tbuckley/cabot-search huggingface dataset:
Carboplatin use in clinical stage one testicular seminoma.
Authors: Deirdre Kelly, John Patrick Buckley, MinYuen Teo, Michael Thomas McCarthy, Lynda M. O'Riordan, Sarah Louise Picardo, Jane Sze Yin Sui, Cliona O'Donnell, Saira Nasim, John McCaffrey
Journal: Journal of Clinical Oncology (2015)

e15549 Background: Clinical stage one testicular seminoma has a survival rate over 99%. Current guidelines recommend Active Surveillance as the mainstay of treatment. The present analysis aims to investigate the prognostic benefit and side effect profile of adjuvant carboplatin in patients with clinical stage one seminoma. Methods: Twenty four patients who were diagnosed with stage one seminoma between the years 2007 – 2014, were assessed retrospectively. Side effect profile of carboplatin, incidence of recurrent disease, incidence of secondary malignancies, time from orchiectomy to starting carboplatin, dose of carboplatin and histologic features were investigated. Results: : Median follow-up period was 5 years and median age was 37 years (29-53). 83% were treated with an AUC of 7.5 and 96% had 2 cycles of carboplatin. 82% of patients began carboplatin within 3 months of orchiectomy. 54% patients experienced no acute toxicities with carboplatin.17% had grade 1 myelosupression, 8% had fatigue and 4% had epididymo-orchitis.In terms of long-term toxicities due to carboplatin;67% were well at follow up,13% had gastrointestinal toxicity,8% had pulmonary changes ,4% had grade two fatigue,4% had a cardiac event and 4% had erectile dysfunction.17% had high risk histologic features with a tumour size greater than 4 cm and rete testis involvement.1 patient had recurrent disease. 1 patient had a second malignancy. All patients were alive at follow up. Conclusions: : Our findings suggest that carboplatin is a safe and well tolerated alternative to Active Surveillance in a selected group of patients. However, histologic features were not useful in predicating prognosis. Further clinical trials are needed to improve our understanding of risk adapted management of clinical stage one testicular seminoma
Active surveillance before sequential targeted therapy in patients with metastatic renal cell carcinoma.
Authors: Maria Jove, Olatz Etxaniz, Nuria Sala, Albert Font, Laura Jimenez Colomo, Maria Saigi, Sabela Recalde, Valentín Navarro-Perez, Pilar Barretina-Ginesta, Maria Ochoa de Olza, Nuria Mulet-Margalef, Xavier Garcia del Muro
Journal: Journal of Clinical Oncology (2015)

e15582 Background: Some patients (pts) with metastatic renal cell carcinoma (mRCC) have an indolent course. Since new target agents are not exempt from toxicity, initial active surveillance (AS) with deferred targeted therapy is sometimes used in pts with asymptomatic or slowly progressive disease. Nevertheless, little data about its benefit are available. Methods: Pts with mRCC treated at 3 Spanish centers from January 2005 to December 2013 were retrospectively studied. AS cohort was defined as pts in whom systemic therapy start was deferred ≥ 6 months (m) from diagnosis of metastases, although nephrectomy was permitted. The primary objective was to determine overall survival (OS). Secondary objectives were to assess combined progression free survival (cPFS), defined as time from diagnosis of metastases to progression on last line of therapy, and impact of AS on treatment exposure and also identification of main discrimination factors associated with the decision of AS by regression tree analysis. Results: 277 pts with mRCC were included: 69 pts (25%) had had initial AS and 208 pts had started therapy in within 6 m. Characteristics of AS pts were: median age 63; 70% males; 94% clear cell RCC; 93% prior nephrectomy; (PS) Heng risk favorable/intermediate 61.5%/38.5%. The median observation time until systemic therapy started in AS pts was 14 m (range 6-76 m). Median OS in AS versus non-AS pts was 62m and 22m (p < .001). When adjusted by prognostic factors, HR = 0.39 (95%CI 0.25-0.63). cPFS was 60m and 20m, respectively (p < .001). There were no differences between both groups in the number of lines of therapy administered and the median time of total treatment exposure: 15m and 11m, respectively (p = .35). The main discrimination categories found in the model were good risk category and lack of bone metastasis. Conclusions: Our results suggest that in a subset of selected pts with good risk features, targeted therapy could be safely deferred for a long period of time without compromising treatment exposure and outcome.
Biomarker prediction of chemotherapy-related amenorrhea.
Authors: Kathryn Jean Ruddy, Anne M. O'Neill, Kathy Miller, Bryan P. Schneider, Emily Baker, Joseph A. Sparano, Chau T. Dang, Donald W. Northfelt, George W. Sledge
Journal: Journal of Clinical Oncology (2013)

9508 Background: Chemotherapy-related amenorrhea (CRA) is associated with infertility and may impact treatment decision-making. We investigated whether anti-mullerian hormone (AMH) levels before chemotherapy predict likelihood of CRA. Methods: 591 patients enrolled on the quality of life substudy of ECOG5103, which randomized breast cancer patients to doxorubicin-cyclophosphamide followed by paclitaxel: 1) alone; 2) with concurrent bevacizumab; or 3) with prolonged bevacizumab. 144 of the 195 women who reported a period &lt;12 months before enrollment consented to serum collection prior to chemotherapy. AMH was measured in 143 with available serum. Participants self-reported menstrual frequency at 12 and 18 months after enrollment. 12-month CRA was defined as no menses for 6 months before the 12-month survey, and 18-month CRA as no menses for 6 months before the 18-month survey. Fisher’s exact test was used to identify associations with CRA. Results: Of the 143, 16 were excluded due to bilateral oophorectomy or initiation of ovarian function suppression within 12 months, and 2 due to missing data at 12 months. In the remaining 125, median age at enrollment was 45 (range 25-55). 103 (82%) had CRA at 12 months, including 68% of patients &lt;/= 45 (43/63) and 97% of patients &gt;45 (60/62). Median pre-chemotherapy AMH was 0.11 (range 0.01-8.63). 12-month CRA was more likely in women who received bevacizumab (p&lt;0.01), were &gt;45 (p&lt;0.01), and had AMH &lt;/=0.11 (p&lt;0.01) pre-treatment. Hormonal tx was not associated with 12-month CRA (p=0.63). 100 patients were eligible for 18-month CRA analysis: 81 (81%) had CRA, including 63% of patients &lt;/= 45 (33/52) and 100% (48/48) of patients &gt;45. 18-month CRA was more likely in women &gt;45 (p&lt;0.01) and with AMH &lt;/=0.11 (p&lt;0.01) pre-treatment. Bevacizumab (p=0.15) and hormonal tx (p=0.07) were not statistically significant predictors of 18-month CRA. Conclusions: Pre-chemotherapy AMH predicts risk of CRA at 12 and 18 months, and is a promising biomarker of ovarian reserve in young breast cancer survivors. Longer studies will be needed to ascertain whether lower pre-treatment AMH is associated with increased risk of later infertility. Clinical trial information: NCT00433511.
A novel approach to assess Her2-status of circulating tumour cells (CTCs) using the automated BioMarQ System.
Authors: Elisabeth Katharina Trapp, Thomas W. P. Friedl, Marianna Alunni-Fabbroni, Leonie Majunke, Jan Keij, Ulrich Andergassen, Aurelia Vattai, Tanja N. Fehm, Volkmar Mueller, Amelie Schramm, Bernadette Jaeger, Wolfgang Janni, Brigitte Kathrin Rack
Journal: Journal of Clinical Oncology (2015)

e11615 Background: Recent data indicate that persisting CTCs after chemotherapy are associated with poor prognosis. (Rack et al. JNCI 2014) CTC profiling for establishing new treatment strategies, like targeted approaches against CTCs, are important. Accurate phenotypic assessment is crucial, so this study aims to test the suitability of the BioMarQ System (BMS)(Janssen Diagnostics, LLC), a research use only enhancement of the FDA-cleared CellSearch System (CSS)(Janssen Diagnostics, LLC) for simultaneous CTC enumeration and HER2 assessment based on automatically generated fluorescence and cell morphology data. Methods: Data on HER2 status of CTCs were obtained by visual assessment after immunocytochemical staining for HER2 with the CSS. Overall 290 CTCs were isolated from the blood of a metastatic breast cancer patient and classified either HER2 positive or HER2 negative by immunocytochemical staining combining visual inspection (CSS) and automatic assessment (BMS). A discriminant analysis was performed to obtain discriminant functions based on fluorescence and/or cell morphology measures that provide the best possible separation of CTCs into the two groups according to visual classification of their HER2 status. Results: Highest concordance with the visual classification of HER2 status was obtained by a discriminant function based on four variables: the median and integrated fluorescence intensity, the cell area (µm2) and the coefficient of variation for the pixel fluorescence within a cell. Based on this discriminant function 84.5% of all cases were correctly assigned to the two visually obtained HER2 categories (160 of 171 CTCs classified HER2 positive and 85 of 119 CTCs classified HER2 negative). Conclusions: This analysis shows that a discriminant function derived from fluorescence and cell morphology measures generated by BMS correctly assigned the CTC HER2-status in 84.5%. This suggests that the BMS may provide an automated and objective support in phenotypic profiling of CTCs. Further analyses of a larger number of CTCs isolated from different patients and cross validation by FISH-analysis are needed to validate the suitability of BMS for objectively assessing the HER2 status of CTCs.
Optimal prophylactic method of venous thromboembolism for gastrectomy in Korean patients: Prospective randomized controlled trial.
Authors: Yoon Ju Jung, Kyo Young Song, Ho Seok Seo, Cho Hyun Park
Journal: Journal of Clinical Oncology (2017)

7 Background: This study was conducted to evaluate the incidence of VTE after surgery gastric cancer patients and determined the optimal method of thromboembolic prophylaxis in Korean patients. Methods: In this trial, 682 patients were assigned to 2 groups; an intermittent pneumatic compression (IPC) with or without 40 mg of enoxaparin. The primary outcome was VTE incidence within 30 days of surgery; defined as deep vein thrombosis (DVT) or documented pulmonary thromboembolism (PTE). The duration of follow-up was 6 months. Results: The primary outcome was assessed in 666 patients. The overall incidence of VTE was 2.10%; that of IPC group was significantly higher than the IPC plus enoxaparin group. Among 14 patients with VTE; 13(92.8%) patients were diagnosed with asymptomatic DVT, 1 patient was diagnosed with PTE. The incidence of bleeding complication was significantly higher in IPC plus enoxaparin group. By month 6, no patient died. Conclusions: Although the incidence of VTE was significantly lower in IPC plus enoxaparin group, symptomatic event was extremely rare and no mortality was observed. In Korean patient with gastric cancer does not need conventional prophylaxis using heparin because of the extremely lower incidence of symptomatic VTE and relatively higher incidence of bleeding complication. Clinical trial information: NCT01448746. [Table: see text]
Association of non-disruptive P53 mutations with poor progression-free survival (PFS) in resected breast cancer treated with neoadjuvant chemotherapy.
Authors: Alejandro Martinez-Bueno, Sonia Baulies, Miguel Angel Molina-Vila, Jordi Bertran-Alamillo, Maria Gonzalez Cao, Xavier Gonzalez, Santiago Viteri Ramirez, Niki Karachaliou, Cristina Teixido, Maria Sanchez-Ronco, Francesc Tresserra, Maria Teresa Cusido, Rafael Fabregas, Rafael Rosell
Journal: Journal of Clinical Oncology (2015)

1042 Background: Neoadjuvant chemotherapy is generally used for treatment of both early stage and locally advanced breast cancer. However, robust prognostic or predictive biomarkers are needed in this setting. TP53 is mutated in 23% of breast cancers, although this frequency varies widely among different histologies. HER-2 amplified and basal-like tumors show the higher rates of mutation: 37% and 45%, respectively. We tested whether TP53 mutations influence disease free-survival (DFS) in breast cancer patients treated with neoadjuvant chemotherapy (NACT). Methods: We assessed TP53 status in pretreatment paraffin-embedded tumor samples from a cohort of 79 breast cancer patients (p) treated homogenously with NACT. Of these, 26 were HER2+ and 53 HER2 negative. TP53 mutations were classified as “disruptive” (D) and “non disruptive” (ND) according to the degree of disturbance of p53 protein function and structure. Results: Mutations in exons 5-8 of TP53 were detected in 16 patients (20%). Of those, 6 harbored disruptive and 10 non-disruptive mutations. As previously reported, TP53 mutations were more common in non-luminal subgroups. After 40 months of follow-up, no recurrences had occurred among TP53 D patients (0%), compared with 7 in the TP53 WT group (11.1%) and 5 in TP53 ND (50%). No deaths were registered in TP53 D group, compared with 4 (6.3%) in TP53 WT and 2 (20%) in TP53 ND. Median progression-free survival (PFS) in patients with ND mutations was 24.5 months (CI 95% 15.2-41.7) while it was not reached in patients TP53-wt or carrying D mutations (P < 0.0001 in a Log Rank test). The association of ND mutations with shorter PFS was maintained when patients were divided according to HER2 status. Conclusions: Non-disruptive mutations in the TP53 gene areassociated with shorter PFS in resected breast cancer treated treated with neoadjuvant chemotherapy. Further studies are warranted to determine whether TP53 ND mutations can be a prognostic marker of poor outcome in this setting.
Cardiac Arrest in Any Location
Authors: Clifton W. Callaway
Journal: JAMA Cardiology (2017)

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Survival outcomes of adjuvant chemotherapy combined with radiation versus chemotherapy alone following pancreatectomy for distal pancreatic adenocarcinoma: Single institution experience.
Authors: Bhavina D O Batukbhai, Joseph M. Herman, Marianna Zahurak, Daniel A. Laheru, Dung T. Le, Christopher Lee Wolfgang, Lei Zheng, Ana De Jesus-Acosta
Journal: Journal of Clinical Oncology (2017)

388 Background: There is limited data of survival following distal pancreatectomy and adjuvant therapy in patients with distal pancreatic adenocarcinoma. This study aimed to evaluate the survival following combined modality (chemo-radiation and chemotherapy) compared to chemotherapy alone following distal pancreatectomy (DP). Methods: Patients who underwent DP for adenocarcinoma of the body or tail of the pancreas between the years 2000 and 2015 at Johns Hopkins were included. Comparison analysis was performed between patients who received combined modality versus chemotherapy alone. Kaplan- Meier curve was used to estimate the median overall survival (OS) and the disease free survival (DFS) at 1, 3 and 5 years after pancreatectomy. Results: A total of 294 patients underwent DP at our institution. Patients were excluded if adjuvant therapy was not administered, developed metastasis prior to adjuvant therapy, had stage IV disease at the time of surgery, received neoadjuvant therapy or had inadequate follow up at our institution to assess survival outcomes. We included a total of 105 patients, of which 45 patients received chemotherapy alone and 60 patients received combined modality. The two groups were similar with respect to nodal and margin status. Patients treated with combined modality had larger &gt; 3cm tumors (p = 0.02). Median OS with combined modality was 60.6 mo and 50.2 mo with chemotherapy only. DFS was 15.2 mo with combined modality and 17.6 mo with chemotherapy only. There was no significant difference between the groups for OS (p = 0.73) or DFS (p = 0.495). Further analysis showed a trend away from chemoradiation in the recent years. Thirty patients (29%) received multi-agent chemotherapy in the adjuvant setting. A tumor diameter &gt; 3cm was a predictive factor for receiving chemoradiation (chi-square p value 0.02). Conclusions: There is no difference in survival with combined modality compared to chemotherapy alone as adjuvant therapy following DP. All patients in this study received adjuvant therapy. We report a higher survival than previously described which could suggest a different biology for distal tumors.
Serum Heavy/Light Chain and Free Light Chain Measurements Provide Prognostic Information, Allow Creation of a Prognostic Model and Identify Clonal Changes (clonal tiding) Through the Course of Multiple Myeloma (MM)
Authors: Heinz Ludwig, Jeffrey Faint, Niklas Zojer, Arthur R Bradwell, Philip Young, Dejan Milosavljevic, Wolfgang Hübl, Stephen Harding
Journal: Blood (2011)
Prospective molecular evaluation of small cell lung cancer (SCLC) utilizing the comprehensive mutation analysis program at Memorial Sloan-Kettering Cancer Center (MSKCC).
Authors: Maria Catherine Pietanza, Anna M. Varghese, Helen H. Won, Lu Wang, Natasha Rekhtman, Lee M. Krug, Paul K. Paik, Gregory J. Riely, Maureen Frances Zakowski, Marc Ladanyi, Michael F. Berger, Mark G. Kris
Journal: Journal of Clinical Oncology (2013)

7600 Background: Oncogenic events in adenocarcinoma and squamous cell cancers of the lung are well described. In contrast, the repertoire of possible molecular targets in SCLC is still unclear. Recent studies using next generation sequencing on rare resected SCLC specimens have provided insights into the molecular heterogeneity of this disease. Comprehensive, prospective molecular profiling of patients with SCLC using the small biopsy specimens available in clinical practice has not been performed. Methods: Utilizing an IRB-approved protocol to prospectively test SCLC tumors (Small Cell Lung Cancer Mutation Analysis Program, “SC-MAP”), these biopsies are evaluated by: FISH for FGFR1 and MET amplification; immunohistochemistry for MGMT and PTEN loss; point mutation genotyping with Sequenom for PIK3CA (and others); and next-generation sequencing with our MSK-IMPACT assay (Integrated Mutation Profiling of Actionable Cancer Targets). MSK-IMPACT uses exon capture followed by massively parallel sequencing to profile all protein-coding exons and select introns of 279 cancer-associated genes, enabling the identification of mutations, indels, and copy number alterations of these genes. We tested the feasibility of this approach in a series of patients with SCLC. We performed next generation sequencing with MSK-IMPACT, with findings confirmed by FISH. Results: We identified 11 patients with SCLC with FFPE samples available from both matched normal tissue and small tumor biopsies, including 3 core biopsies and 8 fine needle aspirations. 9/11 patients had adequate tissue for MSK-IMPACT, which revealed recurrent mutations in Rb1 (N=7) and p53 (N=7), FGFR1 amplification (N=2), and MET amplification (N=1), using as little as 15 nanograms of DNA. FGFR1 and MET amplification were confirmed by FISH testing. We have initiated this prospective SC-MAP program for our patients with SCLC. Conclusions: Comprehensive molecular evaluation of SCLC is feasible on clinically available, small samples. Such analyses will allow us to characterize the molecular diversity of this disease and identify patients who will be candidates for targeted therapies.
5 Year Expression and Neutrophil Defect Repair after Gene Therapy in Alpha-1 Antitrypsin Deficiency
Authors: Christian Mueller, Gwladys Gernoux, Alisha M. Gruntman, Florie Borel, Emer P. Reeves, Roberto Calcedo, Farshid N. Rouhani, Anthony Yachnis, Margaret Humphries, Martha Campbell-Thompson, Louis Messina, Jeffrey D. Chulay, Bruce Trapnell, James M. Wilson, Noel G. McElvaney, Terence R. Flotte
Journal: Molecular Therapy (2017)
Cancer-related side effects and diabetes self-management.
Authors: Keerti Murari, Jordonna Brown, Juan P. Wisnivesky, Jenny J Lin
Journal: Journal of Clinical Oncology (2017)

152 Background: Cancer survivors often experience cancer and treatment-related side effects and may also have comorbidities that may further impact their quality of life. Little is known about how cancer-related side effects and health status impact survivors’ beliefs and management of comorbidities. We undertook this study to assess the relationship between cancer-related side effects and diabetes (DM) self-management behaviors (SMB) and beliefs in cancer survivors with comorbid diabetes. Methods: We recruited diabetes patients recently diagnosed with early-stage breast or prostate cancer who were taking at least one oral hypoglycemic agent. Side effects for prostate cancer survivors were assessed using the Expanded Prostate Cancer Index Composite; side effects for breast cancer survivors were assessed using a standardized questionnaire for hormonal therapy-related side effects. Patients were asked to rate their overall health status and about the perceived impact of cancer treatment on DM. We measured DM medication adherence using the 8-item Morisky Medication Adherence Scale, and DM SMB were evaluated using the Summary of Diabetes Self-Care Activities. Descriptive and univariate analyses were used to assess factors associated with DM SMB. Results: Of the 52 patients recruited, 32 (62%) were male. Twenty-four (46%) patients reported cancer or treatment related side effects, with most (21, 88%) being moderately or severely bothered by these symptoms. Of these patients, 20 (83%) reported non-adherence to their DM medications and 18 (71%) reported checking their fingersticks &lt; 5 times a week. Yet most patients (20, 84%) felt that their diabetes care was at least equally as important as their cancer care. Neither the presence nor severity of side effects was associated with DM SMB. However, patients who reported poorer overall health status were more likely to be worried about the impact of cancer treatment on diabetes management (75% vs. 25%, p &lt; 0.01). Conclusions: Many cancer survivors report moderate to severe treatment-related side effects, although severity of side effects was not found to be associated with DM SMB. Further effort should focus on addressing survivors’ concerns about the impact of cancer treatment on comorbid disease management.