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1. What is the gender representation in authorship in later phase systemic clinical trials in biliary tract cancer (BTC)? - a retrospective review of the published literature.

Author

McNamara, Mairéad, Bridgewater, John, Goyal, Lipika, Jacobs, Timothy, Wagner, Anna, Goldstein, David, Shroff, Rachna, Moehler, Markus, Lowery, Maeve, Bekaii-Saab, Tanios, Kelley, Robin, Furuse, Junji, Rimassa, Lorenza, Morizane, Chigusa, Lamarca, Angela, Hubner, Richard, Knox, Jennifer, and Valle, Juan

Subjects
adult oncology, chemotherapy, hepatobiliary tumours, Humans, Authorship, Biliary Tract Neoplasms, Europe, Physicians, Women, Retrospective Studies, Clinical Trials as Topic, Male, Female
Abstract

OBJECTIVES: Female physicians in medicine are increasing, but disparities in female authorship exist. The aim of this study was to characterise factors associated with female first (FF) and female senior (SF) authorship in later phase systemic oncological clinical trials in biliary tract cancer (BTC) and identify any changes over time. SETTING: Embase/Medline identified trial publications in BTC (2000-2020) were included. χ2 tests and log regression were used (assessed factors associated with FF and SF authorship, including changes over time (STATA V.16)). PRIMARY OUTCOME MEASURE: FF and SF authorship in later phase systemic oncological clinical trials in BTC. SECONDARY OUTCOME MEASURE: Any changes over time? RESULTS: Of 501 publications, 163 met inclusion criteria. The median percentage of female author representation in publications was 25%; there were no female authors in 13% of publications. Geographic location of the home institution of the first and senior authors was Asia (42%/42%), Europe (29%/29%), USA (24%/22%) and other (4%/6%), respectively. Overall, FF and SF author representation was 20% and 10%, respectively. The median position of the first female author was second in all the publication author lists. The phase of trial, journal-impact factor, industry funding or whether the study met its primary endpoint did not impact FF/SF author representation. More SF authors had home institutions in other geographic locations (40% in 10 trials) (p=0.02) versus Asia (6%), Europe (8%) and USA (14%). There were no significant changes in FF/SF representation over time (p=0.61 and p=0.33 respectively). CONCLUSIONS: FF and SF author representation in later phase systemic clinical trial publications in BTC is low and has not changed significantly over time. The underlying reasons for this imbalance need to be better understood and addressed.

Published
2022

3. Thromboxane biosynthesis in cancer patients and its inhibition by aspirin: a sub-study of the Add-Aspirin trial

Author

Joharatnam-Hogan, Nalinie, Hatem, Duaa, Cafferty, Fay H., Petrucci, Giovanna, Cameron, David A., Ring, Alistair, Kynaston, Howard G., Gilbert, Duncan C., Wilson, Richard H., Hubner, Richard A., Swinson, Daniel E. B., Cleary, Siobhan, Robbins, Alex, MacKenzie, Mairead, Scott-Brown, Martin W. G., Sothi, Sharmila, Dawson, Lesley K., Capaldi, Lisa M., Churn, Mark, Cunningham, David, Khoo, Vincent, Armstrong, Anne C., Ainsworth, Nicola L., Horan, Gail, Wheatley, Duncan A., Mullen, Russell, Lofts, Fiona J., Walther, Axel, Herbertson, Rebecca A., Eaton, John D., O’Callaghan, Ann, Eichholz, Andrew, Kagzi, Mohammed M., Patterson, Daniel M., Narahari, Krishna, Bradbury, Jennifer, Stokes, Zuzana, Rizvi, Azhar J., Walker, Georgina A., Kunene, Victoria L., Srihari, Narayanan, Gentry-Maharaj, Aleksandra, Meade, Angela, Patrono, Carlo, Rocca, Bianca, and Langley, Ruth E.

Published
2023
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5. Lenvatinib plus pembrolizumab versus lenvatinib plus placebo for advanced hepatocellular carcinoma (LEAP-002): a randomised, double-blind, phase 3 trial

Author

Strasser, Simone, Thompson, Alexander, Roohullah, Aflah, Sievert, William, Andelkovic, Vladimir, Knox, Jennifer, Davies, Janine, Asselah, Jamil, Brahmania, Mayur, Majeed, Habeeb, Villanueva, Luis, Yanez Weber, Patricio, Garrido, Marcelo, Pizarro, Gonzalo Ignacio, Yanez, Nicolas, Xu, Ruocai, Ou, Shuangyan, Ren, Zhenggang, Pan, Hongming, Meng, Zhiqiang, Gu, Kangsheng, Chen, Xi, Zhang, Tao, Hao, Chunyi, Cao, Peiguo, Guo, Yabing, Qin, Shukui, Xiao, Juxiang, Fang, Weijia, Wang, Xin, Bai, Yuxian, Chen, Xiaoming, Yan, Dong, Zhao, Hong, Ying, Jieer, Bonilla, Carlos, Urrego, Olga, Zambrano, Angela, Lema, Mauricio, Restrepo Gutierrez, Juan Carlos, Cardona, Andres, Franco Millan, Sandra, Oscar, Madiedo, Ramos, Victor, Merle, Philippe, LeSourd, Samuel, Edeline, Julien, Bronowicki, Jean-Pierre, Bourliere, Marc, Cattan, Stephane, Bouattour, Mohamed, Mineur, Laurent, Regnault, Helene, Dauvois, Barbara, Schulze, Kornelius, Folprecht, Gunnar, Geier, Andreas, Waidmann, Oliver, Finkelmeier, Fabian, Venerito, Marino, Berres, Marie-Luise, Berg, Thomas, Lange, Christian, Schmidt, Hartmut, Waldschmidt, Dirk T, Bitzer, Michael, McDermott, Ray, Duffy, Austin, Masi, Gianluca, Zagonel, Vittorina, Tonini, Giuseppe, Piscaglia, Fabio, Gori, Stefania, Rizzo, Mimma, Biscaldi, Elisa, Foltran, Luisa, Cabibbo, Giuseppe, Ikeda, Masafumi, Kudo, Masatoshi, Aikata, Hiroshi, Numata, Kazushi, Marusawa, Hiroyuki, Kato, Naoya, Kurosaki, Masayuki, Morimoto, Manabu, Yamashita, Tatsuya, Koga, Hironori, Masaki, Tsutomu, Tateishi, Ryosuke, Inaba, Yoshitaka, Arakawa, Tomohiro, Suzuki, Yoshiyuki, Akua, Norio, Kobayashi, Masahiro, Hosaka, Tetsuya, Nakamuta, Makoto, Oza, Noriko, Kondo, Shunsuke, Furuse, Junji, Nagashima, Fumio, Kitano, Masayuki, Takaguchi, Koichi, Ryoo, Baek-Yeol, Lim, Ho Yeong, Kim, Jee Hyun, Kim, Tae-You, Kim, Han Sang, Hernandez Hernandez, Carlos, Motola Kuba, Daniel, Segura Gonzalez, Manuel, Cabrera Luviano, Jesus, Huitzil Melendez, Fidel, Ramirez Godinez, Francisco, Silva-Bravo, Fernando, Gane, Edward, Stedman, Catherine, Kwiatkowski, Mariusz, Wyrwicz, Lucjan, Nowakowska-Zajdel, Ewa, Kraj, Leszek, Janczewska, Ewa, Surma-Wlodarczyk, Renata, Breder, Valeriy, Sekacheva, Marina, Orlova, Rashida, Vasilyev, Alexander, Zukov, Ruslan, Vladimirov, Vladimir, Minguez, Beatriz, Matilla Pena, Ana, Fernandez Castroagudin, Javier, Romero Gomez, Manuel, Luis Lledo, Jose, Rubin, Angel, Garcia Sanchez, Araceli, Calleja Panero, Jose, Yu, Ming-Chin, Shen, Ying-Chun, Huang, Yi-Hsiang, Jeng, Long-Bin, Chang, Ting-Tsung, Yang, Sheng-Shun, Chen, Shinn-Cherng, Dechaphunkul, Arunee, Tanwandee, Tawesak, Leerapun, Apinya, Seker, Mesut, Harputluoglu, Hakan, Cicin, Irfan, Oksuzoglu, Berna, Bilici, Mehmet, Sezgin Goksu, Sema, Artac, Mehmet, Cil, Timucin, Yalcin, Suayib, Meyer, Tim, Sarker, Debashis, Rao, Ankit, Palmer, Daniel, Evans, Jeff, Hubner, Richard, Finn, Richard, Ulahannan, Susanna, Zakari, Ahmed, Feun, Lynn, Al-Rajabi, Raed, Sung, Max, He, Aiwu, Kardosh, Adel, Goyal, Lipika, Li, Daneng, Choi, Minsig, Posada, Juan, Dodlapati, Jyothi, Shroff, Rachna, Agrawal, Saurabh, Gopaluni, Srivalli, Akce, Mehmet, Alese, Olatunji, Baron, Ari, Dunne, Richard, Loaiza-Bonilla, Arturo, Frenette, Catherine, Llovet, Josep M, Kumada, Hiromitsu, Cheng, Ann-Lii, Galle, Peter R, Kaneko, Shuichi, Wang, Anran, Mody, Kalgi, Dutcus, Corina, Dubrovsky, Leonid, Siegel, Abby B, and Finn, Richard S

Published
2023
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7. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial

Author

Wainberg, Zev A, Melisi, Davide, Macarulla, Teresa, Pazo Cid, Roberto, Chandana, Sreenivasa R, De La Fouchardière, Christelle, Dean, Andrew, Kiss, Igor, Lee, Woo Jin, Goetze, Thorsten O, Van Cutsem, Eric, Paulson, A Scott, Bekaii-Saab, Tanios, Pant, Shubham, Hubner, Richard A, Xiao, Zhimin, Chen, Huanyu, Benzaghou, Fawzi, and O'Reilly, Eileen M

Published
2023
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8. NET-02: a randomised, non-comparative, phase II trial of nal-IRI/5-FU or docetaxel as second-line therapy in patients with progressive poorly differentiated extra-pulmonary neuroendocrine carcinoma

Author

McNamara, Mairéad G., Swain, Jayne, Craig, Zoe, Sharma, Rohini, Faluyi, Olusola, Wadsley, Jonathan, Morgan, Carys, Wall, Lucy R., Chau, Ian, Reed, Nick, Sarker, Debashis, Margetts, Jane, Krell, Daniel, Cave, Judith, Sothi, Sharmila, Anthoney, Alan, Bell, Christopher, Patel, Alkesh, Oughton, Jamie B., Cairns, David A., Mansoor, Wasat, Lamarca, Angela, Hubner, Richard A., and Valle, Juan W.

Published
2023
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9. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced or metastatic oesophageal squamous cell carcinoma (RATIONALE-306): a global, randomised, placebo-controlled, phase 3 study

Author

Xu, Jianming, Kato, Ken, Raymond, Eric, Hubner, Richard A, Shu, Yongqian, Pan, Yueyin, Park, Sook Ryun, Ping, Lu, Jiang, Yi, Zhang, Jingdong, Wu, Xiaohong, Yao, Yuanhu, Shen, Lin, Kojima, Takashi, Gotovkin, Evgeny, Ishihara, Ryu, Wyrwicz, Lucjan, Van Cutsem, Eric, Jimenez-Fonseca, Paula, Lin, Chen-Yuan, Wang, Lei, Shi, Jingwen, Li, Liyun, and Yoon, Harry H

Published
2023
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16. Antibody-Drug Conjugates and Their Potential in the Treatment of Patients with Biliary Tract Cancer.

Author

Alexander, Shaun, Aleem, Umair, Jacobs, Timothy, Frizziero, Melissa, Foy, Victoria, Hubner, Richard A., and McNamara, Mairéad G.

Subjects
THERAPEUTIC use of antineoplastic agents, THERAPEUTIC use of monoclonal antibodies, BILE duct tumors, TRASTUZUMAB, DRUG approval, ONCOGENES
Abstract

Simple Summary: Survival for patients with biliary tract cancer (BTC) is poor, especially in the advanced stage, where curative treatments are not available. While chemotherapy and immunotherapy are used in standard practice, antibody–drug conjugates (ADCs) have emerged as a novel therapy option. ADCs potentially enhance cancer cell death and reduce side effects. The anti-HER2 ADC Trastuzumab Deruxtecan (T-Dxd) has shown survival benefit for patients whose tumours are HER2-positive, including a subgroup of BTCs. In April 2024, the regulatory authority FDA approved T-Dxd for adults with unresectable or metastatic HER2-positive solid tumours, including BTCs, lacking other treatment options. Ongoing trials are exploring other potentially actionable BTC molecular alterations. This review will discuss the current evidence and ongoing research in this subject area. Background: Biliary tract cancers (BTCs) are aggressive in nature, often presenting asymptomatically until they are diagnosed at an advanced stage. Surgical resection or liver transplantation are potential curative options. However, a large proportion of patients present with incurable locally advanced or metastatic disease and most of these patients are only eligible for palliative chemotherapy or best supportive care. More recently, targeted therapies have proven beneficial in a molecularly selected subgroup of patients with cholangiocarcinoma who have progressed on previous lines of systemic treatment. However, only a minority of patients with BTCs whose tumours harbour specific molecular alterations can access these therapies. Methods: In relation to ADCs, studies regarding use of antibody–drug conjugates in cancer, particularly in BTCs, were searched in Embase (1974 to 2024) and Ovid MEDLINE(R) (1946 to 2024) to obtain relevant articles. Examples of current clinical trials utilising ADC treatment in BTCs were extracted from the ClinicalTrials.gov trial registry. Conclusions: Overall, this review has highlighted that ADCs have shown encouraging outcomes in cancer therapy, and this should lead to further research including in BTCs, where treatment options are often limited. The promising results observed with ADCs in various cancers underscore their potential as a transformative approach in oncology, warranting continued exploration and development and the need for education on the management of their specific toxicities. By addressing current challenges and optimising ADC design and application, future studies could potentially improve treatment outcomes for patients with BTCs and beyond, potentially in both early and advanced stage settings. [ABSTRACT FROM AUTHOR]

Published
2024
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17. Systemic Therapy for Metastatic Pancreatic Cancer—Current Landscape and Future Directions.

Author

Netto, Daniel, Frizziero, Melissa, Foy, Victoria, McNamara, Mairéad G., Backen, Alison, and Hubner, Richard A.

Subjects
PANCREATIC duct, CANCER chemotherapy, SMALL molecules, RAS oncogenes, TUMOR microenvironment
Abstract

Pancreatic ductal adenocarcinoma (PDAC) is a significant cause of cancer-associated mortality, with a rising global incidence. A paucity of strong predictive risk factors mean screening programmes are difficult to implement. Historically, a lack of identifiable and actionable driver mutations, coupled with a relatively immunosuppressed tumour microenvironment, has led to a reliance on cytotoxic chemotherapy. The NAPOLI-3 trial has reported data supporting consideration of NALIRIFOX as a new first-line standard of care. Kirsten Rat Sarcoma Virus (KRAS) G12D mutations are present in >90% of all PDAC's; exciting breakthroughs in small molecule inhibitors targeting KRAS G12D may open new modalities of treatment, and therapies targeting multiple KRAS mutations are also in early clinical trials. Although immunotherapy strategies to date have been disappointing, combination with chemotherapy and/or small molecule inhibitors hold promise and warrant further exploration. [ABSTRACT FROM AUTHOR]

Published
2024
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19. British Society of Gastroenterology guidelines for the management of hepatocellular carcinoma in adults

Author

Suddle, Abid, primary, Reeves, Helen, additional, Hubner, Richard, additional, Marshall, Aileen, additional, Rowe, Ian, additional, Tiniakos, Dina, additional, Hubscher, Stefan, additional, Callaway, Mark, additional, Sharma, Dinesh, additional, See, Teik Choon, additional, Hawkins, Maria, additional, Ford-Dunn, Suzanne, additional, Selemani, Sarah, additional, and Meyer, Tim, additional

Published
2024
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25. Somatostatin Receptor Imaging with [18F]FET-bAG-TOCA PET/CT and [68Ga]Ga-DOTA-Peptide PET/CT in Patients with Neuroendocrine Tumors: A Prospective, Phase 2 Comparative Study.

Author

Dubash, Suraiya, Barwick, Tara D., Kozlowski, Kasia, Rockall, Andrea G., Khan, Sairah, Khan, Sameer, Yusuf, Siraj, Lamarca, Angela, Valle, Juan W., Hubner, Richard A., McNamara, Mairéad G., Frilling, Andrea, Tan, Tricia, Wernig, Florian, Todd, Jeannie, Meeran, Karim, Pratap, Bhavesh, Azeem, Saleem, Huiban, Michael, and Keat, Nicholas

Published
2024
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26. Somatostatin Receptor Imaging with [18F]FET-βAG-TOCA PET/CT and [68Ga]Ga-DOTA-Peptide PET/CT in Patients with Neuroendocrine Tumors: A Prospective, Phase 2 Comparative Study

Author

Dubash, Suraiya, primary, Barwick, Tara D., additional, Kozlowski, Kasia, additional, Rockall, Andrea G., additional, Khan, Sairah, additional, Khan, Sameer, additional, Yusuf, Siraj, additional, Lamarca, Angela, additional, Valle, Juan W., additional, Hubner, Richard A., additional, McNamara, Mairéad G., additional, Frilling, Andrea, additional, Tan, Tricia, additional, Wernig, Florian, additional, Todd, Jeannie, additional, Meeran, Karim, additional, Pratap, Bhavesh, additional, Azeem, Saleem, additional, Huiban, Michael, additional, Keat, Nicholas, additional, Lozano-Kuehne, Jingky P., additional, Aboagye, Eric O., additional, and Sharma, Rohini, additional

Published
2024
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27. A multi-centre review of the efficacy of re-challenge with platinum doublet in patients with oesophagogastric cancer treated with first-line trastuzumab and chemotherapy.

Author

Weaver, Jamie, primary, Ali, Rufqah, additional, Mckay, Marie, additional, Foy, Victoria, additional, Khan, Adeel, additional, Cunningham, Aimee, additional, McQueenie, Esther, additional, Owen-Holt, Vikki, additional, Williams, Kate, additional, Valpione, Sara, additional, Hubner, Richard, additional, Waddell, Tom, additional, Alchawaf, Alia, additional, and Mansoor, Wasat, additional

Published
2024
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28. Moving towards a personalised understanding of the nutritional impact of self-expanding metallic stents (SEMS) in gastro-oesophageal cancer: A retrospective case note review of a tertiary referral oncology centre.

Author

Cunningham, Aimee, primary, Alattal, Taibah, additional, Foulkes, Lindsey, additional, Lewis, Alexandra R, additional, Backen, Alison Catherine, additional, Williamson, Fiona, additional, McQueenie, Esther, additional, Owen-Holt, Vikki, additional, Williams, Kate, additional, Hubner, Richard, additional, Waddell, Tom, additional, Valpione, Sara, additional, Laasch, Hans-Ulrich, additional, Mansoor, Wasat, additional, and Weaver, Jamie, additional

Published
2024
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29. Kinetics of CA19-9 decline in a randomized phase III study of irinotecan liposome injection, oxaliplatin, 5-fluorouracial/leucovorin (NALIRIFOX) or nab-paclitaxel plus gemcitabine (GEM+NABP) in patients who have not previously received chemotherapy for metastatic adenocarcinoma of the pancreas (NAPOLI 3).

Author

Chandana, Sreenivasa R, primary, Wainberg, Zev A., additional, Melisi, Davide, additional, Macarulla, Teresa, additional, Pazo Cid, Roberto A., additional, De La Fouchardiere, Christelle, additional, Dean, Andrew Peter, additional, Kiss, Igor, additional, Lee, Woo Jin, additional, Goetze, Thorsten, additional, Van Cutsem, Eric, additional, Paulson, Andrew Scott, additional, Bekaii-Saab, Tanios S., additional, Pant, Shubham, additional, Hubner, Richard, additional, Xiao, Zhimin, additional, Li, Jia, additional, Benzaghou, Fawzi, additional, and O'Reilly, Eileen Mary, additional

Published
2024
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30. Lenvatinib plus pembrolizumab versus lenvatinib plus placebo for advanced hepatocellular carcinoma (LEAP-002): a randomised, double-blind, phase 3 trial

Author

Llovet, Josep M, primary, Kudo, Masatoshi, additional, Merle, Philippe, additional, Meyer, Tim, additional, Qin, Shukui, additional, Ikeda, Masafumi, additional, Xu, Ruocai, additional, Edeline, Julien, additional, Ryoo, Baek-Yeol, additional, Ren, Zhenggang, additional, Masi, Gianluca, additional, Kwiatkowski, Mariusz, additional, Lim, Ho Yeong, additional, Kim, Jee Hyun, additional, Breder, Valeriy, additional, Kumada, Hiromitsu, additional, Cheng, Ann-Lii, additional, Galle, Peter R, additional, Kaneko, Shuichi, additional, Wang, Anran, additional, Mody, Kalgi, additional, Dutcus, Corina, additional, Dubrovsky, Leonid, additional, Siegel, Abby B, additional, Finn, Richard S, additional, Strasser, Simone, additional, Thompson, Alexander, additional, Roohullah, Aflah, additional, Sievert, William, additional, Andelkovic, Vladimir, additional, Knox, Jennifer, additional, Davies, Janine, additional, Asselah, Jamil, additional, Brahmania, Mayur, additional, Majeed, Habeeb, additional, Villanueva, Luis, additional, Yanez Weber, Patricio, additional, Garrido, Marcelo, additional, Pizarro, Gonzalo Ignacio, additional, Yanez, Nicolas, additional, Ou, Shuangyan, additional, Pan, Hongming, additional, Meng, Zhiqiang, additional, Gu, Kangsheng, additional, Chen, Xi, additional, Zhang, Tao, additional, Hao, Chunyi, additional, Cao, Peiguo, additional, Guo, Yabing, additional, Xiao, Juxiang, additional, Fang, Weijia, additional, Wang, Xin, additional, Bai, Yuxian, additional, Chen, Xiaoming, additional, Yan, Dong, additional, Zhao, Hong, additional, Ying, Jieer, additional, Bonilla, Carlos, additional, Urrego, Olga, additional, Zambrano, Angela, additional, Lema, Mauricio, additional, Restrepo Gutierrez, Juan Carlos, additional, Cardona, Andres, additional, Franco Millan, Sandra, additional, Oscar, Madiedo, additional, Ramos, Victor, additional, LeSourd, Samuel, additional, Bronowicki, Jean-Pierre, additional, Bourliere, Marc, additional, Cattan, Stephane, additional, Bouattour, Mohamed, additional, Mineur, Laurent, additional, Regnault, Helene, additional, Dauvois, Barbara, additional, Schulze, Kornelius, additional, Folprecht, Gunnar, additional, Geier, Andreas, additional, Waidmann, Oliver, additional, Finkelmeier, Fabian, additional, Venerito, Marino, additional, Berres, Marie-Luise, additional, Berg, Thomas, additional, Lange, Christian, additional, Schmidt, Hartmut, additional, Waldschmidt, Dirk T, additional, Bitzer, Michael, additional, McDermott, Ray, additional, Duffy, Austin, additional, Zagonel, Vittorina, additional, Tonini, Giuseppe, additional, Piscaglia, Fabio, additional, Gori, Stefania, additional, Rizzo, Mimma, additional, Biscaldi, Elisa, additional, Foltran, Luisa, additional, Cabibbo, Giuseppe, additional, Aikata, Hiroshi, additional, Numata, Kazushi, additional, Marusawa, Hiroyuki, additional, Kato, Naoya, additional, Kurosaki, Masayuki, additional, Morimoto, Manabu, additional, Yamashita, Tatsuya, additional, Koga, Hironori, additional, Masaki, Tsutomu, additional, Tateishi, Ryosuke, additional, Inaba, Yoshitaka, additional, Arakawa, Tomohiro, additional, Suzuki, Yoshiyuki, additional, Akua, Norio, additional, Kobayashi, Masahiro, additional, Hosaka, Tetsuya, additional, Nakamuta, Makoto, additional, Oza, Noriko, additional, Kondo, Shunsuke, additional, Furuse, Junji, additional, Nagashima, Fumio, additional, Kitano, Masayuki, additional, Takaguchi, Koichi, additional, Kim, Tae-You, additional, Kim, Han Sang, additional, Hernandez Hernandez, Carlos, additional, Motola Kuba, Daniel, additional, Segura Gonzalez, Manuel, additional, Cabrera Luviano, Jesus, additional, Huitzil Melendez, Fidel, additional, Ramirez Godinez, Francisco, additional, Silva-Bravo, Fernando, additional, Gane, Edward, additional, Stedman, Catherine, additional, Wyrwicz, Lucjan, additional, Nowakowska-Zajdel, Ewa, additional, Kraj, Leszek, additional, Janczewska, Ewa, additional, Surma-Wlodarczyk, Renata, additional, Sekacheva, Marina, additional, Orlova, Rashida, additional, Vasilyev, Alexander, additional, Zukov, Ruslan, additional, Vladimirov, Vladimir, additional, Minguez, Beatriz, additional, Matilla Pena, Ana, additional, Fernandez Castroagudin, Javier, additional, Romero Gomez, Manuel, additional, Luis Lledo, Jose, additional, Rubin, Angel, additional, Garcia Sanchez, Araceli, additional, Calleja Panero, Jose, additional, Yu, Ming-Chin, additional, Shen, Ying-Chun, additional, Huang, Yi-Hsiang, additional, Jeng, Long-Bin, additional, Chang, Ting-Tsung, additional, Yang, Sheng-Shun, additional, Chen, Shinn-Cherng, additional, Dechaphunkul, Arunee, additional, Tanwandee, Tawesak, additional, Leerapun, Apinya, additional, Seker, Mesut, additional, Harputluoglu, Hakan, additional, Cicin, Irfan, additional, Oksuzoglu, Berna, additional, Bilici, Mehmet, additional, Sezgin Goksu, Sema, additional, Artac, Mehmet, additional, Cil, Timucin, additional, Yalcin, Suayib, additional, Sarker, Debashis, additional, Rao, Ankit, additional, Palmer, Daniel, additional, Evans, Jeff, additional, Hubner, Richard, additional, Finn, Richard, additional, Ulahannan, Susanna, additional, Zakari, Ahmed, additional, Feun, Lynn, additional, Al-Rajabi, Raed, additional, Sung, Max, additional, He, Aiwu, additional, Kardosh, Adel, additional, Goyal, Lipika, additional, Li, Daneng, additional, Choi, Minsig, additional, Posada, Juan, additional, Dodlapati, Jyothi, additional, Shroff, Rachna, additional, Agrawal, Saurabh, additional, Gopaluni, Srivalli, additional, Akce, Mehmet, additional, Alese, Olatunji, additional, Baron, Ari, additional, Dunne, Richard, additional, Loaiza-Bonilla, Arturo, additional, and Frenette, Catherine, additional

Published
2023
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32. Aspirin as an adjuvant treatment for cancer: feasibility results from the Add-Aspirin randomised trial

Author

Burn, John, Campbell, Sue, Capaldi, Lisa, Carse, Yvonne, Gadgil, Durga, Goldman, Arnold, Gupta, Sudeep, Leonard, Gregory, MacKenzie, Mairead, Parmar, Mahesh, Patrono, Carlo, Petty, Russell, Rothwell, Peter M., Steele, Robert J.C., Joharatnam-Hogan, Nalinie, Cafferty, Fay, Hubner, Richard, Swinson, Daniel, Sothi, Sharmila, Gupta, Kamalnayan, Falk, Stephen, Patel, Kinnari, Warner, Nicola, Kunene, Victoria, Rowley, Sam, Khabra, Komel, Underwood, Tim, Jankowski, Janusz, Bridgewater, John, Crossley, Anne, Henson, Verity, Berkman, Lindy, Gilbert, Duncan, Kynaston, Howard, Ring, Alistair, Cameron, David, Din, Farhat, Graham, Janet, Iveson, Timothy, Adams, Richard, Thomas, Anne, Wilson, Richard, Pramesh, C S, and Langley, Ruth

Published
2019
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34. Impact of intensified chemotherapy in metastatic pancreatic ductal adenocarcinoma (PDAC) in clinical routine in Europe

Author

Javed, Muhammad Ahsan, Beyer, Georg, Le, Nha, Vinci, Alessio, Wong, Helen, Palmer, Daniel, Morgan, Robert D., Lamarca, Angela, Hubner, Richard A., Valle, Juan W., Alam, Salma, Chowdhury, Sumsur, Ma, Yuk Ting, Archibugi, Livia, Capurso, Gabriele, Maisonneuve, Patrick, Neesse, Albrecht, Sund, Malin, Schober, Marvin, and Krug, Sebastian

Published
2019
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36. Prognosis Discussion and Referral to Community Palliative Care Services in Patients with Advanced Pancreatic Cancer Treated in a Tertiary Cancer Centre

Author

Clelland, Sarah, primary, Nuttall, Christina L., additional, Stott, Helen E., additional, Cope, Joseph, additional, Barratt, Natalie L., additional, Farrell, Kelly, additional, Eyong, Manyi V., additional, Gleeson, Jack P., additional, Lamarca, Angela, additional, Hubner, Richard A., additional, Valle, Juan W., additional, and McNamara, Mairéad G., additional

Published
2023
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42. Third-Line Palliative Systemic Therapy for Advanced Biliary Tract Cancer: Multicentre Review of Patterns of Care and Outcomes

Author

Gray, Simon, primary, Letissier, Octave, additional, d’Abrigeon, Constance, additional, Shah, Dinakshi, additional, Wardell, Stephen, additional, Faluyi, Olusola, additional, Lamarca, Angela, additional, Hubner, Richard A., additional, Edeline, Julien, additional, Valle, Juan W., additional, and McNamara, Mairéad G., additional

Published
2023
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43. Sorafenib in combination with transarterial chemoembolisation in patients with unresectable hepatocellular carcinoma (TACE 2): a randomised placebo-controlled, double-blind, phase 3 trial

Author

Meyer, Tim, Fox, Richard, Ma, Yuk Ting, Ross, Paul J, James, Martin W, Sturgess, Richard, Stubbs, Clive, Stocken, Deborah D, Wall, Lucy, Watkinson, Anthony, Hacking, Nigel, Evans, T R Jeffry, Collins, Peter, Hubner, Richard A, Cunningham, David, Primrose, John Neil, Johnson, Philip J, and Palmer, Daniel H

Published
2017
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46. Third-Line Palliative Systemic Therapy for Advanced Biliary Tract Cancer: Multicentre Review of Patterns of Care and Outcomes

Author

Gray, Simon, Letissier, Octave, D’abrigeon, Constance, Shah, Dinakshi, Wardell, Stephen, Faluyi, Olusola, Lamarca, Angela, Hubner, Richard A., Edeline, Julien, Valle, Juan W., and Mcnamara, Mairéad G.

Subjects
third-line, ampulla of Vater, biliary tract, cholangiocarcinoma, chemotherapy, targeted therapy, gallbladder, systemic therapy
Abstract

Phase 3 trials have established standard first-line (1L) and 2L systemic therapy options for patients with advanced biliary cancer (ABC). However, a standard 3L treatment remains undefined. Clinical practice and outcomes for 3L systemic therapy in patients with ABC were therefore evaluated from three academic centres. Included patients were identified using institutional registries; demographics, staging, treatment history, and clinical outcomes were collected. Kaplan-Meier methods were used to assess progression-free survival (PFS) and overall survival (OS). Ninety-seven patients, treated between 2006 and 2022, were included; 61.9% had intrahepatic cholangiocarcinoma. At the time of analysis, there had been 91 deaths. Median PFS from initiating 3L palliative systemic therapy (mPFS3) was 3.1 months (95%CI 2.0-4.1), while mOS3 was 6.4 months (95%CI 5.5-7.3); mOS1 was 26.9 months (95%CI 23.6-30.2). Among patients with a therapy-targeted molecular aberration (10.3%; n = 10; all received in 3L), mOS3 was significantly improved versus all other included patients (12.5 vs. 5.9 months; p = 0.02). No differences in OS1 were demonstrated between anatomical subtypes. Fourth-line systemic therapy was received by 19.6% of patients (n = 19). This international multicentre analysis documents systemic therapy use in this select patient group, and provides a benchmark of outcomes for future trial design.

Published
2023

47. Prospective Observational Study of Prevalence, Assessment and Treatment of Pancreatic Exocrine Insufficiency in Patients with Inoperable Pancreatic Malignancy (PANcreatic Cancer Dietary Assessment—PanDA)

Author

Carnie, Lindsay E., primary, Shah, Dinakshi, additional, Vaughan, Kate, additional, Kapacee, Zainul Abedin, additional, McCallum, Lynne, additional, Abraham, Marc, additional, Backen, Alison, additional, McNamara, Mairéad G., additional, Hubner, Richard A., additional, Barriuso, Jorge, additional, Gillespie, Loraine, additional, Lamarca, Angela, additional, and Valle, Juan W., additional

Published
2023
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48. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial

Author

Wainberg, Zev A., Melisi, Davide, Macarulla, Teresa, Pazo Cid, Roberto, Chandana, Sreenivasa R., De La Fouchardière, Christelle, Dean, Andrew, Kiss, Igor, Jin Lee, Woo, Götze, Thorsten, Van Cutsem, Eric, Paulson, A. Scott, Bekaii-Saab, Tanios, Pant, Shubham, Hubner, Richard A., Xiao, Zhimin, Chen, Huanyu, Benzaghou, Fawzi, O’Reilly, Eileen M., Wainberg, Zev A., Melisi, Davide, Macarulla, Teresa, Pazo Cid, Roberto, Chandana, Sreenivasa R., De La Fouchardière, Christelle, Dean, Andrew, Kiss, Igor, Jin Lee, Woo, Götze, Thorsten, Van Cutsem, Eric, Paulson, A. Scott, Bekaii-Saab, Tanios, Pant, Shubham, Hubner, Richard A., Xiao, Zhimin, Chen, Huanyu, Benzaghou, Fawzi, and O’Reilly, Eileen M.

Abstract

Background: Pancreatic ductal adenocarcinoma remains one of the most lethal malignancies, with few treatment options. NAPOLI 3 aimed to compare the efficacy and safety of NALIRIFOX versus nab-paclitaxel and gemcitabine as first-line therapy for metastatic pancreatic ductal adenocarcinoma (mPDAC). Methods: NAPOLI 3 was a randomised, open-label, phase 3 study conducted at 187 community and academic sites in 18 countries worldwide across Europe, North America, South America, Asia, and Australia. Patients with mPDAC and Eastern Cooperative Oncology Group performance status score 0 or 1 were randomly assigned (1:1) to receive NALIRIFOX (liposomal irinotecan 50 mg/m2, oxaliplatin 60 mg/m2, leucovorin 400 mg/m2, and fluorouracil 2400 mg/m2, administered sequentially as a continuous intravenous infusion over 46 h) on days 1 and 15 of a 28-day cycle or nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2, administered intravenously, on days 1, 8, and 15 of a 28-day cycle. Balanced block randomisation was stratified by geographical region, performance status, and liver metastases, managed through an interactive web response system. The primary endpoint was overall survival in the intention-to-treat population, evaluated when at least 543 events were observed across the two treatment groups. Safety was evaluated in all patients who received at least one dose of study treatment. This completed trial is registered with ClinicalTrials.gov, NCT04083235. Findings: Between Feb 19, 2020 and Aug 17, 2021, 770 patients were randomly assigned (NALIRIFOX, 383; nab-paclitaxel–gemcitabine, 387; median follow-up 16·1 months [IQR 13·4–19·1]). Median overall survival was 11·1 months (95% CI 10·0–12·1) with NALIRIFOX versus 9·2 months (8·3–10·6) with nab-paclitaxel–gemcitabine (hazard ratio 0·83; 95% CI 0·70–0·99; p=0·036). Grade 3 or higher treatment-emergent adverse events occurred in 322 (87%) of 370 patients receiving NALIRIFOX and 326 (86%) of 379 patients receiving nab-paclitaxel–gemcitab

Published
2023

50. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial

Author

Adoo, Clarence, Anderson, Thomas, Asselah, Jamil, Azambuja, Alan, Bampton, Carolyn, Barrios, Carlos Henrique, Bekaii-Saab, Tanios, Bohuslav, Melichar, Chang, David, Chen, Jen-Shi, Chen, Yeu-Chin, Choi, Hye Jin, Chung, Ik Joo, Chung, Vincent, Csoszi, Tibor, Cubillo, Antonio, DeMarco, Linda, de Wit, Maike, Dragovich, Tomislav, Edenfield, William, Fein, Luis Enrique, Franke, Fábio, Fuchs, Martin, Gonzales-Cruz, Vega, Gozza, Alberto, Fernando, Rivera Herrero, Iaffaioli, Rosario, Jakesova, Jitka, Kahan, Zsuzsanna, Karimi, Misagh, Kim, Jun Suk, Korbenfeld, Ernesto, Lang, Istvan, Lee, Fa-Chyi, Lee, Kuan-Der, Lipton, Lara, Ma, Wen Wee, Mangel, Laszlo, Mena, Raul, Palmer, Daniel, Pant, Shubham, Park, Joon Oh, Piacentini, Paolo, Pelzer, Uwe, Plazas, Javier Gallego, Prasad, Cooray, Rau, Kun-Ming, Raoul, Jean-Luc, Richards, Donald, Ross, Paul, Schlittler, Luis, Smakal, Martin, Stahalova, Vladimira, Sternberg, Cora, Seufferlein, Thomas, Tebbutt, Niall, Vinholes, Jeferson Jose, Wadlow, Raymond, Wenczl, Milkos, Wong, Mark, Wang-Gillam, Andrea, Li, Chung-Pin, Bodoky, György, Dean, Andrew, Shan, Yan-Shen, Jameson, Gayle, Macarulla, Teresa, Lee, Kyung-Hun, Cunningham, David, Blanc, Jean F, Hubner, Richard A, Chiu, Chang-Fang, Schwartsmann, Gilberto, Siveke, Jens T, Braiteh, Fadi, Moyo, Victor, Belanger, Bruce, Dhindsa, Navreet, Bayever, Eliel, Von Hoff, Daniel D, and Chen, Li-Tzong

Published
2016
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