zifeng-ai/TrialReviewBench huggingface dataset:
Adjuvant endocrine therapy in HER2-positive breast cancer patients: systematic review and meta-analysis
Topic: Hormone Therapy

Background: Approximately 50% of human epidermal growth factor receptor 2 (HER2)-positive breast cancer lesions express hormone receptors. These tumors present a unique therapeutic challenge, and the optimal endocrine therapeutic approach remains controversial. We aimed to study the optimal adjuvant endocrine therapy in this setting, to better establish the basis for clinical recommendations in HER2-positive disease.

Methods: We conducted a literature search up to May 2020, in which we identified randomized controlled trials (RCTs) that investigated the efficacy of various adjuvant hormonal therapies among premenopausal and postmenopausal patients with hormone receptor (HR)-positive, HER2-positive early breast cancer. Disease-free survival (DFS) was calculated with the random effect model and hazard ratios (HRs) with 95% confidence intervals (CI).

Results: Six RCTs (N = 5390 patients) were included in the final analysis. There was no significant difference in DFS between adjuvant treatment with aromatase inhibitors and tamoxifen (HR 0.99, 95% CI 0.68-1.44, P = 0.96). Furthermore, after omitting the ALTTO trial, as it did not randomize patients to hormonal therapy, no significant difference was observed between the two protocols (HR 1.06, 95% CI 0.65-1.73, P = 0.81).

Conclusion: Our study demonstrates similar DFS with tamoxifen and aromatase inhibitors as adjuvant endocrine treatment in HER2-positive HR-positive early-stage breast cancer patients. Future larger prospective studies focusing on the various contemporary endocrine regimens are warranted to validate our findings.

Keywords: HER2-positive; adjuvant treatment; breast cancer; endocrine therapy.

PICO
Population: HR-positive/HER2-positive early-stage breast cancer
Intervention: 1. adjuvant endocrine therapy (tamoxifen); 2. aromatase inhibitors
Outcomes: disease-free survival

Included studies:
title: Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): a randomised phase 3 trial
title: Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer
title: Assessment of letrozole and tamoxifen alone and in sequence for postmenopausal women with steroid hormone receptor-positive breast cancer: the BIG 1-98 randomised clinical trial at 8·1 years median follow-up
title: Adjuvant Letrozole and Tamoxifen Alone or Sequentially for Postmenopausal Women With Hormone Receptor-Positive Breast Cancer: Long-Term Follow-Up of the BIG 1-98 Trial
title: Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer
title: Adjuvant Lapatinib and Trastuzumab for Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: Results From the Randomized Phase III Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization Trial
Survival outcomes of neoadjuvant versus adjuvant chemotherapy in triple-negative breast cancer: a meta-analysis of 36,480 cases
Topic: Radiation/Chemotherapy

Background: The survival outcomes of neoadjuvant chemotherapy (NACT) versus adjuvant chemotherapy (ACT) for patients with triple-negative breast cancer (TNBC) remain unclear. Therefore, in this study, a meta-analysis was conducted to analyze current evidence on the survival outcomes of NACT versus ACT in TNBC.

Methods: A systematic search was performed on the PubMed and Embase databases to identify relevant articles investigating the survival outcomes of NACT versus ACT in TNBC.

Results: A total of nine studies involving 36,480 patients met the selection criteria. Among them, 10,728 (29.41%) received NACT, and 25,752 (70.59%) received ACT. The pathological complete response (pCR) rate was 35% (95% CI = 0.23-0.48). Compared with ACT, the overall survival (OS) of NACT was poor (HR = 1.59; 95% CI = 1.25-2.02; P = 0.0001), and there was no significant difference in disease-free survival (DFS) between the two treatments (HR = 0.85; 95% CI = 0.54-1.34; P = 0.49). NACT with pCR significantly improved the OS (HR = 0.53; 95% CI = 0.29-0.98; P = 0.04) and DFS (HR = 0.52; 95% CI = 0.29-0.94; P = 0.03), while the OS (HR = 1.18; 95% CI = 1.09-1.28; P < 0.0001) and DFS (HR = 2.36; 95% CI = 1.42-3.89; P = 0.0008) of patients with residual disease (RD) following NACT were worse compared to those receiving ACT.

Conclusion: These findings suggest that, for TNBC, NACT with pCR is superior to ACT in improving OS and DFS, and it turns to be opposite when patients are receiving NACT with RD.

Keywords: Adjuvant chemotherapy; Meta-analysis; Neoadjuvant; Survival outcomes; Triple-negative breast cancer.

PICO
Population: triple-negative breast cancer (TNBC)
Intervention: 1. neoadjuvant chemotherapy (NACT); 2. adjuvant chemotherapy (ACT)
Outcomes: 1. overall survival; 2. disease-free survival (DFS)

Included studies:
title: Adjuvant versus neoadjuvant chemotherapy in triple-negative breast cancer patients with BRCA mutations
title: Neoadjuvant chemotherapy is associated with improved survival compared with adjuvant chemotherapy in patients with triple-negative breast cancer only after complete pathologic response
title: Neoadjuvant versus adjuvant chemotherapy for triple negative breast cancer
title: Retrospective analysis of concurrent docetaxel and epirubicin neoadjuvant versus adjuvant chemotherapy: which leads to better outcomes for different subtype breast cancer patients?
title: the survival benefit of neoadjuvant chemotherapy and pCR among patients with advanced stage triple negative breast cancer
title: Clinical outcomes with neoadjuvant versus adjuvant chemotherapy for triple negative breast cancer: a report from the National Cancer Database
title: Efficacy of neoadjuvant versus adjuvant chemotherapy in Hispanic/Latino H/L women with local or locally advanced triple-negative breast cancer(TNBC) In Vivo
Active Immunotherapy for Glioblastoma Treatment: A Systematic Review and Meta-Analysis
Topic: Immunotherapy

Introduction: Glioblastoma multiforme (GBM) makes 60-70% of gliomas and 15% of primary brain tumors. Despite the availability of standard multimodal therapy, 2 years, 3 years, and 5 years survival rate of GBM are still low. Active immunotherapy is a relatively new treatment option for GBM that seems promising.

Methods: An electronic database search on PubMed, Cochrane, Scopus, and clinicaltrials.gov was performed to include all relevant studies. This study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA). Reported parameters are OS, PFS, AEs, post treatment KPS, and 2 year mortality.

Results: Active immunotherapy provided better OS (HR = .85; 95% CI = .71-1.01; P = .06) and PFS (HS = .83; 95% CI= .66 - 1.03; P = .11) side albeit not statistically significant. Active immunotherapy reduces the risk of 2 year mortality as much as 2.5% compared to control group (NNT and RRR was 56.7078 and 0,0258, respectively).

Conclusion: Active immunotherapy might be beneficial in terms of survival rate in patients with GBM although not statistically significant. It could be a treatment option for GBM in the future.

Keywords: active immunotherapy; glioblastoma; glioblastoma multiforme; high-grade glioma; vaccine.

PICO
Population: Patients with Glioblastoma multiforme (GBM)
Intervention: Active immunotherapy
Outcomes: Overall Survival (OS), Progression-Free Survival (PFS), Adverse Events (AEs), post treatment Karnofsky Performance Scale (KPS), and 2 year mortality

Included studies:
title: Phase III randomized trial of autologous cytokine-induced killer cell immunotherapy for newly diagnosed glioblastoma in korea
title: Adjuvant immunotherapy with whole-cell lysate dendritic cells vaccine for glioblastoma multiforme: A phase II clinical trial
title: Molecular subgroups and B7-H4 expression levels predict responses to dendritic cell vaccines in glioblastoma: An exploratory randomized phase II clinical trial
title: A randomized double-blind placebo-controlled phase II trial of dendritic cell vaccine ICT-107 in newly diagnosed patients with glioblastoma
title: Audencel immunotherapy based on dendritic cells has no effect on overall and progression-free survival in newly diagnosed glioblastoma: A phase II randomized trial
title: Rindopepimut with temozolomide for patients with newly diagnosed, EGFRvIII-expressing glioblastoma (ACT IV): A randomised, double-blind, international phase 3 trial
Comparison of Thermal Ablation and Surgery for Low-Risk Papillary Thyroid Microcarcinoma: A Systematic Review and Meta-Analysis
Topic: Hyperthermia

Objective: Although thermal ablation is effective in treating low-risk papillary thyroid microcarcinomas (PTMCs), comparison of treatment outcomes between thermal ablation and surgery has not yet been systematically evaluated. This study aimed to compare the efficacy and safety of thermal ablation and surgery for the treatment of low-risk PTMCs.

Materials and methods: Ovid-MEDLINE and EMBASE databases were searched for studies reporting comparisons of treatment results between thermal ablation and surgery for patients with low-risk PTMC published up to April 6, 2020. The analysis evaluated the efficacy (local tumor recurrence, occurrence of new tumor, metastasis, and rescue surgery) and safety (complication rate) of thermal ablation and surgery.

Results: This systematic review included four studies with a total of 339 PTMCs in 339 patients who underwent thermal ablation and 320 PTMCs in 314 patients who underwent surgery. There was no local tumor recurrence or distant metastasis in either group. There was no significant difference in the pooled proportion of lymph node metastasis (2.6% with thermal ablation vs. 3.3% with surgery, p = 0.65), occurrence of new tumors (1.4% with thermal ablation vs. 1.3% with surgery, p = 0.85), or rescue surgery (2.6% with thermal ablation vs. 1.6% with surgery, p = 0.62). However, the pooled complication rate was significantly higher in the surgery group than in the ablation group (3.3% with thermal ablation vs. 7.8% with surgery, p = 0.03).

Conclusion: Both thermal ablation and surgery are effective and safe options for the management of low-risk PTMCs, with thermal ablation achieving a lower complication rate. Therefore, thermal ablation may be considered as an alternative treatment option for low-risk PTMC in patients who refuse surgery and active surveillance or are ineligible for surgery.

Keywords: Meta-analysis; Papillary thyroid microcarcinoma; Radiofrequency ablation; Thermal ablation; Thyroid gland.

PICO
Population: low-risk papillary thyroid microcarcinomas (PTMCs)
Intervention: 1. thermal ablation; 2. surgery
Outcomes: 1. new tumor after treatment; 2. lymph node metastasis; 3. complication

Included studies:
title: Comparative study on operative trauma between microwave ablation and surgical treatment for papillary thyroid microcarcinoma
title: A comparative study of short-term efficacy and safety for thyroid micropapillary carcinoma patients after microwave ablation or surgery
title: Ultrasound-guided laser ablation versus surgery for solitary papillary thyroid microcarcinoma: a retrospective study
title: Ultrasound-Guided Radiofrequency Ablation Versus Surgery for Low-Risk Papillary Thyroid Microcarcinoma: Results of Over 5 Years' Follow-Up
TKI Maintenance After Stem-Cell Transplantation for FLT3-ITD Positive Acute Myeloid Leukemia: A Systematic Review and Meta-Analysis
Topic: Immunotherapy

This analysis aimed to systematically review and synthesize the existing evidence regarding the outcome of tyrosine kinase inhibitor (TKI) maintenance therapy after allogeneic stem-cell transplantation for patients with FLT3-ITD-mutated acute myeloid leukemia (AML). We searched publicly available databases, references lists of relevant reviews, registered trials, and relevant conference proceedings. A total of 7 studies comprising 680 patients were included. Five studies evaluated sorafenib and 2 studies evaluated midostaurin, compared with control. The incidence of relapse was significantly reduced after TKI therapy, showing an overall pooled risk ratio (RR) of 0.35 (95% confidence interval [CI], 0.23-0.51; P < 0.001), with a marked 65% reduced risk for relapse. The overall pooled RR for relapse-free survival and overall survival showed significantly improved outcome after TKI maintenance therapy, being 0.48 (95% CI, 0.37-0.61; P < 0.001) and 0.48 (95% CI, 0.36-0.64; P < 0.001). The risk for relapse or death from any cause was reduced by 52% using TKI. No difference in outcome was seen for non-relapse mortality, and the risk for chronic or acute graft-vs. -host disease appeared to be increased, at least for sorafenib. In conclusion, post-transplant maintenance therapy with TKI was associated with significantly improved outcome in relapse and survival in patients with FLT3-ITD positive AML.

PICO
Population: Patients with FLT3-ITD-mutated acute myeloid leukemia (AML) who have undergone allogeneic stem-cell transplantation
Intervention: Tyrosine kinase inhibitor (TKI) maintenance therapy
Comparison: Control (no TKI maintenance therapy or standard of care post transplantation)
Outcomes: Incidence of relapse, relapse-free survival, overall survival, risk of death from any cause, and increased risk for chronic or acute graft-vs.-host disease

Included studies:
title: Effect of sorafenib on the outcomes of patients with FLT3-ITD acute myeloid leukemia undergoing allogeneic hematopoietic stem cell transplantation
title: Sorafenib maintenance in patients with FLT3-ITD acute myeloid leukaemia undergoing allogeneic haematopoietic stem-cell transplantation: an open-label, multicentre, randomised phase 3 trial
title: Midostaurin added to chemotherapy and continued single-agent maintenance therapy in acute myeloid leukemia with FLT3-ITD
title: Haematopoietic cell transplantation with and without sorafenib maintenance for patients with FLT3-ITD acute myeloid leukaemia in first complete remission
title: Sorafenib maintenance after allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia with FLT3-internal tandem duplication mutation (SORMAIN)
title: Maintenance sorafenib is superior to prophylactic donor lymphocyte infusion at improving the prognosis of acute myeloid leukemia with FMS-like tyrosine kinase 3 internal tandem duplication after allogeneic hematopoietic stem cell transplantation
Sequential therapy of abiraterone and enzalutamide in castration-resistant prostate cancer: a systematic review and meta-analysis.
Topic: Hormone Therapy

This systematic review and meta-analysis aimed to assess the prognostic value of sequential of abiraterone (ABI) and enzalutamide (ENZ) therapy in patients with castration-resistant prostate cancer (CRPC).

PICO
Population: Patients with castration-resistant prostate cancer
Intervention: Sequential therapy of abiraterone and enzalutamide
Comparison: No specific comparison group mentioned in the abstract
Outcomes: Prognostic value of sequential abiraterone and enzalutamide therapy

Included studies:
title: Increased survival with enzalutamide in prostate cancer after chemotherapy.
abstract: Enzalutamide (formerly called MDV3100) targets multiple steps in the androgen-receptor-signaling pathway, the major driver of prostate-cancer growth. We aimed to evaluate whether enzalutamide prolongs survival in men with castration-resistant prostate cancer after chemotherapy.
title: Circulating Tumor DNA Genomics Correlate with Resistance to Abiraterone and Enzalutamide in Prostate Cancer.
abstract: Primary resistance to androgen receptor (AR)-directed therapies in metastatic castration-resistant prostate cancer (mCRPC) is poorly understood. We randomized 202 patients with treatment-naïve mCRPC to abiraterone or enzalutamide and performed whole-exome and deep targeted 72-gene sequencing of plasma cell-free DNA prior to therapy. For these agents, which have never been directly compared, time to progression was similar. Defects in 
title: Effects of abiraterone acetate on androgen signaling in castrate-resistant prostate cancer in bone.
abstract: Persistent androgen signaling is implicated in castrate-resistant prostate cancer (CRPC) progression. This study aimed to evaluate androgen signaling in bone marrow-infiltrating cancer and testosterone in blood and bone marrow and to correlate with clinical observations.
Systematic review and meta-analysis of thermal ablation versus surgical nephrectomy for small renal tumours.
Topic: Hyperthermia

A systematic review was undertaken to provide a meta-analysis of clinical trials comparing thermal ablation with surgical nephrectomy for small renal tumours.

PICO
Population: Patients with small renal tumours
Intervention: Thermal ablation
Comparison: Surgical nephrectomy
Outcomes: Clinical outcomes and effectiveness of treatment

Included studies:
title: Microwave ablation versus partial nephrectomy for small renal tumors: intermediate-term results.
abstract: Prospective randomized comparison of intermediate-term outcomes of patients with small renal tumors who were treated with partial nephrectomy (PN) or microwave ablation.
title: Reporting standards for percutaneous thermal ablation of renal cell carcinoma.
Hyperbaric oxygenation for tumour sensitisation to radiotherapy.
Topic: Hyperthermia

Cancer is a common disease and radiotherapy is one well-established treatment for some solid tumours. Hyperbaric oxygenation therapy (HBOT) may improve the ability of radiotherapy to kill hypoxic cancer cells, so the administration of radiotherapy while breathing hyperbaric oxygen may result in a reduction in mortality and recurrence.

PICO
Population: Patients with solid tumours undergoing radiotherapy
Intervention: Hyperbaric oxygenation therapy (HBOT) in combination with radiotherapy
Comparison: Radiotherapy alone
Outcomes: Reduction in mortality and recurrence rates

Included studies:
title: Modification of Hypoxia-Induced Radioresistance in Tumors by the Use of Oxygen and Sensitizers.
abstract: It is now well established that most animal solid tumors contain oxygen-deficient hypoxic cells and that these cells will influence the response of those tumors to radiation. Identifying hypoxic cells in human tumors has proven more difficult, primarily because most of the direct procedures used in animals are not applicable to humans. However, substantial indirect evidence, which goes back to as early as 1909, clearly indicates the presence of hypoxia in human tumors, although with a considerable heterogeneity among individual tumors. Experimental studies during the last 30 years have shown that this source of radiation resistance can be effectively eliminated by a variety of procedures that include high oxygen-content gas breathing, nitrometric radiation sensitizers, blood transfusions, hemoglobin-oxygen affinity modifiers, and nicotinamide. A number of these procedures have also been tested clinically such that by 1995 over 10,000 patients in 83 randomized trials had undergone treatment designed to modify tumor hypoxia before radiation therapy. Although a number of these trials showed no benefit, an overview analysis showed that modification of tumor hypoxia significantly improved the locoregional tumor control after radiotherapy with an odds ratio of 1.21 (95% confidence interval 1.12-1.30). The treatment benefit could mostly be related to an improved response in head and neck with odds ratio 1.31 (1.19-1.43) and to a lesser extent in bladder tumors; no significant effect was observed in other tumor sites (cervix, lung and esophagus). Similar to the local control benefit, the overall survival rate improved with an overall odds ratio of 1.13 (1.05-1.21). The overall results thus showed that the biological issue related to hypoxia appears to be a sound rationale, which may impact the outcome of radiotherapy, especially with head and neck carcinoma. However, despite this wealth of positive data, "hypoxic modification" still has no impact on general clinical practice.
title: Carbogen breathing during radiation therapy-the Radiation Therapy Oncology Group Study.
Cooling for cerebral protection during brain surgery.
Topic: Hyperthermia

The brain is at risk of ischaemia during a variety of neurosurgical procedures, and this can lead to devastating results. Induced hypothermia is the controlled lowering of core body temperature for therapeutic purposes. This remains the current practice during neurosurgery for the prevention or minimization of ischaemic brain injury. Brain surgery may lead to severe complications due to factors such as requirement for brain retraction, vessel occlusion, and intraoperative haemorrhage. Many anaesthesiologists believe that induced hypothermia is indicated to protect the central nervous system during surgery. Although hypothermia is often used during brain surgery, clinical efficacy has not yet been established.

PICO
Population: Patients undergoing brain surgery
Intervention: Induced hypothermia for cerebral protection
Comparison: Standard care without induced hypothermia
Outcomes: Reduction in ischaemic brain injury and prevention of severe complications during surgery

Included studies:
title: Safety and therapeutical benefit of hemicraniectomy combined with mild hypothermia in comparison with hemicraniectomy alone in patients with malignant ischemic stroke.
abstract: Both for hemicraniectomy and for hypothermia, several reports describe a beneficial effect in patients with malignant supratentorial cerebral ischemia. We compared the safety and the clinical outcome in patients with a malignant supratentorial infarction who were treated with hemicraniectomy alone (HA) or received a combination therapy with hemicraniectomy and hypothermia of 35 degrees C (HH), respectively.
title: Effects of therapeutic mild hypothermia on patients with severe traumatic brain injury after craniotomy.
abstract: We investigated the effects of therapeutic mild hypothermia on patients with severe traumatic brain injury after craniotomy (TBI).
title: Mild hypothermia as a protective therapy during intracranial aneurysm surgery: a randomized prospective pilot trial.
abstract: To conduct a pilot trial of mild intraoperative hypothermia during cerebral aneurysm surgery.
title: Mild intraoperative hypothermia during surgery for intracranial aneurysm.
abstract: Surgery for intracranial aneurysm often results in postoperative neurologic deficits. We conducted a randomized trial at 30 centers to determine whether intraoperative cooling during open craniotomy would improve the outcome among patients with acute aneurysmal subarachnoid hemorrhage.
Whole brain radiotherapy for the treatment of newly diagnosed multiple brain metastases.
Topic: Radiation/Chemotherapy

Brain metastases represent a significant healthcare problem. It is estimated that 20% to 40% of patients with cancer will develop metastatic cancer to the brain during the course of their illness. The burden of brain metastases impacts on quality and length of survival. Presenting symptoms include headache (49%), focal weakness (30%), mental disturbances (32%), gait ataxia (21%), seizures (18%), speech difficulty (12%), visual disturbance (6%), sensory disturbance (6%) and limb ataxia (6%).Brain metastases may spread from any primary site. The most common primary site is the lung, followed by the breast then gastrointestinal sites. Eighty-five per cent of brain metastases are found in the cerebral hemispheres, 10% to 15% in the cerebellum and 1% to 3% in the brainstem. Brain radiotherapy is used to treat cancer participants who have brain metastases from various primary malignancies.This is an update to the original review published in Issue 3, 2006.

PICO
Population: Patients with newly diagnosed multiple brain metastases
Intervention: Whole brain radiotherapy
Comparison: Standard care or alternative treatments
Outcomes: Impact on quality and length of survival, symptom improvement, tumor response rates

Included studies:
title: Memantine for the prevention of cognitive dysfunction in patients receiving whole-brain radiotherapy: a randomized, double-blind, placebo-controlled trial.
abstract: To determine the protective effects of memantine on cognitive function in patients receiving whole-brain radiotherapy (WBRT).