bluuebunny/crossref_metadata_2025_split huggingface dataset:
Is there a preferred dose of palonosetron? Results of an abstracted data (AD) meta-analysis (MA) of all eight randomized double-blind (RDB) studies and the impact on guideline considerations
Authors: Raftopoulos H. , Bria E. , Gralla R. , Lesser M. , Napolitano B. , Giannarelli D. 
Published: August 2020

9636 Background: Controversy continues whether there should be a guideline-preferred 5-HT3 antagonist. Large trials with palonosetron (palo) 0.25 mg demonstrated advantages over earlier 5-HT3 agents in preventing emesis with chemotherapy (chemo). Guideline groups have not consistently adopted palo as the preferred 5HT3 agent since these trials omitted the recommended addition of dexamethasone (dex). A recent 1100 patient RDB trial (Yoshizawa, ESMO 2008) found superiority for palo 0.75 mg + dex versus granisetron 3 mg + dex. Both palo and granisetron are approved at varying doses in different countries. This abstracted-data MA was conducted to see if this palo dosing yields differences. If not, results from randomized trials at either dose can aid practice and guideline committees in 5-HT3 agent selection. Methods: A literature search and colleague inquiry identified RDB trials that included treatment arms with 0.25 mg and 0.75 mg of palo. MA primary endpoint: Complete Response (CR - no vomiting, no rescue) over days 1–5 after chemo. Secondary endpoints: 1)Acute CR (day 1), 2)Delayed CR (days 2 - 5), 3) Grade 3–4 toxicities. Data were abstracted and checked by at least 2 reviewers. CMA software v2 (Biostat, NJ) was used to calculate relative risk ratios (palo 0.75 vs palo 0.25) with 95% confidence intervals (CI). Results: 8 trials with 1926 patients included all RDB studies with these palo doses - 4 with HEC and 4 with MEC (6 with IV and 2 with oral palo). The Cochrane Q test indicated no heterogeneity (het) for overall and delayed CR; het seen in the acute setting was accounted for by the 2 smaller dose-finding studies. No significant toxicity differences were found. Conclusions: Palo doses of 0.25 mg or 0.75 mg yield very similar efficacy and safety with both HEC and MEC in this literature-based MA. Results with either dose can aid in practice and guideline considerations for all chemo groups studied. [Table: see text] [Table: see text]
Preoperative fluorouracil (FU)-based chemoradiation with and without weekly oxaliplatin in locally advanced rectal cancer: Pathologic response analysis of the Studio Terapia Adiuvante Retto (STAR)-01 randomized phase III trial
Authors: Aschele C. , Pinto C. , Cordio S. , Rosati G. , Tagliagambe A. , Artale S. , Rosetti P. , Lonardi S. , Boni L. , Cionini L. ,   on behalf of STAR Network Investigators
Published: August 2020

CRA4008 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.
Outcome of primary tumor in patients with synchronous stage IV colorectal cancer receiving combination chemotherapy without surgery as initial treatment
Authors: Poultsides G. A. , Servais E. L. , Saltz L. B. , Patil S. , Kemeny N. E. , Guillem J. G. , Weiser M. , Temple L. K. , Wong W. , Paty P. B. 
Published: August 2020

CRA4030 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]
Maintenance pemetrexed (Pem) plus best supportive care (BSC) versus placebo (Plac) plus BSC: A randomized phase III study in advanced non-small cell lung cancer (NSCLC)
Authors: Belani C. P. , Brodowicz T. , Ciuleanu T. , Kim J. H. , Krzakowski M. , Laack E. , Wu Y. L. , Peterson P. , Krejcy K. , Zielinski C. 
Published: August 2020

CRA8000 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]
Vandetanib plus docetaxel versus docetaxel as second-line treatment for patients with advanced non-small cell lung cancer (NSCLC): A randomized, double-blind phase III trial (ZODIAC)
Authors: Herbst R. S. , Sun Y. , Korfee S. , Germonpré P. , Saijo N. , Zhou C. , Wang J. , Langmuir P. , Kennedy S. J. , Johnson B. E. 
Published: August 2020

CRA8003 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]
An economic analysis of arthralgia/myalgia (A/M) versus recurrence in women with hormone receptor-positive (HR+) breast cancer (BC) on aromatase inhibitors (AIs)
Authors: Hadji P. 
Published: August 2020

e11601 Background: The symptoms of A/M are associated with estrogen suppression and are more common with AIs relative to tamoxifen (TAM). AIs have demonstrated superior efficacy when compared with TAM. In BIG 1–98, letrozole (LET) treatment provides a significant reduction in the risk of distant metastasis (DM); the updated 76 month BIG 1–98 analysis now suggests that early reduction in DM ultimately leads to overall survival (OS) benefit, 40 fewer deaths with LET compared with TAM. [Mouridsen, 2008] It has been reported that women reporting new joint symptoms at 3 months after initiating an AI have a significantly lower risk for recurrence compared with women not reporting these symptoms [Cuzick, 2008]. Methods: Data from the Henry Ford Health System (1995–2005) were used to identify postmenopausal HR+ early BC patients with at least 1 year of AI therapy follow-up after surgery. Total health care costs of managing A/M associated with hormone therapy as well as BC recurrences were estimated from charges incurred during health care encounters for these conditions. Results: In the 834 patients eligible, the treated A/M incidence was 21% and the total health care cost ∼ $429 per symptomatic patient/yr. The average annual cost of any BC recurrence was previously reported at ∼$131,000/yr, with greatest cost seen with DM at ∼ $265,783/yr [Weiderkehr, 2008]. Conclusions: The economic costs of treating A/M are nominal, particularly in light of the superior efficacy of AIs and the economic burden of BC recurrences. DM is the most costly of the recurrences, and in BIG 1–98, reducing early DM appears to impact OS. Discontinuation of AIs, or switching to less effective therapies in an effort to manage A/M, should be weighed against the benefit of AI therapy in reducing BC recurrences, particularly DM, as well as the high costs associated the managing these recurrences. No significant financial relationships to disclose.
Triple detection method for sentinel lymph node detection
Authors: Lee S. , Yang J. , Nam S. , Lee J. , Kim W. , Choi J. , Kim G. , Kim G. 
Published: August 2020

e11605 Background: Sentinel lymph node biopsy is widely accepted method to determine nodal stage of breast cancer. There are several reported method for detecting sentinel lymph node. The aim of this study was to show the new detection method of sentinel lymph node and show the effectiveness of this method. Methods: We did prospective study and enrolled 25 patients who underwent partial mastectomy and sentinel lymph node biopsy. We injected indigocyanine green (green dye) at peritumoral lesion, indigocarmine dye (blue dye) in subareolar area and radioisotope (Tc-99m) injection. Sentinel lymph nodes are identified by color change or radioisotope uptake, and classified by each color (blue or green) and radioisotope uptake. We compared the detection rate from our study with that from the previous studies. Results: Sentinel lymph nodes were detected in all patients (25/25). Green color stained sentinel lymph nodes were identified in 18 patients (18/25), blue color stained sentinel lymph nodes were identified in 15 patients (15/25) and radioactive lymph nodes were identified in 19 patients (19/25). Conclusions: The triple mapping method showed higher detection rate than the previous studies and this method is recommendable to detect sentinel lymph node. No significant financial relationships to disclose.
Male breast cancer retrospective institution review of a 17-year period
Authors: Rodriguez Franco C. , Aguiar Bujanda D. , Saura Grau S. , Bohn Sarmiento U. , Aguiar Morales J. 
Published: August 2020

e11638 Background: Male breast cancer (MBC) is a very uncommon illness relative to female breast cancer (FBC) The are some differences between both that could influence the management, like gene expression, hormonal enviroment and anatomy of the gland. Methods: Retrospective review of patients diagnosed in a seventeen year period (1990–2007). Results: There were 22 male patients diagnosed in our institution with a median age of 62.4 years (range 34 to 83 years) during the period. One had bilateral breast cancer. Stage of disease was I-II in 13 patients (59%), III in 8 patients (36%), and IV in 1 patient (5%). Five patients (22.7%) had familiar history of breast cancer and 3 patients (13%) had familiar history of other kind of neoplasias. Hormonal receptor were positive in thirteen patiens (59%) and 5 were unknown (23%). Ductal carcinoma was the predominant histologic subtype with 17 patients (77%). Other types were pleomorfic, mucoid and papilar carcinoma (one each type) and 3 patients with intrapapilar carcinoma with microinfiltration. Eleven of 20 patologic available axilla had node positive (55%). Grade were I in 3 patients (13%), II in 4 patients (18%), III in 8 (37%) and undefined in in 7 (32%). Surgery was the initial treatment in 18 patients (81%), just 2 of them performing tumorectomy and the other 16 radical mastectomy. 3 patients receive neoadyuvant chemotherapy with 1 complete response and one partial response. 13 patients (59%) received adjuvant radiotherapy (RT) and 17 (77%) adjuvant hormonal therapy (HT) mostly of them with tamoxifen (14/17) and the others 3 patients with aromatase inhibitors. Adjuvant chemotherapy was used in 9 (41%) patients with an antracycline regimen. With a median follow-up of 78 months (range 7–125), overall survival was 77 % with 3 patients died with progression disease and two patients died because of intercurrent illness without evidence of cancer progression. Regarding to our population area we had an incidence of 0.96/100.000 inhabitants during this 17 year period. Conclusions: MBC in our area are in the upper limit of occidental countries incidence. Most cases can be treated with radical intention with surgery (mostly radical) and adjuvant treatment with a good survival percentage. We manage MBC like we do FBC because of absence of clinical randomized trial specific for MBC. No significant financial relationships to disclose.
Peritoneal metastases in breast cancer patients: Differences in survival depending on histological subtype
Authors: Atassi Z. , Varga D. , Plotzki K. , Kurzeder C. , Kreienberg R. 
Published: August 2020

e12024 Background: Distant spread from breast cancer is commonly found in bones, lungs, liver, and central nervous system. Metastatic involvement of peritoneum and retroperitoneum is unusual and unexpected. The aim of the study was to perform a comprehensive analysis of breast cancer patients with peritoneal metastases and to compare survivals depending on biological subtypes. Methods: 44 breast cancer pts with peritoneal metastases were detected out of a database of 2,500 breast cancer patients treated in one institution between 1995 and 2005. Clinical characteristics such as estrogen receptor and progesterone receptor as well as survivals were analized based on breast cancer subtypes. Results: Mean patient age was 54 years, 25 patients (56%) had ductal invasive carcinoma while 19 (44%) were diagnosed lobular invasive carcinoma. 30 (68%) patients had endocrine responsive tumors. A HER-2 percentage is not provided due to the lack of data before the year 2000. Median survival calculated from peritoneal metastases in histologic subgroups was as follows: Median progression free survival was 36.5 months for ductal invasive carcinoma, and 23.5 months for lobular invasive breast cancer. Median overall survival was 46 (Std 38.5) months for ductal invasive breast cancer and 32 (Std 54.5) months for lobular invasive breast cancer. Conclusions: Patients with peritoneal metastases are a heterogenous group with a different outcome. The histologic subtype seems to be an important predictive factor as lobular invasive breast cancer is associated with worsened progression free an overall survival rates. No significant financial relationships to disclose.
Isolated tumor cells versus micro-metastasis in sentinel lymph node biopsy for T1, T2 breast cancer compared to macro-metastasis: Significance after complete axillary dissection
Authors: Alabdulkarim Y. A. , Nassif E. 
Published: August 2020

e12028 Background: Evaluating the axillary lymph nodes is extremely important in the management of breast cancer, with the recent improvement in histopathology techniques detection of micro-metastasis and even isolated cancer cells (ITC) in a setting of sentinel lymph node examination is feasible. In this study we aim to compare the outcome and significance of; positive SLN for macro versus Micro-metastasis, and ITCs. Methods: We reviewed all the patients who had SLN for breast cancer of stage T 1–2 between April 2006 and November 2008. Identifying all those who had positive macro-metastasis, micro-metastasis, or isolated tumor cells, pathology results of the full axillary LN dissection was evaluated for each type. Results: 350 patients had SLN of these 226 had a disease of T1–2, thirty seven patients (16.3%) had full axillary dissection, of these 27/37 had positive SLN for macro-metastasis, six had micro-metastasis and 3/37 had only ITCs. The presence of other LN metastasis was detected in 8 cases (21.6%); all of them were in the macro-metastasis group. No metastasis was found in either the micro-metastasis or the ITC groups. The ITC was only detected with DCIS; while micro-metastasis was present in DCIS or IDC. No relation was identified between the histopathology grade with ITC or micro-metastasis. Conclusions: Our findings did not show any presence of lymphatic metastasis after full axillary dissection, in case of positive micro-metastasis or ITCs in SLN, compared to the group of macro-metastasis. No significant financial relationships to disclose.
Investigation of cognitive screening measures in patients with brain tumors: Diagnostic accuracy and correlation with quality of life
Authors: Olson R. A. , Iverson G. , Parkinson M. , Carolan H. , Ellwood A. , McKenzie M. 
Published: August 2020

e13000 Background: Brief cognitive screening measures are often selected by clinicians and researchers for brain tumor patients, primarily because of their ease of use. Currently, the Mini Mental State Examination (MMSE) is the most commonly chosen, despite a reported low sensitivity. The primary objective of this study was to compare the sensitivity of the MMSE with the Montreal Cognitive Assessment (MoCA). Methods: 44 patients with brain tumors were prospectively accrued and administered the MMSE and MoCA by blinded investigators, 75% of who completed a 4-hour “gold standard” neuropsychological assessment (NPA). Quality of life and community integration were measured with the Functional Assessment of Cancer Therapy-Brain (FACT-Br) and Community Integration Questionnaire (CIQ), respectively. McNemar's test was used to compare sensitivity and specificity at pre-defined cutoff scores and receiver operating characteristic curve analyses were used to examine outcomes across all cutoffs. Correlations were assessed with Spearman's rank correlation coefficient. Results: 55% of patients met criteria for the DSM-IV diagnosis of Cognitive Disorder NOS on the NPA. Using pre-defined cutoffs, the MoCA was significantly more sensitive than the MMSE (55.5% versus 16.6%; p = 0.016), although specificity of the MoCA was poor (60.0%). MMSE scores below 27 were 100% specific; however, this applied to only three subjects. Furthermore, 39% of cognitively impaired subjects scored perfectly on MMSE. A MoCA cutoff of 22 had 28% sensitivity and 93% specificity, and a cutoff of 28 had 94% sensitivity and 20% specificity. The MoCA was correlated with both the FACT-Br (r = 0.319, p = 0.04) and CIQ (r = 0.427, p = 0.005), while MMSE scores did not correlate with either (p > 0.2). Conclusions: The MoCA is more sensitive than the MMSE, though at no cutoff is it both sensitive and specific. Despite its limitations, the MoCA may offer cost saving in the oncology clinic as a cognitive screen: individuals with MoCA scores a) below 22 are likely cognitively impaired, b) above 27 are likely cognitively normal, and c) 22–27 would likely benefit most from NPA. Furthermore, the MoCA is better able to detect cognitive impairment that is related to functional limitations and quality of life. [Table: see text]
Phase I trial combining SCH 66336 to temozolomide (TMZ) for patients with grade 3 or 4 malignant gliomas (MG)
Authors: Desjardins A. , Reardon D. A. , Gururangan S. , Peters K. , Threatt S. , Friedman A. , Friedman H. , Vredenburgh J. 
Published: August 2020

e13004 Background: Ras plays a crucial role in the control of cellular proliferation and differentiation. Farnesylation is an essential step in the post-translational processing of Ras. SCH 66336 inhibits farnesyl transferase, the crucial enzyme in this process. We report a phase I trial of TMZ and SCH 66336. Methods: Eligibility included: adult patients with stable or recurrent MG (GBM, anaplastic astrocytoma [AA], anaplastic oligodendroglioma [AO]) previously treated with radiation therapy (RT) and with or without chemotherapy; interval of at least two weeks between prior RT, or four weeks between prior chemotherapy; Karnofsky ≥ 60%; and adequate hematologic, renal and liver function. Patients were divided in two strata: those receiving enzyme-inducing antiepileptic drugs (EIAED) and those not receiving EIAED. Each patient was treated with TMZ for five days every 28 days, first cycle dosed at 150 mg/m2 and subsequent cycles at 200 mg/m2. SCH 66336 was dosed orally daily and was dose escalated. Responses were assessed after two cycles (8 weeks). The primary endpoints of this study were to determine the maximum tolerated dose (MTD) of SCH 66336 when administered with TMZ, and the toxicity of this combination. Results: Thirty-six patients were enrolled (25 GBM, 6 AA, 3 AO). Fifteen patients have been accrued to the EIAED stratum at SCH 66336 doses of 125, 175, and 250 mg orally BID. Twenty-one patients have been accrued to the non-EIAED stratum at SCH 66336 doses of 75, 100, 150, and 200 mg orally BID. Dose-limiting toxicities were: deep venous thrombosis (1 grade 3); nausea and vomiting (1 grade 3); diarrhea (1 grade 3); elevated ALT (1 grade 3); elevated creatinine (1 grade 3); and fatigue (1 grade 3). Radiographic evaluation reported: 2 partial responses, 14 stable disease for at least 4 cycles, and 11 disease progression after either the first or second cycle. Sixteen patients have completed at least six cycles. One patient is still on treatment, completing cycle 12. The MTD of this combination for the EIAED stratum is 175 mg BID and the non-EIAED stratum is 150 mg BID. Conclusions: SCH 66336 in combination with TMZ is well-tolerated and shows promising response when administered to patient when stable on TMZ alone or after RT and TMZ. No significant financial relationships to disclose.
Phase I study of vandetanib, imatinib mesylate, and hydroxyurea for recurrent malignant glioma
Authors: Kirkpatrick J. P. , Vredenburgh J. J. , Desjardins A. , Gururangan S. , Peters K. B. , Boulton S. T. , Friedman A. H. , Friedman H. S. , Reardon D. A. 
Published: August 2020

e13007 Background: Malignant glioma (MG), an incurable primary CNS tumor, is characterized by frequent aberrant activation of EGFR, VEGFR, and PDGFR. This study will determine the MTD and DLT of vandetanib (V), a once-daily, oral selective inhibitor of VEGFR and EGFR when combined with imatinib mesylate (IM), an inhibitor of multiple tyrosine kinases including PDGFR and hydroxyurea (H). Methods: Adult recurrent MG patients with ≤ 3 prior recurrences, KPS ≥ 60% and adequate organ function were stratified based on concurrent enzyme-inducing anticonvulsant use (EIAC). Both strata were independently escalated using a “3+3” design. H is administered at 500 mg BID while IM is administered at 500 mg BID for patients on EIAC and 400 mg QD for those not on EIAC. V is increased by 100 mg in successive cohorts beginning at 100 mg and 200 mg for patients not on and on EIAC, respectively. Evaluations were after every other 28-day cycle. Pharmacokinetics of V and IM were obtained on days 1 and 28 of cycle 1. Results: Twenty-six patients (grade 4 MG, n = 20; grade 3 MG, n = 6) have enrolled. Only 1 DLT (reversible grade 4 transaminase elevation; dose level 1) occurred among 22 non-EIAC patients and enrollment to this stratum is planned to continue at dose level 4. The MTD of V for patients on EIAC is 200 mg/day due to 2 of 3 patients developing grade 3 thrombocytopenia at the 300 mg/day dose level. Evidence of therapeutic benefit to date includes 1 partial response and 15 patients (58%) with stable disease for at least 4 weeks, including 4 patients for ≥4 months. Conclusions: Combination of V, IM, and H is well-tolerated in recurrent MG patients. Further accrual is ongoing and an update of outcome, toxicity, and pharmacokinetic analyses will be presented. No significant financial relationships to disclose.
Phase I trial of vendetanib and oral etoposide for recurrent malignant gliomas
Authors: Herndon J. , Vredenburgh J. , Reardon D. , Desjardins A. , Peters K. , Gururangan S. , Norfleet J. , Friedman A. , Bigner D. , Friedman H. S. 
Published: August 2020

e13016 Background: Recurrent malignant gliomas have a poor prognosis, with a median survival of 6–15 months, with grade 4 glioblastomas more aggressive than grade 3 anaplastic astrocytomas or oligodendrogliomas. Vascular endothelial growth factor (VEGF) and epidermal growth factor (EGF) are critically important in glioma biology. Vandetanib is a multi-kinase inhibitor, predominantly of VEGF and EGF. We report a phase I trial of vandetanib in combination with oral etoposide for recurrent malignant glioma. Methods: Patients with histologically documented recurrent grade 3 or grade 4 malignant glioma were eligible. Patients were treated with daily oral vandetanib and oral etoposide. The trial design was a modified 3 + 3 Phase I design, with the dose levels outlined below. Results: Eighteen patients have been accrued. There was more hematologic toxicity than expected, with 3/6 of the patients enrolled at dose level 1 developing grade 4 neutropenia. There were no DLT's at the -1 dose level. The protocol was amended to decrease the dose of etoposide to 50 mg daily for 21 days, then 7 days off and dose escalation of vandetanib started again at 100 mg daily. Six patients had no dose limiting toxicity at the new dose level 1 of vandetanib 100 mg daily and etoposide 50 mg daily. Dose escalation continues. There has been clinical activity, with patients remaining stable on study for multiple cycles. Conclusions: Vandetanib and oral etoposide appear to interact to produce more marrow toxicity than expected. A phase II trial is planned when the MTD of vandetanib with reduced dose etoposide is determined. [Table: see text] No significant financial relationships to disclose.