tbuckley/cabot-search huggingface dataset:
Clinical characteristics, prognostic factors, and treatment outcomes of 139 patients of peripheral T-cell lymphomas from AIIMS, New Delhi, India.
Authors: V. Raina, M. K. Singhal, A. Sharma, L. Kumar, R. Kumar, S. Duttagupta, B. Kumar, P. Das
Journal: Journal of Clinical Oncology (2010)

e18549 Background: The largest series on peripheral T-cell lymphoma (PTCL) [International T-cell Lymphoma project] reports the incidence of PTCL (4-21%) from various regions of the world. However, there is a lack of data from India. Methods: Records of 139 patients diagnosed as PTCL between January 2002 to December 2009 according to WHO classification (3rd edition), were reviewed, after excluding cutaneous T cell lymphomas and T lymphoblastic lymphomas. Overall survival (OS) was calculated using Kaplan-Meier method. Univariate and multivariate analyses were used to assess various prognostic variables. Results: PTCL constituted 8.2% of all lymphomas. The median age was 45 years (18-86). The histological distribution was: PTCL unspecified (PTCL-U) 85 patients (61%), anaplastic large cell (ALCL) 32 patients (23%), extranodal NK/T (NKTCL) 17 patients (12.2%), angioimmunoblastic (AITL) 4 patients (2.8%) and 1 of enteropathy type T-cell lymphoma. B symptoms were present in 70%, advanced (stage III/IV) disease 70%, extranodal involvement 59.5%, raised LDH 45%, intermediate to high international prognostic score (IPI) 66%, bone marrow involvement 12.3%, liver involvement 11.3% and performance status (PS) of >1 in 49%. Most patients were treated with anthracycline based multi-agent chemotherapy. The complete remission (CR) rate was 60%. At a median follow-up duration of 10.4 months (0.03-90.8 months) median overall survival was 29.5 months. The projected 5 year survival was PTCL-U 39%; ALCL 62%; NKTCL 52%; AITL 0%. In univariate analyses PS>1 (p=0.003), age ≥60 (p=0.007), total leukocyte count of >11,000/cmm (p=0.04), serum albumin <3.5gm/dl (p<0.0001) and failure to achieve CR (p=0.0001) were significantly associated with an inferior survival. In the multivariate analysis only serum albumin < 3.5gm/dl (p=0.04) and failure to achieve CR (p=0.001) maintained predictive value. Conclusions: PTCL constitute 8.2% of all NHLs at this center. PTCL-U was the most common (61%) variety with projected 5 year survival of 39%. Low serum albumin and failure to achieve CR were the most important prognostic variables for predicting OS. This is first and the only report of PTCL from India. No significant financial relationships to disclose.
Quality of colorectal cancer care in Japan: A nationwide multicenter study.
Authors: T. Higashi, F. Nakamura, K. Sugihara, M. Ishiguro, T. Shinkai, T. Muranaka, M. Ohtani, K. Kondo, T. Sobue, T. Okamura
Journal: Journal of Clinical Oncology (2010)

e16542 Background: Although colorectal cancer is the third leading cause of cancer death in Japan, the quality of care provided for colorectal cancer patients remains largely unknown. Reports of variation in quality from other countries have aroused patient concern. This study aimed to develop quality indicators for colorectal cancer and to shed light on the current status of quality of colorectal cancer care in Japan. Methods: First, we developed process-of-care quality indicators for colorectal cancer through the RAND/UCLA appropriateness methodology, which included preparation of candidate quality indicators, and two rounds of ratings by a panel of 11 multidisciplinary experts with face-to-face discussion between the ratings. Using medical record abstractions, we then applied these quality indicators to the care of colorectal cancer patients in 16 hospitals in 2007 nationwide. Quality scores were calculated as the percentage of patients who received care as described in the quality indicators. Results: The expert panel approved 45 quality indicators, which covered care from diagnostic evaluation, treatment, to follow-up surveillance and management of recurrent disease. In total, the medical records of 1803 patients were abstracted. For some quality indicators, performance was 100% for almost all hospitals (e.g., documentation of resection methods in endoscopic treatment:100% for 3/4 hospitals) while other quality indicators had scores of less than 10% for most hospitals, (e.g., Informed consent about the effectiveness, adverse events, and cost before chemotherapy: < 10% for 3/4 hospitals). Large variation was observed for some indicators (e.g., appropriate lymph node dissection for stage II/III colon cancer; inter-quartile range 39%- 71%). Conclusions: Using quality indicators covering various aspects of colorectal cancer care, our study revealed that quality of care has substantial room for improvement in Japan. Future research should explore effective interventions for improvement. No significant financial relationships to disclose.
A different variable to stratify risk in resected gastric cancer
Authors: U. Esther, d. Ascensión
Journal: Journal of Clinical Oncology (2008)

15532 Background: Nodal involvement is one of the most important prognostic factors in RGC. AJCC/UICC TNM classifications recommend the examination of at least 15 nodes to achieve an optimal staging. This is essential to estimate prognostic subgroups accurately. However, in current clinical practice (CCP) most cases could be understaged because of an inadequate number of lymph node evaluated. The aim of our study was to evaluate the prognostic value of metastatic lymph nodes ratio and other clinicopathological factors in patients with RGC and less than 15 nodes examined. Methods: Analysis of 106 patients. Evaluation of age, gender, tumor location, Borrman/Lauren type, type of gastrectomy, grade, invasion depth of tumor, lymph node involvement (LNI), ratio between metastatic and total number of excised nodes (LNR) assigned according the following classifications: ≤ 20% (LNR1), 21–70% (LNR2), ≥ 71% (LNR3) and adjuvant treatment. Univariate and multivariate logistic regression models were developed to identify factors associated with disease free survival (DFS). Analysis of DFS was made by using Kaplan-Meier methods. Results: Median number of lymph nodes analysed: 6 (0–14). Median follow-up time: 38 months (15–104). Most patients were node positive (61%). Node positive patients were more likely to have advanced T (T3–4) 89%/11% T1–2 (p 0.001). Median number of examined nodes between patients with positive (10) and negative (2) ones was significant (p 0.0001). Recurrence: 54% (38% in LNR1, 50% in LNR2, 67% in LNR3; p 0.05). Cox multivariate analysis revealed that depth of invasion (T3–4 versus T1–2; HR 0.40; p 0.02) and LNR (LNR2 versus LNR1: HR 0.37; p 0.01 and LNR3 versus LNR1: HR 0.54; p 0.002) were independent prognostic factors to predict DFS. Median of DFS (months): LNR1 25, LNR2 21, LNR3 16 (p 0.01). The estimated DFS at 3 (global population/T3–4) and 5 years: LNR1 62/60% and 53%; LNR2 51/36% and 35%; LNR3 31/24% and 20%. Conclusions: LNR is a simple and useful prognostic factor in CCP that could stratify patients into prognostic subgroups in case of inadequate lymph node excision. No significant financial relationships to disclose.
Outcomes of patients (pts) with metastatic renal cell carcinoma (mRCC) treated with pazopanib after progression on other targeted therapies (TT): Updated results.
Authors: Marc Ryan Matrana, Cihan Duran, Aditya Shetty, Lianchun Xiao, Bradley J. Atkinson, Paul G. Corn, Chusilp Charnsangavej, Eric Jonasch, Nizar M. Tannir
Journal: Journal of Clinical Oncology (2013)

367 Background: Pazopanib is an multi-tyrosine kinase inhibitor shown to prolong progression-free survival (PFS) compared to placebo in treatment-naive and cytokine-refractory mRCC. Outcomes and safety on its use after TT are limited. Methods: We retrospectively reviewed records of consecutive pts with mRCC who were treated with pazopanib between November 2009-November 2011 after having progressive disease (PD) with other TT. Radiographic response was assessed by a blinded radiologist using RECIST v1.1 criteria. PFS and overall survival (OS) were estimated by the Kaplan-Meier method. Hazard ratios (HR) were estimated by fitting univariable and multivariable Cox proportional hazards models to evaluate the association of PFS with patient co-variates. Results: 112 pts (median age 63 years, 67% male, 83% clear cell) met inclusion criteria. Median number of previous TT was 2 (range 1-5). 85 events (PD or death) occurred. 14 pts (12.5%) had a partial response. Median PFS was 5.7 months (95% CI: 4.3-8.9 months). PFS was significantly associated with male gender (HR=0.55; 95% CI: 0.34-0.87; p=0.011), clear-cell histology (HR=0.42; 95% CI: 0.24-0.74; p=0.0031), number of metastatic sites (HR= 1.26; 95% CI: 1.05-1.52; p=0.0123), pancreatic metastases (HR=0.40; 95% CI: 0.18-0.85;p=0.0185), Karnofsky PS&lt; 80 (HR=2.07; 95% CI: 1.22-3.48; p=0.0062), and elevated LDH (HR=1.63; 95% CI: 1.03-2.573; p=0.035). Median OS was 16.9 months (95% CI: 10.3–21.9). 26% of pts were still receiving pazopanib at the time of analysis. 51% discontinued pazopanib due to PD and 12% died of PD on treatment. 11% discontinued pazopanib due to adverse events (AEs). There were no treatment related deaths. Common AEs included fatigue (43%), increase LFTs (34%), diarrhea (28%), nausea/vomiting (14%), anorexia (14%), hypertension exacerbation (12%), and hypothyroidism (11%). 89% of AEs were grade 1/2. Conclusions: Pazopanib demonstrated meaningful clinical activity in heavily pretreated pts with mRCC following PD with other TT. AEs were mild/moderate and manageable.
A randomized phase II (RP2) trial of ridaforolimus (R) compared with progestin (P) or chemotheraphy (C) in female adult patients with advanced endometrial carcinoma.
Authors: A. M. Oza, A. Poveda, A. R. Clamp, S. Pignata, G. Scambia, J. M. Del Campo, M. McCormack, L. Sevcik, B. M. Schwartz, S. Guan, R. Lee, J. D. Cheng, F. G. Haluska
Journal: Journal of Clinical Oncology (2011)

5009 Background: Options for women with recurrent endometrial cancer (EC) are limited. Clinical studies suggest mTOR inhibitors such as R have activity in this disease. This trial evaluated activity of R in open-label, randomized phase 2 trial compared R vs.P or C in women with advanced EC. Methods: Patients with unresectable stage III or IVA or metastatic EC treated with 1 or 2 prior lines of chemotherapy were randomized to receive oral R 40 mg daily for 5 days/week or P (medroxyprogesterone 200 mg/day or megestrol 60 mg/day). A protocol amendment allowed chemotherapy (n=13) as a control towards the end of the study. The primary endpoint was progression free survival (PFS). Results: 130 women were randomized to R (64) or P or C (66). Clinical characteristics were well-balanced between groups. Grade 3/4 frequency of common adverse events with R treatment were hyperglycemia 19%, anemia 9%, back pain 8%, asthenia 8%, diarrhea 6%, stomatitis 6%, anorexia 5%, mucosal inflammation 5 %, fatigue 5%, cough 5%, hypokalemia 5%, elevated ALT 5%, elevated GGT 5%, and hypertriglyceridemia 5%. Common grade 3/4 toxicities for the comparator arm were abdominal pain 5% and anemia 5%. An interim analysis of the first 114 patients treated, using predefined statistical rules, demonstrated a median PFS of 3.6 months for R compared to 1.9 months for P (HR=0.53; one-sided p=0.008) as assessed by independent radiology review (IRR). IRR assessed partial response/stable rates were 4.3%/17% in the control arm and 0.0%/35% in the experimental arm. With 57 deaths (44%), median survival was 8.9 months in the control arm and 10.0 months in the experimental arm (HR 0.93, 0.55-1.58; p=0.4). There were no deaths clearly related to treatment (4 non-treatment related (R=2; P/C=2) and 3 probably not treatment related (R=3). Conclusions: This RP2 study met the primary endpoint and demonstrated R significantly prolongs PFS in women with advanced EC compared with control treatment P or C, and demonstrates the promise of R as a novel treatment. The safety profile is consistent with prior R experience.
Economic impact of rituximab as maintenance therapy in previously untreated follicular non-Hodgkin lymphoma.
Authors: J. C. Hornberger, M. Friedmann, L. Han, R. Chien, R. J. Hornberger, S. Satram-Hoang, C. Reyes
Journal: Journal of Clinical Oncology (2011)

e18544 Background: Maintenance rituximab (R) therapy every two months for 2 years after chemoimmunotherapy (R-Chemo) has demonstrated improved progression-free survival (PFS) in previously untreated follicular lymphoma (f-NHL), but its economic implications are yet to be determined. A cost-effectiveness analysis (CEA) and budget-impact analysis (BIA) of R-maintenance versus observation was conducted from a typical US payer perspective. Methods: Treatment-effect assumptions were obtained from the PRIMA trial. We developed a Markov model to project PFS and overall survival (OS) data over a lifetime horizon. Costs calculated in 2010 US dollars included chemotherapy drugs, administration, treatment of grade 3/4 adverse events, and subsequent therapies after disease progression. Drug costs were based on average trial dose and were calculated using CMS fee schedules and wholesale acquisition costs. Utilities for stable and progressed disease were obtained from the literature. Primary endpoints were (1) cost per quality-adjusted life year (QALY) gained and (2) incremental payer budget divided by number of health plan members, referred to as cost per member per month (PMPM). Sensitivity analyses were conducted to identify cost drivers and to quantify the impact of input variables on the outcomes. Results: Compared with observation, R-maintenance increased mean PFS by 1.53 to 2.55 years and OS by 1.19 to 1.88 years. Cost of R-maintenance was $48,975. Cost per QALY gained varied between $16,904 and $35,405, depending on the duration of R-maintenance’s relative risk reduction of progression. R-maintenance increased the cost PMPM by $0.004. Influential drivers of the BIA were the number of f-NHL patients receiving chemo-induction therapy, the number of patients thereafter receiving R-maintenance, and the cost of R-maintenance. Conclusions: The use of R-maintenance therapy for previously untreated f-NHL is cost-effective for oncology with minimal budgetary impact for a typical US health plan.
Distress management in advanced gastrointestinal cancer patients.
Authors: Anna M. King, Cynthia Estrada, Carol P. Marcusen, Susan Glaser, Tanya B. Dorff, Afsaneh Barzi
Journal: Journal of Clinical Oncology (2015)

221 Background: Living with advanced-stage gastrointestinal cancer is a life-altering experience; patients (pts) have pain, fatigue, eating difficulties in addition to their financial challenges and spiritual crisis. As a result, high rates of distress are commonly reported in this population. The aim of this pilot study was to develop a collaborative model for psychosocial assessment and intervention to improve patient quality of life and reduce perceived distress. Methods: The Improving Mood – Promoting Access to Collaborative Treatment (IMPACT) model was utilized to address distress in these pts. Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder Screen (GAD-7), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ C30) were utilized by nurses to screen and flag pts who are experiencing distress. Follow-ups included PHQ-9 and GAD-7 at 2, 6, and 10 weeks and EORTC-QLQ C30 at 10 weeks. Interventions include brief-therapy, education and resource coordination by a social worker, and psychotropic medication prescribed by an oncologist. Results: Between November of 2014 and May of 2015, 65 pts were screened; 15 screened positive and 7 of them were initiated with services, while the remaining 8 declined intervention. The majority of pts who declined were male. Of the 9 receiving intervention, 2 screened negative but provided verbal endorsement of distress. Also, 3 pts receiving intervention were discharged home on hospice and expired before 10 weeks. Three pts reached the 10 weeks time point and of those, one patient reached a 50% reduction in PHQ-9 score by 10-weeks. Each patient required an average 4 hours of staff time for delivery of referral to services and psychotherapy. Conclusions: This model of care can be delivered with a moderate amount of staffing. Though, over a 7 month period, data collected from pts did not suggest a significant decrease in distress. Many pts were found to be consumed by intersecting elements such as other medical concerns, financial stressors and low priority of depression management. Also, disease course impacted accurate measurement of distress. It is suggested for future intervention with oncology pts to control for these factors.
The management of adenocarcinoma of the prostate in rural Georgia: A population-based analysis.
Authors: William A. Hall, Dana Nickleach, Jeffrey M. Switchenko, Joseph Lipscomb, Michael Goodman, Kevin C. Ward, Theresa Wicklin Gillespie
Journal: Journal of Clinical Oncology (2014)

273 Background: The management of adenocarcinoma of the prostate (ACP) in minority populations and in the rural setting remains understudied. We conducted a population-based analysis exploring the management of ACP in rural Georgia. Methods: All cases of ACP diagnosed from 2001 to 2003 in a rural, 33-county, Southwest Georgia region were included. Data were obtained for all patients through direct medical record abstraction. Patient characteristics were described and associated with three specific outcomes: receipt of therapy, initiation of planned therapy, and completion of radiation therapy (RT) when initiated. Results: One thousand eighty seven patients were available for the analysis; median patient age was 69, and 44% of the patients were African American (AA). A total of 804 patients underwent a course of definitive therapy or elected to pursue regular active surveillance (AS). Of the patients 8.9% underwent radical prostatectomy (RP) alone, 3.1% RP and external beam radiation therapy (EBRT), 30.2 % EBRT alone, 10.8% brachytherapy (BT) alone, and 44.5% combination EBRT and BT; 2.5 % of patients underwent AS. Hormone therapy (HT) was used in 43.8% of all patients available for analysis. In a multivariable analysis conducted for the entire patient cohort, not being married (OR 0.60, 95% CI 0.42-0.85, p=0.004), lack of insurance (OR 0.32, 95% CI 0.16-0.61, p=0.008), and older age (OR 0.93, 95% CI 0.91-0.95, p&lt;0.001) were all independently associated with not receiving definitive therapy. Race was not significantly related to receipt of definitive therapy. The full course of EBRT was successfully completed as planned in 98.4% of patients. Conclusions: Amongst those patients undergoing therapy for ACP in rural Georgia, a combination of BT and EBRT was the most common treatment modality. In contrast to recent studies, we found that race was not a significant predictor of receipt of care in Southwest Georgia. In this rural setting, EBRT was associated with extremely high rates of treatment completion. Despite the geographic and socioeconomic challenges associated with rural residency, our population-based study demonstrates that EBRT is a common treatment modality, with high patient compliance, even when used in a rural setting.
Early-onset small bowel and colorectal cancer patients with BRCA mutations: Actionable variants in atypical presentations.
Authors: Karen Vikstrom
Journal: Journal of Clinical Oncology (2016)

545 Background: The paradigm of genetic panel testing for hereditary colorectal cancer (CRC) continues to emerge. An association between Hereditary Breast and Ovarian Cancer (HBOC) syndrome and early onset CRC and has been reported, though only significantly associated with BRCA1 mutations. Guidelines do not include CRC in the HBOC spectrum. We describe nine early-onset ( &lt; 55 years) gastrointestinal (GI) cancer patients with germline mutations in BRCA1 or BRCA2 to highlight actionable findings that would have been missed by traditional CRC genetic testing. Methods: The nine affected patients underwent genetic testing using NGS-based multi-gene cancer panels. Genomic DNA variants were identified and classified according to ACMG criteria. Patient medical histories were obtained by referring clinician and documented on test requisition forms, and were de-identified for analysis. Results: Nine patients had a pathogenic (P) variant in BRCA1 (three cases) or BRCA2 (six cases). Four patients were under the age of 32 at the time of their CRC diagnosis. Of the nine cases, only one met NCCN testing criteria for HBOC syndrome. All patients were negative for P variants in the canonical CRC genes (APC, MUTYH, MLH1, MSH2, MSH6, PMS2, EPCAM). Conclusions: In this series, nine unrelated patients with early-onset CRC were found to carry a BRCA1 or BRCA2 mutation. The presence of BRCA mutations in these CRC patients is alone not strong evidence of causation; however, it suggests that clinicians should consider expanded panel testing in the presence of complex family histories, as these patients would have been found negative by traditional genetic tests. As the phenotypic spectrum of classical cancer syndromes is expanded by broad panel-based testing, it is important to identify patients that fall outside traditional diagnostic criteria, as some patients will have actionable findings in unexpected genes.
Eligibility of colorectal liver metastases for surgery
Authors: B. Langenhoff, B. Langenhoff, P. Krabbe, T. Ruers
Journal: Journal of Clinical Oncology (2005)

3538 Background: selection criteria for resection of colorectal liver metastases are not well described and the possibility of resection is often underestimated by medical oncologists. In this study eligibility criteria that affect surgery of colorectal liver metastases are weighted by surgeons experienced in liver surgery and afterwards a computer decision model is developed. Methods: surgeons who frequently operate on liver metastases were invited to participate. For the survey 25 cases (patient profiles) were constructed by conjoint analysis. The following characteristics were identified: involvement lobes (unilobar/bilobar), location metastases (peripheral to hepatic vein, close to/in hepatic vein, peripheral to portal vein, close to/in portal vein, involvement of caudate lobe), number of metastases (1–4, 5–9, 10 and more), size largest lesion (< 4cm, 4 cm and more) and patient characteristics (age under/below 70 years, synchronous/metachronous disease and extrahepatic resectable disease yes/no). Surgeons were asked for their treatment plan: resection, resection and local ablation, local ablation alone or chemotherapy. The cases were presented on CD-ROM by images of liver metastases on CT slides. Results: 25 surgeons completed the survey (response rate 78%). Surgeons were unaware of characteristics that were used to construct the cases. Involvement of lobes, patient characteristics and location of metastases proved to be of most importance. Number of metastases and to a larger extent size of largest lesion were not of great importance in treatment planning. Data were analysed to estimate a prediction algorithm. Hereby, the probability of treatment options in case of a certain ‘patient’ can be depicted. The prediction algorithm is translated to a computer based decision model. In practice, this decision model can assist medical oncologists and surgeons in defining whether an individual patient with colorectal liver metastases should be referred for surgery. Conclusions: According to the results a computer decision model is developed. By giving in a discrete set of data doctors can predict whether surgery is an appropriate treatment option for a specific patient with colorectal liver metastases. No significant financial relationships to disclose.