Evaluating a novel patient pathway to manage symptomatic breast referrals (the blue flag clinic): a longitudinal observational study.

INTRODUCTION: A novel referral pathway for exhibited breast symptom (EBS) referrals to manage increasing referrals of urgent suspected cancer (USC) was implemented in our trust. We report on the safety and effect on compliance with the 2-week-wait rule (2WW). METHODS: A single-centre longitudinal observational study included all patients referred to a UK breast unit during 13 May 2019 to 27 March 2020 (period 1) and 8 February 2021 to 31 January 2022 (period 2). USC referrals were assessed in a one-stop clinic (red flag clinic [RFC]); EBS referrals were assessed in a new clinic in which clinical evaluation was performed and imaging occurred subsequently (blue flag clinic [BFC]). Patients were followed up to determine the symptomatic interval cancer rate. RESULTS: There were 9,695 referrals; 1,655 referrals (17%) were assessed in the BFC after 63 exclusions. Some 95.9% of patients had a benign clinical examination (P1/P2), 80.1% had imaging (mammogram or ultrasound) and 4% had a tissue biopsy. In total, 16/1,655 (0.97%) BFC patients and 510/7,977 (8.2%) RFC patients were diagnosed with breast cancer (breast cancer detection rate). Some 1,631 patients (with 1,639 referrals) were discharged and followed up for a median of 17 months (interquartile range 12-32) with one subsequent cancer diagnosis (symptomatic interval cancer rate, 0.06%). Implementation of the BFC pathway increased 3-month average trust performance of USC referrals with 2WW standard from 8.5% to 98.7% (period 1) and from 30% to 66% (period 2). CONCLUSIONS: The BFC pathway for EBS patients is safe and implementation led to improvement against the 2WW target for USC referrals, ensuring resources are prioritised to patients with the highest likelihood of breast cancer.

Outcomes of patients with non-lower gastrointestinal cancer diagnosed via the lower gastrointestinal two-week-wait service.

INTRODUCTION: Patients referred via lower gastrointestinal two-week-wait (LGI-2WW) services deemed at 'low risk' of LGI cancer may have delayed or no investigation. However, 20% of patients diagnosed with cancer via the LGI-2WW have non-LGI cancer. This study investigates the outcomes in this under-reported group. METHODS: A retrospective analysis of patients referred to a UK LGI-2WW service with a non-LGI cancer diagnosis (International Classification of Diseases 10th revision) between 1 January 2015 and 31 December 2018. The primary outcome was all-cause mortality. Statistical analysis was undertaken using Kaplan-Meier survival curves with generalised log-rank test and binomial logistic regression of pre-investigation information to predict death. A p-value of < 0.05 represented statistical significance. RESULTS: In total, 140 patients were diagnosed with non-LGI cancer (of 10,155 patients referred via the LGI-2WW pathway). Median follow-up was 13 months (range 0-65 months). Thirty-five patients (35/140; 25%) did not meet LGI-2WW referral criteria. Median survival varied by cancer site (upper gastrointestinal: 43/140 patients, median survival 4 months; gynaecological: 25/140, 25 months; haematological: 22/140, < 50% died; urological: 21/140, 47 months; unknown primary: 12/140, 3 months; lung: 10/140, 17 months; breast: 3/140, 5 months; retroperitoneal: 2/140, 9 months; brain: 1/140, 4 months; adrenal: 1/140, 52 months). Binomial logistic regression was statistically significant (chi-squared goodness-of-fit test = 12.334; p = 0.03); but the presence of comorbidity was the only significant predictive factor of death (p = 0.03). CONCLUSIONS: Patients with non-LGI cancers cannot be easily predicted and have a poor prognosis. Pathways to streamline investigations for LGI cancer should include computed tomography scans for patients at 'low risk' of LGI cancer to ensure that non-LGI cancers are diagnosed.

Significance of a positive sentinel lymph node biopsy in staging for distant metastasis in breast cancer: are current guidelines relevant?

INTRODUCTION: In breast cancer, early identification of distant metastasis changes management. Current guidelines recommend radiological staging in patients with a preoperative positive axilla; no guidelines address a preoperative negative axilla with subsequent positive sentinel lymph node biopsy. This study investigates whether current guidelines adequately identify distant metastasis in a positive sentinel lymph node biopsy population that had radiological staging. MATERIALS AND METHODS: Patients diagnosed with primary breast cancer between 1 January 2013 and 1 October 2017 with a positive sentinel lymph node biopsy and subsequent radiological staging from a single unit were included. A systematic search identified relevant guideline criteria, against which patients were audited. RESULTS: A total of 330 patients with positive sentinel lymph node biopsy were identified; 227 (69%) had radiological staging postoperatively with computed tomography (5.3%), bone scan (2.6%) and both (92%) which identified 8/227 (3.5%) patients had distant metastasis. Patients with distant metastasis (DMp) compared with those without distant metastasis (NDMp) were associated with poorly differentiated tumours (DMp 62% vs NDMp 28%; p = 0.037), high-grade ductal carcinoma in situ (DMp 75% vs NDMp 39%; p = 0.043) and increased mean invasive tumour size (DMp 37mm vs NDMp 24mm; p = 0.014). Binomial logistic regression did not identify any characteristics to predict distant metastasis in staged patients (chi-squared p = 0.162). Two guidelines used postoperative results to inform radiological staging decision; 68/227 (30%) of staged patients met these guideline criteria, five of eight patients with distant metastasis did not meet current guideline criteria for radiological staging. DISCUSSION: Over 50% of patients with distant metastasis did not meet current guideline criteria for radiological staging and would have remained undiagnosed if current guidelines were followed. This study had an acceptable detection rate of 3.5% for distant metastasis. We therefore recommend radiological staging in all patients with positive sentinel lymph node biopsy.