tbuckley/cabot-search huggingface dataset:
Gemcitabine plus vinorelbine as first-line treatment of metastatic breast cancer
Authors: E. Gokmen, C. Sezgin, B. Karabulut, A. Vazquez, S. Sanal
Journal: Journal of Clinical Oncology (2005)

830 Background: Most breast cancer patients (pts) receive antracyclines and taxanes in the adjuvant setting. Alternative chemotherapy regimens are needed when these pts relapse. In this trial, we evaluated the efficacy and feasibility of gemcitabine (G) and vinorelbine (V) in first line treatment of metastatic breast cancer. Methods: Pts were eligible if they had recurrent or metastatic breast cancer, measurable disease, ECOG PS≤ 2, adequate organ function, ability to give informed consent and had received no chemotherapy for metastatic disease. Both G (1200 mg/m2) and V (30 mg/m2) were administered on days 1 and 8 of every 21 day cycle. Chemotherapy was continued until disease progression or development of unacceptable toxicity. Results: Twenty pts have been enrolled. All pts were evaluable for toxicity and 19 for response. One pt who died on day 13 because of preexisting cardiac disease was excluded for response analysis, but included in survival analysis on an intention to treat basis. The median age was 52 years (range 30–80). The sites of metastasis were liver in 5 (25%), lung in 15 (75%), soft tissue in 11 (55%) and bone in 8 (40%) pts. The numbers of metastatic sites were: ≥3 in 5 pts, 2 in 7 pts and 1 in 8 pts. A total of 102 cycles was administered (median 5, range 1–11). In the 19 pts evaluable for response, 8 PRs were observed for an overall response rate of 42%. The median time to progression was 6.8 months (range 3 to 9+). Seven (37%) pts had stabile disease for duration of 3 to 11 months. The survival data are immature at this time. Grade III-IV leukopenia was observed in 8 pts (grade IV in 2 and grade III in 6 pts). Neutropenic fever was not observed. Grade III-IV thrombocytopenia was seen in 1 pt. Two pts required dose reductions. Dose delays were necessary in 10 pts due to myelosuppression. Grade I vomiting was seen in 2 pts. No pts experienced grade II-IV vomiting. Alopecia was seen in 2 pts (10%). The most common non-hematological toxicity was vinorelbine related arm pain. Six pts developed phlebitis (grade III in 2 and grade I-II in 4 pts). Conclusion: The GV combination is a feasible alternative to antracycline-taxane containing regimens with a favorable toxicity profile and an encouraging response rate. The study remains open to achieve the planned pt accrual. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Eli Lilly
Skin prick tests and specific IgE in 10‐year‐old children: Agreement and association with allergic diseases
Authors: A. Chauveau, M.‐L. Dalphin, F. Mauny, V. Kaulek, E. Schmausser‐Hechfellner, H. Renz, J. Riedler, J. Pekkanen, A. M. Karvonen, R. Lauener, C. Roduit, D. A. Vuitton, E. von Mutius, J.‐C. Dalphin
Journal: Allergy (2017)

Accurate assessment of atopic sensitization is pivotal to clinical practice and research. Skin prick test (SPT) and specific IgE (sIgE) are often used interchangeably. Some studies have suggested a disagreement between these two methods, and little is known about their association with allergic diseases. The aims of our study were to evaluate agreement between SPT and sIgE, and to compare their association with allergic diseases in 10-year-old children.Skin prick test, sIgE measurements, and assessment of allergic diseases were performed in children aged 10 years in the Protection against Allergy: STUdy in Rural Environments (PASTURE) cohort. The agreement between SPT and sIgE was assessed by Cohen's kappa coefficient with different cutoff values.Skin prick tests and sIgE were performed in 529 children. The highest agreement (κ=.44) was found with a cutoff value of 3 and 5 mm for SPT, and 3.5 IU/mL for sIgE. The area under the curve (AUC) obtained with SPT was not significantly different from that obtained with sIgE. For asthma and hay fever, SPT (cutoff value at 3 mm) had a significantly higher specificity (P<.0001) than sIgE (cutoff value at 0.35 IU/mL) and the specificity was not different between both tests (P=.1088).Skin prick test and sIgE display moderate agreement, but have a similar AUC for allergic diseases. At the cutoff value of 3 mm for SPT and 0.35 IU/mL for sIgE, SPT has a higher specificity for asthma and hay fever than sIgE without difference for sensitivity.
Co-Transplantation of Hematopoietic Stem Cells and GM-CSF/G-CSF/CSF-Transfected Mesenchymal Stem Cells in SCID Mice.
Authors: Jin-Yeong Han, Rhee-Young Koh, Su-Yeong Seo, Joo-In Park, Hyuk-Chan Kwon, Jae-Seok Kim, Young-Ho Lee, Hyo-Jin Kim
Journal: Blood (2004)
Bicalutamide 80 mg in combination with an LHRHa versus LHRHa monotherapy in previously untreated advanced prostate cancer: a double-blind, placebo-controlled trial
Authors: H. Akaza, H. Yoshida, Y. Takimoto, S. Kagawa, A. Terai, Y. Arai, M. Usami, S. Naito, H. Kanetake, Y. Ohashi
Journal: Journal of Clinical Oncology (2005)

4648 Background: Combination therapy with non-steroidal antiandrogens, but not steroidal antiandrogens, is associated with a survival advantage over castration alone in advanced prostate cancer (Lancet 2000; 355: 1491–8). As previous Japanese trials in this setting have only evaluated steroidal antiandrogens, a randomized, double-blind, placebo-controlled trial was initiated to evaluate bicalutamide (‘Casodex’) 80 mg (licensed dose in Japan) in combination with an LHRHa. Analysis of the primary study variables, the 12-week overall tumor response rate (complete + partial response) and the 12-week prostate-specific antigen (PSA) normalization rate (PSA level ≤4 ng/mL), has shown benefits for bicalutamide 80 mg combination therapy over LHRHa alone (Jpn J Clin Oncol 2004: 34; 20–8). Here, we present an analysis of the secondary study variables - time to progression (TTP), time to treatment failure (TTTF), and overall survival (OS) - performed after all patients (pts) had completed ≥18 months’ follow-up, representing the final planned analysis of all variables except OS. Methods: 205 Japanese pts with previously untreated stage C/D prostate cancer were randomized 1:1 to bicalutamide 80 mg or placebo, each in combination with an LHRHa. TTP, TTTF, and OS were analyzed after ≥18 months’ follow-up (median >128 weeks). Results: When combined with an LHRHa, there were significant (p<0.001) differences in favor of bicalutamide 80 mg over placebo in TTTF (median 117.7 vs 60.3 weeks; HR 0.54; 95% CI 0.38, 0.77) and TTP (median not yet reached vs 96.9 weeks; HR 0.40; 95% CI 0.26, 0.63). Interim OS was similar for bicalutamide 80 mg and placebo (87.3% vs 82.2%; p=0.301). Seven of the 18 pts withdrawn from bicalutamide after disease progression had an antiandrogen withdrawal response. Conclusions: In Japanese pts with advanced prostate cancer, first-line treatment with bicalutamide 80 mg in combination with an LHRHa provides significant benefits over an LHRHa alone, with respect to treatment failure and progression. Follow-up for survival continues. ‘Casodex’ is a trademark of the AstraZeneca group of companies No significant financial relationships to disclose.
Second-line chemotherapy for metastatic urothelial cell carcinoma: Pooled analysis and construction of a prognostic model.
Authors: Samer Salah, Jae-Lyun Lee, Antonio Rozzi, Hiroshi Kitamura, Kazumasa Matsumoto, Sandy Srinivas, Rafael Morales, Joan Carles, Rami Al-Wardat, Mohammad Maakoseh
Journal: Journal of Clinical Oncology (2015)

309 Background: A prognostic model for patients with metastatic urothelial cell carcinoma (UCC) progressing following platinum-based therapy was constructed based on data from the phase 3 vinflunine trial. However, prognostic information for patients treated outside the setting of clinical trials and with variety of second-line regimens are limited. Methods: We gathered individual patient’s data from studies assessing second-line chemotherapy for metastatic UCC and analyzed the influence of factors of interest on overall survival (OS) through univariate and multivariate Cox-regression analysis. A prognostic model was constructed, and data of an independent series from a single institution was utilized for validation. Results: Data for 182 patients from seven studies were pooled. The second-line treatment was single agent in 22 (12%), platinum-based combination (nedaplatin or oxaliplatin) in 59 (33%), and non-platinum combination in 101 (55%). In multivariate analysis, Eastern Cooperative Oncology Group performance status ≥1, Hb&lt;10, and metastatic patterns other than LN only metastasis emerged as independent adverse factors. Patients with all three factors (poor risk), 1-2 factors (intermediate risk), and 0 factors (Good risk) had median OS of 3.1, 8.8, and 16.5 months respectively, p&lt; 0.0001. The corresponding median OS for the validation series (n = 44) were 3.3, 8.1, and 13.3 months, p = 0.023. Platinum – based regimens were associated with OS benefit compared to other combination regimens and to single agents, such benefit was retained when this factor was included in multivariate analysis (HR: 3.1, 95% CI: 1.82- 4.98, p&lt; 0.0001). In addition, freedom of progression at 6 months from initiation of second- line therapy correlated with improved survival compared to progression within 6 months; median OS 13.9 and 6.6 months respectively, p&lt; 0.0001. Conclusions: We proposed and validated a prognostic model for patients with metastatic UCC who are eligible for second-line therapy. The proposed model may prove helpful for risk-stratification. Furthermore, our data suggest that testing second- line platinum-based regimens in randomized trials is warranted.
Investigating high-concentration 8% capsaicin patch in chronic cancer-treatment related peripheral neuropathic pain.
Authors: Sabrina Ramnarine, Barry Laird, Linda J Williams, Marie T Fallon
Journal: Journal of Clinical Oncology (2016)

208 Background: Cancer-treatment related peripheral neuropathic pain is a challenging clinical problem as current interventions have limited efficacy and significant toxicities. This study aims to examine the analgesic effect of high-concentration 8% capsaicin patch in this cohort of patients. Methods: A single arm study was conducted. Patients with long-term peripheral neuropathic pain received a single application of 8% transdermal capsaicin patch to the affected area (chest wall, hands or feet). Assessments at baseline, 4 weeks and 12 weeks post-treatment included: Brief Pain Inventory (BPI) short form (pain severity and interference with function); Hospital Anxiety and Depression Scale (HADS). The primary efficacy measure was a clinically significant improvement in pain (≥ 30% reduction in total BPI score (responders) from baseline to 4 weeks and 12 weeks). Secondary efficacy measures assessed worst pain, function and associated changes in mood. Results: 19 patients, median age 61.5 all had peripheral neuropathic pain for a median of 2 years (IQR 1-3) following treatment for various types of cancer: gynecological (n = 2), breast (n = 6), colorectal (n = 8), multiple myeloma (n = 2) or other (n = 1). At 4 weeks, 37% (7/19) patients showed a clinically significant improvement in pain (≥ 30%). Of the 7 responders, 5 had &gt; 50% reduction in pain. 16% (3/19) suggested a partial improvement (mean 17%). Of the patients reassessed at 12 weeks, 50% (7/14) were responders with all patients exhibiting a reduction in: worst pain score, -1.3 (95% CI: -2.5, -0.06; p = 0.04), interference with function, -10.9 (95% CI: -21.5, -0.4; p = 0.04) and HADS depression score, -1.7 (95% CI: -3.4, 0.02; p = 0.05). Total HADS score correlated with total BPI at 4 weeks (r = 0.68) and 12 weeks (r = 0.70). HADS depression score also correlated with BPI at 12 weeks (r = 0.73). All correlations were significant (p &lt; 0.01). Conclusions: In patients with chronic, resistant, cancer-treatment related peripheral neuropathic pain, high-concentration 8% capsaicin patch may provide some benefit in pain severity, function and mood with the effect continuing at 12 weeks post-treatment. This may warrant further long-term follow up in a larger cohort.
Clinical trials networks, accrual strategies, and enrollment of historically underrepresented populations in medical oncology trials.
Authors: J. L. Berkowitz, A. Fernandez, R. Dichmann, K. A. Kennedy, B. A. DiCarlo
Journal: Journal of Clinical Oncology (2011)

e16549 Background: Oncology research is limited poor accrual into clinical trials. Clinical trials networks may help to improve this by allowing investigations to be available to patients seen in practices that are far from academic centers. Also, strategies may be implemented within each practice to further enhance accrual. This thereby increases patient access to investigational agents while potentially increasing the pace of progress in clinical oncology research. Methods: Our objective was to assess the clinical trial accrual rate in a community practice that is a member of a clinical trials network affiliated with a major academic cancer center and the effects of policies within the practice to increase patient accrual into trials. We retrospectively analyzed the records from 2002-2010 of this practice, which is located over 150 miles from an academic center. Accrued patients were divided into subgroups based upon ethnicity and age. Also, from 2007-2010, the percentage of patients accrued into trials relative to the total number treated onsite was calculated and compared to national averages. Accrual rate was also measured before and after specific strategies, which will be detailed within the poster, were instituted in 2007. Results: In this period, over 200 patients seen at this practice were accrued into clinical trials. Of these patients, 44% were elderly and 20% were Hispanic, both markedly higher than national averages. For 2007-2010, 10% of patients that received on site treatment were accrued into trials, also significantly higher than the national average. The strategies implemented helped to increase the accrual per year from 16 patients per year from 2002-2007 to 37 per year in 2008-2010. Conclusions: Clinical trial networks and specific strategies within community practices can for better accrual rates than the national average. They also greatly enhance the potential for both minority and elderly enrollment, two populations that have been historically underrepresented in clinical trials. Furthermore, this combination of infrastructure and concepts may help to accelerate the progress of medical oncology research towards better treatments for all patients.
Patterns of failure and survival in patients with nasopharyngeal carcinoma treated with intensity modulated radiation therapy in Saudi Arabia.
Authors: Ahmed M Maklad, Yasser Bayoumi, Mohamed Abdalaziz Senosy, AbuSaleh A. Elawadi, Hussain AlHussain, Ashraf Elyamany, Saleh AlDahri, Khalid Hussain AL-Qahtani, Mubarak Shaie Alqahtani, Mutahir A. Tunio
Journal: Journal of Clinical Oncology (2016)

e295 Background: We aimed to investigate the patterns of failure (locoregional and distant metastasis), associated factors, treatment outcomes in nasopharyngeal carcinoma (NPC) patients treated with intensity modulated radiation therapy (IMRT) combined with chemotherapy, results of reirradiation in recurrent cases and its toxicity. Methods: From April 2006 to December 2011, 68 NPC patients were treated with IMRT and chemotherapy at our hospital. Median radiation doses delivered to gross tumor volume (GTV) and positive neck nodes were 66–70 Gy/33-35fractions. For recurrent cases reirradiation was given by SRS 25 -30 Gy/5 fractions or IMRT 50-60 Gy/25-30 fractions according to volume of recurrence and surrounding critical structures. The clinical toxicities, patterns of failures, locoregional control (LRC), distant metastasis control (DMC), disease free survival (DFS) and overall survival (OS) were observed. Results: The median follow up time was 52.2 months (range: 11-87). EBV infection positive was 63.2%.There were 7 locoregional recurrences, 3 regional recurrences with distant metastases and 11 distant metastases. The median interval from the date of diagnosis to failure was 26.5 months (range, 16-50 months). 6/10 (60%) locoregional recurrences were treated with re-irradiation +/- concurrent chemotherapy. Acute grade 3 and 4 mucositis were observed in 2 patients (28.6%); however no significant late toxicities were seen after reirradiation. Nodal recurrences were salvaged by neck dissection. The 5-year LRC, DMC, DFS and OS rates of whole cohort were 81.1%, 74.3%, 60.1% and 73.4% respectively. Cox regression analyses revealed that neoadjuvant chemotherapy, age and Epstein-Barr virus (EBV) were independent predictors for DFS. Conclusions: Distant metastasis is the most common pattern of failure after IMRT with SIB technique with or without neoadjuvant and concurrent chemotherapy in Saudi patients with NPC. Early detection of local and locoregional recurrences is important as reirradiation with IMRT or SRT with or without chemotherapy is still feasible option with acceptable toxicity. However, efforts should be made for proper patient selection.
A pilot study of sunitinib in Chinese patients with heavily pretreated metastatic breast cancer.
Authors: S. Wu, X. Zhao, B. Sun, M. Du, T. Wang, S. Zhang, S. Song, Z. Jiang
Journal: Journal of Clinical Oncology (2011)

e11506 Background: Sunitinib malate, an oral multitargeted tyrosine kinase inhibitor has shown antitumor activity in metastatic breast cancer. This study was conducted to evaluate the efficacy and safety of single-agent sunitinib in chinese breast cancer patients with multiple-resistant to antitumor drugs. Methods: Metastatic breast cancer patients with multiple-resistant to antitumor drugs received the treatment with single-agent sunitinib at dose 50 mg/d in 6-week cycles (4 weeks on, then 2 weeks off treatment), and toxicity-related dose reduction was permitted. The primary end point was objective response rate, and the second end point was the safety. Results: 29 patients were enrolled, the median age was 45 (27-68) ys, the median previous chemotherapy lines was 7 (3-17), 15 patients were ER/PR negative, 14 patients were ER/PR positive, 8 patients were HER-2 positive. 10 patients received a starting dose of sunitinib orally 50mg/d in 6-week cycles schedule, all patients had the dose reduction because of severe hematologic toxicity. So the following 19 patients received a starting dose of sunitinib orally 37.5mg/d schedule. The most frequent nonhematologic toxicity were yellow skin (100%), fatigue (82.8%), and hypertention (34.5%). Grade 3/4 hematologic toxicity included neutropenia (82.8%), thrombocyte decrease (79.3%). Of the 25 patients with measurable disease at baseline, 4 patients achieved a partial response (16%), 10 additional patients (40%) maintained stable disease for more than 10 weeks. Median time to progression and overall survival were 10 and 32 weeks, respectively. Notably, all the responses occurred in patients with a tumor ulcer. The median follow-up time was 26 (6-52) weeks, 4 patients were lost,17 patients were dead, and 8 patients were alive with metastatic disease. Conclusions: These data indicate that sunitinib has the sure activity in the chinene patients with pretreated metastatic breast cancer, especially in tumor ulcer. The recommended sutent monotherapy regimen was administered orally at 37.5mg/d in chinese breast cancer patients, and the major treatment-related adverse effects was hematologic toxicity.
Integrated efficacy results from two phase II studies utilizing sphingosomal vincristine for the treatment of multiply relapsed or refractory non-Hodgkin’s lymphoma
Authors: M. A. Rodriguez, A. Sarris
Journal: Journal of Clinical Oncology (2005)

6637 Background: Sphingosomal vincristine (SV), a novel formulation of vincristine encapsulated in sphingomyelin/cholesterol liposomes or ‘sphingosomes’ was evaluated for the treatment of multiply relapsed aggressive NHL patients in two studies. While combination chemotherapy is the standard front-line treatment, there remains a substantial need for new effective treatments for multiply relapsed patients. Methods: The Phase IIa and IIb trials were single-arm, open-label studies that evaluated the efficacy and safety of single-agent SV administered at 2.0 mg/m2 every 2 weeks. Primary efficacy endpoint in both studies was the ORR, with time-to-event variables evaluated as secondary endpoints. The Phase IIb study was a multicenter international trial while the Phase IIa was a single-center study. Results: In total 211 patients with aggressive NHL were treated in the Phase IIa (92 pts) and Phase IIb (119 pts) studies. Demographic and baseline characteristics were comparable providing evidence in support of efficacy data pooling. Median age was 62 years and median prior treatments was 3. Two-thirds of patients had disease resistant to their last therapy. The ORR was 28% (7% CR/CRu, 21% PR) with a 95% CI of [22%, 35%]. Estimated median TTP was approximately 4 months and overall median survival was estimated at ∼8.5 months. ORR of 48% and estimated median survival of 27 months was reported in patients with sensitive disease compared to 18% and 6 months for patients with resistant disease. Conclusions: New therapies are needed for patients with multiply relapsed aggressive NHL. Single-agent therapy with SV resulted in clinically meaningful rate of response in this heavily pre-treated population. Patients with sensitive disease had a higher response rate and longer estimated median survival than patients with resistant disease. No significant financial relationships to disclose.
Predictive factors for outcome after biliary stenting in malignant obstructive jaundice.
Authors: Pankaj Punia, David Alan Anthoney, Koudeza Khanom, Daniel Swinson
Journal: Journal of Clinical Oncology (2013)

298 Background: Stenting of the biliary treeis a common palliative procedure to relieve obstructive jaundice in advanced malignancy. Although effective in relief of biliary obstruction and subsequent palliation of symptoms, little information is available on predictive factors for survival post-procedure to better guide selection of patients. This retrospective study sought to assess factors influencing post-procedure survival in cancer patients after biliary stenting. Methods: Case notes of all patients from a regional academic cancer centre, who underwent biliary stenting for obstructive jaundice related to malignancy during 2008 and 2009, were reviewed. We collected epidemiological, biochemical, treatment (post-stenting) and survival data on all patients. Kaplan-Meyer analysis was used to assess median survival of patients from the day of first biliary stenting (adjusted for cancer types) and Cox proportional hazard model was used for univariate and multivariate analysis. Results: 194 patients were included in the final analysis. Most cases were related to pancreatic cancer or cholangiocarcinoma (89 and 46 cases each). Median survival (MS) for all the patients was 143 days. Median survival was similar, whether obstruction was secondary to the primary tumor (141cases) or metastatic disease (53 cases). In multivariate analysis serum albumin &lt; 3.4 g/dL ( HR 1.770; 95% confidence interval 1.312 – 2.389, P &lt; 0.001) and age &gt; 75 years (HR 1.490; 95% confidence interval 1.086 – 2.043, p = 0.013) at the time of procedure were two independent prognostic factors predicting for a worse survival post-stenting. The 30 day mortality post-procedure in the 194 patients was 12%. Conclusions: This study suggests that stenting of the biliary tree in cases of malignant obstruction allows durable palliation of symptoms even in cases where further active chemotherapy treatment is not possible. However, the worse outcome observed in those &gt; 75 yrs old or with low albumin at the time of procedure, identify groups with less certain benefit from this invasive procedure and requires confirming in future studies.