tbuckley/cabot-search huggingface dataset:
Risk factors that affect continuation of S-1 chemotherapy as an adjuvant setting after radical gastrectomy for gastric cancer.
Authors: Daisuke Kobayashi, Chie Tanaka, Naoki Iwata, Mitsuro Kanda, Suguru Yamada, Goro Nakayama, Tsutomu Fujii, Hiroyuki Sugimoto, Masahiko Koike, Shuji Nomoto, Michitaka Fujiwara, Yasuhiro Kodera
Journal: Journal of Clinical Oncology (2014)

151 Background: Based on the evidence from ACTS-GC trial, postoperative S-1 administration for 12 months is the current standard of care in Japan for patients with pathological Stage II/III gastric cancer treated with D2 gastrectomy. However, the proportion of patients who actually tolerated 12 months of treatment in the ACTS-GC trial was 65.8%. In the present study, we explored the risk factors that could affect the compliance of S-1 adjuvant therapy. Methods: This retrospective study selected 68 consecutive patients who underwent curative gastrectomy for gastric cancer and received S-1 chemotherapy at our institution between 2003 and 2012. Associations between S-1 compliance, adverse effects and clinical characteristics were analyzed. Results: 51 patients were male, and 17 were female. Patient age ranged between 20 and 80 years (median: 64.0). 47 patients (69%) completed the prescribed S-1 treatment for 1 year. In addition, 5 patients discontinued treatment due to recurrence within 1 year, and 3 patients due to reasons irrelevant to the S-1 toxicity. These 55 patients were designated as non-AE group. The remaining 13 patients (19%) were obliged to discontinue S-1 due to adverse effects within 1 year (AE group). The percentage of female was higher in the AE group (46% versus 20% in the non-AE group). The median age of patients was significantly higher in the AE group (72 versus 63 in the non-AE group, p=0.004). Although there was no difference in the serum creatinine level at the beginning of the treatment, creatinine clearance (CCr) of AE group was significantly lower at 65 mL/min (83 mL/min for the non-AE group, p=0.04). Median body weight loss during the first 3 postoperative months in the AE group (13% of the original weight) was significantly higher (10% in the non-AE group, p=0.04), although the median body weight before treatment didn’t differ between the two groups. Dose reduction was more diligently conducted among the population with CCr&lt; 60 in the non-AE group (4/7) than in the AE group (1/5). Conclusions: Female, old age, low CCr and greater body weight loss affect compliance of the S-1 adjuvant chemotherapy. Meticulous dose modification is required for those with risk for discontinuation.
A randomized comparison of oral methadone as a “first-switch” opioid versus opioid switching between sustained-release morphine and oxycodone for oncology outpatients with pain management problems.
Authors: A. F. Elsayem, K. T. Bain, J. L. Palmer, J. Bearden, M. Fisch
Journal: Journal of Clinical Oncology (2010)

TPS324 Background: Methadone is an opioid with many unique pharmacologic properties and it is much less expensive than other opioids commonly used in cancer pain management. It is a particularly attractive analgesic to use for opioid switching, with the goal of improving analgesia and/or decreasing opioid-related side effects. Prospective trials involving methadone for opioid switching are uncommon in publicly-funded, clinical cooperative groups. This trial in progress will help determine the feasibility, safety, and efficacy of two approaches to opioid switching. It will also provide useful information regarding the feasibility of opioid-related research conducted by oncologists in the outpatient community setting. Methods: This NCI–funded, randomized, prospective, open-label trial intends to enroll 300 cancer patients in the outpatient community setting. Eligible patients have inadequate pain control and/or intolerable opioid-related side effects and are prescribed either sustained-release morphine or oxycodone, with an oral morphine equivalent daily dose between 40mg and 300mg. Patients are randomly assigned to be rotated to either oral methadone or oral sustained-release morphine or oxycodone, and the new opioid dose is determined using study-specific equianalgesic tables. Patients receive immediate-release opioids for breakthrough pain and supportive measures for side effects, and patients have their opioids titrated according to study protocol Evaluation occurs at enrollment and then weekly for a total of 4 weeks using validated tools that include: M. D. Anderson Symptom Inventory (MDASI), Composite Drug Toxicity Score (CDTS), and Revised Edmonton Staging System (rESS) for Cancer Pain. We hypothesize that 60% of patients rotated to methadone will achieve a ≥ 30% reduction in pain and/or opioid-related side effects; whereas 40% of patients rotated to either sustained-release morphine or oxycodone will achieve this response. We define primary success as a 3-point reduction in pain score–measured by MDASI–from baseline to completion of the study. No significant financial relationships to disclose.
Feasibility and efficacy of dose-reduced transcatheter arterial chemoembolization (TACE) for primary liver cancer patients with portal vein thrombosis
Authors: J. Xia, S. Ye, Y. Chen, J. Fan
Journal: Journal of Clinical Oncology (2008)

15676 Background: To evaluate the efficacy and safety of does-reduced transcatheter arterial chemoembolization (TACE) for primary liver cancer patients with major portal vein thrombosis. Methods: 37 patients with major portal vein and/or its first branch thrombosis underwent does-reduced TACE were retrospectively analyzed. The Child's classes were A for 34 patients and B for 3. Results: 14 patients achieved good precipitation of lipiodol in the portal vein thrombosis, the other 23 patients with poor precipitation of lipiodol in the portal vein thrombosis. The overall median survival time was 11.7 months. The cumulative survival rates were 75.0% (6 months), 41.0% (12 months), and 17.6% (18 months). For patients with well precipitation of lipiodol, the median survival time was significantly longer than patients with poor lipiodol precipitation (16.2 VS 6.8 months, p<0.05). The 6m, 12m and 18m survival rate of patients with well lipiodol precipitation was significantly better than that of with poor lipiodol precipitation (100%, 63.5%,31.8% VS 60.3%,13.0%,0%,P<0.05). Cox multi-variable analysis shows that the extent of lipiodol precipitation was the only significant predicting factor for efficacy of therapy (Cox regressive coefficient 1.67, RR 5.31). All the patients were safely tolerated with dose-reduced chemoembolization except 1 died of liver failure 2 weeks after the procedure, 1 case of uppr gastrointestinal bleeding, the other 2 with increased Child-pugh scale. Conclusions: Dose-reduced chemoembolization for primary liver cancer patients with major portal vein thrombosis is safe, and can partially achieve curative effect especially for patients with good precipitation of lipiodol in the portal vein thrombosis. No significant financial relationships to disclose.
Improve optimal treatment in head and neck cancer patients (HNCA).
Authors: Glenn Morris Mills, Rebecca L. DeKay, Srinivas S. Devarakonda, Jennifer Nicholson, Lee Ann Maranto, Vikas Mehta
Journal: Journal of Clinical Oncology (2014)

227 Background: Since 2011, 50% of HNCA patients receiving concurrent chemoradiation with Cisplatin (CIS/XRT) have not been able to complete their therapy per protocol (dose over time interval) leading to suboptimal therapy. Based on historical data, the non-completion rate for patients HNCA receiving radiation/ high dose Cisplatin was 15%. We aim to improve this in our patients. Methods: A chart review of patients on CIS/XRT conducted and, using a Pareto Chart, the data indicated Acute Kidney Iinjury as the major cause for failure of completion. Using methodology from ASCO’s Quality Training Program, a process map for patients on treatment was created and an Ishikawa diagram (cause and effect) assisted in pinpointing breaks in processes. A telephone survey of surviving patients further clarified inadequacies. Using the Plan, Do, Study, Act (PDSA) improvement cycle, inadequacies were identified. Results: Chart review showed that significant side effects from treatment began around the 2 nd cycle of Cisplatin in spite of adequate IV hydration following chemotherapy. Inadequate documentation of dietary and speech pathology consultations, patient weight and serum creatinine levels during treatment were noted. Patients reported minimal PEG tube education and infrequent use of PEG tube for hydration. Analysis of post treatment weight and creatinine level revealed a significant change in creatinine clearance. Checking daily weights, speech pathology and dietary consult prior to initiation of therapy, added hydration instructions to EPIC PEG tube instruction sheet, and nurse practitioner education and follow-up in symptom management clinic were part of the PDSA cycle interventions. If 2lb. weight loss, patients were brought in for repeat lab and IV hydration. Conclusions: Patients with advanced head and neck cancer are frail and subject to acute toxicity from chemotherapy. Change in Creatinine Clearance is a sensitive measure of renal damage/likely predictor of non-completion. Post-intervention patients had fewer unplanned admissions leading to lower costs. PDSA helped identify inadequacies in our education and monitoring processes. More post intervention data are needed to determine if true improvement in patient outcomes exist.
Differential expression of EGFR mutations between primary and corresponding mediastinal nodal metastases in postoperative stage N2 non-small cell lung cancer.
Authors: Q. Fang, S. Wang, W. Ou, H. Yang
Journal: Journal of Clinical Oncology (2011)

e21034 Background: In this retrospective study, we determined the differential expression of EGFR mutations between primary tumors and the corresponding mediastinal nodal metastases, and the differential expression of EGFR mutations between different lymph node stations in postoperative stage N2 non-small cell lung cancer (NSCLC). Methods: In this retrospective study, we determined the differential expression of EGFR mutations between primary tumors and the corresponding mediastinal nodal metastases, and the differential expression of EGFR mutations between different lymph node stations in postoperative stage N2 non-small cell lung cancer (NSCLC). Results: In all 28 cases with N2 disease which had EGFR mutations in primary tumors, EGFR mutations were detected in 33 of all 70 metastatic lymph node stations (47.14%) and in 17 cases (60.71%) who had EGFR mutations in metastatic lymph nodes. Among the 17 cases, 15 were mutations in mediastinal lymph nodes, while 2 were mutations in N1 lymph nodes. Thirteen of 28 cases (46.43%) showed discordance in EGFR mutations between primary tumors and mediastinal nodal etastases. Among the 28 cases, 21 had at least two of metastatic lymph node stations and 7 had just one metastatic lymph node station. Nine of 21 cases (42.86%) with multiple metastatic node stations exhibited discordance in EGFR mutations btween different lymph node stations. Conclusions: EGFR mutations were discordant between the primary tumor and the corresponding mediastinal nodal metastases in patients with stage N2 NSCLC, and the mutations were also discordant between different lymph node stations.
Treatment patterns after abiraterone acetate in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): Post hoc analysis of COU-AA-302.
Authors: Thomas W. Flaig, Matthew R. Smith, Fred Saad, Dana E. Rathkopf, Peter F.A. Mulders, Eric Jay Small, Neal D. Shore, Karim Fizazi, Peter De Porre, Thian Kheoh, Jinhui Li, Mary Beth Todd, Thomas W. Griffin, Charles J. Ryan, Johann S. De Bono
Journal: Journal of Clinical Oncology (2016)

168 Background: Treatment patterns of mCRPC have changed substantially in the last few years. In COU-AA-302 (chemotherapy-naïve men with mCRPC), abiraterone acetate plus prednisone (AA) significantly improved radiographic progression-free survival and overall survival vs placebo plus prednisone (P). There is limited information about treatment patterns after AA. In this post hoc analysis of pts in the AA treatment arm who progressed, we characterized subsequent therapy after pts discontinued study drug. Methods: In COU-AA-302, 546 pts were randomized and received AA. Treatment patterns of pts receiving ≥ 1 subsequent therapy for mCRPC after progressing on AA were collected retrospectively and source verified. Results: As of March 2014, 8% (44/546) of pts continued on AA; 67% (365/546) received ≥ 1 subsequent therapy for mCRPC. 36% (194/546) and 15% (83/546) of pts had ≥ 2 and ≥ 3 subsequent therapies, respectively. 80% (435/543) of pts in the P arm had ≥ 1 subsequent therapy. Most frequent subsequent therapy in AA pts was taxane chemotherapy (docetaxel [DOC], cabazitaxel [CBZ]), androgen signaling–directed therapy (AA, enzalutamide [ENZ], ketoconazole [KETO]), and immunotherapy (sipuleucel-T [SIP-T]) (Table). Among AA pts who received DOC as first subsequent therapy, median age was 69 years; median duration of DOC post-AA (n = 261) was 3 months (IQR: 0.95-5.7); and PSA progression was the most common reason for discontinuation. Among AA pts with baseline PSA and ≥ 1 post-baseline PSA value, 40% (40/100) had ≥ 50% PSA decline (27/100 confirmed responses) with first subsequent DOC chemotherapy. Conclusions: This post hoc analysis indicates that treatment with subsequent therapy was common (67% and 80%) in pts with chemotherapy-naïve mCRPC who progressed with AA or P, respectively. PSA decline suggests antitumor activity in pts who progressed with AA and received subsequent DOC. Despite limitations of a retrospective analysis, these data support further assessment of subsequent therapy following AA treatment for mCRPC. Clinical trial information: NCT00887198. [Table: see text]
Preliminary clinical outcomes of daily ultrasound image-guided intensity modulated radiation therapy (IG-IMRT) in the treatment of primary cancers of the gallbladder
Authors: C. D. Fuller, A. Wong, S. X. Cavanaugh, C. R. Thomas, B. Salter, M. Fuss
Journal: Journal of Clinical Oncology (2005)

4185 Objective: Analysis of toxicity and mortality for a series of patients treated with ultrasound(US)-image guided IMRT for primary gallbladder cancer. Methods: In 8 patients treated by IG-IMRT between 8/2001 and 11/2003 for adenocarcinoma of the gallbladder, target delineation of ICRU 62 defintion target volumes (TV) and non-target organs at risk was performed on contrast-enhanced helical CT scans. Simultaneously, vascular structures in proximity were defined. Before daily radiotherapy treatment, sagittal and axial US images were used to align patient anatomy through superimposition of real-time US and CT delineated guidance structures and clinically relevant volumes. Geometric positional adjustments were performed with system assistance to align patient anatomy with guidance structures through table translocation. Patients were then treated with IMRT, delivering a median prescription of 46 Gy to an average CTV of 434 cm3 (range 81–808 cm3), and a mean PTV of 881 cm3 (range 260-1490 cm3). In 7 patients, a boost was utilized to deliver an additional dose (median 14 Gy, range 3.6–18 Gy) to a mean CTVboost of 236 cm3 (range 81–378 cm3) and average PTVboost of 389 cm3 (range 160–793 cm3). RTOG acute radiation morbidity scores were utilized to assess treatment related acute toxicity. Results: Treatment was well tolerated, with only one patient reporting RTOG grade 3 radiation morbidity. This patient failed to complete treatment due to acute toxicity (RTOG grade 3 upper GI toxicity). All other patients exhibited grade 2 or lower toxicity, with 37% (3/8) reporting no morbidity greater than RTOG grade 1. At a mean total follow-up from treatment of 21 months, 4 patients were living, with 4 deceased. Median survival from XRT was 15.6 (range 2.1–24) months. One-year actuarial survival was 62% (5/8). Conclusions: US-based IG-IMRT is a feasible mechanism of delivering conformal dose to tumors of the biliary system with acceptable toxicity and early survival comparable to previous studies in the literature. While numerically small, to our knowledge this series represents the first reported cohort of gallbladder cancers treated with US guidance or IMRT. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Nomos
A phase I study of prolonged infusion of triapine in combination with a fixed-dose rate of gemcitabine in patients with advanced solid tumors.
Authors: A. Mortazavi, D. Deam, Y. Ling, E. J. Harper, M. A. Phelps, I. J. Espinoza-Delgado, J. P. Monk, G. A. Otterson, M. R. Grever, T. Bekaii-Saab
Journal: Journal of Clinical Oncology (2010)

2602 Background: Triapine (T), an inhibitor of ribonucleotide reductase, enhances the activity of gemcitabine (G), and the synergism is most evident when the pre-exposure time to T is prolonged. In addition, fixed-dose rate G (FDR-G) seems to show improved clinical efficacy over standard dose G. Therefore, a phase I trial was initiated to assess the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), pharmacokinetics (PK), and therapeutic response of prolonged (24-hour) infusion of T, immediately followed by FDR-G. Methods: On any treatment day, T was given as a 24-hour infusion followed, in 0-2 hours, by FDR-G at 1000 mg/m2 over 100 minutes. Initially, this combination was given on days 1 and 8 of a 21-day cycle, with starting dose of 120 mg for T (Arm A). Later, the study was amended after de-escalation to dose level - 2 on arm A, and the combination was given on days 1 and 15 of a 28-day cycle regimen with starting dose of T at 75 mg (Arm B). Steady state concentrations (CSS) of T were measured for PK analysis. Results: The median number of prior systemic therapies was 3 (range 0-12). On Arm B, dose level 2 (90 mg triapine) was defined as the MTD, with DLTs including grade 4 thrombocytopenia, leukopenia, and neutropenia. Overall, the treatment was well tolerated with mild fatigue, nausea, and vomiting being the most common toxicities. Among 24 evaluable patients, 1 had a partial response and 12 (50%) had stable disease (SD) with a median time to progression of 3.5 months. At this point, 18 patient samples were evaluated for PK analysis (T doses ranging from 75 to 120 mg) and the mean CSS was 492 ± 200 nM (range, 241-1,019 nM). PK profile is comparable with previously published data. Conclusions: In heavily pretreated patients with advanced solid tumors the combination of 24-hour infusion of T followed by FDR-G was generally well-tolerated. The MTD (recommended phase II dose, RP2D) was determined to be T 75 mg (24-hour infusion) immediately followed by G 1000 mg/m2 (100-minute infusion), every 2 weeks of a 4-week cycle. There was evidence of interesting activity and we are currently in our 6-patient expansion phase at the MTD to further define preliminary activity and safety of the RP2D. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Lilly NCCN, NCI
Barriers to patients’ understanding of prognosis in advanced cancer.
Authors: Tiffany Pompa, Jason Palopoli, Mark Maddox, Adonas Woodard, Kristine Marie Ward, Maneesh Rajiv Jain, Pamela A. Crilley, Dave Topolsky, John King, Sigmund Benham Khan, Maelys Amat, Michael Styler
Journal: Journal of Clinical Oncology (2016)

24 Background: An informed decision requires good communication between the patient and their oncologist in regards to diagnosis and prognosis, especially in patients with terminal cancer. This discussion entails education about their disease, treatment options, and potential outcomes. The purpose of this study was to assess advanced-stage cancer oncology patients’ comprehension of their disease, treatment options and goals of therapy. Methods: Subjects included patients with a diagnosis of metastatic cancer with an option for palliative or life extending chemotherapy in an out-patient office at Drexel University College of Medicine. Outpatient office charts were reviewed to identify eligible patients. All subjects consented to participate. Participation included completing a 34-item questionnaire about comprehension of their cancer, satisfaction, perception of their physician interaction regarding disease education and potential barriers to patient understanding. Results: 52 patients analyzed to date: 1 patient was not aware he had cancer. 3 patients (5.7%) thought there was no longer cancer in their bodies. 33 patients (62%) thought the goal of therapy was to cure their cancer. 27 patients (51%) thought the goal of therapy was to extend how long they will live. 11 patients (20.7%) thought the goal of therapy was to palliate symptoms. 5 patients (9.4%) did not know why they were on therapy for their cancer. 5 patients (9.4%) indicated they had talked about hospice with their doctor. 5 patients (9.4%) felt they shouldn’t ask any questions. 48 patients (90.5%) felt they were participating in their treatment decisions. 4 patients (7.5%) stated they didn’t understand the medical terms used by the doctors. Compared to what patients wish they knew, almost 30% felt they knew half or very little about their diagnosis and 33% felt they knew half, very little, or nothing about their prognosis. Conclusions: Due to discrepancies between patient understanding and the intended goals of care, our study highlights the need for further guidance in effectively communicating extent of disease and predicted outcome. It is also important to periodically ask patients to discuss their understanding of their diagnosis, prognosis, and treatment options.
A Phase II Multiple Dose Clinical Trial of Histone Deacetylase Inhibitor ITF2357 in Patients with Relapsed or Progressive Multiple Myeloma: Preliminary Results.
Authors: Monica Galli, Silvia Salmoiraghi, Josée Golay, Antonella Gozzini, Alberto Bosi, Claudia Crippa, Giuseppe Rossi, Norbert Pescosta, Sergio Cortelazzo, Alessandra Sechi, Tiziano Oldoni, Alessandro Rambaldi
Journal: Blood (2007)