tbuckley/cabot-search huggingface dataset:
Role of EBUS-TBNA in the diagnosis of bronchogenic carcinoma.
Authors: B. Han
Journal: Journal of Clinical Oncology (2011)

e17534 Background: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a technique of minimally invasive endoscopic staging and of great interest for the identification and staging of mediastinal and hilar lymph nodes in patients with suspected and/or known bronchopulmonary neoplasm. This study was to evaluate diagnostic yield and the safety of EBUS-TBNA in the diagnosis of bronchogenic carcinoma. Methods: Between July, 2009 and Feb, 2010, 95 patients with mediastinal / hilar lymphadenopathy and /or intrathoracic peritracheal or peribronchial masses previously detected with CT scan underwent EBUS-TBNA. No rapid onsite cytology was performed. Results: In all 95 patients, 60 cases of patients were newly diagnosed lung cancer through the pathological examination and clinical follow-up certification. In 60 lung cancer cases, 112 samples were obtained from lymph nodes (LNs) and 11 samples were obtained from intrapulmonary lesions. 58 cases of patients were diagnosed in 60 lung cancer cases, false negative in 2 cases. Sensitivity and specificity of EBUS-guided TBNA method in distinguishing benign from malignant LNs or thoracic masses was 96.67% and 100%, respectively. In absence of any major complication, the procedure was uneventful. Conclusions: EBUS-TBNA seemed a safe and effective technique in making bronchogenic carcinoma diagnosis for mediastinal/hilar LNs and intrapulmonary masses.
Agreement between breast cancer survivors and oncologists on treatments received.
Authors: T. B. Sanft, V. Northrup, A. B. Chagpar, M. Irwin
Journal: Journal of Clinical Oncology (2011)

9106 Background: Literature suggests patients are accurate in reporting broad categories of treatment received but not as accurate with specific details (i.e. dates of surgery or names of drugs). To our knowledge, no study has examined agreement between the self-report of breast cancer survivors and the report of their oncologist regarding treatments received. Methods: This is a subset analysis from the Yale Exercise and Survivorship (YES) study, which randomized 75 postmenopausal stage 0-IIIA breast cancer survivors to exercise or usual care. Participants were required to have finished adjuvant chemotherapy at least 6 months prior to enrollment. Survivors completed questionnaires regarding the stage of cancer, type of therapy received (i.e. radiation, chemotherapy, anti-hormonal therapy), and names of the drugs (indicated from a list of possibilities). The treating oncologist completed a verification form answering the same questions regarding treatments received. We examined agreement between survivors and the treating oncologists by calculating the proportion in agreement and the kappa statistic. Results: 53 paired questionnaires were available for analysis. Mean age at diagnosis was 55 years, the average number of months since diagnosis was 36 (range 9-105 mo). Between physicians and survivors, agreement on stage, radiation, chemotherapy and anti-hormone therapy was 97% (95% CI= 0.92-1.0), 91% (CI=0.78-1.0), 92% (CI=0.81-1.0) and 88% (CI=.76-1.0), respectively. Among those receiving a particular type of chemotherapy or anti-hormonal drug (N=31), agreement is shown in the table. Conclusions: Breast cancer survivors are able to accurately recall broad categories of treatment received, but are not able to accurately report the names of the drugs received. As the number of survivors increases and their health care is shared among many providers, strategies to improve knowledge of treatments received are necessary. Agreement between survivors and oncologists in report of treatment received by specific drug names. Drug Agreement 95% CI Anthracycline 35% 0.11-0.59 Taxane 18% 0.05-0.42 Cyclophosphamide -13% 0.25-0.01 Tamoxifen 86% 0.62-1.0 Letrozole 73% 0.46-1.0 Anastrozole 62% 0.30-0.95
Outcomes of continuously infused 5-fluorouracil, doxorubicin, and mitomycin-C (iFAM) as salvage regimen in patients with biliary tract cancer.
Authors: K. Lim, S. Han, D. Oh, S. Im, T. Kim, Y. Bang
Journal: Journal of Clinical Oncology (2011)

282 Background: In advanced biliary tract cancer, after failure of first-line chemotherapy, salvage chemotherapy has not yet been established and the prognostic factors in salvage setting have not been widely known. The purpose of this study was to evaluate the efficacy and safety of iFAM as salvage chemotherapy in biliary tract cancer and to reveal the prognostic factors. Methods: Eligibility included: 1) age 18-75, 2) histologically confirmed biliary tract cancer, 3) previously treated with palliative first-line chemotherapy, 4) ECOG PS 0-2, 5) adequate organ function. iFAM consisted of 5-FU 800 mg/m 2 over 12 hour on days 1-5, doxorubicin 30 mg/m 2 on day 1, and mitomycin-C 8 mg/m 2 on day 1, every 4 weeks. Results: Between February 2003 and August 2009, 50 patients (pts) were enrolled. The median age was 57.3 yrs (range: 26.0-71.5 yrs), and there were 33 men (66%). 32 pts (64%) had ECOG PS 0-1 and 18 pts (36%) had PS 2. Biliary tract cancers were extrahepatic cholangiocarcinoma (30%), intrahepatic cholangiocarcinoma (30%) and gallbladder cancer (40%). Previous chemotherapy mainly consisted of gemcitabine-based and 5-FU-based regimens. Median cycles of iFAM were 2 (range: 1-6). Best responses to iFAM were PR in 2 (4%) pts and SD in 9 (18%), that is response rate was 4% and disease control rate was 22% (95% CI: 7.35-28.65). The median PFS and OS were 2.2 (95% CI: 2.0–2.4) months and 5.0 (95% CI: 3.3–6.7) months, respectively. Grade 3/4 hematologic toxicities were neutropenia (10%), anemia (2%), and thrombocytopenia (8%). Frequent nonhematologic toxicities were alopecia (34%), stomatitis (28%), vomiting (24%), and diarrhea (12%), which were grade 1/2. ECOG PS (0-1 vs 2) was significant prognostic factor for both PFS (p=0.029) and OS (p=0.025). Poor response to previous chemotherapy (p=0.031) were poor prognostic factors for OS. Conclusions: iFAM is an effective and safe treatment option in refractory biliary tract cancer and can be considered as salvage regimen, especially for patients with good PS and good response to previous chemotherapy. No significant financial relationships to disclose.
A phase I study of granulocyte macrophage colony-stimulating factor (GM-CSF) and escalating doses of thalidomide in patients with high-risk malignant melanoma
Authors: J. Lutzky, R. Weber, Y. Nunez, M. Menendez, M. Rose, S. Trautvetter, M. Timmerman, L. E. Spitler
Journal: Journal of Clinical Oncology (2005)

7569 Background: GM-CSF activates macrophages, stimulates monocytes in vitro, increases the cytotoxicity of monocytes in vivo, and mediates proliferation, migration and maturation of dendritic cells. GM-CSF also has anti-angiogenic activity. Thalidomide enhances IL-12 activity, induces T-cell co-stimulation, stimulates IL-2 mediated T-cell proliferation and possesses anti-angiogenic and anti-metastatic properties. Both drugs have activity against malignant melanoma as single agents. We have reported the results of an exploratory trial of GM-CSF plus thalidomide with intra-patient dose escalation in 11 patients with high-risk melanoma (Proc Am Soc Clin Oncol 22: page 725, 2003, abstr 2916). We now report the initial results of a formal Phase I thalidomide dose-escalation trial. Methods: Patients with melanoma at high-risk for recurrence (all T4, Stage III and NED Stage IV) were eligible. GM-CSF was given SC at a dose 125 mcg/m2 daily for 14 consecutive days, every 28 days. Thalidomide was given orally every night. Both drugs were administered for 1 year. Thalidomide dose was escalated in three-patient cohorts of 50 mg, 100 mg, 200 mg, 300 mg, and 400 mg. Results: Nineteen patients were accrued with the following characteristics: 13 males, 6 females, 2 stage IIC, 11 Stage III, 6 stage IV, median age 63 years (45–76). Twelve patients remain on treatment. Seven patients are off treatment: 1 completed treatment, 2 investigator decision, 1 refused to continue, 2 progressive disease. Eighteen patients are alive. One patient has expired with progressive disease. Six serious adverse events were reported: 1 pneumonia, 1 elevated creatinine, 1 cellulitis, 1 Staphylococcal infection, 1 appendicitis, 1 thrombosis. The most common adverse events were Grade I rash, Grade I-II dizziness, Grade I peripheral neuropathy, Grade I edema, and Grade 1 constipation. Dose limiting toxicity was not encountered in any of the cohorts studied. Conclusions: GM-CSF and thalidomide in this dose and schedule is well tolerated in this high-risk group of patients with malignant melanoma. Assessment of efficacy will require a randomized trial. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Berlex, Celgene Berlex, Celgene
Focal or whole gland salvage prostate brachytherapy with iodine seeds with or without a rectal spacer for a post EBRT local failure: How best to spare the rectum?
Authors: Valentine Guimas, Magali Quivrin, Aurelie Bertaut, Etienne Martin, Frederic Mazoyer, Philippe Maingon, Luc Cormier, Gilles Crehange
Journal: Journal of Clinical Oncology (2016)

e636 Background: Salvage prostate permanent implant (sPPI) for post radiation local failures provides high rates of biochemical control. The cumulative dose delivered to the prostate and the rectum when taking into account the dose from the primary irradiation is still unknown. Besides cancer control, the primary goal of sPPI should be to protect the rectum in order to avoid any rectal fistula in the long term. Methods: We reviewed the post implant CT-based dosimetry of 18 selected patients who underwent sPPI with 125 I seeds for an isolated biopsy-proven local failure several years after external beam radiation therapy (EBRT). Ten patients had a whole prostate sPPI and 8 patients had a multi-parametric MRI-based focal sPPI. Eight patients had an injection of hyaluronic acid (HA) gel in the prostate-rectum space. The BED of the primary EBRT and the BED of the sPPI were calculated using several a/b ratios (1.5, 2, 3, 5 and 10) and t1/2 (1h for the prostate and 0.3h for the rectum). Comparisons of BED parameters and doses delivered to the rectum according to the use of HA gel, prostate irradiation (whole gland versus focal) were performed using Wilcoxon exact test. Results: The median dose received by 90% of the prostate (D90) was 65.0 Gy [12.0 - 107.2] and the median prostate volume receiving 100% of the prescribed dose (V100) was 45.3% [14.4 - 98.3]. The median D90 and the median V100 for the index lesion were 162.0 Gy [139.4 - 199.1] and 96.1% [88.4 – 100.0], respectively. The median cumulative Biological Equivalent Dose (BED) after EBRT+sPPI for the prostate and the rectum were higher for patients treated on whole gland versus patients treated with focal sPPI (313.5 Gy 2 vs 174.4 Gy 2 , p = 0.06 and 258.1 Gy 3 vs 172.6 Gy 3 , p &lt; 0.01, respectively). The median D0.1 cc for the rectum was significantly lower for patients who had HA gel: 63.3 Gy [29.0 - 78.3] compared to patients with no gel: 83.9 Gy [34.9 – 180.0] (p = 0.04). Conclusions: Focal sPPI provided lower cumulative prostate and rectum BED when compared to whole gland plans. D0.1cc delivered to the rectum was significantly lower after sPPI with HA gel while it was not different between focal or whole gland plans.
Fatigue in long-term non-Hodgkin lymphoma survivors.
Authors: Kathryn Elizabeth Hudson, Habtamu Kassa Benecha, Kevin Leo Houck, Thomas William LeBlanc, Amy P Abernethy, Sheryl Zimmerman, Patricia A. Ganz, Sophia Kustas Smith
Journal: Journal of Clinical Oncology (2015)

239 Background: Fatigue is a common and distressing effect of cancer and its treatment, potentially affecting quality of life (QOL) for years after treatment. However, the prevalence and persistence of fatigue among long-term survivors of non-Hodgkin lymphoma (NHL) remains unknown. We aimed to identify demographic, clinical, and psychosocial risk factors for persistent fatigue in this population. Methods: In 2010, surveys were mailed to 682 NHL survivors who participated in a study 5 years earlier; respondents were, on average, 10.4 years post diagnosis. Standardized measures of QOL, symptoms, medical history, and demographic variables were reported at both time points. We defined significant fatigue conservatively as 0.5 standard deviations below the SF-36 scale’s cutoff for fatigue, and we defined persistent fatigue as significant fatigue at both time points. Chi-square, t-tests, and logistic regression were used to determine risk factors and predictors for persistent fatigue. Results: 30.8% (n = 172) and 33.0% (n = 186) of patients reported significant fatigue at time point 1 and 2, respectively; 20% of patients had persistent fatigue. Patients with persistent fatigue were more likely to report: female gender, income &lt; $30,000, less than college education, less exercise, active disease, chemotherapy, at least one recurrence of their disease, less social support, an average of 3.8 more comorbidities, and significantly more posttraumatic stress than those without persistent fatigue (all p &lt; .05). Logistic regression showed that education less than college, more comorbidities, less exercise, and more posttraumatic stress were independent predictors of persistent fatigue (all p &lt; .05). Conclusions: Fatigue plagues one-third of NHL survivors and persists in one-fifth of this population even years after diagnosis. These findings could inform clinical practice in NHL survivorship and highlight targets for intervention.
Racial/ethnic disparities in clinicopathologic features and treatment modalities of triple-negative breast cancer in black premenopausal women.
Authors: Muhammad S Hamid, Raji Shameem, Anita Pudusseri, Robert Graham, Dana Shani, Kevin M. Sullivan
Journal: Journal of Clinical Oncology (2014)

58 Background: Triple-negative breast cancer (TNBC) is a distinct breast cancer subtype associated with poor outcomes. Previous literature has reported an increased prevalence of TNBC in premenopausal black women. However, clinicopathologic features and treatment disparities of TNBC require further investigation. Methods: We used the Surveillance Epidemiology and End Results (SEER) database to collect data for premenopausal, estrogen receptor–negative, progesterone receptor–negative, and HER2 receptor–negative invasive breast-cancer cases diagnosed in 2010. Blacks were compared to the referent non-Hispanic white (NHW) cohort. Variables explored include: age at diagnosis, summary stage, tumor size, presence of metastasis at diagnosis, birth country, marital status, radiation, surgery (total and partial mastectomy), and radiation/surgery sequence. The Kruskall-Wallis test and the Z-test were used to investigate for any racial/ethnic disparities that may exist. Results: Compared to NHW, black patients had more regional disease (42.3% vs. 36.1%, p &lt; 0.05) and distant metastasis (7.37% vs. 4.67%, p &lt; 0.05) at the time of diagnosis, They were more likely to be single (44.0% vs. 17.1%, p &lt; 0.05), born in the United States (39.4% vs. 32.5%, p &lt; 0.05), have fewer cases in the “40-49 years” age range (68.6% vs. 73.0%, p &lt; 0.05), and present with tumor size &gt; 20 mm (26.1% vs. 36.6%, p &lt; 0.05) compared to NHW. While black women received surgical intervention (11.5% vs. 6.8%, p &lt; 0.05) more commonly, adjuvant radiation (41.0% vs. 33.3%, p &lt; 0.05) was utilized less after segmental mastectomy compared to NHW. Conclusions: Poor prognostic tumor characteristics were significantly more likely to be present in black premenopausal women with TNBC compared with NHW patients. Black women were more likely to receive surgical intervention, however, adjuvant radiation was administered significantly less. Further research is necessary to clarify if these disparities have an impact on survival outcomes.
Overall response rate (ORR) in STEAM, a randomized, open-label, phase 2 trial of sequential and concurrent FOLFOXIRI-bevacizumab (BEV) vs FOLFOX-BEV for the first-line (1L) treatment (tx) of patients (pts) with metastatic colorectal cancer (mCRC).
Authors: Johanna C. Bendell, Benjamin R. Tan, James Andrew Reeves, Henry Xiong, Bradley G. Somer, Heinz-Josef Lenz, Howard S. Hochster, Frank Scappaticci, Nicolas Sommer, Bann-mo Day, Herbert Hurwitz
Journal: Journal of Clinical Oncology (2016)

492 Background: 3-drug chemotherapy (CT) + BEV (cFOLFOXIRI-BEV) significantly improved efficacy vs FOLFIRI-BEV for 1L mCRC tx, but safety and the impact of subsequent fluoropyrimidine-BEV maintenance tx require further definition. The phase 2 STEAM (NCT01765582) trial assessed efficacy of 1L cFOLFOXIRI-BEV vs FOLFOX-BEV and safety of alternating 2-drug CT (FOLFOX and FOLFIRI) + BEV tx monthly in a sequential sFOLFOXIRI-BEV regimen. Methods: Pts with unresectable, previously untreated mCRC were randomized 1:1:1 to BEV-containing (5 mg/kg) arms (cFOLFOXIRI, sFOLFOXIRI [alternating FOLFOX and FOLFIRI every 4 weeks {q4w}], or FOLFOX q3w) in a 4–6 month induction phase, followed by BEV-containing maintenance tx. Stratification factors included extent of metastatic disease and tumor location. Primary objectives: 1L ORR, 1L progression-free survival (PFS), safety. Secondary objectives: resection and conversion to resectable disease rates, time to 2L PFS, overall survival. ORR was tested with a 1-sided alpha of 5%; tx arms were compared with a stratified 1-sided Cochran-Mantel-Haenszel test. PFS was analyzed descriptively. Results:Among 280 enrolled pts (median age, 57.5 yrs), 186 remainined in the study on July 1, 2015. Efficacy and safety are shown (see Table). Conclusion: While not statistically significant, there was a trend of increased ORR with cFOLFOXIRI-BEV vs FOLFOX-BEV in 1L mCRC tx. Analysis of PFS is ongoing. All 3 regimens were well tolerated. Clinical trial information: NCT01765582. [Table: see text]
Effect of early integrated palliative care on family caregivers (FC) outcomes for patients with gastrointestinal and lung cancer.
Authors: Areej El-Jawahri, Vicki A. Jackson, Joseph A. Greer, William F. Pirl, Elyse R. Park, Anthony Back, Alona Muzikansky, Mihir Kamdar, Simone Rinaldi, Juliet Jacobsen, Joel Fishbein, Justin Eusebio, Harry VanDusen, Ryan David Nipp, David P. Ryan, Jennifer S. Temel
Journal: Journal of Clinical Oncology (2016)

234 Background: Patients with newly diagnosed advanced cancers who receive early palliative care (PC) integrated with oncology care report improvement in their quality of life (QOL) and mood. While a telephone-based psycho-educational intervention for FC decrease depression, the impact of early, integrated outpatient PC models on FC outcomes remains unknown. Methods: We conducted a randomized trial of early PC integrated with oncology care versus oncology care alone for newly diagnosed patients with incurable lung and gastrointestinal cancers and their FC. Eligible FC were relatives or friends who would likely accompany the patient to clinic visits. FC were eligible to enroll up to 4 weeks after patient enrollment. The intervention entailed at least monthly patient visits with PC from the time of enrollment. FC were not required to attend these visits. We used the Medical Outcomes Study Health Survey Short Form-36 to examine QOL and the Hospital Anxiety and Depression Scale to examine mood at baseline, weeks 12 and 24. We used the two-sample t-test to examine changes in QOL and mood from baseline to week 12 and week 24. Results: We enrolled 350 patients and 275 (78.6%) of potentially eligible FC (control n = 138, intervention n = 137) between 5/2/2011 to 7/20/2015. FC outcomes missing data rate at 12 and 24 weeks were 16.8% and 33.8% respectively. At 12 weeks, FC of patients receiving early PC reported higher vitality (1.1 vs. -3.2, p = 0.05) and social functioning (-3.0 vs. -3.8, p = 0.02), and lower depression symptoms (-0.45 vs. 0.24, p = 0.03) compared to FC of patients assigned to usual care. At 24 weeks, FC of patients assigned to early PC had lower depression symptoms (-0.37 vs. 0.28, p = 0.05), but no differences in vitality or social functioning compared to those receiving usual care. No differences in other SF-36 subscales or anxiety were noted at 12 and 24 weeks. Conclusions: Early involvement of PC for patients with newly diagnosed lung and gastrointestinal cancers leads to improvements in FC depression and aspects of QOL. This work demonstrates that the benefits of early, integrated palliative care models in oncology care extend beyond patient outcomes and positively impact the experience of FC. Clinical trial information: NCT01401907.
Evaluation of nimotuzumab combined with radiotherapy on esophageal carcinoma: A phase II clinical trial.
Authors: L. Wang, J. Liang, N. Li, B. Chen, Z. Hui, J. Lv, H. Fang, Y. Tang, N. Bi, W. Wang, T. Li, D. Chen, M. En, G. Wu, L. Zhao, X. Li, X. Xiu
Journal: Journal of Clinical Oncology (2011)

e14637 Background: To evaluate the safety and efficacy of nimotuzumab in combination with radiotherapy on esophageal carcinoma (ESO). Methods: 42 patients with stage II to IVa of ESO were assigned at random into this prospective, phase II clinical trial during Nov. 2008 to Jul. 2010. All patients received 50-70 Gy of three-dimensional conformal radiotherapy. 200mg of nimotuzumab was administered via intravenous infusion once a week during the radiotherapy. Results: The primary cancer lesions were located upper, middle and lower thoracic segments of the esophagus in 10, 26 and 3 patients, respectivley. Among those, there were 9, 25 and 8 patients with stage II, III and IVa of ESO, respectively. All patients received 50-70 Gy of radiation and 37 patients (88.1%) received nimotuzumab for more than 5 times. The grade 3 toxicities were nause and vomitting, esophagitis, skin reactions, hematology in 1, 3, 4, 1 patients, respectively. There was only one patient who had allergic to nimotuzumab. The CR, PR, SD and PD were observed in 4 (9.5%), 21 (50%), 2 (4.8%) and 15 (35.7%) patients, respectively. The overall disease control rate was 64.3%. With a 6 months of median follow-up, the local recurrence and distance metastasis were observed in 6 (14.3%) and 10 (23.8%) patients. There were 10 patients died with 8 possible cancer-related deaths. The median survival time has not been reached yet. The 6-month and 1-year overall survival rate were 82.4% and 57.8%. Conclusions: Nimotuzumab in combination with radiotherapy is well-tolerated and effective for the treatment of ESO. Long-period toxicity and long-term efficacy need to be further evaluated.