ABSTRACT
Background: Randomized studies of neoadjuvant (NA) trastuzumab and pertuzumab combined with chemotherapy for HER2-positive breast cancers (BC) have reported pathological complete response (pCR) rates of 39 to 61%. This study aimed to determine the real-world efficacy and toxicity of NA trastuzumab and pertuzumab combined with chemotherapy in a UK tertiary referral cancer centre. Methods: HER2-positive early BC patients given neoadjuvant chemotherapy with trastuzumab and pertuzumab between October 2016 and February 2018 at our tertiary referral cancer centre were identified via pharmacy records. Clinico-pathological information, treatment regimens, treatment-emergent toxicities, operative details, and pathological responses and outcomes were recorded. Results: 78 female patients were identified; 2 had bilateral diseases and 48 of 78 (62%) were node positive at presentation. 55 of 80 (71%) tumours were ER-positive. PCR occurred in 37 of 78 (46.3%; 95% CI: 35.3-57.2%) patients. 14 of 23 (60.8%) patients with ER-negative tumours achieved pCR; 23 of 55 (41.8%) were ER-positive and 6 of 19 (31.6%) were ER-positive and PgR-positive. No cardiac toxicity was documented. Diarrhoea occurred in 53 of 72 (74%) patients. Grade 3-4 toxicity occurred in ≥2% patients. These were diarrhoea, fatigue, and infection. The Median follow up period was 45.2 months (95% CI 43.8-46.3) with 71 of 78 (91.0%) remaining disease-free and 72 of 78 (92.3%) alive. Estimated OS at 2 years 86% (95% CI: 75-99%). Conclusion: This data confirms the efficacy of neoadjuvant chemotherapy combined with dual HER2 directed therapy. While no cardiac toxicity was observed, diarrhoea occurred frequently. The low pCR rate observed in ER and PgR-positive BCs warrants further investigation and consideration of strategies to increase the pCR rate.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols , Breast Neoplasms , Neoadjuvant Therapy , Antibodies, Monoclonal, Humanized/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/toxicity , Breast Neoplasms/drug therapy , Breast Neoplasms/pathology , Diarrhea/chemically induced , Diarrhea/epidemiology , Female , Humans , Neoadjuvant Therapy/adverse effects , Trastuzumab/therapeutic use , Treatment OutcomeABSTRACT
OBJECTIVES: To assess whether clinical trials published in the orthodontic literature comply with the Consolidated Standards of Reporting Trials (CONSORT) statement, and whether compliance has changed over time. DESIGN: Retrospective study. SAMPLE: Clinical trials published in four orthodontic journals (American Journal of Orthodontics and Dentofacial Orthopedics, Angle Orthodontist, European Journal of Orthodontics, and Journal of Orthodontics) at three time points [1995/6 (pre-CONSORT), 2000/1 (post-CONSORT) and 2005/6 (post revised-CONSORT)]. METHODS: Trials were scored using a 36-point checklist developed from the CONSORT statement. Each item on the checklist was scored as either included, not included, or not applicable if the trial design did not allow its inclusion. The proportion of trials describing randomization, allocation concealment, and blinding was also calculated. The mean scores were compared between time points and between journals. RESULTS: A total of 151 reports were included. The mean score was 41·5% (SD 10·3). The mean post-CONSORT score was higher than the pre-CONSORT score (Pâ=â0·01; WMD, 5·73; 95% CI, 1·64-9·82), and the mean post revised-CONSORT was also higher than the pre-CONSORT score (Pâ=â0·01; WMD, 4·44; 95% CI, 1·02-7·87). At the post revised-CONSORT time point, the mean score in the journals which had adopted the CONSORT statement was higher than for those which had not (P<0·001; chi square, 17·78; dfâ=â3). Reporting of randomization, allocation concealment and blinding was inadequate at all three time points. CONCLUSIONS: The reporting of clinical trials in the orthodontic literature has improved since the publication of the CONSORT statement, particularly in journals which have adopted the statement. However, the reporting of randomization, allocation concealment and blinding remains inadequate.
Subject(s)
Orthodontics/standards , Randomized Controlled Trials as Topic/standards , Research Report/standards , Checklist , Guideline Adherence , Guidelines as Topic , Humans , Journalism, Dental/standards , Observer Variation , Periodicals as Topic , Reference Standards , Reproducibility of Results , Statistics as TopicABSTRACT
As part of the Membership in Orthodontics examination, candidates are required to present five treated cases. Two of the cases treated by one of the winners of the William Houston Gold Medal from the MOrth diet of the Royal College of Surgeons of Edinburgh in 2009 are described.
Subject(s)
Awards and Prizes , Malocclusion, Angle Class II/therapy , Open Bite/therapy , Adolescent , Cephalometry , Child , Extraoral Traction Appliances , Female , Humans , Male , Malocclusion, Angle Class II/pathology , Orthodontic Appliances, Functional , Orthodontic Space Closure , Overbite/therapy , Tooth ExtractionABSTRACT
Since the mid-1990s, three new initiatives have been introduced by the government to allow the prescribing of medicines by practitioners other than doctors: extended nurse prescribing, supplementary prescribing and patient group directions. Professional education and assessment is vital to ensure that these systems operate safely. After the implementation of patient group directions within a regional cancer centre, a training programme was developed, incorporating an assessment framework for competency development.
