tbuckley/cabot-search huggingface dataset:
Breast cancer in octogenarians
Authors: E. Evron, H. Goldberg, A. Kuzmin, H. Gutman
Journal: Journal of Clinical Oncology (2005)

833 Background: The number of elderly cancer patients in our society increase rapidly. However, guidelines for their care are often lacking and treatments are influenced by various considerations and are usually less aggressive. Information regarding the natural course of the disease and the outcome of therapy in this population is of uppermost importance. Methods: We report of 135 women who were diagnosed with localized breast cancer at age 80 or older, and were treated in 2 tertiary centers in Israel between 1991 and 2001. The medical records of all patients were retrospectively reviewed. 135 patients that had localized disease and were deemed medically fit for surgery were included. Follow up information was obtained from the medical charts and through phone calls to patients or their families. Death dates were obtained from the Israeli main censor population data resources. Results: The median age at diagnosis was 83. Local treatment consisted of modified radical mastectomy or lumpectomy and axillary dissection followed by radiation therapy (“standard local treatment”= SLT) in 51 (38%) patients, and less than standard treatment in 84 (62%) patients. 88% of the tumors were T1 or T2, 75% were hormone-receptors positive. 90 (67%) tumors were Infiltrating Duct Carcinoma (IDC), 80/90 (89%) were grade II or III. Lymph nodes metastases were detected in 31/72 (43%) patients that underwent AXLND. Adjuvant treatment consisted of Tamoxifen in 110 patients, radiation therapy in 36 patients and chemotherapy in 3 patients only. At a median interval of 70 months, 18 (13%) patients had recurrent disease. 11/18 had local recurrence only and 7 had systemic disease. By that time 34 (25%) patients had died. 10 of breast cancer, 17 of other causes and for 7 the cause of death could not be disclosed. There was a trend toward higher disease specific mortality in patients that got less than SLT (p=0.09). The median overall survival has not been reached. Conclusions: The treatment of octogenarians with breast cancer should be individualized. Most of the patients lived more than 6 years after the diagnosis, long period to enjoy the benefits of appropriate therapy. The data do not support the assumption that breast tumors of very old patients are more indolent. No significant financial relationships to disclose.
TOP-M Chemotherapy (Thiotepa, Oncovin [Vincristine], Prednisone, Mitoxantrone) Plus Rituximab for Marginal Zone Lymphoma.
Authors: Morton Coleman, Richard R. Furman, Ruben Niesvizky, Michelle Ashe, Lena Mathews, Jennifer Fiore, Jamie Ketas, John P. Leonard
Journal: Blood (2004)
Renal cell carcinoma in octogenarians: Comprehensive analysis using the SEER database.
Authors: N. J. Hellenthal, M. H. Hayn, H. L. Kim, W. Underwood, T. Schwaab
Journal: Journal of Clinical Oncology (2010)

4624 Background: Little data exist about clinical outcomes in octogenarians who undergo surgery for renal cell carcinoma (RCC). The goal of this study was to determine overall and cancer-specific survival, and the use of partial versus radical nephrectomy in elderly patients. Methods: Utilizing the Surveillance, Epidemiology, and End Results (SEER) database, 60,693 patients in the years 1988 and 2005 were identified who underwent either partial or radical nephrectomy for RCC. Patients were separated into two groups—those younger than age 80, and those 80 years of age or older— and were stratified by the aforementioned variables. Chi-squared and Kaplan-Meier analyses were used to determine differences amongst the cohorts in terms of surgical approach and overall and cancer-specific survival. Results: Four-thousand two-hundred twenty seven patients (7.5%) were over the age of 80. Octogenarians were more likely to undergo radical nephrectomy than their younger counterparts (87% versus 92%, p<0.0001). At a median follow-up of 37 months (range 0-215) in patients <80 years, and 27 months (range 0-203) in patients ≥80 years, octogenarians were more likely to die of all causes (HR 2.32, 95% CI 2.22-2.42, p<0.001) than their younger counterparts. Octogenarians were also more likely to die of RCC (HR 1.33, 95% CI 1.23-1.43, p<0.001), but at a lower hazard ratio than for overall mortality. These cancer-specific differences in survival persisted throughout individual pathologic stages, with the exception of pathologic stage pT4 and metastatic disease. Octogenarians who underwent partial nephrectomy were 0.39 times less likely to die of RCC (95% CI 0.26-0.60, p<0.001) than older patients who underwent radical nephrectomy. Conclusions: Octogenarians who undergo partial nephrectomy have improved overall and cancer-specific survival than those who undergo radical nephrectomy, yet they are less likely to undergo partial nephrectomy than their younger counterparts. Octogenarians experience a decreased overall and cancer-specific survival benefit from extirpative surgery than younger patients. This data should be considered when treating the renal mass in the “elderly” patient. No significant financial relationships to disclose.
Factors affecting multidimensional caregiver burden: Results from national surveys.
Authors: Michael T. Halpern, Mallorie Fiero, Melanie Bell
Journal: Journal of Clinical Oncology (2016)

301 Background: Quality of care for individuals with cancer is affected by the burden on their caregivers. For high quality care, it is important to understand domains of caregiver burden and factors affecting this burden. Methods: Using data from two national surveys, the National Survey of Caregiving (NSOC) linked to the National Health and Aging Trends Survey (NHATS), we identified all participants in the NHATS diagnosed with cancer who had a caregiver participating in the NSOC. Twenty-two items in the NSOC related to caregiver health, mood and outlook were included in factor analysis to develop scales capturing domains of burden. Multivariable regression analyses examined whether activities performed by caregivers and supports for caregivers were associated with these burden scales. Results: Analysis of responses from 245 caregivers of cancer patients identified three scales: emotional burden; psychological burden; and relationship with the patient. Providing assistance managing medical care was associated with increased emotional and psychological burden, while assistance with non-medical issues was increased psychological burden and worsened relationships with patients. Caregiver provision of direct patient care activities was also associated with increased burden but improved relationships with patients. Use of support services showed mixed associations with burden. Conclusions: Using a nationally-representative sample of cancer patients and their caregivers and brief publicly-available survey questions, we present three scales addressing different aspects of caregiver burden that are responsive to caregiver activities and social supports. This may assist in developing and evaluating intervention to decrease caregiver burden and thereby improve quality of care for individuals with cancer.
Impact of oncology drug shortages.
Authors: Ezekiel J. Emanuel, Katie Shuman, Derek Chinn, Keerthi Gogineni
Journal: Journal of Clinical Oncology (2013)

CRA6510 The full, final text of this abstract will be available at abstract.asco.org at 7:30 AM (EDT) on Monday, June, 3, 2013, and in the Annual Meeting Proceedings online supplement to the June 20, 2013, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Monday edition of ASCO Daily News.
Evaluation of the effects of neoadjuvant therapy on stage specific outcome estimates in patients with completely resected gastric cancer.
Authors: Michael C. Lowe, Joanne F. Chou, Marinela Capanu, Daniel G. Coit
Journal: Journal of Clinical Oncology (2016)

139 Background: The current AJCC staging system for gastric cancer is based on pathologic staging and fails to take into consideration the effects of neoadjuvant therapy. We hypothesize that patients receiving neoadjuvant therapy have a worse outcome than patients with identical pathologic stage not receiving neoadjuvant therapy. Methods: We queried a prospectively maintained gastric cancer database for patients undergoing potentially curative resection for gastric adenocarcinoma between 1985 and 2012. Disease-specific survival (DSS) was estimated by Kaplan-Meier methods. The relationship between DSS and previously identified clinical risk factors was evaluated using Cox regression method. Results: A total of 2,752 patients were identified; of these 904 received neoadjuvant therapy and 1,848 received no neoadjuvant therapy. Patients receiving neoadjuvant therapy were younger (60.7 vs. 65.7 years) and more often male (72.9% vs. 62.4%). Their tumors were more often at the GE junction, but histology, differentiation, and rates of perineural and vascular invasion were similar. Of the 904 patients that received neoadjuvant treatment, 108 (11.9%) had a complete pathologic response. At a median follow up of 4.5 years, 5-year DSS is significantly worse for stage I patients (77% vs. 92%, p &lt; 0.001) and stage III patients (18% vs. 28%, p = 0.025) receiving neoadjuvant therapy; there is a trend towards worse survival for stage II patients (60% vs. 67%, p = 0.059). Factors associated with inferior DSS include age, male sex, diffuse or mixed histology, tumor site, depth of invasion, tumor size, number of positive and negative lymph nodes, and neoadjuvant treatment. The effect of neoadjuvant treatment remains significantly associated with DSS (HR 1.30 [95%CI: 1.12-1.50], p = 0.0004) after adjusting for these other known risk factors. Conclusions: Patients receiving neoadjuvant therapy have a worse stage-specific survival compared to patients not receiving neoadjuvant treatment. The AJCC staging system should be updated to reflect this difference in survival in order to appropriately prognosticate based on pathologic staging.
A phase I trial with extended cohort of gemcitabine and vinorelbine followed by autologous peripheral blood stem cell transplantation for recurrent or refractory Hodgkin’s lymphoma
Authors: S. Arai, R. Negrin, K. Blume, L. Johnston, G. Laport, R. Lowsky, J. Shizuru, K. Stockerl-Goldstein, R. Letsinger, R. Wong, S. Horning
Journal: Journal of Clinical Oncology (2005)

6651 Background: High dose chemotherapy and autologous stem cell transplantation (ASCT) is the most effective treatment for recurrent or refractory Hodgkin’s lymphoma (HL). Disease recurrence is still a major cause of treatment failure. Augmented BCNU-regimens are reported to have good outcomes but greater pulmonary toxicity. A novel transplant regimen incorporating gemcitabine and vinorelbine, active drugs in HL different from alkylating agents, was tested to establish MTD of gemcitabine and to assess safety at the MTD. Methods: In this phase I extended cohort study, dose escalation with gemcitabine in combination with vinorelbine followed by high dose BCNU, etoposide (VP-16), and cyclophosphamide (CY) and ASCT. 18 patients with recurrent or refractory HL were enrolled. 7 patients had dose escalation before determining the MTD of gemcitabine at 1250 mg/m2 on the basis of elevated liver transaminases and a symptom complex of fever, HA, and skin toxicity. 11 additional patients were studied at the MTD to establish safety. The regimen consisted of gemcitabine 1250 mg/m2 CI and vinorelbine 30 mg/m2 on day-13 and day-8, BCNU 10 mg/kg on day-6, VP-16 60 mg/kg on day-4, CY 100 mg/kg on day-2. Regimen-related toxicity was the primary endpoint. FFP and EFS were secondary endpoints. Results: 5 patients had no risk features; 13 had high risk features (stage IV disease at relapse, failure to achieve min disease, or B sxs at relapse). Median f/u time was 231 days (44 to 791d). Gr 1–2 skin rash was seen but with complete resolution. Transient fever and liver transaminase elevations also fully recovered. All patients engrafted. Remarkable was reduction in BCNU-induced pneumonitis in only 2 of 18 patients (11%), as compared to our standard regimen incidence rate of 35%. Est FFP and EFS at 1 year in low risk patients was 100% and for high risk patients, 73%(CI:47–99%) Conclusions: This novel transplant regimen has decreased incidence of pulmonary toxicity compared with augmented BCNU-regimens and provides a reduced toxicity platform for further development of post-transplant immunotherapy to improve transplant outcome. No significant financial relationships to disclose.
Autologous EBV-specific cytotoxix T lymphocytes for the treatment of EBV-related nasopharyngeal carcinoma
Authors: P. Pedrazzoli, P. Comoli, S. Secondino, S. Basso, R. Schiavo, I. Schiavetto, C. Frasson, F. Locatelli, R. Maccario, S. Siena
Journal: Journal of Clinical Oncology (2005)

2512 Background: nasopharyngeal carcinoma (NPC) is an EBV-related neoplasm expressing a limited number of viral antigens, including latent membrane protein 2 (LMP-2). Currently, the outcome of patients relapsing after first-line therapy is poor. Thus, alternative forms of effective, low-toxicity treatment are warranted. Based on successful experiences of immunotherapy for EBV-posttransplant lymphoproliferative disease, we explored the feasibility and safety of a T-cell therapy approach with EBV-specific CTLs as salvage therapy for NPC. Methods: our pilot clinical study has included 7 patients with advanced-stage EBV-related NPC with disease in progression after conventional therapies. CTL lines were reactivated and expanded from autologous peripheral blood lymphocytes, and were predominantly CD3+/CD8+ T-cells, displaying specific killing of autologous EBV-LCL, and, in 3 patients, showing a measurable lysis of LMP-2-bearing targets and patient tumor cells. Results: patients have been treated with 2–23 injections of EBV-specific CTL. T-cell transfer was well tolerated, and coincided with clinical benefit in 4 of 7 patients (2 partial responses, 2 disease stabilization). Analysis of IFN-γ producing cells demonstrated an increased frequency of EBV-specific immunity after immunotherapy, with sizeable LMP-2-specific responses in 3 patients. Conclusions: our data indicate that autologous EBV-specific CTLs can be used safely, are able to increase LMP-2-specific responses and exert in vivo anti-tumor immune surveillance in NPC patients. No significant financial relationships to disclose.
Use of pharmacist integration in oncology clinics to identify and resolve moderate to major drug-drug interactions.
Authors: Jack Toshimine Seki, Matthew Hughsam, Monika Krzyzanowska, Aaron Lo, Pamela Ng, Srikala S. Sridhar, Dominic Tsang, Vishal Kukreti
Journal: Journal of Clinical Oncology (2013)

71 Background: Medication reconciliation (MR) in outpatient clinics has been under-evaluated. We postulated that cancer patients would benefit from MR done by a pharmacist as these patients have many care providers, many medications, and are at high risk of drug-drug interactions (DDIs). Hence, we conducted a quality initiative evaluating the role of a pharmacist in the ambulatory clinics. Methods: One pharmacist prospectively rotated amongst four oncology clinics four days a week from June 3 to September 18, 2008. The pharmacist performed MR, and as a consultant developed therapeutic plans related to drug therapeutic problems (DTPs) including adverse reactions and DDIs. Patient medication lists were retrospectively analyzed using Micromedex and DDIs were categorized by frequency, severity and evidence level. A monthly survey (Likert scale) evaluating pharmacist contributions to each clinic team was completed by physicians and nurses. Results: A total of 158 patients were seen in 227 patient visits. The pharmacist identified 141 DTPs in 60 patients across 74 visits. The most frequently observed were no drug for a medical problem (51.1%), dose too low (12.8%), wrong drug (9.9%), and adverse drug reactions (9.2%). In response, 174 therapeutic plans were made. The most frequently recommended actions were drug added (40.8%), dose changed (13.2%), drug discontinued (9.2%), and interval/duration changed (7.5%). A total of 414 DDIs were identified in 110 patients, across 149 patient visits. On average, 2.62 DDIs were reported per patient, and 1.82 DDIs per visit. By severity, 139 (33.6%) major, 258 (62.3%) moderate, 16 (3.9%) minor and 1 (0.2%) contraindicated DDIs were documented. By level of evidence, 46 (11.1%) DDIs were excellent, and 236 (57%) were good. Survey results showed that doctors and nurses agreed/strongly agreed that pharmacist presence was valuable. The most useful contributions identified were consultation regarding DDIs, adverse drug effects, and medication efficacy decisions. Conclusions: DDI rates are high and most are moderate or major in severity. There is a clear benefit from the integration of a pharmacist to the clinics with an improvement in patient safety and quality of care.
Pharmacokinetic and clinical analysis of combination chemotherapy (Cx) with cisplatin (CDDP) and irinotecan (CPT-11) in lung cancer patients undergoing hemodialysis (HD): A phase I study
Authors: H. Mochizuki, H. Yoshizawa, J. Tanaka, Y. Hayashi, A. Ishida, H. Tanaka, H. Kagamu, F. Gejyo
Journal: Journal of Clinical Oncology (2005)

2066 Background: CPT-11 is a promising agent for advanced non-small-cell (NSCLC) and small-cell lung cancer (SCLC). However, combination Cx with CDDP and CPT-11 has not been established for HD patients. The aim of this study was to analyze pharmacokinetic parameters, and to investigate recommended dose and feasibility of combined Cx with CDDP and CPT-11 in lung cancer patients with chronic renal failure undergoing HD. Methods: Three lung cancer patients, one SCLC patient and 2 NSCLC patients with chronic renal failure undergoing HD were treated with CDDP (fixed dose of 60mg/m2) as a 30-minute infusion on day 1, and CPT-11 (escalating from 30 to 60mg/m2 by 10mg/m2 increment) as a 90-minute infusion on days 1, 8, and 15. HD was followed immediately after completion of anticancer agents each day, and the Cx was repeated every 4 weeks. CPT-11 was started at half dose of the standard for normal renal function, and escalated course-by-course within every patient. The dose-limiting toxicities (DLTs) were defined as grade 3/4 non-hematological toxicities, grade 4 thrombocytopenia, and grade 4 leukocytopenia/neutropenia for 4 days or more. The plasma levels of I and its metabolites, SN-38 and SN-38 glucuronide were determined by HPLC for each course of the Cx in every patient, and parameters were calculated. Results: All three patients reached CPT-11 level at 60mg/m2, and achieved partial response. None of them experienced DLTs, and the treatment was feasible at this standard dose for normal renal function. Also the pharmacokinetic parameters were similar to those previously reported for patients with normal renal function. Conclusions: The combination Cx with CDDP (60mg/m2 on day 1) and CPT-11 (60mg/m2 on day 1, 8 and 15) for lung cancer was safe and feasible, even with patients undergoing HD, and may be recommended for further clinical investigation. No significant financial relationships to disclose.
Axitinib in advanced renal cell carcinoma: Outcomes following pazopanib or sunitinib.
Authors: Jennifer Laskey, Balaji Venugopal, Nicola Thomson, Roisin O'Donoghue, Robert J. Jones
Journal: Journal of Clinical Oncology (2016)

609 Background: Axitinib is licensed in Europe for the treatment of adult patients with advanced renal cell carcinoma after failure of sunitinib, but not pazopanib. Efficacy is based on the AXIS trial which reported a progression free survival (PFS) of 4.8 months and an overall survival (OS) of 15.2 months in patients who had received prior sunitinib. Despite widespread use of pazopanib in the first line setting there is no randomised trial evidence to support the use of axitinib after pazopanib. The Beatson Cancer Centre (BCC) renal cancer clinic provides all systemic therapy for a population of 2.8 million. Within BCC axitinib is used post sunitinib or pazopanib. We performed an analysis of patient outcomes in patients who commenced axitinib in WOS between November 2013 and November 2014. Methods: Data were collected prospectively from the electronic clinical records. Duration of treatment was used as a surrogate for progression free survival (PFS). Data were analysed in April 2015 which served as the censor date for those still alive. Results: 46 patients were included. At the time of analysis 38 patients had stopped axitinib and 30 patients had died. 22 patients (48%) had received prior pazopanib and 21 (46%) prior sunitinib. For the patients who received axitinib in the 2 nd line setting (n = 38) median duration of treatment was 4.8 months (95% CI 0.55 – 9.12). Median duration post sunitinib and pazopanib was 4.8 months (95% CI 0 – 9.7) and 5.3 months (95% CI 2.2- 8.4). Median OS was 9.2 months (95% CI 6.44 – 12.05) overall and 9.44 months (95% CI 5.36 – 13.5) and 8.36 months (95% CI 1.7 – 11.6) post sunitinib and pazopanib respectively. Conclusions: PFS appears to be comparable to reported trial data irrespective of first line treatment indicating similar efficacy and tolerability in real life. We found no evidence of a significant difference in OS regardless of first line treatment which supports the current practice of using axitinib post sunitinib or pazopanib. The inferior OS compared to AXIS trial could be multifactorial and requires further investigation.
Efficacy and safety of a phase II study of sorafenib plus gemcitabine in advanced hepatocellular carcinoma.
Authors: V. Srimuninnimit, V. Sriuranpong, S. Suwanvecho, N. Soparattanapaisarn, S. Ithimakin, C. Akewanlop, S. Tanasanvimon, N. Parinyanitikul, N. Kiatikajornthada, H. Suwanrusme, W. Chaiyarat
Journal: Journal of Clinical Oncology (2011)

e14633 Background: Currently, the only standard systemic treatment for advanced hepatocellular carcinoma (HCC) is sorafenib monotherapy. In searching for an improved regimen of systemic treatment, we chose to use gemcitabine which has a modest activity but acceptable toxicity in advanced HCC to combine with sorafenib. Here we report the first efficacy and safety analysis of this novel combination in the treatment of advanced HCC. Methods: The study is a single arm sorafenib plus gemcitabine in patients with metastatic or unresectable HCC. Pathological diagnosis of HCC is mandatory. Treatment includes 4-week cycle of gemcitabine (1,000 mg/m2 day 1, 8, 15) to maximum of 6 cycles together with sorafenib (200 mg twice daily). Patient would continue sorafenib until disease progression or withdrawal from other reason. The primary endpoint is the progression free survival (PFS). Results: Forty five patients were eligible. Almost all patients had Child-Pugh score A (42/45, 93.3%). There were 28/45 (62.2%) patients who had hepatitis B virus associated HCC and 23/45 (51.1%) who had extrahepatic metastases. The overall response rate was 2/39 (5.1%) without complete response and the disease control rate was 30/39 (76.9%). The median PFS was 3.7 (3.5, 3.8) months with the longest time of treatment over 16 months. The median overall survival was at 12 (7.5, 16) months. Reported grade 3/4 treatment related adverse events (AE) include 33% thrombocytopenia, 15.6% neutropenia, and 15.6% hand-foot skin reaction. The study regimen was well tolerated with 4 patients discontinued from the treatment due to adverse events. There was one death during study treatment. Conclusions: The combination of sorafenib and gemcitabine in advanced HCC has a moderate clinical efficacy and encouraging long survival with acceptable toxicities comparing to th sorafenib monotherapy. Future studies in a larger randomized population are warranted.