tbuckley/cabot-search huggingface dataset:
Preoperative recombinant adeno-viral human p53 gene (rAd-p53) therapy in treatment of locally advanced locally advanced papillary thyroid cancer (PTC) and folliculary thyroid cancer (FTC).
Authors: J. Zhu
Journal: Journal of Clinical Oncology (2011)

5583 Background: Locally advanced PTC and FTC increase the complexity of surgery or become unresectable, and have a poor prognosis. This study is to evaluate the benefits of pre-operative rAd-p53 therapy combined with post-operative radioactive iodine (I131) in treatment of locally advanced PTC and FTC. Methods: Patients with historically-diagnosed stage IIB-IVA PTC and FTC or failed primary tumorectomy, were randomly assigned in two groups: experimental group (EG) control group (CG). EG received intratumoral injection of 1-3×1012 rAd-p53 viral particles (VP) per 3 days for 5 times, surgery, and post-operative standard I131 therapy. CG received surgery and post-operative standard I131 therapy. Surgery success rates, long-term efficacy and adverse effects were evaluated. The tumor samples were analyzed for tissue histology, p53 protein expression, and apoptosis. Results: EG including 31 cases, 19 female and 12 male, had radically operative rate of 100%, one-year survival rate of 100%, and no local recurrence and distant metastases. The tissue histological analysis showed increased fibrous tissues, apoptotic cells, and decreased tumor cells in the tumor sample from EG. CG including 29 cases, 18 female and 11 male, had radically operative rate of 79.3%, one-year survival rate of 86.2%, and distant metastatic rate of 10.3%. Six cases of CG could not remove all the tumor tissues due to involving nearby key structures: carotid artery, recurrent laryngeal nerve, larynx, and trachea. The main side effects of rAd-p53 were self-limited fever, occurring in 24 of EG patients. All the study patients are still followed-up, until 3 years after treatment according to the protocol. Conclusions: RAd-p53 might increase radical surgical rate and improve the long-term efficacy of locally advanced PTC and FTC.
Thyroid cancer (Ca) found during radioguided parathyroidectomy (RP) in hyperparathyroid patients
Authors: E. Walsh, S. Saha, V. Rao, M. Ghanem, M. Raiji, D. Wiese, J. Hammoud, M. Bakleh, J. Nelson, N. Tomycz
Journal: Journal of Clinical Oncology (2008)

17011 Background: For single parathyroid adenomas diagnosed by Tc-99m sestamibi parathyroid scans (SPS), minimally invasive (MI) RP is the procedure of choice. However, MIRP fails to identify concurrent thyroid pathology which occurs in 40–50% of hyperparathyroid patients (pts). We conducted a prospective study to determine the rates of thyroid pathology with particular attention to thyroid cancer in pts undergoing RP. Methods: Only pts with hypercalcemia and elevated PTH level were included. All surgeries were performed by a single surgeon. Pts were evaluated preoperatively with SPS and thyroid ultrasound (TUS). Pts with a +ve SPS and −ve TUS underwent MIRP. Pts with a +ve TUS underwent fine needle aspiration and bilateral neck exploration with RP regardless of SPS results. Total or partial thyroidectomy was performed as indicated. Results: There were 252 consecutive hyperparathyroid pts. SPS was +ve in 186 (74%) pts, −ve in 58 (23%), and equivocal in 7 (3%). One pt was unable to tolerate SPS. Parathyroid pathologies were as follows: adenoma in 190 (75.4%), hyperplasia in 42 (16.7%), double adenoma in 9 (3.6%), cyst in 1 (0.4%), and parathyroid Ca in 1 (0.4%) of the pts respectively. No parathyroid pathology was identified in 9 (3.6%) pts. Thyroid pathology requiring surgical resection was found in 135 (54%) pts, and included bilateral goiter in 85 (34%), Hashimoto’s in 33 (13%), papillary Ca in 19 (8%), and follicular adenoma in 5 (2%) pts respectively. In 5 pts thyroidectomy was performed due to intrathyroidal adenomas. In 19 pts with papillary Ca, TUS was +ve in 16 (89%) and −ve in 2 (11%) pts. All of these pts were asymptomatic for papillary Ca at their initial presentation. Metastatic disease to lymph nodes was present in 2 (11%) pts at the time of surgery. Conclusions: Preoperative TUS identifies operable thyroid pathology in 54% of our pts, and helped identify asymptomatic papillary Ca which would have gone undetected had these pts undergone MIRP only. Since the prevalence of thyroid pathology is high in hyperparathyroid pts, preoperative TUS may help stratify pts who are ideal candidates for MIRP from those that should undergo bilateral RP along with thyroidectomy. No significant financial relationships to disclose.
The effect of process engineering on the performance of a chemotherapy outpatient clinic (CC).
Authors: J. Latreille, C. Mimeault, N. Moreau, S. Parent, J. Savaria, J. Bastien, J. Lafreniere, C. C. M. Prady, O. Blaizel, G. Pie, M. Gannon
Journal: Journal of Clinical Oncology (2011)

6135 Background: The number of treatments (Rx) administered in our CC increased by 25% over a 4 y period (6,098 in 2006 to 7,633 in 2009). The number of 4hrs+ Rx increased by 158% from 478 in 2007 to 1,235 in 2009. This increase in workload caused numerous delays, lengthening of workday and a budget deficit. Due to limited resources, and growing dissatisfaction from our patients (pts) and physicians, we had to improve the performance of our CC. Methods: PE documented flow of pts, bottlenecks, CC loading rate and chair occupancy (CO) throughout the day, time to reach 90% occupancy, number of Rx given, work strategy, overtime, scheduling/appointment procedures and overall clinic efficiency/treatment capacity. Results: Analysis revealed that achieving 90% CO took 5.30 hrs. Total capacity utilization was 50%. 71% of pts were admitted late (mean delay: 48 min). Main bottlenecks were: delayed laboratory results and same-day physician’s appointments. PE aimed for 90-100% CO within 90 min after opening and 85-90% utilization of total capacity each day. Changes implemented included: 1-creation of 2 pods of 8 chairs staffed by 3 nurses. Changes in nurse scheduling permitted accelerated CC loading. 2-Lab tests to confirm chemotherapy prior to scheduling were done 24 hrs in advance. 3-A computerized appointment system was implemented which takes into account treatment length and start-up time. Seven months post-implementation analyses revealed high pt, nurse and physician satisfaction. 90% CO is now reached within 90 minutes as planned. Next day schedule is finalized by 2pm of the previous day. Over this period, nursing overtime decreased by 28.2% (262 vs 365 hrs in 2009). Rx increased by 19.5% (4,425 vs 3,702). For last week of this analysis, delays occurred for 50% of pts (99). Mean delay to admission was 30 min. Occupancy for same period was 62% of total. Delays are now caused by treatment not being completed on time either due to side effects or addition of unplanned medication by physician. Treatment length adjustments are being made. Conclusions: PE facilitated a major reorganization of operations in the CC and achieved significant improvement in performance without requiring increases in staff and physical treatment capacity. PE is an ongoing process.
Association of NCCN guideline adherence with improved survival in high-risk stage II and stage III colon cancer.
Authors: Genevieve Marie Boland, Yj Chiang, Ryaz Chagpar, Yan Xing, Chung-Yuan Hu, Barry W. Feig, George J. Chang, Y. Nancy You, Janice N. Cormier
Journal: Journal of Clinical Oncology (2012)

543 Background: Evidence-based treatment guidelines have been proposed as a quality metric for cancer care. There is significant variability in the treatment of high-risk stage II (defined by tumor depth, histologic grade, margin status, and # of nodes retrieved) and stage III colon cancer patients in the National Cancer Database (NCDB). This study examines whether adherence to guidelines is associated with improved outcomes. Methods: Patients with colon adenocarcinoma (1998-2002) were identified from the NCDB. The stage-specific NCCN guidelines were used to classify patients into two groups based on adherence to guidelines (adherent or non-adherent). Overall survival (OS) and relative survival (RS) were calculated for both groups. Relative survival was used as a surrogate for disease-specific survival and calculated using the methods of Dickman et al. Results: A total of 77,350 patients were included in the analytic cohort. Stage-specific outcomes were compared and stage is an independent predictor of survival. As reported in our previous analyses, nonadherence as a result of omission of chemotherapy, was noted in 64.3% and 26.4% of high-risk stage II and stage III patients, respectively. Nonadherence was associated with decreased OS and RS with a hazard ratio for death of 1.43 (95% CI: 1.33, 1.54) for high-risk stage II and 1.89 (95% CI: 1.82, 1.95) for stage III (p &lt; 0.001, Table) RS. Additionally, regression analysis demonstrated that gender, age, race, insurance, income, and type of facility were associated with differences in RS. Conclusions: Guideline-based practice, particularly for high-risk stage II and stage III colon cancer, is associated with improved survival outcomes. Therefore, these guidelines may be appropriate as a metric of performance comparable across various institutions. Additionally, factors associated with deviations from guidelines can be used to focus improvements in the access to and delivery of cancer treatment. [Table: see text]
Incidence of transformation to aggressive lymphoma in limited-stage follicular lymphoma (FL) treated with radiotherapy.
Authors: P. Bains, A. J. Al-Tourah, B. A. Campbell, T. Pickles, R. D. Gascoyne, J. M. Connors, K. J. Savage
Journal: Journal of Clinical Oncology (2010)

8073 Background: Transformation to aggressive lymphoma is a recognized complication in FL, with an annual risk of approximately 3% (Al-Tourah. JCO. 2008). However, the incidence in limited-stage FL treated with curative intent radiotherapy (RT) is unknown. Methods: We recently reported the outcome of 237 patients (pts) with limited-stage grade 1-3A FL defined as stage I or II, no B symptoms and non-bulky disease < 10cm who were treated with curative intent RT at the British Columbia Cancer Agency (ESMO 2009, Abstract 9202). The 10 and 15-year (y) overall survival (OS) of this cohort was 66% and 46%, respectively. The incidence and outcome of transformation in this cohort was reviewed. Results: With a median follow-up of 7.4 y (range 1.8-23), 34 cases of limited-stage FL underwent transformation to aggressive lymphoma with an overall 10-year risk of 20%. The median time to transformation was 3.6 y (.44-10.23). The majority of cases were histologically confirmed (76%) and were diffuse large B-cell lymphoma (90%). At the time of transformation, the median age of pts was 63.5 y, 47% were male, 24% had B symptoms, 59% had an elevated LDH, 53% had extranodal involvement (most common site bone 50%) and 62% had an IPI of ≥3. In 17 pts (50%), transformation represented the first manifestation of lymphoma relapse. There were no risk factors at diagnosis, including grade of FL, that predicted for future risk of transformation in multivariate analysis (MVA). The 10-year OS in transformed vs. non- transformed pts was 53% vs. 70%, respectively (p=.008). For pts treated with curative intent (n=29), therapy with R-CHOP at the time of transformation improved survival (5-year OS 92% vs. 15%, p=.0067) and was the only factor associated with OS in MVA. (HR .06, p=.006). Conclusions: There is a moderate risk of transformation in limited-stage FL treated with curative intent RT and this represents a major factor impacting outcome in these patients. Treatment with rituximab at the time of transformation appears to improve outcome. Given the absence of clinical variables at the time of diagnosis that predict for future transformation, biologic correlates would aid in identifying patients that may benefit from additional initial therapy. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Allos Therapeutics, Eisai, Genentech, Roche Roche Roche Canada
Neurotoxicity in older colorectal patients with diabetes treated with oxaliplatin schedule: Our experience
Authors: P. Guarneri, V. D. Ferari, S. Grisanti, F. Valcamonico, V. Amoroso, G. Rangoni, P. Mapicati, L. Vassalli, E. Simoncini, G. Marini
Journal: Journal of Clinical Oncology (2008)

20724 Background: Diabetes is very common metabolic disease and naturopathic symptoms are one of its complications. Neurotoxicity had been a well-known adverse effect of oxaliplatin and this agent caused neurological damage like diabetic neurotoxicity in the same places, but we observed this toxicity in a different timing. Oxaliplatin is an alkilant agent, this new platin compound is the drug of choice in the treatment of patients with colorectal cancer and it’s the milestone of a lot of schedule (XelOX, FolFOx,|l/). The toxicity profile is characterized by neurotoxicity ( paresthesias dysesthesias at hands and foot, face and pharynx). Methods: From 1/2002 to 12/2006 we treated 653 pts for CRC in adjuvant or metastatic setting, all of these pts received one schedule chemotherapy with Ox. According to ADA (American Diabetes Association) criteria 34 pts had a diagnoses of diabetic disease at the beginning of chemotherapy. All pts who had a glycaemic basal value of 110 mg/dl were included in retrospective analyses. 17 pts were more than 65 yrs old. Male/female were 12/5, Median age was 72 (range 65–78). ECOG PS was 0–1. We made a descriptive statistical evaluation of clinical characteristics (age, gender, cumulative dose, grading, other neurotoxicity,) and continuous variables such as laboratory data (glycemia, calcium serum level and Hb blood concentration). We used χ2 test to valuate in univariate statistic analysis the correlation between single variables and neurotoxicity. Results: 15 pts had neuropathic symptoms, 11 had hand and foot paresthesias, 3 showed mouth and pharynx cold related dysfunction, 4 had other neurological symptoms. In the same time a lot of pts had a multiple symptoms. We observed neurotoxicity grade 3–4 in 6.6 % of pts; 1 pt had allergic reaction to oxaliplatin. Conclusions: We observed a correlation between cumulative dose of OX and neurotoxicity (p= 0.036), cumulative dose and survival, but in our cohort diabetes and iper-glycaemia do not increase neurotoxicity in older diabetes cancer pts in comparison with other pts. We obsedved that Ox can be administered in diabetes without worsening diabetics. No significant financial relationships to disclose.
Imatinib (Glivec) and Nilotinib (AMN107), Two Selective Inhibitors of Bcr-Abl Tyrosine Kinase, Induce Hemoglobin Production in Human K-562 CML Erythroleukemia Cells in Addition To Promoting Apoptosis.
Authors: Asterios S. Tsiftsoglou, Paul W. Manley, Ioannis D. Bonovolias
Journal: Blood (2006)
Safety and feasibility of laparoscopic surgery for colorectal cancer in elderly patients (YSURG1401 study).
Authors: Yosuke Atsumi, Masakatsu Numata, Toru Aoyama, Tsutomu Hayashi, Naoto Yamamoto, Takashi Oshima, Norio Yukawa, Manabu Shiozawa, Takaki Yoshikawa, Yasushi Rino, Munetaka Masuda
Journal: Journal of Clinical Oncology (2016)

725 Background: The safety and feasibility of laparoscopic surgery (LAP) for colorectal cancer has not yet been fully evaluated in elderly patients. The aim of this study was to compare the short term surgical outcomes of LAP and evaluate the safety and feasibility of LAP in colorectal cancer patients aged &gt; 75 years. Methods: This retrospective study enrolled consecutive patients who underwent laparoscopic surgery for colorectal cancer between April 2013 and March 2014 at Yokohama City University Hospital and its related general hospitals. The patients were categorized into two groups: elderly patients (≧75 years of age: group A) and non-elderly patients ( &lt; 75 years of age: group B). Surgical outcomes and postoperative complications were compared between the two groups. The severity of complications was evaluated using the Clavien–Dindo classification. Results: A total of 237 patients were evaluated in the present study. Eighty-four patients were classified into group A, and 153 into group B. Preoperative clinicopathological outcomes demonstrated no significant differences except for the ASA score. When comparing the surgical outcomes between group A and group B, the rate of conversion to open procedure (3.6 % vs 5.2 %, P = 0.751), median operation time (232 min vs 232 min, P = 0.318), median blood loss (20 ml vs 12 ml, P = 0.353). There was no significant difference in the surgical outcomes. Although the incidence of Japanese D3 dissection was significantly lower in Group A (56 % vs 69.3 %, P = 0.047), the incidences of postoperative surgical complications of grade ≧ Ⅱ were similar between two groups (15.5 % vs 11.8 %, p = 0.427). The length of postoperative hospital stay was also similar (10days vs 10days, p = 0.347). Conclusions: The present study suggested that laparoscopic surgery for colorectal cancer is safe and feasible, regardless of the age of the patient, especially for elderly patients who may be candidates for colorectal cancer surgery.
Gemcitabine and capecitabine in metastatic breast cancer (MBC): A Brown University Oncology Group (BrUOG) phase II study
Authors: W. M. Sikov, K. P. Theall, C. W. Seidler, R. S. Strenger, M. A. Fenton
Journal: Journal of Clinical Oncology (2005)

785 Background: Gemcitabine (G) and capecitabine (C) have antitumor activity as single agents in MBC. Each inhibits DNA synthesis, though by different mechanisms. By increasing the activity of pyrimidine nucleoside phosphorylase and depleting intracellular pools of deoxyuridine monophosphate, G promotes conversion of C to its active metabolite in tumor cells. Dose-limiting toxicities do not overlap. Based on a phase I study of the combination (Schilsky et al, JCO 2002), we studied the G + C combination as 1st- or 2nd- line chemotherapy in MBC. Methods: Eligible patients (pts) were age ≥18, ECOG PS 0–1, with measurable or evaluable disease, ≤1 prior chemo regimens for MBC, no prior G or C, ANC≥1200, plts≥100,000, bili≤2.0 mg/dl, CrCl≥30 ml/min. Pts received G 1000 mg/m2 d1&8 with C 830 mg/m2 PO BID (625 mg/m2 PO BID if CrCl 30–50 ml/min) d1–14 q21d. Treatment was held for ANC<1000, plts<75,000, grade(gr) ≥2 diarrhea (D), mucositis (M) or hand-foot syndrome (HFS). Pts were restaged every 3 cycles; those with complete response (CR), partial response (PR) or stable disease (SD) continued on treatment. Results: 25 pts entered the study. Median age 58 (39–78), 18/25 had visceral disease, ER+/ER-/ERunknown = 10/11/4, 9 had prior chemo for MBC. Pts received median 6 cycles of treatment (range 2–19). Day 8 G was held for neutropenia in 17.7% (21/113) of cycles 1–6. C dose was reduced for HFS (3 pts) and gr 3 M (1 pt). Gr 3/4 toxicities included ANC 12/2, plts 0, LFTs 3, M 1, HFS 1, and rash 1. No febrile neutropenia, gr 3 thrombocytopenia, nausea or D were seen. Of 20 evaluable pts (5 pts either didn’t receive the prescribed treatment (3) or were taken off study without progressive disease (PD) before their first re-staging (2)), 10 achieved a PR (50%, 95% CI 27–73%), including 6/8 2nd-line pts, 7 SD (minimum 6 cycles), and 3 PD. Median TTP was 5 months, median DOR 5.5 months, and median survival has not been reached at 12+ months. Conclusions: The G + C regimen is well tolerated in MBC with an encouraging response rate in this phase II study. It may warrant additional study, especially as more pts are exposed to both anthracyclines and taxanes in the adjuvant setting. Supported by grants from Roche Laboratories, Inc. and Eli Lilly & Co. No significant financial relationships to disclose.
Impact of CGA in therapeutic decisions: ELDERLY trial.
Authors: Javier Gallego Plazas, Elena Asensio Martinez, Inmaculada Lozano, Guillermo Ricote, Martin Ore, Almudena Cotes, Alejandra Magdaleno, Mamen Ors, Jose M. Baron, Eric Campello, Patricia Guaraz, Silvia Fernandez, Natividad Martinez
Journal: Journal of Clinical Oncology (2015)

759 Background: Based on results from phase III clinical trials chemotherapy treatment benefit in patients ≥70 years old with stage III and IV colorectal cancer (CRC III-IV) is a subject in question. The ELDERLY trial aims to explore in a pilot program viability and convenience of an evidence based protocol for Comprehensive Geriatric Asessment (CGA) as well as the contribution of further evaluations. Methods: Patients ≥70 years old with CRC III-IV were prospectively and consecutively included. After initial treatment recommendation was made, study protocol for CGA (functional, nutritional, cognitive, social, psychological, and comorbidities) was carried out. Based on CGA, early death risk prediction model and chemotherpy toxicity risk stratification subsequent final treatment recommendation was obtained. Follow up of patients and comparison to historical controls is underway. Results: 20 patients (10 CRC III, 10 CRC IV), median age 79.2 years (71-85), 65% males, were included. ECOG PS was: 0 in 35% of patients, 1 in 35%, 2 in 20%, and 3 in 10% of patients. Initial treatment recommendation was: standard for 60% of patients, adapted standard for 25%, and no treatment for 15% of patients. According to Köhne et al. (Oncologist 2008) fitness categories 25% of patients were in group I, 55% in group II, and 20% of patients in group III. Early death risk, according to Soubeyran et al. (J Clin Oncol 2012), was high for 5% of patients. Chemotherapy toxicity risk, according to Hurria et al. (J Clin Oncol 2011) was low for 15% of patients, intermediate for 60%, and high for 25% of patients. Final treatment recommendation was: standard for 25% of patients, adapted standard for 55%, and no treatment for 20% of patients. Initial and final treatment recommendation diverged in 55% of patients (more conservative final treatment recommendation in 45%, and more intense final treatment recommendation in 10%). Conclusions: Evidence based protocol CGA modified initial treatment recommendations. Follow up of patients and comparison to historical controls could contribute to improve the knwoledge and convenience of this and further evaluations.