Disease Site Group Research Articles

ACR-ARS Practice Parameter for the Performance of Proton Beam Therapy

PurposeThis practice parameter for the performance of proton beam radiation therapy was revised collaboratively by the American College of Radiology (ACR) and the American Radium Society (ARS). This practice parameter was developed to serve as a tool in the appropriate application of proton therapy in the care of cancer patients or other patients with conditions in which radiation therapy is indicated. It addresses clinical implementation of proton radiation therapy, including personnel qualifications, quality assurance (QA) standards, indications, and suggested documentation. Materials and MethodsThis practice parameter for the performance of proton beam radiation therapy was developed according to the process described under the heading The Process for Developing ACR Practice Parameters and Technical Standards on the ACR website (https://www.acr.org/Clinical-Resources/Practice-Parameters-and-Technical-Standards) by the Committee on Practice Parameters – Radiation Oncology of the ACR Commission on Radiation Oncology in collaboration with the ARS. ResultsThe qualifications and responsibilities of personnel, such as the proton center Chief Medical Officer or Medical Director, Radiation Oncologist, Radiation Physicist, Dosimetrist and Therapist, are outlined, including the necessity for continuing medical education. Proton therapy standard clinical indications and methodologies of treatment management are outlined by disease site and treatment group (e.g. pediatrics) including documentation and the process of proton therapy workflow and equipment specifications. Additionally, this proton therapy practice parameter updates policies and procedures related to a quality assurance and performance improvement program (QAPI), patient education, infection control, and safety. ConclusionAs proton therapy becomes more accessible to cancer patients, policies and procedures as outlined in this practice parameter will help ensure quality and safety programs are effectively implemented to optimize clinical care.

An Ontario Health (Cancer Care Ontario) Clinical Practice Guideline: Surveillance Strategies in Patients with Stage I, II, III or Resectable IV Melanoma Who Were Treated with Curative Intent

AimsTo make recommendations on managing the surveillance of patients with stage I, II, III or resectable IV melanoma who are clinically free of disease following treatment with curative intent. Materials and methodsThis guideline was developed by Ontario Health's (Cancer Care Ontario's) Program in Evidence-Based Care and the Melanoma Disease Site Group (including seven medical oncologists, four surgical oncologists, three dermatologists, one radiation oncologist and one patient representative). The MEDLINE, EMBASE, Cochrane Library, PROSPERO databases and the main relevant guideline websites were searched. Internal and external reviews were conducted, with final approval by the Program in Evidence-Based Care and the Melanoma Disease Site Group. The Grading of Recommendations, Assessment, Development and Evaluation approach was followed, and the Modified Delphi method was used. ResultsBased on the current evidence (eight eligible original study papers and four relevant guidelines) and the clinical opinions of the authors of this guideline, the initial recommendations were made. To reach 75% agreement for each recommendation, the Melanoma Disease Site Group (16 members) voted twice and one recommendation was voted on three times. After a comprehensive internal and external review process (including national and international reviewers), 12 recommendations, three weak recommendations and six qualified statements were ultimately made. ConclusionsAfter a systematic review, a comprehensive internal and external review process and a consensus process, the current guideline has been created. The guideline authors believe that this guideline will help clinicians, patients and policymakers make well-informed healthcare decisions that will guide them in clinical melanoma surveillance and ultimately assist in improving patient outcomes.

Improving the quality of self-management support in ambulatory cancer care: a mixed-method study of organisational and clinician readiness, barriers and enablers for tailoring of implementation strategies to multisites

IntroductionImproving the quality of self-management support (SMS) for treatment-related toxicities is a priority in cancer care. Successful implementation of SMS programmes depends on tailoring implementation strategies to organisational readiness factors...

Abstract 26: A novel electronic platform to improve clinical trial workflow and screening

Abstract Background: Early-phase clinical trials are increasingly complex, with “seamless” phase I/II trial designs that include multiple parallel disease and/or biomarker-selected expansion cohorts. Challenges for participating sites in phase 1 (P1) trials include rapid identification of patients for available trial slots, high screen failure (SF) rates, and workload distribution among nurses and data coordinators. The Princess Margaret (PM) Cancer Centre Solid Tumor P1 program is the largest early-phase clinical trial program in Canada. There are currently 53 actively recruiting clinical trials, and approximately 250-300 patients are enrolled annually. To improve operational efficiency at the point of care, we designed a novel electronic platform, termed Phase One Spot Tracker (POST). Methods: An electronic, password-restricted, web-based tracker and smartphone-enabled app was created using PHP Laravel, JavaScript (iOS), and Java (Android). The intention was to replace the two previously used Excel spreadsheets, where one listed the trial information and the other included available slot allocations by trial. These spreadsheets were cumbersome to use in clinic, without the ability to search or filter. POST enabled all users to access the data from any computer or phone, increased the ease of updating information in real time, and functioned as a search engine to locate available spots more quickly. It contains specific information including brief trial description, key eligibility criteria, biopsy requirements, status of trial slots (e.g., screening, available, pending, etc.). The data security of POST is ensured by Amazon Web Services. Results: Prior to launching POST, three time-measured simulations showed that it reduced the coordinators’ workload to update trial information by 30 minutes. Currently POST is used by 65 users, including 7 physicians, 14 nurses, and 29 coordinators at the PM Cancer Centre. POST is used by investigators during a weekly P1 new patient consultation clinic to identify trial candidates as well as in weekly P1 team meetings to review all patients enrolled and approached for clinical trials. We are enhancing the POST platform to enable tracking of SF (patients who undergo study-specific screening procedures but are not enrolled in a clinical trial), timeline for replacing patients who screen fail, and reasons for SF. Conclusions: POST is an electronic, smart phone-enabled platform that can be implemented at the point of care for early-phase clinical trials. POST can also provide real-time tracking data about operational metrics (startup time, screening time, enrollment data, nursing and data coordinator workload, and screen failures) that can be used to drive quality improvement. POST can be extended to other disease site groups as well as to other institutions. This will eventually lead to an increase in work efficiency and provide a better quality of care for cancer patients. Citation Format: Ramy R. Saleh, Olivia Chan, Silvi Kuld, Patrick Marban, Anna Spreafico, Aaron Hansen, Albiruni Razak, Lillian L. Siu, Philippe L. Bedard. A novel electronic platform to improve clinical trial workflow and screening [abstract]. In: Proceedings of the AACR Special Conference on Advancing Precision Medicine Drug Development: Incorporation of Real-World Data and Other Novel Strategies; Jan 9-12, 2020; San Diego, CA. Philadelphia (PA): AACR; Clin Cancer Res 2020;26(12_Suppl_1):Abstract nr 26.

Locoregional management of in-transit metastasis in melanoma: an Ontario Health (Cancer Care Ontario) clinical practice guideline.

The purpose of this guideline is to provide guidance on appropriate management of satellite and in-transit metastasis (itm) from melanoma. The guideline was developed by the Program in Evidence-Based Care (pebc) of Ontario Health (Cancer Care Ontario) and the Melanoma Disease Site Group. Recommendations were drafted by a Working Group based on a systematic review of publications in the medline and embase databases. The document underwent patient- and caregiver-specific consultation and was circulated to the Melanoma Disease Site Group and the pebc Report Approval Panel for internal review; the revised document underwent external review. "Minimal itm" is defined as lesions in a location with limited spread (generally 1-4 lesions); the lesions are generally superficial, often clustered together, and surgically resectable. "Moderate itm" is defined as more than 5 lesions covering a wider area, or the rapid development (within weeks) of new in-transit lesions. "Maximal itm" is defined as large-volume disease with multiple (>15-20) 2-3 cm nodules or subcutaneous or deeper lesions over a wide area.■ In patients presenting with minimal itm, complete surgical excision with negative pathologic margins is recommended. In addition to complete surgical resection, adjuvant treatment may be considered.■ In patients presenting with moderate unresectable itm, consider using this approach for localized treatment: intralesional interleukin 2 or talimogene laherparepvec as 1st choice, topical diphenylcyclopropenone as 2nd choice, or radiation therapy as 3rd choice. Evidence is insufficient to recommend intralesional bacille Calmette- Guérin or CO2 laser ablation outside of a research setting.■ In patients presenting with maximal itm confined to an extremity, isolated limb perfusion, isolated limb infusion, or systemic therapy may be considered. In extremely select cases, amputation could be considered as a final option in patients without systemic disease after discussion at a multidisciplinary case conference.■ In cases in which local, regional, or surgical treatments for itm might be ineffective or unable to be performed, or if a patient has systemic metastases at the same time, systemic therapy may be considered.

Systemic adjuvant therapy for adult patients at high risk for recurrent cutaneous or mucosal melanoma: an Ontario Health (Cancer Care Ontario) clinical practice guideline.

Previous versions of the guideline from the Program in Evidence-Based Care (pebc) at Ontario Health (Cancer Care Ontario) recommended that the use of high-dose interferon alfa 2b therapy be discussed and offered to patients with resected cutaneous melanoma with a high risk of recurrence. Subsequently, several clinical trials in patients with resected or metastatic melanoma found that immune checkpoint inhibitors and targeted therapies have a benefit greater than that with interferon. It was therefore considered timely for an update to the guideline about adjuvant systemic therapy in melanoma. The present guideline was developed by the pebc and the Melanoma Disease Site Group (dsg). Based on a systematic review from a literature search conducted using medline, embase, and the Evidence Based Medicine Reviews databases for the period 1996 to 28 May 2019, the Working Group drafted recommendations. The systematic review and recommendations were then circulated to the Melanoma dsg and the pebc Report Approval Panel for internal review; the revised document underwent external review. For patients with completely resected cutaneous or mucosal melanoma with a high risk of recurrence, the recommended adjuvant therapies are nivolumab, pembrolizumab, or dabrafenib-trametinib for patients with BRAF V600E or V600K mutations; nivolumab or pembrolizumab are recommend for patients with BRAF wild-type disease. Use of ipilimumab is not recommended. Molecular testing should be conducted to help guide treatment decisions. Interferon alfa, chemotherapy regimens, vaccines, levamisole, bevacizumab, bacillus Calmette-Guérin, and isolated limb perfusion are not recommended for adjuvant treatment of cutaneous melanoma except as part of a clinical trial.

Tailoring implementation for a cancer self-management support intervention for patients starting chemotherapy.

287 Background: Multiple implementation strategies are described in the literature; however, there is limited consensus on how to best tailor implementation to organizational and clinician readiness. We undertook a mixed-methods evaluation to inform tailored implementation of self-management support (SMS) in ambulatory cancer care as the first phase of a pilot randomized trial of the intervention in patients starting chemotherapy. Methods: Validated surveys, focus groups and interviews were undertaken with key stakeholders (oncologists, nurses, allied health, and administrative leaders) in the lung, colorectal and lymphoma disease site groups at 3 regional cancer centres in Ontario, Canada. Median responses to individual survey questions were classified as an enabler, barrier or neutral based on predetermined cut-offs. Enablers and barriers were triangulated with qualitative data and mapped to the Consolidated Framework for Implementation Research domains. Implementation strategies to address barriers were identified using the Expert Recommendations for Implementing Change tool. Results: Survey respondents represented all stakeholder groups (n = 78; respondent rate = 50%). Minimal variation was noted across stakeholders and centres. Overall, respondents held positive beliefs about the value of SMS, were familiar with the principles of SMS and felt there was a tangible fit among the intervention, individual beliefs, and existing workflows. Suboptimal communication networks and access to information about the adoption of SMS, as well as a lack of organizational commitment to implementing the intervention were identified as key implementation barriers. Qualitative data reinforced quantitative findings, namely that stakeholders value SMS but were unsure if it would translate into reduced treatment toxicities. 46 implementation strategies were identified based on perceived barriers, of which 28 (61%) were common to all 3 centres. Conclusions: Stakeholders at cancer centres acknowledged that SMS is valuable, but potential barriers to integration of SMS into routine ambulatory practice exist. The impact of the tailored implementation plans will be evaluated as part of the trial.

Patient indications for Mohs micrographic surgery: a clinical practice guideline.

The purpose of the present work was to develop evidence-based indications for Mohs micrographic surgery in patients with a diagnosis of skin cancer. The guideline was developed by Cancer Care Ontario's Program in Evidence-Based Care, together with the Melanoma Disease Site Group and the Surgical Oncology Program, through a systematic review of relevant literature, patient- and caregiver-specific consultation, and internal and external reviews. Given a lack of high-quality, comparative evidence, surgery (with postoperative or intraoperative margin assessment) or radiation (for those who are ineligible for surgery) should remain the standard of care for patients with skin cancer. Mohs micrographic surgery is recommended for patients with histologically confirmed recurrent basal cell carcinoma of the face and is appropriate for primary basal cell carcinomas of the face that are larger than 1 cm, have aggressive histology, or are located on the H zone of the face. Mohs micrographic surgery should be performed by physicians who have completed a degree in medicine or equivalent, including a Royal College of Physicians and Surgeons of Canada Specialist Certificate or equivalent, and have received advanced training in Mohs micrographic surgery.

Hepatitis B Virus (HBV) Screening and Associated Outcomes in Malignant Hematology Patients Receiving Rituximab Therapy within the Rossy Cancer Network

Introduction. Hepatitis B Virus (HBV) reactivation is an important risk of Rituximab therapy, a potent immunosuppressant used as part of chemotherapy regimens against non-Hodgkin's lymphoma. HBV reactivation is a potentially fatal complication that can be largely prevented with antiviral prophylaxis and monitoring of HBV DNA. American Society of Clinical Oncology (ASCO) 2015 guidelines recommend that all patients be screened for both hepatitis B core antibody (anti-HBc) and surface antigen (HBsAg) before initiating Rituximab therapy. According to ASCO, the rates of screening for non-Hodgkin's lymphoma patients before the administration of Rituximab were less than 70% in 2014 for US centers participating in ASCO's Quality Oncology Practice Initiative. A 2014/15 study at the McGill University Health Centre found that about a third of patients were inadequately screened (A Lawandi, et al).Methods. The objective of this retrospective study was to assess the quality of HBV screening and monitoring at the partner hospitals of the Rossy Cancer Network (RCN). From the pharmacy database of the Jewish General Hospital, McGill University Health Centre, and St. Mary's Hospital Center, we obtained the set of patients with hematologic malignancies who began Rituximab treatment between April 2014 and March 2016. We then collected laboratory data on the screening of anti-HBc and HBsAg. Screening was considered appropriate if performed for both anti-HBc and HBsAg in the 6-month window preceding Rituximab administration and considered suboptimal if patients were tested outside this time frame, or for only one of the two tests. Additionally, patient chart reviews were used to collect follow-up information and outcomes for screened patients. Follow-up was considered appropriate when anti-viral treatment was given for infected patients and when patients at risk for reactivation received prophylactic treatment or HBV DNA monitoring.Results. Four hundred and seventy-four patients initiated Rituximab-containing treatment. Of those, 213 (45%) met the criteria for appropriate HBV screening and 138 (29%) for suboptimal screening. Of the patients that were screened (N=351), 6 were actively infected (HBsAg+/ anti-HBc+) and 41 were at risk for reactivation (HBsAg-/ anti-HBc+). All actively infected patients received antiviral treatment as per ASCO guidelines but only 18 (44%) of patients at risk for reactivation received appropriate follow-up, prophylactic treatment or HBV DNA monitoring. HBV reactivation was noted in 2 patients, one of whom died of a hepatic flare.Conclusion. Between 2014 and 2016, less than 50% of Rituximab-treated hematologic cancer patients within the RCN partnered hospitals were appropriately screened for HBV, and 44% of patients at risk for reactivation received appropriate follow-up. In response to these findings, the RCN Hematology Disease Site Group is developing RCN clinical practice guidelines to standardize HBV testing and management of patients at-risk for HBV reactivation. In close collaboration with virologists and hepatologists, the group will provide targeted education sessions to improve compliance with clinical practice guidelines. Additionally, the group aims to implement pharmacy-based interventions, such as coupling Rituximab prescriptions with standard orders for HBV testing, and providing pharmacist autonomy to order HBV testing. DisclosuresAssouline:Novartis: Research Funding; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; BMS: Honoraria, Research Funding, Speakers Bureau; Pfizer: Honoraria, Research Funding, Speakers Bureau; Roche: Honoraria, Research Funding, Speakers Bureau.

Development of the CCRU kit squad: Centralization of biospecimen “kit” management.

295 Background: Personalized medicine has resulted in a rapid increase in biospecimens collection. Each biospecimen collected requires supplies that are provided in the form of “kits”. The number of kit types per protocol ranges anywhere from 2-60, with an average of 30 different kit types per trial. Historically, each trials nurse has managed their own kits resulting in large amounts of nursing time being spent on kit management. Kits took up a large amount of space in clinical areas, including expired kits, and they were being managed in no standardized fashion. Due to rapidly increasing biospecimen volumes, existing methods of kit management were no longer feasible and the CCRU Kit Squad was developed. Methods: Over the course of 12-mos, an extensive assessment of current kit management practices were reviewed with all disease site groups, including workflows and quantities utilized. An e-commerce software platform was selected, and semi-customized to centralize online ordering and receiving of kits, and the creation of a central location was setup for kit storage and daily operations. On-boarding of each group included retrieving existing kits from each nurse, uploading kits to the software, training each nurse to use the software, setting up accounts with each respective vendor for deliveries and re-supply, and disposing of expired kits. Results: Disease site groups were transitioned to the CCRU Kit Squad stepwise from Oct 2016 to Dec 2017 (15-mos), which included 80 nurses, 16 disease site groups, and over 400 clinical trials. By the end of 2017, the average number of kits ordered per day, and per month were 33 and 1003, respectively. Conclusions: The CCRU Kit Squad developed a centralized online service for kit management, thereby reducing administrative burden on clinical trial nurses. It has streamlined the management of biospecimen kits, eliminated wasted space in clinical areas, and facilitated the selection of the right kit for the right test at the right time.

Keeping a Finger on the Pulse: The Potential of a Programmatic Advanced Practice Role

Stereotactic Body Radiation Therapy (SBRT) is a treatment technique that makes possible the delivery of highly focused high dose radiation in a single or few fractions. The SBRT program at our institution has grown rapidly in both anatomic sites and patient numbers since 2008; treating over 900 patients last year to sites including lung, liver, spine, prostate, kidney, pancreas, head and neck and miscellaneous oligometastases. Due to the rapid expansion and the highly technical nature of the program, a clinical specialist radiation therapy (CSRT) role was introduced in 2012 to ensure the highest quality patient care and efficient use of resources. In this role, the CSRT liaises with all disciplines within the radiation oncology program (radiation oncologists, medical physicists, radiation therapists and nurses) and across nearly all primary disease site groups. The responsibilities of the role include direct patient care through new patient, on treatment and follow up visits as well as programmatic leadership via the oversight of protocol standardization, development of new techniques and departmental education. A wide breadth of knowledge is required in this role and participation in patient care across all anatomic sites offers a unique and comprehensive perspective. A key responsibility of the CSRT is to manage and participate in peer review of all SBRT cases. The majority of peer review for SBRT cases is conducted via multi-disciplinary rounds led by the CSRT, who maintains detailed records of identified issues and recommendations. In additional to ensuring the highest quality of care for the patients, the data acquired from SBRT peer review has led to SBRT protocol standardization, process improvements and technique efficiencies. In 2017, 723 SBRT cases were peer reviewed in the multi-disciplinary setting led by the CSRT and 22 of these cases required follow up based on issues identified after peer review. Thirty-one out of 723 cases were completed outside of scheduled rounds at review initiated by the CSRT to ensure completion before more than half of the treatment was delivered. Inappropriate or missing contours was a common theme in cases requiring follow up and this lead to the standardization of chest wall, renal cortex and renal hilum contours across all sites. A trend in dose reduction in liver SBRT was observed and subsequently, a breath-hold technique was implemented in an attempt to reduce treatment volumes and facilitate the delivery of higher doses. Inconsistent dose constraints for abdominal organs were also identified and a task force to harmonize these across anatomical sites was initiated. With involvement in all anatomic sites, a programmatic advanced practice role in SBRT offers a unique perspective that ensures continuity and consistency across all anatomic sites. Continuous evaluation of treatment protocols and outcomes is imperative for the identification of opportunities for improvement across all sites.

Guideline for the Initial Management of Small Cell Lung Cancer (Limited and Extensive Stage) and the Role of Thoracic Radiotherapy and First-line Chemotherapy

AimsWe investigated the efficacy of adding radiotherapy to chemotherapy in patients with extensive stage small cell lung cancer (ES-SCLC) and the appropriate timing, dose and schedule of treatment for patients with ES-SCLC or limited stage SCLC (LS-SCLC). Materials and methodsThe guideline was developed by Cancer Care Ontario's Program in Evidence-Based Care and by the Lung Cancer Disease Site Group through a systematic review of randomised controlled trials. Key recommendationsIn patients with LS-SCLC (stage I, II and III), the addition of thoracic radiotherapy to standard chemotherapy is recommended. However, there is no clear evidence to inform definitive recommendations for optimal timing, sequential versus concurrent therapies and optimal dose or regimen. In patients with LS-SCLC, etoposide–cisplatin is the preferred regimen for adults who are being treated with combined modality therapy with curative intent. In patients with ES-SCLC (stage IV), there is insufficient evidence to recommend the addition of thoracic radiotherapy to standard chemotherapy as a standard practice for survival benefit; however, it could be considered on a case-by-case basis to reduce local recurrence. In patients with ES-SCLC, a platinum agent plus etoposide is the preferred regimen for adult patients who are being treated with combined modality therapy. Cisplatin and irinotecan represents an alternative treatment option to this, but is associated with increased rates of adverse events such as diarrhoea.

Guideline for radiotherapy with curative intent in patients with early-stage medically inoperable non-small-cell lung cancer.

For this guideline, we investigated the effectiveness of radiotherapy with curative intent in medically inoperable patients with early-stage non-small-cell lung cancer (nsclc). The guideline was developed by Cancer Care Ontario's Program in Evidence-Based Care and by the Lung Cancer Disease Site Group through a systematic review of mainly retrospective studies, expert consensus, and formal internal and external reviews. ■ Stereotactic body radiation therapy (sbrt) with curative intent is an option that should be considered for patients with early-stage, node-negative, medically inoperable nsclc. Qualifying Statements■ Because of the high dose per fraction, the planning process and treatment delivery for sbrt require the use of advanced technology to maintain an appropriate level of safety. Consistent patient positioning and 4-dimensional analysis of tumour and critical structure motion during simulation and treatment delivery are essential.■ Preliminary results for proton-beam therapy have been promising, but the technique requires further clinical study.■ Recommended fractionation schemes for sbrt should result in a biologically effective dose of 100 or greater by the linear quadric model, choosing an α/β value of 10 [bed10(LQ) ≥ 100]. Qualifying Statements■ Because of the increased risk of treatment-related adverse events associated with centrally located tumours, consideration of tumour size and proximity to critical central structures is required when determining the dose and fractionation.■ Examples of dose-fractionation schemes used in the included studies have been provided.■ Based on the current evidence and the opinion of the authors, radiation doses at bed10(LQ) greater than 146 might significantly increase toxicity and should be avoided.■ Determination of the radiation bed by the linear quadratic model has limitations for the extreme hypofractionated schemes used in sbrt.

P3.07-016 Ontario's Episode-Based Funding Model Reveals Practice Variation in Adjuvant NSCLC Chemotherapy: Topic: Other – Geographical Differences

A new episode-based funding model (FM) for ambulatory systemic therapy was implemented in Ontario, Canada in April 2014. The FM bundled reimbursement for components of care, including initial consultation, treatment episodes delivered with adjuvant/curative (AC) or palliative intent and supportive care. Options for evidence-informed AC regimens and their optimal number of treatment cycles and chemotherapy suite visits were informed by the provincial lung Disease Site Group (DSG) based on published literature or group concensus. It was expected that cisplatin-vinorelbine (CISPVINO) would be the most commonly used regimen as CISPVINO was used in the clinical trial conducted in Canada that established CISPVINO as a standard of care and is recommended in Ontario’s adjuvant chemotherapy practice guideline. The utilization of AC was analyzed for 35 systemic treatment facilities in Ontario comparing actual practice (AP) with “best practice” (BP) (cycle number). For this analysis, cases were included if they started a new course of AC after January 1, 2014 and completed the treatment before July 30, 2015. The percentage of patients with stage II/IIIa NSCLC receiving AC has been stable at 50-55% for over five years. In this analysis 1,531 cases received some form of AC. 506 cases received chemotherapy with XRT (usually etoposide-cisplatin) and these cases were assumed to be Pancoast tumors or stage IIIa disease on neoadjuvant therapy. The most common regimens prescribed without XRT were cisplatin-vinorelbine (CISPVINO) (331 cases) cisplatin-etoposide (222), carboplatin-etoposide (154) and carboplatin + vinorelbine (74 cases). For all adjuvant chemotherapy excluding XRT (1,025 cases), AP was equal to BP in only 24 % of cases, AP <BP in 73% and AP >BP in 4%. For CISPVINO, AP=BP was achieved in only 36%, AP< BP in 55% and AP > BP in 9%. For the top 5 hospitals by volume administering AC, BP=AP ranged from 8-45%; AP< BP ranged from 41-73%; AP > BP occurred in 20 cases in 3 facilities. This analysis of first-year funding data provided insights on how adjuvant chemotherapy is administered in Ontario. As expected, CISPVINO was the most commonly used AC regimen (32%) when AC was used alone. However, etoposide-cisplatin was also commonly used alone and in combination with XRT and carboplatin was frequently substituted. BP is only achieved in the minority of cases and there is wide institutional variance. Reasons for this variation need to be better understood and opportunities identified to drive efficiency and standardization.

Rituximab in Lymphoma and Chronic Lymphocytic Leukaemia: A Practice Guideline

Rituximab is the first monoclonal antibody to be approved for use by the US Food and Drug Administration in cancer. Its role in the treatment of non-Hodgkin lymphoma, including chronic lymphocytic leukaemia (CLL), has evolved significantly. We aimed to systematically review and update the literature on rituximab in lymphoma and CLL, and provide evidence-based consensus guidelines for its rational use. Validated methodology from the Cancer Care Ontario Program in Evidence-based Care was used. A comprehensive literature search was completed by a methodologist from the Hematology Disease Site Group of Cancer Care Ontario. Data were extracted from randomised controlled trials of rituximab-containing chemotherapy regimens for patients with lymphoma or CLL. Fifty-six primary randomised controlled trials were retrievable and met all inclusion criteria. Clinically important benefits in progression-free survival or overall survival were seen in the following settings: (i) addition of rituximab to combination chemotherapy for initial treatment of aggressive B-cell lymphomas, including diffuse large B-cell lymphoma, Burkitt lymphoma and HIV-related lymphoma with CD4 count ≥50/mm3; (ii) addition of rituximab to combination chemotherapy for initial and subsequent treatment of follicular lymphoma and other indolent B-cell lymphomas; (iii) use of rituximab maintenance in patients with indolent B-cell lymphomas who have responded to chemoimmunotherapy; (iv) addition of rituximab to fludarabine-based chemotherapy or chlorambucil for initial treatment of CLL. The consensus opinion of the Hematology Disease Site Group is that rituximab is recommended for these indications.

Using Data From Ontario's Episode-Based Funding Model to Assess Quality of Chemotherapy.

A new episode-based funding model for ambulatory systemic therapy was implemented in Ontario, Canada on April 1, 2014, after a comprehensive knowledge transfer and exchange strategy with providers and administrators. An analysis of the data from the first year of the new funding model provided an opportunity to assess the quality of chemotherapy, which was not possible under the old funding model. Options for chemotherapy regimens given with adjuvant/curative intent or palliative intent were informed by input from disease site groups. Bundles were developed and priced to enable evidence-informed best practice. Analysis of systemic therapy utilization after model implementation was performed to assess the concordance rate of the treatments chosen with recommended practice. The actual number of cycles of treatment delivered was also compared with expert recommendations. Significant improvement compared with baseline was seen in the proportion of adjuvant/curative regimens that aligned with disease site group-recommended options (98% v 90%). Similar improvement was seen for palliative regimens (94% v 89%). However, overall, the number of cycles of adjuvant/curative therapy delivered was lower than recommended best practice in 57.5% of patients. There was significant variation by disease site and between facilities. Linking funding to quality, supported by knowledge transfer and exchange, resulted in a rapid improvement in the quality of systemic treatment in Ontario. This analysis has also identified further opportunities for improvement and the need for model refinement.

Establishment of practice standards in nomenclature and prescription to enable construction of software and databases for knowledge-based practice review

IntroductionEstablishment of standards within a practice and across disease site groups for nomenclatures, prescription formatting, and measured dose-volume histogram (DVH) metrics is a key enabling step for creating software and database solutions to make routine aggregation of dosimetric data for all patients treated in a practice, practical. A process of physician-driven, iterative dialogs coupled with development of technical tools is required to implement the cultural and procedural changes. The cumulative reward for this effort is a database that can be used for defining practice norms, benchmarking against national standards, and tracking dosimetric effects of longitudinal practice pattern changes. Methods and materialsA 4-year project was carried out to develop and introduce standardizations, modify processes, and develop computer-based tools for reporting, aggregation, and analysis of prescription and DVH metrics. Physician disease site groups developed 42 target and 81 normal tissue templates. From the database of 32,002 DVH metrics, benchmarking was illustrated for a subgroup of breast (281) and prostate (324) patients treated with conventional fractionation over a 16-month period. Breast patients were segregated according to prescription template used: simple (S, tangents only) vs complex (C, tangents + supraclavicular ± intramammary nodes) and left (S-L or C-L) versus right (S-R or C-R). ResultsProstate patients’ median and 50% confidence intervals (CIs) for bladder, stated according to the nomenclature: the percentage of bladder volume receiving doses of ≥40 Gy (V40[%]), V65Gy[%], V70Gy[%], V75Gy[%], and V80Gy[%] were 45.5 (24.9-57.0), 15.6 (9.0-23.8), 7.6 (3.3-13.6), 2.0 (0.0-7.9), and 0.0 (0.0-1.4), respectively. Values for rectum: V50Gy[%], V60 Gy[%], V65Gy[%], V70Gy[%], and V75Gy[%] were 37.1 (27.8-43.5), 21.8 (15.6-25.5), 14.6 (9.6-18.0), 7.7 (1.9-12.3), and 1.0 (0–7.0), respectively. For breast patients, heart:mean Gray values were 1.5 (1.0-2.0), 3.1 (2.2-4.8), 0.4 (0.3-0.7), and 1.1 (0.8-2.2) for S-L, C-L, S-R, and C-R, respectively. Longitudinal, moving window plots of median, 50% CI, and 90% CI for 6-month periods demonstrated the effect of practice changes to reduce heart doses. ConclusionsStandardization was challenging as a practice change, but has resulted in significant improvements for both our clinical and research efforts.

Moving forward after cancer: Implementation of transition appointments and follow-up care plans in Manitoba.

50 Background: Patient experience and local and international clinical research have focused attention on transitions in cancer care from treatment to follow-up. Deficiencies in the quality of survivorship care, including necessary testing, have been demonstrated. The Canadian Partnership Against Cancer has funded projects designed to enhance the implementation of survivorship care plans (SCPs) and to improve cancer system-primary care coordination. CancerCare Manitoba, a provincial agency, is a leader in this work. Methods: The Moving Forward After Cancer initiative combines the generation of standardized written SCPs from the EMR with enhanced patient assessment at the end of curative systemic / radiation therapy. A transition appointment (TA) is provided by the patient’s usual oncology providers and includes screening for distress, appropriate referrals, and provision of a personalized treatment summary and SCP to the patient, with copies to the primary care physician and surgeon. The TA often marks the transfer of medical responsibility to the primary care provider (PCP). Results: Transition appointments have been implemented for colorectal (2012), breast (2014), and lymphoma and gynecologic cancer patients (2015). A total of 364 TAs were done in Manitoba in 2014, of which 140 were with colorectal (stage II and III) and 224 with breast (stage I – III) patients, about 59% and 35% respectively of eligible patients. This is an increase of 385% from the 75 TAs done in 2013. Other patient outcomes being collected include perceptions of continuity of care, confidence in survivorship information, evaluation of the care plan documents and also PCP and oncology team perceptions. In order to support practice change, a workflow solution led by a designated team that is adaptable by all sites across the province has been developed. Conclusions: The provision of TAs and SCPs is being well adopted in Manitoba. We expect that this intervention willimprove the experience of both patients and health care providers and the quality of care at the time of transition to survivorship. Implementation is underway with other disease site groups with the goal of all patients receiving a TA as they transition into survivorship.

How, When and Where to Discuss Do Not Resuscitate: A Prospective Study to Compare the Perceptions and Preferences of Patients, Caregivers, and Health Care Providers in a Multidisciplinary Lung Cancer Clinic

Background: Do Not Resuscitate (DNR) is a significant but challenging part of end-of-life discussions when dealing with incurable lung cancer patients. We have explored the perceptions and preferences of patients, their caregivers (CGs), and health care providers (HCPs) and the current practice and opinions on DNR discussions in a multidisciplinary lung cancer clinic. Materials and Methods: This is a prospective descriptive study with a mixed quantitative and qualitative methodology to capture perceptions of the participants. To obtain a rich description of participant responses to questionnaire items, we employed a ‘think aloud’ process that prompted participants to immediately verbalize their thoughts when responding to questionnaire items. We used content analysis and constant comparison techniques to identify, code and categorize primary themes in the captured data. Results: Ten patients with advanced-stage lung cancer; nine CGs from the lung clinic and ten HCPs from the Thoracic Disease Site Group (DSG) were enrolled in the study. Most patients had only a limited understanding of DNR. Most CGs had a fair to good understanding of DNR. Most HCPs perceived their patients to have understood DNR most of the time. When patients were interviewed, a theme of “anticipated discussion” about DNR was identified. Patients and CGs expressed having faith in the system and responsible physicians as to when to discuss DNR. HCPs embraced a clinician preference-based decision-making approach to engaging in DNR discussions. They desired more resources, more knowledge, more structure and more time to discuss DNR. Most HCPs felt that it would be worth conducting a prospective clinical trial to determine the best time to discuss DNR. Conclusions: This pilot study provides a unique mixed quantitative and qualitative understanding of the perceptions of patients with lung cancer and their CGs and HCPs regarding DNR discussion. Our findings will help further the development of evidence-based guidelines and a broad prospective study that would have important implications for policies and practices around DNR discussions in order to reduce the emotional pain of dying patients, their CGs and HCPs.

Singapore Cancer Network (SCAN) Guidelines for Adjuvant Trastuzumab Use in Early Stage HER2 Positive Breast Cancer

The SCAN breast cancer workgroup aimed to develop Singapore Cancer Network (SCAN) clinical practice guidelines for adjuvant trastuzumab use in early stage HER2 positive breast cancer. The workgroup utilised a modified ADAPTE process to calibrate high quality international evidence-based clinical practice guidelines to our local setting. Five international guidelines were evaluated- those developed by the National Comprehensive Cancer Network (2015), the National Institute of Health and Clinical Excellence (2006, 2009), the European Society of Medical Oncology (2013), the Breast Cancer Disease Site Group in conjunction with the Program in Evidence Based Care and Cancer Care Ontario (2011) and the Scottish Intercollegiate Guidelines Network (2013). Recommendations on suitable candidacy for adjuvant trastuzumab, whether adjuvant trastuzumab should be given concurrently with a taxane or sequentially after completion of adjuvant chemotherapy, the optimal frequency of cardiac monitoring during adjuvant trastuzumab and the optimal duration of adjuvant trastuzumab were developed. These adapted guidelines form the SCAN Guidelines 2015 for adjuvant trastuzumab use in early stage HER2 positive breast cancer.