tbuckley/cabot-search huggingface dataset:
Surgical treatments of Chinese patients with lung malignant tumors.
Authors: Hu Liao, Xiaofei Li, Heng Zhao, Xiangning Fu, Yang Liu, Jian HU, Yin Li, Feng Jiang, Daqiang Sun, Deruo Liu, Haiying Yang, Jiandong Mei, Chenglin Guo, Qiang Pu, Lin Ma, Feng Lin, Yunke Zhu, Guowei Che, Yidan Lin, Lunxu Liu
Journal: Journal of Clinical Oncology (2018)

e20525 Background: Lung cancer is the leading cause of cancer related deaths in China. Along with rapid development of new technologies, the modes of surgeries are experiencing changes. The purposes of the study are to investigate the status quo of surgical operations in Chinese patients. Methods: The study data on the patients with lung cancer (≥ 18 years) who received surgeries in the top 10 study sites from 2014 to 2017 were collected from the collaborative prospective LinkDoc database. The overall survial (OS) was measured based on the method of propensity score matching. Results: A total of 21,772 patients (ratio of male/female: 1.3, 71.7% adenocarcinoma) were recruited. Of all, 59.8% of subjects were non-smokers. The majority of patients (71.4%) were performed with minimally invasive thoracic surgeries (MITS) and most subjects with surgeries were early-stage patients (Ia:47.2%;Ib:14.9%). The percentages of patients with post-operative complications and patients with 30-day mortality rate were 6.5% and 0.54%, respectively. The 1-, 2-, and 3-year OS rates (94.9%, 87.1%, 78.9%) of the patients with MITS were significantly higher than those of the patients (88.1%, 76.2%, 66.5%) with thoracotomy (p < 0.01) (Table 1). Conclusions: In the Chinese patients with surgeries, the proportions of females, non-smokers, early-stage patients, and patients with adenocarcinoma are increasing. The minimally invasive thoracic surgeries have been well developed and performed without compromising perioperative morbidity and mortality. The patients with MITS were observed with better survival benefits compared to those patients with thoractomy within the short follow-up observation period. Clinical trial information: NCT03421093.Table 1 Clinical characteristics of patients with surgeries Parameters Clinical data Gender (%) Male 56.5% Female 43.5% Age (years) 59.3±9.8 Smoking history (%) Non-smoking 59.8% Smoking 20.0% Ever smoked 20.2% Pathological type (%) Adenocarcinoma 71.7% TNM stage (%) Ia 47.2% Ib 14.9% Modes of surgeries (%) Thoracotomy 24.8% VATS 70.0% VATS (Conversion) 3.7% RATS 1.4% Surgical operations Surgical duration (minutes) 152.8±69 Lymph nodes dissection (number) 13.3±9.77 Postoperative stay (days) 9.1±6.16 Perioperative morbidity (%) 6.5% 30-day mortality (%) 0.54%
Current burden of chemotherapy induced anemia and patterns of erythropoiesis-stimulating agents utilization.
Authors: Wing Yu Tang, Anna Vlahiotis, Selwyn Fung, Luiz Arantes, Richard Chambers
Journal: Journal of Clinical Oncology (2018)

e18765 Background: Chemotherapy Induced Anemia (CIA) is a known complication that can result in negative outcomes. Treatment can consist of erythropoiesis-stimulating agents (ESAs) and/or blood transfusions; however updated data on the CIA rate and treatment remains limited. Methods: A retrospective analysis using the U.S. MarketScan Commercial Claims and Laboratory databases was used to identify patients aged 18+ years with ≥ 1 medical claim with a solid tumor cancer diagnosis AND ≥ 1 inpatient or outpatient chemotherapy medical claim within 90 days of each other between 10/1/09 and 9/30/16. Patients were then selected for CIA diagnosis (ICD-9-CM code 285.3 or ICD-10-CM code D64.81) between 1/1/10 and 9/30/16 (index date = initial CIA diagnosis). The baseline period was 3 months prior to the index date, and used to ensure no previous anemia diagnosis or ESA therapy. The follow-up period consisted of the index date plus ≥ 6 months until loss of continuous eligibility, death, or 12 months’ time. Evidence of ≥1 valid lab measure of hemoglobin (HgB) during follow-up was also required. Outcomes measured during follow up included National Cancer Institute CIA severity (increasing severity Grade 0 to 4) and ESA treatment within 60 days after the first valid HgB test. Results: Of 820,484 cancer patients on chemotherapy, 7.7% had CIA diagnosis. A total of 609 patients fulfilled all criteria and had ≥1 HgB lab measure during follow-up. Less than a fifth of patients (n = 102; 16.7%) patients had ≥1 ESA administered within 60 days of CIA diagnosis. Patients who did not receive ESAs tended to be less severe (NCI Severity Level Grade 0 (G0) = 20.9%; G1 = 50.3; G2 = 23.7%; G3 = 3.4%; G4 = 1.8%) comparative to those who did receive ESA (NCI Severity Level G0 = 2.0%; G1 = 24.5%; G2 = 62.7%; G3 = 7.8%; G4 = 2.9%) [p < 0.05 for each comparison (non-ESA v. ESA) of G0 up to G3]. Conclusions: Results suggest CIA to still be an issue among cancer patients and that ESA utilization remains low. CIA patients that did receive ESAs were found to be more severe patients than those who did not receive ESAs. Continued exploration should be mindful of this and also point to need to further discuss treatment options for those that have CIA.
Amikacin Liposome Inhalation Suspension for Treatment-Refractory Lung Disease Caused by <i>Mycobacterium avium</i> Complex (CONVERT). A Prospective, Open-Label, Randomized Study
Authors: David E. Griffith, Gina Eagle, Rachel Thomson, Timothy R. Aksamit, Naoki Hasegawa, Kozo Morimoto, Doreen J. Addrizzo-Harris, Anne E. O’Donnell, Theodore K. Marras, Patrick A. Flume, Michael R. Loebinger, Lucy Morgan, Luigi R. Codecasa, Adam T. Hill, Stephen J. Ruoss, Jae-Joon Yim, Felix C. Ringshausen, Stephen K. Field, Julie V. Philley, Richard J. Wallace, Jakko van Ingen, Chris Coulter, James Nezamis, Kevin L. Winthrop
Journal: American Journal of Respiratory and Critical Care Medicine (2018)

Rationale: Improved therapeutic options are needed for patients with treatment-refractory nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex (MAC). Objectives: To evaluate the efficacy and safety of daily amikacin liposome inhalation suspension (ALIS) added to standard guideline-based therapy (GBT) in patients with refractory MAC lung disease. Methods: Adults with amikacin-susceptible MAC lung disease and MAC-positive sputum cultures despite at least 6 months of stable GBT were randomly assigned (2:1) to receive ALIS with GBT (ALIS + GBT) or GBT alone. Once-daily ALIS was supplied in single-use vials delivering 590 mg amikacin to the nebulizer. The primary endpoint was culture conversion, defined as three consecutive monthly MAC-negative sputum cultures by Month 6. Measurements and Main Results: Enrolled patients (ALIS + GBT, n = 224; GBT-alone, n = 112) were a mean 64.7 years old and 69.3% female. Most had underlying bronchiectasis (62.5%), chronic obstructive pulmonary disease (14.3%), or both (11.9%). Culture conversion was achieved by 65 of 224 patients (29.0%) with ALIS + GBT and 10 of 112 (8.9%) with GBT alone (odds ratio, 4.22; 95% confidence interval, 2.08-8.57; P < 0.001). Patients in the ALIS + GBT arm versus GBT alone were more likely to achieve conversion (hazard ratio, 3.90; 95% confidence interval, 2.00-7.60). Respiratory adverse events (primarily dysphonia, cough, and dyspnea) were reported in 87.4% of patients receiving ALIS + GBT and 50.0% receiving GBT alone; serious treatment-emergent adverse events occurred in 20.2% and 17.9% of patients, respectively. Conclusions: Addition of ALIS to GBT for treatment-refractory MAC lung disease achieved significantly greater culture conversion by Month 6 than GBT alone, with comparable rates of serious adverse events. Clinical trial registered with www.clinicaltrials.gov (NCT02344004).
TCT-303 Association of CHADSVASC Score with Hemorrhagic Stroke in Patients Undergoing Fibrinolytic Therapy for ST Elevation Myocardial Infarction
Authors: Gbolahan Ogunbayo, Robert Pecha, Naoki Misumida, Karam Ayoub, Dustin Hillerson, Ayman Elbadawi, Ahmed Abdel-Latif, Adrian Messerli, Susan Smyth
Journal: Journal of the American College of Cardiology (2018)
Impact of breast cancer treatments on cancer clinic resource utilization.
Authors: Dharmesh Gopalakrishnan, Shazia Tanvir Goraya, Svetlana Banjac, Courtney Yanda, Jame Abraham, Stephen R. Grobmyer, Holly Jane Pederson
Journal: Journal of Clinical Oncology (2017)

e18324 Background: Understanding clinic-based resource utilization among breast cancer (BC) patients is critical for the development of bundled payment models, and redesigning efficient value based systems of care delivery. BC outpatient visits (OVs) are costly from a time and human resource perspective and warrant investigation. Methods: This observational study included patients who were diagnosed with BC (Stages 0 to 3) in 2012 and were followed within our health network. Frequencies of OVs were compared between years 1, 2 and 3 of follow-up across subgroups, using one-sample Kolmogorov-Smirnov test; p &lt; 0.05 was considered significant. Results: Of 643 patients identified, 83% were Caucasian and 99.5 % were females. 99.4% had breast surgery, 60% received radiation, and 42% received chemotherapy. 66% of patients who had mastectomy had reconstruction (73% implants, 27% tissue flap). The average duration of follow-up was 3.2 yrs. The frequency of OVs was highest in the 1 st year after diagnosis across all groups in the Table (all p &lt; 0.001). Breast reconstruction was associated with high clinic resource utilization; tissue flap procedures were associated with significantly more OVs than implant procedures during the 3 years (median of 16 vs.14 visits, p &lt; 0.001). Conclusions: Outpatient visits represent a significant resource requirement associated with breast cancer care. These data are an important baseline as we design improved models of care and bundled payment models, and can be used to set expectations among breast cancer patients and care teams. [Table: see text]
Evaluation of drug sensitivity and tumor heterogeneity in thoracic cancers using CANScript, a novel <i>ex-vivo</i> tumor platform.
Authors: Arun Rajan, Padhma Radhakrishnan, Debapriya Ghosh Mehrotra, Emerson Padiernos, Mohammed Amine Achhal El Kadmiri, Tapan K Maity, Pradip K. Majumder, Udayan Guha
Journal: Journal of Clinical Oncology (2018)

e24246 Background: CANScript (TM), an ex-vivo tumor model, uses tumor explants and autologous patient (pt) plasma and peripheral blood mononuclear cells to replicate the tumor microenvironment (ME) and conserve tumor heterogeneity. It is being evaluated to predict drug sensitivity and study the tumor ME. We describe results of CANScript analysis of thymic epithelial tumors (TETs) and EGFR-mutated (mt) non-small cell lung cancer (NSCLC). Methods: Pts with advanced TETs and EGFR-mt NSCLC were enrolled in an ongoing tissue procurement trial (NCT02146170). Tumors were obtained from resections or biopsies performed when clinically indicated. Blood samples were collected on the same day. CANScript was used to determine tumor sensitivity against prespecified anti-cancer drugs. Assay results, reported by M-score, were compared against clinical observations. Histopathology evaluation using H&E, Ki67, and activated Caspase3, and multiple kinetic assays of cell viability, death and proliferation are used to calculate M-score. Results: Between 2/1/17 and 1/5/18, 13 pts (4 thymoma (T), 4 thymic carcinoma (TC), 5 EGFR-mt NSCLC; median age 56 yrs.; 7 females) were enrolled. Tissue was insufficient in 1 T pt. 2 pts (1 T, 1 TC) have not been treated with drugs evaluated by CANScript; response data is awaited in 2 pts (both TC). The table displays actual and predicted responses (R: response, NR: no response) in the other 8 cases (includes predictions for 2 drugs in 2 NSCLC pts, and against 2 different tumors from 1 NSCLC pt). CANscript correctly predicted for response against 4 of 6 drugs in 5 NSCLC pts and 2 of 3 drugs in 3 TET pts. The 9% observed response rate (RR) is likely due to advanced disease. CANscript predictions can potentially raise the RR to 25%. Differential drug sensitivity was detected against 2 tumors obtained from a NSCLC pt, indicating tumor heterogeneity. Conclusions: CANScript (TM) has the potential to detect tumor heterogeneity and sensitivity to a panel of anti-cancer drugs and can help prioritize treatment. Pre- and post-treatment characteristics of the tumor ME that predict for response are under evaluation and will be presented. Clinical trial information: NCT02146170.Actual Predicted NR R NR 7 3 R 0 1 Sensitivity = 100%, Specificity = 62%
Assessment of a custom designed next generation DNA sequencing gene panel to profile endometrial cancers.
Authors: Eirwen M Miller, Nicole E Patterson, Rouzan G Karabakhtsian, Michal Bejerano-Sagie, Nivi Ravi, Alexander Maslov, Wilber Quispe-Tintaya, Tao Wang, Juan Lin, Harriet Olivia Smith, Dennis Yi-Shin Kuo, Gary L. Goldberg, Cristina Montagna
Journal: Journal of Clinical Oncology (2017)

5593 Background: Using whole genome sequencing (WGS), the Cancer Genome Atlas (TCGA) identified four genomic subtypes of endometrial cancer (EC) with survival differences. Limited clinical data is available in the TCGA dataset restricting correlation of WGS with clinical endpoints. We sought to determine if high depth target sequencing allows for genomic classification of EC and prediction of the tumor biology when clinical variables are known. Methods: Using a custom designed sequencing panel targeting the coding regions of 156 EC genes we analyzed 47 EC samples and matching normal controls. Variants were annotated for pathogenicity. Charts were reviewed for clinicopathologic data. Routine statistical analyses were applied. Results: Endometrioid (EEC) tumors had a significantly higher frequency of total and pathogenic SNVs than serous (USC). Pathogenic PTEN and PIK3CA SNVs were more common in EEC while pathogenic TP53 SNVs were more frequent in USC. The presence of pathogenic TP53 SNVs was significantly associated with disease recurrence/progression. A pathogenic SNV at PTEN locus chr10:89692904 was associated with grade 1 EEC. Six hypermutated specimens were identified with 99-272 SNVs (mean 185.8 v 8.7 in non-hypermutated samples). All 6 were grade 3 EEC, of which 4 patients are alive without clinical evidence of disease (mean follow up 35 months). NTRK3, LRP1B, SLIT2, APC, RAD50, PIK3R1, and JAK2 SNVs were more common in grade 3 EEC than the other histologies. Conclusions: Pathogenic variants in EC associated with PTEN, PIK3CA, and TP53 and the number of somatic variants, as identified by a targeted sequencing, can predict histologic features and clinical behavior. Targeted sequencing panels may be a useful tool to predict the clinical phenotype and guide individualized therapeutic intervention. [Table: see text]
The next generation of quality improvement at MSK: Turning chemotherapy process delays into chemo express.
Authors: Jennifer Tota, Kathleen Levine, Jeanine Gordon, Abigail Baldwin, Jodi Wald, Rori Salvaggio, Melissa Lee-Teh, Scott Freeswick, Roisin O'Cearbhaill, Diane Lauren Reidy
Journal: Journal of Clinical Oncology (2017)

e18230 Background: Chemotherapy wait times can dramatically affect patient experience. MSK’s largest outpatient facility has 76 infusion spaces and 250-300 daily visits. A retrospective review of the facility’s infusion area wait times suggested that the lab (where all patients go to get their vitals and blood drawn) was a major bottleneck leading to process delays in infusion. Methods: We conducted a pilot program using a multi-pronged approach. Our goal was to decrease wait time from 40 minutes to an average of 15 minutes. Our initiative was defined as follows: (1) to redefine lab parameters that are relevant for toxicity and to only consider drawing those necessary labs; additionally, we created guidelines for timing of the labs prior to infusion treatment, (2) to introduce a program known as “ChemoExpress” which offers patients the opportunity to get blood work done prior to the day of their infusion appointment. After the labs result, the outpatient RN calls the patient, assesses symptoms and “clears them” for treatment cueing the pharmacy to prepare and “premix” the drug on the day of treatment. Results: 150 patients have enrolled in ChemoExpress. Patient satisfaction was high based on patient satisfaction surveys (n = 20). Average wait time was 9 minutes (76% less) in ChemoExpress participants as compared to an average wait of 39 minutes for those who did not participate in ChemoExpress. Conclusions: Implementing a process that enables patients to have their bloodwork drawn prior to the day of treatment and drugs prepared in advance of their treatment appointment results in greater efficiency in the overall workflow. It also offers the patient a lower wait time and a more efficient and satisfying experience.
Mesorectal excision with or without lateral lymph node dissection for clinical stage II, III lower rectal cancer: Long-term follow-up data of Japan Clinical Oncology Group study JCOG0212.
Authors: Mitsuyoshi Ota, Shin Fujita, Junki Mizusawa, Yukihide Kanemitsu, Masaaki Ito, Akio Shiomi, Masayuki Ohue, Shoichi Fujii, Shuji Saito, Manabu Shiozawa, Takashi Yamaguchi, Hiroyuki Bando, Kenji Katsumata, Shu Okamura, Yoshito Akagi, Nobuhiro Takiguchi, Shigeki Yamaguchi, Hideyuki Ike, Takayuki Akasu, Yoshihiro Moriya
Journal: Journal of Clinical Oncology (2018)

3607 Background: We conducted the non-inferiority study of mesorectal excision (ME) alone to ME with lateral lymph node dissection (LLND) for clinical stage II/III rectal cancer without lateral pelvic lymph node enlargement. Non-inferiority of ME to ME with LLND was not confirmed in terms of efficacy in the primary analysis. This is the long-term follow-up data of the study with a median follow- up of 84 months for all randomized patients. Methods: Eligibility criteria included clinical stage II/III; main lesion located in the rectum with the lower margin below the peritoneal reflection; no lateral pelvic lymph node swelling larger than 10 mm. After surgeons had confirmed R0 resection by the ME procedure, patients were randomized intraoperatively to ME alone or ME with LLND. The primary endpoint was relapse-free survival (RFS), with a non-inferiority margin for the hazard ratio (HR) of 1.34. The planned sample size was 700 with a power of 75% and a one-sided alpha of 5%. Results: A total 701 of patients enrolled from 33 institutions were randomized to ME+LLND (n = 351) or ME (n = 350) between June 2003 and August 2010. The 7-year RFS was 71.1% and 70.7% in the ME+LLND group and the ME group, respectively. The HR was 1.09 [95% CI: 0.84-1.42] (non-inferiority P =0.064). In subgroup analysis shown in the table, RFS of clinical stage III patients in the ME+LLND group was significantly better than that of those in the ME group (HR: 1.49 [95% CI: 1.02-2.17]). Conclusions: Long-term follow-up data supported that the non-inferiority of ME to ME with LLND was not confirmed in terms of efficacy in the primary analysis. ME with LLND is recommended especially for clinical stage III patients who do not undergo preoperative chemoradiotherapy. Clinical trial information: NCT00190541.Characteristics HR 95% CI Sex Male 0.95 0.69-1.29 Female 1.54 0.92-2.56 Clinical stage II 0.82 0.56-1.19 III 1.49 1.02-2.17 Distance from anal verge ≤ 5 cm 1.11 0.78-1.56 > 5 cm 1.03 0.68-1.56 Tumor size ≤ 5 cm 0.88 0.61-1.28 > 5 cm 1.30 0.88-1.91 Subgroup analysis of RFS
Prognostic relevance of supradiaphragmatic lymph nodes in advanced stage ovarian cancer.
Authors: Daniel Uwe Reimer, Anna Luger, Werner Jaschke, Friedrich Aigner, Anouk Gaber-Wagener, Christian Marth, Alain G Zeimet
Journal: Journal of Clinical Oncology (2018)

e17534 Background: Residual disease after debulking surgery is a major prognostic parameter in ovarian cancer. Thus, complete macroscopic resection and extensive retroperitoneal lymphadenectomy were surgical state-of-the-art over the last decades. Despite this standard procedure no attention was paid on radiologically enlarged and possibly cancer involved supradiaphragmatic lymph nodes (SDLN). Herein we evaluated the prognostic relevance of radiologic detected SDLN at initial presentation in advanced ovarian cancer taking into account the results of the recently published LIONS study. Methods: Baseline CT scans of 126 patients were retrospectively reviewed by two independent radiologists. In none of the patients SDLN was surgically removed. Retroperitoneal lymphadenopathy, presence of SDLN and location of intraperitoneal tumor burden were recorded. The number of detected nodes, short-axis-, long-axis dimension and a calculated SDLN area were evaluated as potential discriminators for clinical relevance and localization of intraabdominal tumor burden. Results: Optimal cutoff of SDLN was found at 6 mm short-axis (SA), 13 mm length-axis (LA), and a resulting area of 61.26 mm². SA ≥ 6 mm and an area ≥ 61.26 mm² correlated with radiologic suspected and histologically confirmed paraaortic lymph node metastases. Both discriminators correlated with stage IIIc/IVa cancers, levels of CA 125 (P = 0.030 and P = 0.0001), and furthermore predicted peritoneal involvement of the upper abdomen and residual disease after debulking surgery (P = 0.002 and P = 0.0001). In addition, SA ≥ 6 mm and SDLN-area ≥ 61.26 mm² were associated with an unfavorable PFS (HR 2.064 [95% CI 1.342 – 3.173] and 2.150 [95% CI 1.402 – 3.298], respectively) and OS (HR 2.360 [95% CI 1.384 – 4.025] and 1.969 [95% CI 1.168 – 3.319], respectively). Patients with SDLN in whom optimal cytoreductive surgery in the abdomen was successfully performed had a significantly lower PFS and OS. Conclusions: Radiologic detected supradiaphragmatic lymph nodes are prognostically relevant in advanced ovarian cancer, especially in patients after optimal cytoreductive surgery. Even more, the preoperative detection of SDLN is useful in the prediction of complete abdominal resection.