tbuckley/cabot-search huggingface dataset:
Lymphedema following irradiation in breast cancer: A cross-sectional study
Authors: S. Goyal, T. Puri, D. N. Sharma, P. K. Julka, G. K. Rath
Journal: Journal of Clinical Oncology (2009)

e11569 Background: Nearly 15–30% of breast cancer patients (pts) face lymphedema (LE) following locoregional therapy, incidence being higher with surgery (Sx) &amp; radiotherapy (RT) combination than with Sx alone. We intended to study the incidence of post-RT LE and associated symptoms. Method: We evaluated 104 unilateral breast cancer pts who had completed curative therapy (Sx + RT + chemotherapy ± hormone therapy HT), with a minimum follow up of 6 months. Besides demographic &amp; treatment details, symptoms associated with LE and objective measurements of upper limb circumference were recorded using an indigenous questionnaire. Results: Median age was 45 years (range 28–65). Chest wall or breast RT was delivered using medial &amp; lateral tangential portals (Cobalt-60 unit) in 88 pts &amp; with 12 MeV electrons in 18 pts. Of all pts, 77 were given supraclavicular &amp; axillary RT. HT was given to 72 pts. Pathological stages were: T1/2- 73, T3/4- 27, Tx-4; N0–44, N1–25, N2/3–33, Nx-2. Arm swelling was reported by 68 pts (mild-40, moderate-28). Other symptoms included reduced range of motion (mild-52, moderate-24), fatigue (48), pain (28), numbness (20), infections (12), shoulder droop (12) and local tenderness (8). Forty-four pts reported having psychological stress (mild-40, moderate-4). Nearly 60% had symptoms mandating change in physical activity (mild-56, moderate-8). Dominant hand was involved in 57 pts. Shoulder exercises were advised in 84 pts; compliance was poor in 16, average in 32, &amp; good in 36. Only 36 pts were advised compression garments, compliance being poor in 28, average in 4 &amp; good in 4. Objective measurements revealed a difference of ≥3 cm in 27 pts in mid-arm circumference (MAC) (median 5.5 cm, maximum 8 cm) &amp; 34 pts in forearm circumference (FAC) (median 3.5, maximum 7 cm). There was no significant association between MAC or FAC with age, stage, body surface area, basal metabolic index, Sx type, chemotherapy or HT. Perceived LE and objective measurements correlated well. MAC difference &gt;3 cm was seen in 28.5% (22/77) pts who received axillary RT and in 18.5% (5/27) of those who received only local RT. Conclusions: LE, with its associated complications, is often understudied in breast cancer survivors. Revision of Sx and RT policies (e.g., omission of axillary dissection &amp; RT in selected pts) may help minimise LE. No significant financial relationships to disclose.
Effect of zoledronic acid on bone marrow micrometastases in women undergoing neoadjuvant chemotherapy for breast cancer
Authors: R. Aft, M. Watson, L. Ylagan, M. Chavez-MacGregor, K. Trinkaus, J. Zhai, M. Naughton, K. Weilbaecher
Journal: Journal of Clinical Oncology (2008)

1021 Background: We conducted a randomized phase II study to determine whether zoledronic acid (ZA) decreases the incidence of disseminated tumor cells (DTC) in women undergoing neoadjuvant chemotherapy. We hypothesized that ZA induced changes in the bone microenvironment would prevent the growth or survival of DTC. Methods: Between March 2003–2006, 120 women with clinical stage II/III breast cancer were randomized to either ZA 4 mg IV every 3 weeks for 1 year starting with the first cycle of chemotherapy or no bisphosphonate. 4 cycles of epirubicin (75 mg/m2)/docetaxel (75 mg/m2) were given prior to surgery and 2 cycles in the adjuvant setting. Eligible patients received endocrine therapy. Bone marrow was collected from each anterior iliac crest prior to therapy, at surgery, and at 1 year, and processed by density gradient. 2x106 cells from each specimen were stain using the pan cytokeratin (CK) antibody A45-B/B3. Slides were reviewed by two pathologists and considered positive if they contained >1 CK-positive, morphologically consistent cell. Clustered regression and chi-square was used for data analysis. Results: Arms were well balanced for grade, menopausal status, and tumor biomarkers. Bone marrow data was available for 119 patients prior to therapy, 112 patients at the time of surgery (3 months), and 79 patients at 1 year. Prior to any therapy, 47% of the ZA-treated and 43% of the no treatment group had detectable DTC in their bone marrow (p=0.651). At surgery, 30% of the ZA- treated and 47% of the no treatment arm had detectable DTC (p=0.071). At one year, 34% in both groups had detectable DTC. In patients who were initially negative for DTC, 79% of the ZA-treated group remained negative at 3 months where as only 51% of the no treatment group remained negative (p=0.028). At one year, 38% of the ZA-treated group remained negative, whereas only 25% of the no treatment group remained negative. Conclusions: Our study evaluated the effect of ZA on DTC in women undergoing neoadjuvant chemotherapy for breast cancer. This is the first demonstration that ZA given with chemotherapy causes a significant proportion of women with no detectable DTC at baseline to continue to be DTC-free at 3 months. ZA given with chemotherapy resulted in more women remaining negative for DTC over time. No significant financial relationships to disclose.
Results of chemotherapy (CT) based protocol for treatment of retinoblastoma (RB)
Authors: L. Goyal, S. Banavali, R. Bhagwat, B. Arora, M. Muckaden, S. Laskar, B. Padhye, A. Nicholson, P. Kurkure, P. Parikh
Journal: Journal of Clinical Oncology (2006)

9068 Background: One the main reasons for delayed presentation of children with RB in India is non acceptance of enucleation. CT is being increasingly utilized as primary treatment of RB to reduce the tumor volume and thus avoid enucleation and/or external beam radiation (EBRT) in early stage disease and reduce the risk of relapse in advanced stage disease. Methods: This retrospective (from 1996 to 2001) study involved 62 Patients (pts) (30 were bilateral) who received CT consisting of monthly cycles of carboplatin, etoposide, vincristine and cyclophosphomide. Pts with stage I disease, were started on CT alone, whereas most of the other pts were also started on concurrent EBRT (50Gy). Where indicated, pts also received local therapy, usually cryotherapy &amp; EBRT. Eyes which did not show response or had stable disease, were advised enucleation. Results: Majority of pts had Reese-Ellsworth groups IV-V (74.1%). 17 pts had Stg I, 22 Stg II, 17 Stg III &amp; 6 Stg IV disease (St Jude’s). All pts received CT (median 12 cycles). Out of 92 eyes only 79 were evaluable (13 were already enucleated).The response rate was 73.2% (51.8% CR or near CR); 12.9% had progressive disease. 47 Pts (74%) received RT. Only 23 pts received focal treatment (Cryotherapy 15, laser 3, combination 5). Vision was present in 38 eyes (48.1%) at presentation. 26 eyes (68.4%) were finally saved with useful vision. 20 pts had recurrence. 18 have died (17 died of disease, 1 treatment related sepsis). In those following up in the clinic, survival is 77% for stage I; 78.5% for stage II; 41.6% for stage III. All stage IV pts have died except 1 with nodal disease. Conclusions: CT has a role in the management of RB, however unless it is coupled with good focal therapy the results are poor as shown here. Also longer follow-ups are required because of late recurrences. This data highlights that in developing countries the social reasons complicate patient treatment &amp; compliance. Further efforts are needed to spread awareness of this disease so that patients are diagnosed and treated in earlier stages so as to improve the outcomes. No significant financial relationships to disclose.
Abstract 19521: Impact of Procedural Complications on Survival in Patients with Severe Aortic Stenosis Treated with Balloon Aortic Valvuloplasty: Results from the BRAVO Study
Authors: Jennifer Yu, Annapoorna Kini, Mauricio Cohen, Samantha Sartori, Usman Baber, Robert Pyo, Jason Kovacic, Brian P O'Neill, Pedro Moreno, Carlos E Alfonso, Rebecca Pinnelas, Christopher Varghese, Socrates Kakoulides, Avery Clarke, Roja Thapi, Swathi Roy, Michael Kim, Roxana Mehran, George Dangas, Samin K Sharma
Journal: Circulation (2012)

Introduction. Previous studies have examined the baseline predictors of survival in patients with severe aortic stenosis treated with balloon aortic valvuloplasty (BAV). However, the impact of procedural complications on long-term survival is unknown. Methods. Weconducted an independent retrospective review of pts who underwent non-emergent BAV at 2 high volume centers from 2005 to 2011. In-hospital events (bleeding, vascular complications, acute kidney injury [AKI], myocardial infarction, stroke) were adjudicated by an independent Clinical Events Committee. Survival status of all patients was ascertained by the Social Security Death Index. We compared patient survival by the occurrence of in-hospital complications. Cox regression analysis was used to adjust for significant baseline and procedural correlates of survival, in order to determine the incremental impact of in-hospital events on longer-term survival. Results. The median follow-up duration among 445 patients post BAV was 288 days. Major bleeding (defined as BARC type ≥ 3), AKI and vascular complications (per VARC definitions) were associated with increased mortality. After adjusting for baseline and procedural variables, AKI remained a strong predictor of mortality (OR 6.9, 95% CI 3.7 - 12.6, p&lt;0.001), major bleeding was associated with a trend for increased mortality (OR 1.5, 95% CI 0.96 - 2.5, p=0.07) and vascular complications were eliminated as a predictor. By Cox methods, anemia, atrial fibrillation/flutter and high creatinine at baseline were also associated with mortality whereas rapid RV pacing and attempted “preclosure” of the access site using a suture-based closure device were associated with improved survival (all p&lt;0.05, Figure). Conclusion. Procedural complications, in particular AKI, have significant impact on long term survival after BAV. Dedicated studies are required to examine the impact of strategies to reduce procedural complications on long term patient outcomes.
Contralateral mastectomy in young women with breast cancer: A population-based analysis of predictive factors and clinical impact.
Authors: Antoine Bouchard-Fortier, Nancy N. Baxter, Kimberley Fernandes, Ximena Camacho, May Lynn Quan
Journal: Journal of Clinical Oncology (2014)

82 Background: Contralateral mastectomy (CM) has recently been shown to be associated with survival benefit in women with breast cancer. The objectives of the present study were to describe factors predictive of CM in young women (≤35 years old) with invasive breast cancer and evaluate its impact on survival, in a large population based cohort. Methods: All women diagnosed with invasive breast cancer aged ≤35 from 1994 – 2003 treated with mastectomy were identified from the Ontario Cancer Registry. Patient demographics, complete tumour and treatment characteristics were abstracted from primary chart review. Cox proportional hazard regression was performed to assess factors associated with performance of CM and its effect on recurrence and overall survival, performance of CM was modeled as a time varying co-variate. The models were controlled for known predictors including age, tumor size, nodal status, ER/PR, LVI, histologic grade, systemic therapy and adjuvant radiation. Results: There were 628 women identified. Of these, 101 underwent a CM (16.1%). On multivariable analysis, factors predictive of CM were negative lymph node status (HR: 1.74, 95% CI [1.052-2.872]; p-value = 0.031) and negative estrogen receptor status (HR: 2.7, 95% CI [1.314-5.736]; p-value = 0.007). After a median follow up of 11 years, no significant survival benefit was observed in women undergoing CM compared to those who did not (HR: 0.95, 95% CI [0.61-1.46], p-value = 0.80). Conclusions: Performance of CM in young women with invasive breast cancer did not result in a significant survival benefit, compared to those without CM. Factors found to be predictive of performance of CM negative lymph node status and negative estrogen receptor status. Further studies are needed to determine if a subset of young women might benefit from CM.
Association of lymphocytosis following treatment with dasatinib with response and outcome.
Authors: C. A. Schiffer, J. E. Cortes, G. Saglio, P. le Coutre, E. Bahceci, D. Dejardin, N. P. Shah
Journal: Journal of Clinical Oncology (2010)

6553 Background: Persistent clonal expansion of cytotoxic T or NK cells has been described in patients with CML and Ph+ ALL during dasatinib therapy. Methods: Data from phase II and III trials of dasatinib were used to conduct a large analysis in all phases of CML after 2 years of therapy. Rates of major (MCyR) and complete (CCyR) cytogenetic response, progression-free survival (PFS: loss of complete hematologic response or MCyR or death; advanced-phase disease: the same or increasing white-blood cells), and adverse events (AEs) were measured in those with and without lymphocytosis (defined as lymphocytes >3.6 x 109/L on ≥2 occasions after 20 days of treatment). Results: Lymphocytosiswas observed in a large proportion of dasatinib-treatedpatients in chronic (31%), accelerated (39%), and myeloid blast (34%) phase. The incidence of lymphocytosis was similar in patients in chronic phase receiving total doses of 100 or 140 mg of dasatinib. Rates of CCyR were higher in patients with lymphocytosis, especially among those with advanced-phase CML (Table). Longer median PFS was observed in patients with advanced disease and lymphocytosis, but not among those in chronic phase. Rates of overall AEs were similar between patients with and without detectable lymphocytosis, including rates of AEs associated with inflammation. Conclusions: Lymphocytosis occurs commonly after treatment with dasatinib and is associated with improved cytogenetic response and longer PFS, suggesting that some of the antileukemic effects of dasatinib may be associated with immune activation. Future studies, including immunological characterization of the lymphocytes and their possible targets, will be of considerable interest. CML phase n Lymphocytosis (%) MCyR (%) CCyR (%) Median PFS (m) Chronic 1,150 Yes (31) 70 58 30 No (69) 58 49 >31 Accelerated 490 Yes (39) 52 44 28.6 No (61) 34 26 20.3 Myeloid blast 257 Yes (34) 38 32 6.9 No (66) 28 18 3.5 Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bristol-Myers Squibb Bristol-Myers Squibb, Chemgenix, Merck, Novartis, Wyeth Bristol-Myers Squibb, Novartis Bristol-Myers Squibb, Merck, Novartis Bristol-Myers Squibb, Novartis
Neoadjuvant treatment with weekly high-dose 5-fluorouracil as a 24h-infusion, folinic acid (AIO regimen) and oxaliplatin in patients with primary resectable liver metastases of colorectal cancer: Long-term results of a phase II trial
Authors: A. Wein, H. Albrecht, U. Reulbach, G. Maennlein, W. Hohenberger, E. G. Hahn, F. Boxberger
Journal: Journal of Clinical Oncology (2008)

15083 Background: Only 15–20% of all patients (pts.) with colorectal liver metastases are suitable for primary surgical resection. Liver resection offers the only chance of cure for these pts. In 2003 Wein et al. (Oncology) published the first data of neoadjuvant therapy following curative resection of liver metastases after a short median follow up (23 months) within a phase II trial. Here we report on the long-term results (median follow up: 45,5 months). Methods: Prospective phase II trial; pts.: n=20; start: 1/1998; end of recruitment: 2/2000; neoadjuvant chemotherapy: oxaliplatin (Eloxatin, 85 mg/m2 i.v. as a 2h-infusion (inf.); d 1, 15, 29 qd 57) and FA (Rescuvolin, 500 mg/m2 i.v. as a 1h- to 2h-inf.; d 1, 8, 15, 22, 29, 36 qd 57) followed by 5-FU (2600 mg/m2 i.v. as a 24h-inf.; d 1, 8, 15, 22, 29, 36 qd 57). Results: Last date of evaluation: 31/5/2007; localisation of the primary tumor: colon: n=40%, rectum: n=60%; histology: adenocarcinoma: n=20; G1/G2/G3/G4: 0/17/3/0; median age: 62,5 years; men/women: 75%/25%; ECOG 0/1: 10/10; higher grade toxicity: diarrhea CTC toxicity grade 3: 30%, vomiting grade 3+4: 15%; response of the neoadjuvant chemotherapy: CR: 10%, PR: 90%; metastatic resection: R0: 80%, R2: 20%. Median survival of all pts. (n=20): 3,0 years; 5-year overall survival (n=20): 40%. Median survival of the pts. (n=16) with R0 resection: 4,8 years; 5-year overall survival of the R0 resected pts.: 50%; 5-year disease-free survival rate: 25%. Median disease-free time period: 20,9 months. Conclusions: The neoadjuvant treatment with weekly high-dose 5-FU in the form of a 24h-inf. combined with FA and Oxaliplatin has proved to be highly effective and well tolerated. Disease-free survival rates and median overall survival rates are promising. Additionally, the data of a phase III trial published by Nordlinger et al. (ASCO 2007) indicate that a perioperative chemotherapy treatment combined with a curative resection of metastases may improve the prognosis in pts. with primarily resectable liver metastases. No significant financial relationships to disclose.
A clinical trial to study the effect of adding cis-retinoic acid during and after conventional treatment for pediatric neuroblastoma patient
Authors: W. Arafat, A. Abdelghany, N. Awad
Journal: Journal of Clinical Oncology (2009)

10057 Background: Neuroblastoma is predominantly a tumor of early childhood, with two thirds of the cases presenting in children younger than 5 years. Cis-retinoic acid has been used as maintenance therapy for treatment of advanced neuroblastoma after BMT. Patients who received cis-retinoic acid had significantly better 3-year event-free survival than patients receiving no maintenance therapy. However, there is no data available about usingcis-retinoic acid during induction phase of chemotherapy. The aim of this study is to evaluate the efficacy of cis-retinoic acid when used in combination with conventional chemotherapy in pediatric patient who is newly diagnosed with locally advanced neuroblastoma. Methods: Seventeen newly diagnosed children with locally advanced neuroblastoma who is candidate to receive chemotherapy were also received cis-retinoic acid starting at a dose of 160 /m 2 day (day 2–15 of chemotherapy) first the 3 patients, 20% dose reduction were allowed if toxicity occurred in first cohort of patient. . Patients were giving the drugs for at least 4 cycles. RT-PCR analysis of several related genes was done from tumor, sample after treatment. Results: Median age 2.4. Male:Female ratio was 1.4:1. Patients were stage III, IV (70%), II (30%). 88% of patients were presented with abdominal mass .Most patient received at least 6 cycles of OPEC/OJEC regimen. N Myc was done to 12 of patients. Median follow up was 6 months. Maximum tolerated dose were 130mg/m 2 , response was seen as CR 30%VGR 40, PR 12%, and PD 18%. Median event free survival was 12 months. Toxicity: Hypercalcemia mucositis, rash, and elevated liver enzymes were the main dose limiting effect of cis-retinoic acid. Preliminary collaborative analysis showed that down regulation of N-MYC is related to response rate. Conclusions: Cis-retinoic acid at dose 130mg/m 2 is a well tolerated drug with chemotherapy. Response to treatment is better than historical control. Randomized phase III trial is warranted. No significant financial relationships to disclose.
Tolerability and incidence of infusion site reactions with emulsion formulation of vinorelbine (ANX-530) compared to vinorelbine solution
Authors: J. Schupp, L. P. Lopez, J. M. Robbins, L. Arboit, H. Requejo, G. Arroyo, C. Blajman, L. Fein, M. Chacón, P. Quintana
Journal: Journal of Clinical Oncology (2008)

13549 Background: ANX-530 is an oil-in-water emulsion formulation of vinorelbine that has demonstrated less vein irritation, equivalent antitumor activity, and similar pharmacokinetic profiles to vinorelbine solution in preclinical studies. Pharmacokinetic equivalence to vinorelbine solution was recently reported in patients treated with each agent in a randomized clinical study. Methods: Thirty-one patients were enrolled in this single-dose 2-period crossover study, randomized for sequence. Patients had an advanced cancer potentially sensitive to vinorelbine after failure of standard treatments. Patients were randomly assigned to receive a single intravenous dose of either ANX-530 or vinorelbine in the first study period, then 1 week later, were crossed over to the other vinorelbine formulation. Both drugs were infused over 10 minutes at a dose of 30 mg/m2 using a calibrated syringe pump. Adverse events were analyzed by a logistic regression model with factors for treatment (ANX-530 vs. vinorelbine), period (Days 1–7 vs. Days 8–14), sequence (ANX-530 followed by vinorelbine vs. vinorelbine followed by ANX-530) and patient within a sequence. Results: Twenty patients had breast cancer, 3 had lung cancer, and 8 had other cancer types. The most common adverse events (AE) were neutropenia, leucopenia, infusion site phlebitis, and constipation. Only neutropenia was statistically significant for a period effect (2nd period greater than 1st, p=0.01). Sequence was not significant for any AE. A treatment effect was observed only in infusion site reactions (see table); and were more frequent with vinorelbine (29%) than ANX-530 (3%), (p<0.01). Conclusions: ANX-530 was associated with significantly fewer infusion site reactions than vinorelbine in a single- dose, crossover comparative study. Infusion Site Reactions ANX-530 (n = 31) Vinorelbine (n = 31) p value 1 9 <0.01 Grade ALL 1 2 3 ALL 1 2 3 Phlebitis 1 0 0 1 7 3 2 2 0.03 Irritation 0 0 0 0 1 1 0 0 - Itching 0 0 0 0 1 1 0 0 - Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Adventrx Pharmaceuticals, Inc.
The prognostic value of nodal ratios in node-positive breast cancer: AUBMC experience
Authors: A. Shamseddine, H. Hatoum, Z. Salem, Z. Abdel Khalek, N. El Saghir, A. Taher
Journal: Journal of Clinical Oncology (2007)

21072 Background: Axillary lymph node metastasis has proven to be the most important factor affecting overall survival (OS) and disease free survival (DFS) in patients with breast cancer. Recent evidence suggests that axillary lymph node ratio (LNR) may be at least as important as absolute number of involved lymph nodes in predicting OS and DFS. The aim of this retrospective study is to evaluate the impact of axillary nodal ratios in node-positive breast cancer as a prognostic factor for survival. Methods: Data from 1181 patients with stage I, II and III breast cancer diagnosed at AUBMC between 1990 and 2001 were studied. The median age at diagnosis was 50 years (23 - 88); the median number of lymph nodes dissected was 17 (0 - 49). Survival was compared in 737 patients with node-positive disease according to a LNR below or more than 0.25 (defined as number of involved lymph nodes divided by total dissected axillary lymph nodes). Results: Patients with LNR = 0.25 had a median follow-up of 30 months (1.2–156) and a median DFS of 26 months (1–156). The 5-year survival was 26.2% (94/358) and the 5-year DFS was 22.9% (82/358). Patients with LNR &lt;0.25 had a median follow-up of 36 months (1.2–157) and a median DFS of 36 months (1–157). The 5-year survival of 33.2% (245/737) and the 5-year DFS was 29.8 % (220/737). LNR showed significance as a continuous variable and a categorical variable (0, &lt; 0.25, and = 0.25) with a p &lt; 0.001 Conclusions: LNR significantly predicts OS and DFS in node-positive primary breast cancer. No significant financial relationships to disclose.