161. Effect of adaptive variable-resistance training on chemotherapy-induced sarcopenia, fatigue, and functional restriction in pediatric survivors of acute lymphoblastic leukemia: a prospective randomized controlled trial.
作者: Ragab K Elnaggar.;Waleed S Mahmoud.;Mohamed S Abdrabo.;Mahmoud S Elfakharany.
来源: Support Care Cancer. 2025年33卷3期214页
With the rising survival rate among children and adolescents with acute lymphoblastic leukemia (ALL), prioritizing patient-centered care to address the long-term effects of chemotherapy through tailored rehabilitation interventions is essential for optimizing their quality of life. The purpose of this study was to investigate the impact of an 8-week intervention using adaptive variable-resistance training (Adaptive-VRT) on chemotherapy-induced sarcopenia, fatigue, and functional restrictions in pediatric survivors of ALL.
162. ENDOLUNG trial, part II. A phase II study of the Akt/mTOR inhibitor and autophagy inducer ibrilatazar (ABTL0812) in combination with paclitaxel/carboplatin in patients with squamous non-small cell lung cancer.
作者: Joaquim Bosch-Barrera.;Purificación Estévez-García.;Paloma Martín-Martorell.;Renaud Sabatier.;Ernest Nadal.;Elia Sais.;Pere Gascón.;Ana Oaknin.;Jordi Rodon.;Jose M Lizcano.;Pau Muñoz-Guardiola.;Gemma Fierro-Durán.;Oriol Pedrós-Gámez.;Héctor Pérez-Montoyo.;Marc Yeste-Velasco.;Marc Cortal.;Antonio Pérez-Campos.;José Alfón.;Carles Domènech.;Teresa Morán.
来源: Lung Cancer. 2025年201卷108105页
Advanced squamous non-small cell lung cancer (sq-NSCLC) has long relied on chemotherapy and, more recently, on its combination with PD-1 immunotherapy. Ibrilatazar (ABTL0812) is an innovative oral agent that induces cytotoxic autophagy selectively in cancer cells. In the ENDOLUNG trial we have evaluated the efficacy and safety of ibrilatazar combined with chemotherapy in sq-NSCLC patients.
163. Pembrolizumab in microsatellite-instability-high and mismatch-repair-deficient advanced solid tumors: updated results of the KEYNOTE-158 trial.
作者: Aurelien Marabelle.;David M O'Malley.;Andrew E Hendifar.;Paolo A Ascierto.;Daniel Motola-Kuba.;Nicolas Penel.;Philippe A Cassier.;Giovanni Bariani.;Ana De Jesus-Acosta.;Toshihiko Doi.;Federico Longo.;Wilson H Miller.;Do-Youn Oh.;Maya Gottfried.;Lili Yao.;Fan Jin.;Alexander Gozman.;Michele Maio.
来源: Nat Cancer. 2025年6卷2期253-258页
The phase 2 trial KEYNOTE-158 ( NCT02628067 ) evaluated pembrolizumab in microsatellite-instability-high and mismatch-repair-deficient (MSI-H/dMMR) noncolorectal tumors. With 373 participants (95% with baseline MSI/dMMR documentation) and 4.5 years of follow-up, the primary endpoint of overall response rate was 33.8%. Secondary endpoints of duration of response, overall survival and progression-free survival were 63.2, 19.8 and 4.0 months, respectively. Grade ≥3 treatment-related adverse events occurred in 50 (13%) participants. These results further support pembrolizumab use in MSI-H/dMMR tumors.
164. COMBINED INTRAVITREAL AFLIBERCEPT AND ANTI-INFLAMMATORY ORAL SUPPLEMENTATION IN THE TREATMENT OF DIABETIC MACULAR EDEMA: Two-Year Randomized Controlled Trial Results.
作者: Paola Marolo.;Giovanni Li Volti.;Anna Nicolosi.;Teresio Avitabile.;Antonio Longo.;Matteo Fallico.;Andrea Russo.;Enrico Borrelli.;Guglielmo Parisi.;Mario Damiano Toro.;Ugo de Sanctis.;Lorenzo Motta.;Michele Reibaldi.
来源: Retina. 2025年45卷6期1134-1142页
To compare intravitreal aflibercept alone versus aflibercept combined with oral anti-inflammatory supplementation in patients with diabetic macular edema.
165. Novel Combination Immunotherapy and Clinical Activity in Patients With HPV-Associated Cancers: A Nonrandomized Clinical Trial.
作者: Charalampos S Floudas.;Meghali Goswami.;Renee N Donahue.;Danielle M Pastor.;Jason M Redman.;Isaac Brownell.;Evrim B Turkbey.;Lisa M Cordes.;Seth M Steinberg.;Michell Manu.;Deneise C Francis.;Elizabeth Lamping.;Jennifer L Marté.;Mary Kackley.;Elizabeth Krauss.;Manuk Manukyan.;Caroline Jochems.;Jeffrey Schlom.;James L Gulley.;Julius Strauss.
来源: JAMA Oncol. 2025年11卷4期394-399页
Patients who experience progression of advanced human papillomavirus (HPV)-associated cancers and who have previously received first-line systemic treatment have a poor prognosis and limited therapeutic options.
166. A phase I dose-escalation and expansion study of RMX1002, a selective E-type prostanoid receptor 4 antagonist, as monotherapy and in combination with anti-PD-1 antibody in advanced solid tumors.
作者: Dan Liu.;Jifang Gong.;Jian Zhang.;Yongqian Shu.;Hao Wu.;Tianshu Liu.;Yanhua Xu.;Lijia Zhang.;Min Li.;Xichun Hu.;Lin Shen.
来源: Invest New Drugs. 2025年43卷2期250-261页
RMX1002 (grapiprant) is a selective E-type prostanoid receptor 4 (EP4) antagonist and a promising candidate for cancer therapy, potentially enhancing anti-tumor immune responses. This study aimed to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of RMX1002 as monotherapy and in combination with anti-PD-1 antibody toripalimab for advanced solid tumors. This multicenter, phase I trial enrolled patients with histologically or cytologically confirmed advanced solid tumors. This study included three phases: Ia (dose-escalation of RMX1002 monotherapy from 200 to 650 mg BID), Ib (dose-escalation from 500 to 650 mg BID in combination with toripalimab), and Ic (dose-expansion of 500 mg BID with toripalimab). Safety, pharmacokinetics, pharmacodynamics, and efficacy were assessed. A total of 45 patients were enrolled (17 in phase Ia, 12 in phase Ib, and 16 in phase Ic). No dose-limiting toxicity was reported, and the MTD was not reached. Overall, 21 patients experienced RMX1002-related adverse events with CTCAE grade ≥ 3. Pharmacokinetics revealed rapid absorption of RMX1002 with the maximum concentration (Cmax) reached within 2 to 5 h, and dose-dependent increases in Cmax and area under the concentration-time curve. The increase in urinary metabolite of PGE2 suggested the inhibition of EP4 signaling pathway. The best response was stable disease, reported in 64.7%, 28.6%, and 18.8% of patients in phase Ia, Ib, and Ic, respectively. RMX1002 was well tolerated and showed a best response of stable disease. RMX1002 500 mg BID with toripalimab 240 mg every 3 weeks is the recommended dose for future trials.
167. First-in-human phase 1 study of an orally bioavailable vascular-disrupting agent DX1002 in patients with advanced solid tumors.
作者: Xiao-Li Wei.;Hao-Xiang Wu.;Dan-Yun Ruan.;Feng Wang.;Li Xu.;Yu-Hong Li.;Yu-Xiang Ma.;Zhi-Qiang Wang.;Yun-Peng Yang.;Liang-Wei Tang.;Bao-Lin Chen.;Zhi-Quan Yong.;Rui-Hua Xu.;Hong-Yun Zhao.
来源: Cell Rep Med. 2025年6卷2期101969页
DX1002 is an oral vascular-disrupting agent and exhibits promising results in preclinical studies, leading to tumor vasculature destruction and xenografted tumor necrosis in various animal models. In the phase 1 trial, 17 patients with solid tumors receive DX1002 ranging from 50 to 1,100 mg. The maximum tolerated dose and recommended phase 2 dose of DX1002 are determined as 600 mg once daily. The most common treatment-related adverse events are nausea (23.5%), vomiting (17.6%), and fatigue (11.8%). All patients are evaluable for anti-tumor response, 12 of which achieve stable disease as best response. One patient with non-small cell lung cancer achieves a stable disease duration of 6.5 months. The median time to progression (TTP) is 2.70 months (95% confidence interval [CI], 0.90-4.60). Interestingly, reduced blood perfusion is observed by contrast-enhanced ultrasound in a patient with colon cancer. In conclusion, DX1002 is well tolerated and exhibits preliminary anti-tumor efficacy in patients with solid tumors. This study was registered at chictr.org.cn (ChiCTR2400080298).
168. Impact of edoxaban-related adverse events in patients with cancer experiencing venous thromboembolism during antineoplastic therapy: Results of the phase IV EDOI study (GOIRC-05-2018).
作者: Giuseppe Maglietta.;Angela Damato.;Silvia Finotto.;Marta Mandarà.;Stefano Tamberi.;Salvatore Grisanti.;Matteo Brighenti.;Marcello Tiseo.;Vincenzo Montesarchio.;Annamaria Catino.;Fabio Gelsomino.;Filippo Giovanardi.;Lorenzo Antonuzzo.;Alessandra Romagnani.;Erika Gervasi.;Massimo Di Maio.;Carmine Pinto.
来源: Eur J Cancer. 2025年219卷115296页
The oral factor Xa inhibitor, edoxaban, is effective and safe in cancer-associated Venous Thromboembolism (VTE) treatment. The EDOI study aims to evaluate compliance and quality of life (QoL) in patients with cancer-associated VTE treated with edoxaban during antineoplastic care.
169. A group sequential response-adaptive randomized double-blinded clinical trial to evaluate the safety and efficacy of add-on olanzapine plus pregabalin for the prevention of chemotherapy-induced nausea and vomiting.
作者: Mathan Kumar Ramasubbu.;Debasish Hota.;Saroj Kumar Das Majumdar.;Dillip Kumar Parida.;Priyanka Mukherjee.;Anand Srinivasan.
来源: Support Care Cancer. 2025年33卷3期203页
Even with antiemetic prophylaxis, patients undergoing cancer chemotherapy often still experience chemotherapy-induced nausea and vomiting (CINV). Neurokinin-1 (NK-1) receptor antagonists will prevent CINV effectively but are not affordable for patients of low socioeconomic status.
170. Population Pharmacokinetics of Fruquintinib, a Selective Oral Inhibitor of VEGFR -1, -2, and -3, in Patients with Refractory Metastatic Colorectal Cancer.
作者: Xiaofei Zhou.;Xiaoyan Yang.;Boris Grinshpun.;Adekemi Taylor.;Laura Strong.;Arvind Dasari.;Andrea Wang-Gillam.;Jin Li.;Rui-Hua Xu.;Neeraj Gupta.;Caly Chien.
来源: J Clin Pharmacol. 2025年65卷7期873-884页
Fruquintinib is a selective, oral tyrosine kinase inhibitor of all three vascular endothelial growth factor receptors 1, 2, and 3, which is approved for patients with previously treated metastatic colorectal cancer regardless of biomarker status. This population pharmacokinetic (PK) analysis characterized sources of interpatient variability on the PK of fruquintinib and its major metabolite M11 using data from 557 subjects who received fruquintinib in five phase I/Ib studies and the FRESCO-2 phase III study. The integrated model was a one-compartment model with first-order absorption, lag time in absorption, and linear elimination for fruquintinib and a one-compartment model with linear elimination for M11. The half-life of fruquintinib and M11 were estimated to be 43.2 and 54 h, respectively. Fruquintinib PK demonstrated dose proportionality. Fruquintinib oral clearance and apparent volume of distribution (V/F) increased with increasing body weight. Fruquintinib absorption rate constant was 60.7% lower with concurrent use of proton-pump inhibitors (PPIs), and fruquintinib V/F was 9.08% lower in healthy subjects versus patients with cancer. Magnitudes of the covariate effects of body weight, concurrent use of PPIs, and health status on fruquintinib exposures were estimated to be <20%, which is not considered clinically meaningful. Age (18.0-82.0 years), sex, race (Asian, Black, and White), ethnicity (Hispanic vs non-Hispanic), Eastern Cooperative Oncology Group performance status score, tumor type, mild or moderate renal impairment, and mild hepatic impairment had no clinically meaningful impact on fruquintinib or M11 PK. This analysis supports the same fruquintinib starting dosage, without need for adjustments, for these patient-specific factors.
171. First-in-human phase I study to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity of PF-07209960 in patients with advanced or metastatic solid tumors.
作者: A Naing.;M McKean.;L S Rosen.;D Sommerhalder.;N M Shaik.;I-M Wang.;C Le Corre.;K A Kern.;N H Mishra.;S K Pal.
来源: ESMO Open. 2025年10卷3期104291页
PF-07209960 is an antibody-cytokine fusion molecule that consists of a single potency-reduced interleukin-15 (IL-15) mutein and a bivalent high-affinity anti-programmed cell death protein 1 (PD-1) full-length IgG. This phase I study (NCT04628780) evaluated the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and potential clinical benefits of PF-07209960 in patients with selected locally advanced or metastatic solid tumors for whom no standard therapy was available.
172. Randomized controlled trial on the efficacy of topical urea-based cream in preventing capecitabine-associated hand-foot syndrome.
作者: Concord Wongkraisri.;Kriengkrai Chusuwanrak.;Apirom Laocharoenkeat.;Leena Chularojanamontri.;Akarin Nimmannit.;Suthinee Ithimakin.
来源: BMC Cancer. 2025年25卷1期275页
Hand-foot syndrome (HFS) is a common adverse event of capecitabine causing treatment modifications. Topical urea cream can reduce sorafenib-induced hand-foot skin reaction. However, its benefit in preventing capecitabine-associated HFS was not seen early in the course and had been unknown with long-term use. The aim of this study was to evaluate the efficacy of urea cream for HFS prophylaxis throughout capecitabine treatment.
173. Updated efficacy and safety of HLX02 versus reference trastuzumab in metastatic HER2-positive breast cancer: A randomized phase III equivalence trial.
作者: Binghe Xu.;Qingyuan Zhang.;Tao Sun.;Wei Li.;Yue'e Teng.;Xichun Hu.;Igor Bondarenko.;Hryhoriy Adamchuk.;Liangming Zhang.;Dmytro Trukhin.;Shusen Wang.;Hong Zheng.;Zhongsheng Tong.;Yaroslav Shparyk.;Futang Yang.;Haoyu Yu.;Jing Li.;Qingyu Wang.;Jun Zhu.; .
来源: Breast. 2025年80卷104413页
Equivalence between HLX02 and trastuzumab sourced from the European Union (EU-trastuzumab), in combination with docetaxel, was demonstrated in a phase III study. This study aimed to evaluate the long-term efficacy and safety data after 3 years of follow-up.
174. Palbociclib exposure in relation to efficacy and toxicity in patients with advanced breast cancer.
作者: S M Buijs.;M I Mohmaed Ali.;E Oomen-de Hoop.;C L Braal.;N Wortelboer.;A van Ommen-Nijhof.;G S Sonke.;I R Konings.;A Jager.;N Steeghs.;H Siebinga.;R H J Mathijssen.;A D R Huitema.;S L W Koolen.
来源: ESMO Open. 2025年10卷3期104290页
Data on exposure-response or exposure-toxicity relationships of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) are limited and inconclusive. We aimed to investigate whether there is an association between palbociclib exposure and progression-free survival (PFS), adverse events (AEs) and dose reductions.
175. Mitoxantrone hydrochloride liposome injection for the treatment of Recurrent/Metastatic head and neck squamous cell Carcinoma: A Multicenter, Open-label, Single-arm, phase 1b study.
作者: Hang Yang.;Peng Sun.;Yu Wang.;Xicheng Wang.;Yanyan Liu.;Jiyong Peng.;Hui Zhou.;Yajun Li.;Hong Zhang.;Jianbing Hu.;Bing Zhang.;Shunhuan Lin.;Chunwei Yang.;Weidong Li.;Yanping Liu.;Meng Ji.;Jinghua Zhao.;Jianfei Xue.;Jiajia Huang.;Zhiming Li.
来源: Oral Oncol. 2025年162卷107211页
Mitoxantrone hydrochloride liposomes (PLM60) have been approved for the treatment of relapsed/refractory peripheral T-cell lymphoma (PTCL) in China. This study evaluated the safety and efficacy of PLM60 in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).
176. A clinical study of tremelimumab, alone or in combination with olaparib, for recurrent epithelial ovarian cancer.
作者: Stéphanie Gaillard.;Neha Verma.;Maureen Berg.;Jeanne Harrison.;Peng Huang.;James M Leatherman.;Michele Doucet.;Rupashree Sen.;Aditya Suru.;Hongyan Cai.;Jennifer Durham.;Danijela Jelovac.;Ashley Cimino-Mathews.;Christopher Cherry.;Sudipto Ganguly.;Leisha A Emens.
来源: Gynecol Oncol. 2025年194卷41-47页
PARP inhibitors may work synergistically to improve the efficacy of immunotherapy in patients with epithelial ovarian cancer (EOC). We performed a parallel-arm study of tremelimumab, alone or with olaparib, in patients with recurrent EOC.
177. Curcumin Supplementation as a Preventive Strategy Against Tamoxifen-Induced Nonalcoholic Fatty Liver Disease in ER+ Breast Cancer Patients: A Triple-Blind Randomized Placebo-Controlled Trial.
作者: Simin Hemati.;Fatemeh Mehrabinejad.;Mohammadreza Elhaie.;Nadia Najafizade.
来源: J Diet Suppl. 2025年22卷2期274-283页
Tamoxifen, a common treatment for estrogen receptor (ER)‑positive breast cancer, is associated with an increased risk of developing nonalcoholic fatty liver disease (NAFLD). Curcumin, a compound in turmeric, has shown potential in mitigating liver disease progression. This study aims to evaluate the efficacy and safety of curcumin in preventing NAFLD in breast cancer patients initiating tamoxifen therapy.In this 6‑month triple‑blind, randomized placebo‑controlled trial, 44 ER+ breast cancer patients scheduled to receive tamoxifen were assigned to receive either curcumin (500 mg daily) or a placebo. NAFLD grade was assessed via ultrasound at baseline and after 6 months. Laboratory values and demographic data were collected, and adverse effects were monitored. Statistical analyses was performed using SPSS version 16.Data of a total of 44 participants (22 participants in each group, mean age: 47.1 ± 6.0 years) were analyses. There were no significant differences between the placebo and curcumin groups regarding the demographic and baseline laboratory values. At study completion, significantly fewer patients in the curcumin group showed an increased NAFLD grade compared to the placebo group (13.6% vs. 54.5%; p = 0.03). Additionally, the prevalence of NAFLD grade ≥ 2 was lower in the curcumin group (13.6% vs. 40.9%; p = 0.04). No adverse effects related to curcumin were reported. Curcumin supplementation demonstrated a protective effect against tamoxifen‑induced NAFLD in ER+ breast cancer patients, suggesting its potential as a prophylactic adjunct to tamoxifen therapy. Larger multi‑centric trials are warranted to confirm these findings.
178. A Phase IB Trial of Selinexor in Combination With Immune Checkpoint Blockade in Patients With Advanced Renal Cell Carcinoma.
作者: Omar Alhalabi.;Mohamed A Gouda.;Denái R Milton.;Hassan Ahmed Momin.;Bulent Yilmaz.;Bettzy Stephen.;Chinenye Lynette Ejezie.;Justin Tyler Moyers.;Serdar A Gurses.;Jeffrey How.;Siqing Fu.;Jordi Rodon.;David S Hong.;Sarina A Piha-Paul.;Vivek Subbiah.;Ecaterina Elena Dumbrava.;Daniel D Karp.;Filip Janku.;Funda Meric-Bernstam.;Nizar M Tannir.;Aung Naing.
来源: Cancer Med. 2025年14卷4期e70280页
Selinexor (SEL) is a nuclear exportin 1 inhibitor that blocks the transport of nuclear proteins, including tumor suppressors, to the cytoplasm. Preclinical data suggest that the combination of SEL with checkpoint blockade may result in improved response to immunotherapy.
179. First-In-Human Dose Finding Study of Venadaparib (IDX-1197), a Potent and Selective PARP Inhibitor, in Patients With Advanced Solid Tumors.
作者: Sung-Bae Kim.;Kyun-Seop Bae.;Jae Lyun Lee.;Won Sik Lee.;Chan-Young Ock.;Myong-Jae Lee.;Jeongsook Bang.;Min Ju Hong.;Eun-Jihn Roh.;Kyoung Soo Ha.;Jong-Ha Lim.;Yong-Man Kim.
来源: Cancer Med. 2025年14卷4期e70576页
Venadaparib, a novel poly (ADP-ribose) polymerase (PARP) inhibitor, has demonstrated high PARP-1/2 selectivity over other PARP family members and exhibited strong PARP-trapping activity, effectively inhibiting tumor growth in homologous recombination deficient (HRD) cancer in vitro and in vivo.
180. Pilot Randomized Trial of an Educational Intervention About Immunotherapy for Patients With Advanced Cancer and Their Caregivers.
作者: Laura A Petrillo.;Kelly Hsu.;Kedie Pintro.;Dustin J Rabideau.;Ashley Z Zhou.;Roshni Sarathy.;An Tran.;Ryan Sullivan.;Kerry L Reynolds.;Areej El-Jawahri.;Angelo Volandes.;Joseph A Greer.;Jennifer S Temel.
来源: J Natl Compr Canc Netw. 2025年23卷2期12-20页
Immune checkpoint inhibitors (ICIs) are widely used cancer drugs. We developed "UPLIFT," a video and question prompt list (QPL) intervention to educate patients about ICI risks and benefits.
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