tbuckley/cabot-search huggingface dataset:
Risk of psychiatric disorders in long-term cancer survivors
Authors: W. F. Pirl, J. Greer, J. S. Temel
Journal: Journal of Clinical Oncology (2008)

9577 Background: Although the physical, mental, and social stresses of surviving cancer may put cancer survivors at greater risk for developing a psychiatric disorder, few data exist on the risks of psychiatric disorders in cancer survivors. This study compares the rates of common psychiatric disorders between long-term cancer survivors and people without cancer histories in a nationally representative sample, the National Comorbity Survey-Replication (NCS-R). Methods: The NCS-R conducted face-to-face diagnostic psychiatric interviews between 2001–2002 in a national sample of 9,282 people ages 18 and older, assessing cancer histories in a sub-set of 5,692 participants. Estimates of the odds ratios for meeting diagnostic criteria for a psychiatric disorder in the last 12 months [major depressive disorder (MDD), generalized anxiety disorder (GAD), panic disorder (PD), and post-traumatic stress disorder (PTSD)] for long-term cancer survivors compared to those without a cancer history were obtained through multiple logistic regression analyses controlling for age, gender, race, education, household income, and marital status. Long-term cancer survivors were defined as respondents reporting a cancer diagnosis at least 5 years prior to the interview and being either ‘in remission‘ or ‘cured.‘ Because of the complex sampling, the final sample weights for the NCS-R were used in the analyses. Results: In the sample, 223 long-term cancer survivors and 5337 people who never had cancer were identified. Approximately 12.47% of the sample met criteria for a psychiatric disoder in the last 12 months. No difference was found between survivors and those without cancer histories, 12.21% and 12.50% respectively, with an adjusted odds ratio of 1.20 (95% CI 0.75–2.07). Additionally, cancer survivors were not found to have significantly higher adjusted odds of having specific disorder in the last 12 months: MDD OR=0.78 (95% CI 0.41, 1.51); GAD OR=1.18 (95% CI 0.64, 2.17); PD OR=.98 (95% CI 0.35, 2.71); and PTSD OR=1.51 (95% CI 0.81, 2.82). Conclusions: Although some previous studies have reported higher rates of psychiatric symptoms in cancer survivors, these symptoms may not be severe enough to meet diagnostic criteria for actual psychiatric disorders or may not fit into current diagnostic categories. No significant financial relationships to disclose.
Verification of T-plus staging system for colorectal cancer based on nomogram analysis of single center’s 25-year follow-up.
Authors: Ke-Feng Ding, Jun Li, Xiang-Xing Kong, Ke-Jun Tang, Di-Kai Bei, Ying Yuan, Su-Zhan Zhang, Shu Zheng
Journal: Journal of Clinical Oncology (2016)

516 Background: We proposed T-plus staging system which abandon the criterion to discriminate stage II/III by lymph node status and strengthens weighting of the T stage according to cluster analysis of the summary survival data of SEER. In this study, this principle of the T-plus staging system was verified with single center data by nomogram analysis. Methods: The 1,099 patients with colorectal cancer diagnosed before 2005 were analyzed to build a novel staging system based on nomogram (nomo-staging system). The remaining 981 patients diagnosed after 2005 were used to test the performance of nomo-staging system, T-plus staging system and the 7 th edition TNM staging system by Akaike information criteria (AIC), Harrell’s c-index and the area under the curve (AUC) of Receiver Operating Characteristic to predict 5-year overall survival. A smaller AIC, higher c-index and higher AUC indicated a better staging system. Results: The nomo-staging system and T-plus staging system were listed in Table 1. The validation found that the 7 th edition TNM staging system showed the weakest performance. For AIC, both nomo-staging system and T-plus staging system showed smaller value than the 7 th edition TNM staging system (3214.912 vs. 3224.643 vs. 3229.810). For Harrell’s c-index, both the T-plus staging system and nomo-staging system showed higher value than the 7 th edition TNM staging system (0.6814 vs. 0.6787 vs. 0.6778). For AUC to predict 5-year OS, the T-plus staging system and nomo-staging system showed slightly higher value than the 7 th edition TNM staging system (0.6944 vs. 0.6924 vs. 0.6913). Conclusions: We propose replacement of lymph node status as the criterion to discriminate colorectal cancer stage II/III with greater weighting of the T stage. [Table: see text]
Effect of the Proteasome Inhibitor Bortezomib in Combination with “DT-PACE” on Stem Cell Collection and Engraftment in Newly Diagnosed Multiple Myeloma (MM) Patients (Pts).
Authors: Ashrof Z. Badros, Javier Bolaños-Meade, Aaron Rapoport, Bashi Ratterree, Sabrina Natt, Kathy Ruehle, Kathy McNamara, Edmund Cox, Sandy Westphal, Robert Fenton, Barry Meisenberg
Journal: Blood (2004)
Factors affecting survival after submyeloablative allogeneic hematopoietic stem cell transplantation (HSCT) for hematologic malignancies
Authors: S. Singhal, M. Cetiner, L. Gordon, A. Evens, M. Tallman, S. Williams, J. Winter, R. Meagher, J. Mehta
Journal: Journal of Clinical Oncology (2005)

6662 Background: Identification of pre-transplant prognostic factors affecting outcome after submyeloablative HSCT may help identify patients who are more likely to benefit from alternative approaches. Methods: The outcome of 63 consecutive patients (27–66 y, median 52) allografted for hematologic malignancies after 100 mg/m2 melphalan without (n=21; prior autograft) or with (n=42; no prior autograft) 50 mg/kg cyclophosphamide was studied to identify variables affecting survival. GVHD prophylaxis comprised cyclosporine-mycophenolate (n=37; HLA-identical sibling donors) or tacrolimus-mycophenolate (n=26, 1-locus mismatched sibling or 9–10/10 allele-matched unrelated). No growth factors were administered after HSCT. Supportive care was uniform. Results: The minimum follow-up was 6 months. 14 patients died of toxicity, and 33 relapsed. 25 relapsing patients died, and the other 8 are alive in complete or partial remission after salvage therapy including immunotherapy. Overall, 24 patients are alive. Of various pre-transplant variables studied in Cox analysis, 6 affected survival significantly (Table). Patients with 0–1 (n=15; low-risk), 2 (n=15; medium-risk), 3 (n=23; high-risk), and ≥4 (n=10; very high risk) adverse factors had highly disparate 18-month survival probabilities of 87%, 66%, 8% and 0% respectively (P<0.0001). Disease-free survival probabilities were 73%, 38%, 9% (at 1 y), and 0% respectively (P<0.0001). Conclusions: Pre-transplant variables affect the outcome of submyeloablative HSCT dramatically. The results are excellent in low-risk patients who require no modification in therapy. The outcome in medium-risk patients is acceptable although improvements are necessary in terms of improving the safety profile as well as reducing relapse. A radically different approach to HSCT is required for high-risk and very high risk patients whose outcome with this regimen is dismal. No significant financial relationships to disclose.
Allogeneic Stem Cell Transplantation in Patients ≥70 Years Old
Authors: Christopher C Walling, Pamela A Shaw, Noelle V Frey, Saar I Gill, Elizabeth O. Hexner, Alison W Loren, Selina Luger, James K Mangan, Mary Ellen Martin, Jacqueline Smith, Edward A. Stadtmauer, David L. Porter
Journal: Blood (2016)
Phase I study of combination chemotherapy consisting of capecitabine plus fractional cisplatin for unresectable gastric cancer in an outpatient setting.
Authors: Tsunehiro Takahashi, Yoshiro Saikawa, Kazumasa Fukuda, Rieko Nakamura, Norihito Wada, Hirofumi Kawakubo, Hiroya Takeuchi, Hiromasa Takaishi, Yuko Kitagawa
Journal: Journal of Clinical Oncology (2015)

173 Background: The combination chemotherapy of capecitabine and cisplatin is one of the standard regimen for unresectable gastric cancer. However, the high dose of cisplatin could cause the nephrotoxicity and require the adequate hydration to avoid the damage of renal during the administration. For that reason, the hospitalization is recommended for the patients to receive the chemotherapy including high dose of cisplatin. The present study aimed to establish the proper dose of fractional cisplatin in the combination with capecitabine in an outpatient setting. Methods: Capecitabine was administered orally every day from the evening of day 1 to the morning of 15. Cisplatin were infused on days 1, 8 and 15 for 60 minutes without hydration. The starting dose of cisplatin was 15 mg/m 2 as level 1. The following cisplatin dose could be given to subsequent cohorts of patients depending on safety findings observed in the previous cohort: level 2, 20 mg/m 2 and level 3, 25 mg/m 2 , respectively. Serum concentration of total platinum was analyzed before the administration of cisplatin on days 1, 8 and 15. Results: A total of 9 patients were recruited. The median age was 64 years and there were 8 males and one female. Histological types included intestinal (n=5) and diffuse (n=4). Eight patients had multiple metastatic sites, including lymph nodes (n=8), peritoneum (n=5), liver (n=3), lung (n=2) and bone (n=1). The major toxicities were thrombocytopenia (67%), leukopenia (56%) and neutropenia (22%). However, no dose-limiting toxicity was observed in each level. Therefore, the recommended dose of cisplatin was 25 mg/m 2 . Of the 9 patients, 6 patients had measurable lesions and 5 patients had partial responses, resulting in an overall response rate of 83%. The median administered course was four. In patients at level 3, the mean concentration of total platinum on days 8 and 15 were 0.25μg/ml and 0.42μg/ml, respectively. Conclusions: The recommend dose of cisplatin was confirmed with 25 mg/m 2 weekly. Although its safety and feasibility should be evaluated in further clinical trial, this regimen could be expected as an outpatient treatment for unresectable gastric cancer. Clinical trial information: 000005708.
Multicenter phase II clinical trial of everolimus in Japanese patients with unresectable or metastatic renal cell carcinoma (mRCC) after failure of treatment with first-line tyrosine kinase inhibitor (TKI) therapy.
Authors: Seiichiro Ozono, Masafumi Oyama, Masahiro Nozawa, Kiyohide Fujimoto, Ken Kishida, Noriaki Tokuda, Go Kimura, Kazuo Nishimura, Akio Matsubara, Hideyasu Matsuyama, Takayuki Sugiyama, Tomomi Kamba, Haruki Kume, Naoya Masumori, Mototsugu Oya, Hiro-Omi Kanayama, Seiji Naito, Shiro Hinotsu, Kojiro Shimozuma, Hideyuki Akaza
Journal: Journal of Clinical Oncology (2014)

455 Background: Everolimus has shown the efficacy and the safety in the phase III trial (RECORD-1) in patients with mRCC after failure of Vascular Endothelial Growth Factor Receptor-TKI. However, 26% of patients received two TKIs (sunitinib and sorafenib) as previous therapy in RECORD-1. In addition, as pre-treatment before TKI, 65% of patients received cytokine therapy and 13% of patients received chemotherapy. Therefore, there is still no clear evidence of everolimus as second line setting after failure of 1st-line TKI therapy. Methods: This study is an open-label, multi-center, single-arm, phase II trial. Primary endpoint is progression-free survival (PFS), and secondary endpoints are overall survival, objective response rate, time-to-treatment-failure, safety and quality of life (EORTC QLQ-C30, FKSI-DRS, EQ-5D). Key eligibility criteria are RCC with clear cell component, patients who received one TKI as first line therapy, patients who did not receive cytokine and chemotherapy and ECOG performance status 0-1. Results: 57 patients were enrolled from 02/11 to 12/12. Median age was 63 years, common sites of metastasis were lung (32.7%) and bone (12.2%), 79.6% had previous nephrectomy, previous TKI therapy were sunitinib (69.4%), sorafenib (22.4%) and axitinib (8.2%). Median PFS was 4.4 months (95% confidence interval: 3.7-6.0). 8.2% had partial response and 57.1% had stable disease according to RECIST v.1.0. The incidence of adverse events (AEs) of all grades was 95.9%. Major AEs were stomatitis (49.0%), hypertriglyceridemia (26.5%) and hypercholesterolemia (24.5%). Serious AEs were stomatitis (10.2%), interstitial lung disease (6.1%) and rash (6.1%). There were no treatment related deaths. All QOL scores were not changed at 2 months, while dyspnea and global health scores of EORTC QLQ-C30 and FKSI-DRS score were worsened at 4 months. Conclusions: This study is a first report of everolimus as second line setting after failure of 1st-line TKI. Further study and long-term follow-up would be warranted. Clinical trial information: UMIN000004742.
SPECT-fused 3D-CT mammary lymphography for endoscopic sentinel node biopsy.
Authors: K. Yamashita
Journal: Journal of Clinical Oncology (2010)

e11041 Background: The endoscopic surgery for the breast diseases has been proven safe and aesthetic, and named as video- assisted breast surgery (VABS). We also applied it for the sentinel node (SN) biopsy. It needs only 1 cm-long skin incision and a narrow tunnel to SN. However, it sometimes has difficulty in detecting the dye-stained node. The radioisotope (RI) may not be uptaken by true SN. We firstly succeeded to fuse the single photon emission computed tomography (SPECT) with 3D-CT mammary lymphography (LG). It can show the detailed position of all SN with or without RI uptake. Methods: 3D-CT LG was performed to mark SN on the skin. Above the tumor and near the areola, 2 mL of Iopamidol 300 was injected subcutaneously. Images of CT scan were taken at 1 and 3 minutes after injection to produce a 3D image of lymph ducts and nodes. For the lymphoscintigraphy, 99mTc phytate 74mBq was injected, and SPECT was taken after 2 hours. We fused it with 3D-CT LG. SN biopsy was performed by dye and RI method The skin incision was made 1 cm long in the axilla on the marked position. The endoscopic view was made through the optical trocar Visiport and showed stained lymph ducts and SNs, which can be navigated by the RI detector probe. Results: We have performed VABS on 260 patients, SN biopsy by the dye-staining method on 50 patients, with 3D-CT LG on 160 patients, and SPECT fused 3D-CT LG on 20 patients. All RI positive SNs coincided with 3D-CT LG detected SNs. We could detect their position on the axillary lymphatic mapping by the RI detector probe during surgery. The average sampled number of SN was 2.3. The dye-negative SN and RI-negative SN could be removed endoscopically. The SN metastases were 45 (28%). The other non-SN of axillary nodes could be observed. There was no false negative study. The wound scars were inconspicuous and aesthetic. Conclusions: SPECT-fused 3D-CT LG facilitates the endoscopic SN biopsy, which is aesthetic and less invasive. No significant financial relationships to disclose.
The relationship between tumor and host factors and survival in patients undergoing adjuvant chemotherapy for colorectal cancer.
Authors: James Hugh Park, Colin H. Richards, Donald C. Mcmillan, Paul G. Horgan, Campbell S. D. Roxburgh
Journal: Journal of Clinical Oncology (2014)

525 Background: The tumor microenvironment and host inflammatory responses are important determinants of outcome in colorectal cancer (CRC), however their impact on survival in patients receiving adjuvant chemotherapy remains unclear. The aim of the present study was to examine the relationship between these factors, clinicopathological characteristics and survival in patients receiving adjuvant chemotherapy for CRC. Methods: 365 patients who had undergone CRC resection at a single institution between 1997-2008 were included; 88 patients subsequently received chemotherapy. Tumor stroma percentage (TSP) and necrosis were assessed on H and E sections and graded as low or high. Local inflammatory response was assessed using the Klintrup-Mäkinen (K-M), Galon and revised Immunoscore (CD45RO + /CD8 + , and CD3 + /CD8 + at the invasive margin and tumor center, respectively). Systemic inflammation was assessed using modified Glasgow Prognostic Score (mGPS). Results: Patients receiving adjuvant chemotherapy were younger with a lower ASA (both P&lt;0.05), had advanced T- and N-stage (P&lt;0.05 and P&lt;0.001, respectively), poor tumor differentiation (P&lt;0.05), venous invasion (VI) (P&lt;0.01), margin involvement, infiltrative invasive margin (both P&lt;0.05) and high TSP (P&lt;0.01). In those patients who received adjuvant chemotherapy, on multivariate analysis of clinicopathological factors, VI (HR 3.00, 95%CI 1.22-7.37, P=0.017), TSP (HR 3.00, 95%CI 1.26-7.12, P=0.013), K-M score (HR 5.24, 95%CI 1.21-22.68, P=0.027) and mGPS (HR 3.10 95%CI 1.47-6.55, P=0.003) were independently associated with cancer-specific survival. When the interrelationships between factors independently associated with cancer survival were examined, VI, mGPS, K-M score and TSP were independent of each other (all P&gt;0.05). Conclusions: Compared to standard CRC pathological staging, the present results suggest that assessment of both tumor microenvironment and host inflammatory responses may have superior prognostic value compared with TNM in patients receiving adjuvant chemotherapy.
Antitumor activity observed in a phase I drug–drug interaction study of cabozantinib (XL184) and rosiglitazone in patients (pts) with renal cell carcinoma (RCC) and differentiated thyroid cancer (DTC).
Authors: T. K. Choueiri, S. K. Pal, M. E. Cabanillas, D. A. Ramies, L. Tseng, J. S. Holland, S. Morrissey, J. P. Dutcher
Journal: Journal of Clinical Oncology (2011)

e13042 Background: Cabozantinib is an oral, potent inhibitor of MET and VEGFR2 that is currently undergoing clinical efficacy evaluation in several oncology indications. In parallel, clinical pharmacology studies are being performed, including assessment of potential drug-drug interactions (DDIs). Renal cell carcinoma (RCC) and differentiated thyroid cancer (DTC) were chosen as indications in this study based on involvement of the MET and VEGFR signaling pathways in these indications. The primary objective of this study is to determine the effect of cabozantinib on single dose PK of the CYP2C8 substrate rosiglitazone. The exploratory objective of this study is to evaluate the preliminary antitumor activity of cabozantinib in pts with RCC and DTC. Methods: Approximately 35 cancer pts initially limited to DTC or RCC may be enrolled to this study. On study Day 1, pts receive a 4 mg tablet of rosiglitazone; PK sampling is completed on Day 2. On Days 2 (post PK sampling) through 21, cabozantinib is administered daily at a starting dose of 175 mg. On study Day 22 pts receive rosiglitazone 4 mg tablet and complete PK assessments. On study Day 57 and every 8 weeks thereafter subjects undergo tumor assessments by mRECIST. Results: To date, 10 pts (9 RCC; 1 DTC) have been enrolled (20 pts anticipated by May 2011). All pts had measurable disease. Median number of prior regimens was 3 (7/9 RCC pts with ≥ 2 lines of prior therapy and 6/9 with at least 1 VEGF pathway inhibitor and 1 mTOR inhibitor). No marked differences in concentration profiles, Tmax, Cmax, or AUC0-24h values were observed in 4 pts who completed the PK portion. Overall, 4/9 RCC pts had a confirmed partial response; 7/10 pts experienced tumor regression (16-49%). Related AEs ≥Grade 3 severity: fatigue (1 pt), amylase and lipase increased and hypophosphatemia (1 pt), and hyponatremia and hypophosphatemia (1 pt). Conclusions: Preliminary data suggests no drug-drug interactions between cabozantinib and rosiglitazone (CYP2C8 substrate). Cabozantinib demonstrates anti-tumor activity in heavily pretreated pts with RCC.
Do patients participating in oncology clinical trials understand the informed consent form? A Brown University Oncology Research Group study.
Authors: Andrew Schumacher, Carolyn Bartley, Anne Kaplan, Benjamin Murphy, Howard Safran, Kayla Rosati, Donna Wilson
Journal: Journal of Clinical Oncology (2012)

23 Background: The informed consent process is used to provide research participants information that includes the purpose and procedures of the research study, risks, benefits, potential alternatives and that participation is voluntary. The goal of informed consent to is to provide this information in language that is understandable to the research participant. The aim of this study is to evaluate whether research participants in adult hematology/oncology clinical trials understand the information presented during the informed consent process. Methods: Patients receiving active treatment on an oncology clinical trial that utilizes chemotherapy, radiation, targeted agents, biologic therapy or hormonal therapy were eligible to participate in this study. After informed consent was obtained, research participants are given a 14-question test. The questions evaluate whether patients understand the following elements on the informed consent related to their oncology treatment study: The purpose and procedures of the research study, risks, benefits, potential alternatives, research related injury compensation, study contact information, measures used to protect confidentiality, and that participation is voluntary. The possible answers to each question are disagree, unsure, and agree. Results: This study was initiated in June 2012. Eleven patients enrolled on this study within the first month. Participants include those on cooperative group studies, pharmaceutical industry trials and investigator initiated trials. The average length of the informed consent document exceeded 20 pages. An initial analysis of data is planned after the study has been open for six months. Conclusions: Informed consents are becoming increasingly lengthy and complex. Much of the language added is regulatory and legal in nature and used to protect the institutions conducting the research. This study will assess the readability of the informed consent and whether patients participating in oncology research trials understand the essential elements of the informed consent document. The first data analysis will be December 2012.
Testicular seminoma: Review of 67 cases from India
Authors: F. V. James, A. Mathew, R. K. Anand
Journal: Journal of Clinical Oncology (2005)

4783 Background: Testicular cancer is the commonest cancer of young adults in western countries. The incidence of testicular cancer is only 0.5/100,000 population in southern part of India. This study reviews the clinical profile and treatment results of patients with testicular seminoma in Regional Cancer Centre (RCC), Trivandrum, India. Materials & Methods: 67 patients treated in RCC, Trivandrum with testicular seminoma during 1994–2001 were reviewed. Age, history of cryptorchidism, stage, treatment, overall survival (OS) and disease free survival (DFS) were examined. Results: Median age was 35 years (range 21–78 y). Median follow up was 36.5 months (range 0–120 m). Thirteen (21%) patients had disease in undescended abdominal testes, while one had disease in surgically corrected maldescent. Thirty six (54%), 23(34%), 4(6%) and 4(6%) patients presented in stages 1,2,3 & 4 respectively. Among stage 1 patients, 21 received adjuvant radiotherapy, 4 had adjuvant chemotherapy and 3 chose observation. Of the stage 2 patients, 14 patients had chemotherapy, 6 had radiotherapy, and 3 had both. All the 8 patients with stage 3&4 had chemotherapy (BEP). Among stage 1 disease, all who received adjuvant treatment remain well, while 2 patients on observation relapsed and both were salvaged with chemotherapy. Among stage 2 patients, 5 deaths occurred (One relapsed as nonsminomatous, 2 had incomplete treatment and 2 failed to respond). All stage 3&4 patients are alive. For all stages, OS and DFS at 5 years are 92% and 87% respectively. OS for stage 1 and 2a is 100% and DFS is 92%. Conclusions: Advanced stage of disease is more common in our centre. Higher proportion of patients had intra-abdominal testicular seminoma due to uncorrected maldescent. Treatment results appear similar to international results. Identifying the factors that leads to lower incidence of testicular cancer in Asian countries would be interesting. No significant financial relationships to disclose.