tbuckley/cabot-search huggingface dataset:
Radiologist-oncologist workflow analysis in application of RECIST
Authors: M. Levy, D. Rubin, K. W. Edwards, B. A. Burtness, A. E. Guardino
Journal: Journal of Clinical Oncology (2008)

6639 Background: Objective criteria for measuring response to cancer treatment are critical to clinical research and practice. Many trials use imaging modalities like CT and NCI's Response Evaluation Criteria in Solid Tumors (RECIST) method to quantify response to treatment using a set of target lesions. We hypothesize that the current radiologist-oncologist communication paradigm is not optimally coordinated with respect to tracking target lesions of interest, resulting in incomplete information for evaluating disease status being recorded in the medical record. Methods: Reports and images were obtained of CT scans of the chest, abdomen and pelvis from patients enrolled in clinical trials at two cancer centers where RECIST is being used to evaluate response to treatment in the metastatic setting. Target lesions were identified at baseline by the oncologists and the radiology reports and images were evaluated for identification and measurement of these target lesions. Results: Thirteen patients were recruited with a total of 42 CT scans (13 baseline, 29 follow-up) interpreted by 16 radiologists. 55 target lesions were identified at baseline by the oncologists (average 4 lesions per patient), and imaged a total of 167 times across studies. At baseline 71% of target lesions were identified in radiology reports and 73% by image annotation, while the longest diameter was reported 55% of the time and annotated 50% of the time. At follow-up 38% of target lesions were identified in reports and 70% by image annotation, while the longest diameter was reported only 28% of the time and annotated 26% of the time. In only 26% of the studies were the report and image annotation data sufficient to calculate the quantitative response rate as define by RECIST. Conclusions: Current reporting of radiology results in the medical record focuses on summarizing findings, which is insufficient for consistent application of quantitative methods to evaluate response to treatment. Our results illustrate the need for new training techniques and informatics tools to improve radiologist-oncologist workflow coordination and to enable quantitative evaluation of response to treatment. No significant financial relationships to disclose.
Extent of lymph node involvement in breast cancer patients with sentinel lymph node metastasis.
Authors: Takeshi Murata, Maiko Takahashi, Tetsu Hayashida, Shigemichi Hirose, Hiromitsu Jinno, Makio Mukai, Yuko Kitagawa
Journal: Journal of Clinical Oncology (2012)

199 Background: Axillary lymph node dissection (ALND) is a standard procedure in patients with positive sentinel lymph node (SLN). However, the appropriate level of ALND remains to be elucidated. The aim of this study is to determine the extent of lymph node involvement and predictors to assess non-SLN status in patients with metastatic SLNs. Methods: A prospective database of 235 breast cancer patients with metastases in SLNs who underwent ALND at Keio University Hospital from January 2001 to December 2011 was reviewed. Results: The median age of the patients was 54 years (range 28-86 years) and the mean tumor size was 2.08±0.74 cm. The mean total number of sentinel, level I, and level II lymph nodes removed was 2.72, 18.2, and 2.47, respectively. Other tumor factors include 66.5 % lymphatic invasion positive, 23.7% being nuclear grade 3, 89.4% estrogen receptor positive, and 83.2% progesterone receptor positive. Among 235 patients with SLN involvement, non-SLN metastases were identified in 72 (30.7%) patients and 13 (5.5%) patients had metastases at level II nodes.A univariate analysis showed a significant correlation between non-SLN involvement and number of tumor-involved SLNs. The mean number of tumor-involved SLNs in patients with positive non-SLNs was 1.86 compared with 1.33 in patients with negative non-SLNs (p=0.001). Patients with 2 or more positive SLNs showed a significantly higher rate of non-SLN metastases compared with patients with 1 positive SLNs (47.4% (37/78) vs. 22.3% (35/157), p&lt;0.001).The mean number of tumor-involved SLNs in patients with positive lymph nodes in level II was 2.08 compared with 1.46 in patients with negative lymph nodes in level II (p=0.016). Patients with 2 or more positive SLNs showed a significantly higher rate of metastases at level II nodes compared with patients with 1 positive SLNs (10.3% (8/78) vs. 3.2% (5/157), p=0.0026). Conclusions: Among 235 patients with SLN involvement, the positive rate of non-SLN metastases was 30.7%, whereas that of level II lymph nodes was 5.5%. The number of tumor-involved SLNs was a significant predictor of non-SLN involvement and level II lymph node metastases.
Dose escalation of capecitabine in combination with biweekly cetuximab and hepatic arterial infusion (HAI) of oxaliplatin in patients with liver metastases of colorectal cancer: Preliminary clinical results
Authors: A. Viudez, R. Zárate, M. Garrido, J. Rodríguez, A. Chopitea, I. Fernández-Troconiz, F. Pardo, J. García-Foncillas
Journal: Journal of Clinical Oncology (2009)

e15080 Background: To determine the maximum-tolerated dose (MTD) and the doses-limiting-toxicities (DLT) of concurrent capecitabine and cetuximab plus HAI of oxaliplatin (LOHP) in patients with hepatic metastases from colorectal cancer (CCR). Methods: Successive cohorts of 3–6 patients (pts) were treated with HAI LOHP (100 mg/m 2 ), biweekly cetuximab (500 mg/m 2 ) and escalation doses of capecitabine (825 mg/m 2 BID d1–7:DL1; 1000 mg/m 2 BID d1- 7:DL2; 1250 mg/m 2 BID d1–7:DL3; 1500 mg/m 2 BID d1–7:DL4) recycled every 14 days. Dose-limiting-toxicities (DLT) were defined as any grade 3–4 events, excepting grade 3–4 skin rash. LOHP and cetuximab PK/PD data were prospectively collected. Results: 19 patients (median age: 60; range: 34–74; 52.9% men, 47.1% females) and ECOG performance status of 1 (range 0–2) were treated at 4 DLs (dose level) as follows: DL: 3 pts, DL2: 6 pts, DL 3: 7 pts and DL 4: 3 pts. All pts were evaluable for toxicity. With a median of follow-up of 21.23 months, ORR was 78.9%, all of them partial response, with 4 pts SD (21.1%). Initially, only 4 pts were considered potentially resectable. Among the remaining 15 pts, 4 (20.6%) could be resected after treatment. Disease progression occurred in 15 pts (78.9%; 3 pts in liver only; 4 pts with extrahepatic metastases; 8 cases with both, hepatic and extrahepatic disease). The TTP was 9.6 months. OS has not been reached. 4 pts have died during the follow-up. Grade ¾ toxicities including Hand-foot Syndrome in 3 pts (1 pt at DL1, other at DL3 and other at DL4), diarrhoea in 3 pts ( one at DL3 and 2 at DL4), anaemia in 2 pts (DL2 and DL4), asthenia in 2 pts (DL2 and DL4) and mucositis in 1 pts (DL3). DLT and MTD were established in DL4 (two pts with diarrhoea grade IV with one of them with grade III HFS) Conclusions: Combination therapy with HAI LOHP plus concurrent capecitabine and cetuximab, can be safely administered to patients with liver metastases from CCR. The MTD and DLT was established in 1500 mg/m 2 BID d1 to d7 of capecitabine. The Doses-recommended (DR) has not been obtained yet. oxaliplatin PK/PD is best defined through a bicompartimental model. Mature results of PK/PD analysis will be presented at 2009 ASCO Symposium. No significant financial relationships to disclose.
Concordance between the 21-gene recurrence score (RS) and the 70-gene profile (MP) in breast cancer (BC) patients (pts).
Authors: N. Denduluri, H. S. Rugo, S. E. Davis, A. Favret, R. Hong, A. Au, D. H. Moore, L. Esserman
Journal: Journal of Clinical Oncology (2011)

13 Background: Genomic assays are increasingly incorporated into treatment planning for pts with early stage BC to provide prognostic and/or predictive information. MP is a validated predictor of recurrence risk (RR) in pts without any treatment and RS is a validated predictor of RR in pts treated with 5 years of hormonal therapy (HT). Because concordance between RS and MP is largely unknown, we analyzed concordance in untreated pts that had both tests performed. Methods: Data are from 50 early stage BC pts treated at 4 US Oncology practices and the University of California, San Francisco. We used linear regression to test whether clinical features were related to discordance, measured as part of the gamma statistic. Results: Median age was 52.5 years, 16% (8 pts) had micro or macroscopic nodal involvement, and 66%, 30%, and 4% of pts had stage I, II, and III disease, respectively. All pts had estrogen receptor positive disease and 2 pts had HER2 overexpression by IHC or FISH. Concordance of MP and RS is shown below. Clinical features, including tumor size, grade, and HER2 were not significantly related to discordance. Gamma concordance was 0.64 (95% CI 0.28 to 0.98, p=0.0013). Conclusions: Concordance is high, mostly due to agreement in low risk scores. Five cases are truly discordant (MP low/RS intermediate or high) based on predicted outcomes. The 11 cases with high-risk MP with low risk RS may reflect endocrine sensitivity to 5 years of HT, or true discordance. Our identification of discordance should stimulate research to further clarify biology and elucidate the drivers of different types of risk. Large studies are underway to refine risk definition and treatment recommendations. [Table: see text]
Genetic polymorphism and toxicity of adjuvant FOLFOX-4 chemotherapy in Korean colon cancer patients.
Authors: H. Chang, S. Han, S. Kim, K. Lee, T. Kim, Y. Park, S. Shin, D. Oh, S. Im
Journal: Journal of Clinical Oncology (2010)

3617 Background: Adjuvant chemotherapy using 5-FU/leucovorin/oxaliplatin (FOLFOX-4) is the standard of care in curatively resected high-risk stage II and stage III colon cancer. Previous reports suggest that genetic polymorphisms can influence the efficacy and toxicity of chemotherapy. We have analyzed the association between genetic polymorphism and toxicity of adjuvant FOLFOX-4 in Korean colon cancer patients. Methods: Patients who underwent curative resection of colon cancer with pathological stage II and III received 12 cycles of adjuvant FOLFOX-4. Each cycle consisted of oxaliplatin (85 mg/m2) on day 1, folinic acid (200 mg/m2) and bolus of 5-FU (400 mg/m2) followed by 22 hour infusion of 5-FU (600 mg/m2) on days 1 and 2 repeated every 2 weeks. Clinical data and peripheral blood samples were prospectively collected. Twenty polymorphisms in 10 genes (TS, MTHFR, ERCC1, XPD, XRCC1, ABCC2, AGXT, GSTP1, GSTT1 and GSTM1) were analyzed by PCR-RFLP, SNaPshot or direct sequencing using genomic DNA from peripheral blood mononuclear cells. Results: A total of 292 patients were included in this study. The frequencies of grade 3/4 neutropenia, thrombocytopenia, anemia and febrile neutropenia were 60.5%, 3.5%, 0.4% and 1.1%, respectively. Grade 3/4 nonhematologic toxicities were diarrhea (5.7%), vomiting (2.4%), nausea (1.7%), sensory neuropathy (1.7%) and hypersensitivity (1.4%). In hematologic toxicity, grade 3/4 neutropenia was significantly associated with ERCC1 19007T/T (p = 0.020) and MTHFR 677T/T (p = 0.027). ABCC2 3972C/C (p = 0.022) and ABCC2-24C/C genotypes (p = 0.047) were associated with grade 3/4 thrombocytopenia. In nonhematologic toxicity, sensory neuropathy was significantly associated with MTHFR 1298A/C or C/C (p = 0.005) and AGXT 1142A/A (p = 0.001) genotypes. XRCC1 2746A/A (p = 0.006) and XPD 156C/C (p = 0.004) genotypes were significantly associated with grade 3/4 diarrhea. Conclusions: This largest pharmacogenetic study of adjuvant FOLFOX-4 in colon cancer shows that the genetic polymorphisms of ERCC1 19007C>T, XPD 156C>A, MTHFR 677C>T, MTHFR 1298A>C, XRCC1 2746G>A, ABCC2 3972C>T, ABCC2 -24C>T, and AGXT 1142A>G may be useful in predicting toxicity of adjuvant FOLFOX-4. No significant financial relationships to disclose.
Neuroendocrine markers as predictor of octreotide acetate therapy in patients with hormone-refractory prostate cancer
Authors: S. Acosta, K.-M. Kälkner, O. Thorsson, M. Fredriksson, A. Nilsson, B. Gustavsson, M. Elingsbo, M. Stridsberg, P.-A. Abrahamsson
Journal: Journal of Clinical Oncology (2004)

4750 Background: Evidences of neuroendocrine differentiation in hormone-refractory prostate cancer has evoked expectations on new therapeutic options. Octreotide acetate has been used with varying results. In this pilot study the predictive value of Octreotide scintigraphy and/or serum Chromogranin-A (s-CrA) was investigated in patients treated with Octreotide acetate. Methods: Twenty patients with biopsy-proven prostate cancer and bone metastases and progressive disease during testosterone ablation therapy entered the trial. At base-line Octreotide scintigraphy, s-CrA, PSA, Alkaline phosohatase (ALP) was performed. Additionally two self-administered questionnaires EORTC QLQ C-30 (v3) and brief pain index were answered and a diary of pharmaceutical was started. The treatment consisted of Octreotide acetate 30 mg intra-muscular injection every month (Sandostatin LAR) after an initial run-in period of treatment with Octreotide acetate 100 μg subcutaneously injected three times a day for three days. The blood samples and questionnaires were repeated every month until the protocol was finished after three months. Results: Sixteen patients were treated per protocol, and 4 increased their global health score more than 10 units, with stable or decreased pain score without increase of analgesics. In 18 evaluable patients the PSA levels increased with an average from 259 to 542 μg/L during three months. Six patients responded with a reduction in ALP (median -26%, range -5 to -78%). Three patients were negative on Octreotide scintigraphy and 17 patients demonstrated positive lesions, generally of low intensity. At base-line s-CrA was elevated above normal range in 14 of the patients. In 6 of these patients s-CrA levels were normalized during treatment. No correlation was found between the result neither from Octreotide scintigraphy and therapy outcome nor between s-CrA and therapy outcome. Conclusions: Octreotide scintigraphy and s-CrA cannot identify those patients who responded on Octreotide acetate therapy with pain relief and improved health related quality of life using validated self assessed questionnaire. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Novartis
To transplant or not to transplant - Lessons learned from 20 years global collaboration in liver transplantation for hereditary transthyretin amyloidosis
Authors: Bo-Goran Ericzon, Henryk E. Wilczek, Marie Larsson, Arie J. Stangou, Priyantha Wijayatunga, Ole Suhr
Journal: Hepatology (2013)

To transplant or not to transplant - Lessons learned from 20 years global collaboration in liver transplantation for hereditary transthyretin amyloidosis
High Serum Vascular Endothelial Growth Factor (VEGF) Level Is An Adverse Prognostic Factor In High Risk Diffuse Large B-Cell Lymphoma (DLBCL) Patients Treated with Dose-Dense Chemoimmunotherapy and Systemic CNS Prophylaxis. Results From a Nordic Phase II Study
Authors: Sari Riihijarvi, Heidi Nyman, Harald Holte, Magnus Bjorkholm, Oystein Fluge, Lars Moller Pedersen, Mats Jerkeman, Eriksson Mikael, Sirpa Leppa
Journal: Blood (2010)
Low negative predictive value of "global hypokinesis" in two-dimensional echocardiography for coronary artery disease
Authors: A.F. Osman, L. Orejarena, S. Solis, A. Grant, Y. Gilliland, Cassidy, C.J. Lavie, J.A. Bernal, R.V. Milani
Journal: Journal of the American College of Cardiology (2000)
Phase III randomized trial of neoadjuvant chemotherapy (NAC) followed by radical hysterectomy (RH) versus RH for bulky stage I/II cervical cancer: Update of Japan Clinical Oncology Group (JCOG) Protocol 0102.
Authors: N. Katsumata, H. Yoshikawa, H. Kobayashi, T. Saito, K. Kuzuya, T. Mizunoe, M. Hiura, T. Kasamatsu, T. Shibata, T. Kamura
Journal: Journal of Clinical Oncology (2010)

5047 Background: In 2006, we reported the results of interim analysis of JCOG 0102 (JCO Sup, 24:18S, 2006: 5013) that NAC followed by RH did not demonstrate clinical benefit compared with RH for bulky stage I/II cervical cancer and enrollment was discontinued according to recommendation of the Data and Safety Monitoring Committee. This report provides update data from JCOG 0102. Methods: Patients (pts) with stage IB2, IIA (> 4 cm), or IIB squamous cell carcinoma of the uterine cervix were randomly assigned to receive either BOMP (bleomycin 7 mg day 1-5, vincristine 0.7 mg/m2 day 5, mitomycin 7 mg/m2 day 5 and cisplatin 14 mg/m2 day 1-5, q 21 days for 2 to 4 cycles) followed by radical hysterectomy (NAC arm) or RH (RH arm). Pts with positive surgical margins, metastatic nodes, infiltration to parametrium, and/or deep myometrial invasion received postoperative irradiation. Eligibility included preserved organ function, aged 20-70, and Performance Status 0 or 1. Primary endpoint was overall survival (OS) to be compared by log- rank test. Assuming 100 eligible pts in each arm, the study had 80% power to detect a 15% increase in 5-year survival at 0.05 one-sided alpha. Results: 134 pts (67 in NAC, 67 in RH) were randomized between 12/01 and 08/05. The median follow-up among surviving patients was 49 months. The proportion of positive lymph nodes after RH was lower in NAC arm (27%) than in RH arm (40%). The 4-year OS and progression-free survival (PFS) were 74.6% and 64.5% for NAC arm and 74.4% and 66.0% for RH arm (p = 0.63 and 0.58), respectively. Conclusions: Consistent with the results of interim analysis, this update analysis demonstrated that neoadjuvant chemotherapy with BOMP regimen followed by radical hysterectomy did not improve OS and PFS compared with conventional RH. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bristol-Myers Squibb, Chugai Pharma, GlaxoSmithKline, Kyowa Hakko Kirin, Nippon Kayaku, sanofi-aventis, Takeda, Yakult
Cancer-related self-efficacy in African American prostate cancer patients compared to whites
Authors: J. Q. Purnell, O. Palesh, K. Mustian, L. Peppone, G. Morrow, L. K. Colman, R. Lord, P. J. Flynn
Journal: Journal of Clinical Oncology (2009)

5067 Background: African American (AA) men are nearly twice as likely as white (W) men to be diagnosed with prostate cancer. Cancer-related self-efficacy (i.e., confidence in one's ability to manage cancer) has been associated with better physical and psychosocial functioning, but little is known about self-efficacy in African American prostate cancer patients. This study compared AA and W ratings of cancer-related self-efficacy for 308 prostate cancer patients (M age = 66.13, SD = 8.48; 9% AA) who participated in a group therapy intervention. Method: Independent groups t-tests were used to determine whether there were significant differences at baseline in mean scores for each group on the Stanford Self-Efficacy Scale (SSE), which asks respondents to rate their confidence in the ability to cope with cancer on a 0–100 scale, with 0 indicating no confidence. SSE subscales measure self-efficacy in the ability to: a) communicate with family, friends, and healtcare providers; b) focus and relax; and c) cope with the possibility of dying. Results: A significant difference was observed on SSE total scores (AA mean = 60.39 vs. W mean = 72.70; t = 3.30; p = 0.003). There were also significant differences on the Focus/Relax (AA mean = 68.90 vs. W mean = 77.64; t = 2.04; p = 0.011) and Cope with Dying (AA mean = 49.72 vs. W mean = 70.12; t = 4.85; p = 0.001) subscales, with a trend towards significance on the Ability to Communicate (AA mean = 62.55 vs. W mean = 70.76; t = 3.36; p = 0.095). Conclusions: Results suggest that, compared to W men, AA men have less confidence in their ability to cope with prostate cancer following diagnosis. AA men report the least confidence in their ability to cope with the possibility of death as a result of cancer, and they also report less confidence in their ability to focus and relax. They may also have greater difficulty discussing their cancer with family, friends, and healthcare personnel. As cancer-related self-efficacy has been linked to symptom-related and psychological adjustment, interventions targeting self-efficacy in AA prostate cancer patients are needed that are tailored to their unique needs. No significant financial relationships to disclose.
Gemcitabine plus carboplatin for patients with pretreated, metastatic breast cancer: A phase II trial
Authors: D. Laessig, U. Vehling-Kaiser, P. Fasching, F. Melchert, H. Koelbl, M. Stauch, P. Maubach, A. Scharl, J. Stemmler, V. Heinemann
Journal: Journal of Clinical Oncology (2006)

10635 Background: In search for treatment regimens which can be applied in anthracycline- and taxane-pretreated patients, the combination of gemcitabine and cisplatin was shown to be effective in several trials. To improve on tolerability and handling of the regimen, cisplatin was replaced by carboplatin in the present trial. Methods: Patients with intensively pretreated, metastatic breast cancer (age 18 to 70 years) and measurable disease were treated with gemcitabine (1000 mg/m 2 iv on days 1 and 8) and carboplatin (AUC 4 iv on day 1) in a 3-week regimen. The trial was performed as a 2-stage phase II study according to the optimal design described by Simon (p 0 = 0.1, p 1 = 0.3, α = 0.05, β = 0.1) with overall remission rate (according to RECIST) as the the primary objective. Results: Of 39 recruited patients (median age: 60 years, range 29 to 77 years) response data are available from 35 patients. A positive hormone receptor status was observed in 77% of patients, and 31% of patients were Her-2 overexpressing. All patients had received prior chemotherapy, and 49% of patients had been subjected to 2 or more treatment regimens for metastastatic disease. Prior treatment consisted of anthracyclines (87%), alkylating agents (77%), taxanes (67%), and antimetabolites (62%). Prior endocrine therapy had been applied to 77% of patients. At the time of evaluation, a total of 183 treatment cycles were documented with a median number of 5 cycles per patient (range 1 to 11). Treatment is presently ongoing in 8 patients. A CR was observed in 1/35 patients, a PR in 8/35 patients for an overall remission rate of 26% (95%-CI: 12% to 43%). Stable disease was documented in 49% (17/35) of patients. Median time to progression was 4.9 months (95%-CI: 2.9 to 6.8 months). In 39 evaluable pts, CTC grade 3/4 leukopenia was observed in 22/2 pts, neutropenia in 14/8 pts, anemia in 3/0 pts, and thrombocytopenia in 11/8 pts. Treatment delays and/or dose reductions were performed in 49% of cycles. Conclusion: Gemcitabine in combination with carboplatin is an effective combination for second- or third-line treatment in patients with metastatic breast cancer. [Table: see text]