tbuckley/cabot-search huggingface dataset:
Avoidance of axillary dissection in cN0 breast cancer patients with metastatic sentinel lymph node(s) using ACOSOG Z-0011 criteria: Is it appropriate for Indian patients?
Authors: Gaurav Agarwal, Sanjay Gambhir, Punita Lal, Narendra Krishnani, Sendhil Rajan
Journal: Journal of Clinical Oncology (2015)

62 Background: A relatively newer algorithm for surgical management of axilla, where axillary node dissection (ALND) is avoided in cN0 EBC patients with 1 to 2 metastatic sentinel nodes (SLN) is now widely practiced in North America. ASCO &amp; NCCN guidelines, and St Gallen consensus statement too have endorsed this strategy. This algorithm, based on the ACOSOG-Z0011 trial results has evoked quite a debate in India too. Concerns relating the quality of Z0011 data and its wide applicability persist. On the other hand, avoidance of ALND and its morbidity seems attractive to the oncologists and patients. In a single institution validation SLN Biopsy (SLNB) data-set, we evaluated the applicability of the “Z0011 strategy” to know its impact on an Indian patient cohort. Methods: In a prospective data-set of 120 cN0 EBC patients (mean age 51.1 years, T1 = 14, T2 = 106, mean tumor size 3.8 cm, 51.7% ER/PR+) who underwent validation SLNB (ALND irrespective of SLNB histology), such patients who fulfilled the selection criteria of ACOSOG-Z0011, i.e. those who underwent BCS and tangential field whole breast irradiation, and 1-2 metastatic SLNs were identified. Results: 66 (55%) of the 120 patients underwent BCS and tangential field whole breast irradiation. Of the 25 out of 66 patients with metastatic SLNs, 5 patients had 3 or more metastatic SLNs, and 2 had extra-nodal spread, thus not fitting the Z0011 criteria. Thus only 18 patients (15% of entire study cohort, and 27.3% of those undergoing BCS) with 1 to 2 metastatic SLNs were eligible for avoidance of ALND based Z0011 criteria. Of these 18 eligible patients, 7 (38.9%) had non-sentinel metastatic nodes. These 7, and the 3 with false negative SLNs could be seen as being left with undertreated axillae. Conclusions: In Indian context, where the majority of patients have large tumors and many opt for mastectomy, avoidance of ALND in presence of metastatic SLNs can be offered to a small proportion of patients. In a single institution validation SLNB data-set, only 15% patients qualified for avoidance of ALND using the Z0011 trial criteria. Besides, avoidance of ALND would have left 8.3% patients potentially undertreated in the axilla.
Effect of recombinant human endostatin on antitumor efficacy of paclitaxel/gemcitabine/cisplatin (TGP) chemotherapy in the treatment of advanced urothelial carcinoma.
Authors: J. Guo, X. N. Sheng, C. L. Cui, L. Si, Z. H. Chi
Journal: Journal of Clinical Oncology (2011)

265^ Background: Rh-endostatin is a new recombinant human endostatin that can inhibit tumor endothelial cell proliferation, angiogenesis, and tumor growth in the pre-clinical studies. A phase III study revealed that rh-endostatin in combination with chemotherapy shows a synergic activity in advanced NSCLC patients. This study aims to evaluate the response, median progression-free survival (PFS), overall survival time (OS), and safety of the regimen, paclitaxel/gemcitabine/cisplatin (TGP) plus rh-endostatin, in patients with advanced urothelial transitional carcinoma. Methods: The phase II trial included 35 patients with histologically diagnozed advanced or metastatic urothelial carcinoma, ECOG performance status 0-1, and GFR&gt;60ml/min. TGP chemotherapy plus rh-endostatin as a first line treatment included: paclitaxel (80 mg/m 2 , d1&amp;8), gemcitabine (1000 mg/m 2 , d1&amp;8), cisplatin (30 mg/m 2 , d1 to 3) and rh-endostatin (15mg, d1 to 14, every 21d). For every 2 cycles, patients were evaluated for progression or response. Patients who had achieved an objective response (complete or partial) or who had stable disease were further treated for two cycles. Results: The overall objective response rate was 62.8% (95% confidence interval [CI, 46.8% to 78.8%]), including 4 (11.4%) complete response (CR) and 18 (51.4%) partial responses (PRs). Six patients (17.1%) had stable disease (SD), and 7 (20.0%) had progression disease (PD). The disease control rate was 80.0%. The median progression-free survival and overall survival have not been reached. The most common adverse events included gastrointestinal reaction, alopecia, and myelosuppression. Grade 3/4 adverse events, including thrombocytopenia in 42.9% (15/35) of patients and leucopenia in 34.3% (12/35) of patients, were observed. Conclusions: The addition of rh-endostatin to TGP regimen for advanced urothelial carcinoma patients might have higher response rate. Rh-Endostatinin combination with TGP chemotherapy showed a synergic activityand a favorable toxic profile in advanced urothelial carcinoma patients. No significant financial relationships to disclose.
Clinical features and the role of surgery in stage IV gastric cancer: A single center experience.
Authors: Narjust Perez-Florez, Larysa Jessica Gromko, Eric Yoon, Andrew Jennis, Zubin M. Bamboat, Martin Gutierrez
Journal: Journal of Clinical Oncology (2015)

212 Background: Gastric cancer is a prevalent global disease with significant mortality. Nearly 22,220 patients are diagnosed annually in the US, with approximately 50% of them presenting with disease that extends beyond loco-regional confines, and only a small percentage undergoing curative resection. We aim to study the clinical characteristics and survival benefit of surgery in stage IV gastric cancer. Methods: We reviewed the records of all patients diagnosed with gastric cancer in our cancer center from 1999 to 2013. A total of 272 stage IV cases were identified. Demographics, tumor characteristics, treatment modalities (surgical vs. non-surgical) and survival rate were analyzed. Kaplan-Meier was used for survival analysis and Cox regression for univariate and multivariate analysis. Results: Within the cohort 70 (26%) patients received surgery and 202 (74%) were treated with chemotherapy ± radiation. Mean age at diagnosis was 64 years in the surgical (S) patients and 66 years in the non-surgical (NS). Non-Hispanics whites were more likely to receive surgery vs. all other ethnic groups combined, representing 77% vs. 23% of the S subgroup (p&lt;0.0001). Patients with proximal tumors were more likely to receive surgery when compared with distal tumors (37 (53%) vs. 14 (20%), p&lt;0.0001). Total gastrectomy was the most common surgical procedure 33 (47%). There was a significant difference in disease specific survival between the two groups, being 17.3 months for S (95%CI: 11.1-23.4) and 5.3 months for NS (95%CI: 3.8-6.7) (p&lt;0.0001). Age &gt; 70 years (OR: 1.74, p&lt;0.02), proximal tumor location (OR: 0.75, p&lt;0.04), surgery (OR: 0.37, p&lt;0.0001) and extended lymphadenectomy (D2) (OR: 0.26, p&lt;0.02) were independent and significant predictors of survival by multivariate analysis. Conclusions: In our cohort, non-Hispanic whites and patients with proximal tumors were more likely to undergo surgery. A major survival benefit was observed for the surgical subgroup when compared to non-surgical treatment for stage IV gastric cancer. Future research should aim to further elucidate the specific role of surgery, as this could potentially impact management and transform the standard of care in stage IV gastric cancer.
Defining the role retropubic radical prostaectomy (RRP) in high-risk (HR) carcinoma prostate (CaP) and their outcome analysis.
Authors: R. Gopal, J. Kulkarni, S. Bansal
Journal: Journal of Clinical Oncology (2011)

e15135 Background: Role of RRP in high risk (HR ) Prostate cancer is still evolving. There is always a discussion regarding the best therapy for this category of individuals. We present our 10 year follow up data to define the role of curative intent RRP. Methods: Between Jan 1993 – Dec 2010, 227 consecutive HR (as per D`Amico high risk criteria) were included in the study. All patients underwent RRP, out of these 191(84%) underwent upfront RRP. We compared the outcome on the basis of PSA score, Biopsy Gleason score, clinical stage, pathological stage, pathological Gleason score and nodal status. 219 patients who had completed at least 6 months of follow up were included for survival analysis. Results: Median age 63 years (35-83). Pre operative PSA was <20 ng/litre in 114(50%) and >20 ng/litre in 113(50%) patients, biopsy gleason score (GS) <8 in 158 (70%) and >8 in 69 (31%) and clinical staging <T2c in 102 (45%) and >T2c in 125 (55%) and while Single HR variable was present in 155 (68%) and >1HR variable in 72 (32%) patients. Pathologically, specimen confined tumors in 50 (22%), and positive Lymph Node (LN+) in 66 (29%) patients were seen. At 10 yrs OAS, BRFS (Biochemical relapse free survival), and MFS (Metastatic free survival) was 71%, 36% and 52% respectively. Patients with only one HR factor had OAS of 77% and with > 1 HR factor had OAS of 55% (p=0.010). On Univariate analysis Biopsy GS >8, Pathological stage pT3b, LN+, pathological GS 4+3, and presence of > 1 variable were significant indicators of BRFS and MFS. On multivariate analysis advanced pathological stage and positive Lymph node were the stronger predictors of outcome in our patients. High PSA score and advanced clinical stage alone did not have any significant bearing on the outcome. Conclusions: We can conclude from our data that high risk prostate cancer patients can be managed effectively with RRP with encouraging survivals.
The role of gender in predicting for reduced drug clearance and increased toxicity in non-small cell lung cancer (NSCLC) patients receiving carboplatin and paclitaxel.
Authors: V. H. Phan, C. Tan, J. L. Vardy, A. Rittau, H. Xu, F. Zhang, A. J. McLachlan, P. J. Beale, S. J. Clarke
Journal: Journal of Clinical Oncology (2011)

7557 Background: There is wide variability in toxicity from chemotherapy attributed to multiple factors including pharmacogenomic (PG), ethnic and nutritional differences. Gender differences in tolerance of anticancer drugs have also been described. The aim of this ongoing study was to investigate predictors of toxicity in advanced NSCLC patients receiving palliative chemotherapy. Methods: Stage III-IV NSCLC patients, receiving paclitaxel (175 mg/m2) and carboplatin (AUC 6) 3 weekly were enrolled. Demographic, nutritional and inflammatory data were collected at baseline. Plasma samples were collected using a limited sampling strategy and drug concentrations measured using ICP-MS for carboplatin and LC-MS for paclitaxel. Empiric Bayesian estimates of clearance (CL) were obtained using population pharmacokinetic (PK) analyses and NONMEM software. Toxicities, monitored weekly in cycle 1, were graded according to CTCAEv3.0 and correlated with the PK data. Results: Forty-four male and 20 female patients were recruited. Median age was 63 years for both men and women. Women experienced more peripheral sensory neuropathy (73.7% vs. 33.3%, p = 0.003), stomatitis (26.3% vs. 7.1%, p = 0.04) and grade 2-3 vomiting (26.3% vs. 7.1%, p = 0.04) than men. There were no significant gender differences in haematological toxicities. PK analyses showed that women had lower paclitaxel CL (10.5 L/h vs. 13.0 L/h, p < 0.0001) and carboplatin CL (7.3 L/h vs. 9.3 L/h, p < 0.0001) than men. Median survival was longer for women (18.4 vs. 16.0 months), although this was not statistically significant. Asians had significant slower clearance of paclitaxel than Caucasians (11.1 L/h vs. 12.7 L/h, p = 0.044). Conclusions: Women with NSCLC had lower clearance of both carboplatin and paclitaxel than men, which was associated with an increased incidence of non-haematological toxicity. The causes for these differences should be explored with PG and metabonomic analyses.
Cardiorespiratory fitness in adult survivors of childhood acute lymphoblastic leukemia (ALL).
Authors: K. C. Oeffinger, P. G. Snell, C. S. Moskowitz, J. F. Chou, D. A. Kent, E. S. Tonorezos, A. L. Dunn, S. M. Smith, T. S. Church
Journal: Journal of Clinical Oncology (2011)

9509 Background: Childhood ALL survivors have an elevated risk of premature cardiovascular disease. Methods: Maximal oxygen uptake (VO2max) was measured in 118 adult survivors of childhood ALL (median age, 23.0 years; range, 18 to 37). To adjust for body fat, VO2max (ml/kg/min) was also expressed relative to lean mass (ml/kg lean mass/min). We compared VO2max measurements for ALL survivors to those estimated from a frequency matched (age, gender, race/ethnicity) sample from the 2003-2004 National Health and Nutritional Examination Survey (NHANES). Multivariable linear regression models were constructed to evaluate the association between therapeutic exposures and outcomes of interest. Results: Compared to NHANES participants, ALL survivors had a substantially lower VO2max (mean 29.2 vs 38.9 ml/kg/min; P<0.001) and VO2max relative to lean mass (mean 43.4 vs 60.6 ml/kg lean mass/min; P<0.001). Further, each subgroup of ALL survivors, based upon key treatment exposures (cranial radiotherapy [CRT], anthracycline chemotherapy), had substantially lower VO2max compared with NHANES participants. In multivariate models including only ALL survivors, treatment exposure was associated with VO2max. Among females, CRT was associated with low VO2max (P = 0.02), but anthracycline exposure > 100 mg/m2was not (P = 0.58). In contrast, among males, anthracycline exposure > 100 mg/m2 was associated with low VO2max (P = 0.03), but CRT was not (P = 0.54). Conclusions: Adult survivors of childhood ALL, regardless of treatment exposure, have substantially lower levels of cardiorespiratory fitness compared with a similarly aged non-cancer population. Cardiorespiratory fitness (mean VO2max) for ALL survivors and NHANES participants. Group VO2max ml/kg/minute P* NHANES (N=570) 39.9 ALL survivors, total (N=118) 29.2 <0.001 CRT, no (N=78) 31.6 <0.001 CRT, yes (N=40) 24.7 <0.001 Anthracycline, none (N=33) 29.1 <0.001 Anthracycline, 60-80 mg/m2(N=45) 30.8 <0.001 Anthracycline, > 100 mg/m2 (N=40) 27.6 <0.001 * P value comparing cardiorespiratory fitness between ALL survivors (or treatment subgroup) and NHANES participants, adjusted for age at testing, gender, race/ethnicity, and current smoking status.
Oncology appointment compliance in navigated and non-navigated patients receiving radiation therapy in an urban public hospital.
Authors: E. A. Marcus, N. Holloway, C. Galligan, R. Cheng, M. McDunn, P. A. Robinson, K. Devine
Journal: Journal of Clinical Oncology (2011)

6109 Background: In Cancer (ca) patients (pts), adherence to treatment (tx) regimens has been determined to be important for pt outcomes. By eliminating barriers to care, Patient Navigation Services (PNS) has potential to improve compliance with complex regimens. In 2003, the American Cancer Society Illinois Division began PNS by placing social workers (LSWs) in institutions such as John Stroger Hospital (JHS). PNS provided assistance with transportation, childcare, insurance, housing , education, and emotional support . This study examined the impact of the program on pts’ adherence to radiation therapy (RT) in an urban medically underserved mainly minority population (pop). Methods: Eligible pts were treated with RT at JHS. A navigated pt was matched with an un-navigated control pts for disease stage (dx), race, sex, age, gender and tumor site. 100 matches were identified. Additional data on planned tx protocol, tx completed, tx delays, tx completion rate and insurance status were collected by manual chart abstraction. Results were analyzed to compare adherence pre and post the availability of PNS For navigated pts, the impact of navigation on adherence pre and post navigation was also examined. Results: The pt pop was 44% male, 56% female 63% African-American, 19% Caucasian, 15% Hispanic and 3% other. A younger cohort than most ca pops, 67% were 40-59 years old and 31% were 60-79 years old. 53% had stage 4 dz and 22% stage 3 dz. 77% were uninsured while only 6% had commercial insurance. The % of missed visits went from 18% in the pre navigated pts to 3% after starting navigation (compared with 6% in the controls). The % of pts who did not miss any appointments increased from 24% to 36% post navigation (22% controls). The % of pts not completing tx for non-medical reasons fell from 19% to 6% post navigation. Conclusions: For those pts who are at risk by age, stage or financial issues, navigation makes a difference in compliance. Navigation improved adherence dramatically, resulting in higher treatment completion rates. Identifying pts at risk for non-compliance, especially those that experience disparities in outcomes, and providing navigation early can improve compliance which may improve outcomes.
<sup>90</sup>Y glass microspheres for the treatment of unresectable metastatic liver disease from chemotherapy-refractory gastrointestinal cancers: A pilot study.
Authors: Nicholas Fidelman, Robert Keith Kerlan, Randall A. Hawkins, Emily K. Bergsland, Robin Kate Kelley, Andrew H. Ko, Wolfgang Michael Korn, Alan Paul Venook
Journal: Journal of Clinical Oncology (2014)

359 Background: This prospective single-institution pilot study was undertaken to document the feasibility, safety, and efficacy of treatment of liver-dominant metastatic gastrointestinal cancer using 90 Y glass microspheres. Methods: Between June 2010 and November 2012, 30 adult patients (22 men, 8 women; median age 61 years) with metastatic chemotherapy-refractory unresectable colorectal (n=15), neuroendocrine (n=9), biliary tract (n=3), pancreas (n=2), and esophageal (n=1) carcinomas underwent 45 lobar or segmental administrations of 90 Y glass microspheres. Data regarding clinical and laboratory adverse events (AE) were collected prospectively for 6 months after each treatment. Radiographic responses were evaluated using Response Evaluation Criteria in Solid Tumors, version 1.1. Time to maximum response, response duration, progression-free survival (hepatic and extrahepatic), and overall survival were measured. Results: Median target dose and activity were 111.6Gy and 2.5GBq per treatment session, respectively. All but 3 clinical AE were grade 1 or 2 in severity. The most frequent clinical AE were fatigue (83%), anorexia (50%), nausea (50%), abdominal pain (40%), vomiting (20%), fever (17%), and sweating (17%). Common metabolic and laboratory AE included hypoalbuminemia (50%), transaminitis (63%), and hyperbilirubinemia (27%). Serious AE included an unplanned hospital admission for carcinoid crisis, grade 3 vomiting, and grade 4 gastric ulcer. Patients with colorectal cancer had hepatic objective response rate (ORR) of 27% and a disease control rate (DCR) of 73%. Median progression-free and overall survival were 1.0 and 4.9 months, respectively. Patients with neuroendocrine tumors had hepatic ORR and DCR of 78% and 100%, respectively. Median progression-free survival was 18.5 months for this cohort. Conclusions: 90 Y glass microspheres device has a favorable safety profile, and achieved prolonged disease control of hepatic tumor burden in a subset of patients, including all patients enrolled in the neuroendocrine cohort. Clinical trial information: NCT01290536.
The asociation between the number of nodes removed at retroperitoneal lymph node dissection and overall- and cancer-specific survival in patients with nonseminomatous germ cell tumor.
Authors: D. Lewinshtein, A. Schatz, C. R. Porter
Journal: Journal of Clinical Oncology (2011)

4572 Background: The benefit of a thorough retroperitoneal lymph node dissection (RPLND) for testicular cancer has been well established and essentially eliminates retroperitoneal recurrence of disease. RPLND is known to be a complex, advanced procedure and the number of nodes removed may vary amongst institutions. Thus, we explored whether number of nodes removed at RPLND may predict overall- and cancer-specific survival in patients with non-seminomatous germ cell tumor (NSGCT) who have undergone RPLND. Methods: We retrospectively searched the Surveillance Epidemiology and End Results (SEER) database for all patients who had undergone RPLND for NSGCT between 1973 and 2006. We performed logistic regression to assess the ability of number of nodes removed at RPLND to predict overall and cancer specific survival. We adjusted for age, stage, and lymph node density. In addition, we used Kaplan-Meier life table analysis to evaluate actuarial survival probability as a function of removed nodes at the time of RPLND. Results: The cohort consisted of 1262 patients. The median age and median number of nodes removed at RPLND were 29 years (0-71) and 16 (+/- 13.5 SD), respectively. Of all patients, 48.5%, 45.9%, and 5.3% were stage I, II and III, respectively. On multivariate analysis, stage (<0.001), age (HR 1.056; p<0.001), and number of nodes removed (p=0.015) were all significant predictors of overall mortality. On Kaplan-Meier analysis, mean time to overall mortality (16.9 vs. 18.4 years, p<0.001) and cancer specific mortality (17.7 vs. 18.8 years, p<0.001) were significantly shorter for patients that had 5 or fewer nodes removed compared to those than had 6 or more removed. Conclusions: The number of nodes removed at RPLND significantly predicted the overall- and cancer-specific survival in patients with NSGCT. Moreover, patients with fewer nodes removed at time of RPLND had significantly shorter mean actuarial overall survival and cancer specific survival. This analysis emphasizes the critical importance of a thorough RLPND on survival in patients with testicular cancer.
Panc Support Project (PSP): Evaluating the integration of palliative care into a pancreatic cancer program at a comprehensive cancer center.
Authors: Eve Makoff, Arvind Manohar Shinde, Richard Tuli, Andrew Eugene Hendifar
Journal: Journal of Clinical Oncology (2016)

241 Background: Pancreatic adenocarcinoma is the 4th leading cause of cancer death in the US. It is predicted to become the 2nd leading cause by 2030. Advanced disease at diagnosis is common. Fewer than 20% of patients having long-term disease control. Given the high prevalence of physical and psychosocial needs, a quality initiative that embedded a PC physician in a pancreatic cancer program was initiated. Methods: From June 2015-October 2015, all stage III/IV pancreatic adenocarcinoma patients were referred for palliative consultation. * The PC physician was introduced as a supportive care medicine provider; a part of the comprehensive pancreas cancer program. *Other resources (ie RN, SW, Chaplain, RD) deployed as indicated *Patients seen initially and at least every 2 months * ESAS, PHQ2, and spiritual screens performed regularly * Data collected regarding symptom trajectory, resource utilization; and timing/place of death. Results: N=17. Conclusions: PSP demonstrated the ability of a PC provider to be effectively accepted and integrated into a pancreas program. Results suggest a benefit in the standardization of symptom screening/ intervention, and a possible favorable impact on healthcare resource utilization. Outcomes will continue to be tracked and compared with patients in the larger cancer community. Further study is indicated to assess the scalability and impact of this model of integrated care. [Table: see text]