bluuebunny/crossref_metadata_2025 huggingface dataset:
Prevalence and correlates of fatigue among patients at a comprehensive cancer center
Authors: Bharne A. A. , Shimabukuro K. A. , Vu P. H. , White M. M. , Mills P. J. , Bardwell W. A. , Messer K. , Bazhenova L.
Published: August 2020

9608

Background: Cancer-related fatigue is a widely reported distressing symptom. We examined patterns and clinical correlates of fatigue among a series of patients with and without cancer at Moores UCSD Comprehensive Cancer Center (MCCC). Methods: All patients who come for initial consultation to MCCC complete a 39-question screen assessing problems including fatigue, sleep, and mood disturbance on a 5-point scale (0 = not a problem, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe). We report prevalence of fatigue from 1,880 consecutive patients; the charts of 515 of these were reviewed for further data. Results: Overall 1,137 of 1,880 (61%) patients reported problems with fatigue. Of the 515, there were 321 cancer and 194 non-cancer patients. 40 patients not responding to the fatigue question were excluded. There was no significant difference in the proportion of cancer (189 of 296; 64%) and non-cancer patients (104 of 179; 58%) reporting fatigue. Prevalence was similar between genders. 126 of 208 (61%) chemotherapy-naïve cancer patients reported fatigue compared to 63 of 88 (72%) patients who received any chemotherapy (p=0.07). In comparison to the chemotherapy-naïve, 37 of 48 (77%) with ongoing or recent (< 6 mo) chemotherapy reported fatigue as a problem (p=0.03); but among patients who underwent chemotherapy > 6 mo prior to the questionnaire, fatigue was not significantly different (26 of 40; 65%). 51 of 189 (27%) cancer patients married or living with a partner reported moderate to severe fatigue compared to 39 of 104 (38%) with no partner (p=0.06). Among cancer patients without sleep or mood problems, 19 of 71 (27%) reported fatigue as a problem compared to 166 of 221 (75%) with sleep and/or mood problems (p < 0.001). Conclusions: Fatigue is prevalent among cancer and non-cancer patients. Although more cancer patients with ongoing/recent chemotherapy reported fatigue compared to the chemotherapy-naïve, after 6 mo there was no significant difference, suggesting that fatigue may only be partly explained by chemotherapy. Social support from a spouse/partner may also help reduce problems with fatigue. Sleep and mood disturbance are associated with fatigue, but many cancer patients reported fatigue in its absence, consistent with previous data and suggestive of other etiologies.

No significant financial relationships to disclose.
Longitudinal assessment of cognitive impairment among lung cancer survivors
Authors: Kohli S. , Szydlo D. W. , Novotny P. J. , Yang P. , Brown P. D. , Buckner J. C. , Sloan J. A.
Published: August 2020

9609

Background: Patients undergoing treatment for cancer often report problems with their cognitive function (CF), which is an essential component in maintaining Quality of Life (QoL). We conducted a longitudinal study of lung cancer (LC) patients to systematically evaluate changes in QOL including changes in CF, over time. Methods: Between 2005–2008, we followed 1757 primary LC patients who responded to CF questions at least once within 8 years of diagnosis. Overall QoL measured by LCSS and LASA (scores 0–100 from worst to best) were assessed among 1,604 of 1,757 (91%) who completed the questionnaire at one or both of two time periods: short-term (T1-within 3 years of diagnosis) and long-term follow-up (T2-beyond 5 years of diagnosis). Questions rated overall CF and problems in thinking clearly. Results: The median age at the time of LC diagnosis was 68 years in men (n=834) and 65 years in women (n=770), p<0.0001. At T1, the mean score of patients reporting problems with CF was 63.2 (±22.45) vs 74.4 (±20.38) who reported no problems (p<0.0001). At T2, the mean score was 62.2 (±24.18) for patients who reported CF problems and 78.1 (±18.28) who reported no changes with their CF (p<0.0001). At T1, the mean score of patients reporting problems thinking clearly was 66.1 (±21.65) vs 75.6 (±20.21) reporting no problems with their thinking (p<0.0001). At T2, the mean score was 70.4 (±20.95) for patients reporting problems thinking clearly vs 82.6 (±17.76) who reported no problems (p<0.0001). Conclusions: Self-reported QoL of lung cancer survivors showed substantial deficits with their cognitive function. Prospective and objective assessments are needed to determine if cancer treatments are positively associated with cognitive decline, to identify the patients at risk, and to test appropriate interventions. Funding Source: NIH grants: CA 115857, CA 84354, CA 80127 and CA 77118.

No significant financial relationships to disclose.
Relationships among health-related quality of life indicators in cancer patients: A pooled study of baseline EORTC QLQ-C30 data from 6,739 patients
Authors: Martinelli F. , Quinten C. , Coens C. , Flechtner H. , Gotay C. , Mendoza T. , Osoba D. , Reeve B. , Wang X. , Bottomley A.
Published: August 2020

9612

Background: Cancer patients frequently experience multiple and co-occuring problems due to their illness and therapies. Clusters are defined as groups of two or more Health-Related Quality of Life (HRQoL) indicators that occur concurrently and may or may not have a common related cause. The objective of this meta-analysis was to identify how HRQoL indicators cluster among cancer patients. Methods: Retrospective pooling of 29 European Organisation for Research and Treatment of Cancer (EORTC) randomized clinical trials, among 10 cancer sites, yielded baseline EORTC QLQ-C30 HRQoL data for a total of 6739 patients. A cluster analysis was performed to identify clusters among the 15 HRQoL scales, via Ward's method. Cronbach's alpha coefficient (α) was used to measure internal consistency. Dendrograms of the HRQoL indicators were plotted for the overall data and for each cancer site. Results: Three main clusters emerged from the pooled dataset: a physical function-related cluster, consisting of physical and role functioning, fatigue and pain (α = 0.83); a psychological function-related cluster, consisting of emotional and cognitive functioning and insomnia (α = 0.64); and a gastrointestinal cluster, consisting of nausea and vomiting and appetite loss (α = 0.68). The same clusters were found in patients with metastatic and non-metastatic disease. The gastrointestinal cluster was reproduced in all 10 cancer sites. We found that pain was not correlated with the other variables of the physical function cluster for patients with brain, colorectal or pancreatic cancer. For the psychological component cluster, cognitive functioning was not correlated with the other variables of the cluster for breast or pancreatic cancer patients, while insomnia was found not to be correlated with the other variables of the cluster for prostate cancer patients. Conclusions: This study shows that relationships among HRQoL indicators exist and that three major constructs can be found: a physical, a psychological and a gastrointestinal component. Understanding these relationships may aid diagnostic criteria, and assessment, management, and prioritization of symptom care.

No significant financial relationships to disclose.
The management of dysphagia in esophageal cancer patients undergoing neoadjuvant chemotherapy: Is invasive tube feeding required?
Authors: Rousseau M. , Guevremont P. , Chasen M. , Spicer J. , Eckert E. , Alcindor T. , Ades S. , Ferri L. E.
Published: August 2020

9613

Background: The dysphagia commonly associated with esophageal cancer often interferes with patient tolerance of neo-adjuvant chemotherapy. Surgical or endoscopic invasive tube feeding (ITF - gastroscopy/jejunostomy/stent) is a commonly employed strategy to maintain nutritional support however it can cause significant morbidity in its own right. We sought to determine if a strategy of careful dietary counseling and appropriately-timed neoadjuvant chemotherapy can obviate the need for ITF. Methods: Pts undergoing neoadjuvant chemotherapy (TAX/CDDP/5FU Q3 weeks x3) for esophageal or GEJ adenocarcinoma at a single institution from 3/07–7/08 were identified from a prospective database. All received dietary counseling and were closely monitored for signs/ symptoms of malnutrition with serial (baseline, after 1st cycle, pre-surgery) Body Mass Index (BMI), albumin, dysphagia scores (0 best - 4 worse), and quality of life (FACT-E). We assessed the response of dysphagia and nutritional status to neoadjuvant treatment and the need for ITF. Data presented as median (range) or mean (±SD), paired t-test or Wilcoxon signed ranks test determined significance. Results: 25 pts received neoadjuvant chemotherapy and significant dysphagia (score 2–4) was found in 14. Dysphagia scores improved in all 14 (all results in Table 1 ), and 10/13 improved after the first cycle. No patient required ITF. QoL as assessed by the FACT-E improved in 13/14 patients. A small decrease in BMI was noted, however serum albumin did not significantly decrease. Conclusions: Appropriately timed neoadjuvant chemotherapy with a highly effective regimen rapidly restores normal swallowing, maintains nutritional status, and obviates the need for ITF in patients with significant dysphagia from esophageal adenocarcinoma. [Table: see text]

No significant financial relationships to disclose.
Vistonuridine: An orally administered, life-saving antidote for 5-fluorouracil (5FU) overdose
Authors: von Borstel R. , O'Neil J. , Bamat M.
Published: August 2020

9616

Background: 5FU is widely used to treat solid tumors and is often administered via infusion pump at or near its maximum tolerated dose (MTD). Toxicities and even death can occur in patients over-exposed to 5FU. Uridine is a direct biochemical antagonist of 5FU toxicity; uridine nucleotides dilute intracellular fluorouridine nucleotides derived from 5FU, reducing their lethal incorporation into RNA. However, uridine is poorly bioavailable (7%) and is therefore not a clinically viable antidote. Vistonuridine is an orally administered prodrug of uridine that delivers approximately 8-fold more uridine than administration of uridine itself. Methods: 17 patients overdosed with 5FU have been treated with vistonuridine as an antidote. Patients received vistonuridine (10g q6h for 20 doses) beginning 8 to 96 hours after overdose. Data from 13 patients with similar 5FU overdoses provide the time course and outcomes for patients receiving available supportive care without vistonuridine. A severity score, integrating dose and infusion rate, was calculated for all the patients, and this tool could be used by healthcare workers to determine the expected severity and outcome of a 5FU overdose. Results: All 17 overdose patients treated with vistonuridine recovered fully. Most, especially those for whom vistonuridine treatment was initiated sooner, had relatively modest toxicity. In marked contrast, all 11 of the literature-reported cases of 5FU overdose for which an outcome of death would have been predicted died from the overdose despite receiving available supportive care. Conclusions: These clinical data illustrate the serious, debilitating and life threatening nature of 5FU overdose and the current lack of effective treatments. Vistonuridine appears to be a safe and effective, life-saving antidote to 5FU overdose.

[Table: see text]
Early hemoglobin decline and survival prognosis in epoetin alfa studies
Authors: Berlin J. A. , Bowers P. J. , Rao S. , Sun S. , Liu K. , Henry D. H.
Published: August 2020

9625

Background: When cancer patients (pts) with chemotherapy-induced anemia (CIA) respond to erythropoietic-stimulating agents (ESA), hemoglobin (Hb) typically increases within 4–8 weeks. This exploratory analysis examined whether mortality differs depending on Hb response after 4 or 8 weeks of epoetin alfa (EPO) treatment or depending on transfusion. Methods: Pt-level data were analyzed from 31 randomized studies (7,215 pts) of epoetin alfa vs non-EPO (15 studies) or placebo (16 studies) in pts with CIA. A landmark analysis was used; Hb change was set at a specific time (4 and 8 weeks) and subsequent survival was examined separately for EPO and placebo. Pts were categorized as “Hb increased” (>0.5 g/dL), “Hb decreased” (>0.5 g/dL), or “Hb stable” (within ±0.5 g/dL) compared to baseline. Hb stable was compared to other Hb change categories with Cox proportional hazards models, stratified by study and adjusted for potential confounders. Results: The hazard ratio (HR) for Hb decreased versus Hb stable at 4 weeks was 1.44 for EPO (95% CI: 1.04, 1.99), indicating worse survival for pts with a decline in Hb. This association was weaker for placebo (HR: 1.12; 95% CI: 0.74, 1.67). Increased risk with declining Hb in EPO-treated pts was most pronounced in studies that maintained Hb ≥12 g/dL or treated pts for >12–16 weeks (1,876 pts). Patterns were similar using the 8-week landmark. In both EPO-treated and placebo pts, transfusion increased the rate of on-study death ∼3.5 fold (treating transfusion as a time-dependent variable). Conclusions: These exploratory findings suggest that both decreased Hb after 4 or 8 weeks of EPO treatment and transfusion are associated with increased risk of death. In spite of adjustment for other prognostic factors, it is likely that this association reflects poorer underlying prognosis of pts whose Hb fails to respond. ESAs should be discontinued in the absence of a Hb response.

[Table: see text]
Phase III study of sustained release granisetron (APF530) compared to palonosetron for the prevention of chemotherapy-induced nausea and vomiting (CINV)
Authors: Grous J. J. , Riegel E. , Gabrail N. , Charu V. , Arevalo-Araujo R. , Yanagihara R. , Nguyen A. , Robertson P. , Cooper B. , O'Boyle E. , Barr J.
Published: August 2020

9627

Background: APF530 is a polymeric formulation of granisetron providing sustained drug release over 5 days. Two doses (5 and 10 mg) of subcutaneous APF530 were evaluated in comparison to 0.25 mg intravenous palonosetron. Efficacy was evaluated in acute (0–24 hrs) and delayed (24–120 hrs) CINV among patients receiving moderate (MEC) or highly (HEC) emetogenic chemotherapy. Methods: Randomized, blinded patients (n=1,395) were stratified into MEC or HEC according to Hesketh et al 1999, and assigned to receive either dose of APF530 or palonosetron. Dexamethasone use was standardized based on the emetogenic strata. Patient diaries recorded emetic episodes, nausea and rescue medications over a 5-day period. Primary endpoint was Complete Response (CR), defined as no emetic episodes and no rescue medication. Non-inferiority to palonosetron was declared if the lower bound of the CI for the difference was above -15%. Results: APF530 was well tolerated. Adverse events were consistent with those previously reported for granisetron. For APF530 Tmax was observed about 24 hrs with sustained levels over 120 hrs. For MEC acute phase CR rates of 74.8% (n=214), 76.9% (n=212) and 75.0% (n=208) were observed for 5 mg, 10 mg APF530 and palonosetron, respectively. Delayed phase CR rates of 51.4%, 59.0% and 57.7% were observed for 5 mg, 10 mg APF530 and palonosetron, respectively. For HEC acute phase CR rates of 77.7% (n=229), 81.3% (n=240) and 80.7% (n=238) were observed for 5 mg, 10 mg APF530 and palonosetron, respectively. Delayed phase CR rates of 64.6%, 68.3% and 66.4% were observed for 5 mg, 10 mg APF530 and palonosetron, respectively. Efficacy was maintained with APF530 over multiple cycles (up to 4). Conclusions: Both doses of APF530 were non-inferior to palonosetron with respect to CR during the acute phase following MEC and HEC. Only the higher dose of APF530 (10 mg granisetron) was non-inferior to palonosetron during the delayed phase of MEC. Both doses of APF530 were comparable to the CR rates of palonosetron during the delayed phase of HEC.

[Table: see text]
A phase III randomized prospective trial of the effect of psychotherapy on distress in 287 prostate cancer patients: A URCC CCOP Study
Authors: Palesh O. , Mustian K. , Heckler C. , Purnell J. , Peppone L. , Weiss M. , Atkins J. N. , Dakhil S. R. , Spiegel D. , Morrow G.
Published: August 2020

9637

Background: Cancer patients suffer from significant psychological distress, including mood and anxiety disorders. Psychiatric disorders are common in cancer and affect 22 to 43% of cancer patients. We previously showed that Supportive Expressive Group Therapy (SET) was effective in reducing distress in women with metastatic breast cancer. The current study expands our earlier research and examines the effect of SET on mood disturbance in prostate cancer patients. Methods: A sample of 318 cancer patients diagnosed with prostate cancer was assessed for mood disturbances by 9 geographically distinct URCC CCOP affiliates. The patients were randomly assigned to receive either 12 weeks of SET or education materials as a control. Patient-reported mood disturbance was assessed using the Profile of Mood States (POMS), a psychometrically valid and reliable measure of mood states, at baseline, 3, 6, 12, 18 and 24 months. Differences between treatment and control groups at follow-up were tested using a mixed-ANOVA model. The dependent variable was individual slopes on the POMS. Results: 287 patients (142 SET and 145 controls) provided complete data. No significant overall effect of intervention on mood was found (p=0.49) and the interaction between baseline mood scores and treatment arm was non-significant (p=0.075). There was a significant main effect for baseline mood (p<0.0001) suggesting that those who have the greatest mood disruption at baseline improve with time independently of treatment arm. Conclusions: This is the first large randomized clinical trial using group psychotherapy among men with prostate cancer. Results suggest that a brief SET intervention does not improve distress among men with prostate cancer. Future studies might consider recruiting patients with particular psychosymptomatology and tailoring interventions. Supported by U10 CA37420 and NCI 1R25CA102618.

No significant financial relationships to disclose.
Cumulative risk for a false-positive test using low-dose computed tomography in lung cancer screening
Authors: Croswell J. M. , Baker S. G. , Marcus P. M. , Clapp J. D. , Kramer B. S.
Published: August 2020

CRA1502

The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology.

No significant financial relationships to disclose.
Impact of sentinel lymph node biopsy on staging of early cervical cancer: Results of a prospective, multicenter study
Authors: Lecuru F. , Bats A. , Mathevet P. , Querleu D. , Leblanc E. , Morice P. , Darai E. , Marret H. , Collin C. , Chatellier G. , Gilaizeau F.
Published: August 2020

CRA5506

The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology.

No significant financial relationships to disclose.
A phase III study comparing concurrent gemcitabine (Gem) plus cisplatin (Cis) and radiation followed by adjuvant Gem plus Cis versus concurrent Cis and radiation in patients with stage IIB to IVA carcinoma of the cervix
Authors: Dueñas-González A. , Zarba J. J. , Alcedo J. C. , Pattarunataporn P. , Beslija S. , Patel F. , Casanova L. , Barraclough H. , Orlando M.
Published: August 2020

CRA5507

The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology.

[Table: see text]
Cancer screening in adult survivors of childhood cancer: A report from the Childhood Cancer Survivor Study (CCSS)
Authors: Nathan P. C. , Ness K. K. , Hudson M. M. , Mahoney M. , Ford J. S. , Landier W. , Armstrong G. , Henderson T. , Robison L. L. , Oeffinger K. C.
Published: August 2020

CRA6501

The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology.

No significant financial relationships to disclose.
Incidence of arthralgia syndrome (AS) related to aromatase inhibitors (AIs) in postmenopausal women with early breast cancer (EBC)
Authors: Maisano R. , Maisano R. , Azzarello D. , Del Medico P. , Giannicola R. , Giuffrè C. , Panuccio V. , Raffaele M. , Zavettieri M. , Falzea A. , Nardi M.
Published: August 2020

e11603

Background: Anastozole (A) and letrozole (L) are standard drugs in up-front adjuvant endocrine therapy in postmenopausal hormone positive EBC. AIs have a higher incidence of osteoporosis, bone fractures and musculoskeletal symptoms, particularly joint pain and stiffness (AS) respect to tamoxifen. The real incidence of AS can be underestimated respect to data derived from clinical trials. Methods: From 1/07 to 12/07 we registered all patients (pts) taking A or L as adjuvant therapy for at least 3 months. We screened 47 pts, 3 pts refused to participate at the study and 2 resulted metastatic. A total of 42 pts were enrolled. The median age was 67 yrs (range 51–89), the median time since menopause was 11 yrs (range 1–48). 30 pts had natural menopause, 7 surgical menopause and 5 reported chemo-induced menopause. 25 pts took A and 17 pts took L. The median duration on therapy was 19 months (range 3–68) and 31 pts had received chemotherapy (9 CMF, 17 anthra-based, 5 anthra-taxane based). Results: 11 pts (26%) did not report AS, 19 pts (45%) had new-onset AS and 12 (29%) had worsening of prior joint pain after starting adjuvant AIs therapy. Most pts reported moderate to severe AS requiring occasional use of nonsteroidal anti-inflammatory drugs (75%), 15% used oral supplements and 10% used opiates, only 4 women used exercise to relieve joint stiffness. 17 pts interrupted the therapy from 7 to 20 days in order to reduce the symptoms and 7 obtained a partial improvement. 11 pts (35%) suffered from AS declared the worsening of quality of life. In univariate analysis presence of AS was not associated with age, entry into menopause, years since menopause, duration of AI therapy or previous chemotherapy. Conclusions: Our data show a higher incidence of AS in clinical practice respect to literature data, which caused worsening of quality of life and could be reason of discontinuation of effective therapy. The exact mechanism of AIs-related arthralgia is unclear, but is believed to be related to estrogen deprivation, however further studies are needed to define the pathogenesis in order to find an effective therapy.

No significant financial relationships to disclose.
The patterns of care studies for operable breast cancer in China
Authors: Tian Y. , Hua D. , Ji Y. , Li X. , Liu J. , Wang B. , Yu D.
Published: August 2020

e11607

Background: To present the results of clinical practices for operable breast cancer (BC) in the developed areas of China during the past decade. Methods: Four academic levels of radiotherapy (RT) departments, located in the Southeast coast of China, were selected. A pattern of care study, about women with operated BC and post-operative RT during 1999 and 2006, was conducted. The recruited samples were evaluated for their medical files completeness at first. For qualified documentations, data collected included patient characteristics, clinical and pathologic features, and treatment course received. Frequencies and corresponding percentages were calculated and analyzed for comparisons between 1999 and 2006. Results: 97 in 1999 and 271 in 2006 were identified as qualified files. Patient's diagnosis median age were 48 (1996) and 46 (2006) years. The clinical staging with I, II, and III (UICC 1997) were in 11%, 69%, 13% of 1999 patients and 15%, 74%, 7% of the 2006. The pathological characteristics were clearly defined in 78% (1999) and 84% (2006), but hormonal receptors and Her2neu were performed in 59% and 0% in the 1999 vs. 73% (p < 0.05) and 1% in 2006 survey. As type and extent of surgery and RT, the percentage of conservative treatment was increased from 4% in 1999 to 12% in 2006 (p< 0.05), postmastectomy RT was done for all the others. The time interval from operation to initiation of RT were longer in 2006, the mean was delayed from 23.8 to 43.4 days. The axillary operation pattern including lymph node dissection, level I/II dissection, and sentinel lymph node biopsy (SLNB), were documented in 61%, 24%, and 8% of patients in 2006. For patients of 1999, no SLNB was performed and 16% with level I/II operation (p< 0.05). Systemic chemotherapy (CT) and/or hormonal therapy were used in 74% (1999) and 98% (2006) of patients respectively (p< 0.05). Anthracyclines and paclitaxel-based CT regimens use significantly increased between 1999 and 2006 (31% vs. 52% and 12% vs. 36%). Conclusions: The practice patterns established in this study provide a baseline data. The present results demonstrate a low level of compliance with Western guidelines of clinical practices with current BC standards and continued improvement in many categories. Establishment and widespread use of international guidelines in China are desirable.

No significant financial relationships to disclose.
Toxicities and adherence rates of hormone treatment in male breast cancer patients treated at a tertiary care center
Authors: Visram H. , Dent S. F.
Published: August 2020

e11613

Background: Male breast cancer (BC) comprises approximately 1% of all breast cancer cases, and over 80% of male BC tumours express the estrogen receptor (ER). Male BC patients (pts) are often offered hormonal treatment (HT) with tamoxifen (T), or more recently aromatase inhibitors (AI's). There is a paucity of information in the literature on the toxicities (Tx) and adherence rates of HT in this population. Methods: We conducted a retrospective chart review of 24 pts diagnosed with male BC at the Ottawa Regional Cancer Centre from 1986–2003. Data collected included pt age, ER status, progesterone receptor (PR) status, systemic chemotherapy, HT, and Tx of treatment. Results: Median age of 24 male BC pts was 70.0 years (r: 46–83 years). The majority (16/24) of pts had ER/PR testing: 12 (75.0%) ER/PR +, 1 (6.3%) ER +/PR-, 2 (12.5%) ER +/PR unknown, and 1 (6.3%) ER/PR-. Of the 15 pts who were ER +, 13 received T and 5 received anastrozole (A) monotherapy during their treatment. One ER - pt received adjuvant T. Three pts with ER status unknown received T. Median duration of treatment with T (17 pts) was 38.0 months (r: 2–79 months). Hot flashes (23.5 %) was the most common reported Tx. Decreased libido, weight gain, rash, and malaise were reported in 2 pts (11.8%) each. Increased liver enzymes, pulmonary embolism, and erectile dysfunction were reported in 1 pt (5.9%) each. Five pts (29.4%) terminated treatment early due to T toxicity (median treatment 15 months; r: 2–54 months). Five pts were treated with A (median 10 months; r: 3–60 months), 4 of whom received prior T treatment. One pt reported loss of libido, and 1 significant depression /suicidal ideation requiring psychiatric treatment. Conclusions: This study provides contemporary data on toxicities and adherence rates of HT in male BC pts in a non-clinical trial setting. Approximately 30 % of male BC pts discontinued T therapy due to Tx, potentially having a negative impact on clinical outcome. Future studies will examine differences in adherence rates and outcomes between T and A in male BC pts.

No significant financial relationships to disclose.
Prognostic factors for patients with invasive ductal carcinoma of the breast who received neoadjuvant chemotherapy
Authors: Tamura N. , Tamura N.
Published: August 2020

e11617

Background: Neoadjuvant chemotherapy (NAC) for patients with invasive ductal carcinoma (IDC) of the breast is performed as a standard therapy in many hospitals for improving outcomes of IDC patients. The purpose of this study is to identify important prognostic clinicopathological factors for 115 IDC patients who operated in our hospital (1997 to 2002) followed by NAC. Methods: The multivariate analyses with an assessment of pathological effect of NAC, grading system for lymph vessel tumor emboli (LVTE), and histological factors of tumors in lymph nodes in addition to well-known prognostic clinicopathological factors were performed in IDC patients with nodal metastasis and in those of pTNM stage III as well as IDC patients as a whole. Results: Multivariate analyses demonstrated that grading system for LVTE was a significant prognostic factor for IDC patients in the both group. Severe tumor stroma in nodal metastatic tumors significantly increased the HRs of tumor recurrence of IDC patients in the both group. Number of mitotic figures in nodal metastatic tumors significantly increased the HRs of tumor death in IDC patients with nodal metastasis. Tumor necrosis in primary-invasive-tumors was a significant factor for tumor recurrence of patients in the both. Conclusions: The study clearly demonstrated that grading system for LVTE, and characteristics of nodal metastatic tumors as well as the presence of tumor necrosis in primary-invasive tumors are very important prognostic factors for IDC patients who received NAC. Since we already reported a prognostic significance of the factors in IDC patients who did not receive NAC in previous studies, we concluded that the factors are also very important for IDC patients who received NAC to accurately assess their outcome.

No significant financial relationships to disclose.
Male breast cancer: Prognostic factors evaluation in a 35-year service
Authors: Botan R. D. , Alvares M. N. , Hassan A.
Published: August 2020

e11618

Background: Treatment for male breast cancer is based on the results of large clinical trials for female breast cancer. Although peculiar differences do exist between men and women, very little is known about the prognostic factors in male breast cancer, even though female breast cancer practical conducts are widely used in male breast cancer. The rarity of this condition makes very difficult to produce randomized trials. Methods: This study is populational and epidemiological and evaluated male breast cancer patients from January 1974 to December 2001 about its prognostic characteristics. Data were collected retrospectively and the sample has been described using descriptive statistics methods. Survival curve was built using Kaplan-Meier method. Staging system was standardized as in the sixth edition of American Joint Committee on Cancer, independently on when the diagnose was made. Due to differences throughtout 35 years on therapeutic on breast cancer, treatment options were categorized in groups to make the survival evaluation possible. Results: From 45 patients with male breast cancer, 91% presented ductal histology, 26% were negative axillary, 9.1% were T1, 25% were T2, 4.5% were T3, 50% were T4 and 12.12% presented with distant metastasis at diagnose. Seventy nine percent were submitted to radical local treatment, while 34% had not been submitted to any kind of systemic treatment (neoadjuvant, adjuvant e hormone therapy). Forty percent of patients have not presented distant recurrence, while 58.3% have not presented local recurrence. A median survival of 126 months has been observed to the analyzed population, ranging from 69–182 months. Five-year survival was 72% and 10-year survival was 54%. These data agreed with the available data in the published literature. Conclusions: Male breast cancer appears to behave biologically and clinically very similar to female breast cancer, but differences do exist and need to be elucidated. Randomized multi-center clinical trials become necessary, as systematic reviews, to build higher statistic power studies.

No significant financial relationships to disclose.
Weight gain after adjuvant treatment in breast cancer patients in Istanbul, Turkey
Authors: Turhal N. S. , Yurt N. , Yurtseven G. , Cabuk D. , Teomete M. , Gumus M.
Published: August 2020

e11620

Background: Weight gain is a common and unwanted result of chemotherapy. We wanted to find out how much weight Turkish beast cancer patients gains after chemotherapy and whether it lasts afterwards. Methods: 183 breast cancer patients who underwent a curative resection and received adjuvant chemotherapy afterwards in a private clinic between 1998 and 2007 are studied. Their weight before and after chemotherapy as well as their weight more than a year after chemotherapy is recorded together with their educational level, menopausal status, the type of chemotherapy or hormonal treatment, stage of disease, marital status, occupation and the underlying diseases. Results: Median age of patients is 53 and 72% is in menopause. Educational level is equally distributed for primary education (26%), High school (30%) and University and above (32%). Majority is (76%) married with two children (43%) and house wife (50%). Family history of any cancer is high (33%). Most of the patients had stage II cancer (57%), received anthracycline± taxane based chemotherapy (97%) and has no underlying disease (67%). The majority also does not smoke (72%) or drink alcohol (93%). Mean weight before the chemotherapy was 69.1 and increased to 70.8 upon completion of chemotherapy (p= 0.000) and 72 kg. more than a year after completion of chemotherapy (p=0.000). The other parameters including hormonal treatment, menopause, educational level and smoking do not have any effect on this weight increase. The all groups had similar weight gain with chemotherapy. Conclusions: Although upon starting the study we expected more, we confirmed some amount of weight gain with chemotherapy in Turkish patients and that gain is seen all across various social groups. The doctors should inform their patients of this change and precaution them toward this unwanted consequence.

No significant financial relationships to disclose.
Family history of breast cancer (BC) and biological and clinicopathologic features in Uruguayan BC patients
Authors: Castillo C. , Artagaveytia N. , Mauriz S. , Meyer C. , Sena G. , Spera G. , Ubillos L. , Xavier F. , Aghazarian M. , Rodríguez R.
Published: August 2020

e11622

Background: Hereditary BC can have a distinct phenotype and behavior in comparison to sporadic BC. The aim of the present study was to investigate if there is any difference in the age at diagnosis, disease extension and biological profile in BC patients (pts) with or without a significant family history of BC. Methods: We retrospectively reviewed clinical charts of BC pts, stage 0- III who had surgery between March 2006 and March 2008. We included pts with known estrogen receptor (ER), progesterone receptor (PR) and HER2 status. The family history was obtained from the clinical charts and confirmed by a telephone interview with a standardized questionnaire. A significant family history of BC was defined by the presence of one of the following criteria: (1) 3 or more BC cases among close relatives, at least one diagnosed before 50 years (2) 2 BC cases among close relatives, at least one diagnosed before 50 years and one of the following: bilateral BC, ovarian cancer diagnosed in the family, male BC, father´s inheritance, Ashkenazi Jewish ancestry Results: 435 pts were identified, with available data on ER/PR and HER2 status in 197 pts. Family history was evaluated in 136 pts (69%) and was classified as significant in 18 (13.2%). Between pts with and without a significant family history of BC cancer there were no difference in the proportion of pts < 50 years old at diagnosis (0.36 vs. 0.39), T3/T4 tumours (0.08 vs. 0.11), axillary node positivity (0.55 vs 0.66), ER/PR+ (0.77 vs. 0.72), HER2 + (0.11 vs. 0.11) and triple negative tumors (0.19 vs 0.17). Conclusions: our data does not show any difference in the main prognostic and predictive factors between operable BC pts with and without a significant family history of BC. These findings are concordant with previous published data about a greater prevalence of BRCA2 mutations in Uruguayan families.

No significant financial relationships to disclose.
A retrospective analysis of treatment in triple-negative brest cancer (TNBC)
Authors: Popovich M. , Russu V. , Lex B. , Tulusan A. H.
Published: August 2020

e11623

Background: TNBC makes about 12.5% of all breast cancer. TNBC show have a poor prognosis due to the aggressive biology with relative resistance to systemic therapies. 85% of TNBC are basal-like subtype. Basal-like TNBC are diagnosed by a positive CK5/14 stainig in immunohistochemical staining. Methods: 200 pts with TNBC in Bayreuth hospital were analysed retrospectively between 1995 and 2006. 52/200 (26%) pts underwent primary systemic therapy (PST). 6/200 pts primary had stage IV disease. In 49 pts ck 5/14 staining was done. Results: The median follow up 56 mts, median age at diagnosis was 52 yrs. At the time of analysis 146/200 pts were alive. DFS was 25 mts, OS 44 mts. 7/42 (16. 6%) had a pathological complete response rate (pCR) after PST, in 5/7 pts PST was based on anthracyclines. The estimated residual tumor size in preoperative MR correlated strongly with the histopathological tumor size (Pearson Correlation r=0,81, p< 0.01). Stage IV patients with viszeral disease had a median age of 69 yrs and median OS 6,3 (2–12 mts). Overall recurrence rate was 24% (48/200 pts). Grading in all TNBC variated (G1: 7 pts (3,5%), G2: 52 pts (26%), G3: 132 pts (66%). Conclusions: The retrospective data demonstrate that basal-like TNBC is an important subgroup with a poor prognosis. In future it will be important to pick up these subgroup to bring them to different therapies. Preoperative MR is a good tool to predict the residual tumor size after PST in all TNBC pts. Anthracycline-based systemic therapy is still standard in adjuvant treatment.

No significant financial relationships to disclose.
Feasibility of breast conservation after neoadjuvant taxae-based chemotherapy in locally advanced breast cancer
Authors: Aboziada M. A. , El-Sayed M. I. , Maximous D. W. , Abdel-Wanis M. E. , Bakr M. M.
Published: August 2020

e11627

Background: Neoadjuvant chemotherapy is the standard of care of locally advanced cancer breast. Our study was aiming to evaluate the feasibility of breast conversation (BC) after neoadjuvant chemotherapy. Methods: Forty five patients had stage IIB and stage IIIA were selected to 3 cycles taxane-based neoadjuvant chemotherapy. Patient who had tumours ≤ 5cm underwent BC while patients who had tumour size >5cm underwent radical surgery. Negative margin is essential for BC. Adjuvant chemotherapy and 3-D radiotherapy ± hormonal treatment were given to all patients. Results: Thirty four patients had BC. Response to chemotherapy was the only statistically significant factor which influences the BC. Incidence of local recurrence was 5.9% for patients who had BC at a median follow up 24 months. Conclusions: Breast conservation is feasible in selected cases of locally advanced, non metastatic cancer breast. We recommend that patients who have tumour size ≤ 4cm after chemotherapy are the best candidates for BC.

No significant financial relationships to disclose.
Primary tumor and patient characteristics in breast cancer as predictors of adjuvant chemotherapy regimen: A regression model
Authors: Francescutti V. , Farrokhyar F. , Tozer R. , Heller B. , Lovrics P. , Jansz G. , Kahnamoui K.
Published: August 2020

e11632

Background: Adjuvant chemotherapy is used to reduce the risk of recurrence of breast cancer. This study was undertaken to determine which patient and tumor characteristics are important in guiding the choice of adjuvant chemotherapy. Methods: A retrospective review was undertaken of patients diagnosed with breast cancer (stages I-III) at a regional cancer center from 2004–7. Patient and tumor characteristics were identified and chemotherapy regimens compared. Binary logistic regression analysis was performed to the choice of FEC/D, CEF, AC/T, or ddAC/T against AC or CMF, or the choice of chemotherapy to hormonal therapy only. Univariate analysis was used to select factors (p<0.1) for entry into a multivariate stepwise logistic regression model using the forward method. Odds ratios with 95% CI were calculated. A p-value of < 0.05 was significant and comparisons were two tailed. Results: Model 1 (n=871) included regimen (AC or CMF vs. aggressive regimen) as the dependant variable. Indicators of choice of aggressive regimen were higher stage [OR 4.7 (CI 3.3, 6.8)], positive nodes [2.5 (1.6, 3.8)], negative PR [2.1 (1.4, 3.1)], higher grade [1.4 (1.0, 1.8)], and age [0.91 (0.88, 0.92)]. Model 2 (n=640) involved choice of any regimen (chemotherapy vs. hormonal therapy only) as the dependant variable. Indicators of choice of chemotherapy were higher stage [7.19 (2.8, 18.4)], higher grade [7.02 (3.3, 14.8)], positive nodes [3.25 (0.98, 10.77)], age [0.85 (0.81, 0.90)], and ER negativity [0.04 (0.004, 0.37)]. Factors not significant in both models were: family history, comorbidities (renal/hepatic dysfunction, diabetes, cardiac history, or neuropathy), treating medical oncologist, histology, Her2/neu, > 3 positive nodes, ratio of positive to total nodes, multicentricity, multifocality, and positive margin status. Conclusions: This study verifies known important factors for choice of chemotherapy regimen as found in current guidelines, quantifies their effects at our center, and excludes others thought to be important. Further studies are required to confirm these results both nationally and internationally, where risk stratification may be different, and if variables predicting adjuvant radiation therapy are similar.

No significant financial relationships to disclose.
Validity of the modified RECIST criteria and EORTC PET criteria evaluated based on the pathologic findings for patients with resectable malignant pleural mesothelioma
Authors: Mimura T. , Watanabe H. , Yamanaka T. , Satouchi M. , Okada M.
Published: August 2020

e11639

Background: The unique growth pattern of malignant pleural mesothelioma (MPM) presents challenges for clinical investigators evaluating the responses to chemotherapy, which is an important surrogate endpoint for patient benefit, particularly in clinical trials. In patients with resectable MPM, multicenter clinical trials of neoadjuvant chemotherapy followed by extrapleral pneumonectomy (EPP) and subsequent radiotherapy have been attempted around the world. The applicability of modified RECIST based on the findings on CT images and EORTC (European Organization for Research and Treatment of Cancer) criteria based on the findings on FDG-PET images to resectable MPM would be challenging and significant, but their validity has never been examined. Methods: Between May 2006 and November 2008, 13 consecutive patients with resectable pathologically proven MPM were included in this study. All were initially treated with combination chemotherapy including cisplatin. EPP was successfully performed in all the patients. In addition to modified RECIST (CR vs PR vs SD vs PD), FDG uptake by the tumor on PET was also evaluated according to the EORTC PET criteria (CMR vs PMR vs SMD vs PMD). Also, pathologic findings (NT; no viable tumor vs MR; minimal residual vs GR; gross residual) were reviewed. Results: According to modified RECIST, in which the definition of measurable lesions is ≥10mm in diameter, 7 of the 13 patients investigated had no measurable lesion. Even when the definition of measurable lesions was changed to ≥5mm, 2 patients had no measurable lesion and 4 had only one lesion. In regard to the response, 4 of 11 patients with any measurable lesions were classified as PR, and 7 were classified as SD, while 8 patients were classified as PMR and 3 were classified as SMD according to the PET findings. Eight patients were classified as GR and 5 as MR. Kappa statistics suggested potential variation between the CT response and the pathologic findings (κ=0.214, 95% CI=-0.377 ∼ 0.806) and between the PET response and the pathologic findings (κ=0.286, 95% CI=-0.049 ∼ 0.620). Conclusions: Our data raise doubts about the validity of applying the modified RECIST criteria as well as EORTC PET criteria to resectable MPM.

No significant financial relationships to disclose.
Combination chemotherapy of irinotecan with fluoropyrimidine in taxane, anthracycline, and fluoropyrimidine-pretreated metastatic breast cancer
Authors: Chang H. , Han S. , Oh D. , Im S. , Kim T. , Bang Y.
Published: August 2020

e12003

Background: Irinotecan (I) has some efficacy in taxane (T) and anthracycline (A)-refractory breast cancer, and combination of I and fluoropyrimidine (F) shows synergistic effects in preclinical model. We conducted this study to reveal the clinical outcomes of I and F combination therapy in T, A, and F-pretreated metastatic breast cancer. Methods: We consecutively enrolled metastatic breast cancer patients treated with I and F combination chemotherapy from 2000 to 2008 in Seoul National University Hospital. They all had been previously heavily treated with T, A, and F. We retrospectively analyzed the clinical outcomes. Results: Twenty-five patients were enrolled. The median age was 38 years (range: 30–56years). The performance status was: ECOG 1 (11 patients), 2 (13), and 3 (1). The most commonly involved site was bone (16 patients), liver (13), and lung (12). The biologic subtype was: hormone receptor (+) 17 patients, HER-2 (+) 2, triple-negative (TNBC) 6. The median time from diagnosis of metastatic breast cancer to the initiation of IF therapy was 34 months (range: 12–97 months). The used regimens were: FOLFIRI (18 patients), TS-1/ irinotecan (6), capecitabine/irinotecan (1). Response was evaluable in 24 patients. There was no CR/PR. Stable disease was shown in 29.2% and 70.8% was PD, that is disease control rate was 29.2% (95% CI:10–45%). The median duration of disease control was 3.9 months (95% CI 3.7–4.2, range 2.4–11). The progression-free survival was 1.4 months (95% CI:0.7–21, range: 0.5–11.4), and overall survival was 6 months (95% CI: 4.2–7.8, range: 1–23). According to the biologic subtypes, the median PFS was 2.0 vs. 1.3 months (p=0.895) and OS was 4 vs. 6 months (p=0.807) respectively in TNBC VS Non-TNBC. In multivariate analysis, patients with good PS showed longer OS (p = 0.035). The Gr 3/4 hematologic toxicity was: neutropenia 18.6%, anemia 1.3%, thrombocytopenia 1.3%. And the major Gr 3/4 non-hematologc toxicity was: diarrhea (4%), hand-foot syndrome (0%), fatigue (0%). No treatment-related death was occurred. Conclusions: Treatment of I combined with F might be an option in metastatic breast cancer patients heavily treated with T, A, and F, irrespective of TNBC. Further prospective studies are warranted.

No significant financial relationships to disclose.