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Clin Otolaryngol ; 47(5): 561-567, 2022 Sep.
Article in English | MEDLINE | ID: covidwho-1874404


OBJECTIVES: To report the incidence of locoregional recurrence in head and neck cancer (HNC) patients under surveillance following treatment undergoing symptom-based remote assessment. DESIGN: A 16-week multicentre prospective cohort study. SETTING: UK ENT departments. PARTICIPANTS: HNC patients under surveillance following treatment undergoing symptom-based telephone assessment. MAIN OUTCOME MEASURES: Incidence of locoregional recurrent HNC after minimum 6-month follow-up. RESULTS: Data for 1078 cases were submitted by 16 centres, with follow-up data completed in 98.9% (n = 1066). Following telephone consultation, 83.7% of referrals had their face-to-face appointments deferred (n = 897/1072). New symptoms were reported by 11.6% (n = 124/1072) at telephone assessment; 72.6% (n = 90/124) of this group were called for urgent assessments, of whom 48.9% (n = 44/90) came directly for imaging without preceding clinical review. The sensitivity and specificity for new symptoms as an indicator of cancer recurrence were 35.3% and 89.4%, respectively, with a negative predictive value of 99.7% (p = .002). Locoregional cancer identification rates after a minimum of 6 months of further monitoring, when correlated with time since treatment, were 6.0% (n = 14/233) <1 year; 2.1% (n = 16/747) between 1 and 5 years; and 4.3% (n = 4/92) for those >5 years since treatment. CONCLUSIONS: Telephone assessment, using patient-reported symptoms, to identify recurrent locoregional HNC was widely adopted during the initial peak of the COVID-19 pandemic in the United Kingdom. The majority of patients had no face-to-face reviews or investigations. New symptoms were significantly associated with the identification of locoregional recurrent cancers with a high specificity, but a low sensitivity may limit symptom assessment being used as the sole surveillance method.

COVID-19 , Head and Neck Neoplasms , COVID-19/epidemiology , Head and Neck Neoplasms/diagnosis , Head and Neck Neoplasms/epidemiology , Head and Neck Neoplasms/therapy , Humans , Neoplasm Recurrence, Local/diagnosis , Neoplasm Recurrence, Local/epidemiology , Neoplasm Recurrence, Local/therapy , Pandemics , Prospective Studies , Referral and Consultation , Symptom Assessment , Telephone
Cancer Sci ; 112(7): 2915-2920, 2021 Jul.
Article in English | MEDLINE | ID: covidwho-1294969


Adjuvant chemotherapy has reduced the risk of tumor recurrence and improved survival in patients with resected colorectal cancer. Potential utility of circulating tumor DNA (ctDNA) prior to and post surgery has been reported across various solid tumors. We initiated a new type of adaptive platform trials to evaluate the clinical benefits of ctDNA analysis and refine precision adjuvant therapy for resectable colorectal cancer, named CIRCULATE-Japan including three clinical trials. The GALAXY study is a prospectively conducted large-scale registry designed to monitor ctDNA for patients with clinical stage II to IV or recurrent colorectal cancer who can undergo complete surgical resection. The VEGA trial is a randomized phase III study designed to test whether postoperative surgery alone is noninferior to the standard therapy with capecitabine plus oxaliplatin for 3 months in patients with high-risk stage II or low-risk stage III colon cancer if ctDNA status is negative at week 4 after curative surgery in the GALAXY study. The ALTAIR trial is a double-blind, phase III study designed to establish the superiority of trifluridine/tipiracil as compared with placebo in patients with resected colorectal cancer who show circulating tumor-positive status in the GALAXY study. Therefore, CIRCULATE-Japan encompasses both "de-escalation" and "escalation" trials for ctDNA-negative and -positive patients, respectively, and helps to answer whether measuring ctDNA postoperatively has prognostic and/or predictive value. Our ctDNA-guided adaptive platform trials will accelerate clinical development toward further precision oncology in the field of adjuvant therapy. Analysis of ctDNA status could be utilized as a predictor of risk stratification for recurrence and to monitor the effectiveness of adjuvant chemotherapy. ctDNA is a promising, noninvasive tumor biomarker that can aid in tumor monitoring throughout disease management.

Circulating Tumor DNA/blood , Colorectal Neoplasms/blood , Neoplasm Recurrence, Local/blood , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Capecitabine/administration & dosage , Chemotherapy, Adjuvant , Colonic Neoplasms/blood , Colonic Neoplasms/genetics , Colonic Neoplasms/pathology , Colonic Neoplasms/therapy , Colorectal Neoplasms/genetics , Colorectal Neoplasms/pathology , Colorectal Neoplasms/therapy , Double-Blind Method , Humans , Japan , Neoplasm Recurrence, Local/genetics , Neoplasm Recurrence, Local/pathology , Neoplasm Recurrence, Local/therapy , Oxaliplatin/administration & dosage , Prospective Studies , Pyrrolidines/administration & dosage , Thymine/administration & dosage , Trifluridine/administration & dosage