tbuckley/cabot-search huggingface dataset:
Measuring the impact of chemotherapy cost discussions between patients and providers at the time of prescribing.
Authors: Ronan Joseph Kelly, Patrick M. Forde, Ashley Bagheri, Jenny Ahn, Arlene A. Forastiere, Kevin D. Frick, Gary L. Rosner, Sydney Morss Dy, Thomas J. Smith
Journal: Journal of Clinical Oncology (2013)

257 Background: In 2007, the ASCO Cost of Care Task Force was established to deal with the soaring costs of cancer treatment in the United States. One of the key recommendations was that the cost of chemotherapy should be introduced into the patient-physician discussion from the outset. It is unknown if these discussions are occurring in academic Institutions and what if any is the impact on the doctor/patient relationship. Methods: The National Comprehensive Cancer Network (NCCN) Guidelines and the Eviti advisor platform were jointly used in an academic oncology center during the patient/doctor consultation to demonstrate treatment options to patients and display the costs at the time of prescribing to providers and patients alike. Questionnaires measured oncology providers attitudes to cost discussions and assessed physician satisfaction with the shared decision making process when costs are introduced into the patient/doctor relationship. Patients were interviewed before and after their doctor consultation to measure their satisfaction with the process using modifications of the shared decision making scale, satisfaction with decision scale and decisional conflict scale. Basic descriptive statistics were applied. Results: Only 5/18 oncologists (28%) reported feeling comfortable discussing costs with patients and just one (6%) admitted to regularly asking patients about financial difficulties. The majority (83%) of doctors reported that the NCCN guidelines should contain cost information. Seventy-one patients (42 females, 29 males) with metastatic breast (27%), lung (49%), and colorectal cancer (24%) have been interviewed. Interestingly, 70% of patients responded that no health care professional has ever discussed costs with them despite 57/71 (80%) rating this as very important information. The majority of patients (75%) had no negative feelings to hearing cost information. Only 4% admitted to developing significant negative feelings. Conclusions: In an era of rising co-pays, patients want cost of treatment discussions and these do not lead to negative feelings in the majority of patients. Additional training to prepare clinicians for how to discuss costs with their patients is needed.
Depression and EGFR mutation status in stage IV non-small cell lung cancer.
Authors: W. F. Pirl, J. Greer, H. Bemis, R. S. Heist, E. Gallagher, L. V. Sequist, J. A. Engelman, L. Traeger, I. T. Lennes, J. S. Temel
Journal: Journal of Clinical Oncology (2010)

9086 Background: Depression is associated with worse survival in metastatic non-small cell lung cancer (NSCLC) but underlying mechanisms are unknown. Clinically we have observed relatively less depression in NSCLC patients with EGFR mutations. We hypothesize that EGFR status might be related to developing depression even before genetic results are known. Methods: Beginning in 8/07 we prospectively screened all consenting new patients at their first visit in the thoracic oncology clinic for depression with the Patient Health Questionnaire-9 (PHQ-9), a validated instrument for depression. Beginning in 3/09 we prospectively screened stage IV NSCLC patients for genetic mutations, including EGFR, using a multiplexed PCR-based analysis. Genetic results return after the first clinic visit, typically in a few weeks. Using the first 50 consecutive patients belonging to both screened groups, we examined associations between EGFR status and depression using Fisher's Exact Test for categorical comparisons and Wilcoxon Rank Sum Test for continuous scores. Results: Forty-seven patients had tumor specimens adequate for genotype testing. Mean age was 57.6 years (sd 14.9); 55.3% (26/47) were male; 87.2% (41/47) were white; and 61.7% (29/47) were smokers. Most (91.5%, 43/47) had adenocarcinoma and were ECOG performance status 0-1 (86.8%, 33/39). Twelve (25.5%) had EGFR mutations. Patients with wild-type (wt) EGFR had significantly higher depression scores on the PHQ-9 compared to EGFR mutants (p=.04). While the median depression score in patients with wt EGFR was 6, no EGFR mutant had a score above 5. Patients with wt EGFR were also more likely to meet categorical criteria for depression (PHQ-9 score of 10 or greater), 31.4% (11/24) compared to 0% (0/12) of those with EGFR mutations (p=.04). Although the small sample could not support multivariate analyses, there were no differences in age, sex, race, performance status, and smoking histories between the two groups. Conclusions: Stage IV NSCLC patients with wt EGFR may be more likely to have depressive symptoms than mutants. This finding needs to be confirmed in larger samples with investigations of possible underlying relationships. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Gatekeeper Biogen Idec, Bristol-Myers Squibb, Daiichi Sankyo, GlaxoSmithKline, MedImmune, Millennium, Novartis, Roche, Schering-Plough Forest, Novartis
A phase I study, with expanded cohort, of biweekly fixed-dose rate gemcitabine (FDR GEM) plus capecitabine (CAP) in patients with advanced pancreatic (APC) and biliary carcinomas (ABC).
Authors: A. M. Espinoza, A. H. Ko, A. P. Venook, E. K. Bergsland, K. A. Jones, R. K. Kelley, W. M. Korn, E. Dito, A. Ong, M. A. Tempero
Journal: Journal of Clinical Oncology (2010)

4136 Background: GEM-based therapy remains the standard of care for APC and ABC. The addition of CAP to GEM has produced modest improvements in clinical outcomes compared to GEM alone in several phase III studies in APC. This NCCN-supported study seeks to optimize dosing, schedule, and administration of these drugs by using an alternating-week dose schedule of FDR GEM plus CAP. Methods: Patients (pts) with previously untreated APC/ABC and ECOG PS 0-1 were eligible. A standard 3+3 dose-escalation schema was used (see Table). First- degree objective: establishment of maximum tolerated dose (MTD); second degree: TTP, OS, radiographic, and CA 19-9 response, and safety. Results: A total of 42 pts (median age 61 yrs; 93% APC/7% ABC; 83% with metastatic dz) have been enrolled. MTD was established at dose level +1; however, due to late toxicity at this dose level (notably gr 2/3 hand-foot syndrome [HFS]), maximum recommended dose (MRD) is dose level 0, at which further cohort expansion took place. Most frequent non-heme AEs: N/V (overall 67%; all gr 1/2), HFS (overall 57%; gr 3/4, 19%), fatigue (overall 55%; gr 3/4 2%), diarrhea (overall 31%; gr 3/4, 2%), and lab abnormalities (overall 45%; gr 3/4 10%). Gr 3/4 hematologic toxicity was observed in 24% of pts (5% neutropenic fever). 43% of pts required dose reduction of one or both drugs, but only 29% at MRD. Of 37 pts eligible for efficacy analysis, 8 (22%) have had unconfirmed PR and 18 (49%) SD for at least 4 cycles, for an overall dz control rate of 71% (median number of cycles received = 10). 18 of 28 pts (64%) with elev baseline CA 19-9 level had >50% decline during rx. Estimated TTP and OS were 5.5 and 9.7 mo, respectively. Specific to the metastatic pancreatic CA cohort (n=32), est. TTP and OS were 6.2 and 10.4 mo, with a 1-yr survival rate of 29%. Conclusions: The MRD for this dosing schedule is FDR GEM 1,000 mg/m2 on day 1 plus CAP 1,000 mg/m2 bid on days 1-7, every 14 days. Preliminary data suggest this alternating-week regimen to be active and well tolerated in pts with APC/ABC. Results from completed accrual (n=44) will be presented at the Meeting. Dose level FDR GEM (d1) CAP (d1-7) 1 cycle = 14 d −1 1,000 mg/m2 800 mg/m2 bid 0 (starting dose) 1,000 mg/m2 bid 1 1,250 mg/m2 bid 2 1,500 mg/m2 bid Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bayer-Onyx, Genentech, Lilly, Novartis
Prognostic factors of concurrent chemo-radiotherapy in head and neck cancers
Authors: K. Thankappan, S. V. Rugmini, R. F. Cohen, B. Sunil, J. Samuel, T. K. Padmanabhan, K. Pavithran, K. R. Sundaram, S. Iyer, M. A. Kuriakose
Journal: Journal of Clinical Oncology (2007)

16527 Background: Concurrent chemo-radiotherapy either as primary or adjuvant treatment is now the standard of care in high- risk head and neck squamous cell carcinomas. This has improved survival rates and chances of organ preservation. Advanced stage, extra- capsular extension, perineural and lympho-vascular invasion and positive surgical margins were considered as poor prognostic factors with radiotherapy alone. Herein we report the significance of these clinical and pathological factors, with concurrent chemo-radiotherapy regimens. Methods:A retrospective analysis of 54 patients with squamous cell carcinoma of head and neck who underwent either primary (21,39 %) or adjuvant (33,61%) concurrent chemoradiation at Amrita Institute of Medical Sciences, Kochi, India, during January 2004 to May 2005 and followed up to Dec 2006. 6 (11%) patients had stage III and 48 (89 %) had stage IV disease. Prognostic significance of clinical and pathological factors was evaluated. Kaplan-Meir curves for survival analysis, log rank test for univariate and Cox proportional method for multivariate analysis were employed. Results: The median follow up was 22 months. Two-year overall (OS) and disease free survival (DFS) rates were 66 % and 52 % respectively. Univariate and multivariate analysis of T stage, nodal stage, radiotherapy interruptions, completion of chemotherapy, schedule of chemotherapy (week 1,4,7 vs weekly), perineural invasion, extra-capsular extension and positive margins showed no significant difference in OS and DFS. However both univariate (p = 0.019 for OS and p = 0.012 for DFS) and multivariate analysis (p = 0.029, HR 0.16,95 %CI - 0.03 to 0.8 for OS and p = 0.017,HR 0.188,95% CI - 0.04 to 0.74 for DFS) revealed lympho-vascular invasion as a significant prognostic factor. Conclusions: Advanced stage, extra capsular invasion and positive margins were conventionally thought to be poor prognostic markers in head and neck cancer. However in our series of patients treated with concurrent chemo radiation lymphovascular invasion was the only significant poor prognostic factor. Other factors were found to be not significant. No significant financial relationships to disclose.
Functional profiling in stage IV NSCLC: A phase II trial of individualized therapy
Authors: R. A. Nagourney, J. Blitzer, E. Deo, R. Nandan, R. Schuman, T. Asciuto, D. Mc Connell, M. Paulsen, S. Evans
Journal: Journal of Clinical Oncology (2009)

e19079 Background: The introduction of new classes of agents has improved survival in NSCLC yet the accurate selection of candidates for these often costly &amp; toxic drugs remains a challenge. Genomic platforms have identified several prognostic &amp; predictive factors e.g. ERCC1, RRM1/2, EGFr mutations but the comparatively small number of known cellular analytes has limited their broad application. Methods: To address the complexity and redundancy of cell-death signaling pathways, we applied Ex Vivo Analysis of Programmed Cell Death (EVA/PCD) (Nagourney, R. Curr Treat Options in Oncol. 2006) to select therapies for chemo- naïve pts with metastatic NSCLC. This functional platform uses morphologic and metabolic endpoints to gauge cellular response to drugs &amp; signal transduction inhibitors in human tumor microspheroids isolated from surgical biopsies. Modified Z-scores &amp; synergy analyses (median-effect) were used to identify the ex vivo best regimen (EVBR) for each pt. from FDA-approved NSCLC drugs. All pts signed informed consent. Results: 22/25 (88%) pts are evaluable with 3/25 (12%) excluded, 1 for CVA &amp; 2 inadequate PFS at time of treatment. There were CR = 2/22 (9%); PR = 10/22 (45%); SD = 9/22 (41%) &amp; PD = 1/22 (5%) for an ORR = 12/22 (54%) &amp; CBR = 21/22 (95%). 1 st line EVBR were CDDP/Gemcitabine 10/25 (40%); CDDP/Taxane 7/25(28%); Erlotinib 5/25(20%); CDDP/Vinorelbine 1/25 (4%); CDDP/Irinotecan1/25(4%) &amp; Ifex/Gemcitabine1/25(4%). Six of 22 (27%) stage IV pts were converted to surgical and/or radiation candidates by therapy. Accrual continues with current TTP ranges from 1.2–35+ months and OS from 1.7 to 46+ months. Conclusions: EVA/PCD ORR in Stage IV NSCLC of 54%, many durable, compares very favorably with reports in this population. By examining drug-induced cell death events in native-state microspheroids, this platform has the unique capacity to capture stromal, vascular and inflammatory cell interactions with tumor cells, now known to be crucial for clinical response prediction. EVA/PCD analysis in NSCLC warrants further evaluation. Supported by the Memorial Medical Center Foundation of Long Beach. [Table: see text]
Treatment outcome for metastatic papillary and chromophobe renal cell carcinoma (RCC) patients treated with tyrosine-kinase inhibitors (TKIs) sunitinib and sorafenib
Authors: A. Plantade, T. Choueiri, B. Escudier, B. Rini, S. Negrier, A. Ravaud, S. Oudard, P. Elson, R. Bukowski
Journal: Journal of Clinical Oncology (2007)

5037 Background: Sunitinib (SUNI) and sorafenib (SORAF) are novel TKIs that have shown significant clinical activity in metastatic clear-cell RCC. Papillary (PAP) and chromophobe (CHRM) histologies represent the majority non-clear-cell RCC. The activity of SUNI and SORAF in non-clear cell histologies has not been evaluated. Methods: Clinical features at study entry and treatment outcomes were evaluated in all patients (pts) with metastatic PAP and CHRM RCC who received either SUNI or SORAF as their initial TKI treatment at one of five different cancer centers in France and USA between 2002 and 2006. Descriptive statistics were used to evaluate the collected data. Overall Response rate (ORR) was investigator-assessed per RECIST criteria. Fisher’s exact test was used for categorical variables and the Kaplan-Meier method was used to estimate survival (Overall Survival (OS) and progression-free survival (PFS)). Results: Median age for the 53 patients was 59 years and 64% were male. The number of patients with PAP and CHRM histologies were 41 (77%) and 12 (23%), respectively. Nephrectomy was performed in 87% of patients and 33/53 (62%) of pts were previously treated (26/33, 79%, with cytokines). ORR, PFS and OS for the entire cohort were 10%, 8.9 months (m) and 12.2 m, respectively. Twenty (38%) and 33 (62%) pts were treated with SUNI and SORAF, respectively. 3/12 (25%) of CHRM pts had an ORR vs. 2/41(4.8%) with PAP histology (P=0.07). PFS for CHRM pts was 9.3 m compared to 6.6 m for PAP pts (p=0.07). OS was not different across histologies and type of TKI received. SUNI treated pts had an ORR of 15% and PFS of 11.9 m compared to 6% (p=0.3) and 5.5 m for SORAF pts (p=0.002), respectively. Other factors found to be associated with shorter PFS include ECOG PS &gt;0 (p=0.03) and hemoglobin&lt; normal (p=0.02). Conclusions: TKI may have activity in metastatic CHRM RCC, similar to what is seen in clear-cell histology. Minimal activity however is noted in PAP RCC, justifying continued investigations of novel agents in this histology. No significant financial relationships to disclose.
Frequency of HPV-associated tonsillar cancer in Sweden
Authors: P. Attner, A. Näsman, L. Marklund, L. Hammarstedt, J. Lindholm, T. Ramquist, T. Dalianis, E. Munck-Wikland
Journal: Journal of Clinical Oncology (2009)

6030 Background: Numerous studies has shown an increase of the incidence of tonsillar squamous cell carcinoma (SCC) both in the USA and in Sweden. This increase in incidence is despite a decreasing prevalence in smoking, a well-known risk factor for developing tonsillar cancer. The proportion of human papillomavirus (HPV) positive tonsillar SCC has also been shown to increase. This study aims to examine the incidence of tonsillar SCC and the proportion of HPV positive tonsillar SCC between 2003–2007 in the County of Stockholm, Sweden in correlation to data from 1970–2002. Methods: All patients (n = 120) diagnosed with tonsillar SCC during 2003–2007 in the County of Stockholm were included in this study. Ninety-eight pre-treatment biopsies were available and presence of HPV DNA and HPV-16 E6 and E7 mRNA were tested by PCR and RT-PCR. Incidence data between 2003–2007 for Sweden and in the County of Stockholm was obtained from the Swedish Cancer Registry. Data reported from 1970 to 2002 was also obtained for comparison. Results: HPV DNA was present in 83/98 (85%) of the tonsillar SCC biopsies from 2003–2007. Of the 77 HPV-16 positive tumors, HPV-16 E6 and E7 mRNA were found in 98% of the analyzed cases. The proportion of HPV-positive cancers had significantly increased both from 1970 to 2007 (p &lt; 0.0001) as well from 2000 to 2007 (p &lt; 0.01), with 68% (95% CI, 53–81) 2000–2002; 77% (95% CI, 63–87) 2003–2005; and 93% (95% CI, 82–99) 2006–2007. The incidence rate of HPV-positive tumors almost doubled each decade between 1970–2007, in parallel with a decline of HPV-negative tumors. Conclusions: Today, almost all tonsillar SCC in the County of Stockholm is HPV positive, and the incidence of HPV-positive cancers is still increasing. The data suggest that we are dealing with an epidemic of a virus-induced carcinoma, and that soon practically all tonsillar SCC will be HPV positive; a similar situation observed in cervical cancer. No significant financial relationships to disclose.
Prospective evaluation of predictive and prognostic molecular markers in colorectal carcinomas.
Authors: R. S. Croner, R. M. Wirtz, B. Lausen, H. Prokosch, C. Roedel, F. Rodel, E. Naschberger, A. Hartmann, W. Hohenberger, M. Stürzl
Journal: Journal of Clinical Oncology (2010)

e14114 Background: Treatment decisions for adjuvant therapy are usually performed after surgery respecting the TNM-criteria in colorectal carcinomas (CRC). Molecular markers in the primary tumor may determine therapy response and prognosis and may be helpful for individualized treatment algorithms. But only few molecular markers are used during clinical routine until now. New marker combinations must be evaluated for their clinical relevance. Methods: Gene expression profiling (HG-U133A, Affymetrix) of 80 CRC stage UICC I-III (UICC I, II, n = 40; UICC III, n = 40) was performed. Data were analysed with emphasis on predictive markers for metastasis and angiogenesis. Differentially expressed genes between stage UICC I, II vs. III were validated by RT-PCR and immunohistochemistry. Then a predictive and prognostic marker combination for a prospective evaluation was generated. Results: Two predictive gene clusters for metastasis (e.g., ADAM22, LDN 16, WNT 16) and reduced angiogenesis (e.g., CXCL 11, CXCL9, CXCL 10) were identified which were associated with significantly reduced or prolonged survival of the patients. This set of genes will be evaluated prospectively with a new automated method, which enables the synchronous analyses of 100 transcripts in RNA from 4-5 slices of routinely paraffin embedded tissue (Polyprobe-Study, Erlangen, Frankfurt, Cologne, Germany). Conclusions: Prognostic and predictive marker signatures wereidentified in CRC by gene expression profiling. New technologies for the analysis of gene expression in routinely embedded paraffin tissues which can be easily implemented into the clinical routine will help to improve clinical decisions in near future. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Siemens Siemens Siemens Siemens Healthcare Diagnostics
Use of 1,318-nm laser technology in lung surgery to control advanced stage IV cancers metastatic to the lungs.
Authors: B. Bis, A. Hudac, A. Rolle
Journal: Journal of Clinical Oncology (2010)

e18124 Background: Lung metastasectomy is an accepted, potential curative treatment in selected patients. Due to the intolerable tissue loss usually no more than 10 metastases are resected. This study proves that the 1,318nm laser technology enables the surgeon to remove a significant higher number of metastases with comparable good survival and good quality of life. Methods: The 1,318 nm laser specially designed for the lung tissue shows simultaneous cutting, coagulation and sealing qualities. These characteristics allow precise resections of multiple, centrally located metastases. Between March 1996 and April 2008 415 patients (196 man, 219 women) with a mean age of 62 years (19-83 years) with uni- and bilateral metastases of different primary tumors were eligible for resection. Patients enrolled in this prospective study met the criteria of eligibility: primary tumor without local recurrence, no extrathoracic metastases, lymph node involvement up to unilateral resectable N2 status and adequate lung function. All parenchymal resections were performed by the 1,318 nm laser. Results: 415 patients had 3,655 lesions (ranged 1-269, mean 9/patient) resected without mortality. 343 patients (83%) had complete resection with 5 and 10 years survival of 43% and 21% respectively. 72 patients (17%) had incomplete resection followed by significantly poorer outcome of 7% 5 years survival. 90 patients (26%) remained disease free without recurrence. In this group up to 58 metastases in one patient (mean 5 metastases per patient) were removed and 5 and 10 years survival was 92% and 82% respectively. The 5 year survival for curatively resected patients with solitary metastasis, 2-9 metastases and over 10 metastases was 55%, 37% and 21% respectively. Conclusions: The 1,318 nm laser technology implemented in lung surgery enables the resection of a high number bilateral and centrally located metastases, usually declared inoperable. As the operation technique is safe, tissue sparing and followed by satisfactory long time survival with good quality of life, patients with advanced metastatic cancer to the lungs should be considered for this treatment. No significant financial relationships to disclose.