SWOG S1815: A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers.

Purpose: SWOG S1815 was a randomized, open label phase III trial, evaluating gemcitabine, nab-paclitaxel, and cisplatin (GAP) versus gemcitabine and cisplatin (GC) in patients with newly diagnosed advanced biliary tract cancers (BTCs).

Methods: Patients with newly diagnosed locally advanced unresectable or metastatic BTC, including intrahepatic cholangiocarcinoma (ICC) and extrahepatic cholangiocarcinoma (ECC) and gallbladder carcinoma (GBC), were randomly assigned 2:1 to either GAP (gemcitabine 800 mg/m, cisplatin 25 mg/m, and nab-paclitaxel 100 mg/m intravenously once per day on days 1 and 8 of a 21-day cycle) or GC (gemcitabine 1,000 mg/m and cisplatin 25 mg/m intravenously once per day on days 1 and 8 of a 21-day cycle).

Results: Among 452 randomly assigned participants, 441 were eligible and analyzable, 67% with ICC, 16% with GBC, and 17% with ECC.

Patient care in complex Sociotechnological ecosystems and learning health systems.

The learning health system (LHS) model was proposed to provide real-time, bi-directional flow of learning using data captured in health information technology systems to deliver rapid learning in healthcare delivery. As highlighted by the landmark National Academy of Medicine report "Crossing the Quality Chasm," the U.S.

An Assessment of the Feasibility and Utility of an ACCC-ASCO Implicit Bias Training Program to Enhance Racial and Ethnic Diversity in Cancer Clinical Trials.

Purpose: Cancer trial participants do not reflect the racial and ethnic diversity in the population of people with cancer in the United States. As a result of multiple system-, patient-, and provider-level factors, including implicit bias, cancer clinical trials are not consistently offered to all potentially eligible patients.

Materials And Methods: ASCO and ACCC evaluated the utility (pre- and post-test knowledge changes) and feasibility (completion rates, curriculum satisfaction metrics, survey questions, and interviews) of a customized online training program combined with facilitated peer-to-peer discussion designed to help research teams identify their own implicit biases and develop strategies to mitigate them.

Increasing Racial and Ethnic Diversity in Cancer Clinical Trials: An American Society of Clinical Oncology and Association of Community Cancer Centers Joint Research Statement.

A concerted commitment across research stakeholders is necessary to increase equity, diversity, and inclusion (EDI) and address barriers to cancer clinical trial recruitment and participation. Racial and ethnic diversity among trial participants is key to understanding intrinsic and extrinsic factors that may affect patient response to cancer treatments. This ASCO and Association of Community Cancer Centers (ACCC) Research Statement presents specific recommendations and strategies for the research community to improve EDI in cancer clinical trials.

The Effect of Disclosing Life Expectancy Information on Patients' Prognostic Understanding: Secondary Outcomes From a Multicenter Randomized Trial of a Palliative Chemotherapy Educational Intervention.

Context: Many advanced patients with cancer have unrealistic prognostic expectations.

Objectives: We tested whether offering life expectancy (LE) statistics within palliative chemotherapy (PC) education promotes realistic expectations.

Methods: In this multicenter trial, patients with advanced colorectal and pancreatic cancers initiating first or second line PC were randomized to usual care versus a PC educational tool with optional LE information.

Effectiveness of a Multimedia Educational Intervention to Improve Understanding of the Risks and Benefits of Palliative Chemotherapy in Patients With Advanced Cancer: A Randomized Clinical Trial.

Importance: Despite requirements of informed consent, patients with advanced cancer often receive palliative chemotherapy (PC) without understanding that the likelihood of cure is remote.

Objective: To determine whether a PC educational video and booklet at treatment initiation could improve patients' understanding of its benefits and risks.

Interventions: Regimen-specific PC videos and booklets presenting information about logistics, potential benefits, life expectancy (optional), adverse effects, and alternatives.

Phase 1 Study of Neoadjuvant Short-Course Radiation Therapy Concurrent With Infusional 5-Fluorouracil for the Treatment of Locally Advanced Rectal Cancer.

Purpose: To assess the safety and feasibility of neoadjuvant short-course radiation therapy (RT) concurrent with continuous infusion 5-fluorouracil (5-FU) for the treatment of locally advanced rectal cancer.

Methods And Materials: Patients with cT3-4 or N + rectal adenocarcinoma based on ultrasound or magnetic resonance imaging were prospectively enrolled in this study. Study treatment consisted of continuous infusion 5-FU combined with short-course RT (5 Gy x 5 fractions) followed by 4 cycles of mFOLFOX, total mesorectal excision (TME), and 6 cycles of adjuvant mFOLFOX.

Patient access to clinical notes in oncology: A mixed method analysis of oncologists' attitudes and linguistic characteristics towards notes.

Background: Providers have expressed concern about patient access to clinical notes. There is the possibility that providers may linguistically censor notes knowing that patients have access.

Purpose: Qualitative interviews and a pre- and post- linguistic analysis of the implementation of OpenNotes was performed to determine whether oncologists changed the content and style of their notes.

Adjuvant radiation therapy for T4 non-rectal colon adenocarcinoma provides a cause-specific survival advantage: A SEER database analysis.

Purpose: While there is no level 1 evidence supporting the use of adjuvant radiotherapy (RT) for non-rectal colon cancer in the modern chemotherapy era, there are studies that suggest a local control benefit. This treatment modality is not part of standard treatment recommendations, and we hypothesized that adjuvant RT provides a benefit in locally advanced disease. Due to the limited number who receive post-operative RT, a national database was searched to provide sufficient power.

Bivalirudin with a post-procedure infusion versus heparin monotherapy for the prevention of stent thrombosis.

Objectives: To evaluate the efficacy of post-primary percutaneous coronary intervention (PCI) bivalirudin infusion (at full PCI dose) to prevent stent thrombosis (ST) compared with heparin monotherapy.

Background: Early randomized controlled trials (RCTs) have shown that compared with heparin use, bivalirudin use during primary PCI is associated with an increased risk of ST. However, bivalirudin was stopped in those trials at the end of the procedure and glycoprotein IIb/IIIa inhibitors (GPIs) were routinely used with heparin.

Identifying How Patient Portals Impact Communication in Oncology.

Patient portals are becoming widespread throughout health-care systems. Initial research has demonstrated that they positively impact patient-provider communication and patients' health knowledge, but little is known about the impact of patient portals in the cancer setting, where highly complex and uncertain medical data are available for patients to view. To better understand communicative behaviors and perceptions of the patient portal and how it is utilized in oncology, in-depth, semi-structured interviews were conducted with 48 participants: 35 patients and 13 oncologists.

OpenNotes in oncology: oncologists' perceptions and a baseline of the content and style of their clinician notes.

Patients' ability to access their provider's clinical notes (OpenNotes) has been well received and has led to greater transparency in health systems. However, the majority of this research has occurred in primary care, and little is known about how patients' access to notes is used in oncology. This study aims to understand oncologists' perceptions of OpenNotes, while also establishing a baseline of the linguistic characteristics and patterns used in notes.

Implications of Patient Portal Transparency in Oncology: Qualitative Interview Study on the Experiences of Patients, Oncologists, and Medical Informaticists.

Background: Providing patients with unrestricted access to their electronic medical records through patient portals has impacted patient-provider communication and patients' personal health knowledge. However, little is known about how patient portals are used in oncology.

Objective: The aim of this study was to understand attitudes of the portal's adoption for oncology and to identify the advantages and disadvantages of using the portal to communicate and view medical information.

Effect of post-primary percutaneous coronary intervention bivalirudin infusion on net adverse clinical events and mortality: A comprehensive pairwise and network meta-analysis of randomized controlled trials.

Objective: To compare the efficacies of various post-percutaneous coronary intervenetion (PCI) bivalirudin doses on net adverse clinical events (NACEs) and mortality.

Background: In primary PCI, lower risk of bleeding with bivalirudin (vs. unfractionated heparin [UFH]) is counterbalanced by an increased risk of acute stent thrombosis (ST).

An updated comprehensive meta-analysis of bivalirudin vs heparin use in primary percutaneous coronary intervention.

Background: Despite several randomized controlled trials and meta-analyses, the ideal anticoagulant for patients undergoing primary percutaneous coronary intervention (PCI) remains controversial. We performed an updated meta-analysis including recently reported randomized clinical trials that compare bivalirudin and heparin with or without provisional administration of a glycoprotein IIb/IIIa inhibitor (GPI) for primary PCI.

Methods And Results: Scientific databases and Web sites were searched for randomized clinical trials.

Phase II study of docetaxel and gefitinib as second-line therapy in gemcitabine pretreated patients with advanced pancreatic cancer.

Background: There is no standard second-line therapy for advanced pancreatic cancer (APC). We evaluated the epidermal growth factor receptor (EGFR) inhibitor gefitinib and docetaxel in a phase II study following gemcitabine failure.

Methods: EGFR overexpression was not required.

Phase II study of rubitecan, an oral camptothecin in patients with advanced colorectal cancer who have failed previous 5-fluorouracil based chemotherapy.

Background: Rubitecan (RFS-2000, 9NC, Orathecin) is an orally bioavailable camptothecin analogue, with evidence of preclinical activity in colon cancer cell lines. We evaluated oral rubitecan (5 days on, 2 days rest per week) on a continuous schedule, in patients with advanced colorectal cancer (CRC), who progressed after 5-fluorouracil based chemotherapy.

Patients And Results: Fourteen eligible patients were treated with rubitecan at 1.

A phase I/II study of trimetrexate and capecitabine in patients with advanced refractory colorectal cancer.

Objective: We tested the hypothesis that the combination of trimetrexate (TMTX) and capecitabine (CAP) would be active in patients with previously treated metastatic colorectal cancer (CRC). Because the optimum dose of this combination was unknown, we used a phase I/II design.

Methods: In the phase I cohort, patients received 110 mg/m2 TMTX intravenously weekly x6 and CAP starting at 750 mg/m2 orally twice daily from days 2 to 15 and 23 to 36 (one cycle).

Phase I and pharmacokinetic study of vinblastine and high-dose megestrol acetate.

Purpose: Preclinical data indicate that progestational agents (progesterone, medroxyprogesterone acetate and megestrol acetate) interact with p-glycoprotein (P-gp) and reverse P-gp-associated resistance to vinca alkaloids and other natural products. Based on these data, we performed a phase I study of high-dose oral megestrol acetate and vinblastine to evaluate the safety of this regimen.

Patients And Methods: Enrolled in the study were 61 patients with advanced solid tumors, refractory to standard therapy.