79 research outputs found
ARNOLD V BRITTON [2015]: AN ODYSSEY OF COMMERCIAL INTERPRETATION
INTRODUCTION
Arnold v Britton [2015][1] clarified that where the language of a contract is unambiguous the literalist interpretation of the wording will outweigh the principle of commercial common sense. The subject of the litigation was a deceptively reasonable service charge clause included in 25 lease agreements at ÂŁ90 a year, which increased by 10 percent compound interest per annum. Due to the high rate of inflation at the time the contracts were entered into, the service charge increased exponentially reaching extortionate rates. Deciding in favour of the landlord, the court marks a shift to a more conservative approach to contractual interpretation, which centers on textual analysis with less regard to external context[2]. But beyond updating the rules of construction, the exercise of balancing literalism and business common sense has served as a lighthouse, illuminating the often-treacherous waves that govern commercial relations. The Lordsâ have deliberated whether commercial sensibilities should be allowed to interfere with the function of a competently drafted service charge and an answer has been reached. However, by favoring the commercially nonsensical interpretation of the provision in question, the Supreme Court has underestimated the value of ensuring amicability and fairness in business relations. The lingering question that remains unanswered and unchallenged is; what commercial behavior is the Supreme Court condoning by choosing to enforce this agreement?
REASONABLENESS OF THE JUDGEMENT
Historically, English principles of contractual interpretation have been perceived as strictly literalist. Contractual interpretation is considered the âascertainment of meaning which the document would convey to a reasonable personâ[3] with access to all relevant background information. Generally, English courts are reluctant to stray away from the natural meaning of an agreement, where the language used is clear. In this case, the wording of the clause in question was identified as unambiguous, leaving little room for a different interpretation. Also, it is important to note that the question of fairness is unimportant as English law âdoes not often accept that people have made linguistic mistakesâ[4] and courts avoid using their red pen to rectify a bad bargain. Interpretation is the exercise of identifying what the parties have agreed, not what the court thinks they should have agreed. Therefore, the Supreme Courtâs decision to assent to the commercially absurd interpretation was justifiable, as the danger of deciding otherwise would render legal relations in the business world volatile and risky. If plain words cannot be trusted, drafters would face an impossible task. Such was the opinion of Lord Neuberger who delivered the majority judgement, emphasizing that âthe language of the clause was simply âtoo clearâ as to lend itself to a different interpretation. He was reluctant to consider the agreement as commercially inconceivable given that inflation had been running over ten percent between 1974 and 1981[5], meaning that this unfair result could have occurred to the detriment of either party. The purpose of this analysis is not to condemn the decision of the Supreme Court, but to underline certain implications that may pose a danger to future commercial relations.
ROLE OF COMMERCIAL COMMON SENSE
The precedents of commercial common sense have emerged in cases were the court is required to navigate the murky waters of an ambiguous agreement. In its genesis it was held that âdetailed semantic and syntactical analysis of wordsâ[6], which leads to a conclusion that is contrary to business common sense, must yield to the commercially probable interpretation. Opposing pedantry, it cuts through language that is commercially ambiguous and is hostile to technical interpretations and linguistic niceties[7]. In principle, business common sense clears the fog of a linguistically ambiguous contract granting flexibility in the process of construction. However, the judgement in Britton reflects the lawâs reluctance to rely on this concept in the fear of disrupting the continuity of English case law.
The service charge clause consisted of two parts, a descriptive part and a quantifying part. Lord Neuberger accepted that there was potential conflict between the two parts of the clause but rejected the lesseeâs argument that the first half should be interpreted as imposing a cap in order to avoid a commercially absurd result. Favouring the landlords fixed-rate interpretation, implies that commercial common sense can also be employed as a vehicle of deception. Just as technical language can conceal the consequences of an agreement, similarly CCS can also be used as a âcamouflage for partisan argumentsâ[8], which are really pleas for escaping a bad bargain. The majority held that âthe natural meaning of the words used was clearâ: the first half of the clause stipulated for an annual charge and the second part quantified that charge. This interpretation of the second half of clause 3(2) was understandable as a variable charge would give rise to many future disputes regarding proportionality. On the contrary, Lord Carnwathâs advocation for a commercially sensible result was acknowledged but ultimately rejected as this would mean âinventing a lack of clarityâ[9] to depart from the natural meaning of the clause. By doing so, the majorityâs insistence on protecting the continuity of English case law and the clear wording of the agreement, was viewed as a higher priority than enforcing commercial logic. It is this very continuity in contractual interpretation which protects commercial parties by enforcing the virtues of certainty and predictability in business relations[10]. Paradoxically, the pursuit for continuity may instead have the effect of muddying the waters of future construction as courts will not always have the luxury of a singular clear interpretation. The majorities conditioning of commercial common sense as a variable dependent on the degree of ambiguity may inspire a heightened need for rectification in similarly ambiguous agreements, and of course the amount of red ink available is always limited.
LACK OF FACTUAL MATRIX
From a superficial perspective, the decision to undermine the importance of this concept in business agreements may be understood as a reminder to lower courts that commercial common sense is not to be employed in unambiguous contracts. However, the question of whether an agreement is commercially sound is to be determined by inquiry to the overall purpose and provisions of a contract[11]. The contention that business common sense should not be âinvoked retrospectivelyâ to avoid offending the natural language of the clause in question appears rather reaching. Pragmatically, not all judges possess the business acumen required to decipher what constitutes a commercially sensible agreement. This is especially true in agreements were the language used lends itself to multiple competing interpretations. Therefore, it is imperative to investigate the factual matrix behind a transaction, to avoid de-valuing the commercial implications of an absurd result.
The question of whether to draw or conceal the proverbial sword of âcommercial common senseâ can be better determined by inquiry to overall purpose of the agreement[12]; a resource the Supreme Court had limited access to, due to the lack of âfactual matrixâ, which includes any information that was available to the parties at the time the contract was entered into. In other words, the decision to undermine the authority of business good sense, while necessary, appears rudderless as the majority had insufficient material to justify this approach. Apart from information about inflation, no other information was available for the majority to justify negating such a crucial agent of commercial interpretation. There was no clause in the agreement which calculated the possible exponential growth of the service charge. A measure which would have benefited both parties, if the majorities contention that the risk was mutual was indeed true (due to the high inflation of the 1970âs). As established in Rainy Sky [2011], the process of construction requires the court to consider the language used having âregard to all the relevant surrounding circumstancesâ[13]. So, the majorityâs reluctance to employ business common sense may be an indicator that they were ill-equipped to do so. But, evading the spotlight of abolishing a crucial tool of construction comes at the cost of thinning the line that the separates commercially unattractive agreements and undeniably absurd clauses, which clearly do not reflect the intention of the parties involved.
UNEXPLORED AMBIGUITIES IN THE AGREEMENT
To continue venturing into a credible rhetoric of skepticism without appearing redundant, one must assess the lack of factual matrix in line with the inherent ambiguities in the lease agreement. These ambiguities were highlighted in Lord Carnwathâs dissenting judgement, advocating for the court to adopt the commercially logical interpretation. For example, the covenant requires the tenant to pay an annual service charge of ÂŁ90 subject to exponential growth since 1974, while the alteration was made in 1980. In other words, the tenant is agreeing to pay six years of service charge before the lease was granted[14]. A result which runs contrary to the logic of a âreasonable commercial personâ. Also, the âtriennialâ covenants included in the early leases, contained the words âevery subsequent Three-year periodâ instead of âevery subsequent yearâ. Whether these ambiguities allude that the variation of the leases were subsisting a loss incurred in the early leases is an argument Lord Carnwath was ill-equipped to employ. As asserted by Lord Neuberger, the court would not endeavor âinventing a lack of clarity in the clause as an excuse for departing from its natural meaningâ[15] as this would mean rewriting an unambiguous agreement. Additionally, there was no evidence available regarding the actual expenditure given by the landlord on meeting her obligations under the provision of the lease, whereas the escalator clause was quantified far more precisely. These minor details, when viewed together, may indeed legitimize the contention of ill-will. Naturally, no authority with the stature of the Supreme Court would dare navigate the potentially hazardous avenue of unilaterally altering the historically accepted nature of the English contract in order to emphasize the real intention of the parties. Ultimately, the clarity of the language used renders any rhetoric regarding ill-intent, futile, as the court would not undermine the clear language of a commercial agreement in order to facilitate such rhetoric. For this reason, no court though these ambiguities substantially material.
WHAT COMMERCIAL BEHAVIOUR IS BEING CONDONED?
Returning to the initial question regarding the commercial principles the Supreme Court is allowing to prosper, it is likely that future matters of heightened linguistic ambiguity will emerge. Given the futility of Parliamentary intervention, due to the adverse impact this would have on many mixed-use developments[16], it is evident that the common law has a monopoly on writing the frameworks of construction. In Britton, Lord Neuberger emphasized seven factors to be employed in contractual interpretation. The weight of these frameworks is not to be undermined, as the Supreme Court is not only clarifying the rules of interpretation but is also implying (avoiding blatantly admitting) that mistakes have been made in prior cases of construction. An example of this is the implied correction of the approach in Aberdeen[17] (6th factor), in which Neuberger claimed that the clear intention of the parties will be given effect over other interpretations. This seems to run contrary to the result of Britton, which disregards the concept of âreasonable commercial intentionâ to avoid offending the clarity of the agreement. Most problematically, the second factor states that where the drafting of an agreement is clear, the court must not search for âinfelicities in order to facilitate a departure from the natural meaningâ[18] [18]. In less polished words, it is justified to assent to an interpretation that is clear even where this clarity stems from an ambiguous agreement, with a commercially absurd result and with limited liberty to the matrix of fact. By favoring the landlordâs interpretation, the court is inadvertently limiting its flexibility in regard to future construction. The same clarity that outweighed all other considerations in the present matter, may be used as a tool to facilitate improbable agreements, in such a way as to allow pedantic parties to overthrow the courtsâ monopoly of construction.
CONCLUSION
Although the decision in Arnold v Britton did not alter the underlying principles of construction, it shed light to the hierarchy of the components to be used in the interpretation of an unambiguous agreement. It is now evident that the clear wording of an agreement will supersede commercial infelicities and linguistic ambiguities. But, by laying the foundations of such a rigid interpretive autonomy, the Supreme Court is effectively better enabling ill-willed parties to monopolize the process of construction, using the overtly elevated judicial status of âclear languageâ in a contract as a tool to legitimize absurd interpretations. The exercise of clarifying the contemporarily accepted rules of construction has occurred at the detriment of other crucial variables.
More recent litigious proceedings have alluded that a mistake may have been made in the judgement of Britton. In the case of Monsolar IQ Ltd v Woden Park Ltd [2021][19], the Court of Appeal rejected the absurd interpretation of an indexation clause in a lease agreement, which clearly did not reflect the intentions of the parties. Ambivalence is evident on whether the Court of Appeal has received or accepted the message left by Britton, as Nugee LJ rejected the contention that Arnold v Britton had modified the Chartbook[20] principle, which states that commercial common sense may indeed outweigh the literal interpretation of wording. Though not binding upon the Supreme Court, the case of Monsolar is didactic of the fact that the line which separates commercially imprudent provisions and nonsensical clauses may indeed be thinning. I believe the Supreme Court has undermined the existence of pedantry amongst commercial parties, seeking to dominate the process of construction by adhering to the hierarchical structure of interpretative components set out in Britton in a way as to serve their own benefit. The rainy sky may have dried up, but the benevolent seas that govern commercial behavior, have yet to be explored.
[1] UKSC 36
[2] Suzanne Robertson, âMaking Sense of Commercial Common Senseâ [2018] VUWLR 279
[3] Investors Compensation Scheme Ltd v West Bromwich Building Society [1998] UKHL 28
[4] ibid.
[5] Katharine Osbergy, Christopher Stothers, âContracts Patents and Chess - Applying Arnold v Britton to patent claim constructionâ [2017] JIPL 23
[6] Antaios Compania Naviera SA v Salen Rederierna AB (The Antaios) [1985] A.C. 191
[7] Neil Andrews, âInterpretation of contracts and âcommercial common senseâ: do not overplay this useful criterionâ [2017] CLR 36
[8] ibid.
[9] Britton (n 1)
[10] Geoffrey Vos, âContractual Interpretation: Do judges sometime say one thing and mean another?â [2017] CLR
[11] Andrews (no 7)
[12] Ibid (no 7)
[13] Rainy Sky SA v Kookmin Bank [2011] UKSC 50
[14] Paul Clark, âDrafting after Arnold v Brittonâ [2015] 373
[15] Britton (no 1)
[16] Ibid (no 14)
[17] [2011] UKSC 56
[18] ibid (no 1)
[19] EWCA Civ 961
[20] [2009] UKHL 3
Repeatability of quantitative18F-FLT uptake measurements in solid tumors: an individual patient data multi-center meta-analysis
INTRODUCTION: 3'-deoxy-3'-[18F]fluorothymidine (18F-FLT) positron emission tomography (PET) provides a non-invasive method to assess cellular proliferation and response to antitumor therapy. Quantitative18F-FLT uptake metrics are being used for evaluation of proliferative response in investigational setting, however multi-center repeatability needs to be established. The aim of this study was to determine the repeatability of18F-FLT tumor uptake metrics by re-analyzing individual patient data from previously published reports using the same tumor segmentation method and repeatability metrics across cohorts. METHODS: A systematic search in PubMed, EMBASE.com and the Cochrane Library from inception-October 2016 yielded five18F-FLT repeatability cohorts in solid tumors.18F-FLT avid lesions were delineated using a 50% isocontour adapted for local background on test and retest scans. SUVmax, SUVmean, SUVpeak, proliferative volume and total lesion uptake (TLU) were calculated. Repeatability was assessed using the repeatability coefficient (RCâ=â1.96Â ĂÂ SD of test-retest differences), linear regression analysis, and the intra-class correlation coefficient (ICC). The impact of different lesion selection criteria was also evaluated. RESULTS: Images from four cohorts containing 30 patients with 52 lesions were obtained and analyzed (ten in breast cancer, nine in head and neck squamous cell carcinoma, and 33 in non-small cell lung cancer patients). A good correlation was found between test-retest data for all18F-FLT uptake metrics (R2ââ„â0.93; ICCââ„â0.96). Best repeatability was found for SUVpeak(RC: 23.1%), without significant differences in RC between different SUV metrics. Repeatability of proliferative volume (RC: 36.0%) and TLU (RC: 36.4%) was worse than SUV. Lesion selection methods based on SUVmaxââ„â4.0 improved the repeatability of volumetric metrics (RC: 26-28%), but did not affect the repeatability of SUV metrics. CONCLUSIONS: In multi-center studies, differences â„Â 25% in18F-FLT SUV metrics likely represent a true change in tumor uptake. Larger differences are required for FLT metrics comprising volume estimates when no lesion selection criteria are applied
Incidence of Venous Thromboembolism in Critically Ill Coronavirus Disease 2019 Patients Receiving Prophylactic Anticoagulation
This article is made available for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.Objectives: One of the defining features of the novel coronavirus disease 2019 infection has been high rates of venous thromboses. The present study aimed to describe the prevalence of venous thromboembolism in critically ill patients receiving different regimens of prophylactic anticoagulation.
Design: Single-center retrospective review using data from patients with confirmed severe acute respiratory syndrome coronavirus 2 requiring intubation.
Setting: Tertiary-care center in Indianapolis, IN, United States.
Patients: Patients hospitalized at international units Health Methodist Hospital with severe acute respiratory syndrome coronavirus 2 requiring intubation between March 23, 2020, and April 8, 2020, who underwent ultrasound evaluation for venous thrombosis.
Interventions: None.
Measurements and Main Results: A total of 45 patients were included. Nineteen of 45 patients (42.2%) were found to have deep venous thrombosis. Patients found to have deep venous thrombosis had no difference in time to intubation (p = 0.97) but underwent ultrasound earlier in their hospital course (p = 0.02). Sequential Organ Failure Assessment scores were similar between the groups on day of intubation and day of ultrasound (p = 0.44 and p = 0.07, respectively). d-dimers were markedly higher in patients with deep venous thrombosis, both for maximum value and value on day of ultrasound (p < 0.01 for both). Choice of prophylactic regimen was not related to presence of deep venous thrombosis (p = 0.35). Ultrasound evaluation is recommended if d-dimer is greater than 2,000âng/mL (sensitivity 95%, specificity 46%) and empiric anticoagulation considered if d-dimer is greater than 5,500âng/mL (sensitivity 53%, specificity 88%).
Conclusions: Deep venous thrombosis is very common in critically ill patients with coronavirus disease 2019. There was no difference in incidence of deep venous thrombosis among different pharmacologic prophylaxis regimens, although our analysis is limited by small sample size. d-dimer values are elevated in the majority of these patients, but there may be thresholds at which screening ultrasound or even empiric systemic anticoagulation is indicated.Dr. Khanâs institution received funding from the National Institutes of Health. The remaining authors have disclosed that they do not have any potential conflicts of interest
Can we predict which COVID-19 patients will need transfer to intensive care within 24 hours of floor admission?
Background
Patients with COVIDâ19 can present to the emergency department (ED) at any point during the spectrum of illness, making it difficult to predict what level of care the patient will ultimately require. Admission to a ward bed, which is subsequently upgraded within hours to an intensive care unit (ICU) bed, represents an inability to appropriately predict the patient's course of illness. Predicting which patients will require ICU care within 24 hours would allow admissions to be managed more appropriately.
Methods
This was a retrospective study of adults admitted to a large health care system, including 14 hospitals across the state of Indiana. Included patients were aged â„ 18 years, were admitted to the hospital from the ED, and had a positive polymerase chain reaction (PCR) test for COVIDâ19. Patients directly admitted to the ICU or in whom the PCR test was obtained > 3 days after hospital admission were excluded. Extracted data points included demographics, comorbidities, ED vital signs, laboratory values, chest imaging results, and level of care on admission. The primary outcome was a combination of either death or transfer to ICU within 24 hours of admission to the hospital. Data analysis was performed by logistic regression modeling to determine a multivariable model of variables that could predict the primary outcome.
Results
Of the 542 included patients, 46 (10%) required transfer to ICU within 24 hours of admission. The final composite model, adjusted for age and admission location, included history of heart failure and initial oxygen saturation of 6.4 or glomerular filtration rate < 46. The odds ratio (OR) for decompensation within 24 hours was 5.17 (95% confidence interval [CI] = 2.17 to 12.31) when all criteria were present. For patients without the above criteria, the OR for ICU transfer was 0.20 (95% CI = 0.09 to 0.45).
Conclusions
Although our model did not perform well enough to stand alone as a decision guide, it highlights certain clinical features that are associated with increased risk of decompensation
Characteristics of COVID-19 Patients with Bacterial Co-infection Admitted to the Hospital from the Emergency Department in a Large Regional Healthcare System
Introduction
The rate of bacterial coinfection with SARSâCoVâ2 is poorly defined. The decision to administer antibiotics early in the course of SARSâCoVâ2 infection depends on the likelihood of bacterial coinfection.
Methods
We performed a retrospective chart review of all patients admitted through the emergency department with confirmed SARSâCoVâ2 infection over a 6âweek period in a large healthcare system in the United States. Blood and respiratory culture results were abstracted and adjudicated by multiple authors. The primary outcome was the rate of bacteremia. We secondarily looked to define clinical or laboratory features associated with bacteremia.
Results
There were 542 patients admitted with confirmed SARSâCoVâ2 infection, with an average age of 62.8 years. Of these, 395 had blood cultures performed upon admission, with six true positive results (1.1% of the total population). An additional 14 patients had positive respiratory cultures treated as true pathogens in the first 72âh. Low blood pressure and elevated white blood cell count, neutrophil count, blood urea nitrogen, and lactate were statistically significantly associated with bacteremia. Clinical outcomes were not statistically significantly different between patients with and without bacteremia.
Conclusions
We found a low rate of bacteremia in patients admitted with confirmed SARSâCoVâ2 infection. In hemodynamically stable patients, routine antibiotics may not be warranted in this population
Adding 6 months of androgen deprivation therapy to postoperative radiotherapy for prostate cancer: a comparison of short-course versus no androgen deprivation therapy in the RADICALS-HD randomised controlled trial
Background
Previous evidence indicates that adjuvant, short-course androgen deprivation therapy (ADT) improves metastasis-free survival when given with primary radiotherapy for intermediate-risk and high-risk localised prostate cancer. However, the value of ADT with postoperative radiotherapy after radical prostatectomy is unclear.
Methods
RADICALS-HD was an international randomised controlled trial to test the efficacy of ADT used in combination with postoperative radiotherapy for prostate cancer. Key eligibility criteria were indication for radiotherapy after radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to radiotherapy alone (no ADT) or radiotherapy with 6 months of ADT (short-course ADT), using monthly subcutaneous gonadotropin-releasing hormone analogue injections, daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as distant metastasis arising from prostate cancer or death from any cause. Standard survival analysis methods were used, accounting for randomisation stratification factors. The trial had 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 80% to 86% (hazard ratio [HR] 0·67). Analyses followed the intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov, NCT00541047.
Findings
Between Nov 22, 2007, and June 29, 2015, 1480 patients (median age 66 years [IQR 61â69]) were randomly assigned to receive no ADT (n=737) or short-course ADT (n=743) in addition to postoperative radiotherapy at 121 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 9·0 years (IQR 7·1â10·1), metastasis-free survival events were reported for 268 participants (142 in the no ADT group and 126 in the short-course ADT group; HR 0·886 [95% CI 0·688â1·140], p=0·35). 10-year metastasis-free survival was 79·2% (95% CI 75·4â82·5) in the no ADT group and 80·4% (76·6â83·6) in the short-course ADT group. Toxicity of grade 3 or higher was reported for 121 (17%) of 737 participants in the no ADT group and 100 (14%) of 743 in the short-course ADT group (p=0·15), with no treatment-related deaths.
Interpretation
Metastatic disease is uncommon following postoperative bed radiotherapy after radical prostatectomy. Adding 6 months of ADT to this radiotherapy did not improve metastasis-free survival compared with no ADT. These findings do not support the use of short-course ADT with postoperative radiotherapy in this patient population
Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial
Background
Previous evidence supports androgen deprivation therapy (ADT) with primary radiotherapy as initial treatment for intermediate-risk and high-risk localised prostate cancer. However, the use and optimal duration of ADT with postoperative radiotherapy after radical prostatectomy remains uncertain.
Methods
RADICALS-HD was a randomised controlled trial of ADT duration within the RADICALS protocol. Here, we report on the comparison of short-course versus long-course ADT. Key eligibility criteria were indication for radiotherapy after previous radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to add 6 months of ADT (short-course ADT) or 24 months of ADT (long-course ADT) to radiotherapy, using subcutaneous gonadotrophin-releasing hormone analogue (monthly in the short-course ADT group and 3-monthly in the long-course ADT group), daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as metastasis arising from prostate cancer or death from any cause. The comparison had more than 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 75% to 81% (hazard ratio [HR] 0·72). Standard time-to-event analyses were used. Analyses followed intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and
ClinicalTrials.gov
,
NCT00541047
.
Findings
Between Jan 30, 2008, and July 7, 2015, 1523 patients (median age 65 years, IQR 60â69) were randomly assigned to receive short-course ADT (n=761) or long-course ADT (n=762) in addition to postoperative radiotherapy at 138 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 8·9 years (7·0â10·0), 313 metastasis-free survival events were reported overall (174 in the short-course ADT group and 139 in the long-course ADT group; HR 0·773 [95% CI 0·612â0·975]; p=0·029). 10-year metastasis-free survival was 71·9% (95% CI 67·6â75·7) in the short-course ADT group and 78·1% (74·2â81·5) in the long-course ADT group. Toxicity of grade 3 or higher was reported for 105 (14%) of 753 participants in the short-course ADT group and 142 (19%) of 757 participants in the long-course ADT group (p=0·025), with no treatment-related deaths.
Interpretation
Compared with adding 6 months of ADT, adding 24 months of ADT improved metastasis-free survival in people receiving postoperative radiotherapy. For individuals who can accept the additional duration of adverse effects, long-course ADT should be offered with postoperative radiotherapy.
Funding
Cancer Research UK, UK Research and Innovation (formerly Medical Research Council), and Canadian Cancer Society
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