Abstract:
IMPORTANCE:Time to events, or survival end points, are common end points in randomized clinical trials. They are usually analyzed under the assumption of proportional hazards, and the treatment effect is reported as a hazard ratio, which is neither an intuitive measure nor a meaningful one if the assumption of proportional hazards is not met. OBJECTIVE:To demonstrate that a different measure of treatment effect, called the net chance of a longer survival, is a meaningful measure of treatment effect in clinical trials whether or not the assumption of proportional hazards is met. DESIGN:In this simulation study, the net chance of a longer survival by at least m months, where m months is considered clinically worthwhile and relevant to the patient, was calculated as the probability that a random patient in the treatment group has a longer survival by at least m months than does a random patient in the control group minus the probability of the opposite situation. The net chance of a longer survival is equal to zero if treatment does not differ from control and ranges from -100% if all patients in the control group fare better than all patients in the treatment group up to 100% in the opposite situation. We simulated data sets for realistic trials under various scenarios of proportional and nonproportional survival hazards and plotted the Kaplan-Meier survival curves as well as the net chance of a longer survival as a function of m. Data analysis was performed from August 14 to 18, 2015. MAIN OUTCOMES AND MEASURES:The net chance of a longer survival calculated for values of m ranging from 0 to 40 months. RESULTS:When hazards are proportional, the net chance of a longer survival approaches zero as m increases. The net chance of a longer survival (Δ) was 13% (95% CI, 6.5%-19.4%; P < .001) when any survival difference was considered clinically relevant (m = 0 months). When survival differences larger than 20 months were considered relevant (m = 20), the net chance of a longer survival was very close to zero (Δ[20] = 0.5%; 95% CI, -0.1% to 1.1%; P = .09). In contrast, when treatment effects are delayed or when some patients are cured by treatment, the net chance of a longer survival benefit remains high and tends to the cure rate. For crossing hazards, the Δ was negative (Δ = -6.9%; 95% CI, -14.0% to -0.5%; P = .047). However when large survival differences were considered (m = 20), the Δ(m) was positive (Δ[20] = 8.9%; 95% CI, 6.7%-11.1%; P < .001). CONCLUSIONS AND RELEVANCE:The net chance of a longer survival is useful whether or not the assumption of proportional hazards is met in the analysis of survival end points and may be helpful as a measure of treatment benefit that has direct relevance to patients and health care professionals.
journal_name
JAMA Oncoljournal_title
JAMA oncologyauthors
Péron J,Roy P,Ozenne B,Roche L,Buyse Mdoi
10.1001/jamaoncol.2015.6359subject
Has Abstractpub_date
2016-07-01 00:00:00pages
901-5issue
7eissn
2374-2437issn
2374-2445pii
2517399journal_volume
2pub_type
杂志文章相关文献
JAMA Oncology文献大全abstract:Importance:Sarcopenia (low muscle mass), poor muscle quality (low muscle radiodensity), and excess adiposity derived from computed tomography (CT) has been related to higher mortality in patients with metastatic breast cancer, but the association with prognosis in patients with nonmetastatic breast cancer is unknown. ...
journal_title:JAMA oncology
pub_type: 杂志文章
doi:10.1001/jamaoncol.2018.0137
更新日期:2018-06-01 00:00:00
abstract:Importance:The risk stratification of adrenocortical carcinoma (ACC) based on tumor proliferation index and stage is limited. Adjuvant therapy after surgery is recommended for most patients. Pan-genomic studies have identified distinct molecular groups closely associated with outcome. Objective:To compare the molecula...
journal_title:JAMA oncology
pub_type: 杂志文章
doi:10.1001/jamaoncol.2019.1558
更新日期:2019-07-11 00:00:00
abstract:Importance:Hyperprogressive disease (HPD) is a new pattern of progression recently described in patients with cancer treated with programmed cell death 1 (PD-1) and programmed cell death ligand 1 (PD-L1) inhibitors. The rate and outcome of HPD in advanced non-small cell lung cancer (NSCLC) are unknown. Objectives:To i...
journal_title:JAMA oncology
pub_type: 杂志文章,多中心研究
doi:10.1001/jamaoncol.2018.3676
更新日期:2018-11-01 00:00:00
abstract:Importance:Tumor-treating fields (TTFields) therapy improves both progression-free and overall survival in patients with glioblastoma. There is a need to assess the influence of TTFields on patients' health-related quality of life (HRQoL). Objective:To examine the association of TTFields therapy with progression-free ...
journal_title:JAMA oncology
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1001/jamaoncol.2017.5082
更新日期:2018-04-01 00:00:00
abstract:IMPORTANCE:Contrary to practice guidelines, breast magnetic resonance imaging (MRI) is commonly used in the preoperative evaluation of women with breast cancer. While existing literature has found little benefit to MRI in most patients, potential downstream consequences associated with breast MRI are not well described...
journal_title:JAMA oncology
pub_type: 杂志文章
doi:10.1001/jamaoncol.2015.3018
更新日期:2015-12-01 00:00:00
abstract:Importance:A high 21-gene recurrence score (RS) by breast cancer assay is prognostic for distant recurrence of early breast cancer after local therapy and endocrine therapy alone, and for chemotherapy benefit. Objective:To describe clinical outcomes for women with a high RS who received adjuvant chemotherapy plus endo...
journal_title:JAMA oncology
pub_type: 杂志文章,随机对照试验
doi:10.1001/jamaoncol.2019.4794
更新日期:2020-03-01 00:00:00
abstract:Importance:Unresectable intrahepatic cholangiocarcinoma (IHC) carries a poor prognosis, with a median overall survival (OS) of 11 months. Hepatic arterial infusion (HAI) of high-dose chemotherapy may have potential benefit in these patients. Objective:To evaluate clinical outcomes when HAI chemotherapy is combined wit...
journal_title:JAMA oncology
pub_type: 杂志文章
doi:10.1001/jamaoncol.2019.3718
更新日期:2019-10-31 00:00:00
abstract:IMPORTANCE:Time to surgery (TTS) is of concern to patients and clinicians, but controversy surrounds its effect on breast cancer survival. There remains little national data evaluating the association. OBJECTIVE:To investigate the relationship between the time from diagnosis to breast cancer surgery and survival, usin...
journal_title:JAMA oncology
pub_type: 杂志文章
doi:10.1001/jamaoncol.2015.4508
更新日期:2016-03-01 00:00:00
abstract:Importance:Hand-foot syndrome (HFS) is a common adverse effect of capecitabine treatment. Objective:To compare the incidence and time to onset of grade 2 or greater HFS in patients receiving pyridoxine vs placebo and to identify biomarkers predictive of HFS. Design, Setting, and Participants:This single-center, rando...
journal_title:JAMA oncology
pub_type: 杂志文章,随机对照试验
doi:10.1001/jamaoncol.2017.1269
更新日期:2017-11-01 00:00:00
abstract:Importance:Three years of adjuvant imatinib mesylate therapy is associated with reduced recurrence rates and improved overall survival in patients with high-risk primary gastrointestinal stromal tumor (GIST) compared with patients who receive 1 year of treatment. The impact of a longer duration of therapy is unknown. ...
journal_title:JAMA oncology
pub_type: 杂志文章,多中心研究
doi:10.1001/jamaoncol.2018.4060
更新日期:2018-12-01 00:00:00
abstract:Importance:Low-cost sequencing of multiple genes is increasingly available for cancer risk assessment. Little is known about uptake or outcomes of multiple-gene sequencing after breast cancer diagnosis in community practice. Objective:To examine the effect of multiple-gene sequencing on the experience and treatment ou...
journal_title:JAMA oncology
pub_type: 杂志文章
doi:10.1001/jamaoncol.2018.0644
更新日期:2018-08-01 00:00:00
abstract:Importance:RAS wild-type (wt) status is necessary but not sufficient for response to anti-epidermal growth factor receptor (EGFR) agents in advanced colorectal cancer (aCRC). RNA expression of EGFR ligands epiregulin (EREG) and amphiregulin (AREG) may correlate with EGFR-targeted therapy efficacy in aCRC, so may repres...
journal_title:JAMA oncology
pub_type: 杂志文章
doi:10.1001/jamaoncol.2015.6065
更新日期:2016-05-01 00:00:00
abstract:Importance:Breast cancer risk and comorbidities increase with age. Data are lacking on the association of adjuvant chemotherapy with survival in elderly patients with multiple comorbidities and node-positive breast cancer. Objective:To examine the association of chemotherapy with survival in elderly patients with mult...
journal_title:JAMA oncology
pub_type: 杂志文章
doi:10.1001/jamaoncol.2020.2388
更新日期:2020-10-01 00:00:00
abstract:Importance:Conventional adjuvant radiotherapy for breast cancer given daily for several weeks is onerous and expensive. Some patients may be obliged to choose a mastectomy instead, and some may forgo radiotherapy altogether. We proposed a clinical trial to test whether radiotherapy could be safely limited to the tumor ...
journal_title:JAMA oncology
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1001/jamaoncol.2020.0249
更新日期:2020-07-01 00:00:00
abstract:IMPORTANCE:Although axillary lymph node evaluation is standard of care in the surgical management of invasive breast cancer, a benefit has not been demonstrated in ductal carcinoma in situ (DCIS). Despite uncertainty regarding the efficacy, axillary evaluation is often performed in women with DCIS. OBJECTIVE:To determ...
journal_title:JAMA oncology
pub_type: 杂志文章
doi:10.1001/jamaoncol.2015.0389
更新日期:2015-06-01 00:00:00
abstract:Importance:Colorectal cancer (CRC) incidence and mortality among individuals younger than 50 years (early-onset CRC) are increasing. The reasons for such increases are largely unknown, although the increasing prevalence of obesity may be partially responsible. Objective:To investigate prospectively the association bet...
journal_title:JAMA oncology
pub_type: 杂志文章
doi:10.1001/jamaoncol.2018.4280
更新日期:2019-01-01 00:00:00
abstract:Importance:To date, the benefit of genome-driven cancer therapy has not been quantified. Objective:We sought to estimate the annual percentage of patients in the United States with advanced or metastatic cancer who could be eligible for and benefit from US Food and Drug Administration (FDA)-approved genome-driven ther...
journal_title:JAMA oncology
pub_type: 杂志文章
doi:10.1001/jamaoncol.2018.1660
更新日期:2018-08-01 00:00:00
abstract:Importance:A significant proportion of patients with early-stage triple-negative breast cancer (TNBC) are treated with neoadjuvant chemotherapy. Sequencing of circulating tumor DNA (ctDNA) after surgery, along with enumeration of circulating tumor cells (CTCs), may be used to detect minimal residual disease and assess ...
journal_title:JAMA oncology
pub_type: 杂志文章
doi:10.1001/jamaoncol.2020.2295
更新日期:2020-09-01 00:00:00
abstract:Importance:Financial conflicts of interest (FCOIs) among authors of clinical practice guidelines have the potential to influence treatment recommendations. Objective:To quantify FCOIs with industry among authors of the National Comprehensive Cancer Network (NCCN) guidelines. Design, Setting, and Participants:We asses...
journal_title:JAMA oncology
pub_type: 杂志文章
doi:10.1001/jamaoncol.2016.2710
更新日期:2016-12-01 00:00:00
abstract:Importance:Black individuals are underrepresented in cancer clinical trials. Objective:To examine whether Black and White men with prostate cancer differ in their willingness to discuss clinical trials with their physicians and, if so, whether patient-level barriers statistically mediate racial differences. Design, S...
journal_title:JAMA oncology
pub_type: 杂志文章
doi:10.1001/jamaoncol.2020.3697
更新日期:2020-09-17 00:00:00
abstract:Importance:Capecitabine is not considered a standard agent in the adjuvant treatment of early breast cancer. The results of this study suggest that addition of adjuvant capecitabine to a regimen that contains docetaxel, epirubicin, and cyclophosphamide improves survival outcomes of patients with triple-negative breast ...
journal_title:JAMA oncology
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1001/jamaoncol.2016.6120
更新日期:2017-06-01 00:00:00
abstract:Importance:Programmed cell death 1 (PD-1) inhibitor-related pneumonitis is a rare but clinically serious and potentially life-threatening adverse event. Little is known about its incidence across different tumor types and treatment regimens. Objective:To compare the incidence of PD-1 inhibitor-related pneumonitis amon...
journal_title:JAMA oncology
pub_type: 杂志文章,meta分析,评审
doi:10.1001/jamaoncol.2016.2453
更新日期:2016-12-01 00:00:00
abstract:Importance:Multiple myeloma (MM) is the second most common hematological malignant abnormality. The introduction of immunomodulatory drugs (IMiDs) and proteasome inhibitors (PIs) has greatly improved the overall survival of patients with MM. Prevention and treatment of cardiovascular and thrombotic issues associated wi...
journal_title:JAMA oncology
pub_type: 杂志文章,评审
doi:10.1001/jamaoncol.2016.3350
更新日期:2017-07-01 00:00:00
abstract:Importance:The role of cytoreductive nephrectomy in patients with metastatic renal cancer in the era of targeted therapy is uncertain. Objective:To establish the safety and efficacy of upfront pazopanib therapy prior to cytoreductive nephrectomy in previously untreated patients with metastatic clear cell renal cancer....
journal_title:JAMA oncology
pub_type: 杂志文章,多中心研究
doi:10.1001/jamaoncol.2016.1197
更新日期:2016-10-01 00:00:00
abstract:IMPORTANCE:Positive phase 3 cancer clinical trials are widely hailed, while trials with negative results are often interpreted as scientific failures. We hypothesized that these interpretations would be reflected in the scientific literature. OBJECTIVE:To compare the scientific impact of positive vs negative phase 3 c...
journal_title:JAMA oncology
pub_type: 杂志文章
doi:10.1001/jamaoncol.2015.6487
更新日期:2016-07-01 00:00:00
abstract:Importance:Primary tumor location is emerging as an important prognostic factor owing to distinct biological features. However, the side of origin of colon cancer (CC) still does not represent a prognostic parameter when deciding for adjuvant or palliative chemotherapy. Objective:To determine the prognostic role of le...
journal_title:JAMA oncology
pub_type: 杂志文章
doi:10.1001/jamaoncol.2016.4227
更新日期:2017-02-01 00:00:00
abstract:Importance:Approximately 50% of the risk for the development of testicular germ cell tumors (TGCTs) is estimated to be heritable, but no mendelian TGCT predisposition genes have yet been identified. It is hypothesized that inherited pathogenic DNA repair gene (DRG) alterations may drive susceptibility to TGCTs. Object...
journal_title:JAMA oncology
pub_type: 杂志文章,多中心研究
doi:10.1001/jamaoncol.2018.6477
更新日期:2019-04-01 00:00:00
abstract:Importance:Axicabtagene ciloleucel, an anti-CD19-CD28-CD3ζ chimeric antigen receptor T-cell therapy, was the first US Food and Drug Administration-approved, genetically engineered T-cell therapy for adults with relapsed or refractory large B-cell lymphoma (LBCL) after 2 or more lines of systemic therapy. There has not ...
journal_title:JAMA oncology
pub_type: 杂志文章,评审
doi:10.1001/jamaoncol.2019.3869
更新日期:2020-02-01 00:00:00
abstract:Importance:Currently, preoperative radiotherapy for all soft-tissue sarcomas is identical at a 50-Gy dose level, which can be associated with morbidity, particularly wound complications. The observed clinical radiosensitivity of the myxoid liposarcoma subtype might offer the possibility to reduce morbidity. Objective:...
journal_title:JAMA oncology
pub_type: 杂志文章
doi:10.1001/jamaoncol.2020.5865
更新日期:2021-01-01 00:00:00
abstract:Importance:Why some triple-negative breast cancers (TNBCs) have high and others have low immune cell infiltration is unknown. Understanding how immune surveillance shapes the cancer genome could help in the selection of patients and the development of more effective immunotherapy strategies. Objective:To examine the a...
journal_title:JAMA oncology
pub_type: 杂志文章
doi:10.1001/jamaoncol.2017.2140
更新日期:2017-12-01 00:00:00