tbuckley/cabot-search huggingface dataset:
Chemoradiation for locally advanced perihilar cholangiocarcinoma.
Authors: Seungtaek Lim, Hye Jin Choi, Jinsil Seong
Journal: Journal of Clinical Oncology (2014)

372 Background: Locally advanced perihilar cholangio-carcinoma (LA-PHC) is a rare malignancy with dismal prognosis, and chemoradiation (CRT) is used to palliate symptoms and extend survival. However, its role has not been established due to the rarity of these tumors. We intended to investigate the efficacy of chemo-concurrent radiotherapy (CRT) for patients with LA-PHC. Methods: This study included 52 patients who received CRT for LAPHC in a single institue. Patients received external beam radiotherapy with a median dose of 50.4Gy (range, 720-5400) with gemcitabine or 5-FU (or its analogues). The objective response rate (ORR), disease control rate (DCR), and overall survival (OS) were evaluated. All statistical analysis were performed by SPSS program version 18.0. Results: The median OS was 14.2 months (95% CI, 8.9~19.5). The ORR and DCR was 12% and 85%, respectively. Thirteen patients (19%) whose disease were converted to resectable after CRT had a significant survival advantage compared to patients who underwent CRT alone (29.2 vs. 10.8 months, P=0.005). CA 19-9 response (defined as more than 30% decrease in the CA 19-9 level compared to baseline) at 1month after CRT predicted prolonged survival (Table). CRT was generally well tolerated. Although gemcitabine-based CRT had a higher ORR, DCR, and CA 19-9 response at 1 month than 5FU-based CRT, the difference was not statistically different, and there was no difference in OS between two regimens. Moreover, patients treated with gemcitabine based CRT suffered more severe hematologic toxicity (grade 3 or 4 neutropenia, 20% vs. 4%). Conclusions: This study suggested that CRT is a good therapeutic option in the treatment of LA-PHC. Also, CA 19-9 response 1 month after completion of CRT was identified as a predictive marker of survival in patients who underwent CRT. Further research is warranted regarding optimal chemotherapy regimen, and schedule of radiation. [Table: see text]
Equity in patient-provider communication regarding treatment-related symptoms and health-related quality of life (HRQOL) among breast cancer survivors.
Authors: Cleo A. Samuel, Jennifer Schaal, Linda Robertson, Eugenia Eng, Jemeia G Kollie, Christina Yongue, Karen Foley, Beth Smith, Mellissa K Yee, Kristin Black, Katrina Ellis, Lucretia Hoffman, Alexandra Lightfoot, Claire Morse, Neda Padilla, Sam Cykert
Journal: Journal of Clinical Oncology (2016)

127 Background: Compared with white breast cancer patients, black patients more often report inadequate symptom control and decrements in health-related quality of life (HRQOL). Racial differences in patient-provider communication (PPC) are well-documented and linked to worse health outcomes for minorities; however, less is known about inequities in symptom and HRQOL discussions among cancer patients and providers. As part of an NCI-funded systems change intervention to improve racial equity in treatment completion among Black and White cancer patients, we assessed racial differences in PPC regarding treatment-related symptoms, HRQOL issues (e.g., physical, psychosocial, financial, and spiritual well-being), and symptom management among breast cancer survivors (BCS). Methods: We conducted 6 focus groups (FGs) and semi-structured interviews with 22 stage 1-3 BCS (3 black FGs; 3 white FGs) from 2 cancer centers. Guided by a community-based participatory research approach, our diverse community-academic-medical team facilitated FGs and conducted qualitative analyses. Results: Although both black and white BCS reported multiple treatment-related symptoms and changes in HRQOL, perspectives on PPC differed. Some black and white BCS described positive aspects of PPC, including providers’ thorough explanations of treatment side effects and responsiveness to symptom concerns. However, white BCS expressed greater satisfaction with PPC, while black BCS more often described concerns regarding providers’ verbal (e.g., nondisclosure, dismissiveness) and non-verbal communication (e.g., unapproachability, poor eye contact) skills in the context of symptom management. Most BCS, regardless of race, indicated that providers typically discussed physical symptoms/HRQOL issues, but often failed to mention non-physical side effects of treatment (e.g., social isolation, financial toxicity). Conclusions: Racial differences in PPC exist among BCS and may contribute to inequities in symptom management and HRQOL. Inadequate communication regarding non-physical symptoms likely represents a critical missed opportunity for improving the quality and equity of palliative care.
Effect of postoperative complications on adjuvant chemotherapy use in stage III colon cancer.
Authors: Ryan P Merkow, David J Bentrem, Mary Frances Mulcahy, Clifford Y. Ko, Karl Y. Bilimoria
Journal: Journal of Clinical Oncology (2012)

3608 Background: The National Quality Forum has endorsed the use of adjuvant chemotherapy in stage III colon cancer, yet a substantial treatment gap exists in the United States. Our objective was to evaluate the contribution of postoperative complications on the use of adjuvant therapy after colectomy for cancer. Methods: Patients from the National Surgical Quality Improvement Program and the National Cancer Data Base who underwent colon resection for cancer were linked (2006-2008). The association of complications on adjuvant chemotherapy use was assessed using multivariable regression models. Results: From 140 hospitals, 2368 patients underwent resection for stage III colon adenocarcinoma. Overall, 36.8% (871/2,368) patients were not treated with adjuvant therapy, of which 47.8% (416/871) had documented severe comorbidities or advanced age (≥80) as the reason for no adjuvant therapy receipt. Of the remaining 455 patients, 21.3% (97/455) had ≥1 serious complication that could account for adjuvant therapy omission. The remaining 41.1% (358/871) patients did not have a documented reason for not recieving adjuvant therapy. Complications associated with adjuvant therapy omission were abscess/anastomotic leak (OR 1.91, 95% CI 1.02-3.59), renal failure (OR 7.16, 95% CI 1.92-26.79), prolonged ventilation (OR 7.92, 95% CI 2.97-21.13), re-intubation (OR 5.69, 95% CI 2.13-15.18), and pneumonia (OR 4.05, 95% CI 2.07-7.90). Abscess/anastomotic leak was associated with a 28-day delay in time to adjuvant chemotherapy (73 vs. 45 days, p&lt;0.05). Superficial surgical site infection did not decrease adjuvant therapy receipt but delayed the time to its use (57 vs. 44 days, p&lt;0.05). The occurrence of postoperative sepsis was associated with a 15-day delay to adjuvant chemotherapy (60 vs. 45 days, p&lt;0.05). Conclusions: Serious postoperative complications explained nearly one quarter of the adjuvant chemotherapy treatment gap among stage III colon cancer patients. Postoperative complications affect treatment utilization and should be considered when calculating adherence with the Stage III adjuvant therapy for colon cancer measure. Judging provider performance using quality metrics is challenging without clinical data.
Oncology health care and patient out-of-pocket cost trends in a commercially insured population
Authors: V. J. Willey, M. F. Pollack, G. D. Lawless
Journal: Journal of Clinical Oncology (2008)

6503 Background: Health care costs continue to rise at the same time health care purchasers are requesting new benefit designs with greater patient cost sharing. This study examined the cost trends associated with health care in oncology patients, the cost drivers, and level of out-of-pocket (OOP) costs from 2003 to 2006. Methods: This retrospective cohort study identified oncology patients from January 1, 2003 to December 31, 2006 from a large US health plan database. Patients with 2 or more medical claims with an ICD-9 code for four common cancers (breast, colorectal, lung & non-Hodgkin's lymphoma) were included. Health plan and patient paid amounts were collected for the periods that patients were continuously enrolled in the health plan after diagnosis. Costs were summed by year, stratified into various medical service and drug categories, and means were calculated in the diagnosis year (Index Year) and throughout their continuous enrollment (Complete History). Results: A total of 74,630 patients were identified. Health plan paid Index Year costs rose 57% over the 4 years and 13% in the Complete History group. Patient OOP costs increased at a greater rate over the period (Index Year = 109%, Complete History = 37%), with OOP Index Year costs rising 54% to over $5,000 in 2006 (Table). Medical services costs were the major cost driver in the Index Year and Complete History groups, with drugs accounting for 23 and 30% of total costs, respectively. Biologic drugs were approximately 10% of costs in each group with a trend of increasing costs for therapeutic biologics and decreasing costs for supportive care biologics. Conclusions: Health care costs in the year of cancer diagnosis have risen sharply from 2003 to 2006 while costs for oncology patients in all phases of treatment have risen modestly. OOP costs for oncology patients have risen at a much greater rate than health plan costs; especially in 2006 as “high deductible” plans have become more common. It will be important to study the impact of this increased OOP burden on clinical outcomes. Health Plan Paid and Patient Out-of-Pocket (OOP) Costs by Year Year Index Year Complete History Plan Paid Patient OOP Plan Paid Patient OOP Costs ($) YOY % Change Costs ($) YOY % Change Costs ($) YOY % Change Costs ($) YOY % Change 2003 37,504 2,434 24,335 1,937 2004 41,505 10.7 2,666 9.6 25,554 5.0 2,097 8.2 2005 53,099 27.9 3,303 23.9 25,949 1.5 2,172 3.6 2006 57,657 8.6 5,094 54.3 27,044 4.2 2,646 22.3 Overall Trend 57% 109% 13% 37% YOY % Change = year over year percentage change in costs Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Amgen
Nab-paclitaxel (Nab-P) and gemcitabine (G) as first-line chemotherapy (CT) in advanced pancreatic cancer (APDAC) elderly patients (pts): A “real-life” study.
Authors: Guido Giordano, Vanja Vaccaro, Eleonora Lucchini, Gianna Musettini, Paola Bertocchi, Francesca Bergamo, Elisa Giommoni, Matteo Santoni, Marco Russano, Serena Campidoglio, Daniele Santini, Alberto Zaniboni, Vittorina Zagonel, Stefano Cascinu, Enrico Vasile, Davide Melisi, Michele Milella, Antonio Febbraro
Journal: Journal of Clinical Oncology (2015)

424 Background: Nab-P and G represents a standard of care in first line APDAC treatment. Neverthless, activity, efficacy and safety of Nab-P + G have not been established in elderly pts and clinical trials on APDAC treatment contain fewer elderly pts compared with everyday clinical practice. Aim of this analysis is to evaluate outcomes and toxicities of elderly pts treated with first line Nab-P + G in a “real world” population. Methods: Clinical records of APDAC pts receiving Nab-P 125 mg/m 2 and G 1000 mg/m 2 on days 1,8 and 15 of a 28 day cycle as first line CT were retrospectively reviewed, investigating activity (Disease Control Rate, DCR: Stable Disease + Partial Response + Complete Response, SD+PR+CR), efficacy (Progression Free Survival, PFS and Overall Survival, OS) and safety. Analysis was then performed in ≥ 70 years group of pts. OS and PFS were estimated with Kaplan-Meyer method with 95% CI. Cox-regression model was applied to the data with univariate and multivariate approach. Results: 105 pts (M/F:58/47), median age 64 (range 37-77) ECOG Performance Status of 0/1/2: 46/41/17 respectively were included in our analysis. 37 pts (35%) were ≥ 70 years old. In overall population Nab-P+G was administered for a median number of 6 cycles (range 1-12). 4 CR, 24 PR and 28 SD were observed (DCR: 53%), median PFS was 7 months (95% C.I. 5.93 - 8.08) and median OS was 11 months (95% C.I. 9.58 – 12.41). Pts aged ≥ 70 received a median number of 5 cycles (range 1 - 10). DCR was 48% (9 PR + 9 SD) with no differences in PFS (6.5 months, 95%C.I. 5.36 – 7.64, p=0.49) and OS (10 months, 95% C.I. 8.53 – 11.47 p=0.67) with &lt; 70 years old pts. Treatment was mildly tolerated and toxicity profile appeared to be different in elderly pts than younger ones with more G3-4 non-haematological (27% vs 15% p=0.03) and fewer haematological (12% vs 29% p=0.004) events respectively. Conclusions: These data, evaluated under daily practice conditions, in absence of clinical trials on APDAC elderly pts, show that pts aged ≥ 70 may benefit of first-line Nab-P and G combination, as well as younger ones, both in terms of response and survival experiencing a tolerable, but significantly different toxicity profile.
Combination of 5FU-based chemoradiation with EGFR inhibitor cetuximab and effect on PCR rate in patients undergoing neoadjuvant treatment in advanced rectal cancer.
Authors: Robert Semrau, Martin Kocher, Daniel Vallbohmer, Arnulf Hoelscher
Journal: Journal of Clinical Oncology (2014)

623 Background: Neoadjuvant chemoradiation is a standard treatment for advanced rectal cancer patients. Here, we investigate whether treatment combined with the EGFR inhibitor cetuximab could enhance prognosis. Safety and efficacy (pathohistological regression rate, pCR) of chemoradiation in combination with cetuximab were evaluated. Methods: In a single-center phase I/II study patients with adenocarcinoma of the rectum (up to 16 cm above the anal verge) in stage cT3-4, cN0-1, were treated with cetuximab (weekly 250mg/m 2 , loading dose 400mg/m 2 ) combined with radiotherapy (50,4Gy in 28 fractions) and 5-FU. Maximal tolerated dose of 5FU in combination with cetuximab and radiotherapy was determined in a phase I part (3+3 design; dose level 1: 750 mg/m 2 5FU days 1-5 and 29-33; dose level 2: 1000 mg/m 2 5FU days 1-5 and 29-33. Surgery was performed between 4 to 6 weeks after combined treatment. pCR rate of tumor cells was determined after surgery. Results: 20 patients were included into the trial, 19 patients received treatment: In the phase I part 2 out of 6 patients in level 2 experienced dose limiting toxicities (thrombocytopenia and diarrhea grade 3). Therefore, dose level 1 was considered safe for further enrollment. All 19 patients received the complete course of radiotherapy (50,4Gy). 15 patients received the complete cetuximab schedule, one patient discontinued after an allergic reaction at the first infusion, 3 patients missed 1 cycle of cetuximab in week 3 or 6. 18 patients continued to surgery. Sphincter preservation surgery was performed in 12 patients (63.2%), R0-resection rate was 100%. pCR grade IV (pCR) was documented in 1 patient (5,5%), grade III in 4 patients and grade I and II in 13 patients. So far no local recurrences occurred, 4 patients died (3 patients due to metastatic disease progression). Conclusions: The MTD of 5FU in combination with radiotherapy and cetuximab was 750mg/m 2 . Treatment was well tolerated and did not alter surgical management. However, pCR-rate was not elevated compared to standard 5FU-based preoperative chemoradiation. Whether the addition of cetuximab improves prognosis in this group of patient remains unclear. Clinical trial information: 2005-004139-23.
Perioperative treatment for locally advanced rectal carcinoma (LARC) in elderly patients: Evaluation of compliance, tolerability, and outcome in a Spanish referral institution.
Authors: G. Argiles, O. Castillo, B. Navalpotro, E. Espin, D. Moreno-Fernandez, T. Macarulla, M. E. E. Fernandez, M. Alsina, R. Gallego, G. Sánchez-Ollé, J. Giralt, J. Tabernero, J. Capdevila
Journal: Journal of Clinical Oncology (2011)

e19650 Background: Rectal cancer is a major cause of death. It is known that after 70y old each increment of 5y increases cancer-specific mortality in a 30%. A possible explanation for this poorer outcome relates to a less aggressive treatment approach. Perioperative chemoradiotherapy (CHRT) and radical surgery is the standard of care for LARC. We report a comparative analysis evaluating the compliance, tolerability and outcome of the preoperative treatment for LARC between patients (pts) ≥70y and <70y. Methods: We analyzed pts with LARC from 01/2008 to 10/2009, treated with neoadjuvant CH (5-FU, capecitabine) with concomitant RT (50.4 Gy/1.8 Gy session) or RT alone (5x5 Gy) followed by surgery and adjuvant CH (5FU or Oxaliplatin-based). Two groups were defined (<70y and ≥70y). We comparatively analyzed the following features: ECOG PS, neoadjuvant and adjuvant treatment, compliance, pre-treatment clinical stage, response, toxicity, type of surgery, pathological stage, disease-free (DFS) and overall survival (OS). Results: Ninety-one pts were analyzed (43 <70y, 48 ≥70y), with comparable baseline characteristics: ECOG (p=0.15), stage at diagnosis (p=0.12), and gender (p=0.85). RT was received by 86% and 77% (p=0.27), and CH was added to RT in 77% and 55% in the <70y and in ≥70y groups (p=0.015), respectively. In elderly cohort, 48% of were unable to complete the treatment compared to 24% in the younger group (p= 0.015, OR 1.47, 95% CI: 1.07-2.02) and had higher toxicity risk (p=0.046, OR=2.09, 95%CI: 0.998-4.44). Capecitabine-based CHRT was more used in ≥70y (79% vs 55%, p=0.056). No significant differences in surgery (p=0.63), mesorectal excision (p=0.65), pathological response (p=0.90), positive lymph nodes (p=0.28), DFS (log rank p=0.33) and OS (log rank p=0.58) were seen between the two groups. Adjuvant CH was administered less frequently in elderly pts (p=0.014, OR 1.62, 95%CI: 1.09-2.40). Conclusions: Although pts ≥70y presented a worse compliance of perioperative therapy this did not jeopardize their outcome. Age should not be considered a determining factor when deciding the best treatment option in a multidisciplinary approach.
A multi-institution phase II trial of irinotecan and carboplatin for extensive or relapsed small-cell lung cancer
Authors: M. T. Huynh, L. Fehrenbacher, H. West, A. Davies, J. Simmons, P. Lara, L. Yarorkovsky, M. Russin, D. Gandara, D. Lau
Journal: Journal of Clinical Oncology (2005)

7169 Purpose: Combined irinotecan and platinum are emerging as a promising regimen for treatment of metastatic small-cell lung cancer (SCLC). We are conducting a multi-institution trial to evaluate the efficacy and toxicity of a novel 21-day schedule of irinotecan and carboplatin in extensive and relapsed SCLC. Methods: To date, 58 patients have enrolled with the following characteristics: male/female, 31/27; median age, 64 years; performance status (PS), 0–1 (81%), 2 (19%). Dosing schemas are based on population-based maximum tolerated doses determined in a previous intrapatient dose-escalation trial (Oncology 17:11–16, 2003). Patients with chemonaive extensive disease (Arm A) are treated with irinotecan 200 mg/m2 and carboplatin AUC of 5; while patients with previously chemotherapy-treated and relapsed disease (Arm B) received irinotecan 150 mg/m2 and carboplatin AUC of 5, every 21 days for 6 cycles. Forty patients are planned for each arm. Results: The most common grade 3/4 toxicity included neutropenia (38%), thrombocytopenia (14%), diarrhea (18%) and nausea/emesis (10%). Grade 3/4 toxicity was not observed in 54% of patients. Among 44 assessable patients, response rates of 68% and 37% were observed, respectively, for Arm A and Arm B. Of note, durable complete response of brain metastases was observed in some patients. Conclusions: The 3-weekly regimen of irinotecan and carboplatin is relatively well tolerated and promising for treatment of extensive or relapsed SCLC. This regimen warrants further evaluation in a phase III trial. No significant financial relationships to disclose.
Pharmacokinetics, activity, and safety of ODM-201 in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer: An open-label phase I trial with long-term extension.
Authors: Christophe Massard, Heidi Penttinen, Petri Bono, Egils Vjaters, Vilnis Lietuvietis, Teuvo L. J. Tammela, Annamari Vuorela, Pirjo Nykänen, Pasi Pohjanjousi, Karim Fizazi
Journal: Journal of Clinical Oncology (2015)

230 Background: The open phase I trial, ARAFOR, with long-term extension evaluated pharmacokinetics (PK), antitumor activity and safety of ODM-201 in chemotherapy-naïve patients with progressive mCRPC. Methods: PK phase: Patients received one 600 mg dose of ODM-201 capsules (6 x 100 mg) in fed state and one dose of either tablet formulation (TabA or TabB, 2 x 300 mg) in fed and fasted state in random order. Extension: Patients received ODM-201 600 mg (capsule) twice daily until disease progression/ intolerable adverse event (AE). A data cut-off date Apr 4, 2014 was used for analyses. Results: 30 patients were enrolled in PK and treated in the extension phase. Baseline characteristics: median age 68 yrs, ECOG score 0 in 67%, and ECOG 1 in 33% patients, median PSA 18.2 ng/mL. Median time from PC diagnosis to start of ODM-201 treatment was 39 months. Median time on ODM-201 treatment was 9.5 months (trial is on-going). ODM-201 plasma concentration–time curves were similar for the capsule, TabA, and TabB at fed state. Median t max at fed state was longer than in fasted state (5–6 h vs. 4 h). Absorption was slower and plasma exposure about 2-fold greater at fed state compared to fasted state (AUC t , AUC ¥ and C max values). All 30 patients completed the first 12 weeks of the extension phase. Prostate-specific antigen (PSA) responses (≥50% reduction from baseline) were seen in 25 (83%) patients (PSA reductions ≥90% in 9 [30%] patients). At 12 weeks, RECIST responses in soft tissue were noted in 6 patients (29%) and stable disease in 13 (62%) patients, 3 (11%) had improvement in skeletal metastases and 18 (67%) stabilised bone disease. 21 (70%) reported at least 1 AE, and treatment-related AEs occurred in 6 (20%) patients. No treatment-related AEs of grade 2 or higher were reported. Conclusions: Tablet and capsule formulations showed comparable single-dose pharmacokinetics. Dose level of 600 mg twice daily (capsule) showed significant antitumor activity and had a favourable safety profile. Updated results from the extension phase will be presented. A phase 3 ARAMIS trial at a dose of 600 mg twice daily in men with non-metastatic CRPC is currently ongoing. Clinical trial information: NTC01784757.
Phase I study of the anti-VEGFR-3 monoclonal antibody IMC-3C5 in subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy is available.
Authors: R. E. Martell, E. G. Chiorean, H. Youssoufian, M. D. Rutstein, B. Pytowski, L. Benjamin, L. Abad, J. Patel, T. Steele, M. Dowd, A. Qin, C. F. Kukel, F. E. Fox, A. Dontabhaktuni, A. Morozov
Journal: Journal of Clinical Oncology (2011)

TPS150