bluuebunny/crossref_metadata_2025_split huggingface dataset:
Salvage surgery for local recurrence after breast conservation therapy—Is re-lumpectomy an appropriate treatment?
Authors: Ofuchi T. , Amemiya A. , Ono M. , Hatayama J. , Takeda A. 
Published: March 2020

608 Background: Since 1983 through 2005, 2439 clinical stage I or II patients (pts) were treated with lumpectomy and postoperative irradiation. During median follow-up of 75 months, 142 patients experienced local recurrence as first and sole event were judged as candidate for further local therapy. The purpose of this study is to evaluate the outcome of salvage treatment, with specific reference to feasibility of second breast conservation surgery. Methods: Among those with operable local recurrences, 73 pts who requested conservation of their breasts and whose recurrences were judged to be small enough to be locally re-excised with adequate margins underwent second lumpectomy (Re-LMP). 51 pts were treated by mastectomy with or without immediate reconstruction (MAS). Adjuvant systemic therapy of limited duration was given at the discretion of patients and therapists. Survival and local re-recurrence after salvage surgery were estimated by Kaplan-Meier method. Results: Age of patients ranged from 28–69 (mean: 41). Median follow-up length after salvage surgery was 53 months (6–194 months). Patient/Tumor characteristics were similar in Re-LMP and MAS groups. Local re-recurrence: Re-LMP: 31 pts developed in-breast re-recurrence (34% at 3yrs, 49% at 5yrs). MAS: 6 pts experienced chest wall recurrence (11% at 3yrs, 11% at 5yrs, p=0.0005). Independent risk factor for re-recurrence was not identified. Survival: In initial clinical stage I patients, 3 pts treated with Re-LMP died after salvage surgery and all treated with MAS survived (94% and 100% at 5yrs, p=0.2). In clinical stage II patients, 6 in Re-LMP and 8 patients in MAS died (89%, 57% at 5yrs after salvage surgery, p=0.02). Poor prognostic factors for both groups were initial stage and stage at the time of local failure. Conclusions: For an isolated in-breast recurrence, salvage mastectomy with or without immediate reconstruction provides excellent local control. At the present time, mastectomy should be offered as 1st treatment option. Although survival is not jeopardized, Re-LMP alone does not offer adequate local control. Additional local therapy i.e. re-radiotherapy or aggressive systemic therapy may improve this poor result. Prospective studies should be initiated. No significant financial relationships to disclose.
Estimating the real cost of adjuvant (A) trastuxumab (T) in patients(pts) with HER-2+ (H+) early stage breast cancer (ESBC)
Authors: Wilson E. , Crown J. , Ballot J. , McDonnell D. , Sheehan E. , Healy J. 
Published: March 2020

6081 Background: Pts with H+ metastatic (M) ESBC have a high risk of relapse. T has been reported to reduce the risk of relapse for pts with H+ESBC by approximately 50% when combined with A chemotherapy (CT). We attempted to study the real cost of AT in the context of current use of T in MBC (MT), and of the predicted reduction in the risk of relapse. Methods: We conducted a retrospective analysis of the mean per pt cost of AT and MT, and standard ACT in St. Vincent’s Hospital. The costs/pt for AT and MT were €34k, and €47k respectively, and for the listed agents in standard A: docetaxel(D)-8.8k, paclitaxel(P)-7.4 k, filgrastim(G)-9.3 k. Based on published/presented data (BCIRG 001), we assumed a 35% risk for relapse at five years for pts with H+BC receiving conventional A, and a 50% risk reduction (RR) for AT, giving an absolute benefit of 17.5%. We then devised an equation to calculate the Crp for AT: Crp=[a-M(NRA/104)]/[NRA/104] where a = cost per pt for treatment (Tx) with AT, M = cost per pt for Tx with T in MBC, N = % of pts relapsing after standard A, RA = % reduction in the risk of relapse after Tx with AT (over standard A). Results: The corresponding real T costs/100 pts for the following reductions in relapse rate would be:25%-€3.4m 50%-€2.6m-, 80%-€2.1m, 100%-€1.8m. The Crp for AT with a 50% reduction in relapse rate is €147k. With a 100% reduction in the RR we estimate the Crp to be €50k. We studied D (D-BCIRG 001), P (P-CALGB 9344) and G (G-CALGB 9741 dose-dense), and noted the following published absolute relapse reductions for these tx: D-7%, P-5% and G-4%. The following costs per relapse prevented were calculated: P-148 k; G-231k; D-126k. Conclusions: Using the equation, the real cost per relapse prevented of AT can be calculated, and comparisons made with the cost-effectiveness of other accepted A. Assuming no re-treatment with MT, AT appears to be a relatively cost-efficient means of reducing relapses. Reports of the efficacy of short AT regimens suggest the possibility of even greater cost-effectiveness. This equation could possibly be used to calculate the cost effectiveness of other novel A molecular therapies. [Table: see text]
The use of warfarin for venous thromboembolism (VTE): Practical problems for patients and resource implications for an oncology unit
Authors: Morris P. G. , O’Dwyer D. , Davenport C. , O’Callaghan C. , Breathnach O. S. , Grogan L. 
Published: March 2020

6088 Background: Recent evidence has suggested improved efficacy with low molecular weight heparin (LMWH) over oral coumarins for the treatment of cancer patients with VTE. Oral anticoagulants present multiple practical problems for patients undergoing chemotherapy, including side-effects, disruption of anticoagulation for invasive procedures, multiple drug interactions and multiplicity of patient visits. To assess the practice implications of these issues, a review was carried out in a busy medical oncology unit. Methods: A retrospective review of all patients treated with the coumarin derivative, warfarin for VTE during the last year was undertaken. Patients on prophylactic warfarin for central venous devices were excluded. Computerised laboratory records were used to identify patients. Patients were assessed for adverse events and therapeutic efficacy. The extra volume of work involved in monitoring blood tests and treating complications was quantified. Results: 55 patients with VTE were treated with warfarin from 07/01/04 to 06/30/05. The majority (73%) had metastatic carcinoma. 21 invasive interventions required disruption of anticoagulation. 90% of these were in patients with metastatic disease. Each patient was subtherapeutic (International normalised ratio <2.0) for a mean of 30.7 days (25% of mean duration of anticoagulation). There were 8 admissions for haemorrhage. Nine patients died on warfarin, 8 of whom had metastatic disease. In one patient with significant cardiac comorbidity warfarin therapy contributed to early death. No patterns of drug interactions were identified. A total of 1,369 coagulation tests were performed. There were 382 extra blood test visits, representing 26% of all day ward blood visits. On treatment, 13 patients (24%) were changed from warfarin therapy to LMWH. In 4 patients there was progression of VTE. In 9 patients, all with metastatic disease LMWH was substituted to qualitatively improve patient care by minimising hospital visits and facilitating home based care. Conclusions: This study identifies the high rate of treatment change to LMWH and quantifies the extra resource utilization with coumarin therapy. This supports the increased primary use of LMWH in selected cancer patients. No significant financial relationships to disclose.
Influence of tumor type, disease status, and patient age on self-reported interest regarding participation in cancer clinical trials
Authors: Rivkin S. E. , Markman M. , Petersen J. , Montgomery R. 
Published: March 2020

6100 Background: There is limited data available regarding the reasons cancer patients decide to enter clinical trials. Methods: To explore this issue, aggregate responses to the question, “Are you interested in learning about clinical trials for your condition?” obtained from > 115,000 cancer patients (or their families) who entered data into one of several proprietary decision-support programs embedded within approximately 100 cancer-related Internet sites, were analyzed. Results: The proportion of patients (or their families) who expressed interest in learning of the availability of clinical trials ranged from as low as 21% (endometrial and cervix cancer patients > 80 years old; n=178) to as high as 85% (recurrent ovarian cancer patients, aged 51–60; n=842). Patients > 80 years old, regardless of sex, tumor type, or disease status, were substantially less likely to desire such information. Patients with self-declared more “serious conditions” (e.g., metastatic breast cancer [71%; n=5,444], recurrent prostate cancer [70%; n=4,121]), and those with cancers widely known to have a poor prognosis (e.g., non-small cell lung cancer [75%; n=23,298]), were more likely to request data on trials, than those with an overall more “favorable” prognosis (e.g., newly diagnosed prostate cancer [46%; n=21,348]). There were no observed differences in interest between men and women with similar conditions. Conclusion: In this large data base, major differences in self-expressed interest regarding availability of clinical trails were observed. Particularly notable were the reduced interest among the very elderly, and the increased interest by patients with the most serious cancer-related conditions. [Table: see text]
Assessment of nutrition in cancer patients and its effect on treatment outcome—A study from a developing country
Authors: Mukhopadhyay S. , Paul C. , Thander K. , Gorai J. , Purakayet M. , Biswas S. , Choudhury R. , Ahmed R. , Gupta P. , Mukhopadhyay A. 
Published: March 2020

6125 Background: In developing countries one-third of the people suffer from mal-nutrition. It has been shown that a good nutritional status can reduce complications of treatment, strengthen the immune system and contribute to the patient’s general well being throughout treatment. A good nutritional status is therefore essential for optimal treatment of a cancer patient. The aim of our study was to see the nutritional status of cancer patients on diagnosis and effect of nutrition on outcome of therapy. Methods: In this study we prospectively analyzed the nutritional status of 500 cancer patients in Netaji Subhash Chandra Bose Cancer Research Institute, a tertiary cancer center of eastern India during period from January 2004 to December 2005. The age range of the patients was 19 years to 74 years (median age 46 years). The parameter analyzed were weight for age, total protein, serum albumin and mid arm circumference. The weight for age and mid arm circumference were taken as normal if they were between 3rd and 97th percentile curve of the growth chart recommended by the Indian Council of Medical Research. The albumin level and the total protein were considered normal if the value is equal to or more than 3gm% and 5.8gm%. Result: It was seen that total 120 patients (24%) were low weight for age and 100 patients (20%) had low mid arm circumference. Total 90 patients (18%) had low serum albumin while 130 patients (26%) were low serum protein. Low weight for age, low serum albumin and low mid arm circumference were significant factors in disease free survival and toxicity of chemotherapy (p value < .001) Conclusion: We conclude that mal-nutrition is a major finding in cancer patients in developing country like ours. The patient with mal-nutrition had less disease free survival and more toxicities during therapy as compared to well-nourished patients. No significant financial relationships to disclose.
Laparoscopic treatment of endometrial cancer: A cost-effectiveness analysis
Authors: Abaid L. N. , Boggess J. , Wu J. 
Published: March 2020

6127 Background: Endometrial cancer has traditionally been staged using an open abdominal incision. Laparoscopic staging offers the benefits of a minimally invasive approach and may also be economically advantageous. Methods: A decision model was developed to determine the cost-effectiveness of laparoscopy versus laparotomy for surgical staging of a hypothetical cohort of women, aged 35 to 80 years, with early-stage endometrial cancer. The analysis was performed from a societal perspective with a time horizon of six weeks. The primary outcome was cost-effectiveness, measured as cost per complete staging procedure. Parameters in the decision model included rates of mortality, intraoperative complications (bowel, bladder, or vascular injury and intraoperative hemorrhage), deep venous thrombosis (DVT), blood transfusion, and length of hospitalization. Assumptions included that laparoscopy and laparotomy were equally effective for staging, and that the length of hospitalization was one day for laparoscopy versus three days for laparotomy. Probability estimates were obtained from a review of the medical literature and from institutional data. Results: The cost for laparoscopic staging per subject was $14,616 compared to $16,184 for laparotomy. Thus, the incremental cost-effectiveness ratio (ICER) was $1,568 per complete staging procedure, and laparoscopy was more cost-effective than laparotomy. Based on one-way sensitivity analyses, the factor that had the greatest influence on the model was length of hospital stay after laparotomy. The ICER was insensitive to changes in the rates of mortality, intraoperative complications, and blood transfusions. Conclusions: Laparoscopic surgery for endometrial cancer is a cost-effective alternative to laparotomy, primarily because it reduces the length of the postoperative hospitalization. No significant financial relationships to disclose.
Barriers and stimuli for genetic counseling among unaffected women at high risk for breast cancer
Authors: Cummings S. , Pakilit A. , Stolley M. , Khan S. 
Published: March 2020

6144 Background: Genetic counseling (GC) is available to provide risk assessment and education about hereditary cancer, explore the medical and psychosocial impact of these risks, and to facilitate genetic testing (GT) and its complex interpretation. While the motivations for undergoing GT have been well documented, little is known about patient motives to initially seek GC. Current uptake of GC services does not match the number of eligible patients. This study attempted to characterize the barriers and stimuli for cancer GC among unaffected women at high risk for breast cancer. Methods: IRB approval was obtained for this qualitative interview study. 54 unaffected patients who received a cancer genetics referral from a high-risk breast clinic were invited to participate. 18 subjects completed written questionnaires and 60-min telephone interviews, which were audiotaped and transcribed. A detailed coding system was developed and N*Vivo software was used in order to identify themes in the factors affecting intent to pursue GC. Results: We identified four themes in the factors affecting uptake of GC: 1)patient understanding of GC, 2)patient awareness of increased cancer risk, 3) family-tied life events (e.g. reproduction, caretaking, death), and 4) support for GC from physicians and family. The most common theme was patient understanding of GC. Subjects did not seem to differentiate between GC and GT, and they deferred GC until they were prepared to undergo GT. Conclusion: We identified barriers and stimuli for GC that were similar to those previously described for GT. The misconception that GC automatically leads to GT, and the subsequent low uptake of GC referrals, may be influenced by the current practice of non-directive referrals. Providing more directive referrals for GC, without being directive about GT, may reduce barriers to GC. No significant financial relationships to disclose.
Circulating tumor cells: Tools for monitoring and targets for therapy
Authors: Pachmann K. , Camara O. , Lobodasch K. , Dengler R. , Runnebaum I. , Hoeffken K. , Pachmann U. 
Published: March 2020

617 Background: Analysis of peripheral blood may help to early monitor the process of dissemination of metastatic cells into vital organs . The true number of circulating epithelial tumor cells (CETC) being still controversial, we, omitting all possibly selective enrichment procedures, detect a considerable number of such cells in breast cancer patients. CETC have been shown to respond to therapy in exactly the same way as the primary tumor and we have now probed CETC for monitoring effectiveness of adjuvant therapy. Methods: CETC were monitored in 97 patients before and after each cycle during adjuvant therapy using fluorchrome labeled antibody against epithelial antigen and laser scanning fluorimetry. Results: CETC could be detected in all patients after surgery. Four different forms of therapy response were observed: Patients with 1) CETC from ER+PR+ tumors responding only marginally with appreciable numbers remaining after therapy. These patients (about 40% of patients) have remained in CR; 2) rapidly decreasing CETC,sometimes to below the threshold of detection. These patients, too, remained in CR; 3) constantly or intermittently increasing resistant cells. All these patients have experienced early relapse 5–24 months after diagnosis); 4) Most interestingly, some cells initially respond very well to therapy but show a renewed increase during continuing therapy. These patients, too, have relapsed. Conclusion: Prognostic factors deduced from the primary tumor cannot predict outcome for the individual patient, whereas our approach monitoring CETC allows real-time survey of therapy response in individual patients. We confirm the observation of low responsiveness of ER+ tumors also in disseminated cells, with dormant CETC in most cases, not eliminated by current therapies but also not leading to early relapse. In contrast, most patients with CETC increasing during therapy suffer early relapse. This indicates not only that these cells are an important indicator of imminent relapse but also distant metastases may be the result of growth or regrowth of these cells. In some patients treatment influences subpopulations differently with a resistant population emerging responsible for relapse. No significant financial relationships to disclose.
Concurrent administration of weekly trastuzumab and adjuvant breast radiotherapy increases skin, esophageal, and cardiac acute toxicities
Authors: Belkacemi Y. , Gligorov J. , Laharie-Mineur H. , Marsiglia H. , Ozsahin M. , Azria D. 
Published: March 2020

630 Background: Trastuzumab (T) combined with chemotherapy (CT) has been recently shown to improve the outcome in patients with HER2-positive breast cancer. Its administration either weekly or every 3 weeks for one year is recommended as adjuvant therapy. Nevertheless, little is known about the toxicity of radiotherapy (RT) and T administered concurrently. Methods: Since June 2005, 95 patients (pts) with stage II-III HER2-positive breast cancer were treated concurrently with adjuvant T and RT. At this time, 53 have completed their combined therapy. Median age was 48y and 22 pts were menopausal. Twelve and 41 pts received T weekly or every 3 weeks, respectively. Neoadjuvant CT using anthracyclin/taxane regimen was administered in 27 pts. T was initiated after the last cycle of anthracyclin. Hormonal treatment was given to 17 hormone-receptor positive pts. RT was delivered to the whole breast (45–50 Gy ± a 10 to 16 Gy-boost, n=24) or to the chest wall (50 Gy, n=29). Internal mammary chain (IMC) and supraclavicular nodes were irradiated in 41 pts. Toxicity assessment (dermatitis, esophagitis and left ventricular dysfunction) was implemented according to the CTC v3.0 criteria. Results: Grade (G) 2 or more skin and esophageal toxicities were observed in 27/53 (51%) and 7/53 (13%) pts, respectively. Post-RT left ventricular dysfunction was observed in 22 pts (G1 in 14, G2 in 6, and G3 in 2). In univariate analyses, unfavorable factors influencing G2 or more cardiac toxicity were postmenopausal status (p=0.03), IMC irradiation (p=0.005) and weekly T administration (p=0.0001). Multivariate analysis revealed the concurrent administration of weekly T and RT (WTRT) as an unfavorable independent prognostic factor for cardiac toxicity (p=0.0001) and for G2 or more dermatitis (p=0.05). The two unfavorable prognostic factors for esophagitis (G2 or more) were concurrent administration of WTRT (p=0.008) and total mastectomy (p=0.004). Conclusion: Our preliminary results show that in addition to increased skin and esophageal acute toxicities, concurrent administration of weekly T and RT significantly decreases the left ventricular ejection fraction compared to the 3-week schedule. Results for the whole cohort will be presented at the meeting. No significant financial relationships to disclose.
Evaluation of a recombinant HER2 vaccine: Induction of specific antibodies, T-cells and preliminary activity in metastatic breast cancer patients
Authors: Limentani S. A. , Campone M. , Dorval T. , Tan-Chiu E. , Curigliano G. , De Boer R. , Canon J. , Bachelot T. , Louahed J. , Brichard V. G. 
Published: March 2020

631 Background: We designed a vaccine to induce T cells able to recognize epitopes from HER2 and to engender a polyclonal antibody reponse. Methods: The vaccine is a recombinant HER2 protein, including its extra and part of its intra-cellular domains (ECD/ICD), combined with a potent immunologic adjuvant. Cohorts of patients with Stage II/III breast cancer (BC) received 20, 100 or 500 μg in the adjuvant setting. Treatment comprised of six vaccinations over 14 weeks, for the 500-μg dose, recall injections were given on weeks 34 and 38. The trial was extended to include an alternative vaccination schedule: 500 μg on days 0, 28 and 98. In an on-going trial, patients with metastatic BC treated in the first line setting are receiving the 500-μg treatment and being assessed for clinical response. Results: The vaccine was well tolerated, with no symptomatic cardiotoxicity. Antibody (Ab) response against ECD was dose-dependent, with 2/12, 9/14 and 14/15 immune responders in the respective cohorts after four vaccinations. Response was dose-related. Ab isotypes were analyzed in the 500 μg cohort: in 50% of patients, high levels of IgM (30–60%) against ECD were found after four vaccinations. The switch towards IgG was complete in all patients after six vaccinations. The efficacy of booster vaccinations was observed mainly in patients with low IgM after eight weeks. After two vaccinations, Ab titers on the alternative 500 μg vaccination schedule were as high as after four vaccinations utilizing the initial schedule. The anti-ECD antibodies in 11/15 patients (500 μg level) bound HER2-overexpressing breast-cancer cell lines. In sera from 2 patients tested thus far, the gene-expression resembled that of trastuzumab. Assays show that specific T cells were obtained; detailed analysis is continuing. Among metastatic patients, two showed evidence of tumor regression after vaccination. Conclusions: The HER2 vaccine was well tolerated and induced (dose-dependently) anti-ECD Ab that bound the HER2 receptor. Data suggest that the vaccine also induced specific T-cell immunity. The alternative vaccination schedule may increase the Ab titers. This data justifies further evaluation of this vaccine in the phase II/III setting. [Table: see text]