tbuckley/cabot-search huggingface dataset:
A phase I/II study of divided-dose docetaxel, cisplatin, and fluorouracil (DCF) for patients with recurrent or metastatic squamous cell carcinoma of the esophagus.
Authors: Toshiyasu Ojima, Mikihito Nakamori, Masaki Nakamura, Makoto Iwahashi, Masahiro Katsuda, Keiji Hayata, Shuichi Matsumura, Hiroki Yamaue
Journal: Journal of Clinical Oncology (2015)

132 Background: The aim of this phase I/II study was to evaluate the efficacy and safety of the combined use of docetaxel, cisplatin (CDDP) and 5-fluorouracil (5-FU) (DCF) in patients with recurrent/metastatic squamous cell carcinoma of the esophagus (SCCE). This study adopted divided doses of docetaxel and CDDP in order to reduce the toxicities of the treatment. Methods: The dose of docetaxel was escalated using the following protocol in the phase I stage: level 1, 30; level 2, 35 and level 3, 40 mg/m 2 , which was intravenously infused for two hours on days 1 and 8. CDDP was administered at a dose of 12 mg/m 2 infused for four hours on days 1-5. The 5-FU was administered at a dose of 600 mg/m 2 continuously infused from day 1 to 5. This regimen was repeated every four weeks. Results: The study subjects were nine patients (phase I) and 48 patients (phase II). The recommended dose was determined as level 3 in phase I. In the phase II stage, the overall response rate was 62.5%, with a complete response rate of 12.5%. The median progression-free survival was six months, and the median overall survival was 13 months. Grade 3/4 toxicities of leukopenia, neutropenia and febrile neutropenia occurred in 64.6, 68.8 and 14.6% of the patients, while grade 3/4 non-hematological toxicities were relatively rare. No treatment-related death was recorded. Conclusions: This modified DCF regimen can be a tolerable definitive chemotherapy for unresectable SCCE because of its high efficacy, although adequate care for severe neutropenia is needed. Clinical trial information: NCT00915850.
Prevalence of cancer anemia and correlation between anemia status and survival time in Chinese patients with gastric carcinoma
Authors: R. Li, X. Wang, G. Yu, J. Pan, J. Wang
Journal: Journal of Clinical Oncology (2008)

20647 Background: Prevalence of cancer anemia as well as correlation between anemia status and survival time in Chinese patients with gastric carcinoma (GC) are not clear although some other tumor types and other populations have had such data. This study was conducted to study prevalence of cancer anemia in Chinese patients with GC, especially the correlation between anemia and survival time. Methods: Age, gender, hemoglobin (Hb), survival status and disease stage (T, N and M), histopathology type, tumor differentiation and tumor size (diameter) were studied. Definition of anemia was Hb<120 g/L and was further categorized as mild: 119–100 g/L; moderate: 99–80 g/L; or severe: <80 g/L, based on toxicity grading criteria from the National Cancer Institute. Descriptive statistics were used to explore sample characteristics and hemoglobin. Chi-square statistics were used to examine differences between dichotomous variables. Kaplan-Meier method was used to explore correlation between anemia status and survival time. Cox regression model was used to evaluate prognostic factors. Results: 1,110 GC patients entered the study. 44.1% of patients were anemic, 20.5% patients had mild anemia, 12.3% had moderate anemia and 11.2% had severe anemia. 61.6% female and 36.5% male were anemic, statistical significance existed between two genders. Anemic patients were 27.2%, 45.1%, 51.4% and 47.2% with stage I, II, III and IV disease. 684 patients had survival data. Median survival time (MST) of anemic patients (AP) vs. non-anemic patients (NAP) was 23.9±1.7 Mon vs. 35.1±2.2 Mon (p<0.01). In patients with stage I disease, MST of AP vs. NAP was 63.5±7.1 Mon vs. 79.9±2.0 Mon, (p<0.01). But in patients with stage II, III and IV disease, MST had no differences between AP and NAP. Cox regression model accepted tumor size, tumor differentiation and disease stage as prognostic factors. Conclusions: There exists high prevalence of cancer anemia in Chinese patients with GC. Female patients are relatively intend to be anemic than male patients. AP‘s MST was shorter than NAP, but this phenomenon didn’t appeared in stage II, III and IV disease. Cox regression indicates tumor condition and disease stage may be more important than anemia in predicting survival time in Chinese patients with GC. No significant financial relationships to disclose.
Lymphatic invasion as an independent prognostic factor in pancreatic cancer patients undergoing curative resection followed by adjuvant chemotherapy with gemcitabine or S-1.
Authors: Keisuke Kazama, Toru Aoyama, Yusuke Katayama, Koichiro Yamaoku, Masaaki Murakawa, Akio Higuchi, Amane Kanazawa, Yousuke Atsumi, Manabu Shiozawa, Makoto Ueno, Manabu Morimoto, Takaki Yoshikawa, Yasushi Rino, Munetaka Masuda, Soichiro Morinaga
Journal: Journal of Clinical Oncology (2016)

290 Background: The objective of this retrospective study was to clarify prognostic factors in pancreatic cancer patients undergoing curative resection followed by adjuvant chemotherapy with gemcitabine or S-1. Methods: Both overall survival (OS) and recurrence-free survival (RFS) were examined in 122 pancreatic cancer patients who underwent curative surgery and received adjuvant gemcitabine or S-1 after surgery between 2005 and 2014. Results: When the length of OS was evaluated according to the log-rank test, significant differences were observed in lymphatic invasion and the T status. Univariate and multivariate Cox’s proportional hazard analyses demonstrated that lymphatic invasion was the only significant independent prognostic factor for both OS and RFS. The 5-year OS was 30.1% in the lymphatic invasion-negative group and 12.1% in the lymphatic invasion-positive group (p &lt; 0.001). Moreover, the 5-year RFS was 20.5% in the lymphatic invasionnegative group and 10.4% in the lymphatic invasionpositive group (p = 0.006). Conclusions: Lymphatic invasion is the most important prognostic factor for OS and RFS in patients with pancreatic cancer who undergo curative resection followed by adjuvant chemotherapy. The present results suggest that adjuvant chemotherapy is not sufficient, especially in patients with risk factors. Such patients should be evaluated as a target group for clinical trials of novel treatments.
Final results of a phase II trial of S-1 with biweekly docetaxel for non-small cell lung cancer previously treated with platinum-based chemotherapy (NJLCG0701).
Authors: O. Ishimoto, T. Sakakibara, M. Maemondo, N. Morikawa, K. Okudera, K. Usui, T. Suzuki, A. Inoue, T. Nukiwa, S. Sugawara
Journal: Journal of Clinical Oncology (2010)

7604 Background: S-1, a novel oral fluorouracil derivative, is active against non-small cell lung cancer (NSCLC). A preclinical study showed the synergistic effect of docetaxel and S-1 in vivo. On the basis of the findings of the dose-escalation study of bi-weekly administered docetaxel and S-1, we conducted a phase II study to evaluate the efficacy and toxicity of this combination as a second-line treatment for patients (pts) with previously treated NSCLC. Methods: Pts with NSCLC that was previously treated with one regimen of platinum-based chemotherapy were included. Other eligibility criteria were performance status (PS) of 0/1 and measurable lesions. Pts received S-1 (80 mg/m2) on days 1–14 and docetaxel (25 mg/m2) on days 1 and 15 of each 28-day cycle. The primary endpoint was the overall response rate (ORR), and secondary endpoints were progression-free survival (PFS), overall survival, and the toxicity profile. Assuming that 20% ORR in eligible pts indicated potential usefulness and 5% ORR is the lower limit of interest, the estimated accrual was 34 pts. Results: We enrolled 35 pts from 7 institutions (Feb. 2007–Sep. 2008). Patient characteristics: male/female, 23/12; median age, 64 years (43–74 years); and PS, 0/1 (17/18). The median number of treatment cycles was 3 (1–7). The objective responses were CR 0; PR 9; SD 14; PD 10; and NE 2, resulting in an ORR of 26% (95% confidence interval [CI], 11–40). The overall disease control rate was 66% (95% CI, 50–81); median PFS, 4.1 months; and overall survival time, 16.3 months. Hematologic grade 3/4 toxicity included neutropenia (31%) and anemia (11%). Nonhematologic grade 3 toxicity included diarrhea (17%), infection (8.6%), anorexia (5.7%), rash (5.7%), aspartate aminotransferase (AST) (5.7%). No grade 4 non-hematologic toxicity was observed. There was 1 possible treatment-related death due to pneumonitis and infection after the first chemotherapy cycle. Conclusions: The combination of S-1 and biweekly docetaxel is an active regimen with a tolerable toxicity profile for previously treated NSCLC. Further evaluation of this regimen as compared to docetaxel alone or pemetrexed is warranted. No significant financial relationships to disclose.
A Randomized Phase 2 Study of Sapacitabine, An Oral Nucleoside Analogue, in Elderly Patients with AML Previously Untreated or in First Relapse.
Authors: Hagop M. Kantarjian, Guillermo Garcia-Manero, Selina Luger, Parameswaran Venugopal, Lori J. Maness, Meir Wetzler, Wendy Stock, Steven Coutre, Gautam Borthakur, Judy Chiao
Journal: Blood (2009)
Different pancreatic cancer genomic risk prediction models derived from microdissected and non-microdissected paraffin-embedded tissue
Authors: R. Mori, E. A. Collisson, A. C. Hoffmann, G. E. Kim, H. Shimada, S. Togo, P. V. Danenberg, J. Cooc, K. D. Danenberg, M. A. Tempero
Journal: Journal of Clinical Oncology (2008)

4622 Background: Microarray studies of genomic risk models for patients with various cancers often use fresh frozen tissue containing both tumor and non-tumor tissue. To assess the effect of using isolated tumor tissue for microarray analysis versus the entire unprocessed specimen, we compared gene expression profiles associated with long-term and short term-survival derived from microdissected and non-microdissected FFPE pancreatic cancer specimens. Methods: We selected pathologically confirmed pancreatic ductal adenocarcinoma from archival FFPE specimens from a single center. Among 20 specimens, 14 were from long-term (>36 mos.) and 6 from short-term (< 5 mos.) survivors. Multiple slide sections taken from each paraffin block were either microdissected to isolate tumor cells or isolated en bloc. Non-microdissected samples contained roughly 20% tumor cells, as is typical for this desmoplastic disease. Following isolation, RNA was amplified, labeled, and hybridized to Affymetrix U133 Plus 2.0 GeneChips. Differentially expressed gene lists were determined between long (>645 days) and short survivors (<204 days) by T-Test and hierarchical clustering. Results: Between the groups of all microdissected and all non-microdissected specimens there were 8531 differentially expressed genes at p<0.05. In the microdissected samples, gene clusters created with supervised analyses based on outcome identified 359 differentially expressed genes between the long-term and the short-term survivor groups (p=0.005). Interestingly, 219 differentially expressed genes were also identified in the non-microdissected samples (p=0.005). However, Venn diagrams showed only 3 genes in common genes between the two groups. Diagnostic gene sets from microdissected samples failed to properly classify the non-microdissected samples and vice versa. Conclusion: Gene profiles generated from microdissected and non-microdissected samples of the same tumors are very dissimilar, but both contain prognostic information. Thus, non-microdissected samples containing a minority percentage of tumor cells do not give gene profiles characteristic of cancer, but most likely of pathologic stromal-tumor interaction. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Response Genetics, Inc Response Genetics, Inc Response Genetics, Inc
Effect of an individualized dose/schedule strategy for sunitinib in metastatic renal cell cancer (mRCC) on progression-free survival (PFS): Correlation with dynamic microbubble ultrasound (DCE-US) data.
Authors: G. A. Bjarnason, B. Khalil, R. Williams, J. M. Hudson, B. Lloyd, L. M. Milot, M. Atri, A. Kiss, P. Burns
Journal: Journal of Clinical Oncology (2011)

356 Background: Sunitinib area under the curve (AUC) correlates with response and PFS (Houk et al). Current recommendations for dose modification do not take this into account. Methods: A single center retrospective review identified mRCC patients (pts) where individualized (individ) sunitinib dose/schedule modifications (DSM) were used to maximize dose and minimize time off therapy (Rx). Pts were started on 50 mg 28 days (d) on/14 d off. DSM were done to keep toxicity (fatigue, skin, GI) at ≤ grade-2. DSM-1 was 50 mg 14 d/7 d with individ increases in d on Rx based on toxicity. DSM-2 was 50 mg 7 d/7 d with individ increases in d on Rx. DSM-3 was 37.5 mg continuously with individ 7 d breaks. DSM-4 was 25 mg continuously with individ 7 d breaks. Results: In 171 pts; median age was 60y; 20% good, 60% intermediate, 20% poor prognosis by Heng criteria; 80% had nephrectomy; 79% clear cell histology; 60% were previously untreated. At a median follow-up of 10.7 months (mo), overall median PFS was 7.9 mo. Of 39 pts still on therapy, 37 were on a DSM Rx. Pts were allocated to three groups based on the dose/schedule used for the longest time. The PFS/response% (PR+SD) for each group was 4.4 mo/65.6% (standard 50 mg 28 d/14 d; 43 pts), 8.0 mo/78.2% (DSM-1/DSM-2; 69 pts) and 10.4 mo/81.3% (DSM-3/DSM-4; 59 pts) with improved PFS (p=0.001) in both DSM groups vs. the standard schedule but no difference in response. 30 pts were studied by DCE-US at baseline, and after 7 d and 14 d on Rx or after 14 d and 28 d on Rx. In responding pts, tumor blood volume decreased at d 7 and again at d 14 vs. baseline but was stable or increased at d 28 vs. d 14. A rebound was seen after 14 d off Rx. Conclusions: Based on the U.S. data, previous pharmacokinetic data (steady state at 10-14 d) and this clinical data, starting pts on 50 mg 14 d/7 d followed by individ DSM may be safe and active. This DSM strategy, was associated with a favorable toxicity profile, apparent improvement in PFS and a good PR+SD rate in a group of unselected mRCC pts, warranting confirmation in a prospective trial. Pts that tolerate 50 mg 28 d/14 d with minimum toxicity may need dose escalation and/or less time off therapy to optimize PFS. [Table: see text]
A phase I/II study of αGalactosylceramide-pulsed dendritic cells in patients with advanced or recurrent non-small cell lung cancer
Authors: S. Motohashi, K. Nagato, T. Fujisawa, M. Taniguchi, I. Yoshino, T. Nakayama
Journal: Journal of Clinical Oncology (2008)

3027 Background: Human natural killer T (NKT) cells are activated by a specific ligand, α-Galactosylceramide (αGalCer) in a CD1d dependent manner. Previous findings showed that αGalCer-pulsed dendritic cells (DCs) exerted a strong antitumor activity in the mouse tumor metastatic models. With these results, we performed phase I/II study of αGalCer-pulsed dendritic cells in patients with advanced or recurrent non-small cell lung cancer (NSCLC) to obtain more findings about safety, immune responses and anti- tumor responses. Methods: Patients with advanced NSCLC or recurrent lung cancer refractory to the standard therapy were eligible. αGalCer-pulsed DCs (1x109/m2) were intravenously administered four times. Immune responses were monitored weekly by a flow cytometry analysis and an enzyme-linked immunospot assay. Additional follow-up was performed to clarify the prognosis and cause of death. Results: Twenty-three patients were enrolled in this study and 17 cases (73.9%) completed. No severe adverse event related to the treatment was observed. After the injection of αGalCer-pulsed DCs, increased numbers of IFN-γ producing cells in the peripheral blood were detected in 10 patients (58.8%). Five cases remained as stable disease (SD), and the remaining twelve cases were evaluated as progressive disease (PD). The estimated median survival time (MST) of the 17 cases was 18.3 months (range, 3.6 to 36.6 months). Ten patients who displayed increased IFN-γ producing cells (>2 fold) showed prolonged MST (19.1 months, range, 10.5 to 36.2 months) as compared to poor-responder patients (n=7, 9.5 months, range, 3.6 to 13.0 months) (log-rank test P=0.0046). Conclusions: The administration of αGalCer-pulsed DCs was well tolerated and was accompanied by the successful induction of NKT cell-dependent immune responses. The increased IFN-γ producing cells in PBMCs might be associated with prolonged survival. These results are encouraging and warrant further evaluation for survival benefit of this immunotherapy. No significant financial relationships to disclose.
A phase II study of neoadjuvant antiangiogenic therapy combined with capecitabine (C) and radiotherapy (RT) in patients (pts) with locally advanced rectal cancer (LARC)
Authors: F. Torino, S. Cascinu, F. Ciardiello, A. Ballestrero, M. Lencioni, G. Filippelli, A. Martignetti, C. Granetto, R. Sarmiento, G. Gasparini
Journal: Journal of Clinical Oncology (2008)

15113 Background: Preoperative chemotherapy (pCT/RT) improves the outcome of surgery in LARC. The inhibition of vascular endothelial growth factor (VEGF) may enhance the efficacy of CT/RT. The aim of this open phase II study was to evaluate the efficacy and toxicity of Bevacizumab (BV), a recombinant humanized antibody anti-VEGF when combined with pCT/RT. The primary endpoint was the pathologic complete response (pCR) rate. Planned biological correlates include biomarkers predictive of responsiveness or resistance to treatment. Methods: From December 2005 to April 2007, all the planned 43 consecutive pts with stage II/III rectal adenocarcinomas have been enrolled (25 male, 18 female; median age: 63 years, range 28–78; PS: 0–1). All pts underwent pancolonscopy, endorectal ultrasonography, pelvic nuclear magnetic resonance and computed tomography for staging. BV was given by intravenous infusion (5mg/Kg q2wks for 4 courses), the first administration 2 weeks before pCT/RT. C (825mg/mq bid) was given concurrently with RT, delivered with a 3-field-technique (50.4Gy over 5-weeks boost inclusive). Surgery was performed 6–8 weeks after RT. Results: 40 pts are assessable for response (intent-to-treat analysis): 1 pt died to progressive disease (PD) before treatment, 2 pts refused surgery. Fourty-two pts are evaluable for toxicity. No G4 toxicity was reported. G3 toxicities included: neutropenia (2 pts), diarrhea (3 pts), hypokalemia (1 pt). Other adverse events were mild, including G2 hypertension (3 pts). Four pts obtained a pCR (9.3%; 2.72–23.13, CI 95%). Twenty-one pts were downstaged (48.8%) and 11 out of them had only focal residual disease (25.6%). Downsizing was obtained in 3 pts (6.9%). In 9 pts (20.9%) disease remained stable. Three pts (6.9%) had PD. Sphincter sparing surgery was accomplished in 29 pts (72.5%). Conclusions: BV and C + standard RT is a feasible and safe regimen. A remarkable rate of tumor downstaging and conservative surgery have been obtained. The results of biological correlates will be presented at the meeting. No significant financial relationships to disclose.
Development and validation of the clinician palliative perception scale (CPPS).
Authors: Aaron Kee Yee Wong
Journal: Journal of Clinical Oncology (2016)

179 Background: Worldwide healthcare systems identify a need to provide better evidence based service models for palliative care. There is little data and no standard tool that informs clinicians’ perceptions on palliative care to identify areas for service improvement and education. We aimed to develop and validate a tool to determine perceptions of hospital staff on palliative care provision, self confidence in providing palliative care, and predictors and barriers to requesting assistance. Methods: 604 hospital clinicians were recruited in person and online from a large metropolitan public tertiary teaching hospital network involving 5 campuses and 2 medical schools. They completed the CPPS (Clinician Palliative Perception Scale). Principal components analysis, exploratory factor analysis, and logistic regression were performed to examine the factor structure and relationship to clinical practice. Results: Four factors were extracted: confidence in providing palliative care, requesting assistance, global perceptions on palliative care provision, and barriers to referring. Increased confidence was significantly associated with increased likelihood of referring or requesting assistance and also associated with a good global perception on palliative care provision. Confidence was also significantly associated with years of experience and with spending &gt; 50% time looking after dying patients. Good perception of palliative care provision was highest among oncologists. Conclusions: This is the largest quantitative study ever done looking at perceptions of palliative care provision among health professionals. The CPPS is a valid and reliable tool useful for both practice and research. Its 4 identified constructs are consistent with literature on perceptions and utilisation of palliative care services. Barriers to referring involved misconceptions that palliative care would prematurely shorten patient lifespans. Others did not refer due to confidence in their own skill. This tool can be used to correlate these constructs against other solid outcome measures to assist in service improvement and identifying research needs. It can also be used to determine clinicians’ educational requirements.
Impact of cancer on the quality of life and health status of patients and their family members.
Authors: Y. T. Shih, I. Pan
Journal: Journal of Clinical Oncology (2010)

6054 Background: The estimated number of cancer survivors in the United States was 11.4 million in 2006 (≫ 4% of the population). The number in cancer families, defined as survivors and their family members, is expected to grow as the number of survivors increases. We examined the short-term and long-term impact of cancer on the health status and quality of life of individuals in cancer families. Methods: We identified four groups of individuals directly or indirectly affected by cancer from the 2002-2003 Medical Expenditure Panel Survey: current cancer patients and their non-cancer family members, and previous cancer patients and their noncancer family members. We compared their quality of life (Qol) and health status with an age-gender matched control group of individuals in non-cancer families. QoL was measured with the SF-12 and reported as Physical Component Summary (PCS) and Mental Component Summary (MCS), whereas health status was measured using the EQ-5D and reported as preference- based index score and rating scale. We conducted regression analyses to compare QoL and EQ-5D scores among the five groups while controlling for demographic and socioeconomic characteristics. Results: We identified 673 and 1,346 individuals in cancer and non-cancer families, respectively. Results from regression are show in Table. Conclusions: Cancer had a temporary negative effect on MCS and preference score and a sustained negative effect on PCS and rating scale among cancer patients, and a temporary negative effect on the preference score among noncancer individuals in cancer families. Comparison of QoL and EQ-5D scores between groups PCS MCS Preference Rating scale Noncancer families (reference group) Current cancer families (short-term effect) Current cancer patients -4.1 (-5.9, -2.3) -2.8 (-4.6, -0.9) -0.08 (-0.1, -0.04) -9.7 (-13, -6.3) Noncancer family members -0.9 (-3.1, 1.2) -1.5 (-3.7, 0.6) -0.06 (-0.1, -0.01) -3.1 (-7.1, 0.9) Previous cancer families (long-term effect) Previous cancer patients -1.5 (-2.9, -0.1) -0.8 (-2.3, 0.6) -0.02 (-0.06, 0.01) -3.0 (-5.6, -0.3) Noncancer family members -0.1 (-1.5, 1.4) 0.5 (-1.0, 1.9) -0.001 (-0.04, 0.03) 0.7 (-1.9, 3.3) Numbers in parentheses were 95% confidence intervals. No significant financial relationships to disclose.