tbuckley/cabot-search huggingface dataset:
Male breast cancer: Our experience
Authors: L. Tozzi, C. D’Addetta, M. Bisceglia, R. Murgo, G. Cilenti, M. El Jaouni, T. P. Latiano, G. Scaramuzzi, S. Parisi, E. Maiello
Journal: Journal of Clinical Oncology (2006)

10733 Background: Male breast is an uncommon disease, accounting for &lt;1% of all malingnancies in the man. In contrast to women with breast cancer, men with breast cancer are older and have more advanced disease. Methods: Data regarding 25 male patients who underwent surgery for breast cancer in the our Istitution between January 1994 and December 2005 were analyzed. The main characteristics of these patients included: median age 64 years (range 32–87); positivity family cancer history: specific 4 pts, non-specific 3, no circumstance 18; risk factors: obesity 6 pts, gynaecomastia 4, diabetes 5, liver transplant 1. Five cases of second neoplasia were observed: 2 patient with prostate cancer, 1 synchronous colon carcinoma, 1 head and neck cancer, 1 pancreatic cancer. Results: All but one pts (with syncrhronous metastases at presentation) underwent mastectomy. Pathological characteristics included: pT1 tumors 3 pts (12%); pT2 7 pts (28%), pT3 2 (8%), pT4 13 (52 %); infiltrating ductal carcinomas in 88% of cases; axillary lymph node involvement in 12 (50%); 22 patients had estrogen- and progesterone-receptor positive tumors, 2 pts negative, 1 pts unknown. After surgery 14 pts received RT, 13 pts hormonotherapy and 16 patients adjuvant chemotherapy (7 CMF, 9 anthracyclin-based therapy). Median disease free survival was 41.5 months (range 5–116).With a median follow-up of 66 months, we observed 12 deaths (10 pts for progressive disease) and the overall survival rate was 52% (13 pts; 11 disease-free). According to the family cancer history we observed 5/7 (71%) and 7/18 (39%) deaths in positive and negative cases, respectively. Conclusions: The approach to male breast cancer patients is similar to that for female patients. Our data confirm the suspected epidemiologic risk factors such as prostate cancer, gynecomastia and dietary factors; furthermore, cases with family cancer history seems to have a worse prognosis. No significant financial relationships to disclose.
Whether all general practice initiatives are effective in gaining asthma control in mild asthmatics
Authors: Olga Nagatkina, Vitaly Kupaev, Julia Bogdanova, Dmitry Nagatkin
Journal: European Respiratory Journal (2014)

Mild asthmatics are usually observed only by general practitioners.  The aim was to find out whether there are any initiatives effective and suitable for gaining control among mild asthma patients in General Practice.  We enrolled 95 mild atopic asthmatic patients (age 43.3±15.6 yrs, 64.9% female). We observed the patients during one year. Patients were encouraged by their general practitioners to pass education patients schools (group or/and distant electronic one), undertake regular physician observation every 3 month and follow the personal written asthma action plan. We used criteria of effectiveness: results of ACT and ACQ-5, FEV 1  data, frequency of use of reliever medicine and etc.  During the research period 54.7% of patients passed group asthma-school (correlation with age r=-0.04), 43.6% - passed distant electronic asthma-school (correlation with age r=-0.77, p  Conclusion: In spite of variety of initiatives, each patient with mild asthma needs personal written asthma action plan and obligatory passing any type of patients9 education.
Psychological and spiritual well-being of breast cancer survivors in a community-based cancer survivorship clinic.
Authors: K. C. Demel, B. N. Jahagirdar, D. M. Anderson, C. Anderson, D. J. Schneider, J. P. Jaffe, S. Cruse, G. Tarchand, D. Christensen-Johnston, R. Hurley
Journal: Journal of Clinical Oncology (2010)

e19673 Background: Maximizing quality of life (QOL) is an important aspect of care for cancer survivors. In 2006, the Institute of Medicine (IOM) highlighted the need to conduct clinical research in survivors' attitudes regarding care, especially as it may impact access to supportive services. Methods: In 2009, we developed a community-oriented cancer survivorship program at HealthPartners (St. Paul, MN). All patients were asked to complete the previously validated City of Hope QOL instrument (COH-QOL), which incorporates assessment of the four main QOL domains on a 1 to 10 scale. Various supportive services were utilized based on the self-reported survey. Results: So far 40 breast cancer survivors, 90% representing early stage (0-III) disease, have participated. Median time from diagnosis was 1 year (range 0-10 years). The median level of distress at diagnosis was 10, fell to 8 during treatment and 3 after completion of cancer treatment. Overall quality of life was rated highly by the respondents, with a median score of 9. Women expressed low levels of depression and anxiety (median score 3 and 2 respectively). Many survivors reported a change in spiritual life as a result of cancer (median score 7), a positive change in life caused by cancer (median 7.5), and a sense of purpose in life (median score 8). There was no statistical correlation between spiritual activity and overall quality of life (Pearson R = −0.282). Conclusions: Breast cancer survivors face the highest degree of distress at the time of diagnosis, which may be underappreciated by the patient at that time. Therefore, screening tools and appropriate triage should be developed early on in the treatment phase to gather psychological support. Overall quality of life was high in this population. Breast cancer caused several positive changes in lives of the survivors in this study. No significant financial relationships to disclose.
Low-dose methotrexate and cyclophosphamide in recurrent ovarian cancer
Authors: R. Scheusan, S. Curescu, D. Stanculeanu, P. Curescu
Journal: Journal of Clinical Oncology (2009)

e16574 Background: Ovarian cancer continues to be the leading cause of death secondary to gynecologic cancers among women. Despite the fact that new chemotherapeutic drugs have been found effective, the prognosis of these women continues to be poor. Metronomic chemotherapy, chronic administration of chemotherapy at relatively low, minimally toxic doses on a frequent schedule with no prolonged drug-free breaks, is a potentially novel approach to the control of advanced cancer disease. It is thought to work primarily through antiangiogenic mechanisms and has, as an advantage, the property of significantly reducing toxic side-effects. Purpose: to evaluate the efficacy and toxicity of metronomic chemotherapy using low dose methotrexate and cyclophosphamide in patients with refractory pretreated ovarian cancer. Methods: From May 2007 to July 2008, 11 patients with refractory pretreated ovarian adenocarcinoma were included. Patient's characteristics: median age 51 years (range 41–64), ECOG 0–2, progression after more than two lines of chemotherapy for recurrent disease. Treatment: low-dose oral methotrexate 2.5 mg bd on days 1 and 2 each week and cyclophosphamide 50 mg/day administered continuously until disease progression. Follow-up: every month clinical examination, ECOG, blood test; every two months CA-125; every four months CT-scan. Results: All patients were evaluable for response and toxicity. There was no complete response; 2 pts (18.18%) - partial response and the overall clinical benefit rate was 54.54%. The median time to progression was 4.4 month. Main toxicities according to WHO criteria were: grade 1–2 gastrointestinal toxicities (nausea, vomiting) 4 pts (36.36%), grade 1–2 anemia 4 pts (36.36%), grade 1–2 neutropenia 2 pts (18.18%). No grade 3–4 toxicities was observed. Conclusions: Metronomic metotrexate-cyclophosphamide is minimally toxic and effective in heavily pretreated recurrent ovarian cancer. In conclusion, metronomic regimen could represent a potentially significant palliative treatment for these patients. A better understanding of mechanism of actions would help determine the optimal dose and schedule for metronomic chemotherapy regimens as antiangiogenic therapy. No significant financial relationships to disclose.
Phase II study of irinotecan plus leucovorin and bolus 5 fluorouracil as first or second line chemotherapy in patients with advanced gastric or esophageal-gastric junction adenocarcinoma
Authors: M. Gerolymos, A. Koutras, E. Kontogeorgou, G. Iconomou, G. Vourli, E. Tsiata, T. Makatsoris, C. Chrysanthopoulos, H. Kalofonos
Journal: Journal of Clinical Oncology (2007)

15128 Background: The aim of this study was to evaluate the activity and safety of 5-fluorouracil (5-FU) / leucovorin (LV) and irinotecan as first- or second-line treatment in patients with advanced gastric adenocarcinoma. Methods: Treatment consisted of irinotecan 80 mg/m 2 intravenously (i.v.), followed by LV 200 mg/m 2 (i.v.) and 5- FU 450 mg/m 2 as an i.v. bolus. Treatment was administered weekly for 6 weeks, followed by a 2-week rest period. Results: Thirty-one patients (23 chemo-naïve, 8 chemo-exposed) were enrolled. The overall response rate was 22.6% and the disease control rate was 38.7%. Among the patients who received the regimen as first-line treatment, objective response rate was 30.4% and the disease control rate was 52.1%. However, progression of the disease was recorded in all the patients receiving the combination as second-line chemotherapy. The median time to disease progression (TTP) was 4 months and the median duration of survival was 7 months. The median TTP was 6 months for patients treated with first-line chemotherapy and 2.5 for those who received study treatment as second line. Furthermore, the median survival duration was 8 months and 6 months, respectively. The most frequent grade 4 toxicity was febrile neutropenia. Grade 3 or 4 non-hematological toxicities were rare. There were no treatment-related deaths. Conclusions: The combination of 5-FU/LV and irinotecan as first-line treatment was found to be well tolerated, with efficacy comparable to that of other regimens in advanced gastric cancer. Accordingly, this regimen can be regarded as one of first-line options, particularly in patients who can not tolerate aggressive chemotherapy. No significant financial relationships to disclose.
Treatment of acute myeloid leukemia (AML) in first remission (CR1) with unrelated donor (UD) allogeneic hematopoietic cell transplantation (HCT).
Authors: Q. Bashir, B. Andersson, L. De Padua Silva, G. Rondon, A. Chiattone, C. Hosing, M. Fernandez-Vina, S. Giralt, R. E. Champlin, M. J. De Lima
Journal: Journal of Clinical Oncology (2010)

6532 Background: The benefit of allogeneic HCT in patients with AML in CR1 is frequently offset by excessive transplant related mortality (TRM), which can deny the benefit of the graft-versus-leukemia effect. Conversely, decreasing TRM while preserving antileukemic activity can have marked impact on outcomes. Methods: We transplanted 44 patients in CR1 using the conditioning regimen of IV busulfan (Bu)130 mg/m2 (day-6 to -3), fludarabine (Flu) 40 mg/m2 (day-6 to -3) and antithymocyte globulin (4.0 mg/kg). Graft-versus-host-disease (GVHD) prophylaxis consisted of mini-MTX and tacrolimus, with (n=14) or without pentostatin (n=30). High-resolution allele level HLA typing was performed for all donors/recipients (HLA-A, B, C, DRB1, DQB1 and DPB1). Eligibility: age<65, high/intermediate risk AML. Results: Median age was 48 (range: 13-63) years; 7 patients (16%) had secondary AML. Cytogenetic risk class: intermediate, 41% (N=18), good, 1 case (with CNS disease), and poor, 57% (N=25). Stem cell source was bone marrow in 68% (N=30) and peripheral blood in 32% (N=14). Median follow-up is 28 months. All patients engrafted. Grade II-IV acute (a) GVHD rate was 14% (N=2) in patients who received and 27% (N=8) for those who did not receive pentostatin. Chronic (c) GVHD rate was 39% (N=17; extensive in 7). 100-day and 3-year TRM rate was 5% (N=2) and 16% (N=7), respectively. Six patients (14%) have relapsed and 10 patients (23%) have died (3 of relapse and 7 of TRM causes). 3-year event-free and over all survival is 70% and 78%, respectively. For key outcomes see Table. Conclusions: UD HCT after the myeloablative, reduced toxicity IV Bu-Flu regimen for patients with AML in CR1 yields excellent disease control with low risk for TRM. Patient, disease, and donor characteristics (N)—median follow-up is 28 months 3-year actuarial event-free survival (%) (p value) 3-year actuarial overall survival (%) (p value) All patients (n=44) 70 78 Secondary AML Yes (n=7) 57 (0.4) 56 (0.2) No (n=37) 73 84 Cytogenetic risk category Intermediate (n=18) 82 (0.5) 83 (0.9) Poor (n=25) 62 78 HLA 10/10 Yes (n=39) 70 (0.6) 78 (0.9) No (n=)5 80 80 HLA-DPB1 mismatch 0 (n=11) 58 (0.4) 63 (0.5) 1 (n=22) 78 80 2 (n=11) 78 90 No significant financial relationships to disclose.
Docetaxel (D) plus estramustine monophosphate (EMP) in patients (pts) with hormone refractory prostate cancer (HRPC)
Authors: T. Nelius, F. Reiher, T. Lindenmeir, J. Burandt, O. Rau, S. Filleur, T. Klatte, R. Yap, E. P. Allhoff
Journal: Journal of Clinical Oncology (2005)

4780 Background: D mono therapy has proven efficacy in pts with HRPC, but combination of D/EMP has improved response rates do to synergistic and significant activity. However, the optimal dose and schedule of this combination is not well established. Since many pts experience side effects of EMP, use of lower dose EMP was tested. This study evaluated PSA decline in subgroups, safety, and quality of life (QoL). Methods: We conducted a phase II trial, administering D (70mg/m2 IV, d1, q3w) and EMP (280 mg/d PO starting 1 day prior to D, for 5 consecutive days). Initially, 6 cycles were administered. Chemotherapy (CT) was restarted after significant PSA rise. Eligible pts had HRPC with radiological and/or biochemical evidence of progression following antiandrogen withdrawal with castrate testosterone levels. Other requirements included a Karnofsky index >50%; adequate organ function prior CT was permitted and no prior CT except EMP. Pts were monitored for measurable PSA response and toxicity. Results: Between 05/01 and 12/04, 62 pts were treated. Median age was 67.5 years (range: 40–82), median PSA was 177.8 ng/ml (range: 0.68–4973). Median number of cycles was 6 (range: 1–6). Main grade 3–4 hematologic toxicities were: neutropenia 10.1%, anemia 5.2%. Main grade treatment toxicities (pts) were allergic reaction (1) and febrile neutropenia (1). Median survival was 24 months (ms). Pts with PSA levels < 150 ng/ml had a mean survival time of 32 months compared to 18 months for pts with PSA levels > 150 ng/ml, with similar radiological tumor burden at time of treatment initiation. PSA responses/mean survival: PSA↓ >75%/35ms: 25 pts, PSA↓ >75–50%/24ms: 13pts, PSA↓ < 50%/15ms: 24pts. There was no worsening of QoL using the FACT-P instrument and the pain score was stable throughout treatment. There were no drug related deaths during trial. Conclusions: D/EMP combination has substantially activity in HRPC with predictable and manageable toxicity. There is a clear improvement in survival compared to historical treatment groups. This supports its use as first line therapy for HRPC. This trial demonstrated also a survival advantage for pts with early chemotherapeutic intervention. No significant financial relationships to disclose.
A randomized phase II trial of adjuvant chemotherapy with cisplatin, epirubicin, 5-fluorouracil, gemcitabine (PEFG regimen) or gemcitabine alone after curative resection for pancreatic cancer
Authors: M. Reni, S. Cereda, G. Aprile, M. C. Tronconi, C. Milandri, P. Passoni, A. Rognone, G. Balzano, V. Di Carlo, E. Villa
Journal: Journal of Clinical Oncology (2009)

4608 Background: The PEFG regimen yielded a statistically relevant outcome advantage as compared with gemcitabine (G) in patients with advanced pancreatic adenocarcinoma (PA). The current trial assessed the impact upon disease control of PEFG regimen and single agent G after curative resection for PA. At time of trial design, both arms were experimental since the role of adjuvant therapy in PA was debated. Methods: After R0 or R1 resection for PA, patients with stage IB-III disease, aged 18–70 years, Karnofsky performance status (PS) &gt;60 were randomized within 8 weeks from surgery to receive either G 1 g/m 2 /weekly Q3 every 4 weeks (Arm A), or PEFG (cisplatin and epirubicin at 40 mg/m 2 each on day one, gemcitabine at 600 mg/m 2 on days 1 and 8 and 5-FU at 200 mg/m 2 /day on days 1 to 28) every 4 weeks (Arm B). In both treatment arms chemotherapy was administered for 3 months and followed by radiotherapy (54–60 Gy in 27–30 fractions) with concurrent 5-FU 250 mg/m 2 /day. A CT scan was performed every three months. The primary endpoint was the probability of being disease-free at 1 year (DFS1y) from surgery. The Fleming design was used to calculate the sample size. Assuming P0=35% and P1=55%, α .05 and β.10, the study was to enroll 51 patients per arm. The treatment arm had to be considered of interest with &gt; 23 patients being DFS1y. Results: Between August 2003 and August 2008, 102 patients were enrolled, stratified by center and resection margin and randomized (51 per arm). All patients were eligible. One patient in arm A and 2 in arm B refused the assigned treatment. An intent-to-treat analysis was performed. Patients’ characteristics were (A/B): median age 61/60, median PS 90/90, stage IIA 19/12%; stage IIB 73/81%; stage III 8/7%; grade 3 30/46; R1 36/30; pre- and post-surgery surgery CA19.9 &gt; upper limit of laboratory normal 68/80% and 29/33%, tumor size &gt; 2.9 cm 41/43%. To date, 41 patients per arm are assessable for the primary endpoint: 19 (46%) and 28 (68%) patients were DFS1. Main G3–4 toxicity was: neutropenia in 21/85% and thrombocytopenia in 0/23% of patients. Conclusions: With a mature follow-up for 80% of patients, PEFG reached the primary endpoint of the trial and warrants further study while G not yet. No significant financial relationships to disclose.
A Multicenter Stratified Phase Ii Study of Cetuximab for the Treatment of Patients With Recurrent High-grade Glioma
Authors: Bart Neyns, Jan Sadones, Eric Joosens, Frank Bouttens, Luc Verbeke, Jean-François Baurain, Lionel Dhondt, Theo Strauven, Cristo Chaskis, Alex Michotte
Journal: Neuro-Oncology (2008)
Bevacizumab and erlotinib in the treatment of patients with metastatic renal carcinoma (RCC): Update of a phase II multicenter trial
Authors: D. R. Spigel, J. D. Hainsworth, J. A. Sosman, E. L. Raefsky, A. A. Meluch, D. Edwards, P. Horowitz, K. Thomas, K. Yost, M. P. Stagg, F. A. Greco
Journal: Journal of Clinical Oncology (2005)

4540 Background: Several new drugs which target signaling pathways downstream from the VHL gene product defects characteristic of clear cell RCC have shown antitumor activity in advanced RCC. We previously reported promising results with a combination of bevacizumab and erlotinib in patients (pts) with metastatic RCC. These drugs target 2 pathways critical to the growth and dissemination of clear cell RCC. We now present updated efficacy data after a median follow-up of 16 months. Methods: Eligibility criteria included: metastatic clear cell RCC, 0 or 1 previous systemic regimens, previous nephrectomy, ECOG PS 0 or 1, adequate organ function, no active CNS metastases, no bleeding abnormalities, informed consent. All pts received bevacizumab 10mg/kg IV q 2 weeks, and erlotinib 150mg po daily. Pts were evaluated for response (RECIST criteria) after 8 weeks; treatment continued until tumor progression. Results: Between 2/03 and 1/04, 63 pts were treated: median age 61 years; male/female, 50/13; ECOG 0/1, 36/27. 43 pts (68%) were previously untreated; the remainder had received IL-2 and/or interferon. 15 of 59 evaluable pts (25%) had objective responses (PR 14, CR 1). 36 pts (61%) had stable disease; however, 13 of these pts (22% of total) had minor objective responses (10–30% decrease by RECIST criteria). The median duration of treatment was 8 months; 26 pts received > 12 months of therapy. Median and 18-month progression-free survival (PFS) are 11 months and 26%, respectively. Median survival has not been reached; 78% and 60% of pts were alive at 12 and 18 months, respectively. 1-year PFS in the subgroups with major response (PR/CR), minor response, and stable disease are 80%, 57%, and 27%, respectively (p=.007). 2 pts discontinued treatment because of grade 3 skin toxicity; only 1 grade 4 toxicity occurred (GI bleed). Grade 3 toxicity: diarrhea 13%; rash 13%; nausea/vomiting 10%; hypertension 8%; bleeding 6%; proteinuria 6%; pruritus 3%. Conclusions: These updated results confirm the high level of activity of bevacizumab/erlotinib in patients with metastatic RCC, and support continued exploration of this combination as well as other rational combinations of targeted agents. No significant financial relationships to disclose.
Survival analysis of sequential use of first-line tamoxifen versus aromatase inhibitors for estrogen-positive metastatic breast cancer in postmenopausal women
Authors: V. Kyritsis, M. de Lemos, C. Speers, J. Barnett
Journal: Journal of Clinical Oncology (2008)

1093 Background: Tamoxifen has been the gold standard of treatment in postmenopausal women with estrogen receptor-positive (ER+) metastatic breast cancer (MBC). Over the past decade, new aromatase inhibitors (AIs)—anastrozole, letrozole, exemestane—have emerged as equally efficacious alternatives to tamoxifen. Recent data suggest that first-line AI therapy may even confer a moderate but statistically significant increase in overall survival compared to tamoxifen (∼4 months). Traditionally, patients with disease progression after tamoxifen are often treated with second-line AI. Similarly, tamoxifen may be used as second-line for disease progression after AI therapy. It is unclear if the sequence of use of tamoxifen vs. AI would confer any difference in benefits. We performed a population-based analysis of survival associated with sequential use of first-line tamoxifen versus AIs for ER+ MBC to examine whether there is any difference in overall survival for patients in BC. Methods: This is a population-based retrospective analysis. Patients were identified from the BC Cancer Agency Information System (CAIS), systemic therapy drug database, and the provincial registry (Breast Cancer Outcomes Unit). Data was analyzed for all postmenopausal women treated with the sequential use of tamoxifen to AIs and from AIs to tamoxifen for ER+ MBC (stage IV disease) from January 1998 through December 2003 in BC. Patients treated with other first-line hormonal agents were excluded. The primary outcome is overall survival, defined as the time to death by any cause from the date of first-line tamoxifen or AI therapy. Overall survival was compared between patients treated with tamoxifen versus AI. Results: We found that there is an overall survival benefit with the use of sequential first line tamoxifen to AI therapy in comparison to AI to tamoxifen in our patient population. Conclusions: This analysis will provide pertinent information regarding the survival benefit between the sequential use of first-line treatment with tamoxifen and AI. The preliminary data provided by this analysis will assist in decision making regarding appropriate sequential use of hormonal therapy for ER+ MBC. No significant financial relationships to disclose.