Guidelines for time-to-event end point definitions in breast cancer trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)

Gourgou-Bourgade, Sophie; Cameron, D; Poortmans, P.; Asselain, Bernard; Azria, D.; Cardoso, F.; A'Hern, R.; Bliss, Judith M.; Bogaerts, Jan; Bonnefoi, Hervé; Brain, Étienne; Cardoso, M.J.; Chibaudel, Benoist; Coleman, R.; Čufer, Tanja; Lago, Lissandra Dal; Dalenc, Florence; Azambuja, Evandro de; Debled, M.; Delaloge, Suzette; Filleron, Thomas; Gligorov, J.; Gutowski, Marian; Jacot, William; Kirkove, C.; MacGrogan, Gaëtan; Michiels, Stefan; Negreiros, I.; Offersen, Birgitte Vrou; Llorca, F. Penault; Pruneri, Giancarlo; Roché, Henri; Russell, Nicola S.; Schmitt, Fernando; Servent, V.; Thürlimann, Beat; Untch, Michael; Hage, Jos A. van der; Tienhoven, Geertjan van; Wildiers, Hans; Yarnold, J.; Bonnetain, Franck; Mathoulin‐Pélissier, Simone; Bellera, Carine; Dabakuyo‐Yonli, Tienhan Sandrine

doi:10.1093/annonc/mdv478

Cited by 69 publications

(58 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Another limitation is that anthropometric measurements were not clinically assessed, but self-reported. However, a validation study 18 in a subset of the E3N cohort showed high correlation coefficients (>0.80) between weight, height, hip, waist, bust circumferences and BMI measured by a technician, and those measured by the women. Lastly, the low number of BMI-defined obese women and few events in those women limited the study of the association between obesity and survival.…”

Section: Discussionmentioning

confidence: 94%

“…Survival follow-up started at the date of diagnosis of the first primary invasive breast cancer. We defined invasive diseasefree survival (iDFS) as time to second invasive cancer event or death from any cause, overall survival (OS) as time to death from any cause and breast cancer-specific survival (BCSS) as time to death from breast cancer, as recommended by Hudis et al 12 and Gourgou-Bourgade et al 18 For OS and BCSS analyses, women were followed until the event of interest or until December 7, 2011. Women who did not answer the last questionnaire (11.0%) were considered lost to followup in the iDFS analyses, and censored at the date of the last completed questionnaire plus 6 months.…”

Section: Statistical Analysesmentioning

confidence: 99%

See 1 more Smart Citation

Prediagnostic body size and breast cancer survival in the E3N cohort study

His

Fagherazzi

Mesrine

et al. 2016

Intl Journal of Cancer

View full text Add to dashboard Cite

Obesity has been associated with poor breast cancer prognosis, however most studies have focused on body mass index (BMI) and few have considered the distribution of adipose tissue. We investigated associations between prediagnostic adiposity and breast cancer survival, considering BMI, waist and hip circumferences (WC and HC), and waist-to-hip ratio (WHR).Analyses included 3,006 women from the French E3N prospective cohort study diagnosed with primary invasive breast cancer between 1995 and 2008. We investigated overall, breast cancer-specific, and disease-free survival, overall and according to stage, menopausal and hormonal status and year of diagnosis, using Cox proportional hazard models adjusted for tumor characteristics and lifestyle risk factors.Women with a prediagnostic HC > 100 cm were at increased risk of death from all causes (hazard ratio (HR) >100vs < 95 cm 5 1.38, 95% Confidence Interval (CI) 5 1.02-1.86, P trend 5 0.02) and from breast cancer (HR >100vs < 95 cm 5 1.50, CI 5 1.03-2.17, P trend 5 0.03), and of second invasive cancer event (HR >100vs < 95 cm 5 1.36, CI 5 1.11-1.67, P trend 5 0.002), compared to those with HC <95 cm. Associations were stronger after adjustment for BMI. BMI, WC and WHR were not associated with survival after breast cancer. Our study underlines the importance of going beyond BMI when studying the association between adiposity and breast cancer survival. Further studies should be conducted to confirm our results on hip circumference.Breast cancer is the most prevalent cancer in women in both developed and developing countries. 1 With 5-year relative survival rates of 80% or more in developed countries, 2 an increasing number of women are currently living with a diagnosis of breast cancer. For these cancer survivors, it is essential to identify modifiable risk factors that could influence their prognosis.Breast cancer characteristics such as TNM stage, lymph node status, tumor size, tumor grade, histological type, lymphatic and vascular invasion, hormone receptor and HER2 status, and age at diagnosis are known predictive or prognostic factors. 3,4 A recent meta-analysis conducted by the World Cancer Research Fund (WCRF) has shown that obesity and excess weight before diagnosis were associated with increased mortality (from all causes and from breast cancer). 5 However, the WCRF expert panel judged that the level of evidence for the association between a healthy body mass index (BMI) and a better survival was only limited, despite suggestive evidence. 6 Weaknesses have been underlined in observational studies as well as in clinical trials. In particular, cohort studies need to assess more systematically important prognostic factors, such as tumor characteristics, treatment or time period of cancer diagnosis (because of rapid changes in treatments). On the other hand, results from clinical trials, which

show abstract

Section: Discussionmentioning

confidence: 94%

Section: Statistical Analysesmentioning

confidence: 99%

Prediagnostic body size and breast cancer survival in the E3N cohort study

His

Fagherazzi

Mesrine

et al. 2016

Intl Journal of Cancer

View full text Add to dashboard Cite

show abstract

“…Alternatively, patient uncertainty regarding specific terminology could arise because the definition of some endpoints remains debated even among disease experts and clinical trialists. 28 Why do these findings matter? Meaningful communication of a clinical trial's endpoints, design, and results appear to be closely linked with patient interest and acceptance.…”

Section: Discussionmentioning

confidence: 99%

Patient familiarity with, understanding of, and preferences for clinical trial endpoints and terminology

Itzstein

Railey

Smith

et al. 2020

Cancer

View full text Add to dashboard Cite

Background Although there is increased attention to designing and explaining clinical trials in ways that are clinically meaningful for patients, there is limited information on patient preferences, understanding, and perceptions of this content. Methods Maximum difference scaling (MaxDiff) methodology was used to develop a survey for assessing patients' understanding of 19 clinical terms and perceived importance of 9 endpoint surrogate phrases used in clinical trials and consent forms. The survey was administered electronically to individuals with metastatic breast cancer affiliated with the Metastatic Breast Cancer Alliance. Analyses were performed using Bayesian P values with statistical software. Results Among 503 respondents, 77% had a college degree, 70% were diagnosed with metastatic disease ≥2 years before survey completion, and 77% had received ≥2 lines of systemic therapy. Less than 35% of respondents reported understanding “fairly well” the terms symptomatic progression, duration of disease control, time to treatment cessation, and endpoints. Income level and time since onset of metastatic disease correlated with comprehension. Patients who had received ≥6 lines of therapy perceived that time until serious side effects (P < .001) and time on therapy (P < .001) were more important compared with those who had received only 1 line of therapy. Positively phrased parameters were associated with increased perceived importance. Conclusions Even among educated, heavily pretreated patients, many commonly used clinical research terms are poorly understood. Comprehension and the perceived importance of trial endpoints vary over the course of disease. These observations may inform the design, discussion, and reporting of clinical trials.

show abstract

“…Lymph node recurrences outside these nodal basins were considered as distant metastatic disease. An event in the contralateral breast was defined as a new primary tumour and was not considered as a recurrence, unless it could be proven that it was metastatic disease.…”

Section: Methodsmentioning

confidence: 99%

Prognostic impact of repeat sentinel lymph node biopsy in patients with ipsilateral breast tumour recurrence

Poodt

Vugts

Schipper

et al. 2019

British Journal of Surgery

View full text Add to dashboard Cite

Background: Ipsilateral breast tumour recurrence (IBTR) has an unfavourable prognosis, with a significant subsequent risk of distant recurrence. Repeat sentinel lymph node biopsy (rSLNB) has recently been demonstrated to be technically feasible and useful in tailoring adjuvant treatment plans in patients with IBTR. The prognostic impact of rSLNB in patients with IBTR remains unclear. This study analysed the risk of distant recurrence after IBTR, and evaluated the prognostic impact of rSLNB and other patient and tumour characteristics on distant recurrence-free survival. Methods: Data were obtained from the SNARB (Sentinel Node and Recurrent Breast Cancer) study. Cox proportional hazards analyses were performed to assess the prognostic effect of tumour, patient and treatment factors on distant recurrence-free survival.Results: Of the 515 included patients, 230 (44⋅7 per cent) had a tumour-negative rSLNB and 46 (8⋅9 per cent) a tumour-positive rSLNB. In 239 patients (46⋅4 per cent) the rSLNB procedure was unsuccessful. After a median follow-up of 5⋅1 years, 115 patients (22⋅3 per cent) had developed a recurrence. The overall 5-year distant recurrence-free survival rate was 84⋅2 (95 per cent c.i. 80⋅7 to 87⋅7) per cent. An interval of less than 2 years between primary breast cancer treatment and ipsilateral recurrence (P = 0⋅018), triple-negative IBTR (P = 0⋅045) and absence of adjuvant chemotherapy after IBTR (P = 0⋅010) were independently associated with poor distant recurrence-free survival. The association between the outcome of rSLNB and distant recurrence-free survival was not statistically significant (P = 0⋅682). Conclusion:The outcome of rSLNB is not an important prognostic factor for distant recurrence, and its value as a staging tool in patients with IBTR seems disputable.Members of the SNARB study group are co-authors in this study and are listed in Appendix S1 (supporting information)

show abstract

Guidelines for time-to-event end point definitions in breast cancer trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)

Cited by 69 publications

References 0 publications

Prediagnostic body size and breast cancer survival in the E3N cohort study

Prediagnostic body size and breast cancer survival in the E3N cohort study

Patient familiarity with, understanding of, and preferences for clinical trial endpoints and terminology

Prognostic impact of repeat sentinel lymph node biopsy in patients with ipsilateral breast tumour recurrence

Contact Info

Product

Resources

About