tbuckley/cabot-search huggingface dataset:
Outcomes and feasibility of nipple-sparing mastectomy for node-positive breast cancer patients.
Authors: Brittany L. Murphy, Tanya L. Hoskin, Judy Caroline Boughey, Amy C. Degnim, James W. Jakub, Adam C Krajewski, Steven R. Jacobson, Tina J. Hieken
Journal: Journal of Clinical Oncology (2015)

60 Background: Indications for nipple-sparing mastectomy (NSM) with immediate reconstruction have expanded. For cancer patients, NSM is thought best-suited for early stage patients, with nodal involvement initially viewed as a relative contraindication. We undertook this study to evaluate the use and early outcomes of NSM in node-positive (LN+) breast cancer. Methods: We identified 240 cancers in 226 patients (14 bilateral) scheduled for NSM and operated on at our institution 1/2009-6/2014. Data on intraoperative conversion from NSM, recurrence and follow-up was abstracted from the medical record. Chi-square and long-rank tests were used for statistical analysis. P-values &lt; 0.05 were considered significant. Results: Of 240 cancers, 182 were LN- and 58 were LN+. More LN+ patients had T2/T3 tumors (27/58, 47%) than LN- patients (31/182, 17%), p &lt; 0.0001, but ER and HER2 status was similar. Of 58 LN+ cases, 19 (33%) were cN1 confirmed by positive LN cytology and 39 (67%) were cN0 but LN+ at operation. 10 patients LN+ at diagnosis received neoadjuvant therapy (NT) followed by operation (at which 6 were pLN+ and 4 rendered ypN0); 39 cN0 (4 NT, 35 primary surgery) and 9 cN1 primary surgery patients were pLN+ at operation with a median of 1 LN+. NSM was successful in 13/14 LN+ NT patients (93%) and 39/44 LN+ primary surgery patients (89%), p = 0.64. Six LN+ patients (10%) were converted to skin-sparing mastectomy (SSM) at initial operation based on frozen section pathology (n = 5) or at a second operation (n = 1) vs 13/182 LN- patients (7%), p = 0.44. Among cancer patients treated with NSM, 7 locoregional recurrences (5 in LN+, 2 in LN- patients) occurred at 25 mos median follow-up. 3-year locoregional disease-free estimates were 87% (95% CI 75-100%) for LN+ vs 99% (95% CI 97-100%) for LN- patients, p = 0.007. One nipple-areolar recurrence occurred, in a LN- patient. 3-year breast cancer-specific survival was 97% (95% CI 92-100%) in LN+ vs 99% (95% CI 98-100%) in LN- patients, p = 0.40. Conclusions: Conversion from planned NSM to SSM did not differ significantly between LN+ and LN- patients. Short-term oncologic outcomes were satisfactory. These data suggest that NSM may be appropriate for carefully selected LN+ breast cancer patients.
A comparison of outcomes regarding robotic versus open partial nephrectomy.
Authors: Zachary Adam Hamilton, Margaret Le, Kahlil Saad, David Duchene, Jeffrey M. Holzbeierlein, Moben Mirza
Journal: Journal of Clinical Oncology (2013)

441 Background: The latest SEER Cancer Statistics estimated that 60,920 new cases of kidney cancer were diagnosed in 2011 in the United States. The standard of care for small renal masses has transitioned from radical to partial nephrectomy with strong data to support excellent oncologic outcomes, long-term preservation of renal function, and better overall survival. The literature shows that laparoscopic approaches are favorable when compared to open techniques, but outcomes in robotic surgery are still gaining data. The objective of this study is to perform a review of outcomes comparing open versus robotic partial nephrectomy. Our hypothesis is that surgical outcomes and length of stay will favor robotic surgery. Methods: We performed a retrospective review of partial nephrectomies from 2009 to 2012 for solitary masses suspected as carcinoma at the Kansas University Medical Center. Estimated blood loss, age, length of stay, intraoperative transfusion, and margin status were recorded. When available, nephrometry scores were calculated based on preoperative imaging. Results: A total of 78 open partial nephrectomies and 63 robotic partial nephrectomies were analyzed. In the open cohort, the surgical blood loss was higher compared to the robotic cohort (328ml vs. 222ml, p=0.03). Nephrometry scores and mean mass size were higher in the open cohort (7.3 vs. 5.9, p&lt;0.01 and 3.2cm vs. 2.7cm, p=0.01, respectively). The mean length of stay was 2.8 days for the robotic cohort and 4.3 days for the open cohort. No significant difference was noted in age or BMI. Of note, there were five intraoperative blood transfusions in the open group and none in the robotic group. Four margins were positive in the robotic cohort and one in the open cohort. Nephrometry score and mass size did not correlate with blood loss. Conclusions: For partial nephrectomy blood loss is significantly lower with robotic techniques as compared to open surgery. This relationship is not affected by mass size or nephrometry score. Positive margins rate is higher in robotic surgery, while blood transfusion rate is lower in robotic surgery. Length of stay is decreased with robotic surgery. Robotic partial nephrectomy seems to afford the advantage of decreased blood loss and decreased length of stay.
A phase I study to evaluate safety, immunogenicity and antitumor activity of a HER2 multi-peptide virosome vaccine in patients with metastatic breast cancer
Authors: C. Wiltschke, U. Wiedermann, R. Zurbriggen, K. Elandt, K. Brämswig, J. Jasinska, H. Pehamberger, O. Scheiner, C. C. Zielinski
Journal: Journal of Clinical Oncology (2008)

3055 Background: Anti-HER2 directed immunotherapy has proven to be beneficial in patients with HER2 overexpressing breast cancer. This makes HER2 an attractive target for a therapeutic vaccine. We have shown that vaccination of rodents with three HER2-peptides representing B-cell epitopes of the extracellular domain of HER2 can induce elevated HER2-specific IgG levels and result in a delayed tumor onset and reduced tumor growth progression in c-neu transgenic mice. We have now initiated a phase I clinical trial with an anti-HER2 vaccine- construct of immunopotentiating reconstituted influenza virosomes with the three peptides (PEV6A) in patients with metastatic breast cancer (MBC). Methods: 9 patients with MBC were enrolled in a single arm, single-centre study. The endpoints were safety, production of peptide- and HER2-specific antibodies, and T-cell responses. Patients were required to have low HER2 expressing tumors (+ or ++) and positive hormone receptors. All patients had stable disease at the time of study entry and continued with their anti-hormonal treatment until progression. Patients received 3 intramuscular vaccinations in monthly intervals each consisting of PEV6A containing 10ug of each peptide. Results: All possibly drug-related adverse events were mild to moderate. No patient experienced any possibly drug-related serious adverse events. Injection site reactions such as erythema and edema were the most frequent possibly drug-related AEs. One patient died one month after the last vaccination due to disease progression. All the remaining 8 patients are alive, 6 are stable for a period of up to 12 months and 2 had disease progression after 5 and 7 months respectively. In seven patients immunogenicity was proven by solid peptide specific antibody responses. Conclusions: PEV6A is safe, very well tolerated and immunogenic. The production of HER2-peptide specific antibody could imply clinical benefit comparable to passive anti-HER2 antibody therapy. These data clearly support the further development of virosomal peptide vaccines to induce an antitumor antibody immune response. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration BioLife-Science Inc., Vienna, Pevion Biotech Ltd. BioLife-Science Inc., Vienna, Pevion Biotech Ltd. BioLife-Science Inc., Vienna BioLife-Science Inc., Vienna, Pevion Biotech Ltd., Pevion Biotech Ltd. Berne
Reactivation of chronic hepatitis B virus in cancer patients receiving immunosuppression: The case for screening.
Authors: R. B. Mendelsohn, S. Nagula, Y. Taur, M. Kamboj, K. Sepkowitz, A. D. Zelenetz, E. Ludwig
Journal: Journal of Clinical Oncology (2010)

9088 Background: Reactivation of hepatitis B virus (HBV) infection following immunosuppressive therapy can cause significant morbidity and mortality. This study aims to estimate the frequency and clinical consequences of reactivation of HBV in a diverse group of cancer patients (pts) receiving immunosuppression. Methods: We retrospectively reviewed all pts at Memorial Sloan-Kettering Cancer Center between 2003 and 2009 who had an HBV DNA PCR>1000 to identify cases of reactivation of HBV. The medical record was used to distinguish between reactivation and de novo infection. Pt demographics, type of malignancy, immunosuppressive agent, and clinical outcome were recorded. Results: Between 2003 and 2009, 241 pts had HBV PCR>1000 copies including 23 with associated abrupt increase in serum ALT. Twenty-two of these pts (median age: 53; 45% Asian descent) had no risk factors for acute HBV, suggesting reactivation. Immunosuppressive therapy began a median of 21 days (range 1-175) prior to reactivation. Varied chemotherapeutic agents were used; 1 pt received high dose steroids only. Seven (32%) patients had lymphoma, and 15 (68%) had other tumors: hepatocellular carcinoma (2), glioblastoma (2), leukemia (2), multiple myeloma (1), esophageal ca (1), sarcoma (1), breast ca (1), lung ca (1), jejunal ca (1), pancreatic ca (1), ovarian ca (1), and neuroendocrine tumor (1). Four (21%) pts died from liver failure; 19 (86%) required hospitalization (median LOS 5 days (range 2-33)). Four pts had clinically significant delays in cancer treatment due to HBV reactivation. Three pts were transferred for liver transplant evaluation; 1 pt underwent transplant. Conclusions: Reactivation of HBV during chemotherapy-induced immunosuppression is a completely preventable disease with substantial morbidity and mortality. Our 3 cases per year of clinically significant HBV reactivation occurred in patients of various nationalities without association with a particular malignancy or medication. Because of these findings, we now screen all patients initiating immunosuppressive therapy for HBV; subsequent use of antiviral prophylaxis is based on planned treatment and HBV risk group. No significant financial relationships to disclose.
Weekly topotecan in patients with platinum-sensitive and platinum-resistant recurrent ovarian and peritoneal cancers.
Authors: M. K. Tummala, S. Alagarsamy, P. Chyou, W. P. McGuire
Journal: Journal of Clinical Oncology (2010)

e15540 Background: To assess antitumor activity and toxicity of a weekly topotecan schedule in patients with recurrent platinum- sensitive/resistant ovarian, tubal or primary peritoneal cancer. Methods: Patients with measurable disease after prior treatment with platinum. Results: 30 patients enrolled, 17 with platinum sensitive disease and 12 with platinum resistant/refractory disease. 27 patients had ovarian primary and 2 with peritoneal primary. Median age 58 yrs (range 39-82 yrs). 93% of patients were treated with prior platinum/paclitaxel combination therapy; 40% treated with liposomal doxorubicin. Each cycle of treatment consisted of a 30 minute infusion of topotecan (4 mg/m2/day) administered weekly for 6 weeks followed by 2 weeks off. Starting dose was chosen from historical phase I data. Mean number of cycles/patient was 2.26. 20 patients stopped treatment after three cycles of due to disease progression. Weekly topotecan was well tolerated with 23% patients having grade 3 neutropenia and 3% with grade 4 neutropenia. One patient each experienced grade 3 and grade 4 thrombocytopenia. Three patients (10%) had grade 3 anemia and one patient had grade 4 anemia. A single patient experienced grade 3 fatigue. In 30 evaluable patients there were no complete or partial responses with 4 patients having stable disease; 26 patients had progressive disease. The median progression-free survival was 149 days (range 14-543 days) and median overall survival was 387 days (range 49-1,614 days). At the end of the study 39% of the patients were alive at the time of last contact. 27/30 patients had at least one further salvage systemic therapy after stopping topotecan. Conclusions: Weekly topotecan was well tolerated in this heavily pretreated population of platinum sensitive and platinum refractory ovarian and peritoneal cancer patients. The toxicity profile was better than historical data with the 5-day topotecan regimen. However, weekly topotecan in this specific schedule had minimal anti-tumor activity. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration GlaxoSmithKline
Associations between uncertainty, anxiety, and quality of life in men with favorable-risk prostate cancer on active surveillance: Two-and-a-half years' follow-up.
Authors: Patricia A. Parker, John W. Davis, David Latini, George Baum, Xuemei Wang, John Francis Ward, Deborah A. Kuban, Steven J. Frank, Andrew Lee, Christopher Logothetis, Jeri Kim
Journal: Journal of Clinical Oncology (2014)

135 Background: Active surveillance (AS) has emerged as a viable option for many men with early stage prostate cancer (PC). This approach of careful monitoring with prostate-specific antigen (PSA) level, digital rectal examination, and prostate biopsy may allow men to avoid or delay the potentially debilitating side effects of such aggressive treatments as surgery or radiation; however, AS may create uncertainty and anxiety for men with PC. We examined the associations between illness uncertainty and anxiety and general and PC-specific quality of life (QOL) of 191 men with favorable-risk PC participating in the AS program at MD Anderson Cancer Center. Methods: Men completed measures of uncertainty (Mishel Uncertainty in Illness Scale), anxiety (State-Trait Anxiety Inventory), and general (SF-12, Physical Health [PCS] and Mental Health Component Score [MCS]) and disease-specific (Expanded Prostate Index Composite [EPIC]) QOL questionnaires upon study entry and every 6 months. These results are through a 2.5 year follow-up. Results: Men were primarily (86%) white and an average age of 67.2 (SD=8.9). Average baseline PSA was 3.3 ng/mL (SD=1.6), 98% had a Gleason score of 6, and 85% had cT1c disease. Both general and PC-specific QOL were relatively unchanged across the 2.5 year study period, except for statistically significant declines in the EPIC Sexual score (p&lt;0.05). Controlling for demographic (age, ethnicity) and clinical characteristics (study entry PSA, PSA density, testosterone, BMI, baseline number of biopsies, family history of cancer, whether patients were taking a 5-alpha-reductase inhibitor, and whether the tumor was reclassified during the study), illness uncertainty was a significant predictor of all EPIC summary scores, PCS, and MCS (all, p&lt;0.05). Anxiety was also a significant predictor of all EPIC summary scores and MCS (all, p&lt;0.05), but not PCS (p=0.08). Conclusions: Both increased anxiety and increased illness uncertainty were associated with poorer general and disease specific QOL. Interventions that focus on reducing uncertainty and anxiety may enhance the QOL of men on AS for PC.
Concordance and disease type variables between adjuvant chemotherapy (AC) recommended and received as assessed by the Quality Oncology Practice Initiative (QOPI).
Authors: Joseph O. Jacobson, Pamela Kadlubek, Jennifer L. Malin, Caitlyn T. Solem, Michael N. Neuss
Journal: Journal of Clinical Oncology (2012)

214 Background: AC is indicated following curative-intent surgery for common solid tumors to reduce the chances of recurrence. Limited data are available to assess discrepancies between potential eligibility for chemotherapy, treatment recommendation and actual administration. For patients with completely resected early stage breast (BC), colorectal (CRC), and nonsmall lung cancer (NSCLC), QOPI assesses patient eligibility for AC, measures the rates of chemotherapy recommendation and administration. This analysis seeks to assess concordance between these measures and to explain differences. Methods: QOPI data are submitted by practices into a web-based system and stored as a relational database. For all categorical variables, frequency, and percent are presented. Concordance is shown as a rate—percent of charts eligible divided by those that met criteria. χ 2 tests were used to compare rates of recommended/received chemotherapy across cancer types. Results: Data were merged for 30,126 patients from the Fall 2011 and Spring 2012 QOPI collection periods. The analysis was limited to BC, CRC, and NSCLC patients for whom AC was clinically indicated by disease type and stage (eligible patients). Conclusions: Oncologists recommend AC with a high degree of predictability for eligible patients with BC and CRC, but at a lower rate for patients with NSCLC. Eligible NSCLC patients receive AC at a rate far lower than BC and CRC patients; these lower rates are due to patient refusal and medical contraindications. Patient factors such as consent and comorbidity must be considered in establishing quality measure benchmarks as they vary significantly among disease type. [Table: see text]
Incidence and risk factors for cholangitis during systemic chemotherapy among patients with advanced biliary tract cancer.
Authors: J. Hashimoto, C. Morizane, S. Kondo, H. Ueno, S. Mitsunaga, K. Nakachi, M. Ikeda, Y. Arai, T. Okusaka
Journal: Journal of Clinical Oncology (2011)

313 Background: Patients with biliary tract cancer (BTC) have a high risk of developing cholangitis. In patients with advanced BTC receiving systemic chemotherapy, cholangitis might interfere with the execution of the treatment. Furthermore, cholangitis during severe immunosuppression might develop into lethal complications such as sepsis or shock. Purpose: To determine the incidence of cholangitis among patients with advanced BTC undergoing systemic chemotherapy and to identify risk factors for the development of cholangitis. Methods: We reviewed the records of 301 patients with advanced BTC who received systemic chemotherapy at our hospital between February 2002 and July 2009. The clinical data of patients treated with gemcitabine monotherapy (GEM) as a first-line chemotherapy was retrieved. Results: One hundred and thirty-one patients were successfully followed up throughout the entire GEM treatment. Forty-three patients had intrahepatic BTC (32.8%), 28 had extrahepatic BTC (21.4%), 11 had hilar BTC (8.4%), 7 had ampullary cancer (5.3%), and 42 had gallbladder cancer (32.1%). Interventional radiological treatment or biliary reconstruction for biliary obstruction was performed in 50 patients (37.9%) prior to the start of chemotherapy. The median time to GEM treatment failure was 126 days. Cholangitis developed in 30 patients (22.9%) during GEM, and severe cholangitis developed in 10 patients (7.6%). The median time to the first episode of cholangitis from the start of chemotherapy was 65 days. Chemotherapy was discontinued because of cholangitis in 4 patients (3.1%), but no deaths as a result of cholangitis occurred. A multivariate analysis using a logistic regression model demonstrated that the presence of hilar obstruction (p=0.0002, OR: 10.748), the loss of sphincter of Oddi function (p=0.0005,OR: 8.960), and the presence of internal biliary drainage (p=0.007, OR: 4.472) were independent risk factors of cholangitis. Conclusions: The incidence of cholangitis during GEM treatment was 22.9% among the advanced BTC patients in this study. Hilar obstruction, the loss of sphincter of Oddi function, and internal biliary drainage may be risk factors of cholangitis. No significant financial relationships to disclose.
When to intervene to increase use of adjuvant hormone therapy among women with hormone-sensitive breast cancer.
Authors: V. P. Quinn, J. A. Strauss, J. E. Schottinger, C. T. Cheetham, R. Haque
Journal: Journal of Clinical Oncology (2011)

511 Background: There are approximately 150,000 new hormone-sensitive breast cancer cases in the U.S. each year. Numerous studies have shown that adjuvant hormonal therapy (AHT) dramatically reduces breast cancer recurrence and mortality. Daily treatment for 5 years is the recommended therapy. Yet, reports of under-utilization are alarming, ranging from 30% to more than 50%. Methods: We examined under-utilization of AHT among members of Kaiser Permanente Southern California (KPSC), a nonprofit prepaid managed care organization dedicated to providing evidence-based medicine. KPSC serves 3.3 million socioeconomically diverse members broadly representative of the racial/ethnic groups living in southern California. Subjects were members of the health plan for one or more years and had comprehensive medical and pharmacy benefits. We identified 10,827 women diagnosed with breast cancer between 2000 and 2007 from the health plan’s SEER-affiliated cancer registry who were eligible for AHT. We used automated pharmacy prescription records to describe uptake and utilization of AHT (primarily tamoxifen and aromatase inhibitors) over the 5 years of recommended therapy. Results: In this insured population, we found 14% of eligible breast cancer survivors did not begin AHT. Of those who started AHT, over 30% had sub-optimal adherence defined as a medication possession ratio <80%. Discontinuation of AHT, defined as greater than 90 days without medication, began in year 1 (7%) and reached 22% and 25% by the end of years 4 and 5, respectively. Conclusions: Monitoring and intervention for use of AHT needs to begin by one year after breast cancer diagnosis and continue across the 5 years of recommended therapy in order to ensure women receive optimal benefit from this life-saving treatment.