601. Neoadjuvant-Adjuvant or Adjuvant-Only Pembrolizumab in Advanced Melanoma.
作者: Sapna P Patel.;Megan Othus.;Yuanbin Chen.;G Paul Wright.;Kathleen J Yost.;John R Hyngstrom.;Siwen Hu-Lieskovan.;Christopher D Lao.;Leslie A Fecher.;Thach-Giao Truong.;Jennifer L Eisenstein.;Sunandana Chandra.;Jeffrey A Sosman.;Kari L Kendra.;Richard C Wu.;Craig E Devoe.;Gary B Deutsch.;Aparna Hegde.;Maya Khalil.;Ankit Mangla.;Amy M Reese.;Merrick I Ross.;Andrew S Poklepovic.;Giao Q Phan.;Adedayo A Onitilo.;Demet G Yasar.;Benjamin C Powers.;Gary C Doolittle.;Gino K In.;Niels Kokot.;Geoffrey T Gibney.;Michael B Atkins.;Montaser Shaheen.;James A Warneke.;Alexandra Ikeguchi.;Jose E Najera.;Bartosz Chmielowski.;Joseph G Crompton.;Justin D Floyd.;Eddy Hsueh.;Kim A Margolin.;Warren A Chow.;Kenneth F Grossmann.;Eliana Dietrich.;Victor G Prieto.;Michael C Lowe.;Elizabeth I Buchbinder.;John M Kirkwood.;Larissa Korde.;James Moon.;Elad Sharon.;Vernon K Sondak.;Antoni Ribas.
来源: N Engl J Med. 2023年388卷9期813-823页
Whether pembrolizumab given both before surgery (neoadjuvant therapy) and after surgery (adjuvant therapy), as compared with pembrolizumab given as adjuvant therapy alone, would increase event-free survival among patients with resectable stage III or IV melanoma is unknown.
602. Ide-cel or Standard Regimens in Relapsed and Refractory Multiple Myeloma.
作者: Paula Rodriguez-Otero.;Sikander Ailawadhi.;Bertrand Arnulf.;Krina Patel.;Michele Cavo.;Ajay K Nooka.;Salomon Manier.;Natalie Callander.;Luciano J Costa.;Ravi Vij.;Nizar J Bahlis.;Philippe Moreau.;Scott R Solomon.;Michel Delforge.;Jesus Berdeja.;Anna Truppel-Hartmann.;Zhihong Yang.;Linda Favre-Kontula.;Fan Wu.;Julia Piasecki.;Mark Cook.;Sergio Giralt.
来源: N Engl J Med. 2023年388卷11期1002-1014页
Survival is poor among patients with triple-class-exposed relapsed and refractory multiple myeloma. Idecabtagene vicleucel (ide-cel), a B-cell maturation antigen-directed chimeric antigen receptor (CAR) T-cell therapy, previously led to deep, durable responses in patients with heavily pretreated relapsed and refractory multiple myeloma.
603. Randomized double-blind, placebo-controlled study of oral gabapentin for prevention of neuropathy in patients receiving paclitaxel.
作者: Praful Pandey.;Akash Kumar.;Deepam Pushpam.;Sachin Khurana.;Prabhat Singh Malik.;Ajay Gogia.;Elavarasi Arunmozhimaran.;Mamta Bhushan Singh.;Dinu Santha Chandran.;Atul Batra.
来源: Trials. 2023年24卷1期79页
Peripheral neuropathy is a common dose-limiting side effect of paclitaxel. To date, there is no effective strategy to prevent paclitaxel-induced peripheral neuropathy. A recent small phase II study demonstrated the potential role of oral gabapentin in this setting. This phase III study is aimed to assess the efficacy of oral gabapentin in preventing paclitaxel-induced neuropathy.
604. Vestibulotoxicity in Patients Undergoing Cisplatin-Based Cancer Treatment: A Phase IIIB Randomized Controlled Clinical Trial.
This study aimed to evaluate the incidence of balance disorders and the efficacy of dexamethasone in protecting patients undergoing cisplatin-based cancer treatment against vestibulototoxicity.
605. Adjuvant Osimertinib for Resected EGFR-Mutated Stage IB-IIIA Non-Small-Cell Lung Cancer: Updated Results From the Phase III Randomized ADAURA Trial.
作者: Roy S Herbst.;Yi-Long Wu.;Thomas John.;Christian Grohe.;Margarita Majem.;Jie Wang.;Terufumi Kato.;Jonathan W Goldman.;Konstantin Laktionov.;Sang-We Kim.;Chong-Jen Yu.;Huu Vinh Vu.;Shun Lu.;Kye Young Lee.;Guzel Mukhametshina.;Charuwan Akewanlop.;Filippo de Marinis.;Laura Bonanno.;Manuel Domine.;Frances A Shepherd.;Damien Urban.;Xiangning Huang.;Ana Bolanos.;Marta Stachowiak.;Masahiro Tsuboi.
来源: J Clin Oncol. 2023年41卷10期1830-1840页
The phase III ADAURA (ClinicalTrials.gov identifier: NCT02511106) primary analysis demonstrated a clinically significant disease-free survival (DFS) benefit with adjuvant osimertinib versus placebo in EGFR-mutated stage IB-IIIA non-small-cell lung cancer (NSCLC) after complete tumor resection (DFS hazard ratio [HR], 0.20 [99.12% CI, 0.14 to 0.30]; P < .001). We report an updated exploratory analysis of final DFS data.
606. Adjuvant Temozolomide Chemotherapy With or Without Interferon Alfa Among Patients With Newly Diagnosed High-grade Gliomas: A Randomized Clinical Trial.
作者: Chengcheng Guo.;Qunying Yang.;Pengfei Xu.;Meiling Deng.;Taipeng Jiang.;Linbo Cai.;Jibin Li.;Ke Sai.;Shaoyan Xi.;Hui Ouyang.;Mingfa Liu.;Xianming Li.;Zihuang Li.;Xiangrong Ni.;Xi Cao.;Cong Li.;Shaoxiong Wu.;Xiaojing Du.;Jun Su.;Xiaoying Xue.;Yiming Wang.;Gang Li.;Zhiyong Qin.;Hui Yang.;Tao Zhou.;Jinquan Liu.;Xuefeng Hu.;Jian Wang.;Xiaobing Jiang.;Fuhua Lin.;Xiangheng Zhang.;Chao Ke.;Xiaofei Lv.;Yanchun Lv.;Wanming Hu.;Jing Zeng.;Zhenghe Chen.;Sheng Zhong.;Hairong Wang.;Yinsheng Chen.;Ji Zhang.;Depei Li.;Yonggao Mou.;Zhongping Chen.
来源: JAMA Netw Open. 2023年6卷1期e2253285页
High-grade gliomas (HGGs) constitute the most common and aggressive primary brain tumor, with 5-year survival rates of 30.9% for grade 3 gliomas and 6.6% for grade 4 gliomas. The add-on efficacy of interferon alfa is unclear for the treatment of HGG.
607. Eflapegrastim versus Pegfilgrastim for Chemotherapy-Induced Neutropenia in Korean and Asian Patients with Early Breast Cancer: Results from the Two Phase III ADVANCE and RECOVER Studies.
作者: Yong Wha Moon.;Seung Ki Kim.;Keun Seok Lee.;Moon Hee Lee.;Yeon Hee Park.;Kyong Hwa Park.;Gun Min Kim.;Seungtaek Lim.;Seung Ah Lee.;Jae Duk Choi.;Eunhye Baek.;Hyesun Han.;Seungjae Baek.;Seock-Ah Im.
来源: Cancer Res Treat. 2023年55卷3期766-777页
We investigated the consistent efficacy and safety of eflapegrastim, a novel long-acting granulocyte-colony stimulating factor (G-CSF), in Koreans and Asians compared with the pooled population of two global phase 3 trials.
608. A Pilot Randomized Controlled Trial Evaluating Essential Oils for Chemotherapy-Induced Peripheral Neuropathy.
作者: Dawn L Langley-Brady.;Richard T Campbell.;Nita J Maihle.;Vernon A Barnes.;Angela R Bratton.;Julie K Zadinsky.
来源: Pain Manag Nurs. 2023年24卷3期289-298页
Chemotherapy-induced peripheral neuropathy (CIPN) is a painful, debilitating consequence of cancer treatment affecting up to 60% of patients. Pharmacological approaches to CIPN are often ineffective and cause adverse effects. Essential oils are an underutilized non-pharmacological approach to pain reduction.
609. Impact of Baseline Expectancy on Outcome Prediction of Real and Sham Acupuncture for Persistent Chemotherapy-Induced Peripheral Neuropathy Pain in Solid Tumor Survivors: A Secondary Analysis of a Randomized Clinical Trial.
作者: Xiaotong Li.;Lilly Zhi.;Katherine Y Han.;Susan Q Li.;Khalada Ahmad.;Christina Seluzicki.;Rui Wang.;Ting Bao.
来源: Integr Cancer Ther. 2023年22卷15347354221149992页
Chemotherapy-induced peripheral neuropathy (CIPN) pain significantly worsens cancer survivors' quality of life. Expectancy may play an important role in acupuncture response. We sought to explore whether expectancy predicts pain outcome in real acupuncture (RA) and sham acupuncture (SA) in cancer survivors.
610. A First-in-Human Phase I Study of Milademetan, an MDM2 Inhibitor, in Patients With Advanced Liposarcoma, Solid Tumors, or Lymphomas.
作者: Mrinal M Gounder.;Todd M Bauer.;Gary K Schwartz.;Amy M Weise.;Patricia LoRusso.;Prasanna Kumar.;Ben Tao.;Ying Hong.;Parul Patel.;Yasong Lu.;Arnaud Lesegretain.;Vijaya G Tirunagaru.;Feng Xu.;Robert C Doebele.;David S Hong.
来源: J Clin Oncol. 2023年41卷9期1714-1724页
This study evaluated the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of milademetan, a small-molecule murine double minute-2 (MDM2) inhibitor, in patients with advanced cancers.
611. Circulating galectin-1 delineates response to bevacizumab in melanoma patients and reprograms endothelial cell biology.
作者: Nadia Bannoud.;Juan C Stupirski.;Alejandro J Cagnoni.;Pablo F Hockl.;Juan M Pérez Sáez.;P Alfredo García.;Yamil D Mahmoud.;Julián Gambarte Tudela.;Marco A Scheidegger.;Andrea Marshall.;Pippa G Corrie.;Mark R Middleton.;Karina V Mariño.;M Romina Girotti.;Diego O Croci.;Gabriel A Rabinovich.
来源: Proc Natl Acad Sci U S A. 2023年120卷3期e2214350120页
Blockade of vascular endothelial growth factor (VEGF) signaling with bevacizumab, a humanized anti-VEGF monoclonal antibody (mAb), or with receptor tyrosine kinase inhibitors, has improved progression-free survival and, in some indications, overall survival across several types of cancers by interrupting tumor angiogenesis. However, the clinical benefit conferred by these therapies is variable, and tumors from treated patients eventually reinitiate growth. Previously we demonstrated, in mouse tumor models, that galectin-1 (Gal1), an endogenous glycan-binding protein, preserves angiogenesis in anti-VEGF-resistant tumors by co-opting the VEGF receptor (VEGFR)2 signaling pathway in the absence of VEGF. However, the relevance of these findings in clinical settings is uncertain. Here, we explored, in a cohort of melanoma patients from AVAST-M, a multicenter, open-label, randomized controlled phase 3 trial of adjuvant bevacizumab versus standard surveillance, the role of circulating plasma Gal1 as part of a compensatory mechanism that orchestrates endothelial cell programs in bevacizumab-treated melanoma patients. We found that increasing Gal1 levels over time in patients in the bevacizumab arm, but not in the observation arm, significantly increased their risks of recurrence and death. Remarkably, plasma Gal1 was functionally active as it was able to reprogram endothelial cell biology, promoting migration, tubulogenesis, and VEGFR2 phosphorylation. These effects were prevented by blockade of Gal1 using a newly developed fully human anti-Gal1 neutralizing mAb. Thus, using samples from a large-scale clinical trial from stage II and III melanoma patients, we validated the clinical relevance of Gal1 as a potential mechanism of resistance to bevacizumab treatment.
612. Cisplatin with veliparib or placebo in metastatic triple-negative breast cancer and BRCA mutation-associated breast cancer (S1416): a randomised, double-blind, placebo-controlled, phase 2 trial.
作者: Eve Rodler.;Priyanka Sharma.;William E Barlow.;Julie R Gralow.;Shannon L Puhalla.;Carey K Anders.;Lori Goldstein.;Debu Tripathy.;Ursa A Brown-Glaberman.;Thu-Tam Huynh.;Christopher S Szyarto.;Andrew K Godwin.;Harsh B Pathak.;Elizabeth M Swisher.;Marc R Radke.;Kirsten M Timms.;Danika L Lew.;Jieling Miao.;Lajos Pusztai.;Daniel F Hayes.;Gabriel N Hortobagyi.
来源: Lancet Oncol. 2023年24卷2期162-174页
Poly(ADP-ribose) polymerase (PARP) inhibitors are effective in germline BRCA1 or BRCA2 (BRCA1/2) mutation-associated metastatic breast cancer. However, studies evaluating PARP inhibitors plus platinum-based chemotherapy in germline BRCA1/2-wildtype triple-negative breast cancer are scarce. A large proportion of germline BRCA1/2-wildtype triple-negative breast cancer shows homologous recombination deficiency (HRD), resulting in a BRCA-like phenotype that might render sensitivity to PARP inhibitors. The S1416 trial assessed the efficacy of cisplatin combined with the PARP inhibitor veliparib in three predefined groups of metastatic breast cancer: germline BRCA1/2-mutated, BRCA-like, and non-BRCA-like.
613. Patterns, predictors and prognostic relevance of high-grade hematotoxicity after temozolomide or temozolomide-lomustine in the CeTeG/NOA-09 trial.
作者: J Weller.;N Schäfer.;C Schaub.;T Tzaridis.;T Zeyen.;M Schneider.;A L Potthoff.;F A Giordano.;J P Steinbach.;P S Zeiner.;T Kowalski.;M Sabel.;P Hau.;D Krex.;O Grauer.;R Goldbrunner.;O Schnell.;G Tabatabai.;F Ringel.;F Schmidt-Graf.;S Brehmer.;J C Tonn.;L Bullinger.;P Vajkoczy.;M Glas.;H Vatter.;U Herrlinger.;C Seidel.
来源: J Neurooncol. 2023年161卷1期147-153页
In the randomized phase III trial CeTeG/NOA-09, temozolomide (TMZ)/lomustine (CCNU) combination therapy was superior to TMZ in newly diagnosed MGMT methylated glioblastoma, albeit reporting more frequent hematotoxicity. Here, we analyze high grade hematotoxicity and its prognostic relevance in the trial population.
614. Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology, 2002-2021.
作者: Sundeep Agrawal.;Shaily Arora.;Laleh Amiri-Kordestani.;R Angelo de Claro.;Lola Fashoyin-Aje.;Nicole Gormley.;Tamy Kim.;Steven Lemery.;Gautam U Mehta.;Emma C Scott.;Harpreet Singh.;Shenghui Tang.;Marc R Theoret.;Richard Pazdur.;Paul G Kluetz.;Julia A Beaver.
来源: JAMA Oncol. 2023年9卷2期266-272页
Single-arm trials have allowed for transformative therapies to be made available to patients expeditiously. However, using single-arm trials to support drug approval presents several challenges that must be carefully considered.
615. Validation of different personalized risk models of chemotherapy-induced nausea and vomiting: results of a randomized, double-blind, phase III trial of fosaprepitant for cancer patients treated with high-dose cisplatin.
作者: Yuanyuan Zhao.;Bing Zhao.;Gang Chen.;Yinlan Chen.;Zijun Liao.;Haiming Zhang.;Weineng Feng.;Yinyin Li.;Heng Weng.;Weidong Li.;Yuefen Zhou.;Biyong Ren.;Yanda Lu.;Jianhua Chen.;Zhenteng Liu.;Zhenzhong Su.;Wenliang Wang.;Li Zhang.
来源: Cancer Commun (Lond). 2023年43卷2期246-256页
Highly emetogenic chemotherapy induces emesis in cancer patients without prophylaxis. The purpose of this study was to evaluate the efficacy and safety of a fosaprepitant-based triple antiemetic regimen for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with solid malignant tumors, determine risk factors and externally validate different personalized risk models for CINV.
616. Single and Combined Use of Benson Relaxation Technique and Oxygen Therapy on Chemotherapy-Induced Nausea and Vomiting in Gastric Cancer Patients.
作者: Yaser Moradi.;Hossein Jafarizadeh.;Rahim Asghari.;Omid Mirzamohammadi.;Vahid Alinejad.
来源: Explore (NY). 2023年19卷4期587-593页
Nausea and vomiting are the most common complications of chemotherapy encountered by cancer patients. To alleviate these complications and reduce patients' problems, it is necessary to use complementary methods.
617. Mechanistic and thermal characterization of acupuncture for chemotherapy-induced peripheral neuropathy as measured by quantitative sensory testing.
作者: W Iris Zhi.;Raymond E Baser.;Dristi Talukder.;Ying Zi Mei.;Steven E Harte.;Ting Bao.
来源: Breast Cancer Res Treat. 2023年197卷3期535-545页
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating side effect of chemotherapy. Acupuncture is a promising non-pharmacological intervention for CIPN. However, the physiological effects of acupuncture treatment remain poorly understood. We examined the effects of acupuncture on CIPN using semi-objective quantitative sensory testing (QST).
618. Evaluating laser photobiomodulation for chemotherapy-induced peripheral neuropathy: a randomised phase II trial.
作者: Christina Teng.;Sam Egger.;Prunella L Blinman.;Janette L Vardy.
来源: Support Care Cancer. 2022年31卷1期52页
This study aims to evaluate the efficacy and safety of laser photobiomodulation (PBM) for treatment of established chemotherapy-induced peripheral neuropathy (CIPN) in cancer survivors.
619. Zanubrutinib or Ibrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia.
作者: Jennifer R Brown.;Barbara Eichhorst.;Peter Hillmen.;Wojciech Jurczak.;Maciej Kaźmierczak.;Nicole Lamanna.;Susan M O'Brien.;Constantine S Tam.;Lugui Qiu.;Keshu Zhou.;Martin Simkovic.;Jiri Mayer.;Amanda Gillespie-Twardy.;Alessandra Ferrajoli.;Peter S Ganly.;Robert Weinkove.;Sebastian Grosicki.;Andrzej Mital.;Tadeusz Robak.;Anders Osterborg.;Habte A Yimer.;Tommi Salmi.;Megan-Der-Yu Wang.;Lina Fu.;Jessica Li.;Kenneth Wu.;Aileen Cohen.;Mazyar Shadman.
来源: N Engl J Med. 2023年388卷4期319-332页
In a multinational, phase 3, head-to-head trial, ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, was compared with zanubrutinib, a BTK inhibitor with greater specificity, as treatment for relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In prespecified interim analyses, zanubrutinib was superior to ibrutinib with respect to overall response (the primary end point). Data from the final analysis of progression-free survival are now available.
620. Cardioprotection Using Strain-Guided Management of Potentially Cardiotoxic Cancer Therapy: 3-Year Results of the SUCCOUR Trial.
作者: Tomoko Negishi.;Paaladinesh Thavendiranathan.;Martin Penicka.;Julie Lemieux.;Klaus Murbraech.;Sakiko Miyazaki.;Mitra Shirazi.;Ciro Santoro.;Goo-Yeong Cho.;Bogdan A Popescu.;Wojciech Kosmala.;Ben Costello.;Andre la Gerche.;Phil Mottram.;Liza Thomas.;Stephanie Seldrum.;Krassimira Hristova.;Manish Bansal.;Koji Kurosawa.;Nobuaki Fukuda.;Hirotsugu Yamada.;Masaki Izumo.;Kazuko Tajiri.;Maciej Sinski.;Dragos Vinereanu.;Evgeny Shkolnik.;Jose Banchs.;Shelby Kutty.;Kazuaki Negishi.;Thomas H Marwick.
来源: JACC Cardiovasc Imaging. 2023年16卷3期269-278页
Global longitudinal strain (GLS) can predict cancer therapeutics-related cardiac dysfunction and guide initiation of cardioprotection (CPT).
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