tbuckley/cabot-search huggingface dataset:
Clinicopathologic characteristics of early onset colon-rectal cancer: A single center experience.
Authors: Narjust Perez-Florez, Arpita Gandhi, Larysa Jessica Gromko, Enoc Fernandez, Andrew Jennis, Zubin M. Bamboat, Donald A. McCain, Martin Gutierrez
Journal: Journal of Clinical Oncology (2015)

538 Background: Colorectal cancer (CRC) is the second leading cause of cancer deaths in the U.S. Early recognition of CRC in young patients (pts) is a challenge, and clinicopathologic features at the time of presentation are not well described. The aim of this study was to compare clinico-pathological characteristics and survival between early onset CRC (Age &lt;50) and late onset CRC (Age ≥50). Methods: We reviewed the records of all patients diagnosed with CRC at our institution from 1999 to 2013. Total of 3,066 pts were studied. Demographics, tumor characteristics, and survival rate were analyzed. Patients with polyposis syndromes or genetic predisposition for CRC were excluded. Kaplan-Meier and Cox regression were used for the statistical analysis. Results: Of 3,066 pts, 425 pts (14%) under the age of 50 were identified (28-49). Hispanics (13% vs 8%, p&lt;0.01) and African Americans (7% vs. 4%, p&lt;0.009) were more prevalent in the early onset subgroup (EO) when compared to the late onset subgroup (LO). Pts were more likely to have sigmoidal and rectal tumors in the EO 187 (44%) than in the LO 799 (30%), (p&lt;0.0001). Mucinous and signet cell tumors were more frequent histological subtypes in EO pts (12% vs. 7%, p&lt;0.0003; 5% vs. 3%, p&lt;0.04, respectively). At diagnosis, EO pts were more likely to have well-differentiated tumors and advanced disease than LO pts (59% vs. 34%, p&lt;0.0001; 61% vs. 44%, p&lt;0.0001, respectively). Median survival was 133 months in EO (95% CI: 113-160) and 87 months in LO (95% CI: 77-89) (p&lt;0.01). African American descent (OR: 1.6 p&lt;0.009), Hispanic ethnicity (OR: 1.9 p&lt;0.001) right-colon tumors (OR: 1.65 p&lt;0.003) and positive margins (OR: 1.98 p&lt;0.001) were independent and significant predictors of survival by multivariate analysis in the EO subgroup. Colon cancer was the primary cause of death in 24% of EO vs. 11% LO (p&lt;0.0001). Conclusions: In our cohort, EO subgroup was more likely to have advanced disease with predominance of well-differentiated and left-colon tumors. EO subgroup has better overall survival and that could be explained by the lack of comorbidities in this group. Further research should aim to elucidate the basis of these differences, as this could potentially impact screening and management.
The oncology palliative care matrix: A community-derived evaluation tool for constructing oncology palliative care programs.
Authors: Lynne Padgett
Journal: Journal of Clinical Oncology (2012)

253 Background: While the Institute of Medicine and the Center to Advance Palliative Care have provided the impetus for many cancer centers to build palliative care programs, guidance regarding the “nuts and bolts” of program development is lacking. The Oncology Palliative Care Matrix (OPCM) is a unique self-assessment tool designed to facilitate both program evaluation and planning for provision of oncology palliative care. Methods: The National Cancer Institute Community Cancer Centers Program (NCCCP) Palliative Care Working Group developed the OPCM to assess palliative care capacity. The tool covers 17 components associated with quality palliative care delivery (e.g., staff training, patient identification, advanced care planning, attention to spiritual care). All NCCCP sites (16 enrolled in 2007, 14 enrolled in 2010) completed the matrix in 2010 evaluating their capacity with respect to each of these domains at the following time points: baseline (entry to the NCCCP program), 2 years after NCCCP enrollment (2007 sites only), and the upcoming year (goals for the future). Results: At baseline, matrix responses reflected variability in service capacity across the 17 domains. Reported capacity for specific palliative care components improved for the 2007 sites after 2 years in NCCCP; all sites identified ‘reach’ goals for the coming year. For example, at baseline, 63% of 2007 sites and 50% of 2010 sites referred only patients at end-of-life or with advanced disease and severe symptoms for palliative care services. However, after 2 years in NCCCP, 44% of 2007 sites still referred only these patients, while 56% made referrals to palliative care for patients at all cancer stages and/or as needed during post-treatment. Further, 100% of 2007 sites and 86% of 2010 sites aspired to this expanded referral capacity in the future. Conclusions: The OPCM shows utility in the community setting for self-assessment of capacity and strategic planning to improve quality palliative care delivery. It also highlights that some components of quality care may be easier to achieve/improve (e.g., referral for palliative care) than others (e.g., regular symptom assessment, palliative care staff support).
Hospital re-admission patterns and outcomes following major urologic cancer surgery.
Authors: Jasmir G. Nayak, Sarah Holt, John L. Gore
Journal: Journal of Clinical Oncology (2015)

497 Background: Peri-operative morbidity and mortality varies considerably among hospitals. Given the highly complex surgery required for urologic cancer, post-operative adverse event management may be superior if treated in the same institution as the index surgery. Methods: We accessed the Washington State Comprehensive Hospital Abstract Reporting System from 2009-2013 to identified patients who underwent radical nephrectomy (RN), partial nephrectomy (PN), radical cystectomy (RC) or retroperitoneal lymph node dissection (RPLND) for malignant disease. Mortality rates were assessed in those with an adverse outcome requiring hospital re-admission within 90 days of surgery. The primary hospital (PH) was the institution where the main surgery took place. Secondary hospitals (SH) were all other hospitals. Relationships with mortality were examined using multi-variate modeling. Results: 4,542 patients were identified who underwent major urologic cancer surgery, of which 56% were RN, 26% PN, 15% RC and 2% RPLND. Overall, 795 (18%) experienced an adverse event following surgery requiring hospital admission. 64% of patients returned to their PH for management, but was dependent on the surgery performed (60% RN, 65% PN, 67% RC and 83% RPLND). When stratified by hospital volume, patients were more likely to present to their PH (p=0.0005), with more patients returning to their PH if it was a low vs. high volume center (72% vs 55%). Comorbidities and length of stay on index surgical admission did not affect whether patients chose to present to their PH or a SH for adverse event management. The overall mortality rate was 5%. On multi-variate analysis, patients who underwent surgery at a high-volume PH and presented to a SH for adverse event management had higher rates of mortality (p=0.03). Conclusions: Adverse events within 90 days of surgery of major urologic cancer surgery are associated with a low mortality rate, and most patients present to their PH for management. However, patients presenting to a SH experienced a higher mortality rate following an adverse event. These findings require further investigation and may aid in future quality improvement initiatives to reduce the morbidity associated with these complex surgeries.
A phase Ib study exploring the combination of everolimus and dovitinib in VEGF-refractory clear cell renal cancer.
Authors: Amanda Marie Fitzpatrick, Michelle Greenwood, Abigail Foreshew, Jude Nixon, Anju Sahdev, Naveed Sarwar, Louise Lim, Robert J. Jones, Simon Chowdhury, Simon J. Crabb, Thomas Powles
Journal: Journal of Clinical Oncology (2014)

531 Background: Everolimus (mTOR inhibitor) and dovitinib (VEGF and FGF-2 inhibitor) demonstrate activity in metastatic clear cell renal cancer. The combination of these agents has a broad spectrum of relevant activity. In this study we establish the tolerability and an early activity signal of this combination. Methods: Patients with metastatic clear cell renal cancer who have failed VEGF targeted therapy were eligible. Up to four cohorts of three to six patients (3+3 design) were treated with escalated doses of daily oral everolimus (5-10 mg PO OD) and dovitinib (200-500mg 5/7 days PO) Dose-limiting toxicities (DLTs) were assessed determine the MTD. An expansion cohort (n=15) was treated to obtain additional efficacy and safety information. Results: Overall 18 patients were recruited into the study. Fifteen patients received the MTD, which was everolimus 5 mg PO OD and dovitinib 200mg PO day 1-5/7. The MTD was associated with toxicity, which included fatigue, mucositis and diarrhoea in 73%, 53% and 53% (CTC grade 1-4) of patients respectively. Frequent biochemical abnormalities occurred such as hypertrygliceridaemia in 67%. Higher doses of the combination were not tolerable due to grade 3 fatigue in 2/3 patients and grade 3 nausea in 1/3 patients within 1 month of therapy. The response rate at the MDT was 1/15 (7%) while the progression free survival for the MTD was 7 months (95% CI 2.2-11 months). Conclusions: Dovitinib and everolimus had modest activity, but did not meet all of the the planned efficacy endpoints. Fatigue was the dose limiting toxicity. Clinical trial information: NCT01714765.
Phase II trial of fulvestrant in castration resistant prostate cancer
Authors: M. K. Chadha, U. Ashraf, V. Payne, C. Silliman, P. Escott, D. Lawrence, L. Tian, E. Levine, D. L. Trump
Journal: Journal of Clinical Oncology (2008)

16079 Background: Preclinical evidence supports the role of estrogen receptor signaling in prostate cancer. In this phase II trial we investigated the tolerability and efficacy of fulvestrant, a pure estrogen receptor antagonist, in the treatment of castration resistant prostate cancer (CRPC). Methods: Patients with CRPC were enrolled after written informed consent. Fulvestrant was administered at a dose of 500 mg by intramuscular injection on day 0, then 250 mg intramuscularly on day 14, day 28 and monthly. History, physical examination, serum prostate specific antigen (PSA) levels and toxicity was evaluated monthly. Computed tomography and bone scan were repeated every 3 months to assess disease. Treatment was continued until disease progression, unacceptable toxicity, non-compliance or consent withdrawal. Results: Twenty patients were enrolled over a period of six months. All patients were Caucasians with median age of 69.5 years [range: 47–85 years]. Sixteen patients (80%) patients had radiological evidence of metastasis and 4 patients (20%) had rising PSA as the only evidence of progressive disease. The median PSA was 41.4 ng/ml (range: 7.1–933.5). Patients received a median of 3 treatment cycles of fulvestrant [range: 1–11]. Median time to progression was 4.3 months (95% confidence interval of 3 to 5.7 months) and median overall survival was 19.4 months (range: 9.9–19.4 months) after a median follow-up of 16 months. No patient showed ≥50% reduction in PSA or radiologic improvement. Few adverse events were noted, none of which were attributed directly to fulvestrant. Conclusion: Fulvestrant was well tolerated but failed to produce clinical or PSA response in men with CRPC. Treatment received, outcome and survival Complete/partial response 0 Stable disease 16 (80%) Progressive disease 4 (20%) Time to progression (median; range) 4.3 months (3-5.7) Off treatment reason: Treatment ineffective 2 (10%) PSA progression 12 (60%) Bone progression 6 (30%) Soft tissue progression 2 (10%) Median cycles completed 3 (1–11) Dose delays 2 Median survival (months) 19.4 Median follow-up (months) 16 Deaths 3 (15%) Two patients went off treatment with both bone and soft tissue progression. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration AstraZeneca Oncology
Racial disparities and the outcome of metastatic (met) colorectal cancer (CRC).
Authors: Afsaneh Barzi, Maryam Shabihkhani, Steven Yu, Dongyun Yang, Lingyun Ji, Heinz-Josef Lenz
Journal: Journal of Clinical Oncology (2013)

373 Background: Over the past decade survival of patients (pts) with CRC has improved. Although, the mortality rate for CRC is lower in Hispanics (H) than Whites (W), the decrease in mortality has been smaller among H during this period. H are the largest and minority in U.S. and therefore it is important to explain the discordant improvement in their outcome from CRC. We conducted a retrospective review of our CRC pts to determine whether treatment (TX) related factors would explain the observed difference in the outcome. Methods: Data for pts treated with at least one cycle of chemotherapy (CT) in the first line setting for met CRC at Los Angeles County Hospital and Norris Cancer Center between 2004 and 2011 were collected. Pts, disease, and TX related factors were reviewed and included for analysis. H were compared to non-Hispanics (NH) including Asians (A), Blacks (B), and W as a group and to W. Descriptive statistics were used to describe the population and where appropriate chi-square, Wilcoxon, and log-rank tests were used for comparison between the groups. Results: A total of 190 pts, 53% H, 24% A, 10% B, and 13% W were included for analysis. The median age of the population was 55 (21-82) years. 72 % of pts had de-novo met disease. 47% of patients had left, 24% right sided, and 29% rectal cancer. One-third of the patients received bevacizumab in the first line setting. Median time (MT) from first symptom to presentation was 85 days (d); 87 d in H and 74 d in NH (P=0.57). MT from diagnosis to TX was 70 d; 72 d H and 69 d NH (P=0.79). The median time from first TX to progression (TTP) was 8.9 (95% CI: 9.9-12.9) months (m) in H, 11.5 m in NH (P=0.058), and 12.6 m in W (P=0.079). Median BMI was 25.6; 26.5 in H, 24.1 in NH (P=0.001). There was no significance statistical difference between site of the disease, type and number of cycles of CT among the groups. Conclusions: Despite similar access to care in H and NH in our cohort, TTP is shorter for H than NH and W. Although the P is nonsignificant in this small sample, the trend is intriguing. The results need to be confirmed in larger cohorts and prospective studies. Given that the TX for met CRC is mostly unchanged since 2004, the results suggest an inherent biological difference between H and NH with obesity playing a significant role in the outcome.
AVAPERL1 (MO22089): Maintenance (mtc) bevacizumab (bev) with or without pemetrexed (pem) in patients (pts) with advanced nonsquamous non-small cell lung cancer (nsNSCLC) treated with first-line (1L) bev-cisplatin (cis)-pem: Interim safety data.
Authors: F. Barlesi, A. Scherpereel, R. Gervais, V. A. Gorbunova, A. Vikström, M. Ahn, J. Kim, A. Chella, J. Aerts, N. Ferrer, J. M. Trigo Perez, B. Lutiger, A. Rittmeyer
Journal: Journal of Clinical Oncology (2011)

7562 Background: 1L bev-based therapy followed by mtc bev offers clinical benefit over standard chemotherapy alone, as do either 1L cis-pem or mtc pem. AVAPERL1 is designed to investigate if continuing pem with bev offers additional benefit over bev alone following 1L bev-cis-pem therapy. The study is fully enrolled and is ongoing. Methods: Eligible pts with advanced, metastatic or recurrent nsNSCLC received 4 cycles of 1L therapy with bev (7.5 mg/kg)-cis (75 mg/m2)-pem (500 mg/m2) q3w. Pts with CR/PR/SD were randomized to receive bev or bev-pem until disease progression or unacceptable toxicity. Adverse events (AEs) were graded by NCI CTC v.3.0. Results: As of 08 Oct 10, 373 pts who received ≥ 1 dose of any study drug were included in the safety analysis. Baseline characteristics (%): male 59; stage IV 92; adenocarcinoma 88; ECOG PS 0/1 45/53; median age 60 yr. Median follow-up time was 4.4 months; 43% of pts are on treatment, 34% in follow-up and 23% off-study. 227 pts (61%) completed 1L therapy and initiated mtc therapy. AEs are summarized in the table. Consistent with the safety profile of regimens indicated for use with bev, the most common grade (G) ≥3 AEs by % pts are: neutropenia (8), embolism (3), hypertension, anemia, fatigue, diarrhea, nausea, vomiting, hyperglycemia, pneumonia and dyspnea (2 each). The most common SAEs by % pts are pneumonia (3), dyspnea, embolism, pulmonary embolism, neutropenia, renal failure and nausea (2 each). Conclusions: 1L bev-cis-pem was well tolerated with a safety profile comparable to that of regimens indicated for use with bev; most AEs were G 1/2. 61% of pts initiated mtc; to date, the incidence of G ≥3 AEs was similar in both mtc arms, but more SAEs were reported in patients treated with bev-pem. Safety population n=373 Bev mtc n=110 Bev-pem mtc n=117 AE any G, n 2,877 867 1,134 Pts with any G AE, n (%) 345 (92) 102 (93) 110 (94) AE G ≥3, n 300 55 44 Pts with G ≥3 AE, n (%) 169 (45) 38 (35) 45 (38) SAE, n 198 29 55 Pts with SAE, n (%) 131 (35) 22 (20) 36 (31) Pts with AE by phase, % 1L 87 82 86 Mtc 42 65 72 Pts with AE by intensity, % G 1/2 82/71 85/73 90/74 G 3/4 39/8 31/4 37/6 G5 5 3 2
Adrenalectomy for malignant disease: Utilization and outcomes by surgeon specialty and surgical approach.
Authors: Izak Faiena, Alexandra Tabakin, Jeffrey Leow, Neal Patel, Parth K Modi, Amirali H. Salmasi, Benjamin I. Chung, Steven L. Chang, Eric A. Singer
Journal: Journal of Clinical Oncology (2015)

489 Background: Adrenal cancers have traditionally been treated using an open surgical approach. With advances in minimally invasive surgery (MIS), adrenal tumors have become more amenable to MIS resection. We report a study on the utilization and outcomes of surgery for adrenal cancers on a national level. Methods: Data on patients who underwent open, laparoscopic, or robotic adrenalectomy for adrenal cancer (ICD-9 code 194.0) from 2003-2013 were extracted from the nationally representative Premier Hospital Database. Surgeon specialty, patient demographics, hospital characteristics, intraoperative and perioperative data, and complications were compared. Data were analyzed using univariate and multivariate logistic regression analyses. Results: 4,781 adrenalectomies were performed for malignant disease. Surgery was more commonly performed in patients &gt;50 years of age (83%), men (64%), and white race (80%). There was no significant difference in rate of adrenalectomy with regards to comorbidities, insurance status, teaching vs. non-teaching hospital, hospital bed size, or geographic region. Adrenalectomy for malignant disease was more commonly performed by non-urologists (66 vs. 34%; p=0.011). Among non-urologists, open surgery was most common followed by laparoscopic and robotic approaches (56.3% vs. 37.4% vs. 6.4%, respectively) as compared to urologists (48.8% vs. 38.4% vs. 12.9%, respectively). There was no difference in complication rate or operative time between surgeon types. On multivariate regression analysis, the best predictor of major complication was a Charlson Comorbidity Index (CCI) &gt;2 (OR 6.1, 95% CI 2.9-12.5; p&lt;0.0001). Surgical approach and surgeon specialty were not predictors of complications. Conclusions: Adrenalectomy for malignant disease was more commonly performed by non-urologists via an open approach. Patient CCI &gt;2 was associated with a higher rate of post-op complications, while surgical approach did not influence complication rate. These findings indicate that MIS can be performed safely for adrenal cancers. Prospective study of MIS for adrenal cancer is needed to evaluate its oncologic efficacy.
Management of cT1 micropapillary bladder cancer.
Authors: Daniel Levi Willis, Mario Fernandez, Rian J. Dickstein, Sahil Parikh, Jay Bakul Shah, Louis L. Pisters, Charles Guo, Bogdan Czerniak, H. Barton Grossman, Colin P.N. Dinney, Ashish M. Kamat
Journal: Journal of Clinical Oncology (2013)

308 Background: We have previously reported that intravesical BCG is ineffective as therapy for micropapillary variant of bladder cancer. Since then, smaller reports have emerged with differing conclusions. Here we report our updated experience and expanded number of patients with micropapillary bladder cancer (MPBC), with emphasis on cT1 MPBC. Methods: An IRB approved institutional review of our bladder cancer database identified 255 patients presenting with MPBC with 72 patients staged as cT1N0M0 at the time of initial diagnosis. Statistical and descriptive analysis was performed using IBM SPSS Statistics version 20 and survival analysis was performed using the Kaplan-Meier estimator and compared using the log-rank test. Results: Of the 72 patients with cT1 MPBC, intravesical BCG was used in 38 patients (53%), while 32 (44%) proceeded directly to radical cystectomy. This included 15 (20%) who received neoadjuvant chemotherapy for lymphovascular invasion (LVI). Kaplan-Meier estimates of overall survival (OS) and disease specific survival (DSS) at 5 and 10 years were 66% and 45%, and 70% and 61%, respectively. Among those receiving BCG, 28 (74%) recurred at a median of 7 mo., and 17 (45%) progressed, including 8 (30%) who developed metastatic disease. Among the 10 post BCG patients who underwent cystectomy after progression, median DSS was 43 mo. (mean=53 mo.) and 5 year DSS was 33%, whereas among those proceeding directly to cystectomy, median DSS was not reached (mean=152 mo.) and the 5 year DSS rate was 92% (p&lt;0.001). For OS, upfront cystectomy conferred a median survival of 170 mo. versus 92 mo. for those receiving BCG as initial therapy (p=0.05). There was no association of OS with the presence of CIS, repeat transurethral resection (TUR), or history of intravesical therapy prior to the diagnosis of MPBC. Interestingly, the extent of micropapillary component in the initial TUR specimen did have prognostic value for those treated with BCG as patients with focal MPBC were 2.3 times less likely to progress (p=0.02). Conclusions: Our updated findings support the use of upfront radical cystectomy prior to progression of disease in patients with cT1 MPBC. BCG therapy should be attempted only in select patients as there is a high risk of disease progression during BCG treatment.