tbuckley/cabot-search huggingface dataset:
Primary CNS lymphoma in HIV-positive and -negative patients: Comparison of clinical characteristics, outcome, and prognostic factors.
Authors: S. Bayraktar, U. D. Bayraktar, A. Stefanovic, I. S. Lossos
Journal: Journal of Clinical Oncology (2010)

e12502 Background: Primary central nervous system lymphoma (PCNSL) accounts for approximately 4% of all primary brain tumors and has a poor prognosis in both immunocompetent as well as in immunocompromised patients. We conducted a retrospective analysis to examine the clinical characteristics and prognostic factors in HIV-negative and positive patients with PCNSL and to assess the effect of highly active antiretroviral therapy (HAART) therapy on the outcome of HIV-positive patients. Methods: Patients diagnosed with PCNSL between 1999 and 2008 at our institution were divided into two groups based on their HIV status. Their demographic and clinical characteristics were compared using the chi-square test. Kaplan-Meier survival curves were constructed employing the univariate log-rank test. Multivariate analyses of survival were performed by Cox proportional hazards models incorporating the prognostic factors identified in the univariate log rank test. Results: Forty-one HIV-positive patients and 45 HIV-negative patients were included in the statistical analysis. HIV-positive patients were younger; more likely to present with seizures and elevated serum LDH levels. The most commonly used chemotherapy regimen in the HIV-negative group was methotrexate-based, following the DeAngelis protocol, with an overall response rate (ORR) of 73%. All HIV-positive patients were treated with azidothymidine combinations, with a cumulative ORR of 56%. There were significant differences in complete remission (CR) rates (p = 0.010) and overall survival (OS) (p = 0.034) in favor of the HIV-negative group. In the HIV-positive group, OS was better in patients with KPS > 70 and patients who received HAART, but remained inferior to that in the HIV-negative patients. Moreover, in patients who were not on HAART before PCNSL diagnosis, initiation of HAART was associated with better OS (4.0 vs. 1.1 months, p = 0.007). Conclusions: HIV-positive patients had a worse prognosis compared to HIV-negative patients despite similar clinical characteristics. Better performance status (KPS > 70) and treatment with HAART conferred better OS in HIV-positive patients. No significant financial relationships to disclose.
Colorectal cancer in elderly patients: A single-center experience.
Authors: G. Resch, M. Poetscher, W. Schauer, W. Hoebling, B. Mayrbaeurl, S. Burgstaller, J. Thaler
Journal: Journal of Clinical Oncology (2011)

576 Background: In Austria more than 40% of cancers occur in adults over the age of 75 years. As the current population ages and more people live longer, the incidence of cancer in elderly patients (pts) is expected to rise. Several studies have shown that cancer treatment is beneficial for elderly pts in adjuvant and palliative setting. However, elderly pts with cancer have been underrepresented in clinical trials and there is little literature on this pts group. We now want to present our own experience in the treatment of elderly pts with colorectal cancer (CRC). Methods: Since July 2006 all pts with new diagnosed CRC were recorded in a tumor registry at the Klinikum Wels- Grieskirchen. Patients were followed for treatment decision, progression free survival and overall survival. In this retrospective analysis elderly pts &gt;75 years diagnosed with CRC have been evaluated. Results: Overall, 165 pts &gt;75 years (range 75-92) with a diagnosis of CRC stage I-IV were recorded from July 2006-July 2010 in our registry. Seventy-six (46.1%) and 89 (53.9%) out of these pts were men and women. Stage I has been diagnosed in 25 pts (15.2%), stage II in 57 pts (34.5%), stage III in 47 pts (28.5%) and stage IV in 36 pts (21.8%). 30.7 % (51 pts) had a tumor located in the rectum and 69.3% had colon cancer. 154 out of 165 pts underwent surgery (tumorectomy or colectomy). In one patient with stage II and in 11 pts with stage IV surgery was not possible because of poor performance status. Adjuvant chemotherapy was given in 8 pts with stage II and in 25/47 pts with stage III CRC. 11/36 pts were treated with palliative chemotherapy in stage IV CRC. 17 pts with stage I-III develop distant metastases and 11 out of these pts have been treated with palliative chemotherapy. Hemihepatectomy and lobectomy has been performed in 7 and 1 pts. Overall 13 pts (7.9%) were treated within a clinical trial for CRC. Chemotherapy regimens, progression free survival and overall survival data will be presented. Conclusions: Although elderly pts often have comorbidities and poor performance status, age alone should not determine treatment options and person's eligibility in clinical trials. A careful discussion of treatment risks and benefits, especially in elderly pts, needs to be considered in the therapy decision. No significant financial relationships to disclose.
Growth kinetics and outcomes of cT1b renal masses under active surveillance.
Authors: Reza Mehrazin, Marc C. Smaldone, Alexander Kutikov, Jeffrey J. Tomaszewski, Tianyu Li, Rosalia Viterbo, Richard E. Greenberg, David Y. T. Chen, Robert G. Uzzo
Journal: Journal of Clinical Oncology (2014)

440 Background: The natural history of untreated T1b renal masses is poorly understood. We assessed the growth kinetics and outcomes of ≥cT1b cortical renal tumors which continue to remain on radiographic AS compared to those who underwent definitive surgery after a period of AS. Methods: Prospectively maintained, renal tumor database was reviewed to identify enhancing solid and cystic masses managed expectantly from 2000-2012. cT1a masses, transitional cell carcinoma or those suspected for metastatic disease were excluded from analysis. Localized tumors &gt; 4.0 cm (≥T1b) that were radiographically followed for &gt; 6 months were included for analysis. Clinical and pathological records were reviewed to determine tumor growth rate and clinical outcomes in those remained on AS or those who underwent delayed intervention. Mean for tumor size on presentation, annual linear tumor growth rate (LGR), Charlson comorbidity index (CCI), and follow-up (FU) were calculated. Chi−square test &amp; Logistic regression were used for uni- and multi-variable analyses. Results: Of 457 pts managed with AS, 67 cT1b tumors (in 63 patients) were identified. 43 pts (67%) were managed solely with AS, while 21 pts (33%) progressed to intervention. The median age at presentation pts managed with AS and intervention was 77 and 60 yrs respectively (p=0.0002), while no difference was observed in median CCI (3 vs. 2, p=0.6). No difference was observed in tumor size at presentation between pts managed with AS and those undergoing delayed intervention (5.9 vs. 5.4 cm, p=0.8). In contrast, the mean LGR significantly differed between pts managed expectantly and pts progressed to intervention (0.37 vs. 0.73 cm/yr; p=0.02). On MVA, age (OR=0.9,CI:0.8−0.98) and LGR (OR=11,CI:1.8−60) were significant predictors of surgical intervention. With a mean FU period of 38.9 ± 24.0 months (6−105), 9 pts died (14%) from other cause and no pt progressed to metastatic disease. Conclusions: Localized cT1b≥ renal masses show comparable growth rates to small tumors managed expectantly with low rates of progression to metastatic disease with short term follow up. An initial period of AS to determine tumor growth kinetics is a reasonable option in select pts with significant competing risks and limited life expectancy.
Randomized phase II study of best available fluoropyrimidine compared with continuation of gemcitabine (Gem) monotherapy in patients with Gem-refractory pancreatic cancer.
Authors: Tatsuya Ioka, Kazuhiro Katayama, Nobuko Ishida, Ryoji Takada, Takuo Yamai, Nobuyasu Fukutake, Reiko Ashida, Hiroyuki Uehara, Hiroaki Ohigashi, Hidenori Takahashi, Osamu Ishikawa
Journal: Journal of Clinical Oncology (2013)

287 Background: Gem is a standard chemotherapy for unresectable pancreatic cancer (PC) patients (pts); however there is no standard regimen for Gem-refractory PC pts. We often continue to administer Gem for Gem-refractory PC pts because Gem is less toxic. The aim of this study is to elucidate the efficacy of second line treatment in PC. Methods: The pts who were treated with standard dose of Gem and diagnosed disease progression with radiographic findings were randomly allocated to arm A (to treat with best available fluoropyrimidine) or arm B (to continue to treat with standard dose of Gem). Each doctor could choose one of the available fluoropyrimidine (5FU, UFT and S-1) in arm A. Results: We collected 80 patients from Jan, 2004 to Sep, 2008 into this trial. 27 pts (67.5%) were treated with S-1, 8 pts (20%) with UFT and 5 pts (12.5%) with 5FU in arm A. Response Rate were 10% in arm A and 0% in arm B, respectively. Disease Control Rate were 50% and 17.5%, Progression Free Survival Time were 113 days and 50 days (p&lt;0.1050) and Overall Survival Time were 226 days and 161 days (p&lt;0.0384), respectively. Conclusions: Fluoropyrimidine statistically improve survival time in Gem-refractory PC pts, compared to continue Gem. Clinical trial information: UMIN000002154.
Symptom distress and patterns of palliative-care referral among oncology outpatients.
Authors: Kaylan Christianer, Craig D Blinderman
Journal: Journal of Clinical Oncology (2016)

185 Background: The early implementation of palliative care services is recognized as an important aspect of oncologic care. However, rates of referral to palliative care services among oncology patients are still low, and the decision to refer is frequently at the discretion of the treating oncologist or by patient request. We sought to better identify the patterns of referral to outpatient palliative care, as well as patient symptom burden in an effort to target early and high-yield palliative care interventions. Methods: We conducted a cross-sectional survey among outpatients presenting to a Hematology/Oncology practice at a tertiary care hospital. Patients presenting to the clinic were asked to complete an Edmonton Symptom Assessment Scale (ESAS) survey at time of registration. Chart review was completed to identify basic demographic information, timing and extent of cancer diagnosis, basic medical and psychiatric comorbidities, and existing referral to palliative care services. Results: Between November 15, 2014 and December 24, 2014, a total of 146 complete surveys were collected from oncology outpatients. The most common malignancies were hematologic (40.4%), lung (24.6%), breast (8.2%), gastrointestinal (6.8%) and genitourinary (6.8%); 30.1% had metastatic disease at the time of the visit. A total of 13 patients (8.9%) were receiving outpatient palliative care services. As compared to patients not receiving palliative care services, those who were reported higher overall symptom distress scores (26.3 vs. 12.7, p = 0.013) and pain scores (3.5 vs. 1.6, p = 0.03). Patients receiving palliative care services also had fewer years since diagnosis (2.8 years vs. 4.5 years, p = 0.028), and a non-significant trend toward higher rates of metastatic disease (72.7% vs. 47.3%, p = 0.059). Conclusions: Overall, low rates of referrals to palliative care were found among oncology outpatients. In addition, this study suggests oncology patients are referred to palliative care at later stages of disease, when they are already experiencing significant symptom burden. Future research will determine which patients will benefit from earlier referrals to palliative care before symptoms become more advanced.
Development of provincial clinical standards for the province of Ontario.
Authors: Sara Urowitz, Denise Marshall, Jeff Myers, Deanna Bryant
Journal: Journal of Clinical Oncology (2015)

117 Background: The province of Ontario is committed to improving palliative care services. This commitment to change is outlined in The Declaration of Partnership, the provincial roadmap for improving palliative care. To help drive this change in the clinical environment, a Clinical Council for Palliative Care was established to be responsible for providing direction on clinical implications of policy, and advancing clinical improvement in palliative care in Ontario. To this end, Clinical Council has articulated a set of 12 interrelated provincial clinical standards which outline priority areas for clinical change and improvement in the province. Methods: Key stakeholder engagement was undertaken to identify evidence-based, best practices for delivery of palliative services. A consensus process was used to identify the priority set of essential clinical standards for high quality care that is both practical and scalable. Expert working groups were established to refine the standards based on evidence and leading or best practice to the Ontario context. Response was solicited from stakeholders, and qualitative analysis was conducted; standards will be refined based on feedback. Results: Based on the results of the stakeholder engagement, a “Clinical Change Strategy” was identified and a set 12 “clinical imperatives” were identified. Through the consensus process 12 Provincial Clinical Standards were endorsed. Conclusions: Engaging in an evidence informed process with key stakeholders has enabled the creation of a set of 12 interconnected Provincial Clinical Standards for palliative care in Ontario. These standards will help to advance high quality palliative care in the province. The standards represent a population health based strategy for change, which can have a positive impact at the systems level. Stakeholder feedback will result in further refinement of the standards, which will ultimately provide the foundation for standardized approaches for palliative services across Ontario.
Phase II study of chemoradiotherapy with docetaxel for elderly patients with stage II/III esophageal carcinoma: An updated report.
Authors: Akihiro Ohba, Jun Hashimoto, Ken Kato, Yoshinori Ito, Nobukazu Hokamura, Chikatoshi Katada, Hiromichi Ishiyama, Sachiko Yamamoto, Takashi Ura, Takeshi Kodaira, Shigehiro Kudo, Takayuki Nakamura
Journal: Journal of Clinical Oncology (2015)

208 Background: Definitive chemoradiotherapy (CRT) is one of the curative options for resectable esophageal carcinoma (EC). However, there are limited data on CRT in elderly patients, and it is difficult for elderly patients to receive chemotherapy containing cisplatin. The aim of this prospective study was to clarify the efficacy and safety of definitive CRT with docetaxel (DTX) in elderly patients. Methods: The eligibility criteria for this study were as follows: clinical stage II-III (UICC 6th, non-T4) EC; performance status (PS) 0-1; age &gt; 70; and no desire for surgical treatment. Chemotherapy consisted of 6 cycles of a 1-h infusion of DTX (10 mg/m 2 ) repeated weekly. Radiation was concurrently applied at a dose of 60 Gy in 30 fractions. We calculated that with a sample size of 37 patients, assuming that the expected and threshold 2-year survival was 50% and 30% with one-sided alpha of 5% with 80% power. Results: Between July 2008 and January 2011, 16 patients were enrolled. The study was closed prematurely due to poor accrual. The median age was 77 years (range, 73-81); male/female: 14/2; PS 0/1: 4/12; clinical Stage IIA/IIB/III: 3/4/9. Of the 16 patients, 14 (88%) completed the CRT, 1 patient (6%) could not complete the treatment because of grade 3 esophagitis, and 1 (6%) refused to continue the treatment. The median follow-up time was 57.9 months. Six patients achieved complete response (CR), resulting in a 37.5% CR rate (95% confidence interval (CI): 15.2-64.6). The 2-year overall survival rate was 62.5% (95% CI: 39.0-86.0). The median survival time was 27.8months (95% CI: 23.7-31.9). Acute toxicities included grade 3/4 esophagitis (31%), anorexia (13%), leukopenia (6%), neutropenia (6%), thrombocytopenia (6%), mucositis (6%), and infection (6%). No treatment-related deaths were observed. Grade 3 or 4 esophagitis, pleural effusion, pericardial effusion, and pneumonitis developed as late adverse events in 13%, 13%, 6%, and 6% of patients, respectively. Conclusions: Although it is difficult to conclude about efficacy of CRT with DTX for elderly stage II-III EC patients, considering that this study was terminated prematurely, CRT with DTX seemed to have substantial clinical activity. Clinical trial information: 000001846.
Phase I study of dasatinib in combination with capecitabine, oxaliplatin, and bevacizumab followed by an expanded cohort in previously untreated metastatic colorectal cancer.
Authors: J. H. Strickler, A. L. Cohn, C. Arrowood, S. Haley, M. Morse, H. Uronis, G. C. Blobe, S. D. Hsu, Y. Zafar, H. Hurwitz
Journal: Journal of Clinical Oncology (2011)

3586 Background: SRC is a non-receptor tyrosine kinase involved in normal and tumor cell signaling functions including cell proliferation, angiogenesis and survival. Dasatinib (D) is a potent inhibitor of SRC kinase activity. Preclinical data suggests the addition of D to standard chemotherapy agents for colon cancer may increase anti-tumor activity. We evaluated D in combination with capecitabine (C), oxaliplatin (O) and bevacizumab (B) in a phase I dose escalation study followed by an expanded cohort in first-line colorectal. Methods: For dose escalation, eligible patients had advanced solid tumors with adequate organ function and no increased risk for class-related toxicities. B and O were given intravenously, and C and D were orally administered; cycle length was 21 days. C was dosed at 850 mg/m2 on days 1-14; O was dosed at 130 mg/m2 and B was dosed at 7.5 mg/kg on day one of each cycle. D was dosed at 50 mg twice daily in cohort one and 70 mg once daily in cohort -1. Dose limiting toxicity (DLT) was assessed in cycle 1. Results: Dose escalation is complete with 10 subjects evaluable for DLT toxicity and 11 subjects evaluable for efficacy. Two DLTs were observed out of 4 evaluable subjects in cohort one. Six evaluable subjects were enrolled in the -1 cohort with 1 DLT. Two subjects have been enrolled in the expanded cohort. Possible grade ≥3 treatment-related adverse events (AEs) included neutropenia, febrile neutropenia, anorexia, diarrhea, fatigue, anemia, dehydration and grade 5 GI-perforation. One non-treatment related death was due to disease progression. D-related nausea, anorexia and fatigue were responsive to low dose oral steroids; fluid retention was responsive to diuretics. Of 13 subjects evaluable for efficacy, 3 subjects had a partial response (PR), 6 had stable disease (SD) as best response. Conclusions: D in combination with C, O and B is well-tolerated with a toxicity profile similar to standard C, O and B.The recommended phase II dose is C at 850 mg/m2 on days 1-14, O at 130 mg/m2 and B at 7.5 mg/kg on day one of each cycle, and D at 70 mg once daily. Enrollment in the expanded cohort of first-line colorectal is nearing completion.
Extended-Duration Enoxaparin for Venous Thromboembolism Prophylaxis in Acutely Ill Medical Patients: An Evaluation of the EXCLAIM Study Based on a Recently Recommended Composite Efficacy Endpoint.
Authors: Sebastian M. Schellong, Russell D. Hull, Victor F. Tapson, Manuel Monreal, Meyer-Michel Samama, Alexander G.G. Turpie, Roger D. Yusen
Journal: Blood (2007)
Phase II proof-of-concept study of atiprimod in patients with advanced low- to intermediate-grade neuroendocrine carcinoma
Authors: M. W. Sung, L. Kvols, G. Jacob, C. Talluto, J. C. Torres, A. Parta, E. Rodriguez, R. Shepard
Journal: Journal of Clinical Oncology (2008)

4611 Background: Effective systemic therapies for carcinoid tumors are lacking. No therapy to date has been shown to prolong survival, either overall or progression free, and therapy remains purely palliative with no significant reduction of the cancer burden or even stabilization of disease. Atiprimod is a novel proapoptotic and antiangiogenic drug that deactivates Akt and STAT3 signaling pathways. Methods: Subjects were dosed for 14 consecutive days on study drug followed by 14 consecutive days with no study drug (1 treatment cycle) using the following dosing schedule: 120 mg/day for the first 4 treatment cycles, 90 mg/day for the next 2 treatment cycles, and 60 mg/day for the final 6 treatment cycles. Subjects with elevated liver enzymes were started at a lower dose. No subject is allowed to receive lower than 60 mg/day for any treatment cycle. Tumor response evaluation was performed every 2 months. Symptom response evaluation was performed every month. Results: Documented disease progression was required for entry into the study. Of the 23 evaluable subjects to date who completed > 2 cycles, 21 or 91.3% had stable disease. There were only 4 subjects who had progressive disease on- study and all had their progression before or at cycle 2. All subjects who completed > 2 cycles have continued to have stable disease. Over half had a symptom response defined as >20% decrease. Only 5 of 48 subjects had Grade 3/Grade 4 AEs that might have been related to study drug. Conclusions: Atiprimod treatment is extremely well tolerated. Significant anti-tumor activity has been observed in patients with refractory progressive carcinoid tumors leading to a significant increase in PFS. Updated results will be presented. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Callisto Pharmaceuticals Callisto Pharmaceuticals Callisto Pharmaceuticals
Sentinel lymph node biopsy (SLNB) improves survival among SEER patients with melanoma
Authors: P. Gimotty, F. Yoon, R. Hammond, P. Rosenbaum, D. Guerry
Journal: Journal of Clinical Oncology (2008)

9005 Background: SLNB provides prognostic information. Its therapeutic impact is unclear. In a randomized trial of patients 18–75 years old with intermediate risk (INT) primary melanomas (1.2–3.5 mm in thickness and at least level III), Morton et al found no significant advantage in melanoma-specific survival (MSS) for those randomized to SLNB. However, the trial was underpowered. To validate these results in a large dataset, we examined survival in similar patients from SEER (1998–2002). We also did an analysis of patients with 0.75–1.2 mm melanomas (THIN). Methods: SEER patients with and without a SLNB were matched using 7 established prognostic factors and diagnosis year as well as a propensity score. Kaplan-Meier curves were used to estimate 5-year rates (MMS and OS). Paired survival times were compared using the Prentice-Wilcoxon test. Results: SLNB rates (1998–2002) were 71% and 43% among SEER patients with INT (n=2309) and THIN (n=2634) melanomas. The match resulted in 674 INT and 1126 THIN pairs. The SEER INT patients’ tumors were similar to those in the Morton study on all factors except level and ulceration: the latter had lower levels and more ulceration. For SEER INT patients with SLNB MSS times were significantly longer [p<0.001, hazard ratio (HR)=0.39]. 5-year MSS rates were 88% (95% CI= 85–91%) with SLNB and 75% (72–79%) without. For THIN patients with SLNB MSS times were also significantly longer (p=0.034, HR=0.53). 5-year MSS rates were 97.2% (96–98.5%) with a SLNB and 95.6% (94.2–97.1%) without. OS was also significantly longer for both INT and THIN groups having SLNB. Conclusions: These data indicate that SLNB improves survival. No significant financial relationships to disclose.
The Expression Pattern of Small Nucleolar and Small Cajal Body-Specific RNAs Characterizes Distinct Molecular Subtypes of Multiple Myeloma
Authors: Domenica Ronchetti, Katia Todoerti, Giacomo Tuana, Luca Agnelli, Laura Mosca, Marta Lionetti, Sonia Fabris, Patrizia Colapietro, Monica Miozzo, Manlio Ferrarini, Pierfrancesco Tassone, Antonino Neri
Journal: Blood (2012)