tbuckley/cabot-search huggingface dataset:
Phase II study of combination paclitaxel and carboplatin in patients with advanced or recurrent endometrial cancer.
Authors: B. Shan, H. Wang, Y. Ren, X. Tu, Z. Jiang
Journal: Journal of Clinical Oncology (2011)

e15580 Background: A phase II trial of combination paclitaxel and carboplatin (PC) was performed in patients with advanced or recurrent endometrial cancer in Fudan University Shanghai Cancer Center to estimate the efficacy and toxicity. Methods: Eligible patients with measurable disease were enrolled between July 2007 and September 2010. Six courses of paclitaxel (135 mg/m2) and carboplatinum (AUC 5) on day 1 every 3 weeks were administered in outpatients. Response rates were evaluated according to the response evaluation criteria in solid tumors. Results: Forty patients with assessable disease enrolled, 16 with residual disease after primary or second cyto-reductive surgery (group A), 24 with unresectable recurrent or metastatic disease (group B). In the complete series, 12 CR (30%) and 16 (40%) PR were recorded, with an ORR (overall response rate) of 70% (95% CI 53%~83%). Significantly more patients in group A experienced CR than group B (56.2% VS 16.67%, P=0.009), but the difference of ORR was not statistically significant (P=0.205). In unvariate analysis, residual disease ≤ 2cm and chemotherapy-naïve were associated with increased CR (P<0.001, P=0.011). In multivariate analysis, only chemotherapy-naïve was associated with increased response rate (P=0.041). The 2-year OS and DFS were 71.8% and 77.6%, respectively. Hematological toxicities (G3/G4) were neutropenia (45%/7.5%), anemia (12.5%/2.5%) and thrombocytopenia (7.5%/5.0%). Reversible G3 hypersensitivity (5%), G2 vomiting (2.5%) and G2 cardiotoxicity (2.5%) was uncommon. Conclusions: PC regimen has an acceptable toxicity profile and appears to have activity in advanced or recurrent endometrial cancer, especially in chemotherapy-naïve patients. Further studies are urgently warranted to confirm the efficacy of PC regimen and to explore new agents for PC-refractory patients.
A prospective study of capecitabine (cape), oxaliplatin (ox), bevacizumab (B), and radiation therapy (RT) (CAPOX-B RT) in patients with locally advanced or R1 biliary cancers: High risk of liver failure with extended hepatectomy.
Authors: T. S. Hong, D. P. Ryan, L. S. Blaszkowsky, H. J. Mamon, D. Berger, C. Fernandez-del Castillo, A. X. Zhu
Journal: Journal of Clinical Oncology (2011)

e14593 Background: To evaluate the safety and efficacy of CAPOX-B RT for locally advanced or R1 biliary tract adenocarcinoma. Methods: Pts with locally advanced or R1 resected biliary cancers (including gallbladder carcinoma) were eligible for this prospective IRB approved phase II study. Pts received concurrent cape 825 mg/m2/d PO BID d1-14, d22-35, ox 50 mg/m2 IV d1, 8, 22, 35 and B 5 mg/kg IV d1, 15, 35. RT was 50.4 Gy over 28 fractions with 3D-CRT or IMRT. RT liver planning constraints were V30<1/3 and mean liver dose < 30 Gy. The 6 week chemotherapy cycle was repeated after the completion of radiation therapy. 29 pts who received radiation for biliary cancers were evaluated for comparison, 7 of whom received adjuvant gemcitabine-based chemotherapy followed by 5-FU chemoradiation (CRT) after extended hepatectomy (EH). Results: 8 pts were enrolled before the study was closed due to poor accrual. Median age was 58 (range 46-80). 4 patients were female. 4 patients had Klatskin tumors, 2 distal CBD, 1 intrahepatic cholangiocarcinoma, and 1 gallbladder. 4 patients had surgery, 3 of whom had EH. At last follow up, all patients are deceased. Median survival was 12 mo (range 6-35). 4 pts developed liver failure, all within 6 mo of completing therapy. All 3 patients who had EH died of liver failure. Of the pts with liver failure, average liver volume was 1689 cc, average V30 = 37%, average mean liver dose = 27 Gy, and average volume spared 30 Gy (VS30) =1,097 cc. Of the 7 control pts receiving CRT after EH, average liver volume was 1,544 cc, average V30 = 26%, average mean liver dose = 19 Gy, and average VS30 =1,162 cc. No liver toxicity was noted in these pts. Conclusions: Our study suggests that CAPOX-B RT and EH is associated with a high rate of liver failure, in spite of standard radiation planning constraints. Conversely, no liver failure was seen following EH after standard adjuvant therapy. This regimen should not be further developed or used off clinical trial.
Cetuximab plus chemoradiation combined therapy for locally advanced inoperable pancreatic adenocarcima: A phase I study
Authors: A. Demols, C. Mahin, R. Maréchal, T. Delaunoit, I. Borbath, A. Hendlisz, C. Jacquy, C. Mitine, J. Van Laethem
Journal: Journal of Clinical Oncology (2008)

4629 Background: Chemoradiation using gemcitabine is an active therapy in advanced pancreatic cancer. Cetuximab is a potent radiosensitizer. This phase I study aims to evaluate the feasability and toxicity of a combination of gemcitabine, cetuximab and radiation in locally advanced unresectable pancreatic adenocarcinoma. Methods: Three escalating steps of treatment have been designed in cytologically proven locally advanced pancreatic cancer patients (PS 0–1). Gemcitabine (300mg/m2) and cetuximab (loading dose 400mg/m2 then 250mg/m2 weekly) were given weekly according to radiation duration. Group 1: 6 patients, 36 Gy in 20 fractions of 1,8 Gy. Group 2: 6 patients, 45 Gy in 25 fractions. Group 3: 13 patients, 50,4 Gy in 30 fractions. Results: 16 men and 9 women were included. Median age was 63 (range 45–80) for the whole series. No toxic death was observed. No MDT was reached. In the first group, two patients received only 19/20 radiation fractions: one for abdominal pain due to peptic ulcers and one for practical reason. In the second group, radiation was completed in all the patients. In group 3, three patients received only 25/30 fractions; one for PD, one for liver abcesses and one for fatigue gr3. Doses of gem were reduced in 4 patients due to gr3 ANC toxicity. No dose reduction of cetuximab was necessary in all but one patient experiencing gr3 allergia at the first infusion. Overall, no grade 4 toxicity was recorded. No gr3 toxicity was observed in group 1, one hematologic and 3 non-hematologic ones were recorded in group 2, and 2 and 11 in group 3, respectively. Typical skin rash toxicity (gr1+gr2) was observed in 19/25 patients (76%). There were 20/25 evaluable patients, there were one radiologic CR, 8 PR, 6 SD and 5 PD. Moreover, one patient (group 1) can be curatively (R0) resected after chemoradiation and PR. Median TTP/OS were 131/275, 111/326 and 84/112 days for group 1, 2 and 3, respectively. Conclusions: This combined treatment is well tolerated without MDT reached and appears to be active. Toxicity was clearly increased for the maximal schedule without significant increase of efficacy and, we therefore recommend to give 45 Gy with this combination. Supported by Merck KgaA. No significant financial relationships to disclose.
Analysis of overall survival and self-reported fatigue in patients with locally advanced esophageal cancer: A Mayo Clinic Esophageal Adenocarcinoma and Barrett’s Esophagus Registry Consortium study.
Authors: M. C. Stauder, Y. Romero, B. Kabat, P. J. Atherton, M. B. Fredericksen, C. Deschamps, A. Jatoi, J. A. Sloan, M. Botros, R. C. Miller
Journal: Journal of Clinical Oncology (2011)

9057 Background: We analyzed overall survival (OS) and self-reported fatigue scores in patients with esophageal cancer (EC) enrolled in the Mayo Clinic Esophageal Adenocarcinoma and Barrett’s Esophagus Registry (EABE). Methods: Patients enrolled in the EABE between September 2001 and January 2009 returned a baseline quality of life questionnaire (n=1,481) including a Linear Analog Self Assessment (LASA) fatigue score which was scored on a 0-10 scale, with 0 as the most extreme fatigue. Patients were categorized as having a clinically deficient fatigue (DF) level if they reported a score of ≤ 5 and a clinically non-deficient fatigue (nDF) level if they reported a score of >5. Kaplan-Meier methodology and Cox models explored the relationship between OS and fatigue scores in patients with EC. Results: A total of 667 patients with EC were included in the EABE, of which 659 returned a registry questionnaire with a valid LASA fatigue score recorded. Median age at the time of registry entry was 65 years (range 23-92). A total of 392 (59%) and 267 patients (41%) reported DF and nDF, respectively. On univariate analysis, patients with nDF had improved 5-year OS compared to patients with DF. In patients having esophagectomy prior to LASA, those reporting nDF had improved survival compared to patients with DF (54% vs 40%, HR=0.63, p=0.04). A similar result was seen in patients having no esophagectomy prior to LASA (28% vs 20%, HR=0.75, p=0.03). Among the 368 patients with locally advanced EC (LAEC), those reporting nDF had improved 5-year OS compared to patients with DF. This remained significant on multivariate analysis (HR=0.71, p=.015). Conclusions: Patient-reported fatigue is associated with overall survival in patients with esophageal cancer, including those with LAEC. Therefore, fatigue scores should be considered as a stratification factor in the design of future clinical trials. N (events) 5-year OS P value HR (95% CI) All EC patients DF nDF 392 (218) 267 (126) 28% (22% - 35%) 37% (30% - 46%) .006 0.74 (0.59 – 0.92) Locally advanced EC DF nDF 216 (144) 152 (84) 17% (11% - 26%) 28% (19% - 40%) .003 0.67 (0.51 – 0.87)
A public health intervention program to improve the initial management of soft tissue sarcomas
Authors: S. Mathoulin-Pelissier, C. A. Bellera, J. Coindre, C. Chevreau, V. Lebrun-Ly, D. Cupissol, E. Bompas, S. Albert, M. Saves, B. N. Bui
Journal: Journal of Clinical Oncology (2008)

17546 Background: A quasi-experimental before/after study funded by a National Grant, has been implemented to set up and evaluate a public health intervention designed to improve the quality of the initial management of Soft Tissue Sarcomas (STS), in collaboration with the French Sarcoma Group (FSG), regional cancer registries and cancer regional networks. As a preliminary step, we have validated quality indicators (QIs) for cancer care, i.e., we have assessed which QIs are the most relevant to evaluate the quality of the management of STS. Methods: This two-year study involves five regions (covering 20% of the French population); 300 STS cases per year will be recruited. The public health program is implemented in four regions (the fifth region serves as a control), and the interventions are the following ones: 1) information written campaign directed towards all relevant practitioners, 2) oral communications in dedicated meetings by opinion leaders, 3) systematic written information to the surgeons whenever an STS is histological proven. To validate QIs, a consensus Delphi method was set up. Based on Good Clinical Practices and a literature review, we prepared a set of 25 QIs, and relied on a panel of advisory FSG experts (n = 19) involving multiple medical specialties. Results: Data specific to the implementation of the public health program are currently being collected. Preliminary data suggest an increased number of reported STS cases compared to the initial estimation which was based on a national estimation. For example, 46 cases were recruited over 6 months in one region (3 millions inhabitants), instead of the expected 30 cases (50% increase). With respect to the QIs, response rates were excellent (95%); consensus was reached for 18 items, with perfect consensus for 9 QIs (e.g., the need for multidisciplinary management teams, appropriate surgical biopsy techniques). Conclusions: Our analysis confirms the presence of a consensus among French STS experts. The relevant QIs will be used to evaluate the public health intervention which will allow us to 1) obtain a picture of the current practices in the management of STS patients; 2) assess if simple actions can improve practices; 3) estimate the STS incidence in 5 regions. No significant financial relationships to disclose.
Final results of a phase I study of picoplatin and pegylated liposomal doxorubicin in advanced solid tumor malignancies
Authors: D. S. Dizon, F. Maluf, C. A. Aghajanian, A. I. Daud, P. Sabbatini, S. Pezzulli, S. Soignet, D. R. Spriggs
Journal: Journal of Clinical Oncology (2008)

2568 Background: Picoplatin is a novel, sterically hindered platinum(II) complex designed to circumvent mechanisms of platinum resistance. Given the single agent activity seen in multiple tumor types, we conducted a phase I study of picoplatin in combination with pegylated liposomal doxorubicin (PLD) in patients with advanced solid tumors. Methods: Patients with advanced solid tumors and a PS 0-2 who received up to three prior regimens for metastatic disease were eligible. Patients received picoplatin followed by PLD on day one of a 28-day cycle. Four dose levels were tested (picoplatin/PLD, mg/m2): 100/20, 100/30, 100/40, and 120/40. Results: Sixteen patients were enrolled (7M:9F) and all were evaluable for toxicity. The median age was 52 (range, 27–76). Diagnoses represented were as follows: ovarian (5), non-small cell lung (2), head and neck (2), bladder (2), and one each with mesothelioma, melanoma, thymic, peritoneal, and renal cell cancer. Sixty-two courses of treatment were delivered with a median of 4 cycles per patient (range, 1–7). The first three dose levels were well tolerated with minimal toxicity reported. At the fourth dose level (n=6), 2 experienced G3/4 leukopenia, 3 had G3/4 neutropenia, and 2/6 had G3/4 thrombocytopenia. Nonhematologic adverse events were mild with only one patient experiencing G3 constipation. Frequent nonhematologic toxicities included fatigue, stomatitis, hand-foot syndrome, nausea, vomiting, and constipation. Twelve patients were evaluable for response. Four patients (42%) responded (1CR, 4PR) and five (42%) had stable disease. Conclusions: Therapeutic doses of both picoplatin and PLD were administered with acceptable toxicity was demonstrated. The recommended phase II doses of picoplatin and PLD are 120 mg/m2 and 40 mg/m2, respectively. Given the preliminary activity, further clinical testing of this combination is warranted. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Ortho Biotech
A comparison of preoperative chemoradiation versus extended surgery with lateral node dissection for lower rectal cancer: A report from a single referral center in Japan.
Authors: T. Konishi, M. Ueno, Y. Fukunaga, S. Nagayama, Y. Fujimoto, T. Akiyoshi, M. Oya, H. Kuroyanagi, T. Watanabe, T. Yamaguchi, T. Muto
Journal: Journal of Clinical Oncology (2011)

e14070 Background: It has been reported that preoperative chemoradiation (preCRT) and extended surgery with lateral node dissection (LND) both decrease local recurrence compared with total mesorectal excision (TME) alone in locally advanced lower rectal cancer. However, there have been few studies combining these two strategies. The present study aims to analyze the oncological benefit of preCRT with selective LND compared with extended surgery. Methods: Between 1985 and 2002, all patients with T3-4 lower rectal cancer routinely underwent extended surgery with LND without CRT (Group A). Since 2002, all such patients underwent preCRT followed by simple TME, and LND was selectively performed after preCRT if pelvic lymph nodes were positive on pretreatment images (Group B). Patients who refused to receive preCRT in this period underwent extended surgery with LND (Group C). Oncological outcomes were compared between patients undergoing curative resection in each group. PreCRT regimen consisted of a total dose of 45-50Gy delivered with 5-FU-based chemotherapy. Results: A total of 252, 123 and 53 patients were eligible for the study in Group A, B and C, respectively. There was no difference regarding the patient backgrounds except that LND was omitted in 71% of Group B. Histological examination revealed that Group B showed more T0-2 tumors (0%, 39% and 0% in Group A, B and C, respectively, p<0.0001), less positive lymph node (54%, 37% and 56%, p=0.0082), less lymphovascular invasion (90%, 68% and 92%, p<0.0001) and less advanced stage (stage I/II/III, 0/45/55%, 31/32/37% and 0/46/54%, p<0.0001). Proportion of sphincter preserving surgery was higher in Group B (48%, 68% and 58%, p=0.0009). Disease free survival at 3 years showed no difference among the groups (66%, 77% and 67%, p=0.1328). However, local recurrence rate at 3 years was lower in Group B (21%, 6% and 16%, p=0.0045). Conclusions: Preoperative CRT with selective LND contributes to decrease local recurrence, downstage the tumor and increase the chance for sphincter-preservation compared with extended surgery alone.
Epidemiology and natural history of central venous access device (CVAD) use and infusion pump performance among patients (pts) treated for metastatic colorectal cancer (mCRC): Analysis from the NO16966 trial.
Authors: E. Chu, D. G. Haller, T. H. Cartwright, C. Twelves, E. McKenna, N. Scotto, F. Gilberg, J. Cassidy, W. Sun, M. W. Saif, H. Schmoll
Journal: Journal of Clinical Oncology (2011)

e14010 Background: A paucity of data on the natural history of CVADs in solid tumor pts, including mCRC, exists in the literature. CVAD use is associated with frequent and serious adverse events (AEs) in pts with hematologic malignancies, often occurring early (3-4 months after placement). Here we report the largest prospective evaluation of CVAD use and associated outcomes in mCRC. Methods: The NO16966 study employed a 2x2, placebo-controlled design. Pts without prior treatment for mCRC were randomized to receive infusional 5-FU/LV plus oxaliplatin (FOLFOX4) or capecitabine plus oxaliplatin (XELOX) and placebo or bevacizumab. Data were prospectively collected regarding CVAD placement/removal/replacement, associated AEs, pump malfunctions, and adherence to oral capecitabine. Analyses were descriptive; no formal statistical tests were performed. Results: CVAD placement data were available for 1341/1998 (67%) pts. Overall, 1194 pts had CVADs placed (FOLFOX4: n=797; XELOX: n=397) at baseline. Fewer XELOX pts required removal/replacement (8.8% vs 19.3%). Median time to first replacement was shorter with FOLFOX4 (133 days [95% CI: 105-155] vs 170 days [90-365]). Associated AEs were more frequent with FOLFOX4 (11.5% vs 2.4%), as were chronic AEs (7-9% vs 1-3%) with similar trends for infection and administration site AEs. Pump type used was split evenly across cycles (programmable vs single use). Malfunctions during fluoropyrimidine infusion occurred in 16% of FOLFOX4 pts, mostly with single use pumps. Pts treated with oral capecitabine showed high levels of adherence. Conclusions: CVAD-associated complications, need for replacement and pump malfunctions during treatment were common. XELOX-treated pts required fewer placements/replacements and experienced fewer associated AEs. Oral fluoropyrimidine regimens could reduce CVAD use and associated complications in the front-line treatment of mCRC. These observations may be relevant to the adjuvant setting as most events occur soon after placement. As adjuvant therapy is curative, any risk of potentially serious complications should be minimized.
Occurrence, severity, and impact of cancer-related fatigue in Taiwanese patients with cancer: A national survey.
Authors: Ruey Kuen Hsieh, Shiow-Ching Shun, Kun-Ming Rau, Tzeon-Jye Chiou, Yung-Chuan Sung, Su-Peng Yeh
Journal: Journal of Clinical Oncology (2015)

77 Background: Cancer-related fatigue (CRF) is common symptom in cancer patients. However, there is no study related to occurrence, severity and impact of CRF in Taiwan. The aim of this study was to report the occurrence and severity of CRF, and its impact on quality of life in cancer inpatients and outpatients in Taiwan. Methods: A national survey with cross-sectional study design was used. Patients were recruited from 20 hospitals with inpatients unit (n = 574) and outpatients clinics (n = 633) in Taiwan. The structured questionnaire was used to assess patients’ demographic, clinical, and CRF characteristics among Taiwanese cancer patients. The CRF were assessed by International Classification of Diseases 10th Revision (ICD-10) and Brief Fatigue Inventory–Taiwan Form (BFI-T). Quality of life (QOL) was assessed by FACT-general. Descriptive statistics and bivariate correlations were used to compare the occurrence, severity, and impacts on quality of life of CRF between cancer inpatients and outpatients. Results: Overall, the occurrence was 23.36% based on ICD-10 CRF criteria and 31.9% and 15.6 for inpatients and outpatients, respectively. About94.4% of inpatients and 89.7% of outpatients experienced fatigue. Inpatients had significant higher fatigue severity (current fatigue, general fatigue, and worst fatigue) during the past 24 hours compared to the outpatients. Enjoyment of life was the most interfered by fatigue in both inpatients and outpatients. The mean levels of current fatigue, general fatigue and worst fatigue were moderate in inpatients, and they were mild to moderate in outpatients. The mean score of FACT-general was 17.57 in overall with the lowest level of functional well-being, and 15.68 and 19.29 in inpatients and outpatients. Conclusions: The occurrence based on the ICD-10 CRF criteria was relative low compared to self-report. Fatigue interfered patients’ enjoyment of life and the patients had the lowest level of quality of life in functional well-being. Healthcare providers should pay attention on how to decrease cancer patients’ fatigue in order to improve their QOL, especially in inpatients.
Patients’ perceptions of early palliative oncology care: A qualitative analysis.
Authors: Breffni Hannon, Nadia Swami, Monika Krzyzanowska, Natasha B. Leighl, Amit M. Oza, Malcolm J. Moore, Gary Rodin, Ian Tannock, Camilla Zimmermann
Journal: Journal of Clinical Oncology (2013)

e20639 Background: Early palliative care referral is encouraged for patients with advanced cancer. However, little is known about patients’ perceptions of the impact and relevance of early referral. We conducted a qualitative study in which patients with advanced cancer were interviewed following completion of a randomized controlled trial comparing early palliative care with standard oncology care. Our aim was to delineate what, in the opinion of patients, were the respective roles of the oncology and palliative care teams in an outpatient setting. Methods: We conducted qualitative interviews with patients following completion of a cluster randomised controlled trial of early versus routine palliative care referral. Participants were recruited from 24 medical oncology clinics at a comprehensive cancer center. Selective sampling was employed to ensure equivalent numbers of participants from intervention vs. control arms, male vs. female, age ≥60 vs. &lt;60 years, with high vs. low self-reported quality of life, and with high vs. low satisfaction with care. Forty-eight patients (26 intervention and 22 control) with advanced lung, breast, gynecological, gastrointestinal and genitourinary cancers completed interviews lasting 25 to 90 minutes. Control patients were asked about the role of oncology; intervention patients were asked about both teams. Interviews were recorded, transcribed and analysed using NVivo. A grounded theory approach was used to explore emerging themes. Results: Several themes emerged in relation to the contrast between oncology (OC) and palliative care (PC) including (1) the focus of the consultation, with OC tending to focus on cancer or treatment options while PC was regarded as being more holistic, including physical, psychological and family domains; (2) the model of care delivery, with OC described as being clinician-led and time-limited, in contrast with PC where time was more flexible and the patient set the agenda; and (3) the complementary nature of early palliative care alongside standard oncology care in terms of overall well-being. Conclusions: From a patient perspective, palliative care and medical oncology have distinct and complementary roles, supporting the relevance of early referral.