tbuckley/cabot-search huggingface dataset:
The impact of “significant others” on breast cancer patients’ treatment decision making.
Authors: Suepattra G. May, Katharine Rendle, Meghan Halley, Nicole Ventre, Allison W. Kurian, Peter Paul Yu
Journal: Journal of Clinical Oncology (2012)

20 Background: Shared medical decision making (SDM) has been lauded by advocates for its potential to democratize the patient-physician relationship. However, the practice of SDM is still conceived of as largely a dyadic moment that exists between the patient and the physician. Few studies have looked at the role of significant others (spouses, partners, family members and friends) in decision making or considered how discussions and actions outside the consultation room affect a patient’s medical decisions. This prospective study investigated the impact of significant others on the decision making deliberations of newly diagnosed breast cancer patients. Methods: Forty-one newly diagnosed breast cancer patients were interviewed at four critical time points throughout treatment to explore how they deliberated decisions with both care providers and significant others. Surveys assessing HRQOL, role preferences and treatment satisfaction along with EHR abstraction augmented interview data. Grounded theory analysis was used to identify recurrent themes in the qualitative data, and survey data were analyzed using IBM SPSS Statistics 20. Results: Emergent themes from our analysis identified several factors that patients consider when faced with cancer treatment decisions, including 1) presentation of treatment options 2) patient or significant other conflict/concordance with care team recommendations 3) perceived risk of recurrence and 4) short and long term impact of treatment on daily life. Participants stressed the need for clinicians to view patients beyond diagnosis and recognize their larger care network as influential factors in their decision making. Conclusions: Our interviews highlight how the current healthcare delivery structure rarely acknowledges the circles of care that can exert influence on decision making. Lack of attention to non-clinical others can lead to sub-optimal medical decision making because these influences are not adequately understood by clinicians. Findings from this study suggest the need to enhance clinicians’ and researchers’ understanding of the influence of others in patients’ treatment decision making, enabling them to intervene in these practices.
A comparison of proton and photon radiotherapy in reducing cardiac exposure for patients receiving radiation therapy for distal and esophagogastric junction cancer.
Authors: Ted Chen-Tai Ling, Jerry Monroe Slater, Rachel Mifflin, Prashanth Nookala, Roger Grove, Anh Ly, Baldev Patyal, Jerry D. Slater, Gary Yang
Journal: Journal of Clinical Oncology (2014)

167 Background: Recent studies indicate that radiation exposure to heart may have a greater impact on perioperative cardiac morbidities than do other clinical factors. The purpose of this study is to investigate dose distributions of proton and photon treatment plans in patients (pts) with distal and esophagogastric junction (GEJ) carcinoma, focusing specifically on dose reduction to cardiac structures. Methods: Ten pts between 2010 and 2013 were included in this study. Three separate plans were generated for each patient: 3D proton plan, 3D photon plan, and Intensity modulated radiotherapy (IMRT) photon plan. The clinical target volume (CTV) consisted of the pre-operative extent of tumor plus a 10mm manual expansion in all directions. The planning target volume (PTV) was generated by a further expansion on the CTV ranging from 10-15mm. A dose of 50.4Gy given in 28 fractions was delivered to the PTV. All plans were optimized to allow 90% isodose coverage of at least 95% of the PTV. Dose-volume histograms were calculated and analyzed in order to compare plans between the three modalities. ANOVA and two-tailed paired t-tests were performed for all data parameters. Results: The 3D proton plans showed decreased dose to partial volumes of the entire heart, arteries, valves, atria, and ventricles in comparison to both the IMRT and 3D photon plans (see Table). The IMRT plans showed decreased dose delivered to the LAD artery, pericardium, and atria in comparison to the 3D photon plans (see Table). Conclusions: For pts receiving radiation therapy for distal esophageal and GEJ cancer, proton plans are technically feasible with adequate coverage while resulting in lower dose to cardiac structures. This may result in decreased cardiac toxicity and less complications in a multimodality setting. [Table: see text]
Therapeutic clinical trial enrollment among young adults diagnosed with cancer.
Authors: P. S. Blanchette, M. Crump, A. A. Gupta
Journal: Journal of Clinical Oncology (2011)

6096 Background: Young adults (YA) with cancer have poor enrollment in therapeutic clinical trials. This study compares trial participation among young and older adults (OA) at a tertiary cancer care center, with a view to identifying and removing barriers. Methods: Trial enrollment data was compared between YA (age ≤39 years) and OA (age >39 years) followed at Princess Margaret Hospital (PMH), Toronto, from 2006-2008. Trials open to active accrual were: 1) therapeutic: systemic therapy, radiation, or surgery; 2) Phase I, II or III; 3) investigator initiated, industry or cooperative group. Number of trials activated and accrual data were collected through the Clinical Trial Support Unit at PMH. Number of patients with cancer were identified through the PMH Cancer Registry. Proportions of patients enrolled in clinical trials were compared between groups using a chi-square test. Results: A total of 25,958 patients (YA: 2,699; OA: 23,259) and 318 clinical trials were identified. The table reports the number of patients, trial availability and enrollment rate for the top 5 most common diagnoses for YA and OA. YA had significantly lower enrollment rates as compared to older adults (7.0% vs. 11.9%; p<0.001) including early phase trials (4.6% vs. 7.5%; p<0.001) and phase III trials (2.4 vs. 4.4%; p<0.001). Conclusions: Trial enrollment rates were significantly lower among YA patients compared to OA across the spectrum of tumor types. Further study is underway to understand differences in trial participation between YA with different primary tumours and identify barriers to enrollment among YA. Trial availability (phase I, II, III) and enrollment among the top five most common YA and OA cancers at PMH (2006-2008). Cancer site No. of patients Percent of cancer diagnoses No. of clinical trials Ratio of clinical trials: Patients No. of patients enrolled Percent enrollment Young adults Breast 338 13% 22 1:15 18 5% CNS 298 11% 11 1:27 20 7% Testicular 250 9% 0 0:250 0 0% Sarcoma 241 9% 3 1:80 1 <1% Hodgkin lymphoma 213 8% 3 1:71 15 7% Total 1,340 50% 39 1:34 54 4%† Older Adults Prostate 3,855 17% 30 1:129 494 13% Breast 3,811 16% 22 1:173 237 6% Lung 2,534 11% 37 1:68 345 14% Colorectal 1,987 9% 20 1:99 183 9% Head and neck 1,893 8% 16 1:118 85 4% Total 14,080 61% 125 1:112 1,344 10%† † p <0.001
Primary letrozole therapy <i>versus</i> the combination of letrozole plus oral cyclophosphamide in elderly breast cancer patients. A single Institution randomized phase II trial
Authors: A. Bottini, D. Generali, A. Berruti, M. P. Brizzi, G. Allevi, S. Bonardi, A. Bersiga, S. Aguggini, M. Milani, R. Dionisio, L. Dogliotti
Journal: Journal of Clinical Oncology (2005)

8108 Background: Letrozole has repeatedly found to be active as primary endocrine therapy in breast cancer patients. The aim of the study was to explore the activity of single agent Letrozole or Letrozole plus oral cyclophosphamide in a elderly patient population. Methods: From November 2001 to June 2004 114 elderly patients with T2-T4N0–1 estrogen receptor positive primary breast cancer were randomized to receive primary letrozole (arm L) (1 tablet/daily) or letrozole plus low dose protracted administration of oral cyclophosphamide (arm LC) (1 tablet 50 mg daily). Six month treatment was planned in both arms before definitive surgery. Paired tumor specimens were obtained before chemotherapy by incisional biopsy and at surgery. Results: Median age (range) was 79 years (64–89) in the 57 patients randomised in L arm and 75 years (62–94) in the 57 randomized in LC arm. Tumor characteristics were well balanced across the two treatment groups. Three patients were not available because too early. Among the 55 assessable patients in arm L, 22 attained a clinical complete response cCR (40.1%), 18 a partial response PR (32.7%), 11 stable disease SD (20.0%) and 2 progressive disease PD (3.6%); 2 patients were not evaluable. The corresponding disease response in the 56 assessable cases in the LC arm were: 25 cCR (44.6%), 25 PR (44.6%), 3 SD (5.4%) and 3 PD (5.4%). Three patients attained a pathological complete response, 2 in the L arm, 1 in the LC arm; 2 patients had residual in situ carcinoma (cis), 1 in each arm. Baseline Ki67 did not differ between the two arms [mean (95% confidence interval): 15.2% (12.8–17.6) in L arm and 19.5% (15.0–23.9) in LC arm, respectively]. Both treatments led to a significative reduction in Ki67 expression, but at residual tumor histology Ki67 immunostaining was lower in LC patients as opposed to L ones: mean 5.9% (95% CI 2.4–9.4) and 9.9% (95% CI 6.1–13.6). Conclusions: Primary hormone therapy with letrozole confirms to be very active in breast cancer patients. The addition of cyclophosphamide may lead to a higher response rate and greater reduction in proliferative activity. Statistics will be provided at the meeting. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Novartis
Human papillomavirus (HPV) infection as a prognostic factor in patients with oropharyngeal squamous cell carcinoma treated in a prospective phase II clinical trial
Authors: S. Jo, A. Juhasz, K. Zhang, C. Ruel, S. P. Wilczynski, Y. Yun, J. D. Ellenhorn, B. Paz, N. Vora, S. Shibata
Journal: Journal of Clinical Oncology (2008)

6035 Background: HPV16 is associated with improved survival in a patient (pt) subset with head and neck squamous cell carcinoma (HNSCC). In cervical cancer models, HPV oncoproteins, E6 and E7, can induce VEGF and HIF-1 expression. The purpose of this study was to determine HPV status in HNSCC pts enrolled in a prospective single-institution phase II clinical trial, and assess its effect on clinical outcome, HIF-1α and VEGF expression. Methods: Pts had resectable, untreated stage III, IV HNSCC of oral cavity, oropharynx, hypopharynx, or larynx, and stage II cancer of base of tongue, hypopharynx, or larynx. Neoadjuvant chemotherapy (NCT) consisted of docetaxel 60 mg/m2, a 96-hour infusion of cisplatin 25mg/m2/d, 5-FU 700 mg/m2/d, and LV 500 mg/m2/d. Pts received up to 3 cycles. Responding pts had organ-sparing surgery, then adjuvant radiation or chemoradiation. HPV status was determined by conventional PCR in fresh frozen biopsy samples and Taqman PCR on formalin-fixed, paraffin-embedded tissue prior to treatment. HIF-1α, VEGF expression were assessed by IHC and quantitative real-time PCR (RT-PCR). Multivariate Cox proportional hazards regression analysis of time to disease progression or death was used to calculate hazard ratios (HRs) and 95% confidence intervals (CIs) for HPV+ status. Results: HPV16 was detected in 14 (13 were oropharyngeal tumors) of 24 evaluable cases. There were no significant differences in response rates after NCT (86% vs. 90%) in HPV+ and HPV- pts, respectively. After median follow-up of 52.9 months, there was a trend toward better progression-free (HR=0.15, 95% CI 0.002–12.54; p=0.06) and overall survival (HR=0.14, 95% CI 0.001–14.12; p=0.10) for HPV+ pts. There was no difference in VEGF protein expression, but in a subset of 13 fresh frozen samples, RT-PCR revealed significant increase in VEGF mRNA transcript levels in HPV+ tumors (p<0.01). No difference was seen for HIF-1α expression. Conclusion: HPV presence portended a better prognosis in pts with oropharyngeal SCC treated with multimodality treatment in a prospective clinical trial. The benefit did not reach statistical significance due to small pt number. The level of VEGF mRNA was up-regulated in HPV16+ tumors possibly by a HIF-1 independent manner. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration sanofi-aventis sanofi-aventis
Survey of cancer survivors' understanding of their cancer care and follow-up plan.
Authors: Farhan Shahzad Imran, Caroline Andrews, Kathy Doerner, Brittany Heatherington, Susan Hodes, Nancy Mary Pictor, Cathy Reda-Cheplowtiz, Jeanine S Santelli, Saad Jamshed
Journal: Journal of Clinical Oncology (2016)

51 Background: The follow up care for cancer survivors is often sidelined due to the lack of well-defined guidelines. A “Survivorship care plan (SCP)” has been proposed to summarize key aspects of the cancer care and the future follow-up plan. Cancer survivors who had not received SCP were surveyed to gauge their understanding of their cancer care. Methods: Patients who had completed cancer therapy with curative intent during a 2 year period (2013-2014) were mailed the survey questionnaire. This questionnaire was designed to test understanding of their diagnosis (stage), care team, symptoms of relapse, surveillance plan, and short and long term side effects of their treatment. The Cancer Center’s medical record database was systematically searched to identify subjects. Microsoft Excel was used to calculate descriptive statistics on the quantitative data and frequency counts for the qualitative data. Results: 161 cancer survivors completed the survey of the total 342 mailed. The majority of these patients had breast (92%) cancer. Other cancer survivors had a diagnosis of lung (6%) and colon (2%) cancer. Only 2% patients did not know their cancer diagnosis. 12% patients did not know the stage of their cancer. 98% patients were able to report their surgeons’ name, however 85% and 89% could not recall their medical and radiation oncologist, respectively. 95% patients recalled discussing their follow-up plan with their provider but only 86% patients knew which test(s) should be performed as part of their cancer surveillance. Only 68% patients accurately listed a few symptoms suggesting cancer recurrence, while 62% survivors correctly listed a few potential long term side-effects of cancer treatment. Conclusions: There are several deficiencies in survivors’ understanding of their cancer care. Further research is needed to assess and compare if these deficits can be improved by a SCP document.
Phase II trial of paclitaxel and cisplatin combination given biweekly as first-line chemotherapy in patients with advanced or metastatic squamous cell carcinoma of esophagus from a single center in China.
Authors: Y. Zhou, J. Huang, L. Yang, G. R. Cai, H. B. Xu, W. J. Wang, K. Y. Shi, Y. Sun
Journal: Journal of Clinical Oncology (2011)

e14646 Background: Triweekly chemotherapy of paclitaxel and cisplatin has been proven to be effective in metastatic esophageal squamous cell carcinoma (ESCC).The purpose of this phase II trial was to evaluate efficiency and safety of biweekly chemotherapy of Paclitaxel and cisplatin in ESCC. Methods: Patients with advanced, surgically unresectable, or metastatic squamous cell carcinoma of the esophagus were enrolled; no prior chemotherapy for advanced or metastatic cancer; Karnofsky performance status (PS) ≥80; and adequate renal, hepatic, and hematologic function were treated with Paclitaxel 150mg/m2 iv d1 and cisplatin50- 60mg/m2 iv d2 every 2 weeks. Antitumor activity was assessed by computed tomography (CT) at baseline and after 8 weeks, and further by CT every 8 weeks. Results: 36 patients were recruited and 35 of them were evaluable for tumor response and safety. Patient characteristics were median age of 55 (42-71) years; gender, 78% male and 22% female. 3 patients had a complete response(8.5%); 16 had confirmed partial response and 2 had unconfirmed partial response. The overall response rate was 54.3%.9 had stable disease, giving a disease control rate (CR+PR+SD) of 85.7%.Median time to progression was 9.7 months (95% CI,8.2-11.1). Median survival time was 17.2 months (95% CI, 13,0-21.4). The most frequent grades 3–4 toxicity was neutropenia (60.0%; grade3 42.9%+grade4 17.1%). No toxic related death was observed. Conclusions: Biweekly chemotherapy of paclitaxel and cisplatin is a remarkably active and generally well-tolerated first-line treatment for patients with metastatic ESCC.
Serum proteomics and ingenuity pathway analysis (IPA)-guided discovery of response markers to androgen ablation (AA) in prostate cancer.
Authors: Manish Kohli, Ann L. Oberg, Douglas W. Mahoney, Shaun M Riska, Yuji Zhang, Roman M. Zenka, Deepak M. Sahasrabudhe, Rui Qin, Rachel Carlson, Sheng Zhang
Journal: Journal of Clinical Oncology (2012)

11 Background: Currently there are no serum markers of response to AA. We performed a proteome based analysis of serum from prostate cancer patients, followed by mapping of candidate markers to networks based on known molecular interactions in Ingenuity Knowledge Base (IKB). Methods: Isobaric mass tags for relative and absolute quanititation (iTRAQ) analyzed by reverse-phase liquid chromatography coupled to tandem mass spectrometry (LC/MS/MS) was performed in serum of 3 non-localized prostate cancer cohorts. The first cohort included 15 paired untreated hormone-sensitive “pre AA” and 3-month “post AA” specimens; the second included 10 “early AA failure” (median failure time: 11 months) and the third included 10 “late AA failure” specimens (median failure time: 95 months). Differentially expressed candidate proteins were identified by comparisons of (i) paired pre/post AA proteomes and (ii) post AA proteome with the combined AA failure cohorts at a False Discovery Rate of 0.2. To facilitate biological interpretation of multiple candidates identified in the comparisons, IPA was used. Candidate markers implicated in IPA networks with statistical significance were pursued in a second, independent patient cohort for association with time to AA failure using univariate Cox regression analysis. Results: Median PSA for pre/post AA first cohort were 3.15 and 0.29 ng/ml. Median PSA for the second and third cohorts were 27.3 and 4.3 ng/ml. Between post AA and AA failure cohorts, 149 proteins were differentially expressed. Between early and late AA failure 98 proteins were differentially expressed; 47 proteins were common in both comparisons. Network enrichment analysis of the 47 proteins by IPA identified four interaction networks (p&lt;0.01), one of which highlighted a role for 17-β-estradiol (E1). Gas chromatography used for measuring 3-month post AA initiation serum E1, estrone (E2) and testosterone levels (N=38) detected high E1, E2 levels associated with longer time to AA failure (P=0.07 for E1; P=0.08 for E2) in the independent cohort. Conclusions: A global proteomic analysis identified post AA initiation serum E1, E2 levels as potential response markers, which needs validation.
Measuring cancer care quality: An update on development and validation of the CAHPS survey for cancer care prototype.
Authors: Kathleen J. Yost, Christian Evensen, San Keller, Steven Garfinkel
Journal: Journal of Clinical Oncology (2016)

270 Background: At the 2013 ASCO Quality Symposium, we presented the formative development work and results of the 1 st field test of the Cancer CAHPS survey. At that time, we noted next steps in the development and validation of the survey. In this poster/presentation, we will provide updates on these activities. Methods: The Spanish translation was completed in 2013. We conducted interviews with 9 cancer patients in 2014 to identify composite labels that resonated with consumers. We collaborated with diverse cancer care providers (health maintenance organizations, medical foundations, small oncology practices, and comprehensive cancer centers) to identify an approach to sampling patients that could be standardized across settings. With the input of stakeholders, we added additional Shared Decision Making (SDM) and Access to Care questions. Data on the revised survey were collected in a 2 nd field test from May 2015 – November 2015. We will analyze these data to assess the feasibility of the sampling approach and confirm the psychometric properties of the survey. We embedded several secondary experiments in the 2 nd field test including assessing the effect of language (Spanish vs. English) and mode of administration (mail only vs. web-mail mixed mode) on survey responses. Results: The Spanish-language survey is currently being fielded. Consumers identified “user friendly” composite labels, abbreviated here as Communicates well, SDM, Explains treatment, Supports self-management, Access, Delays, and Claims. We developed a comprehensive sampling approach that relies on billing data to identify cancer patient eligible to receive the survey. Preliminary findings indicate that the standardized sampling approach is feasible. The survey was administered to 3,581 patients across 4 cancer centers (i.e. reporting units) in the 2 nd field test. Results of the psychometric analyses and embedded experiments will be completed in December 2015 and available for dissemination in January 2016. Conclusions: The cumulative findings from the 1 st and 2 nd field tests and other development activities conducted to date will be used to support an application for the CAHPS trademark.
Efficacy and feasibility of paclitaxel and cisplatin combination chemotherapy for the treatment of 5-flurouracil (5-FU), doxorubicin refractory advanced gastric cancer
Authors: Y. Kim, B. Prrk, J. Seo, J. Gang, S. Lee
Journal: Journal of Clinical Oncology (2008)

15674 Background: The standard chemotherapy regimen for recurrent gastric cancer has not yet been established. We performed a prospective study on the combination chemotherapy of paclitaxel and cisplatin to the patients who have already treated 5-FU, doxorubicin based (FA, FAM) chemotherapy. The primary objectives of the study were evaluating the disease response and regimen's safety. Methods: Patients who have already treated adjuvant 5-FU, doxorubicin based chemotherapy- 5-FU, doxorubicin (FA) or 5- FU,doxorubicin, mitomycin-C (FAM)- with recurrent gastric cancer received intravenous paclitaxel 175 mg/m2 on day 1, and cisplatin 75 mg/m2 on day 2. This cycle was repeated every 3 weeks. The response was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, and the toxicity was evaluated by National Cancer Institute common toxicity criteria. Results: From March 2004 to September 2006, 21 patients from were enrolled. A total of 121 treatment cycles (median: 4.2 cycles) were administered. The responses were evaluable in 21 patients; (previously treated adjuvant FA 10 cases, FAM 11 cases) The objective response rate (RR) was 28.5 % (6/21, 95% CI: 19.7–41.3) with two complete responses, and stable disease was observed in 42.8% (9/21, 95% CI: 32.3–56.7)of the patients. The median follow up duration was 27 months, and the median time to progression was 5.6 months (95% CI: 3.9- 8.2). The overall survival time was 7.8 months (95% CI: 7.0–10.0) with a 1-year survival rate of 19.2% (95% CI: 7.6–28.8). The most common toxicity was neutropenia. WHO grade 3–4 neutropenia was occurred 8 patients (38.0%) and febrile neutropenia was observed in 3 patients (14.2%), grade 3–4 anemia and thrombocytopenia occurred in 5 patient (23.8%) and 4 patients (19.0%) respectively. Grade 3–4 non-hematologic toxicities included nausea in 6 patients (28.5%) and alopecia in 5 patient (23.5%). There were no treatment related mortalities. Conclusions: Paclitaxel and cisplatin produced promising activity against recurrent gastric cancer for the previously 5-FU, doxorubicin based (FA, FAM) treated patients as a salvage treatment with an acceptable toxicity profiles. No significant financial relationships to disclose.