tbuckley/cabot-search huggingface dataset:
Celecoxib (CEL) and weekly docetaxel (DOC) in elderly or PS2 patients (pts) with advanced non-small cell lung cancer (NSCLC)
Authors: R. A. Chaplen, G. P. Kalemkerian, A. Wozniak, N. Shehadeh, J. C. Ruckdeschel, M. J. Kraut, L. Heilbrun, R. Parchment, S. M. Gadgeel
Journal: Journal of Clinical Oncology (2004)

7102 Background: Weekly (DOC) is active and well tolerated in elderly or PS2 patients with advanced NSCLC. Cyclooxygenase-2 (COX-2) promotes tumor growth through the production of prostaglandin E2 (PGE2) and the induction of vascular endothelial growth factor (VEGF). Pre-clinical data show that celecoxib (CEL), a COX-2 inhibitor, has antitumor activity and enhances taxane efficacy.Methods: We are conducting a phase II study of CEL plus weekly DOC in elderly or PS2 pts with stage IIIB (pleural effusion)/IV NSCLC. Eligibility criteria include: age ≥ 70 yrs (PS 0–2) or age < 70 yrs with PS2; normal hepatic, renal and bone marrow function. CEL 400 mg po bid (daily) is started 7 days before the first dose of DOC 36mg/m2 IV given on days 1, 8, 15 of a 28 day cycle. Blood is collected pre-treatment, on day 8 of CEL, and on days 8 and 29 after first dose of DOC for VEGF and PGE2 levels. Results: 21 eligible pts have been treated: Median age 73 yrs (51–79 yrs); Gender 17M:4F; PS2 - 11; ≥70 yrs-14;PS2–11;adenocarcinoma 11, squamous cell 4, BAC-1; stage IV-21. Fifty two cycles (range 1–6) of DOC have been administered. Two pts are not yet assessable for response. The confirmed response rate is 21% (4/19 - 1 CR, 3 PR) and 5 pts have had stable disease. There has been no grade 3–4 hematologic toxicity. Non-hematologic toxicity: grade 3 fatigue (3); Grade 1/2 toxicities: hepatic transaminitis (1), azotemia (2), edema (2), nausea (1), diarrhea (1), rash (1). One pt died of myocardial infarction after 5 months and one died after a stroke at 1 month. One pt developed pulmonary embolism. Ten tumors were analyzed for COX-2: 6-Inadequate for IHC; 3-positive;1- negative. VEGF levels in 6 pts show no consistent pattern. Median survival time (MST) in all pts is 5.6mo and TTP is 3.0mo. In pts ≥70yrs MST is 8.6mo and TTP is 3.9 mo. Conclusions:The combination of CEL and weekly DOC is well tolerated and has encouraging activity in this select population with advanced NSCLC. A total of 39 pts will be accrued. Supported by Aventis and Pfizer. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Pfizer Pfizer Pfizer Aventis Aventis Pharmaceuticals; Pfizer
Abstract 17159: A Changing Landscape: Contemporary Characteristics of Major Cardiovascular Superiority Trials
Authors: RuiJun Chen, Katherine H Chau, Behnood Bikdeli, Yasir Akram, Natdanai Punnanithinont, Joseph S Ross, Harlan M Krumholz
Journal: Circulation (2013)

Background: Superiority clinical trials hold promises of impactful interventions for the future of evidence-based medicine but require extensive resources and may place study patients at risk. Adva...
Antitumor Effects of Antibody—Diphtheria Toxin Conjugates. III. Cyclophosphamide-Induced Immune Unresponsiveness to Conjugates2
Authors: Frederick L. Moolten, Neva J. Capparell, Shirley H. Zajdel
Journal: JNCI Journal of the National Cancer Institute (1975)

Journal Article Antitumor Effects of Antibody—Diphtheria Toxin Conjugates. III. Cyclophosphamide-Induced Immune Unresponsiveness to Conjugates Get access Frederick L. Moolten, Frederick L. Moolten Search for other works by this author on: Oxford Academic PubMed Google Scholar Neva J. Capparell, Neva J. Capparell Search for other works by this author on: Oxford Academic PubMed Google Scholar Shirley H. Zajdel Shirley H. Zajdel Search for other works by this author on: Oxford Academic PubMed Google Scholar JNCI: Journal of the National Cancer Institute, Volume 55, Issue 3, September 1975, Pages 709–712, https://doi.org/10.1093/jnci/55.3.709 Published: 01 September 1975 Article history Received: 25 April 1975 Accepted: 21 May 1975 Published: 01 September 1975
Onco-fertility care in a children's hospital: A quality improvement initiative.
Authors: Masanori Hayashi, Catherine Michelle Albert, Alexandra Gubin, Ann Katz, Cara Kramer, David Mark Loeb, Allen Ray Sing Chen
Journal: Journal of Clinical Oncology (2013)

41 Background: Patients who will receive gonadotoxic cancer therapy should be counseled on fertility risks and be offered appropriate fertility preservation methods. Previous studies have shown low adherence to these quality measures. At Johns Hopkins Pediatric Oncology, a baseline survey revealed that only 70% of patients or their parents recalled receiving fertility counseling at initial diagnosis, and 50% of eligible patients were referred for fertility preservation procedures. Methods: A multidisciplinary group comprising Pediatric Oncology physicians, nurses, and social workers was formed to address barriers to appropriate oncofertility care. The team identified staff education, a practice standard, and familiarity with fertility preservation resources as needs. Many active resources were available, such as a pediatric ovarian cryopreservation research protocol. Results: Comprehensive fertility counseling and preservation practices for boys and girls were established to provide guidance and resources to the treating primary oncology team. Girls are risk stratified according to the planned therapy for their disease, and offered ovarian or oocyte cryopreservation if therapy carries an intermediate to high risk of fertility loss. Non-invasive sperm banking is recommended for all post-pubertal males who will receive therapy with any degree of gonadotoxicity. An oncofertility team provides 24/7 consultation for the primary oncology team and patients and proactively identifies newly diagnosed patients who need counseling. The comprehensive protocol has been published on the online center-wide policy repository, and the consult service has been frequently utilized. A cross-sectional questionnaire study will be performed annually to monitor compliance to protocol and quality of care. Conclusions: A proactive team approach can overcome barriers to quality oncofertility practice.
Complications of local/regional treatment of breast cancer and quality of life
Authors: B. Ozcinar, V. Ozmen, S. A. Guler, B. M. Gulluoglu, N. Kocaman, M. Ozkan, M. E. Muslumanoglu, A. Igci, M. Kecer, T. Dagoglu
Journal: Journal of Clinical Oncology (2009)

e11597 The aim of this prospective clinical study was to evaluate early and late complications of different surgical procedures, and compare conservative surgical treatments (breast conserving surgery, sentinel lymph node biopsy) to more radical ones (mastectomy, axillary lymph node dissection), and find factors that were related to these complications. 218 early stage breast cancer patients (stage I and II) were enrolled in this study. Physical complications (restrictions in shoulder motions, shoulder functional capacity, pain, lymphedema and sensory loss), psychological complications and the factors related to these complications were studied in patients after breast cancer surgery and/or radiotherapy at first week, at 9th-12th months and at mean follow up time of 34 months. Lymphedema rates after surgery were 14.7 %, 24.8% and 17.0% at first week, 9th-12th months, and long term respectively. In early postoperative period, pain and functional capacity of the effected shoulder were worse than preoperatively measured values and all axis of motion of shoulder joint were effected significantly. On the other hand, at 9th-12th months, only internal flexion was still affected. At the long term period, all axis of motion of shoulder joint, pain and functional capacity were in normal range as before treatment. The factors related to lymphedema were axillary lymph node dissection (p=0.002), radiation therapy to axillae (p&lt;0.001). The patients who had both axillary lymph node dissection and axillary radiotherapy had more lymphedema than the patients who only had axillary lymph node dissection or sentinel lymph node biopsy (p=0.004). The factors related to postoperative depression at early period were cigarette smoking (p=0.008), axillary lymph node dissection (p=0.045) and arm lymphedema (p=0.005). At long term period they were axillary lymph node dissection (p=0.021), mastectomy (p=0.036), drain usage (p=0.028) and sensory loss (p=0.027). The patients who had sentinel lymph node biopsy, axillary dissection without axillary radiotherapy had better quality of life. The patients with cigarette smoking, axillary lymph node dissection, mastectomy, drain, lymphedema and sensory loss had increased incidence of depression than others, these results were statistically significant. No significant financial relationships to disclose.
Palliative percutaneous nephrostomy in 26 patients with recurrent cervical cancer
Authors: R. Dienstmann, C. Da Silva Pinto, M. Tutungi Pereira, I. Avila Small
Journal: Journal of Clinical Oncology (2005)

8235 Background: Cervical cancer (CC) is a public health problem in Brazil, with annual incidence rates of 20 to 40 cases/ 100.000 women. Most patients with recurrent disease have local symptoms and develop renal failure. There are no clear guidelines to predict which patients in palliative care should benefit from percutaneous nephrostomy (PN) in terms of survival and quality of life. This study aims to evaluate the outcome of patients with recurrent CC in palliative care submitted to PN and thereby identify those who can potentially benefit from this intervention. Methods: Retrospective study of 26 patients assisted in the Palliative Care Unit of INCA from January 2002 to June 2004. Results: Median age was 44 years (28 - 67). All patients were previously treated with radiotherapy with or without chemotherapy and brachytherapy. At relapse, all patients presented with locally advanced disease and 3 had metastatic disease. PN was unilateral in all patients. Sixteen patients (61%) had improvement of uremic symptoms after PN and 6 (23%) in Performance Status (PS). Median creatinine levels before and after PN were 7 and 3 mg/dl, respectively. Normalization of renal function was achieved in 10 patients (38%). Until December 2004, 24 patients have died. Median survival after PN was 61 days (95% CI: 44 - 78). Median survival was 82 days (64 - 100) in 16 patients with PS 1 - 3 and 16 days (5 - 27) in 10 patients with PS 4 (log rank p < 0.0001). Survival in patients with creatinine prior to PN lower and higher than 7 mg/dl (n: 14/12) was 74 days (48 - 100) and 48 days (0 - 106), respectively (p 0.06). In patients with creatinine after PN lower and higher than 3 mg/dl (n: 13/13) median survival was 74 days (58 - 90) and 20 days (0 - 69), respectively (p 0.02). Sixteen patients (61%) died due to renal failure, 6 (23%) from urinary sepsis and 4 (16%) from cachexia. Half of the patients had complications of PN, mainly urinary tract infection (n: 6), catheter loss (n: 6) and bleeding (n: 1). Conclusions: These data suggest that PN can be of clinical benefit for patients with recurrent CC and PS 1 to 3, offering them a chance of prolonged palliation. Improvement of renal function after PN leads to increase in survival. Complications of this procedure are frequent and most patients die in renal failure. No significant financial relationships to disclose.
Quantitative CT-estimation of total and regional lung inflation in patients with bronchial asthma (BA)
Authors: Andrey V. Il'in, Juliy M. Perelman, Anatoliy V. Lensin
Journal: European Respiratory Journal (2012)

Background:  Functional abnormalities are often the first and the only symptoms in BA. Spirometry do not allow lung inflation.  Aim:  To estimate the potential of CT in identification of total and regional lung hyperinflation in BA patients.  Methods:  70 BA patients were examined compared with 20 healthy persons. The method of two stage multispiral CT by Activion 16 (Toshiba) with the further 3D-reconstruction and volumetry (-850 HU and lower) was used. The quantitative densitometric estimation at axial scanning in fixed upper, middle and lower lung zones was also done. Bronchodilation test with salbutamol inhalation was used.  Results:  The lung dysfunction was registered in 66 patients. By 3D-volumetry, lung inflation at maximal expiration against inspiration in mild BA was 3.8±2.46% (in healthy people - 0.3±0.55%, p Conclusion:  By 3D-volumetry and densimetric analysis the conclusions about the lung inflation abnormality and the volume of “air traps” in BA patients can be drawn, which considerably supplements the spirometry.
Trastuzumab (T) plus capecitabine (C) in heavily pretreated patients (pts) with advanced breast cancer (ABC)
Authors: R. Bartsch, C. Wenzel, G. Altorjai, U. Pluschnig, G. J. Locker, M. Rudas, R. M. Mader, C. C. Zielinski, G. G. Steger
Journal: Journal of Clinical Oncology (2007)

1055 Background: In pts with Her2 positive ABC, taxane or vinorelbine plus T are among the most widely applied options in the first line setting. We evaluated the efficacy and tolerability of TC in pts with Her2 positive ABC after anthracycline and docetaxel or vinorelbine failure. Methods: Forty consecutive pts (median age 57.5 years) were included. As of December 2006, all are evaluable for toxicity and 35 for response. C was administered at a daily dose of 2,500 mg for two consecutive weeks (w) every 3 w, with dose modifications if necessary. T was administered in 3 w cycles at a dose of 6 mg/kg bodyweight after a loading dose of 8 mg/kg. Time to progression (TTP) was defined as primary endpoint. Response was evaluated every three months (m) using UICC criteria. TTP and overall survival (OS) were estimated using the Kaplan-Meier product limit method. Differences in TTP for 2 nd line and beyond 2 nd line were analyzed with the log-rang test. Results: All pts had prior exposure to an anthracycline and at least one anti-microtuble agent (i.e. a taxane or vinorelbine). All had at least one earlier T containing treatment line for ABC. Median time of observation was 18.5 m. We observed a complete response in 2.9%, partial response in 20%, stable disease = 6 months in 48.6%, and progression in 28.6% of pts. OS was median 24 m (95% CI 20.3–27.7), and TTP 8 m (95% CI 5.8–10.1). No significant difference was found for 2 nd and beyond 2 nd line treatment. Diarrhoea (5%) and hand foot syndrome (16%) were the only treatment-related adverse events that occurred with grade 3 or 4 intensity. A dose reduction was necessary in 22.5%. Two pts developed brain metastases (BM) while on therapy, 6 had BM at time of treatment initiation, a further 5 developed BM during follow up. Of 6 pts with BM, 3 gained clinical benefit from treatment (one pt not yet evaluable). Conclusions: TC appears to be an effective and safe option as salvage therapy in a heavily pretreated population. TTP and response rates are similar to results from C plus lapatinib. Of note is the activity in pts with BM. Further, only 2 pts (5%) developed BM while on treatment. Therefore, a direct comparison of TC with C plus lapatinib or T plus lapatinib seems warranted. No significant financial relationships to disclose.
Bicalutamide (150 mg) monotherapy versus LHRHa as neoadjuvant treatment in intermediate- and high-risk prostate cancer: A case matched study.
Authors: Darren M. Mitchell, Cliona McDowell, Ursula McGivern, Gemma Corey, Jolyne O'Hare, Joe M. O'Sullivan
Journal: Journal of Clinical Oncology (2014)

226 Background: The role of neo-adjuvant Lutenising Hormone Releasing Hormone Agonist (LHRHa) therapy prior to radical radiotherapy of intermediate and high risk prostate cancer (PC) has been clearly defined. Anti-androgen (AA) monotherapy is often used as an alternative to castration therapy in this setting due to a more favorable toxicity profile, however the evidence base is weaker. We compared biochemical failure free survival (BFFS) and prostate-specific antigen (PSA) kinetics in men receiving radical radiotherapy for localised prostate cancer and neo-adjuvant hormones with either AA or LHRHa therapy. Methods: All men with intermediate and high risk PC treated with AA monotherapy prior to radical prostate radiotherapy between April 2004 and December 2008 were individually case matched for key prognostic factors with men treated with neoadjuvant LHRHa monotherapy at our institution. BFFS, PSA kinetics, and absolute pre-RT, post neo-adjuvant hormone PSA (PRPH-PSA) level were analyzed. Results: Sixty five men treated with AA monotherapy were matched to with 65 men treated with LHRHa. The median follow-up was 74 months and 67 months, respectively. Phoenix BFFS was seen in 14 (23.4%) and nine (13.8%) of AA and LHRHa patients respectively with the log rank test indicating no statistically significant difference between the groups. Statistically significant differences were seen between groups in the PRPH-PSA with a geometric mean of 2.0ng/ml (range 0.1 – 11.2) for AA patients and 1.0ng/ml (range 0.1 – 11.1) for LHRHa patients (p&lt;0.001). There was no significant difference between groups in the geometric mean PSA halving time or velocity during the neo-adjuvant period. A PRPH-PSA of less than 1.0ng/ml and less than 0.1ng/ml was seen in 16 (24.6%) and two (3%) of the AA patients and 34 (52.3%) and three (4.6%) of LHRHa patients, respectively. Conclusions: Our case matched study demonstrates that there was no statistical difference in BFFS between patients receiving neo-adjuvant AA versus LHRHa at median follow-up of 72 months. AA monotherapy resulted in less PRPH-PSA suppression when compared to neo-adjuvant LHRHa alone. Longer follow-up is required to determine if the differences in PSA kinetics translate into clinically meaningful differences.
Male breast cancer in Parma Province: Descriptive epidemiology, molecular markers and clinical variables
Authors: M. Michiara, M. A. Bella, N. Naldi, A. Musolino, P. Zanelli, B. Bortesi, M. Capelletti, V. De Lisi, P. Sgargi, V. Franciosi
Journal: Journal of Clinical Oncology (2004)

9655 Background: germ-line mutations of BRCA2 are associated with an increased risk of male breast cancer and with a family history of female breast and/or ovarian cancer. Methods: through the data of Parma Cancer Registry, we collected all cases of male breast cancer from January 1st, 1978 to December 31st, 2000. Of these, we reviewed family history, clinical and pathological records. DNA samples were obtained from 19 patients and BRCA2 mutational analysis is ongoing. Results: total number of incident cases was 54. Male to female ratio for breast cancer incidence was 1:117 in Parma during this period. Mean age of the male breast cancer incident cases was 67, (range 32–87). The average number of incident cases and the average crude incidence rate increased from 1.6 and 0.93, respectively (1978–82) to 3.0 and 1.57 (1998–2000), and similarly, the age standardized rate changed from 0.49 to 0.74. The relative 5 year survival rate shows an improvement from 68% (1978–81) to 93% (1990–94). Thirty three were ductal infiltrating carcinomas, 2 lobular, 1 mucoid, 2 papillary, 1 cribriform, 1 tubular, 8 NOS, 3 adenocarcinomas, 2 papillary adenocarcinomas and 1 was without microscopic confirmation. Interestingly, lobular histology was seen only in two cases of hyper-estrogenism (one case for drug exposure and the other for liver cirrhosis). No cases of Klinefelter's syndrome were observed. The distribution by stage, which is available for 37 patients is as follows: 9 stage I, 14 stage II, 14 stage III, 0 stage IV. With regard to the 19 patients screened for germ line BRCA2 mutations, 6/19 (31%) and 2/19 (10%) patients had a family history of breast cancer and ovarian cancer, respectively. Estro-Progestinic receptor status was positive in 14 (73%) cases and HER-2/neu immunostaining was positive in 5 out of the 12 (41%) evaluated samples. Conclusion: Our results are preliminary and need to be completed with data obtained by BRCA2 direct sequencing. Our future purpose is to address the question of the contribution of BRCA2 germ line mutation to the phenotype of these tumors. No significant financial relationships to disclose.
Genetic changes in two cell lines from human malignant mesothelioma during long term culturing
Authors: V. Relan, K. R. Quinn, C. M. Wright, S. M. Savarimuthu, M. E. Tan, B. E. Clarke, E. E. Duhig, I. A. Yang, K. M. Fong, R. V. Bowman
Journal: Journal of Thoracic Oncology (2011)
The role of stereotactic conformal radiation boost in the temozolomide-based chemoradiation for glioblastoma multiforme: Preliminary analysis
Authors: M. Balducci, S. Manfrida, G. R. D’Agostino, C. Anile, L. Azario, A. Mangiola, N. Dinapoli, G. Apicella, P. Vitucci, V. Valentini, N. Cellini
Journal: Journal of Clinical Oncology (2007)

12513 Background: Glioblastoma multiforme (GBM) is the most common primary brain tumor in adults. Aim of this analysis was to evaluate tolerance and outcome of the dose intensification by stereotactic conformal radiotherapy (SCRT) and concomitant chemotherapy with temozolomide Methods: From October 2003 to April 2006, 58 patients (34 males, 58.6%, 24 females, 41.4%) with histological diagnosis of glioblastoma multiforme received postoperative radiochemotherapy with SCRT boost. Median age was 58 yrs. ( range 25–80 yrs.). Twenty-nine out of 58 patients (50%) received a total dose of 70 Gy by conformal radiotherapy and SCRT boost delivered as concomitant and sequential, or sequential alone. The remainig 29 patients (50%) received a standard of 5940 cGy (180 cGy/day; CTV3: tumor bed + residual tumor if present + oedema; CTV2: tumor bed + residual tumor if present + 1.5 cm margins. CTV1: tumor bed + residual tumor if present + 0.5 cm margins only for the SCRT group). All patients received concomitant Temozolomide, 75 mg/m 2 for a median duration of 28 days (range 14–45, depending on the chemoradiation schedule), and adjuvant chemotherapy with temozolomide for 6 cycles or until disease progression. Toxicity was recorded according to RTOG criteria; Survival analysis was calculated by the Kaplan-Mayer method and log-rank testing was used for groups comparison. Results: A 100% compliance was observed in both the groups of patients. A grade 3–4 acute neurological toxicity was registered in two patients treated with SCRT compared to one patient in the group which did not receive SCRT. One case of radionecrosis was observed in the SCRT group; in no case of either group neurological worsening nor corticosteroidal dependence were registered. At a median follow-up of 19 months (range 4–39), a trend towards a better outcome was observed in patients treated with SCRT, since the 1-year OS was 85.9% for SCRT patients (median not achieved) compared to 68.7% for the remaining patients (p=0.07). Conclusion: Our preliminary analysis suggests that a higher dose of RT delivered by conformal stereotactic boost did not increase acute or late toxicity and could achieve a better outcome in patients affected by GBM No significant financial relationships to disclose.