301. Blinatumomab in Standard-Risk B-Cell Acute Lymphoblastic Leukemia in Children.
作者: Sumit Gupta.;Rachel E Rau.;John A Kairalla.;Karen R Rabin.;Cindy Wang.;Anne L Angiolillo.;Sarah Alexander.;Andrew J Carroll.;Susan Conway.;Lia Gore.;Ilan Kirsch.;Holly R Kubaney.;Amanda M Li.;Jennifer L McNeer.;Olga Militano.;Tamara P Miller.;Yvonne Moyer.;Maureen M O'Brien.;Maki Okada.;Shalini C Reshmi.;Mary Shago.;Elizabeth Wagner.;Naomi Winick.;Brent L Wood.;Tara Haworth-Wright.;Faraz Zaman.;Gerhard Zugmaier.;Sue Zupanec.;Meenakshi Devidas.;Stephen P Hunger.;David T Teachey.;Elizabeth A Raetz.;Mignon L Loh.
来源: N Engl J Med. 2025年392卷9期875-891页
B-cell acute lymphoblastic leukemia (B-cell ALL) is the most common childhood cancer. Despite a high overall cure rate, relapsed B-cell ALL remains a leading cause of cancer-related death among children. The addition of the bispecific T-cell engager molecule blinatumomab (an anti-CD19 and anti-CD3 single-chain molecule) to therapy for newly diagnosed standard-risk (as defined by the National Cancer Institute) B-cell ALL in children may improve outcomes.
302. Plasma arginine as a predictive biomarker for outcomes with immune checkpoint inhibition in metastatic colorectal cancer: a correlative analysis of the CCTG CO.26 trial.
作者: Lucy X Ma.;Emma Titmuss.;Jonathan M Loree.;Derek J Jonker.;Hagen F Kennecke.;Scott Berry.;Felix Couture.;Chaudhary E Ahmad.;John R Goffin.;Petr Kavan.;Mohammed Harb.;Bruce Colwell.;Setareh Samimi.;Benoit Samson.;Tahir Abbas.;Nathalie Aucoin.;Francine Aubin.;Sheryl Koski.;Dongsheng Tu.;Christopher O'Callaghan.;Eric X Chen.
来源: J Immunother Cancer. 2024年12卷12期
Nutritional stress is a mechanism that allows tumor cells to evade the immune system. Arginine (ARG), an amino acid involved in immunomodulation, aids in regulating T-lymphocyte cell activity and the antitumor response. ARG deficiency in the tumor microenvironment can impair T-cell response while ARG supplementation may promote antitumor immune activity. In this exploratory post hoc analysis of the randomized phase II CO.26 trial, we investigated the role of plasma ARG in predicting response to immune checkpoint inhibitors (ICI) in patients with microsatellite stable refractory metastatic colorectal cancer (mCRC).
303. Randomized, Phase III Trial of Mixed Formulation of Fosrolapitant and Palonosetron (HR20013) in Preventing Cisplatin-Based Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: PROFIT.
作者: Huaqiang Zhou.;Yuanyuan Zhao.;Mingjun Zhang.;Jun Yao.;Shuang Leng.;Xiumin Li.;Li Lin.;Jinping Chen.;Songnan Zhang.;Xia Qin.;Zhiquan Qin.;Tienan Yi.;Ruoyu Wang.;Xiang Li.;Yan Yu.;Zhenghua Wang.;Qinhong Zheng.;Jiazhuan Mei.;Aimin Zang.;Na Li.;Fengjun Cao.;Ke Cao.;Weiwei Li.;Yanda Lu.;Dang Lin.;Yan Zhou.;Runxiang Yang.;Wenfeng Fang.;Ningning Zhou.;Yunpeng Yang.;Yaxiong Zhang.;Gang Chen.;Ting Zhou.;Xue Yang.;Huan Wang.;Yujiao Wang.;Yan Huang.;Li Zhang.
来源: J Clin Oncol. 2025年43卷9期1123-1136页
Mixed formulation of fosrolapitant and palonosetron (PALO), HR20013, is a novel fixed-dose intravenous antiemetic combination that could simultaneously antagonize neurokinin-1 and 5-hydroxytryptamine-3 receptors. This study was designed to evaluate the efficacy and safety of HR20013 plus dexamethasone (DEX) versus fosaprepitant (FAPR) plus PALO + DEX for preventing chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC).
304. Early versus deferred use of CDK4/6 inhibitors in advanced breast cancer.
作者: Gabe S Sonke.;Annemiek van Ommen-Nijhof.;Noor Wortelboer.;Vincent van der Noort.;Astrid C P Swinkels.;Hedwig M Blommestein.;Cristina Guerrero Paez.;Linda Mol.;Aart Beeker.;Karin Beelen.;Lisanne C Hamming.;Joan B Heijns.;Aafke H Honkoop.;Paul C de Jong.;Quirine C van Rossum-Schornagel.;Christa van Schaik-van de Mheen.;Jolien Tol.;Cathrien S Tromp-van Driel.;Suzan Vrijaldenhoven.;A Elise van Leeuwen-Stok.;Inge R Konings.;Agnes Jager.; .
来源: Nature. 2024年636卷8042期474-480页
Cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) in combination with endocrine therapy improve the outcomes of patients with hormone-receptor (HR)-positive, HER2-negative advanced breast cancer and can be used early as first-line treatment or deferred to second-line treatment1-7. Randomized data comparing the use of CDK4/6i in the first- and second-line setting are lacking. The phase 3 SONIA trial (NCT03425838) randomized 1,050 patients who had not received previous therapy for advanced breast cancer to receive CDK4/6i in the first- or second-line setting8. All of the patients received the same endocrine therapy, consisting of an aromatase inhibitor for first-line treatment and fulvestrant for second-line treatment. The primary end point was defined as the time from randomization to disease progression after second-line treatment (progression-free survival 2 (PFS2)). We observed no statistically significant benefit for the use of CDK4/6i as a first-line compared with second-line treatment (median, 31.0 versus 26.8 months, respectively; hazard ratio = 0.87; 95% confidence interval = 0.74-1.03; P = 0.10). The health-related quality of life was similar in both groups. First-line CDK4/6i use was associated with a longer CDK4/6i treatment duration compared with second-line use (median CDK4/6i treatment duration of 24.6 versus 8.1 months, respectively) and more grade ≥3 adverse events (2,763 versus 1,591, respectively). These data challenge the need for first-line use of a CDK4/6i in all patients.
305. Tislelizumab for consolidation therapy in patients with pathologically residual Esophageal Squamous Cell Carcinoma after definitive concurrent Chemoradiotherapy: a multicenter, randomized, controlled phase II trial.
Although concurrent Chemoradiotherapy (cCRT) is presently the standard intervention for patients with inoperable, locally advanced Esophageal Squamous Cell Carcinoma (ESCC), it has been associated with poor long-term survival outcomes. Notably, Immune Checkpoint Inhibitors (ICIs) improve the long-term survival of Esophageal Cancer (EC) patients, with manageable Adverse Effects (AEs). Herein, 90 patients with residual pathology after radical simultaneous Radiotherapy (RT) for inoperable/refused-to-operate ESCC were enrolled and randomized into two treatment groups (Chemotherapy+immunotherapy and chemotherapy alone) in a 2:1 ratio. This study will also discuss the value of immunotherapy in improving long-term survival outcomes in patients with pathological residuals after concurrent RT for locally advanced, inoperable ESCC.Clinical trial registration: http://www.chictr.org.cn/identifier is ChiCTR2200063345.
306. Effectiveness of smartphone-based virtual reality relaxation (SVR) for enhancing comfort in cancer patients undergoing chemotherapy: a randomized controlled trial.
作者: Made Satya Nugraha Gautama.;Haryani Haryani.;Tsai-Wei Huang.;Jin-Hua Chen.;Yeu-Hui Chuang.
来源: Support Care Cancer. 2024年32卷12期824页
Comfort, anxiety, and pain significantly impact the quality of life and treatment adherence in cancer patients undergoing chemotherapy. Virtual reality (VR) technology offers a novel non-pharmacological intervention to address these primary concerns. While vital signs provide objective physiological data, they are considered secondary outcomes that may reflect changes in patients' subjective experiences.
307. Neurologic dance training and home exercise improve motor-cognitive dual-task function similarly, but through potentially different mechanisms, among breast cancer survivors with chemotherapy-induced neuropathy: Initial results of a randomized, controlled clinical trial.
作者: Lise C Worthen-Chaudhari.;Jewel E Crasta.;Patrick M Schnell.;Kristin Lantis.;Joseph Martis.;Jacqueline Wilder.;Courtney R Bland.;Madeleine E Hackney.;Maryam B Lustberg.
来源: J Alzheimers Dis. 2025年105卷4期1114-1130页
BackgroundDual-task function is compromised among individuals with prodromal Alzheimer's disease (AD) and others at risk of developing AD. While exercise has been studied as a therapeutic candidate, the activity of social dance might promote dual-task rehabilitation as well or better than conventional exercise.ObjectiveCompare effects of social dance versus home exercise on dual-task function and intervention adherence among individuals with increased risk of developing AD: survivors of breast cancer (BC) with chemotherapy-induced neuropathy (CIN).MethodsFifty-two (n = 52) survivors of BC with CIN-related symptoms and functional deficits were randomized (1:1) to 8 weeks of biweekly physical activity that took the form of partnered AdapTango dance (20 min) or home exercise (45 min) (NCT05114005, registered 08/15/2021). Primary outcome: dual-task function (TUG-Cog counting backward by 3 s). Secondary outcome: adherence. Exploratory outcomes: participant rating of perceived exertion in physical versus cognitive domains and cognitive load during dual-task performance.ResultsBoth interventions improved Timed-Up-and-Go with cognitive task (TUGCog) after 4 weeks (p < 0.001); gains were maintained at 8 weeks of intervention (p < 0.001) and 1 month follow-up (p < 0.001). The dance intervention met adherence feasibility criteria for 8 weeks; exercise met criteria for 4 weeks. The ratio of cognitive to physical exertion was higher for dance (1 to 1) than exercise (0.8 to 1.0; p < 0.001). Dance, only, was associated with reduced cognitive load (p = 0.02).ConclusionsAmong survivors of BC with CIN, small doses of social dance improved dual-task function comparably to larger doses of home exercise, possibly due to differences in cognitive engagement.
308. Clinical Trial of Mandala Coloring for Management of Chemotherapy-Induced Nausea and Vomiting.
Chemotherapy-induced nausea and vomiting (CINV) is one of the common side effects of anticancer treatment. Pharmacological treatments may be insufficient in managing CINV. Management of symptoms caused by treatment regimens in the cancer care process is crucial for patients' quality of life and compliance with treatment. This randomized controlled trial was designed to determine the effect of mandala coloring on CINV and patients' comfort levels.
309. [Clinical efficacy observation of heat-sensitive moxibustion combined with intrapleural perfusion of cisplatin in treatment of malignant pleural effusion].
作者: Mei Zhou.;Shuo Yang.;Ri-Xin Chen.;Xiao-Fang Yang.;Jing Zhao.;Wen-Xuan Xie.;Yue Liao.;Dong Liu.
来源: Zhen Ci Yan Jiu. 2024年49卷11期1190-1197页
To investigate the clinical efficacy of heat-sensitive moxibustion combined with intrapleural perfusion of cisplatin in comparison with simple intrapleural perfusion of cisplatin on malignant pleural effusion (MPE).
310. Radiotherapy with cetuximab or durvalumab for locoregionally advanced head and neck cancer in patients with a contraindication to cisplatin (NRG-HN004): an open-label, multicentre, parallel-group, randomised, phase 2/3 trial.
作者: Loren K Mell.;Pedro A Torres-Saavedra.;Stuart J Wong.;Julie A Kish.;Steven S Chang.;Richard C Jordan.;Tian Liu.;Minh Tam Truong.;Eric W Winquist.;Vinita Takiar.;Trisha Wise-Draper.;Jared R Robbins.;Cristina P Rodriguez.;Musaddiq J Awan.;Beth M Beadle.;Christina Henson.;Samir Narayan.;Sharon A Spencer.;Steven Powell.;Neal Dunlap.;Assuntina G Sacco.;Kenneth Shung Hu.;Henry S Park.;Julie E Bauman.;Jonathan Harris.;Sue S Yom.;Quynh-Thu Le.
来源: Lancet Oncol. 2024年25卷12期1576-1588页
Management of patients with locoregionally advanced head and neck squamous cell carcinoma (HNSCC) when cisplatin is contraindicated is controversial. We aimed to assess whether radiotherapy with concurrent and adjuvant durvalumab would improve outcomes compared with radiotherapy with cetuximab.
311. Safety and efficacy of pembrolizumab, radiation therapy, and surgery versus radiation therapy and surgery for stage III soft tissue sarcoma of the extremity (SU2C-SARC032): an open-label, randomised clinical trial.
作者: Yvonne M Mowery.;Karla V Ballman.;Angela M Hong.;Scott M Schuetze.;Andrew J Wagner.;Varun Monga.;Rachel S Heise.;Steven Attia.;Edwin Choy.;Melissa A Burgess.;Susie Bae.;David I Pryor.;Brian A Van Tine.;Gabriel Tinoco.;Bartosz Chmielowski.;Carolyn Freeman.;Alessandro Gronchi.;Christian F Meyer.;Mark A Dickson.;Lee Hartner.;Lara E Davis.;Benjamin C Powers.;Everett J Moding.;Kent J Weinhold.;Matt van de Rijn.;Brian E Brigman.;Richard F Riedel.;David G Kirsch.
来源: Lancet. 2024年404卷10467期2053-2064页
Approximately half of patients with localised, high-risk soft tissue sarcoma of the extremity develop metastases. We aimed to assess whether the addition of pembrolizumab to preoperative radiotherapy and surgery would improve disease-free survival.
312. Topical application of the Hedgehog inhibitor patidegib in patients with Gorlin syndrome: a phase II trial.
作者: John T Lear.;Catherine A Harwood.;Zeeshaan Hasan.;Jonathan Kentley.;Jason Thomson.;Andre Khoo.;Alix Alderman.;Mark DeSouza.;Ervin H Epstein.;Gerd G Kochendoerfer.;Jean Y Tang.
来源: Br J Dermatol. 2025年192卷4期611-617页
Patients with Gorlin (basal cell naevus) syndrome (GS) have numerous phenotypic abnormalities due to overactivity of the hedgehog (HH) signalling pathway, most commonly caused by a heritable mutation in PTCH1, which encodes a major inhibitor of this pathway. Oral HH inhibitors (HHi) can reverse some of the manifestations, most prominent of which is the development of numerous cutaneous basal cell carcinomas (BCCs). In order to improve the benefit-risk ratio, we developed a gel containing a small cyclopamine-derived molecule that can be applied topically in expectation that this mode of delivery can reduce the burden of BCCs without producing the systemic adverse effects that cause patients to stop oral HHi treatment.
313. Efficacy and Safety of Biosimilar Cetuximab Versus Innovator Cetuximab in Indian Patients With Head and Neck Cancer: A Multicenter, Randomized, Double-Blind, Phase III Trial.
作者: Kumar Prabhash.;Chetan Deshmukh.;Hemant Malhotra.;Atul Sharma.;Minish Jain.;Nilesh Dhamne.;Rajnish Nagarakar.;Prasantha Ganesan.;Vijay K Mahobia.;Chandan K Das.;Rejnish Kumar.;Prakash S Shivanna.;Manu P Avaronnan.;Puligundla K Chaithanya.;Vaibhav Chaudhary.;Kartar Singh.;Suhas Aagre.;Bellala Ravishankar.;Dhruv Mehta.;Kandipalli Shilpa.;Vashishth Maniar.;Koushik Chatterjee.;Saroj D Majumdar.;Rohitashwa Dana.;Vanita Noronha.;Nandini Menon.;Akhilesh Sharma.;Roshan Pawar.;Vinayaka Shahavi.;Rajiv Yadav.;Amol Aiwale.
来源: JCO Glob Oncol. 2024年10卷e2400059页
Squamous cell carcinoma of the head and neck (SCCHN) is the sixth most common cancer, with approximately 225,419 new cases with over 125,000 deaths annually in India. This trial compared the efficacy and safety of biosimilar cetuximab versus innovator cetuximab (IC) in combination with platinum-based chemotherapy in patients with recurrent locoregional or metastatic SCCHN.
314. Adverse events in the placebo arm of SOLO2/ENGOT-Ov21 maintenance trial of olaparib in recurrent ovarian cancer.
作者: Katherine Elizabeth Francis.;Sandy Simon.;Val Gebski.;Florence Joly.;Jonathan A Ledermann.;Richard T Penson.;Amit M Oza.;Jacob Korach.;Nuria Lainez.;Sabrina Chiara Cecere.;Giulia Tasca.;Martina Gropp-Meier.;Keiichi Fujiwara.;Elizabeth S Lowe.;Michael Friedlander.;Eric Pujade-Lauraine.;Chee Khoon Lee.
来源: Gynecol Oncol. 2025年192卷50-55页
In women with platinum sensitive recurrent ovarian cancer (PSROC) undergoing maintenance treatment, adverse events (AEs) not attributable to the current treatment are not well understood. We used data from SOLO2/ENGOT-Ov21 to evaluate AEs reported in the placebo arm and to explore their longitudinal trajectories.
315. Ocular Pharmacodynamics of Intravitreal Faricimab in Patients With Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema.
作者: Cheikh Diack.;Robert L Avery.;Chui Ming Gemmy Cheung.;Karl G Csaky.;Leonid Gibiansky.;Felix Jaminion.;Ekaterina Gibiansky.;Denise Sickert.;Ivo Stoilov.;Valerie Cosson.;Katrijn Bogman.
来源: Transl Vis Sci Technol. 2024年13卷11期13页
Evaluate the ocular pharmacodynamics (PD) of intravitreal faricimab, a bispecific inhibitor of angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), in patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME).
316. ONS-5010 (bevacizumab-vikg) Safety and Efficacy in Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration.
作者: Firas M Rahhal.;Allen Hu.;Mark Humayun.;Meena S George.;Cameron Javid.;Jeremiah Brown.;John D Pitcher.;Terry Dagnon.;Jennifer Kissner.
来源: Ophthalmic Surg Lasers Imaging Retina. 2025年56卷3期178-189页
This was a prospective multicenter, randomized, double-masked, active-controlled study, the aim of which was to demonstrate the efficacy and safety of intravitreal ONS-5010 (bevacizumab-vikg) in eyes with neovascular age-related macular degeneration (nAMD). This was a phase III trial on ONS-5010 (NORSE TWO).
317. Effect of Music on Anxiety and Fatigue in Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial.
作者: Havva Gezgin Yazıcı.;Çiğdem Ökten.;Esra Karabulut.;Mehmet Aliustaoğlu.
来源: Arch Iran Med. 2024年27卷11期611-617页
Anxiety and fatigue are symptoms typically experienced by cancer patients undergoing chemotherapy. In dealing with these symptoms, listening to music may help patients.
318. Plain language summary: tarlatamab for patients with previously treated small cell lung cancer.
作者: Myung-Ju Ahn.;Byoung Chul Cho.;Enriqueta Felip.;Ippokratis Korantzis.;Kadoaki Ohashi.;Margarita Majem.;Oscar Juan-Vidal.;Sabin Handzhiev.;Hiroki Izumi.;Jong-Seok Lee.;Rafal Dziadziuszko.;Jürgen Wolf.;Fiona Blackhall.;Martin Reck.;Jean Bustamante Alvarez.;Horst-Dieter Hummel.;Anne-Marie C Dingemans.;Jacob Sands.;Hiroaki Akamatsu.;Taofeek K Owonikoko.;Suresh S Ramalingam.;Hossein Borghaei.;Melissa L Johnson.;Shuang Huang.;Sujoy Mukherjee.;Mukul Minocha.;Tony Jiang.;Pablo Martinez.;Erik S Anderson.;Luis Paz-Ares.
来源: Future Oncol. 2024年20卷40期3355-3364页
This is a summary of a phase 2 clinical study called DeLLphi-301. The study looked at how effective and safe a medicine called tarlatamab was in participants with small cell lung cancer (SCLC). Participants previously received at least two other treatments for their SCLC. Tarlatamab is a new medicine that locates a protein called DLL3 on the cancer, which allows T cells to attack the cancer. T cells belong to the body's natural defense system known as the immune system. The DeLLphi-301 study separated participants into two groups to receive tarlatamab 10 mg or 100 mg to determine which dose best shrank SCLC with minimal side effects. All participants received a small first dose (1 mg tarlatamab) to decrease the risk of an immune system reaction called cytokine release syndrome (CRS). Tarlatamab was given through the participant's vein once every 2 weeks. This method of administration is known as intravenous (IV) infusion.
319. Neoadjuvant and adjuvant toripalimab for locoregionally advanced nasopharyngeal carcinoma: a randomised, single-centre, double-blind, placebo-controlled, phase 2 trial.
作者: Sai-Lan Liu.;Xiao-Yun Li.;Jin-Hao Yang.;Dong-Xiang Wen.;Shan-Shan Guo.;Li-Ting Liu.;Yi-Fu Li.;Mei-Juan Luo.;Si-Yi Xie.;Yu-Jing Liang.;Xue-Song Sun.;Zhen-Chong Yang.;Xiao-Fei Lv.;Dong-Hua Luo.;Ji-Bin Li.;Qing Liu.;Pan Wang.;Ling Guo.;Hao-Yuan Mo.;Rui Sun.;Qi Yang.;Kai-Qi Lan.;Guo-Dong Jia.;Ru Li.;Chong Zhao.;Rui-Hua Xu.;Qiu-Yan Chen.;Lin-Quan Tang.;Hai-Qiang Mai.
来源: Lancet Oncol. 2024年25卷12期1563-1575页
Patients with locoregionally advanced nasopharyngeal carcinoma with a high pretreatment plasma concentration of Epstein-Barr virus (EBV) DNA remain at high risk for recurrence after concurrent chemoradiotherapy. This study aimed to compare the efficacy and safety of neoadjuvant-adjuvant treatment with the PD-1 inhibitor toripalimab and concurrent chemoradiotherapy versus placebo and concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma.
320. A Phase 1 Randomized, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Enteric-Coated Stabilized Sulforaphane (SFX-01) in Male Participants.
作者: Glen Clack.;Christopher Moore.;Linette Ruston.;David Wilson.;Annelize Koch.;Danielle Webb.;Nicholas Mallard.
来源: Adv Ther. 2025年42卷1期216-232页
Sulforaphane (SFN) is a naturally occurring isothiocyanate associated with various health benefits, including reduced cancer risk, and has been extensively explored as a potential therapeutic. However, its inherent instability presents challenges in formulation, storage, and administration as a medicinal product. SFX-01 (Sulforadex®) is a patented synthetic form of d,l-SFN stabilized within a biologically inert alpha-cyclodextrin complex.
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