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SCI 写作速查 · 非课程,随手参考

Introduction疾病负担描述

XXX remains the leading cause of cancer-related mortality worldwide, accounting for approximately N deaths annually.

XXX 仍是全球癌症相关死亡的主要原因,每年约造成 N 例死亡。

改写自 CA Cancer J Clin 2024

Introduction疾病负担描述

The incidence of XXX has been steadily increasing over the past decade, particularly in developing countries.

XXX 的发病率在过去十年中持续上升,尤其是在发展中国家。

改写自 Lancet Oncol 2023

Introduction治疗现状概述

Current standard-of-care treatment for advanced XXX includes platinum-based chemotherapy with or without immunotherapy.

当前晚期 XXX 的标准治疗方案包括含铂化疗联合或不联合免疫治疗。

改写自 ASCO 指南 2024

Introduction治疗现状概述

Despite recent advances in targeted therapy, the 5-year survival rate for metastatic XXX remains below X%.

尽管靶向治疗近期取得了进展,转移性 XXX 的 5 年生存率仍低于 X%。

改写自 SEER 数据库

Introduction未满足需求

However, a substantial proportion of patients develop resistance to these agents, highlighting an urgent unmet clinical need.

然而,相当比例的患者对这些药物产生耐药,突显了迫切的未满足临床需求。

改写自 Nat Rev Clin Oncol 2024

Introduction未满足需求

Optimal sequencing of these therapies and identification of predictive biomarkers remain major challenges.

这些治疗的最优序贯策略和预测性生物标志物的识别仍是主要挑战。

改写自 J Clin Oncol 2024

Introduction研究目的

We therefore conducted this multicenter, randomized, phase 3 trial to evaluate the efficacy and safety of XXX versus standard chemotherapy in patients with previously untreated advanced XXX.

因此,我们开展了这项多中心、随机、III 期临床试验,以评估 XXX 对比标准化疗在既往未经治疗的晚期 XXX 患者中的疗效和安全性。

改写自 NEJM 2023

Introduction研究目的

The primary objective of this study was to compare progression-free survival between the two treatment groups.

本研究的主要目标是比较两个治疗组之间的无进展生存期。

改写自 JCO 2024

Introduction研究假设

We hypothesized that the addition of XXX to standard therapy would significantly improve overall survival.

我们假设在标准治疗基础上加上 XXX 会显著改善总生存期。

改写自 Lancet 2023

Introduction文献综述

Previous studies have demonstrated inconsistent results regarding the benefit of XXX in this patient population.

既往研究对于 XXX 在该患者群体中的获益显示了不一致的结果。

通用学术句型

Introduction文献综述

A growing body of evidence suggests that XXX plays a critical role in tumor immune evasion.

越来越多的证据表明 XXX 在肿瘤免疫逃逸中发挥关键作用。

改写自 Immunity 2024

Introduction研究缺口

However, the optimal treatment strategy for patients who progress on first-line therapy has not been well defined.

然而,一线治疗后进展患者的最佳治疗策略尚未明确。

改写自 Lancet Oncol 2024

Introduction研究缺口

Little is known about the efficacy and safety of XXX in patients with brain metastases, as these patients have been largely excluded from pivotal trials.

关于 XXX 在脑转移患者中的疗效和安全性知之甚少,因为这些患者在关键试验中大多被排除。

改写自 JCO 2024

Introduction研究背景

XXX is a novel bispecific antibody that simultaneously targets PD-1 and VEGF, designed to enhance antitumor immunity while inhibiting angiogenesis.

XXX 是一种新型双特异性抗体,同时靶向 PD-1 和 VEGF,旨在增强抗肿瘤免疫的同时抑制血管生成。

改写自 Nat Rev Drug Discov 2024

Introduction研究背景

Activating mutations in the EGFR gene are present in approximately XX% of patients with non-small-cell lung cancer in Asian populations.

EGFR 基因激活突变存在于约 XX% 的亚洲人群非小细胞肺癌患者中。

改写自 NEJM 2023

Introduction临床意义陈述

Given the poor prognosis associated with advanced XXX, there is a pressing need to develop more effective therapeutic strategies.

鉴于晚期 XXX 的不良预后,迫切需要制定更有效的治疗策略。

通用学术句型

Methods患者入排标准

Eligible patients were aged 18 years or older with histologically confirmed advanced or metastatic XXX and an ECOG performance status of 0 or 1.

入组患者年龄 ≥ 18 岁,组织学确诊为晚期或转移性 XXX,ECOG 体力状态 0 或 1 分。

改写自 JCO 2024

Methods患者入排标准

Key exclusion criteria included active autoimmune disease, prior organ transplantation, and untreated brain metastases.

关键排除标准包括活动性自身免疫性疾病、既往器官移植和未经治疗的脑转移。

改写自 NEJM 2023

Methods研究设计

This was a multicenter, open-label, randomized, controlled phase 3 trial conducted across 120 sites in 15 countries.

这是一项在 15 个国家 120 个中心开展的多中心、开放标签、随机对照 III 期试验。

改写自 Lancet Oncol 2024

Methods研究设计

Patients were randomly assigned in a 1:1 ratio to receive either XXX plus chemotherapy or placebo plus chemotherapy.

患者按 1:1 比例随机分配接受 XXX 联合化疗或安慰剂联合化疗。

改写自 JCO 2024

Methods终点定义

The primary endpoint was progression-free survival assessed by independent central review according to RECIST version 1.1.

主要终点为由独立中心评审根据 RECIST 1.1 版评估的无进展生存期。

改写自 NEJM 2023

Methods终点定义

Secondary endpoints included overall survival, objective response rate, duration of response, and safety.

次要终点包括总生存期、客观缓解率、缓解持续时间和安全性。

改写自 Lancet 2024

Methods统计方法

The sample size was calculated to provide 90% power to detect a hazard ratio of 0.70 for progression-free survival at a two-sided significance level of 0.05.

样本量计算为在双侧显著性水平 0.05 下提供 90% 的把握度检测无进展生存期的风险比为 0.70。

改写自 JCO 2024

Methods统计方法

All efficacy analyses were performed in the intention-to-treat population, and safety was assessed in all patients who received at least one dose of study treatment.

所有疗效分析在意向治疗人群中进行,安全性在所有接受至少一剂研究治疗的患者中评估。

改写自 Lancet Oncol 2023

Methods生物标志物

PD-L1 expression was assessed centrally using the 22C3 pharmDx assay, with positivity defined as a tumor proportion score of 1% or higher.

PD-L1 表达由中心实验室使用 22C3 pharmDx 检测评估,阳性定义为肿瘤比例评分 ≥ 1%。

改写自 KEYNOTE 系列

Methods统计分析

Subgroup analyses were prespecified according to age, sex, ECOG performance status, PD-L1 expression, and line of therapy.

根据年龄、性别、ECOG 体力状态、PD-L1 表达和治疗线数预先规定了亚组分析。

改写自 JCO 2024

Methods统计软件

All statistical analyses were performed using SAS version 9.4 and R version 4.2.

所有统计分析使用 SAS 9.4 版和 R 4.2 版进行。

通用学术句型

Methods随机化与盲法

Randomization was performed using a centralized interactive web-response system with permuted blocks stratified by ECOG performance status and PD-L1 expression.

随机化使用集中式交互式网络应答系统进行,采用置换区组法,按 ECOG 体力状态和 PD-L1 表达分层。

改写自 NEJM 2023

Methods随机化与盲法

The trial had a double-blind, double-dummy design to minimize bias in both efficacy and safety assessments.

本试验采用双盲、双模拟设计,以最大程度减少疗效和安全性评估中的偏倚。

改写自 Lancet 2024

Methods患者流程

A total of N patients were screened, of whom N were eligible and underwent randomization.

共筛选 N 例患者,其中 N 例符合条件并接受随机分组。

通用学术句型

Methods样本量计算

Approximately N events were required for the primary analysis, and the final analysis was planned when approximately N events had occurred.

主要分析需要约 N 个事件,最终分析计划在约 N 个事件发生时进行。

通用学术句型

Methods检测与评估

Tumor response was assessed every 6 weeks by computed tomography or magnetic resonance imaging and evaluated according to RECIST version 1.1.

每 6 周通过 CT 或 MRI 评估肿瘤反应,并根据 RECIST 1.1 版进行评估。

改写自 JCO 2024

Methods伦理与合规

The trial was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines, and the protocol was approved by the institutional review board at each participating site.

本试验根据赫尔辛基宣言和 GCP 指南进行,方案经各参研机构的伦理委员会批准。

通用学术句型

Methods伦理与合规

All patients provided written informed consent before any study-related procedures.

所有患者在任何研究相关程序前均提供书面知情同意。

通用学术句型

Methods数据监查

An independent data monitoring committee reviewed unblinded safety and efficacy data at prespecified intervals throughout the study.

独立数据监查委员会在整个研究过程中按预设时间间隔审查非盲安全性和疗效数据。

通用学术句型

Results基线特征

A total of N patients underwent randomization, and baseline characteristics were well balanced between the two treatment groups.

共 N 例患者接受随机分组,两组间的基线特征均衡。

通用学术句型

Results基线特征

The median age was XX years (range, XX–XX), and XX% of patients were male.

中位年龄为 XX 岁(范围 XX–XX),XX% 患者为男性。

通用学术句型

Results基线特征

The median follow-up duration was XX months (IQR, XX–XX).

中位随访时间为 XX 个月(IQR,XX–XX)。

通用学术句型

Results疗效数据

The objective response rate was XX% in the experimental arm compared with XX% in the control arm (P = 0.001).

试验组的客观缓解率为 XX%,对照组为 XX%(P = 0.001)。

通用学术句型

Results疗效数据

The disease control rate was XX% in the XXX group and XX% in the placebo group.

XXX 组的疾病控制率为 XX%,安慰剂组为 XX%。

通用学术句型

Results生存数据

Median progression-free survival was XX months in the XXX group versus XX months in the control group (HR 0.XX; 95% CI, 0.XX–0.XX; P < 0.001).

XXX 组中位无进展生存期为 XX 个月,对照组为 XX 个月(HR 0.XX;95% CI 0.XX–0.XX;P < 0.001)。

改写自 NEJM 2023

Results生存数据

Median overall survival was not reached in the XXX group and was XX months in the control group (HR 0.XX; P = 0.002).

XXX 组中位总生存期未达到,对照组为 XX 个月(HR 0.XX;P = 0.002)。

改写自 Lancet 2024

Results生存数据

The 12-month overall survival rate was XX% and XX%, respectively.

12 个月总生存率分别为 XX% 和 XX%。

通用学术句型

Results生存数据 — 亚组

The progression-free survival benefit was consistent across all prespecified subgroups, including patients with PD-L1 TPS < 1%.

无进展生存获益在所有预设亚组中一致,包括 PD-L1 TPS < 1% 的患者。

改写自 KEYNOTE 系列

Results安全性

Treatment-related adverse events of any grade occurred in XX% of patients in the XXX group and XX% in the control group.

任意级别的治疗相关不良事件在 XXX 组中发生率为 XX%,对照组为 XX%。

通用学术句型

Results安全性

Grade 3 or higher treatment-related adverse events were reported in XX% and XX% of patients, respectively.

3 级及以上治疗相关不良事件分别在 XX% 和 XX% 的患者中报告。

通用学术句型

Results安全性

The most common adverse events in the XXX group were fatigue (XX%), nausea (XX%), and anemia (XX%).

XXX 组最常见的不良事件为乏力(XX%)、恶心(XX%)和贫血(XX%)。

通用学术句型

Results安全性

Immune-related adverse events were observed in XX% of patients, most commonly pneumonitis (XX%) and colitis (XX%).

免疫相关不良事件在 XX% 的患者中观察到,最常见的是肺炎(XX%)和结肠炎(XX%)。

改写自免疫治疗相关文献

Results安全性 — 因AE停药

Treatment discontinuation due to adverse events occurred in XX% of patients in the experimental arm.

因不良事件导致停止治疗在试验组中发生率为 XX%。

通用学术句型

Results患者流程图

The study flow diagram is shown in Figure 1. Of the N patients who underwent randomization, N were assigned to the XXX group and N to the control group.

研究流程图见图 1。在 N 例接受随机分组的患者中,N 例分配至 XXX 组,N 例分配至对照组。

通用学术句型

Results探索性终点

In an exploratory analysis, patients with TMB ≥ 10 mut/Mb showed a numerically greater benefit from the experimental treatment.

在探索性分析中,TMB ≥ 10 mut/Mb 的患者从试验治疗中显示出数值上更大的获益。

改写自 JCO 2024

Results交互作用

No significant treatment-by-subgroup interaction was observed for any of the prespecified baseline factors (all P for interaction > 0.05).

在任何预设的基线因素中均未观察到显著的治疗-亚组交互作用(所有交互 P > 0.05)。

通用学术句型

Results里程碑分析

The 3-year overall survival rate was XX% in the XXX group versus XX% in the control group, representing a sustained long-term benefit.

XXX 组的 3 年总生存率为 XX%,对照组为 XX%,代表持续的长期获益。

通用学术句型

Results安全性细节

No new safety signals were identified, and the adverse event profile was consistent with the known safety profiles of the individual agents.

未发现新的安全性信号,不良事件谱与各药物的已知安全性谱一致。

通用学术句型

Results安全性细节

Treatment-related deaths occurred in XX patients (XX%) in the XXX group and XX (XX%) in the control group.

治疗相关死亡在 XXX 组发生 XX 例(XX%),对照组 XX 例(XX%)。

通用学术句型

Results患者报告结局

Patient-reported quality of life, as measured by the EORTC QLQ-C30 global health status scale, was maintained in both groups throughout the treatment period.

根据 EORTC QLQ-C30 总体健康状况量表测量的患者报告生活质量在两组中均于治疗期间保持稳定。

改写自 Lancet Oncol 2024

Discussion总结发现

These findings demonstrate that the addition of XXX to standard therapy significantly improves progression-free survival with a manageable safety profile.

这些发现表明在标准治疗基础上加上 XXX 可显著改善无进展生存期,且安全性可管理。

改写自 NEJM 2023

Discussion总结发现

Taken together, these results support XXX as a new standard-of-care option for patients with previously untreated advanced XXX.

综上,这些结果支持 XXX 作为既往未经治疗的晚期 XXX 患者的新标准治疗选择。

改写自 Lancet 2024

Discussion既往对比

Consistent with previous studies, we observed a significant PFS benefit in patients with high PD-L1 expression.

与既往研究一致,我们在 PD-L1 高表达患者中观察到显著的 PFS 获益。

通用学术句型

Discussion既往对比

In contrast to earlier reports, we did not observe a significant difference in the incidence of grade 3 or higher adverse events between groups.

与早期报告相反,我们未观察到两组间 3 级及以上不良事件发生率有显著差异。

通用学术句型

Discussion既往对比

These results are in line with the findings of the KEYNOTE-XXX and CheckMate-XXX trials.

这些结果与 KEYNOTE-XXX 和 CheckMate-XXX 试验的发现一致。

改写自免疫治疗文献

Discussion机制解释

The observed survival benefit may be attributable to the synergistic effect of combining anti-PD-1 therapy with chemotherapy-induced immunogenic cell death.

观察到的生存获益可能归因于抗 PD-1 治疗与化疗诱导的免疫原性细胞死亡之间的协同作用。

改写自 Nat Rev Immunol 2024

Discussion机制解释

One potential explanation for the lack of OS benefit is the high rate of crossover in the control arm.

缺乏 OS 获益的一个可能解释是对照组的高交叉率。

通用学术句型

Discussion局限性

Several limitations of this study should be acknowledged. First, the open-label design may have introduced bias in the assessment of patient-reported outcomes.

本研究存在若干局限性应予以承认。首先,开放标签设计可能对患者报告结局的评估引入偏倚。

通用学术句型

Discussion局限性

Second, the relatively short follow-up duration limits the interpretation of long-term survival outcomes.

其次,相对较短的随访时间限制了对长期生存结局的解读。

通用学术句型

Discussion局限性

The generalizability of our findings to broader patient populations, including those with ECOG 2, remains to be validated.

我们的发现对更广泛患者人群(包括 ECOG 2 分患者)的普适性仍有待验证。

通用学术句型

Discussion临床意义

These findings have important clinical implications for the first-line treatment of advanced XXX.

这些发现对晚期 XXX 的一线治疗具有重要的临床意义。

通用学术句型

Discussion临床意义

Our results suggest that PD-L1 testing should be routinely performed to guide treatment decisions in this patient population.

我们的结果表明应常规进行 PD-L1 检测以指导该患者群体的治疗决策。

改写自 ASCO 指南

Discussion未来方向

Further studies are warranted to evaluate the efficacy of this combination in the neoadjuvant and adjuvant settings.

需要进一步研究评估该联合方案在新辅助和辅助治疗中的疗效。

通用学术句型

Discussion未来方向

Ongoing biomarker analyses may help identify patients most likely to benefit from this therapeutic strategy.

正在进行的生物标志物分析可能有助于识别最可能从该治疗策略中获益的患者。

通用学术句型

Discussion结论

In conclusion, XXX plus chemotherapy demonstrated a clinically meaningful and statistically significant improvement in progression-free survival with an acceptable safety profile.

总之,XXX 联合化疗在无进展生存期方面显示出具有临床意义和统计学显著性改善,且安全性可接受。

改写自 NEJM 2023

Discussion结论

These results support the use of XXX as a new first-line treatment option for patients with advanced XXX.

这些结果支持将 XXX 作为晚期 XXX 患者的新一线治疗选择。

通用学术句型

Discussion局限性

The lack of central radiology review is a limitation; however, RECIST assessments were performed by experienced investigators using standardized criteria.

缺乏中心放射学审查是一个局限性;然而,RECIST 评估由经验丰富的研究者使用标准化标准进行。

通用学术句型

Discussion既往对比

Our results compare favorably with those reported in the KEYNOTE-XXX trial, which demonstrated a median PFS of XX months in a similar patient population.

我们的结果与 KEYNOTE-XXX 试验报告的结果相比更为有利,该试验在类似患者人群中显示中位 PFS 为 XX 个月。

改写自免疫治疗文献

Discussion机制解释

The durability of response observed in the experimental arm suggests the induction of long-term immunological memory against tumor antigens.

试验组中观察到的缓解持久性表明诱导了对肿瘤抗原的长期免疫记忆。

改写自 Nat Med 2024

Discussion临床实践影响

These findings are likely to change clinical practice by establishing XXX-based combination therapy as the preferred first-line regimen for this patient population.

这些发现可能会改变临床实践,将基于 XXX 的联合治疗确立为该患者群体首选的的一线方案。

通用学术句型

Discussion临床实践影响

The manageable safety profile and convenient oral administration of XXX make it an attractive alternative to intravenous regimens in the maintenance setting.

XXX 可控的安全性和便捷的口服给药使其在维持治疗中成为静脉方案的吸引人的替代选择。

改写自 JCO 2024

Discussion费用与可及性

Cost-effectiveness analyses are warranted to evaluate the economic impact of this treatment strategy in different healthcare systems.

需要进行成本效益分析以评估该治疗策略在不同医疗体系中的经济影响。

通用学术句型

Discussion未来方向

Prospective biomarker-stratified trials are needed to validate the predictive value of circulating tumor DNA dynamics for early response assessment.

需要前瞻性生物标志物分层试验来验证循环肿瘤 DNA 动态变化对早期疗效评估的预测价值。

改写自 Nat Rev Clin Oncol 2024

Discussion未来方向

Combination strategies incorporating radiotherapy to augment the abscopal effect represent a promising avenue for future research.

联合放疗以增强远隔效应的联合策略代表了未来研究的一个有前景的方向。

改写自 Lancet Oncol 2024

Discussion结论

In summary, the favorable benefit-risk profile of XXX supports its adoption as a standard therapeutic option in this setting.

综上所述,XXX 良好的获益-风险特征支持其作为该场景下标准治疗选择的采用。

通用学术句型