Accès ouvert déclaré
2025
article
Tumor Treating Fields With Gemcitabine and Nab-Paclitaxel for Locally Advanced Pancreatic Adenocarcinoma: Randomized, Open-Label, Pivotal Phase III PANOVA-3 Study
Hani M. Babiker, Vincent J. Picozzi, Sreenivasa R Chandana, Hao Chunyi, Lucjan Wyrwicz, Christelle de la Fouchardière, Inmaculada Alés, Woo Jin Lee, Kynan Feeney, Philip A. Philip, Makoto Ueno, Thomas Seufferlein, Teresa Macarulla, David R. Spigel, Marc Matrana, Nicholas Blondin, Emil Lou, Rachna T. Shroff, Douglas Orr, Michael J. Anderson, Anthony F. Shields, John Hamm, Sumana Nagireddy, Joanna Kolodney, Andrew L. Coveler, Ajit Maniam, Judith D. Sears, Joseph Stilwill, Francis P. Arena, Mike Cusnir, Anna Niewiaroska, William Small, Jason Tache, Sharona Ross, Samer Shihabi, Sunil Gandhi, J. N. Reeves, Garrett Green, Trevor Feinstein, Timothy K. Huyck, Nadia Ramdin, Robert Marsh, Yixing Jiang, Hassan Hatoum, Sudhir Manda, Mark D. Kochenderfer, Henrik Illum, Donald Richards, P. Valilis, Lucas Wong, Herbert B. Newton, Maen Abdelrahim, David Einspahr, Richard Siegel, Scott McKenney, Mohit Narang, Marc Uemura, Higinia R. Cárdenes, Kannan Thanikachalam, Joshua P. Raff, Joseph Ye, Deepti Behl, Audrey E. Kam, Paul DeRose, A. Tasneem, Warren Brenner, Jennifer De Los Santos, James Z. Wang, D C Rausch, Gaurav Trikha, Jae‐Hyun Park, Nashat Gabrail, Rex B. Mowat, Khawaja Jahangir, Robert P. Schumaker, Edward Soffen, Eric Bravin, Mukul Kumar Gupta, Ivan Dario Bedoya-Apraez, Tyler Y. Kang, Frédéric Lemay, Mark Vincent, Richard Létourneau, Martin Fuchs, Christine Doehring, Mike Haberkorn, Arndt Vogel, Karen Rußwurm, Marc Küng, Maria Passhak, Ravit Geva, Ayala Hubert, Salomon M. Stemmer, Talia Golan, Hélène Senellart, Isabelle Trouilloud, Jean-Frederic Blan, Florence Le Roy, J. Martin-Babau, Méher Ben Abdelghani, Richard Greil, Georg Schreil, Armin Gerger, Wolfgang Eisterer, T. Macarulla Mercadé, Antonio Cubillo, Carmen Guillén‐Ponce, Inmaculada Alés Díaz, Fernando Rivera, Javier Gállego, Ricardo Yayá, Mariano Ponz Sarvise, Bruno Vincenzi, Mario Airoldi, Giovanna Bellotti, Domenico Corsi, Lorenzo Antonuzzo, Petra Holečková, Luboš Petruželka, Rostislav Kotasek, Radim Němeček, Jean‐Luc Van Laethem, Ivan Borbath, Jun‐Eul Hwang, Sung Yong Oh, Sun Jin Sym, Moon Hee Lee, Jin Young Kim, Sang Cheul Oh, Joon Oh Park, Jin Won Kim, Myung Ah Lee, Hye Jin Choi, Seok Yun Kang, Hong Jae Chon, Rodryg Ramlau, Andrzej Mruk, Beata Freier, Ewa Anna Kosakowska, Judit Kocsis, Tibor Csőszi, Yousuf Al-Farhat, A. Bassam, Chunyi Hao, Bo Liang, Shundong Cang, Gang Jin, Changzeng Zuo, Lijie Song, Zheng Wu, Jie Gao, Tao� Zhang, Yusheng Wang, Xin Yuan, Zhi-Hua Li, Rufu Chen, Wei Li, Xiujun Cai, Zhizhen Zhu, Yuxian Bai, Chunmei Bai, Thomas Yau, Warren Joubert, Ka Yeung Mark Wong, Gavin Marx, Marion Harris, Ana Mišir, Adilson Faccio, Felipe Melo Cruz, Ana Paula Victorino, Tadeu Ferreira Paiva, Fábio Franke, Katsuki Arima Tiscoski, Gabriel Parolla, Flora Lilno, Mariana Bruno Siqueira, Marcos Lyra, Paulo M. Hoff, Jose Luis Martinez Lira, Dolores Mendoza Oliva, Jesus Elvis Cabrera Luviano, Erika Castillo Gutiérrez, Vanessa Rosas Camargo, Osvaldo Hernandez Flores, David Cortez, Saúl Campos-Gómez, Iván Romarico González Espinoza, Jessica Reyes Contreras, Ángel Gómez Villanueva, Omar Zayas Villanueva
46Citations signalées, ce qui n’est pas une note de qualité
31Institutions déclarées
12Pays d’affiliation déclarés
Rattachement africain : cn, us, es, cz, kr, jp, de, pl, hu, fr, au, be.
Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
PURPOSE Tumor treating fields (TTFields) use alternating electric fields to disrupt cancer cell proliferation. Feasibility of TTFields therapy with gemcitabine/nab-paclitaxel was previously demonstrated in patients with advanced pancreatic adenocarcinoma. PANOVA-3 was designed to confirm safety and efficacy of TTFields in patients with unresectable locally advanced pancreatic adenocarcinoma (LA-PAC). METHODS In this global phase III trial, 571 patients with newly diagnosed LA-PAC were randomly assigned to receive gemcitabine 1,000 mg/m 2 and nab-paclitaxel 125 mg/m 2 by intravenous infusion once a day on days 1, 8, and 15 of a 28-day cycle with or without TTFields. The primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), local PFS, pain-free survival, and overall response rate (ORR). Distant PFS was analyzed post hoc. RESULTS OS was significantly prolonged using TTFields with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel (median, 16.2 months [95% CI, 15.0 to 18.0] v 14.2 months [95% CI, 12.8 to 15.4]; hazard ratio [HR], 0.82 [95% CI, 0.68 to 0.99]; P = .039). PFS, local PFS, and ORR were not improved. Pain-free survival was significantly prolonged with TTFields with gemcitabine/nab-paclitaxel (median, 15.2 months [95% CI, 10.3 to 22.8] v 9.1 months [95% CI, 7.4 to 12.7]; HR, 0.74 [95% CI, 0.56 to 0.97]; P = .027), as was distant PFS (median, 13.9 months [95% CI, 12.2 to 16.8] v 11.5 months [95% CI, 10.4 to 12.9]; HR, 0.74 [95% CI, 0.57 to 0.96]; P = .022). Device-related skin adverse events (AEs) were experienced by 76.3% of patients. Most device-related skin AEs were mild to moderate, with 7.7% of patients reporting a grade 3 AE. CONCLUSION This study demonstrated significant OS, pain-free survival, and distant PFS benefits for TTFields with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in patients with unresectable LA-PAC, with no additive systemic toxicity.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Tumor Treating Fields With Gemcitabine and Nab-Paclitaxel for Locally Advanced Pancreatic Adenocarcinoma: Randomized, Open-Label, Pivotal Phase III PANOVA-3 Study
- Date Crossref
- 20/07/2025
- Éditeur
- American Society of Clinical Oncology (ASCO)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Les institutions déclarées
Une affiliation ne permet pas de déduire la nationalité d’un auteur.
Les sujets associés
Microbial Inactivation MethodsPancreatic and Hepatic Oncology ResearchCancer Research and Treatments