tbuckley/cabot-search huggingface dataset:
United States trends in patterns of care in clinical stage I testicular cancer: Results from the National Cancer Database (1998-2011).
Authors: Claudio Jeldres, Craig R. Nichols, Khanh Pham, Siamak Daneshmand, Christian K. Kollmannsberger, Brandon M. Hayes-Lattin, Erika Wolff, Katherine Odem-Davis, Christopher R. Porter
Journal: Journal of Clinical Oncology (2014)

369 Background: There has been significant evolution in worldwide guidelines for management of clinical stage I (CS1) testicular cancer where active surveillance (AS) strategies are now considered a first choice, especially for patients with lower recurrence risk after orchiectomy. Conversely, local therapies for CS1 such as primary retroperitoneal lymphadenectomy (RPLND) in non-seminoma and regional radiation in seminoma are phasing out of recommendations. In the US, there have been no comprehensive efforts to measure uptake of guideline recommendations and modern patterns of care for early-stage testicular cancer. Methods: Access to the testicular cancer data set within the National Cancer Data Base (NCDB) was granted to Virginia Mason Medical Center (A SWOG affiliated cancer research program) for this retrospective cohort study. We identified all patients with CS1 testicular cancer between 1998 and 2011. Management options after orchiectomy such as adjuvant radiotherapy, adjuvant chemotherapy, RPLND, or AS were analyzed using cross tabulation and trend analysis. Results: Within the NCDB, of 75,902 patients with testicular cancer, 31,208 and 13,301 were diagnosed with CS1 seminoma and non-seminoma, respectively. For CS1 seminoma, AS use increased from 25.2% in 1998 to 55.8% in 2011. Similarly adjuvant chemotherapy use also increased (1.9 % to 16.7%). Conversely, use of adjuvant radiation decreased from 72.9% to 27.5%. For CS1 non-seminoma, AS remained the main treatment modality ranging between 58.8% and 66.2%. The use of adjuvant chemotherapy increased (28.3% in 2011) and the rate of primary RPLND constantly decreased down to 12.9% that same year. Interestingly, 50.3% of patients with CS1 non-seminoma and negative lympho-vascular invasion status had chemotherapy rather than AS. Trends analyses were statistically significant for all treatment modalities (p&lt;0.05). Conclusions: Active surveillance as a management strategy has increased and is currently the most common treatment modality used for both CS1 seminoma and non-seminoma in the US. Regional therapies in CSI seminoma and non-seminoma are decreasing but persist even in patients with a low risk of recurrence.
A phase II/III randomized study in advanced non-small cell lung cancer (NSCLC) with first line combination versus sequential gemcitabine (G) and docetaxel (D): Update on quality of life (QoL), toxicity, and costs
Authors: C. Manegold, N. Thatcher, C. Kortsik, G. Koschel, W. Spengler, J. Mezger, A. Müller, L. R. Pilz
Journal: Journal of Clinical Oncology (2005)

7057 Background: Single-agent gemcitabine (G) and docetaxel (D) are not cross-resistant and are effective in chemotherapy-naïve and pretreated patients (pts). The study was to evaluate the clinically, relevant hematologic toxicity (CRHT) in two treatment settings. Interim analysis including survival has been previously presented (ASCO 2004 abstract no. 7095). Methods: Pts received G/D in doses of 1000 mg/m2 /75 mg/m2/q3w either concomitantly in arm A: {G days 1,8 + D day 8 for 6 cycles} or sequentially in arm B: {G: days 1,8 for 3 cycles followed by D: day 1 for 3 cycles}. NCI-CTC grade 3–4 thrombocytopenia requiring transfusion, anaemia requiring transfusion or febrile neutropenia requiring IV antibiotics were defined as CRHT. Results: The table shows the characteristics, costs, and the outcome for 292 pts. In arm B pts received 69% of G and 46% of D of mean doses in arm A, respectively. In arm B CRHT appeared less often (anaemia, p=0.038 and febrile neutropenia, p=0.037, respectively). Interventions (transfusion and IV antibiotic treatment days) were more frequently with Arm A. QoL according to EORTC-LC13 measurement also favored Arm B. Overall survival as reported earlier was not different. Conclusion: Treatment costs are significantly lower if both drugs are given sequentially. Coevally there is more CRHT with concomitant drug application by higher transfusion rates and antibiotic treatment days as with sequential application. From the data available there is no indication that efficacy will differ. Arm A: combination G+D (n=152) Arm B: sequential G→D (n=140) Arm A: combination (n=552 cycles) Arm B: sequential (n=563 cycles) Baseline characteristics Toxicities: CRHT grade 3–4 (cycles) Gender (m/f) 115/37 106/24 Anaemia / transf. 14 5 Median age, years [range] 63.2 [36.6–78.7] 64.4 [39.7–81.2] Thrombocytopenia / transf. 1 1 WHO PS (0–1/1) 128/24 121/19 Febrile neutropenia / IV antibiotics 7 1 Histology: adeno/squamous/other 66/48/38 59/39/42 All interventions Stage IIIB/IV 22/130 21/119 RBC transf. (units) 81 43 Total dosage per patient in mg Platelet transf. (units) 1 2 G 12237 8407 IV antibiotics (treatment days) 400 220 D 433 201 Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Eli Lilly Eli Lilly, sanofi-aventis Eli Lilly, sanofi-aventis
Impact of mucositis on patient experience during treatment for head and neck cancer
Authors: V. K. Mehta, M. Abboud-Finch, J. A. Petersen, J. T. Marron
Journal: Journal of Clinical Oncology (2008)

17034 Background: To many patients, mucositis is a painful and debilitating adverse effect of cancer treatment. We studied the impact of mucositis on patients who had completed radiation therapy (RT) for head and neck (H&N) cancer using a web-based survey. Methods: Patients with H&N cancer who had registered to use NexCura’s online NexProfiler® Treatment Option Tool for H&N Cancer between Aug 2001 & Oct 2006 and previously opted to participate in surveys were invited to complete an online survey about their cancer treatment experiences. Of the 5,246 individuals invited, 233 completed the survey of 84 questions during a 4 week period in Jan-Feb 2007. All eligible patients had received RT as part of their treatment. Results: Of233 respondents (74% male), 15% received RT alone and 85% received RT + chemotherapy. 86% completed treatment in 2001–2006. 77% of patients rated some form of mucositis as their most severe side effect of treatment. The most severe symptoms of mucositis reported were: mouth sores/ulcers, 21%; mouth soreness, 32%; throat soreness, 35%; dry mouth, 42%; change in taste or no taste, 36%; mouth pain/burning, 29%; difficulty/pain on swallowing, 27%. Hospitalization was needed for 54% of patients, in 24% of cases due to inability to eat or drink, or dehydration. 30% of patients were hospitalized for >5 days (13% for >10 days) and 34% of hospitalized patients were admitted via an ER. 60% of all patients required a PEG tube (9% of those for >12 mo), 16% a NG tube, and 18% TPN. 78% still have difficulty with swallowing certain foods. 91% of all patients lost more than 10 lb during treatment and 48% of those are still underweight. Conclusions: In a large post-treatment survey of H&N cancer patients, we found that mucositis is the most severe adverse effect affecting patients. Helping to alleviate these symptoms requires significant medical supervision and substantial resources. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Amgen, MedImmune Amgen Amgen, MedImmune
TGFBR1*6A is not a susceptibility allele for colorectal cancer in a Spanish population
Authors: A. Castillejo, T. Mata-Balaguer, T. Sanchez, P. C. Montenegro, V. M. Barberá, E. Ochoa, R. Lázaro, C. Guillén, A. Carrato, J. Soto
Journal: Journal of Clinical Oncology (2008)

22202 Background: Polymorphic variants of genes functionally related to cancer are being characterized as low penetrance susceptibility alleles. TGF-Beta receptor type 1 is a mediator of TGF-beta growth inhibitory signals. TGFBR1*6A (rs11466445) is a common polymorphic variant of the TGF-beta receptor 1 gene, which, it has been suggested, acts as a tumour susceptibility allele. Nevertheless, the role of this polymorphism as a risk factor for colorectal cancer is still controversial. The aim of this study was to assess the association between TGFBR1*6A and colorectal cancer occurrence, patients' age, gender, tumour location and stage. Methods: We performed a case control study with a total of 800 subjects from Spain: blood DNA from 400 sporadic colorectal cancer cases and 400 non-cancer, age, gender, and ethnic matched controls. Genotyping analysis for TGFBR*6A was performed by PCR and capillary electrophoresis. We also analyzed colorectal tumour DNA for this polymorphism in a total of 81 cases from our series, including four metastatic tumours. Results: No statistically significant association between TGFBR1*6A allele and colorectal cancer occurrence was found (p>0.05). The OR for carriers of the TGFBR1*6A allele was 1.147 (95% CI: 0.799–1.647); and 0.855 (95% CI: 0.299–2.449) for TGFBR1*6A homozygous individuals when compared to the reference TGFBR1*9A homozygous individuals. No significant differences were found between TGFBR1*6A and *9A alleles regarding patients' age, gender, tumour location and stage. The results of the genotyping of tumour DNA (n=81) showed somatic mutation in only two cases. The mutation was the same in both cases and consisted of deletion of a triplet from the GCG repeat in exon 1, thereby changing genotype 9/9 in normal DNA to 9/8 in both tumours. Interestingly, these two tumours were located in the right colon, both were stage III, and they were positive for microsatellite instability, suggesting that these mutations originated as a consequence of a deficient DNA mismatch repair system. Conclusions: Our results suggest that the TGFBR1*6A allele does not confer an increased risk for colorectal cancer in our population. No significant financial relationships to disclose.
Association of baseline c-reactive protein with incident cancer and survival in cancer patients
Authors: K. H. Allin, S. E. Bojesen, B. G. Nordestgaard
Journal: Journal of Clinical Oncology (2009)

11052 Background: We tested the hypothesis that baseline plasma levels of C-reactive protein (CRP) associate with risk of incident cancer in the general population, and early death in cancer patients. Methods: 10,408 individuals from the Danish general population, who had CRP measured at baseline, were followed for up to 16 years; 1,624 developed cancer and of these, 998 died during follow-up. Follow-up was 100% complete. We excluded individuals with a cancer diagnosis at baseline. Results: Baseline CRP levels &gt;3 vs. &lt;1 mg/L were associated with multifactorially adjusted hazard ratios of 1.3 (95% CI, 1.0–1.6) for cancer of any type, of 2.2 (1.0–4.6) for lung cancer, of 1.9 (0.8–4.6) for colorectal cancer, and of 0.7 (0.4–1.4) for breast cancer. Corresponding hazard ratios for the highest vs. the lowest quintile of baseline CRP levels were 1.3 (1.0–1.6), 2.1 (1.2–3.8), 1.7 (0.8–3.2), and 0.9 (0.5–1.7), respectively. Multifactorially adjusted hazard ratios for early death in cancer patients were 1.8 (1.2–2.7) for CRP &gt;3 vs. &lt;1 mg/L and 1.4 (1.1–1.7) for the highest vs. the lowest quintile. Elevated CRP levels associated with early death in cancer patients with localized disease, but not in cancer patients with metastases (interaction; P=.03). Conclusions: Elevated levels of CRP in cancer-free individuals are associated with increased risk of cancer of any type, of lung cancer, and possibly of colorectal cancer. Moreover, elevated levels of baseline CRP associate with early death after a diagnosis of any cancer, particularly in patients without metastases. No significant financial relationships to disclose.
Risk-Adapted Therapy of Adult Acute Myeloid Leukemia (AML): Safety and Efficacy of Repetitive HD-ARA-C Courses with Low-Dose Autologous Blood Stem Cell Support.
Authors: Tamara Intermesoli, Elena Oldani, Caterina Micò, Vittoria Guerini, Anna Salvi, Emanuela Ruggeri, Andrea Rossi, Ursula Giussani, Piero Bellavita, Alessandro Rambaldi, Tiziano Barbui, Renato Bassan
Journal: Blood (2005)
Does three-dimensional intraoperative specimen imaging reduce the need for re-excision in breast cancer patients?
Authors: Anees B. Chagpar, Meghan Butler, Brigid K. Killelea, Nina Ruth Horowitz, Karen Stavris, Donald R. Lannin
Journal: Journal of Clinical Oncology (2014)

107 Background: Intraoperative specimen radiography is used by surgeons to evaluate partial mastectomy specimens to ensure that the lesion in question has been adequately removed. We sought to determine whether three-dimensional (3D) specimen imaging would better predict margin status and reduce the need for re-excision than conventional two-dimensional (2D) imaging. Methods: A prospective study using standard 2D as well as 3D specimen imaging was undertaken. Surgeons were asked whether the additional orthogonal view would change their management (i.e., result in further margins being taken intraoperatively), and the impact of this on final margin status. Results: Of the 100 women participating in the study, pathology results were available in 99. Of these, 10 had no residual tumor in the definitive specimen (either due to neoadjuvant chemotherapy, or due to the entire tumor being removed in the core biopsy). The remaining 89 patients formed the cohort of interest. 21 (23.6%) had DCIS, 18 (20.2%) had invasive cancer, and 50 (56.2%) had both. The median tumor size of the largest component was 1.7 cm (range; 0.2 – 8.1 cm). Based on the conventional two-dimensional imaging, surgeons stated they would take more tissue in 26 patients (29.2%). Of the 63 patients in whom no further excision would have been indicated on 2D imaging, the 3D imaging changed management in 4 patients (6.3%). Two of these patients would have had positive margins if the intraoperative resection done on the basis of the 3D imaging would have been omitted. Patients who surgeons felt, either by 2D or 3D intraoperative imaging, warranted intraoperative re-excision tended to have a closer initial margin than those in whom re-excision was thought not to be needed on the basis of intraoperative imaging (median 1.0 vs. 2.0 mm, p=0.038). Furthermore, patients in whom an immediate intraoperative margin was taken (either due to imaging or as a matter of routine) were less likely to require subsequent re-excision (13.4% vs. 40.9%, p=0.012). Conclusions: While 3D specimen imaging changes management in only 6.3% of cases, these data highlight the role of intraoperative immediate re-excision in potentially reducing re-excision rates.
The prognostic value of stroma desmoplasia in pancreatic ductal adenocarcinoma.
Authors: Emmanouil Fokas, Michael A Silva, Zenobia D'Costa, Robin Bockelmann, Zahir Soonawalla, Stanley K. Liu, Eric O'Neill, Somnath Mukherjee, William Gillies McKenna, Ruth J Muschel, Lai Mun Wang
Journal: Journal of Clinical Oncology (2016)

211 Background: Pancreatic ductal adenocarcinoma (PDAC) often presents an abundant desmoplastic stroma. We assessed the prognostic value of stroma density and activity in patients with resectable PDAC treated with surgery and adjuvant gemcitabine-based chemotherapy. Methods: FFPE-tissue originating from the pancreatectomy of 145 patients was immunohistochemicallystained for haematoxylin-eosin and Masson’s trichrome to assess stroma density, and alpha-smooth muscle actin (αSMA) expression for activated pancreatic stellate cells. Their expression was correlated with clinicopathological characteristics as well as overall survival (OS), progression-free survival (PFS), local progression-free survival (LPFS) and distant metastases free-survival (DMFS). Results: After a mean follow-up of 20 months (range, 2-69 months), the median OS was 21 months and the 3-year OS was 35.7 %. In multivariate analysis, highly-dense stroma was an independent prognostic parameter for OS (p = 0.001), PFS (p = 0.007), LPFS (p = 0.001) and DMFS (p = 0.002), while αSMA expression lacked significance. Interestingly, highly-dense stroma retained significance for the four clinical endpoints only in early (pT1-2) but not late (pT3-4) stage tumors. Additionally, late pT-stage (pT3-4), the presence of lymph node metastases (pN+ vs pN0), perineural/neural invasion PNI and adjuvant chemotherapy also correlated with prognosis in multivariate analysis. Conclusions: In summary, stroma density represents an independent prognostic marker in PDAC patients treated with adjuvant chemotherapy. Our findings highlight the complexity of desmoplasia and indicate that highly-dense stroma is associated with better outcome. Further validation of the prognostic value of stroma as a biomarker and its role in PDAC biology is warranted and will be performed in a prospective study.
The financial burden of rehabilitation: Variation in clinician charges and implications for patient financial liability.
Authors: Mackenzi Pergolotti, Jessica A. Lavery, Bryce B. Reeve, Stacie Dusetzina
Journal: Journal of Clinical Oncology (2014)

40 Background: Occupational and Physical therapies (OT/PT) are effective treatments to decrease disability and functional status. Few studies have examined the variations in the cost of outpatient OT/PT. For adults with cancer, the added financial burden of cancer rehabilitation is unknown. The study objectives were to (1) describe the variation in patient financial burden for the most commonly used OT/PT services by the provider type (either OT or PT) and State; and (2) determine the impact of therapy caps on the price of service provided among Medicare beneficiaries. Methods: This retrospective, population-based study used the Medicare Provider Utilization and Payment Data Public Use File (PUF), released in April 2014 by the Center for Medicare and Medicaid Services (CMS) to examine variations in care by level of insurance (uninsured, insured and reimbursed), between providers and across states with descriptive statistics. We also examined the impact of the therapy cap on number of visits allowed and the proposed reduction of the therapy cap dollar amount on services use and patient out-of-pocket liability. Results: 3,663 (9.2%) OT’s and 36,247 (90.8%) PT’s were included. Differences between provider’s charges were minimal. Wisconsin, Illinois, Tennessee and Texas had the most inflated charges, respectively, for OT and PT. 12-14 visits plus evaluation are covered under 2012 therapy cap, and the amount of visits would be cut to 7-9 with the MedPAC cap. Conclusions: This study suggests there is wide variation between the potential patient liability for the price of OT/PT based on service provided, state received and insurance coverage. For older adults with cancer who need OT/PT services, this will be an additional cost to their care. Patients without insurance pay a premium for OT/PT services.
Identification of chemosensitivity markers for postoperative adjuvant chemotherapy using cellular, molecular, and immunohistochemical profiles of advanced carcinomas from gastrointestinal tract.
Authors: S. Nishizuka, K. Ishida, N. Uesugi, T. Matsuo, T. Chiba, M. Ikeda, T. Sugai, K. Otsuka, K. Koeda, G. Wakabayashi
Journal: Journal of Clinical Oncology (2011)

55 Background: The prediction of chemotherapeutic efficacy is a fundamental problem. We have developed an effective system to identify prediction markers based on an in vitro approach using a quantitative matrix of chemosensitivity assay (CSA) and protein expression by reverse-phase protein lysate microarrays (RPA), followed by tissue microarrays (TMA). In the present study, we attempted to identify predictive markers by extracting candidate proteins from the “chemosensitivity x protein expression matrix” of 12 cancer cell lines and 12 chemotherapeutic agents, followed by examination using TMA in post-operative adjuvant chemotherapy for advanced gastric and colorectal carcinomas. Methods: The “chemosensitivity x protein expression matrix” was constructed using quantitative data from CSA and RPA. TMA was constructed from parafin-embedded, formalin-fixed surgically removed tissues from 30 gastric and 49 colorectal carcinomas. All subjects had received post-operative adjuvant chemotherapy. Expression and/or localization of candidate marker proteins on TMA were evaluated for the comparison of time to relapse (TTR) between the groups based on the score of each candidate marker protein. Results: TTR was compared in each binary score for a candidate marker that showed a moderate to high correlation coefficient of the “chemosensitivity x protein expression matrix” of 144 combinations. Among these candidate combinations, it was found that the presence/absence of NFkB protein nuclear localization and the TTR of those patients who received 5-FU based adjuvant chemotherapy differed significantly. The three-year relapse rate was 28% in NFkB absent cases, whereas it was 84% in the present cases. Conclusions: We identified NFkB nuclear localization as an effective 5-FU based chemotherapeutic prediction marker in the context of gastrointestinal post-operative adjuvant chemotherapy. The combination of CSA, RPA, and TMA technologies may allow rapid identification of chemotherapeutic prediction markers. No significant financial relationships to disclose.
Everolimus plus octreotide LAR (E+O) versus placebo plus octreotide LAR (P+O) in patients with advanced neuroendocrine tumors (NET): Updated results of a randomized, double-blind, placebo-controlled, multicenter phase III trial (RADIANT-2).
Authors: J. C. Yao, J. D. Hainsworth, E. Baudin, M. Peeters, D. Hoersch, L. B. Anthony, J. Klimovsky, K. Grouss, V. Jehl, M. Pavel
Journal: Journal of Clinical Oncology (2011)

159 Background: Octreotide LAR has been the foundation of NET therapy; however, additional treatment options are needed. Everolimus, an oral inhibitor of mTOR, demonstrated promising antitumor activity in patients with NET as a single agent and in combination with octreotide LAR in two phase II studies. Methods: Patients (n = 429) with well or moderately differentiated advanced NET and history of carcinoid symptoms received oral everolimus 10 mg/d + octreotide LAR 30 mg IM q 28 days (n = 216) or placebo + octreotide LAR (n = 213). Common primary sites included the small intestine, lung, and colon. The primary endpoint was progression-free survival (PFS) per central review by RECIST. Crossover from P+O to open-label E+O was allowed at disease progression. Results: Median PFS (95% CI) with E+O was 16.4 months (13.67-21.19) vs. 11.3 months (8.44-14.59) for P+O. E+O was associated with a 23% reduction in risk of progression: HR = 0.77; 95% CI: 0.59-1.00; one-sided p-value = .026 (pre-specified significance boundary is p ≤ .0246). A high rate of informative censoring resulted in loss of power in central review results. Correcting for the informative censoring bias, the pre-specified marginal Cox model using inverse probability of censoring weights (IPCW) analysis showed a significant 5.5-month improvement in median PFS with E+O; HR = 0.60; 95% CI: 0.44-0.84, with one-sided p-value = .0014. The benefit of E+O was seen across all patient subgroups. Updated analyses of the impact of pre-study and post-progression octreotide LAR therapy will be reported. Most frequent drug-related adverse events (AEs) with E+O were stomatitis, rash, fatigue, and diarrhea; mostly grade 1-2. Grade 3-4 AEs reported in &gt;5% were stomatitis, fatigue, diarrhea, infections, and hyperglycemia. Conclusions: In this large phase III trial, E+O provided a 5.1-month clinically meaningful increase in median PFS compared with P+O in the central adjudicated review. Correcting for the informative censoring bias, a significant PFS improvement of 5.5 months was seen, with a p value = .0014. The safety profile of E+O was acceptable. [Table: see text]