tbuckley/cabot-search huggingface dataset:
Clinical-pathologic stage discrepancy in patients with bladder cancer treated with radical cystectomy: Associations with clinical variables and survival.
Authors: Phillip J. Gray, Stacey A. Fedewa, William U. Shipley, Chun Chieh Lin, Katherine S. Virgo, Adam Stuart Kibel, Ashish M. Kamat, Jonathan E. Rosenberg, Ahmedin Jemal, Anthony L. Zietman, Jason Alexander Efstathiou
Journal: Journal of Clinical Oncology (2013)

248 Background: Radical cystectomy (RC) is the most common treatment for bladder cancer (BC) in the United States. We examined clinical-pathologic stage discrepancy using the National Cancer Data Base. Methods: 16,953 patients with BC treated with RC between 1998 and 2009 were analyzed. Clinical factors associated with stage discrepancy were assessed by multivariable generalized estimating equation models. Survival analysis was conducted for patients treated between 1998 and 2004 (N=7,270) using a Cox proportional hazards model. Results: 41.9% of patients were upstaged at RC while 5.9% were downstaged. Upstaging was more common in females (OR 1.08, p=.04), the elderly (OR 1.26 for age ≥80 vs. 18-59, p=.001), higher tumor grade (OR 2.29 for grade 3-4 vs. grade 1, p&lt;.0001), non-urothelial histology (OR 1.31, p=.002 for squamous and OR 1.26, p=.03 for adenocarcinoma), and with extended lymphadenectomy (OR 1.27 for ≥10 lymph nodes examined vs. 0-9, p&lt;.0001). Downstaging was less common in the elderly (OR 0.50 for age ≥80 vs. 18-59, p&lt;.0001), in Hispanics (OR 0.58, p=.009) and with variant histology (OR 0.55, p=.003 for squamous and OR 0.3, p&lt;.0001 for adenocarcinoma). Receipt of neoadjuvant chemotherapy (CT) was highly associated with downstaging (OR 2.31, p&lt;.0001). 5-year survival by stage is shown in the table. Upstaging was associated with increased 5-year mortality (HR 1.79, p&lt;.0001) as was receipt of CT (HR 1.28, p=.02 for neoadjuvant and HR 1.23, p&lt;.0001 for adjuvant). Extended lymphadenectomy was associated with decreased 5-year mortality (HR 0.82 for ≥10 lymph nodes examined vs. 0-9, p&lt;.0001). Downstaging was not associated with survival (HR 0.88, p=0.17). Conclusions: This study is the largest to date to analyze stage discrepancy and survival in BC patients treated with RC. Upstaging is common and is associated with decreased 5-year survival. These data can be used in pre-operative risk stratification, treatment decision making and comparison with studies of non-operative management. [Table: see text]
Gene Expression Profiling (GEP) in Multiple Myeloma (MM): Comparison of Purified MM Cells (PMM), Random Bone Marrow Biopsies (RBX) and Fine Needle Biopsies from Focal Lesions (FNBX).
Authors: Yongsheng Huang, Fenghuang Zhan, Bart Barlogie, John Shaughnessy
Journal: Blood (2005)
Complete pathologic response after combined-modality treatment for rectal cancer and long-term survivals: A meta-analysis.
Authors: L. Zorcolo, A. S. Rosman, A. Restivo, M. Pisano, G. R. Nigri, A. Fancellu, M. Melis
Journal: Journal of Clinical Oncology (2011)

479 Background: Recent literature suggests that a complete pathologic response (CPR) following neoadjuvant chemoradiotherapy (combined modality treatment, CMT) for rectal cancer is associated with improved survivals compared to partial or no response (NPR). However, previous reports have been limited by small sample size and single-institution design. To overcome these limitations, we performed a meta- analysis of studies evaluating the prognostic value of CPR. Methods: A systematic literature review was conducted to detect studies comparing long-term results of patients with CPR or NPR after CMT for rectal cancer. Variables were pooled only if evaluated by 3 or more studies. Both qualitative and quantitative data were pooled using a random-effects model. Study endpoints included rates of complete pathological response, local recurrence (LR), distant recurrence (DR), as well as 5-year overall (OS) and disease-free survival (DFS). Results: There were 13 studies suitable for the meta-analysis, that overall reported on outcomes of 2030 patient with rectal cancer treated with CMT. CPR was achieved in 332 patients (16.4%). CPR and NPR patients groups were similar with respect to age, male gender, tumor size, distance of tumor from the anus and pre- treatment stage (p &gt; 0.3 for all comparisons). Median follow-up ranged from 23.5 to 46 months. CPR patients had lower rates of LR (0.7% vs. 2.6%; odds ratio [OR]=0.45, 95% CI 0.22–0.90), DR (5.3% vs. 24.1%; OR=0.15, 95% CI 0.07–0.31) and LR+DR (0.7% vs. 4.8%; OR=0.32, 95% CI 0.13–0.79). OS was 92.6% for CPR vs. 73.2% for NPR (OR=3.6, 95% CI 1.84–7.06), and DFS was 89.1% vs. 64.3% (OR=4.3, 95% CI 1.8-10.1). Conclusions: Our meta-analysis confirms that a CPR following CMT for rectal cancer is associated with an improved local and distal control as well enhanced OS and DFS. No significant financial relationships to disclose.
Peritoneal surface disease (PSD) from appendiceal cancer treated with cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC): Overview of 481 cases.
Authors: Konstantinos I. Votanopoulos, Greg B. Russell, Reese W. Randle, Perry Shen, John H. Stewart, Edward Allen Levine
Journal: Journal of Clinical Oncology (2014)

565 Background: Appendiceal cancer PSD treated with CRS/HIPEC has shown significant variability in the obtained survival benefit. Methods: A prospective database of 1,069 procedures was reviewed for primary, grade, nodal and performance status, resection type, morbidity, mortality, and survival. Results: 481 CRS/HIPEC procedures, 317 (77.3%) for low grade (LGA) and 93 (22.7%) for high grade (HGA) appendiceal primaries, were identified. Median follow up was 44.4 months. 30 and 90 day major morbidity were 27.8% and 9.3% while the 30 and 90 day mortality was 2.7% and 5.6% respectively. Median ICU and hospital stay was 1 and 9 days. In multivariate analysis, Clavien III/IV complications, were related to incomplete CRS (p = 0.0037), involved nodes (p &lt; 0.0001) and comorbidities (p = 0.003). Multivariate analysis of the LGA patients indicated survival to be dependent on nodal status (p = 0.003 HR 3.6), complete cytoreduction (p &lt; 0.0001) and preoperative chemotherapy (p = 0.04 HR 2.2). The multivariate survival of HGA was dependent on complete cytoreduction (p = 0.0003 HR 3.8) and preoperative chemotherapy (p = 0.0064 HR 2.5). In patients with complete cytoreduction, median survival for node positive LGA and HGA patients was less than their node negative counterparts. (85 months vs. not reached (82% alive at 90 months) and 30 vs. 153 months respectively p &lt; 0.0001). Conclusions: Positive nodes are associated with decreased survival not only in HGA but also in LGA patients even after a complete cytoreduction. Nodal status is superior to grade of disease as a prognostic indicator of survival. Node negative HGA primaries after complete CRS can obtain a comparable survival benefit to LGA counterparts.
Politicians will be “colluding” in unsafe care if they block NHS plans, says King’s Fund chief
Authors: Gareth Iacobucci
Journal: BMJ (2017)

Politicians will be guilty of “colluding” in the delivery of unsafe care if they fail to back evidence based changes to NHS services across England, the head of a leading healthcare think tank has said. The message from the King’s Fund’s chief executive Chris Ham came as the organisation published a new analysis1 of the 44 sustainability and transformation plans (STPs) which are being developed by health and care leaders across England. The report, which makes a series of recommendations for turning the draft proposals into credible plans (box 1), argues that, despite the controversy that has accompanied the plans to date, STPs remained the best hope of delivering “essential reforms” to NHS services. #### Box 1: Key messages from the report ##### Local STP leaders should
Incidence and outcome of anemia during adjuvant anthracycline-based chemotherapy (CHT) in early breast cancer (BC) patients (pts): A single-institution pilot survey
Authors: M. E. Cazzaniga, F. Villa, I. Viganò, A. Aridizzoia, M. Vaghi, I. Colombo, P. Lissoni, L. Frontini, E. Dapretto, P. Bidoli
Journal: Journal of Clinical Oncology (2008)

20714 Background: Various CHT regimens, particularly platinum-based ones, are able to induce anemia. However, the incidence and outcome of anemia induced by non-platinum based therapies have not been extensively investigated. In particular, few data are available regarding the anemia related to anthracycline-based regimens, even if early BC pts treated with such treatments often report fatigue. We conducted a retrospective pilot survey to investigate the incidence and outcome of anemia among BC pts treated with anthracyclines as adjuvant therapy. Methods: Using our chemotherapy archive, we identified 100 consecutive early BC pts treated with different anthracycline-based adjuvant CHT, for whom baseline Hb levels were available. We subsequently collected Hb values after each cycle of CHT and at the end of the treatment. Seventeen pts were subsequently excluded from this analysis due to the lack of end-of-treatment (EOT) Hb values. Most of the pts (72%) received a combination of adryamicin + cyclophosphamide (AC) for 4 cycles. Median age was 54 years (29- 79). Results: Median baseline Hb level was 12.7 mg/dL (9.2 - 15.2), whereas median EOT level was 12.2 mg/dL. No significant decrease of Hb levels has been observed throughout the planned CHT. Results are reported in Table 1. We subsequently analyzed the incidence of anemia in 2 subgroups of pts, identified according to baseline Hb levels (<12 mg/dL vs ≥ 12 mg/dL), finding similar results. Conclusion: Our preliminary results indicate that anthracycline-based CHT does not induce anemia in this group of pts. Further analyses could clarify if the incidence of anemia can raise during more complex treatments. Median (range) Hb Levels During Adjuvant CHT Baseline After 1st cycle After 2nd cycle After 3rd cycle EOT Median Hb (mg/dL) 12.7 12.6 12.2 12.2 11.8 Range (9.2-15.2) (8.1-14.7) (8.8-14.6) (9.2-14.1) (9.6-13.1) No significant financial relationships to disclose.
Factors associated with participant adherence in the NSABP Study of Tamoxifen and Raloxifene (STAR)
Authors: W. M. Cronin, R. S. Cecchini, D. L. Wickerham, V. G. Vogel, J. P. Costantino, N. Wolmark
Journal: Journal of Clinical Oncology (2008)

6518 Background: Results of the STAR trial, which enrolled 19,747 participants between 1999–2004, showed that raloxifene was as effective as tamoxifen in preventing breast cancer in women at increased risk for developing the disease. We have now analyzed STAR data on adherence (taking 2 pills per day) and persistence (willingness to remain on the protocol regimen). Methods: Prior to trial initiation, sites were required to submit plans to maintain adequate adherence, and compliance-related factors were evaluated during the trial via site performance evaluations. Participant pre-entry characteristics, pill counts, and symptoms were collected prospectively. Participants were categorized as persistent or non-persistent based on whether they remained on therapy or withdrew. Odds ratios and 95% confidence intervals were calculated for factors that had the potential to affect participant adherence. Results: With 47 months of follow-up data, participants who were persistent took 92% of their required pills, and even those who eventually dropped out of the study for non-protocol reasons (non-persistent) took 81%. A number of factors were associated with non- persistence, including history of depression, pre-existing medical conditions, the recruitment source of the participant and the responsible STAR site. Conclusions: Persistence in the STAR trial exceeded expectations. For those factors where persistence was not related (5-year predicted risk of breast cancer, less extensive family history, etc.), we surmise that study staff were successful in their efforts or that patient selection played a role in limiting non-adherence. However, despite site staff interventions, factors including a history of depression, pre-existing medical conditions, recruitment source for the participant, and STAR site, were associated with higher non-persistence rates. The strength of these predictive factors points to the need for careful evaluation of potential participants, and continued surveillance and compliance-promoting interventions for participants who are recruited into clinical trials. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration AstraZeneca, Eli Lilly and Company AstraZeneca, Eli Lilly and Company AstraZeneca, Eli Lilly and Company
Developing a culturally and linguistically responsive survivorship care plan for breast cancer.
Authors: Kimlin Tan Ashing, Monica Rosales, Mayra Serrano, Gingi Fulcher, Isaac Benjamin Paz, Jeffrey N. Weitzel, Lily L. Lai
Journal: Journal of Clinical Oncology (2013)

e20651 Background: African and Latina-American breast cancers patients (BCA) experience the greatest morbidity and mortality, suggesting a critical need for improved surveillance and quality care. The Institute of Medicine (IOM) and the Commission on Cancer (CoC) recommend that survivors receive personalized Treatment Summaries and Survivorship Care Plans (TSSCP) in order to facilitate best practice in clinical surveillance and follow-up care. This TSSCP template development study joined advocacy, scientific and medical communities to comprise a diverse advisory council (AC, N=38) to inform the development of the TSSCP-AA (African American) and TSSCP-S (Latino) templates targeting BCA. This abstract reports on the development, and presents the TSSCP-AA and TSSCP-S. Methods: The overall study was guided by the Shared Care and Psychooncology Models, and Contextual Model of Health Related Quality of Life. The AC provided input into the culturally relevant modifications of the American Society of Cancer Oncology (ASCO) TSSCP template to create the TSSCP-AA and TSSCP-S. Health care professionals enlisted from cancer centers and community hospitals (n=51) evaluated the TSSCP-AA and TSSCP-S templates on the following domains: content, clarity, utility, and cultural and socioecological responsiveness. Results: AC input revealed that the clinical (i.e., comorbidities) and cultural contexts (i.e., language, spirituality) must inform TS and SCP, respectively. Preliminary evaluation analyses documented that health professionals rated our TSSCP-AA and TSSCP-S templates as excellent to outstanding on content, clarity, utility, cultural responsiveness, and socioecological responsiveness (p&lt;0.01). Conclusions: The evaluation results imply that the TSSCP-AA and TSSCP-S templates achieved cultural responsiveness with high acceptability and utility among professionals and survivors. We created both paper and electronic versions of theTSSCP-AA andTSSCP-S (English and bilingual English-Spanish formats) for providers to create individualized TSSCPs. Further, our TSSCP development approach can be adopted for TSSCP template development targeting ethnic/linguistic minority cancer survivors.
The 21-gene breast cancer assay in small (&lt;1cm) tumors.
Authors: Christy Ann Russell, Melissa Conrad Stoppler, Megan Rothney, Amy P. Sing
Journal: Journal of Clinical Oncology (2014)

33 Background: Tumor size is a clinicopathologic factor often used in early stage breast cancer (EBC) management to estimate prognosis and make decisions about therapy. While in general, small tumors have a lower chance of recurring than large tumors, some patients with small tumors have poor outcomes. The 21-gene breast cancer assay (OncotypeDX) yields a Recurrence Score result that predicts the 10-yr risk of distant recurrence (DR) and the likelihood of chemotherapy (CT) benefit in patients (pts) with ER+ EBC. This study reviews the clinical evidence and experience of the 21-gene assay in subcentimeter (subCM) tumors and shows that the Recurrence Score is more reflective of the underlying tumor biology. Methods: A meta-analysis of Genomic Health validation and supportive studies reporting Recurrence Score result and tumor size was conducted in order to describe the distribution of Recurrence Score results. Results: There were 10 GHI-sponsored studies (7,094 pts) that presented Recurrence Score results as a function of tumor size. The studies varied in the recorded tumor sizes, ranging from &lt; = 0.5 cm to &gt; 5 cm. Four studies specifically examined the distribution of Recurrence Score results in subCM tumors and identified a total of 629 pts out of 2,912 pts (21.6%) that fit the size criteria of &lt; 1cm. A broad distribution of score results was observed in subCM tumors in the four studies combined: 61% low, 25% int, 15% high. Conclusions: These results demonstrate that not all pts with subCM tumors have low risk disease, and that the 21-gene assay can help inform the risk of DR more precisely as well as predict the likelihood of CT benefit. Approximately 40% of pts had intermediate or high score results, suggesting an increased potential for DR and CT benefit. The clinical implications of this meta-analysis are that size doesn’t tell the whole story. There is underlying biology reflected in the Recurrence Score that can better inform the treatment decision for pts with ER+ EBC. [Table: see text]
The relationship between the development of rash and clinical and quality of life outcomes in colorectal cancer patients treated with cetuximab in NCIC CTG CO.17
Authors: C. J. O’Callaghan, D. Tu, C. S. Karapetis, H. J. Au, M. J. Moore, J. R. Zalcberg, M. Trudeau, D. Yip, B. Vachan, D. J. Jonker
Journal: Journal of Clinical Oncology (2008)

4130 Background: The National Cancer Institute of Canada Clinical Trials Group CO.17 trial, conducted in collaboration with the Australasian Gastrointestinal Trials Group, demonstrated cetuximab monotherapy (vs best supportive care - BSC) improved overall (OS) and progression-free survival (PFS) and maintained quality of life (QoL) in patients previously treated for advanced colorectal cancer that expressed the Epidermal Growth Factor Receptor (EGFR). We analyzed the correlation between the occurrence of rash and clinical and QoL outcomes in CO.17 patients who received cetuximab therapy. Methods: Rash was graded weekly according to NCI CTC version 2.0 criteria. In the principle analysis, patients were classified into the “no rash” group until rash of any grade developed (= entered “rash” group). A Cox model with rash as a dichotomous time-dependent covariate (CMTDC) was used to compare clinical and QoL outcomes between these two groups. Two additional exploratory landmark-type analyses (LTA) were also performed by first excluding all patients who died within 28 days of randomization, and then classifying patients according to severity of rash (grade 0, 1, 2+) based on 1) the worst grade of rash ever developed (LTA1) and 2) the worst grade of rash on or before day 28 of the study (LTA2). These three groups were compared in Cox models as fixed covariates. Results: In patients who received cetuximab and experienced rash, the median time to onset of rash was 10 days and 90% experienced rash within 29 days. The hazard ratio (HR) of OS between the “rash” and “no rash” groups estimated from CMTDC was 0.58 (95% CI: 0.38–0.87; p=0.009). The median OS and corresponding HR from two landmark- type analyses are presented in the table below. Results for other clinical outcomes and QoL will be presented. Conclusions: All analyses demonstrated a strong correlation between rash development and clinical benefit in colorectal patients treated with cetuximab. Median Overall Survival Worst ever grade of rash (LTA1) Worst grade of rash by day 28 (LTA2) Grade 0 2.6 months 4.3 months Grade 1 4.8 months 4.6 months Grade 2+ 8.4 months 9.1 months HR: Grade 2+ vs Grade 0 0.33 (95% CI 0.22–0.50; p<0.001) 0.52 (95% CI: 0.37, 0.74; p=0.0002) HR: Grade 2+ vs Grade 1 0.54 (95% CI: 0.41–0.72; p<0.0001) 0.53 (95% CI: 0.39–0.72; p<0.0001) No significant financial relationships to disclose.
Intermittent versus continuous oxaliplatin-fluoropyrimidine (Ox-Fp) chemotherapy (CT) in first-line treatment of patients (pts) with advanced colorectal cancer (aCRC): Predictive factors (PF), quality of life (QL), and final efficacy results from the MRC COIN trial.
Authors: R. Adams, R. H. Wilson, M. T. Seymour, A. M. Meade, A. Madi, J. Cassidy, D. Fisher, S. Kenny, R. S. Kaplan, T. S. Maughan
Journal: Journal of Clinical Oncology (2010)

3525 Background: Intervals off CT may be a welcome respite for pts. The COIN trial compared intermittent and continuous CT strategies. Methods: Pts had measurable, inoperable aCRC; no prior CT for metastases; WHO performance status 0-2 and were randomized to A: cOxFp - continuous Ox + fluorouracil/leucovorin q2w or Ox + capecitabine q3w until treatment failure or C: iOxFp - same regimen for 12 wks, with further 12 wk courses upon progressive disease (PD). The trial was powered to exclude an HR > 1.162, equivalent to an absolute difference in 2-yr survival greater than 4.6%. The EORTC QLQ-C30 was the QL tool used pre-randomization, at 6 and 12 wks, and 12-wkly thereafter. Clinical and biochemical parameters at baseline and 12 weeks were analysed to identify factors predicting benefit from cOxFp or iOxFp. Individual clinicians were classified into those above or below average in complying with the protocol goal of restarting iOxFp on PD. Results: 1,630 pts were accrued 2005-08. Pts on iOxFp had significantly less toxicity, and spent a median of 15 wks on treatment compared to 25 wks on cOxFp. The intention-to-treat (ITT) OS analysis showed a 9% relative increase in the hazard of death in pts on iOxFp (HR 1.084, 80% CI 1.008-1.165). Median OS was 15.6 mths on cOxFp and 14.3 mths on iOxFp. QL at 24 wks suggested improved role functioning, less fatigue, anorexia and diarrhoea on iOxFp. In the Per Protocol Analysis, after exploring 16 factors, there was a suggestion of treatment interactions with: liver-only metastases (p = 0.07) and platelet count (p = 0.003) at baseline and KRAS status (p = 0.07). Noncompliance in recommencing iOxFp (< 60%) also led to a modest early survival disadvantage for Arm C, but this was not statistically significant (HR 1.14, p = 0.2 cf HR 1.05, p = 0.7 for compliant clinicians). Conclusions: Intermittent therapy is a reasonable strategy, with minimal detriment in OS, but improved QL, less time on CT and less toxicity. We have identified several potential predictive variables which could, if validated, aid selection of patients for this innovative approach. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Pfizer, Roche Amgen, Merck Serono, Roche, sanofi-aventis Amgen, Merck Serono, Roche, sanofi-aventis