Correction: Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial.
Ontology highlight
ABSTRACT:
SUBMITTER: Ribi K
PROVIDER: S-EPMC7109133 | biostudies-literature | 2020 Mar
REPOSITORIES: biostudies-literature
Publications
Correction: Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial.
Ribi Karin K Luo Weixiu W Colleoni Marco M Karlsson Per P Chirgwin Jacquie J Aebi Stefan S Jerusalem Guy G Neven Patrick P Di Lauro Vincenzo V Gomez Henry L HL Ruhstaller Thomas T Abdi Ehtesham E Biganzoli Laura L Müller Bettina B Barbeaux Annelore A Graas Marie-Pascale MP Rabaglio Manuela M Francis Prudence A PA Foukakis Theodoros T Pagani Olivia O Graiff Claudio C Vorobiof Daniel D Maibach Rudolf R Di Leo Angelo A Gelber Richard D RD Goldhirsch Aron A Coates Alan S AS Regan Meredith M MM Bernhard Jürg J
British journal of cancer 20200301 7
An amendment to this paper has been published and can be accessed via a link at the top of the paper. ...[more]
Similar Datasets
Project description:BackgroundIn the phase III SOLE trial, the extended use of intermittent versus continuous letrozole for 5 years did not improve disease-free survival in postmenopausal women with hormone receptor-positive breast cancer. Intermittent therapy with 3-month breaks may be beneficial for patients' quality of life (QoL).MethodsIn the SOLE QoL sub-study, 956 patients completed the Breast Cancer Prevention Trial (BCPT) symptom and further QoL scales up to 24 months after randomisation. Differences in change of QoL from baseline between the two administration schedules were tested at 12 and 24 months using repeated measures mixed-models. The primary outcome was change in hot flushes at 12 months.ResultsThere was no difference in hot flushes at 12 months between the two schedules, but patients receiving intermittent letrozole reported significantly more improvement at 24 months. They also indicated less worsening in vaginal problems, musculoskeletal pain, sleep disturbance, physical well-being and mood at 12 months. Overall, 25-30% of patients reported a clinically relevant worsening in key symptoms and global QoL.ConclusionLess symptom worsening was observed during the first year of extended treatment with the intermittent administration. For women experiencing an increased symptom burden of extended adjuvant endocrine therapy, an intermittent administration is a safe alternative.Clinical trial informationClinical trial information: NCT00651456.
| S-EPMC6734915 | biostudies-literature
Project description:BackgroundClinical trials evaluating the benefit of pelvic radiotherapy (PRT) in the radiotherapeutic management of patients with higher-risk prostate cancer have limited the superior field border to the S1/S2 or L5/S1 interspace. However, imaging and surgical series have demonstrated a high frequency of prostatic lymph node (LN) drainage beyond these landmarks.ObjectiveTo determine the patterns of radiographically defined abdominopelvic LN failures and their potential implications for PRT field design.Design, setting, and participantsDuring 1992-2008, 2694 patients with localized prostate cancer were treated with prostate/seminal vesicle-only radiotherapy without PRT. Some 156 patients had their first failure within the abdominopelvic LNs, of whom 60 had isolated failures within the pelvic LNs.Outcome measurements and statistical analysisA radiologist reviewed all imaging and mapped each LN failure to a template consisting of 34 abdominopelvic LN stations.Results and limitationsThe median follow-up was 8.9 yr. Of patients who experienced first recurrence in the pelvic LNs (n=60), the common iliac station was involved in 55% (n=33) of patients, including 10% (n=6) who had isolated common iliac failures. Use of a PRT field superior border of L5/S1 would fully cover only 42% of the first recurrences among these patients. Extending the field to cover the common iliac stations would increase coverage to 93% of recurrences. The presence of T3/T4 disease and omission of androgen-deprivation therapy both independently conferred an approximate fivefold increase in the likelihood of having a common iliac LN failure. Use of imaging as a surrogate for LN involvement is the primary study limitation.ConclusionsPelvic LN failures frequently occur superior to the commonly used L5/S1 landmark for PRT coverage, and use of ADT may be protective of more superior LN failures. The current RTOG 0924 trial is evaluating the benefit of PRT with extended superior coverage to L4/5 when possible, which, according to our data, should significantly improve the coverage of potential sites of failure.Patient summaryWe looked at lymph node recurrence patterns after external beam radiotherapy of the prostate in men who did not have their lymph nodes treated. We found that there was a high incidence of pelvic lymph node recurrences above the internal and external iliac lymph node regions. Therefore, the current field recommendation for pelvic lymph nodes that stops at the superior border of the internal and external iliac vessels provides inadequate coverage of common sites of cancer recurrence, namely the common iliac lymph nodes.
| S-EPMC5571898 | biostudies-literature
Project description:BackgroundBiomarkers to optimize extended adjuvant endocrine therapy for women with estrogen receptor (ER)-positive breast cancer are limited. The HOXB13/IL17BR (H/I) biomarker predicts recurrence risk in ER-positive, lymph node-negative breast cancer patients. H/I was evaluated in MA.17 trial for prognostic performance for late recurrence and treatment benefit from extended adjuvant letrozole.MethodsA prospective-retrospective, nested case-control design of 83 recurrences matched to 166 nonrecurrences from letrozole- and placebo-treated patients within MA.17 was conducted. Expression of H/I within primary tumors was determined by reverse-transcription polymerase chain reaction with a prespecified cutpoint. The predictive ability of H/I for ascertaining benefit from letrozole was determined using multivariable conditional logistic regression including standard clinicopathological factors as covariates. All statistical tests were two-sided.ResultsHigh H/I was statistically significantly associated with a decrease in late recurrence in patients receiving extended letrozole therapy (odds ratio [OR] = 0.35; 95% confidence interval [CI] = 0.16 to 0.75; P = .007). In an adjusted model with standard clinicopathological factors, high H/I remained statistically significantly associated with patient benefit from letrozole (OR = 0.33; 95% CI = 0.15 to 0.73; P = .006). Reduction in the absolute risk of recurrence at 5 years was 16.5% for patients with high H/I (P = .007). The interaction between H/I and letrozole treatment was statistically significant (P = .03).ConclusionsIn the absence of extended letrozole therapy, high H/I identifies a subgroup of ER-positive patients disease-free after 5 years of tamoxifen who are at risk for late recurrence. When extended endocrine therapy with letrozole is prescribed, high H/I predicts benefit from therapy and a decreased probability of late disease recurrence.
| S-EPMC3888138 | biostudies-literature
Project description:Background: It remains controversial whether the addition of adjuvant chemotherapy (ACT) to total mesorectal excision (TME) plus lateral pelvic lymph node dissection (LLND) can provide a survival benefit after neoadjuvant chemoradiotherapy (nCRT) in patients with clinically suspected lateral pelvic lymph node metastasis (LPNM). We aim to investigate the effectiveness of ACT after nCRT with TME plus LLND for patients with clinically suspected LPNM. Methods: From January 2015 to December 2021, 138 patients with clinically suspected LPNM who were treated with nCRT followed by TME plus LLND at three institutions were enrolled in this study. The patients were categorized into the ACT group (n = 95) and the non-ACT group (n = 43). Results: The mean follow-up period was 37 months. The 3-year disease-free survival (DFS) rate for the entire cohort was 74.8%. Ninety-five patients (68.8%) received ACT, without any oncologic benefit (3-year DFS rates for the ACT and non-ACT groups were 67.0% and 80.5%, respectively, P = 0.130). Additionally, multivariate analysis showed that lymphatic invasion (hazard ratio [HR]: 6.26, P = 0.005) was an independent risk factor for DFS. Subgroup analyses revealed that for patients ≥ 64 years and those with ypStage 0, the distribution of 95% confidence interval (CI) values tended to focus on the non-ACT strategy. Conclusion: The efficacy of the addition of ACT to TME plus LLND after nCRT in LARC patients with clinically suspected LPNM was not confirmed in this study. Moreover, patients with age ≥ 64 years and those with ypStage 0 may not receive benefit from ACT after nCRT followed by TME plus LLND.
| S-EPMC9608212 | biostudies-literature
Project description:Our aim is to evaluate the association between body mass index (BMI) and preoperative total testosterone (TT) levels with the risk of single and multiple metastatic lymph node invasion (LNI) in prostate cancer patients undergoing radical prostatectomy and extended pelvic lymph node dissection. Preoperative BMI, basal levels of TT, and prostate-specific antigen (PSA) were evaluated in 361 consecutive patients undergoing radical prostatectomy with extended pelvic lymph node dissection between 2014 and 2017. Patients were grouped into either nonmetastatic, one, or more than one metastatic lymph node invasion groups. The association among clinical factors and LNI was evaluated. LNI was detected in 52 (14.4%) patients: 28 (7.8%) cases had one metastatic node and 24 (6.6%) had more than one metastatic node. In the overall study population, BMI correlated inversely with TT (r = -0.256; P < 0.0001). In patients without metastases, BMI inversely correlated with TT (r = -0.282; P < 0.0001). In patients with metastasis, this correlation was lost. In the overall study population, BMI (odds ratio [OR] = 1.268; P = 0.005) was the only independent clinical factor associated with the risk of multiple metastatic LNI compared to cases with one metastatic node. In the nonmetastatic group, TT was lower in patients with BMI >28 kg m-2 (P < 0.0001). In patients with any LNI, this association was lost (P = 0.232). The median number of positive nodes was higher in patients with BMI >28 kg m-2 (P = 0.048). In our study, overweight and obese patients had a higher risk of harboring multiple prostate cancer lymph node metastases and lower TT levels when compared to patients with normal BMI.
| S-EPMC7275807 | biostudies-literature
Project description:This study aimed to evaluate the value of lymph node (LN) number as a predictor for adjuvant treatment in node-positive endometrial cancer. Data of 441 patients diagnosed with International Federation of Gynaecology and Obstetrics (FIGO) stage IIIC endometrial cancer and who underwent adjuvant chemotherapy alone or chemoradiotherapy between 2009 and 2015 from the Taiwan Cancer Registry were reviewed. The patients were stratified based on the number of positive LN as follows: 1, 2-5, and ≥ 6. The overall survival (OS) was analysed using the Kaplan-Meier method and the Cox proportional hazards model. In multivariable analysis, chemoradiotherapy was independently associated with improved OS (hazard ratio [HR]: 0.62, 95% confidence interval [CI]: 0.43-0.90; p = 0.01) compared with chemotherapy alone. Patients with ≥ 6 positive LNs were associated with a worse OS (HR: 2.22, 95% CI: 1.25-3.95; p = 0.006) and those with 2-5 LNs were not associated with a worse OS (HR: 1.56, 95% CI: 0.94-2.59; p = 0.09) compared to patients with one LN. When stratified based on LN number, chemoradiotherapy was found to significantly improve the 5-year OS of patients with ≥ 6 positive LNs compared to chemotherapy alone (35.9% vs. 70.0%, p < 0.001). No significant differences between chemotherapy alone and chemoradiotherapy were observed in 5-year OS among patients with one LN (73.1% vs. 80.8%, p = 0.31) or 2-5 positive LNs (71.4% vs. 75.7%, p = 0.68). Lymph node number may be used to identify node-positive endometrial cancer patients who are likely to have improved OS with intensification of adjuvant therapy.
| S-EPMC7345621 | biostudies-literature
Project description:Glioblastoma multiforme (GBM) is the most common and lethal type of adult brain cancer. Current GBM standard of care, including radiotherapy, often ends up with cancer recurrence, resulting in limited long-term survival benefits for GBM patients. Immunotherapy, such as immune checkpoint blockade (ICB), has thus far shown limited clinical benefit for GBM patients. Therapeutic vaccines hold great potential to elicit anti-cancer adaptive immunity, which can be synergistically combined with ICB and radiotherapy. Peptide vaccines are attractive for their ease of manufacturing and stability, but their therapeutic efficacy has been limited due to poor vaccine co-delivery and the limited ability of monovalent antigen vaccines to prevent tumor immune evasion. To address these challenges, here, we report GBM radioimmunotherapy that combines radiotherapy, ICB, and multivalent lymph-node-targeting adjuvant/antigen-codelivering albumin-binding vaccines (AAco-AlbiVax). Specifically, to codeliver peptide neoantigens and adjuvant CpG to lymph nodes (LNs), we developed AAco-AlbiVax based on a Y-shaped DNA scaffold that was site-specifically conjugated with CpG, peptide neoantigens, and albumin-binding maleimide-modified Evans blue derivative (MEB). As a result, these vaccines elicited antitumor immunity including neoantigen-specific CD8+ T cell responses in mice. In orthotopic GBM mice, the combination of AAco-AlbiVax, ICB, and fractionated radiation enhanced GBM therapeutic efficacy. However, radioimmunotherapy only trended more efficacious over radiotherapy alone. Taken together, these studies underscore the great potential of radioimmunotherapy for GBM, and future optimization of treatment dosing and scheduling would improve the therapeutic efficacy.
| S-EPMC10465217 | biostudies-literature
Project description:Breast cancer treatment has undergone major changes in the last 20 years. Specifically, the role of axillary lymph node dissection has changed from radical axillary dissection with excision of a high number of lymph nodes to sentinel lymph node biopsy (SLNB). This paradigm shift is associated with a controversial debate regarding the significance of axillary staging, the need for surgery, and the role of radiotherapy. Looking ahead, lymph node staging and axillary treatment might shift from SLNB and/or axillary dissection to ultrasound-guided needle biopsy and irradiation of regional lymph nodes in order to reduce treatment-related sequelae in early-stage breast cancer.
| S-EPMC6062724 | biostudies-literature
Project description:IntroductionThe management options for regional lymph nodes (LNs) in men with penile cancer include surveillance, surgery, and chemotherapy. The use of radiotherapy (RT) for nodal disease follows tradition and single-institution policies. We aimed to analyse the existing evidence regarding the management of penile cancer patients with suspected or known metastatic pelvic LNs using pelvic LN dissection (PLND) with RT versus PLND or RT alone.MethodsA systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, with no filters for language or time. The search was conducted in EMBASE, MEDLINE/PubMed, and Cochrane Library. Inclusion criteria were adult men with penile cancer and suspected metastatic pelvic LNs, undergoing PLND with or without RT or RT alone. Primary outcomes included disease-specific survival and locoregional recurrence. Secondary outcomes included overall survival and complications of therapy.ResultsA total of 552 articles were identified. Only eight retrospective studies were eligible for inclusion (including 406 patients). All studies had a high risk of bias. None of the studies reported the use of neoadjuvant RT. Indications for PLND varied but were usually two or more clinically positive inguinal nodes with or without extracapsular extension. Adjuvant RT was mainly used in positive pelvic LNs or pN2/pN3 stages. The rate of locoregional recurrence following adjuvant RT was 70%. Complications of treatment were reported in two studies only.ConclusionsThere is insufficient evidence to recommend the use of adjuvant RT following PLND in penile cancer patients. The quality of evidence is low due to the retrospective design and high risk of bias. Randomized clinical trials are required to assess the efficacy and safety of adjuvant RT and PLND.
| S-EPMC8992723 | biostudies-literature
Project description: Not available
| S-EPMC10852382 | biostudies-literature