time of enrollment. Results: Between July 2006 and November 2006, 9 patients with refractory malignant ascites from colon cancer (3 pts), breast cancer (3 pts), uterine cancer (2 pts) and ovarian cancer (1 pt). Prior therapy included systemic chemotherapy and large volume paracentesis. Patients with ovarian and uterine cancer also received intraperitoneal cisplatin. All patients had rapid re-accumulation within 2 weeks of paracentesis before treatment. Patients were given intraperitoneal bevacizumab at 5 mg/kg monthly. Complications included grade I nausea in one patient, grade I abdominal pain in one patient, and partial small bowel obstruction in one patient that was managed conservatively. Malignant ascites resolved without reaccumulation or repeat paracentresis in 9/9 after a single intraperitoneal dose of bevacizumab over a median observation period of over two months. No objective tumor responses were observed. QoL assessment, pharmacokinetic studies of intraperitoneal Bevacizumab and pharmacodynamic studies on serum and ascites fluid VEGF are ongoing and will be reported. Conclusions: Intraperitoneal bevacizumab is a relatively safe and highly efficacious way to palliate the symptoms of refractory malignant ascites. No significant financial relationships to disclose.