tbuckley/cabot-search huggingface dataset:
A multinational phase II clinical trial of neoadjuvant imatinib for large gastrointestinal stromal tumor of the stomach.
Authors: Han-Kwang Yang, Yukinori Kurokawa, Min-Hee Ryu, Haruhiko Cho, Sook Ryun Park, Toru Masuzawa, Hyuk-Joon Lee, Sohei Matsumoto, Oh Kyoung Kwon, Hiroshi Honda, Kyung Hee Lee, Kazuyoshi Yamamoto, Seong-Ho Kong, Takashi Ishikawa, Jeong Hwan Yook, Kazuhito Nabeshima, Seokyung Hahn, Toshio Shimokawa, Yoon-Koo Kang, Toshirou Nishida
Journal: Journal of Clinical Oncology (2016)

130 Background: Neoadjuvant therapy is expected to reduce the risk of primary surgery, such as rupture of the tumor, hemorrhage, and multi-visceral resection, and to improve survivals for patients with a large gastric gastrointestinal stromal tumor (GIST). This study aims to evaluate the efficacy and safety of neoadjuvant imatinib therapy for a large gastric GIST. Methods: Patients with gastric GIST, which is 10cm or larger and without metastasis, received neoadjuvant imatinib (400mg/day) for 6 months, and up to 9 months if maximal response is expected. Postoperative adjuvant imatinib was prescribed for at least 1 year and up to 3 years according to adjuvant treatment guideline. The primary endpoint was complete (R0) resection rate. A primary analysis were performed by the time all the operations were finished, to examine the efficacy and safety of the neoadjuvant treatment. Results: Between Feb 2010 and Sep 2014, 55 patients were enrolled in Japan and Korea. One patient with a jejunal GIST and one patient with PDGFRA-18 D842V mutation were excluded from analysis. Mean tumor diameter was 12cm (10-23). 86.8% of patients (46/53) completed neoadjuvant treatment. Dose reduction of imatinib was performed in 26.4% (14/53). The most frequent Grade 3 or 4 adverse events were G3 rash (5/53, 9.4%) and G3/4 neutropenia (4/53, 7.5%). Disease control rate (PR+SD) and response rate (PR) of neoadjuvant imatinib was 100% and 62.3% by RECIST, and 100% and 98.1% by Choi criteria, respectively. There was no case of CR or PD. 50 patients underwent operation, and R0 resection rate was 90.6% (n = 48, 95% CI 79.3% - 96.9%), which was significantly higher than the threshold value of 70% (p &lt; 0.001). Combined resection of other organs (except gall bladder) was performed in 24.5% (n = 13), and 83.0% of patients (n = 44) could preserve ≥ 50% of the stomach. Postoperative complication occurred in 18.0% (9/50). Conclusions: Neoadjuvant imatinib treatment is effective and safe treatment option for a large primary GIST allowing high R0 resection rate with acceptable incidence of adverse events and postoperative complications. Clinical trial information: UMIN000003114.
Assessing the utility of a patient-reported screener question to detect fatigue symptoms: Improving the quality of systematic symptom measurement in clinical practice.
Authors: Pascale Tomasini, Catherine Brown, Ashlee Vennettilli, Aein Zarrin, Aditi Dobriyal, Linda Chen, Maryam Mirshams, Deval Patel, Margaret Irwin, Valerie Ho, Anthea Ho, Vivien Pat, Hannah Solomon, Henry Thai, Mary Mahler, Wei Xu, Doris Howell, Geoffrey Liu
Journal: Journal of Clinical Oncology (2014)

236 Background: In Ontario, there is a concerted effort to screen all cancer outpatients for clinically significant symptoms at every visit, without causing undue burden on the patient. Although fatigue symptoms are common in cancer patients, severe fatigue may require clinical intervention. To reduce reporting fatigue, we evaluated the use of a single item screener question to detect severe fatigue, as defined through the FACT-Fatigue Scale (FACT-F), with the goal of reducing patient reporting burden. Methods: 316 Princess Margaret Cancer Centre outpatients across a wide range of cancers at all phases of therapies and disease stages were asked to report fatigue symptoms using the FACT-F. The ability of one screener question “I feel fatigued” to detect severe fatigue symptoms in any of the six other fatigue-related questions was evaluated. Using the presence of any severe fatigue symptom as the reference, sensitivity (Se) and specificity (Sp) of the screener question was determined. Results: Median age was 59 (19-91) years; 45% were male. The prevalence of significant, severe fatigue-related symptoms for the six individual questions covering various fatigue domains ranged from 4% to 7%. 12% of patients exhibited at least one severe symptom on FACT-F (prevalence). Defining a positive screen as “quite a bit” or “very much” fatigued, with 16% prevalence, the screener question was able to correctly identify any severe symptom 81% of the time (Se) and was able to rule out any severe symptoms 92% of the time (Sp). Conclusions: The use of a screener question to accurately detect patient symptoms provide patients with the ability to be involved in their care without being overly burdened in the process. At the meeting we will provide updated results on 500 patients, the potential modifying role of clinico-demographic factors, and results of the performance two additional screener questions on fatigue. While patient-reported outcomes are widely used in research, they may also be a practical and acceptable means to accurately detect clinically important symptoms in the clinic.
Real-world experience with sipuleucel-T in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) who received prior docetaxel (D): Data from PROCEED.
Authors: A. Oliver Sartor, Matthew R. Cooperberg, Nicholas J. Vogelzang, Mark Creamer Scholz, Raoul S. Concepcion, William R. Berry, Christopher Pieczonka, Shaker R. Dakhil, Jeffrey L. Vacirca, Andrew Sandler, Candice McCoy, James Boyd Whitmore, Robert Claude Tyler, Celestia S. Higano
Journal: Journal of Clinical Oncology (2013)

30^ Background: Sipuleucel-T is an autologous cellular immunotherapy indicated for asymptomatic or minimally symptomatic mCRPC. The phase III IMPACT trial showed a significant improvement in overall survival with sipuleucel-T treatment (tmt). In IMPACT, D use was prohibited within 3 months prior to registration due to the potential immunosuppressive impact of chemotherapy. PROCEED is an ongoing, multicenter, phase 4 registry enrolling pts receiving sipuleucel-T in the real-world setting. Enrollment has no restrictions on D use; thus, data from PROCEED may help determine whether prior D affects sipuleucel-T manufacture. Here we present preliminary results on baseline demographics and product parameters in PROCEED subjects with and without prior D exposure. Methods: Pts who were treated with sipuleucel-T within the prior 6-months at clinical sites were asked to provide informed consent to participate in PROCEED. Results: By September 2012, 560 pts completed sipuleucel-T tmt; 15% previously received D (median 291 days prior to 1 st sipuleucel-T infusion). Patients with prior D had higher PSA levels, and those with recent D use tended to have a lower performance status and higher Gleason scores, but product parameters were generally comparable between the groups (see table). Conclusions: Pts enrolled in PROCEED with and without prior D exposure had different baseline demographics and disease characteristics. However, sipuleucel-T product parameters were comparable regardless of prior D exposure. Clinical trial information: NCT01306890. [Table: see text]
Outcomes of children exposed to chemotherapy in utero for breast cancer.
Authors: J. K. Litton, S. Hodge, D. Mattair, M. M. Ramirez, P. K. H. Morrow, A. M. Gonzalez-Angulo, C. M. Barnett, G. N. Hortobagyi, R. L. Theriault
Journal: Journal of Clinical Oncology (2011)

1099 Background: Increasing data are available regarding treating women diagnosed with breast cancer during pregnancy with chemotherapy in the second and third trimesters. Previous studies have demonstrated similar outcomes for pregnant and non-pregnant patients who receive standard therapies. However, there are limited data regarding potential health concerns for the children exposed to chemotherapy in utero. Methods: Between 1989-2010, 81 pts were treated with FAC during pregnancy in a prospective registry trial at our institution using a standardized chemotherapy regimen of 5-fluorouracil, doxorubin and cyclophosphamide (FAC) given during the second and third trimesters. Other standard systemic therapies were given after delivery. Outcomes of the women have been previously reported. Delivery records were obtained and IRB-approved health surveys sent to the parents or guardians of the children. Questions encompassed delivery, puberty and all health concerns. Results: Thus far, 41 of the surveys have been returned (51%). Median age of the children is 4 years (range <1-21 years). Mean weight at delivery was 3.09 kg (range 2.27 – 3.7 kg). Sixteen (39%) were delivered by c-section. During the delivery hospitalization 7 children (17%) required extra oxygen, 2 (4.8%) had hypoglycemia, and 2 (4.8%) had jaundice. Of the entire cohort (n=81) 1 child was born with Down's syndrome, 1 with clubfoot and 1 with ureteral reflux (hydronephrosis). Three parents described some childhood language delay. There have been no reported significant delay in puberty and no children have had children of their own to date. Other reported health problems include 15 (36.6%) children with reports of allergies and/or eczema, 2 with asthma, 1 with arthritis-like symptoms, 1 with migraine headaches and 1 with a history of absence seizures. Survey data for the entire cohort will be updated at the time of presentation. Conclusions: Children exposed to chemotherapy in utero, overall appear to be doing well with no significant trend in increased medical problems, with the biggest long term health concern being allergies/eczema. Continued long-term follow-up of this and other cohorts is needed to provide more information to parents and pediatricians.
Effect of intervention on quality measures of symptom management in the Michigan Oncology Quality Consortium (MOQC).
Authors: Jeffrey B. Smerage, Katie Abstoss, Jane Severson, J. Cameron Muir, Claudia Jane Martin, Kevin G. DeHority, Douglas W. Blayney
Journal: Journal of Clinical Oncology (2012)

70 Background: Michigan oncology practice groups that participated in MOQC [JOP 5(6):281, 2009] used the Quality Oncology Practice Initiative (QOPI) tool. Adherence to processes of disease specific care was high, but poor in domains associated with palliative care. These measures did not change over time [Health Affairs. 31(4):718, 2012]. These findings prompted us to test interventions to improve quality in palliative care domains. Methods: MOQC created a process, based on the IHI Framework for Spread, to assist oncology practice groups in establishing their own primary Palliative Care services, including the implementation of Edmonton Symptom Management Scale. 8 practice groups formed teams of local change agents to participate in the Palliative Care Demonstration (PC Demo) project. The teams participated in 3 in-person and 4 online learning sessions over 8 months, led by palliative care and quality experts. Teams were provided tools, training materials, and necessary support to implement the improvements and measure their success. The learning network facilitated the sharing of best practices and lessons learned throughout the process. The teams presented their results broadly to other MOQC participants at project conclusion. Results: Success was measured using palliative care-focused ASCO QOPI results. PC Demo sites consecutively improved their scores in many of the QOPI measures, and their rate of improvement from Fall 2011 to Spring 2012 was greater than that of their peers. Conclusions: We observed that collecting and distributing data in our consortium was insufficient to improve palliative oncology care. Providing practice groups with the appropriate infrastructure improved their capacity and capability to make the necessary changes to improve performance. [Table: see text]
Patterns of antidepressant use in patients with cancer: An analysis from SOAPP (E2Z02: Symptom Outcomes and Practice Patterns).
Authors: Michael Fisch, Fengmin Zhao, Judith Manola, Andrew H. Miller, William F. Pirl, Lynne I. Wagner
Journal: Journal of Clinical Oncology (2012)

59 Background: Antidepressant (AD) use is common in outpatient oncology, but the pattern and determinants of prescribing for commonly used AD are unknown. Methods: 3,106 pts with cancer of the breast, prostate, colon/rectum, or lung were enrolled from multiple sites in a study of symptoms. Five depression case-finding methods were explored: 3 based on MDASI items reported by patients (1) sadness/depression&gt;=4, (2) distress&gt;=4, (3) interference with mood&gt;=7 or enjoyment&gt;=7; 2 based on clinician’s report (4) presence of psychological distress, (5) depression being listed as one of top 3 symptoms. AD use (excluding tricyclic antidepressants and psychostimulants) was examined by depression status. Logistic regression models were used to examine the effect of demographic and clinical characteristics on AD use. Results: Rates of depressive symptoms varied by casefinding method (1=29%, 2=28%, 3=14%, 4=24%, 5=11%); 47% (1,457) pts were defined as having depressive symptoms by at least one method. AD were prescribed in 25% of depressed pts compared to 14% of non-depressed pts. After adjusting for other covariates, factors associated with greater use of AD included depression (OR=1.7, p&lt;0.01), family history of depression (OR=2.2, p&lt;0.01), female sex (OR=1.8, P&lt;0.01), younger age (OR=1.2, P=0.04), non-Hispanic White race (OR=2.0, p&lt;0.01), prior chemo/immune/ hormonal treatment (OR=1.5, p&lt;0.01), more concurrent medication use (OR=3.3, p&lt;0.01), anxiolytics use (OR=2.0, p&lt;0.01), sedative use (OR=2.1, p&lt;0.01), receiving counseling (OR=1.6, p=0.04), patient’s perception of poor QOL (OR=1.3, p=0.02), duration of current treatment &gt;1 year (OR=1.6, p&lt;0.01), and being enrolled by a CCOP (OR=1.8, p=0.01). These significant associations remained regardless of the case-finding method used for depression. Conclusions: One-fourth of solid tumor pts with depressive symptoms are taking an AD. Antidepressant prescribing varies by type of institution, race/ethnicity, age, concomitant medication exposure and several other clinical factors. There is an opportunity to improve outcomes through quality improvement initiatives related to antidepressant prescribing.
Visualization rate of internal mammary sentinel lymph nodes with modified technique of radiotracer injection.
Authors: Yong-sheng Wang, Peng-fei Qiu, Guo-ren Yang, Yan-bing Liu, Bin-bin Cong, Tong Zhao, Peng Chen, Xiao Sun, Chun-jian Wang, Zhao-Peng Zhang, Tao Yang, Xiang Bi
Journal: Journal of Clinical Oncology (2013)

99 Background: Even though the 2009 AJCC incorporated the internal mammary sentinel lymph node biopsy (IM-SLNB) concept, there has been limited change in surgeons practice patterns due to the low visualization rate of the internal mammary sentinel lymph nodes (IM-SLNs) with the conventional injection technique (average 13%, 0~37%). In this prospective study, different radiotracer injection techniques were evaluated to achieve a relative high visualization and detection rate of IM-SLNs (NCT01642511). Methods: The 190 patients enrolled in this study were divided into three groups according to the study period and radiotracer ( 99m Tc-labeled sulfur colloid) injection technique. Group A: conventional technique (radiotracer injection only into the tumor quadrant) for the initial 58 cases; Group B: two-quadrant injection at the 6 and 12 o’clock positions, 2.0~3.0 cm from nipple in the latter 132 cases. Group B was then separated into two groups according to the radiotracer injection volume: Group B1, low volume (&lt;0.5ml/point, n=41); Group B2, high volume (≥0.5ml/point, n=91). Radiotracer was injected into the parenchyma under the ultrasonographic guidance for all patients. IM-SLNB was performed for patients with IM-SLNs visualized on preoperative lymphoscintigraphy and/or detected by intraoperative gamma probe. Results: Group B was associated with a significantly higher IM-SLNs visualization rate (76.5%, 101/132) compared to Group A (15.5%, 9/58, P=0.000), and Group B2 with the highest visualization rate (86.8% vs. 53.7% Group B1, P=0.000). All techniques had the same visualization rate of the axillary SLNs (P=0.915). The visualization rate of IM-SLNs was related to the patient’s age (P=0.037) and injection volume (P=0.000). The successful rate of IM-SLNB was 92.3%, and arrived 100% after 20 cases learning curve. The postoperative IM-SLNB complications were 0. Conclusions: Modified technique of radiotracer injection (Qiu's injection technique: two-quadrant, high volume and ultrasonographic guidance) significantly improved the visualization rate of IM-SLNs, provided an effective technique to evaluate the status of internal mammary, and would promote research on the IM-SLNB.
Oxaliplatin (OXA), uracil/tegafur (UFT) and radiotherapy (RT) in operable rectal cancer (RC). Preliminary results of a multicenter phase II study
Authors: C. Fernandez-Martos, C. Bosch, J. Aparicio, M. J. Safont, I. Maestu, J. M. Campos, L. Peña, J. L. Guallar, R. Romero
Journal: Journal of Clinical Oncology (2005)

3648 Background: In stage II-III RC, preoperative therapy (PT) with UFT (400 mg/m2, 5 days a week over 5 weeks) and RT (45Gy) produces downstaging (DS) in 54%, and pathological complete response (pCR) in 9% of patients (pts) as shown by our group [JCO 2004,22:3016]. Response is related with conservative surgery and survival. One way to improve response is to combine RT with the new actives and radiosensitizing agents, and OXA is one of them. The aim of this study is to asses the efficacy (pCR) and safety of PT with UFT/OXA and RT. Methods: The preliminary results of the phase I study of the combination were presented (ProcASCO, 2003). Dose-Limiting toxicity was diarrhea and the recommended dose for phase II study was: UFT 400 mg/m2, 5 days a week over 5 weeks combined with OXA: 85 mg/m2 d1, 15 and 29 and pelvic RT 50 Gy (1.8 Gy/day over 5 weeks and a weekly 1 Gy boost) in four defined fields. In the phase II study pts had to have non metastastic, middle or distal operable RC, uT3-T4 en endosonography. All pts were operated 5–6 weeks after PT. Results: Since October 2003, 22 pts (14M/8F) median age 59 (39–72) were accrued. To-date 13 (12uT3, 1uT4) are evaluable for pathological response and toxicity. The mean distance from pectineus line was 6 cms (2–11). There was DS (uT vs. pT) in 92% (12/13). 4pT0, 1pT1, 6pT2, 2pT3. There were 2 pT0N0 (pCR 15%) and in an additional 23% there were only residual microscopic foci. Efficacy results were reviewed by a second independent pathology evaluation. R0 resection was performed in all pts. Total dose of RT was achieved in 92%. Relative dose intensity for UFT was 92% and 98% for OXA. No G3–4 hematological toxicity was observed and G3 diarrhea was 15%. Conclusions: This regimen has a good activity with low toxicity profile. The addition of OXA more likely than RT boost seems to improve the efficacy of the UFT/RT regimen. Supported by an unrestricted grant by Sanofy-Aventis Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration sanofi-aventis sanofi-aventis
Perioperative chemotherapy for upper gastrointestinal cancer: Correlation between response to treatment and outcome.
Authors: Thierry Alcindor, Lorenzo Ferri, Steven Ades, Amin Andalib, Khalid Al-Baimani, Marc Hickeson, Giovanni Artho, Martin Robert Chasen, Victoria Marcus, Michael P. Thirlwell
Journal: Journal of Clinical Oncology (2012)

95 Background: Perioperative chemotherapy improves outcomes of surgery for upper GI cancer. Some patients have rapid recurrence. We hypothesized that any type of response to chemotherapy would predict better disease-free survival (DFS). Methods: From May 2007 to Sep 2009, 43 patients with operable adenocarcinoma of the esophagus, stomach or gastroesophageal junction went on a multicenter phase II trial. 3 cycles of docetaxel/cisplatin/5FU were given pre and post surgery. We compared DFS between responders and nonresponders after 3 cycles. Clinical response was defined as improvement of ≥ 2 points on a dysphagia score (0: normal swallowing, to 4: total obstruction), metabolic response as ≥ 35% reduction of maximum SUV by PET scan. Lack of nodal involvement or significant histologic regression (less than 50% viable tumor) was considered pathologic response. Log-rank test was used for univariate analysis, Cox regression model for multivariate analysis. All p values are double sided, median follow-up from surgery is 808 days. Results: Clinical response data for 29/40 patients: 26 responses (90%). Median DFS was 405 days for clinical responders vs. 210 days for nonresponders (p= 0.018). Metabolic response data for 28/40 patients : 22 responses (70%). Median DFS was 276 days in metabolic nonresponders, and has not been reached in responders (p = 0.009). 14 patients had no nodal involvement at resection (N0) and had longer DFS (median not reached) than the 26 with N+, who had median DFS of 562 days (p = 0.045). A nonsignificant trend (p = 0.192) was seen in favor of the 20 with significant tumor regression (DFS 565 days) compared to the 20se without it (median DFS not reached). All results were supported by multivariate analysis. Conclusions: These preliminary results indicate that clinical, metabolic and pathologic responses may be individually predictive of longer DFS in patients receiving perioperative chemotherapy for upper GI adenocarcinoma. This requires confirmation in larger datasets. The optimal management of nonresponders is unclear at present. Acknowledgements: Biostatistics Unit (McGill University Health Centre) and Cedars Cancer Institute (Henry R Shibata Fellowship to Dr Alcindor).
Toxicity of adjuvant treatment with high-dose interferon alpha 2b (HD-IFN) in high-risk stage III melanoma patients (pts): The Italian experience
Authors: A. Romanini, S. Sarti, R. Murr, S. Doria, M. Rondini, C. Orlandini, T. Menichetti, J. Pigozzo, V. Chiarion-Sileni
Journal: Journal of Clinical Oncology (2005)

7568 Background: Data from randomized clinical trials consistently demonstrate that adjuvant HD-IFN in stage III melanoma patients (pts) is associated with approximamate 10% improvement in relapse-fre survival (RFS) compared with surgery alone (Kirkwood JM, et al. JCO 14:7–17,1996 and 18:2444–58, 2000) Methods: Since February 1996, we treated stage III melanoma pts without evidence of disease after surgery, with IFN 20 MUI/sqm i.v. daily x 5/wk for 4 consecutive weeks (Induction Phase, IP) followed by IFN 10 MUI/sqm s.c. x 3/wk for 48 consecutive weeks (Maintenance Phase, MP). This report concerns a retrospective record of the toxicity and feasibility of the above mentioned treatment delivered in a day-hospital setting in 3 hospitals in Italy. Results: One-hundred and fifty pts with a median age of 50 years (range 20–75), ECOG PS:0 were assessed. Pts were treated for the following reasons: stage III disease: 113 (75%); primitive cutaneous lesion ≥4mm: 24 pts (16%); other reasons: 13 pts (9%). Each pt received the IP as outpatient and the MP at home. All (99%) but 1 pt completed the IP with a median duration of 4 weeks (range 4–28 days). Ninety one pts (54%) completed the IP without delays or withdrawals. Sixty nine pts (46%) required dose reduction and 2 (1%) dose delay. Eighty eight pts (59%) completed the MP. Dose reduction was required in 25 pts (32.6%) and dose delay in 15 (10%). No pt required hospital admission because of toxicity during treatment and none died because of toxicity. After a median follow-up of 24 months (mos; range: 2–97), 67 (44%) pts relapsed and 47 (31%) died. Median RFS is 29 mos (range:17.2–40.8). Median overall survival is 62 mos (95%C.I. 34.9–90.7). Conclusions: HD-IFN is currently used in Italy and feasible in a day-hospital setting. Its toxicity is predictable, amenable and reversible with adequate dose adjustments. No significant financial relationships to disclose.