tbuckley/cabot-search huggingface dataset:
Which factors will make the duration short between last palliative chemotherapy and death?
Authors: K. Hashimoto, K. Yonemori, N. Katsumata, M. Hotchi, H. Uno, T. Kouno, C. Shimizu, K. Tamura, M. Ando, M. Takeuchi, Y. Fujiwara
Journal: Journal of Clinical Oncology (2008)

20575 Background: There are no standard criteria for physician to quit palliative chemotherapy (PC) in order to switch into best supportive care only. While vignettes study (C.G.Koedoot et al, 2004) previously provided trends of preference for PC from the point of physicians and patients (pts), there is no report in clinical practice to identify the specific factors which affects the indication of PC in near-the- end-of-life (NEL) setting. Methods: We retrospectively analyzed 383 deceased pts who received PC in our division from 2002 to 2006. There are 244 pts whose date of last PC and death were available. Univariate and multivariate analysis were performed to examine the factors affecting the duration between last PC and death. Results: The variety and numbers of the cancer were Breast/Gynecological/unknown primary/others and 133/77/24/20, respectively. Median duration between last PC and death was 100 days (range; 5 to 1206). Thirty two pts (12.6 %) and 82 pts (32.3 %) died within 30 and 60 days after PC, respectively. Twenty one pts (8.1 %) were symptomatic when PC started. Two hundred four pts (83.6 %) were referred to hospice. The factors to have short duration between last PC and death by univariate analysis were male sex, young age, attending doctor, good ECOG performance status (PS), expected high response rate (RR), cancer type, symptomatic pts and previous informed consent (IC) without introduction to hospice. The strong factor which affected the duration between last PC and death the most was the IC without introducing about hospice (P<0.0001). Other factors such as young age, good PS, good RR and symptomatic pts are also significantly correlated to short duration between PC and death. Conclusions: Young pts who were symptomatic, in good PS and also expected to achieve good response by chemotherapy tend to choose PC instead of visiting hospice till the very NEL stage. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Bristol-Myers, Kyowa Hakko, Nippon Kayaku, Pfizer, sanofi-aventis
Cetuximab dose-escalation study in patients with metastatic colorectal cancer (MCRC) with no or slight skin reactions on cetuximab standard dose treatment (Everest): Preliminary PK and efficacy data of a randomized study
Authors: Eric Van Cutsem, Yves Humblet, Hans Gelderblom, Jan B. Vermorken, Frederic Viret, Bengt Glimelius, Fortunato Ciardiello, Elisa Gallerani, Oliver Kisker, Marc Peeters
Journal: Annals of Oncology (2006)
Prospective phase II trial for recurrent high-grade gliomas with capacitive coupled low radiofrequency (LRF) hyperthermia
Authors: E. D. Hager, H. Sahinbas, D. H. Groenemeyer, F. Migeod
Journal: Journal of Clinical Oncology (2008)

2047 Background: In spite of many new approaches the treatment of malignant gliomas is still disappointing. Concomitant radiotherapy with temozolomide could improve in a RCT median survival of pts with glioblastoma multiforme from 12.1 to 14.6 months (EORTC 26981- 22981; NCIC,3; ASCO 2004). About 20% of pts with gliomas benefit from therapy depending on genomic mutations. Deep hyperthermia with low radiofrequency capacitive coupled electrodes (LRF-DHT) at 13.56 MHz is feasible in treating pts with brain tumors (Hager ED et al., ASCO 2003,#470). 4/5 of the effective LRF-energy can induce selectively apoptosis in cancer cells instead of heat. Heat alone would be contraindicated for the treatment of tumors in the brain. Therefore, electro-hyperthermia (EHT) is also referred to this technique. Methods: N=179 pts with highly- malignant gliomas (WHO grade III/IV at recurrence or progression) where treated with LRF-DHT after recurrence and/or progression after first-line therapy of the disease after surgery, radiotherapy and/or chemotherapy. N= 53 pts in the astrocytoma WHO grade III group and N=126 pts in the WHO grade IV group (glioblastoma multiforme), KI >50%, where analyzed in an intention-to-treat observational study. Enrollment time was from 02/2000 to 04/2007. Results: Complete data where collected from all pts and considered for evaluation if at least 1 cycle of LRF-DHT could be performed. The median overall survival times (MST) are listed in table 1. Longstanding complete and partial remissions could be achieved after recurrence in both groups. Conclusions: LRF-DHT is feasible in treating pts with highly malignant gliomas without any severe side effects. Hyperthermia with capacitive coupled electrodes may increase overall median survival time (MST) by about 6 months after recurrence and/or progression after first-line therapy. Quality of life and survival could be improved by this method. Further trials are urgently warranted. MST of patients with WHO grade III and IV gliomas (Kaplan-Meier Estimation) MST from Grade III; N =: 53 pts months±se [95%CI] Grade IV; N = 126 pts months±se [95%CI] 1st Diagnosis of Disease 37.0±3.7 [29.8; 44.2] 19.0±1.6 [15.9; 22.1] 1st LRF- Hyperthermia 10.0±1.9 [6.3; 13.7] 7.0±0.8 [5.4; 8.6] Censored N (%) 25 (19.8%) 14 (26.4%) No significant financial relationships to disclose.
Objective versus subjective predictors of patient clinical benefit from phase I treatment
Authors: F. W. Harper, E. I. Heath, M. E. Gleason, P. M. LoRusso, T. L. Albrecht
Journal: Journal of Clinical Oncology (2008)

13526 Background: Increasing use of cytostatic agents, which have less defined response criteria than cytotoxic agents, have complicated oncologist (MD) decisions about patient (PT) response to Phase I (P1) treatment. MDs are increasingly called to make judgments about PT “clinical benefit” and generally endorse the importance of PT quality of life (QOL) in these decisions. This study investigated the relative contribution of objective clinical factors (imaging, labs, toxicity) and subjective PT factors (PT-reported QOL and performance status [PS]) to MD decisions about P1 treatment response. Method: Data was collected over a 4-month period from 30 P1 PTs (all stage 4) and 3 MDs in a comprehensive cancer center. PTs completed daily QOL reports using Palm pilots; MDs completed ratings of (a) importance of objective and subjective decision factors and (b) treatment decision (GO or NO GO). Results: PTs were 93% Caucasian and 47% female. Mean PT age was 57 (SD=12.4; range=31–81). Mean time in study was 51.76 days (SD=31.5, range=4–142). MDs completed ratings and treatment decisions for 153 visits. Data were analyzed with multilevel logistic regression; predictors were objective clinical (IMAGING, LABS, TOXICITY) and subjective PT (QOL, PS) factors with treatment decision (GO or NO GO) as the outcome. Results showed that, after controlling for PT demographics, the only significant predictors of MD treatment decision were imaging (B=6.79, SE=2.21, odds ratio=898, p<.01) and toxicity (B=4.91, SE=1.36, odds ratio=134, p<.001). Surprisingly, despite being rated by MDs as “very important”, PT QOL and PS did not significantly predict MD treatment decisions (p>.05). Conclusions: Toxicity and imaging were the most important factors in MD decisions about treatment response in P1 patients. By comparison, neither patient QOL nor PS factored into MD decisions, suggesting that in the absence of well-defined criteria, MDs use objective clinical data (and not subjective PT reports) to assess treatment response and make treatment decisions. These paradoxical findings - that MDs rate PT-reported QOL and PS as important but do not use them in treatment decisions - suggests a need to explore how PT subjective treatment response can be better utilized and incorporated into treatment decisions. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration AstraZeneca, Genentech, Pfizer, Takeda Aventis, Genentech, GlaxoSmithKline Amgen, Ariad, Array Biopharma, AstraZeneca, Biatar, Boeringer Ingelheim, Bristol-Myers Squibb, Endocyte, Exelixis, Genentech, GlaxoSmithKline, ImClone, Merck, Nereus, Novartis, Pfizer, Roche, sanofi-aventis, Ziopharm
Overall survival rate is most important measure
Authors: D. Warwick, M. Freeman
Journal: BMJ (1995)

used in the multivariate analysis.For instance, could social class factors (smoking history, body mass index) or other factors (drug treatment) have varied among the hospital populations and affected the results?Similarly, could the large observed differences between the sexes indicate particular comorbidities that were not measured?The proportion of the total variability in 90 day mortality that was due to the casemix factors used in the model is not stated.If this proportion was small there may have been other casemix factors that were not taken into consideration; the modelling process used by the authors could be better judged if all the factors considered were stated and the extent of the total variability in 90 day mortality explained by the model was recorded.It seems implausible that treatment in hospital 6 should have exerted such a pronounced protective effect.Appreciable variations in survival due to differences in the processes of care among hospitals are difficult to identify after adjustment for casemix.2Adequate adjustment for casemix is difficult, and many studies tend to collect few data with which to attempt such adjustments.This study may have considered too few casemix factors for any reliable comment to be made about the effect of the processes of care in the different hospitals.
Efficacy results of node-negative HER2-amplified breast cancer subset from BCIRG 006 study: A phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC-T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (AC-TH) with docetaxel, carboplatin, and trastuzumab (TCH).
Authors: V. Valero, D. J. Slamon, W. Eiermann, N. J. Robert, T. Pienkowski, M. Martin, J. R. Mackey, M. A. Lindsay, V. Bee-Munteanu, M. F. Press, G. Sauter, J. Crown
Journal: Journal of Clinical Oncology (2011)

553 Background: Trastuzumab-chemotherapy-based adjuvant therapy (AC-TH or TCH) provide significant improvement in disease-free survival (DFS) and overall survival (OS) compared to chemotherapy-based adjuvant therapy (AC-T) in HER2 amplified breast cancer [Rommond E et al NEJM 2005 and Slamon D et al SABC 2009 and NEJM 2011 (in press)]. BCIRG 006 included 928 patients (pts) with stage I or II node-negative high risk HER-2 amplified breast cancer. We reported patient and tumor characteristics and efficacy outcome [disease-free survival (DFS) and overall survival (OS)] of this subset of pts. Methods: Pts were randomized to either AC (60/600 mg/m2 q3wk ×4) followed by T (100 mg/m2 q3wk × 4) or AC followed by TH × 4 (H q1wk during chemotherapy then q3wk × 9 months) or TCH (75 mg/m2 / AUC6 q3wk × 6, and H q1wk during chemotherapy then q3wk × 7.5 months). High risk axillary node negative HER-2 amplified breast cancer was prospectively defined as any of these patient/tumor characteristics: age ≤35 years, or tumor >2cm, or negative ER and PR, or nuclear grade 2 or 3. Results: A total of 3,222 pts were accrued in BCIRG 006, 928 (29%) had node negative breast cancer. Patients had one or more patient/tumor characteristics: 7% <35 years; 50% tumor >2 cm; 49% ER and PR negative; grade 2 28%; and grade 3 68%; 50% had pT1 (459) and 48% had pT2 (441). 309 pts received AC-T, 310 in AC-TH and 309 in TCH. At a median follow-up of 65 months, there were 108 events and 42 deaths. DFS and OS for AC-T, AC-TH and TCH were 85.2%, 92.6%, 89.7% and 92.9%, 97.5% and 96.2%, respectively. DFS: hazard ratio of 0.47 with AC-TH, p-value=0.003 and 0.64 with TCH, p-value=0.057 as compared to AC-T. At this time, there is no statistically significant difference between the two trastuzumab-containing arms. Conclusions: Results of this trial confirm the significant benefit of trastuzumab-chemotherapy-based adjuvant therapy compared to adjuvant chemotherapy alone in high risk node negative HER-2 amplified breast cancer. Results of different node-negative subgroups will also be presented.
Capecitabine (X) in the routine treatment of advanced breast cancer (BC): Results from a large (n = 870) noninterventional study
Authors: W. Schoenegg
Journal: Journal of Clinical Oncology (2009)

e12021 Background: This observational study evaluated patient (pt) characteristics, treatment schedule and setting, efficacy and tolerability of X in routine clinical practice in Germany. Methods: Pts with advanced BC pretreated with or ineligible for anthracycline-containing therapy received X. As there was no specific protocol for X administration, data on dose, treatment duration, treatment delays/interruptions, and concomitant anticancer therapy were collected as well as efficacy data. Pts were followed until disease progression or completion of 12 cycles (with long-term follow-up in pts who were progression-free after 12 cycles). Results: Between 2002 and 2007, 870 pts were recruited from 135 centers, of whom 846 were eligible. Most pts (62%) were aged 50–69 years and 64% had received prior taxane therapy. X was given as monotherapy in 64% (median starting dose 1070 mg/m 2 bid) and combination chemotherapy in 36% (median starting dose 987 mg/m 2 bid), typically with vinorelbine or docetaxel. Generally, pts receiving X alone were slightly older and were more likely to have hormone receptor-positive disease than those receiving combination therapy. 35% of pts received X as first-line therapy. Pts received a median of 7 cycles; 26% received ≥12 cycles. Overall response rate (RR) was 41% (95% CI: 38–45) and median progression-free survival (PFS) was 7.5 months (95% CI: 7.1–8.3). RR was higher with combination therapy (49%) than monotherapy (37%), but PFS was similar in the two subgroups. Good performance status at baseline was a significant predictor of efficacy. The most common non-hematologic adverse event was hand-foot syndrome (all grades: 54%; grade 3: 7%), leading to premature treatment discontinuation in 6%. Myelosuppression and alopecia were substantially less common when X was administered as monotherapy than as combination chemotherapy. Conclusions: X, either alone or in combination, is a feasible and effective treatment for advanced BC. Our findings in real-life clinical practice compare favorably with results from interventional studies, perhaps reflecting the longer treatment duration possible at a more tolerable dose. No significant financial relationships to disclose.
Phase 1b study defining the optimal dosing combinations of the mTOR inhibitor AP23573 and Paclitaxel (PTX)
Authors: S. Cresta, D. Tosi, C. Sessa, L. Viganò, M. Maur, D. Hess, A. Locatelli, D. S. Wages, J. Albanell, L. Gianni
Journal: Journal of Clinical Oncology (2007)

3509 Background: AP23573 is a novel mTOR inhibitor with demonstrated anti-tumor activity in clinical trials. In vitro, AP23573 exhibits at least additive anti-proliferative activity in combination with a variety of agents including taxanes. This trial studied the combination of AP23573 and paclitaxel (PTX) in patients with advanced solid tumors. Methods: This was a modified, sequential (3+3) dose finding study with starting doses of 25 mg AP23573 i.v. and 80 mg/m 2 PTX i.v. as Dose Level 1 (DL1) on days 1, 8 and 15 of a 28 day cycle. Doses of either drug were adjusted in successive cohorts. Blood samples and skin biopsies were collected for pharmacokinetic (PK) and pharmacodynamic (PD) studies. Dose limiting toxicity definitions included neutrophils &lt;500/μL; thrombocytopenia = Grade 3 (CTC), any non- hematologic toxicities = Grade 2; missing 2 consecutive doses due to any toxicity. For PK and PD analysis, AP23573 and PTX were administered one day apart at the start of Cycle 1, reversing the sequence at Day 8. Results: Enrollment is complete and 29 patients with a variety of tumors (sarcoma, pancreatic, H&amp;N, melanoma, thymoma) have been treated. Grade 3 thrombocytopenia and Grade 2 mouth sores were seen at DL1 as well as missed doses due to moderate (Grade 2) neutropenia. Adverse events include mouth sores and fatigue which were mild and reversible. Available PK data for AP23573 and PTX suggest no interaction. PD analysis in peripheral blood mononuclear cells demonstrates no interference by PTX on mTOR inhibition by AP23573. PD data in skin biopsies are forthcoming. Both 12.5 mg AP23573/80mg/m 2 PTX and 37.5mg AP23573/60mg/m 2 PTX are maximal dose combinations that appear to be well tolerated. Activity has been observed at multiple AP23573 mg/PTX mg/m 2 dose levels (25/60, 12.5/80, 25/80). Five patients have been on study for &gt;4 cycles, including 2 patients with partial responses (H&amp;N and pancreatic). Conclusions: Combined therapy with AP23573 and PTX is safe. It is notable that evidence of anti-tumor activity was observed at modest doses of each drug when in combination. Combinations of these agents at both doses cited would be recommended for evaluation in trials examining efficacy in specific tumors. No significant financial relationships to disclose.
J-HOPE study: Evaluation of end-of-life cancer care in Japan from the perspective of bereaved family members
Authors: M. Miyashita, T. Morita, K. Sato, S. Tsuneto, Y. Shima
Journal: Journal of Clinical Oncology (2009)

9577 Background: The Japan Hospice and Palliative Care Evaluation (J-HOPE) study was conducted in 2007 and 2008. The aim of the study was to evaluate the quality of end-of-life care at regional cancer centers (CCs), inpatient palliative care units (PCUs), and home hospices (HHs) in Japan from the perspective of bereaved family members. Methods: A nationwide cross-sectional mail survey was conducted in 2007 and 2008. The survey was sent to bereaved families 6–18 months after the death of a patient at 56 CCs, 100 PCUs, or 14 HHs. Outcome measures were the good death inventory, the care evaluation scale, and overall satisfaction with care. The protocol of this study was approved by the institutional review boards of each participating institution. Results: Of the 13,181 bereaved family members that received the survey, 8,163 (62%) participants returned their responses. Among bereaved family members, significantly fewer responded that patients were free from physical distress at CCs (50%) than PCUs (80%) and HHs (73%) (P&lt;0.0001). Significantly fewer patients trusted the physicians at CCs (79%) when compared with PCUs (83%) and HHs (88%) (P&lt;0.0001). Significantly fewer patients were valued as people at CCs (83%) than PCUs (93%) and HHs (95%) (P&lt;0.0001). In addition, significantly fewer participants felt physicians should have worked to improve the patients' symptoms more quickly at CCs (55%) when compared with PCUs (78%) and HHs (77%) (P&lt;0.0001). Significantly fewer participants felt nurse should improve their knowledge and skills regarding end-of-life care at CCs (51%) when compared with PCUs (76%) and HHs (78%) (P&lt;0.0001). A total of 51% of participants reported that nurses should improve their knowledge and skills regarding end-of-life care. Finally, significantly fewer participants were satisfied with the end-of-life care provided by CCs (80%) when compared with PCUs (93%) and HHs (94%) (P&lt;0.0001). Conclusions: Overall, the bereaved family members appreciated the end-of-life care provided by CCs, PCUs, and HHs in Japan. However, in some situations, the quality of end-of-life care provided by CCs was lower than that provided by PCUs and HHs. No significant financial relationships to disclose.
DECOMPRESSIVE LAPAROTOMY FOR ACS: EFFECT ON ORGAN FUNCTION AND MORTALITY (WSACS CTWG STUDY 007)
Authors: J. De Waele, D. Debergh, Martin Björck, M. Malbrain, I. Nesbitt, J. Cohen, V. Kaiolani, R. Iratury, M. Mone, T. Kimball
Journal: Intensive Care Medicine (2014)
Smoking Before Surgery Predicts Poor Long-Term Survival in Patients With Stage I Non–Small-Cell Lung Carcinomas
Authors: Takehiko Fujisawa, Toshihiko Iizasa, Yukio Saitoh, Yasuo Sekine, Shin-ichiro Motohashi, Tomohisa Yasukawa, Kiyoshi Shibuya, Kenzo Hiroshima, Hidemi Ohwada
Journal: Journal of Clinical Oncology (1999)

PURPOSE: The majority of lung carcinoma patients requiring resection have smoking habits prior to surgical treatment, and the correlation of smoking with postoperative complications is well known. However, few studies have investigated the correlation between long-term survival and cigarette smoking in patients with primary, resected lung carcinoma. We analyzed the relationship between clinical factors, including cigarette smoking before surgery, and 10-year survival in stage I non–small-cell lung carcinoma (NSCLC). PATIENTS AND METHODS: Cigarette smoking habit and other factors influencing either the overall survival or the disease-specific survival rates of patients with stage I primary, resected NSCLC were evaluated according to the Cox proportional hazards model using a total of 369 patients with stage I–NSCLC. RESULTS: Comparison of the cause of death in patients with 30 or more pack-years and patients with less than 30 pack-years showed significant differences in the prevalence of recurrent disease and onset of nonmalignant disease. Multivariate analysis demonstrated significant correlations between overall survival and age and pack-years. Disease-specific survival showed significant correlations with age, tumor classification, and visceral pleural invasion. CONCLUSION: Smoking pack-years is an important clinical prognostic factor in evaluating overall long-term survival in patients with stage I primary, resected NSCLC.
Cancer therapy with unloaded monocyte-derived dendritic cells in patients with inoperable pancreatic and gall bladder cancer
Authors: T. Nesselhut, R. Y. Chang, C. Matthes, D. Marx, D. R. Lorenzen, N. Cillien, M. Martin, R. Gorter, J. H. Peters
Journal: Journal of Clinical Oncology (2004)

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