Trends and Prescriber Variation in the Duration of Oxaliplatin-Containing Adjuvant Chemotherapy for Stage III Colon Cancer From 2007 to 2019: A Population-Based Retrospective Cohort Study.

INTRODUCTION: The International Duration Evaluation of Adjuvant Therapy (IDEA) collaboration in 2017 established 3 months of adjuvant therapy as an alternative to 6 months of therapy for stage III colon cancer. We determined the association between the IDEA publication, changes in clinical practice, and prescriber variation. PATIENTS AND METHODS: Using linked databases, we identified Ontarians aged ≥18 years at diagnosis of stage III colon cancer between 2007 and 2019 who received oxaliplatin-containing adjuvant therapy. The outcome was duration of therapy, categorized as ≤25%, >25% to ≤50%, >50% to ≤75%, and >75% of a 6-month course of therapy to approximate treatment durations in the IDEA collaboration. We examined trends in duration over time using an interrupted time series regression model. We analyzed treatment duration after accounting for patient and prescriber characteristics, using multivariable mixed effects logistic regression models to quantify between-prescriber variation. RESULTS: We included 4695 patients with stage III colon cancer who received oxaliplatin-containing adjuvant chemotherapy, of whom 77.5% initiated treatment pre-IDEA and 22.5% initiated treatment post-IDEA. Post-IDEA, there was a 16.4% (95% CI, 12.5%-20.3%) absolute increase in the proportion of patients treated with ≤50% of a maximal course of therapy. This trend was greatest among patients with low-risk tumors. Prescriber variation increased pre-IDEA to 15.6% post-IDEA (variance partition coefficient 5.4% pre-IDEA and 15.6% post-IDEA). CONCLUSION: The publication of IDEA was associated with increases in short duration adjuvant therapy and prescriber-level practice variation for stage III colon cancer. Clinicians should be better supported to make consistent recommendations about adjuvant duration under conditions of uncertainty and trade-offs.

The Association of Oxaliplatin-Containing Adjuvant Chemotherapy Duration with Overall and Cancer-Specific Mortality in Individuals with Stage III Colon Cancer: A Population-Based Retrospective Cohort Study.

PURPOSE: Few studies have examined the relationship between duration of oxaliplatin-containing adjuvant chemotherapy for stage III colon cancer and mortality in routine practice. We examined the association between treatment with 50% versus >85% of a maximal course of adjuvant therapy (eight cycles of CAPOX, twelve cycles of FOLFOX) and mortality in stage III colon cancer. METHODS: Using linked databases, we identified Ontarians aged ≥18 years at diagnosis of stage III colon cancer between 2007 and 2019. In the primary comparison, we compared patients who received 50% or >85% of a maximal course of adjuvant therapy; in a secondary comparison, we evaluated a dose effect across patients who received FOLFOX in one-cycle increments from six to ten cycles against >85% (more than ten cycles) of a maximal course of FOLFOX. The main outcomes were overall and cancer-specific mortality. Follow-up began 270 days after adjuvant treatment initiation and terminated at the first of the outcome of interest, loss of eligibility for Ontario's Health Insurance Program, or study end. Overlap propensity score weights accounted for baseline between-group differences. We determined the hazard ratio, estimating the association between mortality and treatment. Non-inferiority was concluded in the primary comparison for either outcome if the upper limit of the two-sided 95% CI was ≤1.11, which is the margin used in the International Duration Evaluation of Adjuvant Chemotherapy Collaboration. RESULTS: We included 3546 patients in the analysis of overall mortality; 486 (13.7%) received 50% and 3060 (86.3%) received >85% of a maximal course of therapy. Median follow-up was 5.4 years, and total follow-up was 20,510 person-years. There were 833 deaths. Treatment with 50% of a maximal course of adjuvant therapy was associated with a hazard ratio of 1.13 (95% CI 0.88 to 1.47) for overall mortality and a subdistribution hazard ratio of 1.31 (95% CI 0.91 to 1.87) for cancer-specific mortality versus >85% of a maximal course of therapy. In the secondary comparison, there was a trend toward higher overall mortality in patients treated with shorter durations of therapy, though confidence intervals overlapped considerably. CONCLUSION: We could not conclude that treatment with 50% of a maximal course is non-inferior to >85% of a maximal course of adjuvant therapy for mortality in stage III colon cancer. Clinicians and patients engaging in decision-making around treatment duration in this context should carefully consider the trade-off between treatment effectiveness and adverse effects of treatment.

Nimble Approach: fast, adapting, calculating and ethically mindful approach to managing colorectal cancer screening programmes during a pandemic.

OBJECTIVE: To describe a conceptual framework that provides understanding of the challenges encountered and the adaptive approaches taken by organised colorectal cancer (CRC) screening programmes during the initial phase of the COVID-19 pandemic. DESIGN: This was a qualitative case study of international CRC screening programmes. Semi-structured interviews were conducted with programme managers/leaders and programme experts, researchers and clinical leaders of large, population-based screening programmes. Data analysis, using elements of grounded theory, as well as cross-cases analysis was conducted by two experienced qualitative researchers. RESULTS: 19 participants were interviewed from seven programmes in North America, Europe and Australasia. A conceptual framework ('Nimble Approach') was the key outcome of the analysis. Four concepts constitute this approach to managing CRC screening programmes during COVID-19: Fast (meeting the need to make decisions and communicate quickly), Adapting (flexibly and creatively managing testing/colonoscopy capacity, access and backlogs), Calculating (modelling and actively monitoring programmes to inform decision-making and support programme quality) and Ethically Mindful (considering ethical conundrums emerging from programme responses). Highly integrated programmes, those with highly integrated communication networks, and that managed greater portions of the screening process seemed best positioned to respond to the crisis. CONCLUSIONS: The Nimble Approach has potentially broad applications; it can be deployed to effectively respond to programme-specific challenges or manage CRC programmes during future pandemics, other health crises or emergencies.

Adjuvant Therapy for Stage II Colon Cancer: ASCO Guideline Update.

PURPOSE: To develop recommendations for adjuvant therapy for patients with resected stage II colon cancer. METHODS: ASCO convened an Expert Panel to conduct a systematic review of relevant studies and develop recommendations for clinical practice. RESULTS: Twenty-one observational studies and six randomized controlled trials met the systematic review inclusion criteria. RECOMMENDATIONS: Adjuvant chemotherapy (ACT) is not routinely recommended for patients with stage II colon cancer who are not in a high-risk subgroup. Patients with T4 tumors are at higher risk of recurrence and should be offered ACT, whereas patients with other high-risk factors, including sampling of fewer than 12 lymph nodes in the surgical specimen, perineural or lymphovascular invasion, poorly or undifferentiated tumor grade, intestinal obstruction, tumor perforation, or grade BD3 tumor budding, may be offered ACT. The addition of oxaliplatin to fluoropyrimidine-based ACT is not routinely recommended, but may be offered as a result of shared decision making. Patients with mismatch repair deficiency/microsatellite instability tumors should not be routinely offered ACT; if the combination of mismatch repair deficiency/microsatellite instability and high-risk factors results in a decision to offer ACT, oxaliplatin-containing chemotherapy is recommended. Duration of oxaliplatin-containing chemotherapy is also addressed, with recommendations for 3 or 6 months of treatment with capecitabine and oxaliplatin or fluorouracil, leucovorin, and oxaliplatin, with decision making informed by key evidence of 5-year disease-free survival in each treatment subgroup and the rate of adverse events, including peripheral neuropathy.Additional information is available at www.asco.org/gastrointestinal-cancer-guidelines.

A "Tea and Cookies" Approach: Co-designing Cancer Screening Interventions with Patients Living with Low Income.

BACKGROUND: In our primary care organization, we have observed income gradients in cancer screening for our patients despite outreach. We hypothesized that outreach strategies could be improved upon to be more compelling for our patients living with low income. OBJECTIVE: To use co-design to adapt our current strategies and create new strategies to improve cancer screening uptake for patients living with low income. DESIGN: An exploratory, qualitative study in two phases: interviews and focus groups. PARTICIPANTS: For interviews, we recruited 25 patient participants who were or had been overdue for cancer screening and had been identified by their provider as potentially living with low income. For subsequent focus groups, we recruited 14 patient participants, 11 of whom had participated in Phase I interviews. APPROACH: To analyse written transcripts, we took an iterative, inductive approach using content analysis and drawing on best practices in Grounded Theory methodology. Emergent themes were expanded and clarified to create a derived model of possible strategies to improve the experience of cancer screening and encourage screening uptake for patients living with low income. KEY RESULTS: Fear and competing priorities were two key barriers to cancer screening identified by patients. Patients believed that a warm and encouraging outreach approach would work best to increase cancer screening participation. Phone calls and group education were specifically suggested as potentially promising methods. However, these views were not universal; for example, women were more likely to be in favour of group education. CONCLUSIONS: We used input from patients living with low income to co-design a new approach to cancer screening in our primary care organization, an approach that could be broadly applicable to other contexts and settings. We learned from our patients that a multi-modal strategy will likely be best to maximize screening uptake.

Long-term results of anterior sphincteroplasty.

PURPOSE: This study was designed to evaluate the outcome of anterior sphincteroplasty in a large series with ten-year follow-up. METHODS: The long-term results in 191 consecutive patients who were a median of ten years from sphincteroplasty were assessed. A questionnaire was administered to assess current bowel function, degree of incontinence, and quality of life as measured by the Fecal Incontinence Quality of Life Scale. Subjective assessment of early outcome was available for most patients at a median follow-up of three years. RESULTS: During the follow-up period, three patients died and one developed severe dementia. Five patients required further surgery for incontinence and were considered failures. Of the remaining 182 patients, 130 (71 percent) returned a completed questionnaire. At ten years follow-up, 6 percent had no incontinence, 16 percent were incontinent of gas only, 19 percent had soiling only, and 57 percent were incontinent of solid stool. Results worsened significantly between the assessments at three and ten years. The only significant predictors of a poor outcome were older age and fecal incontinence at three years. Preoperative anorectal physiology studies did not predict outcome. Scores on the Fecal Incontinence Quality of Life Scale were lower in those with fecal incontinence, indicating a poorer disease-specific quality of life. CONCLUSIONS: Only 40 percent of patients maintain fecal continence long-term after sphincteroplasty. Older patients and patients with poorer short-term function are more likely to have fecal incontinence at ten years. Incontinence at ten years had a negative effect on quality of life. Further research is needed to develop techniques to improve long-term continence in these patients.