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361. Efficacy, safety, and cost-effectiveness of biosimilars of bevacizumab in näive patients with diabetic macular edema.

作者: Shalini Virani.;Akshay Bhatiwal.;Parveen Rewri.
来源: Indian J Pharmacol. 2024年56卷4期248-252页
Anti-vascular endothelial growth factor (VEGF) therapy restores retinal architecture and enhances vision in diabetic macular edema (DME). Bevacizumab is an off-label anti-VEGF drug that effectively treats DME. The safety and efficacy of bevacizumab biosimilars, which are more affordable than the original medication, still need to be established. This study aimed to assess the cost-effectiveness, efficacy, and safety of biosimilars for treating patients with naïve DME across various price ranges that are accessible in the Indian market.

362. Dose Justification for Asciminib in Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia with and Without the T315I Mutation.

作者: Francois Pierre Combes.;Sherwin K B Sy.;Ying Fei Li.;Sebastien Lorenzo.;Kohinoor Dasgupta.;Shruti Kapoor.;Matthias Hoch.;Yu-Yun Ho.
来源: Clin Pharmacokinet. 2024年63卷9期1301-1312页
Asciminib is approved in patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) treated with ≥ 2 prior tyrosine kinase inhibitors. Here, we aimed to demonstrate similarity in efficacy/safety of asciminib 80 mg once daily (q.d.) versus 40 mg twice daily (b.i.d.) in patients with CML-CP without T315I mutation and support the use of the 200-mg b.i.d. dosage in patients harboring T315I, using model-informed drug development.

363. Effect of Adding Electroacupuncture to Standard Triple Antiemetic Therapy on Chemotherapy-Induced Nausea and Vomiting: A Randomized Controlled Clinical Trial.

作者: Guoshuang Shen.;Dengfeng Ren.;Fuxing Zhao.;Miaozhou Wang.;Zhen Liu.;Xiumei Feng.;Yingjian He.;Xinlan Liu.;Xiaoling Ling.;Yi Zhao.;Feixue Song.;Jiyan Ma.;Enxi Li.;Tong She.;Zhilin Liu.;Zitao Li.;Shifen Huang.;Yongzhi Chen.;Jingru Yang.;Xuan Li.;Li Duan.;Mengting Da.;Yonghui Zheng.;Yongxin Li.;Jiuda Zhao.
来源: J Clin Oncol. 2024年42卷34期4051-4059页
We aim to determine the effectiveness of adding electroacupuncture to standard triple antiemetic therapy for treating chemotherapy-induced nausea and vomiting (CINV).

364. The hepatorenal protective effects of silymarin in cancer patients receiving chemotherapy: a randomized, placebo-controlled trial.

作者: Safoora Sadat Erfanian.;Hourieh Ansari.;Shaghayegh Haghjooy Javanmard.;Zahra Amini.;Ali Hajigholami.
来源: BMC Complement Med Ther. 2024年24卷1期329页
Breast cancer is one of the most common diseases globally that may have side effects on liver and renal function. Pharmacological treatments to reduce adverse liver and renal effects are still limited. It has been proposed that silymarin may possess hepatoprotective and anti-inflammatory properties. The present trial aims to assess the hepatorenal protective efficacy of silymarin supplementation in cancer patients receiving chemotherapy in an outpatient setting.

365. "The protective effect of nano curcumin supplementation on doxorubicin induced cardiotoxicity in breast cancer patients; a randomized, double-blind clinical trial".

作者: Mehdi Tohidi.;Abolghasem Allahyari.;Sajjad Ataei Azimi.;Hedieh Alimi.;Sepideh Elyasi.;Farid Qoorchi Moheb Seraj.;Hasan Mehrad-Majd.
来源: J Oncol Pharm Pract. 2025年31卷7期1076-1085页
BackgroundAnthracycline drugs play a fundamental role in breast cancer treatment; however, the cardiotoxicity side effects obscure the advantages of treatment. Curcumin has antioxidant and anti-inflammatory effects.Materials and MethodsIn this study, we investigated the effect of nanocurcumin supplementation on Doxorubicin induced Cardiotoxicity. In this randomized clinical trial, a week before starting the doxorubicin regimen for breast cancer patients, the control group received placebo and curcumin group received 80 mg daily dosage of nano curcumin capsules for six months. Echocardiography parameter changes before chemotherapy and after six months were evaluated.Results46 patients were included. Left ventricle (LV) ejection fraction significantly decreased and LV end diastolic volume significantly increased in control group but no significant changes were observed in the curcumin group (LVEF: 2.62 ± 59.35 to 4.23 ± 56.85, p-value: 0.014 vs 59.55 ± 1.91 to 58.46 ± 3.41, p-value:0.135; LVEDV: 77.09 ± 15.33 to 80.65 ± 14.54, p-value:0.023 vs 72.41 ± 15.34 74.00 ± 14.25, p-value: 0.294). Additionally, LVEF, LV end systolic diameter (LVESD), and end diastolic diameter (LVEDD) insignificantly more decreased in control group versus curcumin group (LVEF: 4.13 ± 2.50- vs 3.36 ± 1.08-, p-value: 0.223; LVESD: 0.27 ± 0.06-vs 0.120.45 ±, p-value:0.110; LVEDD: -0.44 ± 0.33 vs 0.070.33 ±, p-value:0.269). Furthermore, symptomatic cardiomyopathy and ejection fraction ratio less than 53% were not observed. The LVEF reduction >15% was observed was also high in the control group, (p-value = 0.020).ConclusionThis study shows the possible effect of nanocurcumin capsules to reduce the cardiotoxicity of anthracycline chemotherapy medications.

366. Strain surveillance during chemotherapy to improve cardiovascular outcomes: the SUCCOUR-MRI trial.

作者: Thomas H Marwick.;Elizabeth Dewar.;Mark Nolan.;Mitra Shirazi.;Peter Dias.;Leah Wright.;Ben Fitzgerald.;Leighton Kearney.;Piyush Srivastava.;John Atherton.;Kazuaki Negishi.;Aaron L Sverdlov.;Sudhir Wahi.;James Otton.;Joseph Selvanayagam.;Liza Thomas.;Paaladinesh Thavendiranathan.
来源: Eur Heart J. 2024年45卷41期4414-4424页
The detection of cancer therapy-related cardiac dysfunction (CTRCD) by reduction of left ventricular ejection fraction (LVEF) during chemotherapy usually triggers the initiation of cardioprotective therapy. This study addressed whether the same approach should be applied to patients with worsening of global longitudinal strain (GLS) without attaining thresholds of LVEF.

367. The combined effect of physical exercise, pranayama, and diet on fatigue in adult cancer patients undergoing chemotherapy: a randomized controlled trial.

作者: Suchitra Ajay Mehta.;Anjali Mangesh Joshi.;Minori Ramteke.;Poonam Tandiya.
来源: Support Care Cancer. 2024年32卷9期618页
Cancer patients undergoing chemotherapy continue to experience significant fatigue, which affects their quality of life. The present study aims to evaluate the combined effect of comprehensive physical exercise, pranayama (regulated breathing practices of yoga), and dietary support intervention on fatigue in cancer patients undergoing chemotherapy.

368. Impact of Prior Chemotherapy on Response to Second-line Pembrolizumab in Urothelial Cancer: Exploratory Analysis of the Phase 3 KEYNOTE-045 Trial.

作者: Ronald de Wit.;David J Vaughn.;Yves Fradet.;Lawrence Fong.;Miguel A Climent.;Andrea Necchi.;Daniel P Petrylak.;Winald R Gerritsen.;Howard Gurney.;David I Quinn.;Stéphane Culine.;Cora N Sternberg.;Dean F Bajorin.;Toni K Choueiri.;Jin Xu.;Kentaro Imai.;Blanca Homet Moreno.;Joaquim Bellmunt.;Jae-Lyun Lee.
来源: Eur Urol. 2025年88卷5期462-471页
Until recently, the standard first-line treatment for advanced urothelial carcinoma (UC) was platinum-based combination chemotherapy followed by avelumab maintenance therapy for patients without progressive disease (PD). For patients with advanced UC who experience PD or recurrence, standard-of-care treatment is pembrolizumab monotherapy based on the phase 3 KEYNOTE-045 study. This post hoc analysis of the KEYNOTE-045 study evaluated the efficacy of pembrolizumab compared with chemotherapy by the best response to prior platinum-based chemotherapy.

369. Belzutifan versus Everolimus for Advanced Renal-Cell Carcinoma.

作者: Toni K Choueiri.;Thomas Powles.;Katriina Peltola.;Guillermo de Velasco.;Mauricio Burotto.;Cristina Suarez.;Pooja Ghatalia.;Roberto Iacovelli.;Elaine T Lam.;Elena Verzoni.;Mahmut Gümüş.;Walter M Stadler.;Christian Kollmannsberger.;Bohuslav Melichar.;Balaji Venugopal.;Marine Gross-Goupil.;Alexandr Poprach.;Maria De Santis.;Fabio A Schutz.;Se Hoon Park.;Dmitry A Nosov.;Camillo Porta.;Jae Lyun Lee.;Xavier Garcia-Del-Muro.;Elisa Biscaldi.;Ray Manneh Kopp.;Mototsugu Oya.;Li He.;Aobo Wang.;Rodolfo F Perini.;Donna Vickery.;Laurence Albiges.;Brian Rini.; .
来源: N Engl J Med. 2024年391卷8期710-721页
Belzutifan, a hypoxia-inducible factor 2α inhibitor, showed clinical activity in clear-cell renal-cell carcinoma in early-phase studies.

370. Oral Cannabis Extract for Secondary Prevention of Chemotherapy-Induced Nausea and Vomiting: Final Results of a Randomized, Placebo-Controlled, Phase II/III Trial.

作者: Peter Grimison.;Antony Mersiades.;Adrienne Kirby.;Annette Tognela.;Ian Olver.;Rachael L Morton.;Paul Haber.;Anna Walsh.;Yvonne Lee.;Ehtesham Abdi.;Stephen Della-Fiorentina.;Morteza Aghmesheh.;Peter Fox.;Karen Briscoe.;Jasotha Sanmugarajah.;Gavin Marx.;Ganessan Kichenadasse.;Helen Wheeler.;Matthew Chan.;Jenny Shannon.;Craig Gedye.;Stephen Begbie.;R John Simes.;Martin R Stockler.
来源: J Clin Oncol. 2024年42卷34期4040-4050页
The aim of this randomized, placebo-controlled, two-stage, phase II/III trial was to determine the efficacy of an oral cannabis extract in adults with refractory nausea and/or vomiting during moderately or highly emetogenic, intravenous chemotherapy despite guideline-consistent antiemetic prophylaxis. Here, we report results of the prespecified combined analysis including the initial phase II and subsequent phase III components.

371. Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): long-term, health-related quality-of-life results from a double-blind, randomised, controlled, phase 3 trial.

作者: Emanuel Bührer.;Michal Kicinski.;Mario Mandala.;Madeline Pe.;Georgina V Long.;Victoria Atkinson.;Christian U Blank.;Andrew Haydon.;Stéphane Dalle.;Adnan Khattak.;Matteo S Carlino.;Andrey Meshcheryakov.;Shahneen Sandhu.;Susana Puig.;Dirk Schadendorf.;Rahima Jamal.;Piotr Rutkowski.;Alfonsus J M van den Eertwegh.;Corneel Coens.;Dmitri Grebennik.;Clemens Krepler.;Caroline Robert.;Alexander M M Eggermont.
来源: Lancet Oncol. 2024年25卷9期1202-1212页
In the European Organisation for Research and Treatment of Cancer (EORTC) 1325-MG/KEYNOTE-054 study, adjuvant pembrolizumab improved recurrence-free survival and distant-metastasis-free survival in patients with resected stage III melanoma. Earlier results showed no effect of pembrolizumab on health-related quality of life (HRQOL). Little is known about HRQOL after completion of treatment with pembrolizumab, an important research area concerning patients who are likely to become long-term survivors. This study reports long-term HRQOL results.

372. Pain and Health-related Quality of Life with Biweekly Versus Triweekly Cabazitaxel Schedule in Older Men with Metastatic Castration-resistant Prostate Cancer in the Multicenter, Randomized CABASTY Trial.

作者: Stephane Oudard.;Yohann Tran.;Carole Helissey.;Charles Vauchier.;Raffaele Ratta.;Mostefa Bennamoun.;Eric Voog.;Ali Hasbini.;Antoine Thiery-Vuillemin.;Kais Aldabbagh.;Carolina Saldana.;Emmanuel Sevin.;Eric Amela.;Gunhild Von Amsberg.;Nadine Houede.;Dominique Besson.;Susan Feyerabend.;Martin Boegemann.;David Pfister.;Martin Schostak.;Olivier Huillard.;Frederic Di Fiore.;Amandine Quivy.;Dewi Vernerey.;Antoine Falcoz.;Karima Youcef-Ali.;Salma Kotti.;Eve M Lepicard.;Philippe Barthelemy.
来源: Eur Urol Oncol. 2025年8卷1期126-134页
The CABASTY study showed that more frequent administration of a lower dose of cabazitaxel (CBZ) reduced toxicity in older men with metastatic castration-resistant prostate cancer (mCRPC), without compromising efficacy. Here, we investigated the impact of a biweekly CBZ schedule on patient-reported pain and health-related quality of life (HRQoL).

373. Clinical effect analysis of different regimens of capecitabine in the treatment of patients with advanced colon cancer.

作者: Feng Ju.;Kaixia Chen.;Dengyang Yin.
来源: J Chemother. 2025年37卷5期426-435页
To assess the efficacy and safety of capecitabine in treating advanced colon cancer. Patients with advanced colon cancer were randomized into three groups: control group (n = 50, daily dose 2,500 mg/m2), the medium-dose group (n = 50, daily dose 2,000 mg/m2), and the low-dose group (n = 50, daily dose 1,500 mg/m2) capecitabine for 4 cycles(12 weeks). Afterwards, the response rate, quality of life, and adverse reactions of the three groups were collected for comparison. Efficacy rates were 50%, 70%, and 72%, respectively, with the low-dose group showing the highest efficacy (χ2 = 6.424, p = 0.040); Quality of life comparison results indicated significant differences in physical function (F = 98.528, p < 0.001), role function (F = 123.418, p < 0.001), social function(F = 89.539, p < 0.001), emotional function (6 F = 77.295, p < 0.001), cognitive function (F = 83.529, p < 0.001), and overall quality of life (F = 99.528, p < 0.001) among the three groups, and the three groups returned consistent scores, with the low-dose group scoring highest. Incidence rates were 86.00%, 46.00%, 34.00%, with the control group having the highest rate (χ2 = 16.505, p < 0.001). Capecitabine at a dosage of 1,500 mg/m2 demonstrated a good therapeutic effect and improved the quality of life in patients with advanced colon cancer, with a lower incidence of adverse reactions. A prolonged treatment cycle with reduced dosage is suggested to further improve treatment outcomes and patient prognosis. Trial registration The study was registered on clicaltrials.gov 'NCT06246461' on 30/01/2024.

374. Discontinuation versus continuation of imatinib in patients with advanced gastrointestinal stromal tumours (BFR14): exploratory long-term follow-up of an open-label, multicentre, randomised, phase 3 trial.

作者: Jean-Yves Blay.;Quentin Devin.;Florence Duffaud.;Maud Toulmonde.;Nelly Firmin.;Olivier Collard.;Emmanuelle Bompas.;Benjamin Verret.;Isabelle Ray-Coquard.;Sebastien Salas.;Clemence Henon.;Charles Honoré.;Mehdi Brahmi.;Armelle Dufresne.;Marc Pracht.;Alice Hervieu.;Nicolas Penel.;Francois Bertucci.;Maria Rios.;Esma Saada-Bouzid.;Pauline Soibinet.;David Perol.;Sylvie Chabaud.;Antoine Italiano.;Axel Le Cesne.
来源: Lancet Oncol. 2024年25卷9期1163-1175页
The long-term impact of tyrosine kinase inhibitor (TKI) discontinuation on resistance and survival in patients with advanced gastrointestinal stromal tumours (GIST) is unclear. We report the exploratory long-term outcomes of patients with advanced GIST stopping imatinib in the BFR14 trial.

375. Trastuzumab deruxtecan in patients with HER2-positive advanced colorectal cancer (DESTINY-CRC02): primary results from a multicentre, randomised, phase 2 trial.

作者: Kanwal Raghav.;Salvatore Siena.;Atsuo Takashima.;Takeshi Kato.;Marc Van den Eynde.;Filippo Pietrantonio.;Yoshito Komatsu.;Hisato Kawakami.;Marc Peeters.;Thierry Andre.;Sara Lonardi.;Kensei Yamaguchi.;Jeanne Tie.;Cristina Gravalos Castro.;Hung-Chih Hsu.;John H Strickler.;Tae-You Kim.;Yongjun Cha.;Daniel Barrios.;Qi Yan.;Takahiro Kamio.;Kojiro Kobayashi.;Aislyn Boran.;Makito Koga.;John D Allard.;Takayuki Yoshino.
来源: Lancet Oncol. 2024年25卷9期1147-1162页
Trastuzumab deruxtecan has shown encouraging activity in patients with treatment-refractory HER2-positive, RAS wild-type and BRAF wild-type metastatic colorectal cancer. Dose optimisation and further antitumour assessments in patients with RAS mutations and those with previous anti-HER2 therapy are warranted. We aimed to evaluate two doses of trastuzumab deruxtecan (5·4 mg/kg and 6·4 mg/kg) to establish the recommended dose in patients with pretreated HER2-positive, RAS wild-type or mutant metastatic colorectal cancer.

376. Abiraterone, Olaparib, or Abiraterone + Olaparib in First-Line Metastatic Castration-Resistant Prostate Cancer with DNA Repair Defects (BRCAAway).

作者: Maha Hussain.;Masha Kocherginsky.;Neeraj Agarwal.;Nabil Adra.;Jingsong Zhang.;Channing J Paller.;Joel Picus.;Zachery R Reichert.;Russell Z Szmulewitz.;Scott T Tagawa.;Timothy M Kuzel.;Latifa A Bazzi.;Stephanie Daignault-Newton.;Young E Whang.;Robert Dreicer.;Ryan D Stephenson.;Matthew B Rettig.;Daniel Shevrin.;Travis Gerke.;Arul M Chinnaiyan.;Emmanuel S Antonarakis.
来源: Clin Cancer Res. 2024年30卷19期4318-4328页
Deleterious germline/somatic homologous recombination repair mutations (HRRm) are present in ∼25% of patients with metastatic castration-resistant prostate cancer (mCRPC). Preclinically, poly(ADP-ribose) polymerase (PARP) inhibition demonstrated synergism with androgen receptor pathway (ARP)-targeted therapy. This trial evaluated the efficacy of ARP inhibitor versus PARP inhibitor versus their combination as first-line therapy in patients with mCRPC with HRRms.

377. Evaluation of oral silymarin formulation efficacy in prevention of doxorubicin induced hepatotoxicity in patients with non-metastatic breast cancer.

作者: Ashkan Fatemi Shandiz.;Gholamreza Karimi.;Mahdiyeh Dayyani.;Sare Hosseini.;Sepideh Elyasi.
来源: J Oncol Pharm Pract. 2025年31卷6期965-976页
IntroductionChemotherapy-induced hepatotoxicity is a common complication in breast cancer patients, especially with doxorubicin-containing regimens. Liver enzyme abnormality is reported in 34.8% of patients undergoing AC-T regimen and fatty liver is reported in 30% to 50% of cases. Antioxidant and anti-inflammatory properties of silymarin, a polyphenolic flavonoid extract derived from Silybum marianum, may be useful in preventing chemotherapy-induced hepatotoxicity. This study evaluated the effect of oral silymarin for preventing doxorubicin induced hepatotoxicity in non-metastatic breast cancer patients.MethodsIn this triple-blind, placebo-controlled clinical trial, 50 patients with non-metastatic breast cancer were assigned to receive either 140 mg silymarin tablets or the placebo three times daily for 63 days and were evaluated for liver function test before the study and at the end of each chemotherapy cycle (every 3 weeks) for 4 cycles. In addition, an ultrasonography assessment was performed upon entry and the end of the study.ResultsBased on ultrasonography, the fatty liver grade was significantly higher in the placebo group at the end of the study. Moreover, the serum levels of aspartate aminotransferase (p = 0.015) and alkaline phosphatase (p = 0.004) at 6-week intervals, and the serum level of alkaline phosphatase (p = 0.002) at 9-week intervals were significantly lower in the silymarin group.ConclusionOral formulation of silymarin 420 mg/day for 63 days significantly prevented hepatotoxicity caused by doxorubicin in patients with non-metastatic breast cancer mostly based on liver ultrasonography but not laboratory parameters. Further investigations are suggested on different doses, durations and formulations of silymarin, particularly nano-formulations for increasing its oral bioavailability.

378. Olanzapine as Antiemetic Prophylaxis in Moderately Emetogenic Chemotherapy: A Phase 3 Randomized Clinical Trial.

作者: Vikas Ostwal.;Anant Ramaswamy.;Sarika Mandavkar.;Prabhat Bhargava.;Deepali Naughane.;Sharon Flavia Sunn.;Sujay Srinivas.;Akhil Kapoor.;Bal Krishna Mishra.;Anuj Gupta.;Bipinesh Sansar.;Vikash Pal.;Aparajita Pandey.;Avinash Bonda.;Indraja Siripurapu.;Vamshi Krishna Muddu.;Sadhana Kannan.;Deepali Chaugule.;Rajshree Patil.;Manali Parulekar.;Aditya Dhanawat.;Mehek Trikha.;Jaya Ghosh.;Vanita Noronha.;Nandini Menon.;Vijay Patil.;Kumar Prabhash.;Ian Olver.
来源: JAMA Netw Open. 2024年7卷8期e2426076页
The role of olanzapine has not been adequately evaluated in moderately emetogenic chemotherapy (MEC) regimens with or without neurokinin-1 receptor antagonists.

379. Outcomes With Postrecurrence Systemic Therapy Following Adjuvant Checkpoint Inhibitor Treatment for Resected Melanoma in CheckMate 238.

作者: Jeffrey Weber.;Michele Del Vecchio.;Mario Mandalá.;Helen Gogas.;Ana M Arance.;Stephane Dalle.;C Lance Cowey.;Michael Schenker.;Jean-Jacques Grob.;Vanna Chiarion-Sileni.;Iván Márquez-Rodas.;Marcus O Butler.;Anna Maria Di Giacomo.;Luis de la Cruz-Merino.;Petr Arenberger.;Victoria Atkinson.;Andrew Hill.;Leslie A Fecher.;Michael Millward.;Nikhil I Khushalani.;Paola Queirolo.;Georgina V Long.;Maurice Lobo.;Margarita Askelson.;Paolo A Ascierto.;James Larkin.
来源: J Clin Oncol. 2024年42卷31期3702-3712页
In phase III CheckMate 238, adjuvant nivolumab significantly improved recurrence-free survival compared with ipilimumab in patients with resected stage IIIB-C/IV melanoma without a significant difference in overall survival (OS). Here, we investigate progression-free survival (PFS) and OS after postrecurrence systemic therapy.

380. The relationship of mental health symptoms to chemotherapy toxicity risk in older adults with cancer: Results from the geriatric assessment-driven intervention study.

作者: Reena V Jayani.;Anahid Hamparsumian.;Canlan Sun.;Daneng Li.;Leana Cabrera Chien.;Jeanine Moreno.;Vani Katheria.;Simone Fernandes Dos Santos Hughes.;Warren D Taylor.;William Dale.
来源: Cancer. 2024年130卷22期3894-3901页
Depression and anxiety are prevalent in older adults with cancer but are often undertreated. Older adults are also at increased risk of chemotherapy toxicity (CT). This study evaluated the impact of depression and anxiety symptoms on severe CT risk in older adults with cancer.
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