Talactoferrin alfa versus placebo in patients with refractory advanced non-small-cell lung cancer (FORTIS-M trial)

Ramalingam, Suresh S.; Pérez-Soler, Román; Douillard, Jean Yves; Thatcher, Nicholas; Wang, Y.; Pultar, Philippe; Zhu, Junming; Malik, Rajesh; Della-Fiorentina, Stephen; Begbie, Stephen; Jennens, Ross; Dass, Joshua; Pittman, K.; Ivanova, N.M.; Koynova, T; Petrov, Petar; Tomova, Antoaneta; Tzekova, Valentina; Couture, Félix; Hirsh, Vera; Burkes, Ronald L.; Sangha, Randeep; Ambruš, Miloslav; Janaskova, Terezie; Musil, J; Novotny, Juergen; Zatloukal, Petr; Jakesova, Jitka; Klenha, Kamil; Roubec, Jaromı́r; Vaňásek, J; Fayette, Jérôme; Barlési, Fabrice; Bennouna-Louridi, Jaafar; Chouaïd, C.; Mazières, Julien; Vallerand, H.; Robinet, G.; Souquet, Pierre-Jean; Spaëth, Dominique; Schött, Roland; Léna, H.; Martinet, Yves; Kouri, Claude El; Baize, Nathalie; Scherpereel, Arnaud; Molinier, O.; Fuchs, F.; Josten, K.; Manegold, Christian; Marschner, Norbert; Schneller, Folker; Overbeck, Tobias R.; Thomas, Michael; Pawel, Joachim von; Reck, Martin; Schuette, Wolfgang; Hagen, Volker; Schneider, Claus-Peter; Georgoulias, V.; Varthalitis, Ioannis; Zarogoulidis, Kostas; Syrigos, Kostas; Papandreou, Christos N.; Böcskei, Csaba; Csánky, Eszter; Juhász, Erzsébet; Losonczy, György; Mark, Z.; Molnár, István; Pápai-Székely, Zsolt; Tehenes, S.; Vinkler, Ilona; Almel, Sachin; Bakshi, Ashish; Bondarde, Shailesh Arjun; Maru, Akio; Pathak, Ashutosh; Pedapenki, R.M.; K, Krishna Prasad; Prasad, S.; Kilara, Nalini; Gorijavolu, D.; Deshmukh, Chetan; John, S. K. P.; Sharma, Lalit Mohan; Amoroso, Domenico; Bajetta, Emilio; Bidoli, Paolo; Bonetti, Andrea; Marinis, Filippo de; Maïo, Massimo Di; Passalacqua, Rodolfo; Cascinu, Stefano; Bearz, Alessandra; Bitiņa, Marianna; Brize, Arija; Purkalne, Gunta; Skrodele, M.; Baba, Asami; Ratnavelu, Kananathan; Saw, M.; Samson-Fernando, M.C.; Ladrera, Guia; Jassem, Jacek; Koralewski, P.; Serwatowski, Piotr; Krzakowski, Maciej; Cebotaru, C.; Dumitru, Filip; Ganea-Motan, D.E.; Ianuli, Carmen; Manolescu, Ileana; Udrea, Anghel Adrian; Burdaeva, Olga; Byakhov, M.; Filippov, Aleksandr; Lazarev, Sergey; Мосин, И. В.; Орлов, С. В.; Udovitsa, Dmitry; Khorinko, Andrey V.; Проценко, Светлана; Chang, Alex Y.; Lim, Hong Liang; Tan, Yuping; Tan, Eng Huat; Piulats, R. Bastus; García‐Foncillas, Jesús; Valdivia, Javier; Castro, Julio; Gómez, M. Dómine; Kim, S.W.; Lee, J.-S.; Kim, H.K.; Lee, J.S.; Shin, Sang-Hoon; Kim, D.-W.; Kim, Y.-C.; Park, K.C.; Chang, Christopher; Chang, Gee‐Chen; Goan, Yih‐Gang; Su, Wu‐Chou; Tsai, Chun‐Ming; Kuo, Han Pin; Benekli, Mustafa; Demir, Gökhan; Gökmen, Erhan; Sevinç, Alper; Crawford, Jeffrey; Giaccone, Giuseppe; Haigentz, Missak; Owonikoko, Taofeek K.; Agarwal, Meetesh; Pandit, Sarbagya; Araújo, Raphael L. C.; Vrindavanam, Nandagopal; Bonomi, Philip; Berg, Anke van den; Wade, JL; Bloom, Roy D.; Amin, B.; Camidge, Ross; Hill, Debbie; Rarick, Mark U.; Flynn, P.; Klein, Linda; Russo, Katherine L.; Neubauer, Marcus A.; Richards, P.; Ruxer, Robert L.; Savin, Michael A.; Weckstein, Douglas; Rosenberg, Robert D.; Whittaker, T.; Richards, Donald A.; Berry, W.; Ottensmeier, Christian; Dangoor, Adam; Steele, N.; Summers, Yvonne; Rankin, Elaine M.; Rowley, Kate; Giridharan, S.; Kristeleit, Hartmut; Humber, C.; Taylor, Paul D.

doi:10.1093/annonc/mdt371

Cited by 47 publications

(29 citation statements)

References 24 publications

(28 reference statements)

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Unfortunately, a subsequent trial did not identify such an improvement after administration of talactoferrin in patients with advanced NSCLC persisting after two regimens of anticancer therapy (Ramalingam et al 2013). …”

mentioning

confidence: 99%

Anticancer activities of bovine and human lactoferricin-derived peptides

Arias

Hilchie

Haney

et al. 2017

Biochem. Cell Biol.

View full text Add to dashboard Cite

mentioning

confidence: 99%

Anticancer activities of bovine and human lactoferricin-derived peptides

Arias

Hilchie

Haney

et al. 2017

Biochem. Cell Biol.

View full text Add to dashboard Cite

“…Parikh et al on the other hand, showed that oral talactoferrin-α in monotherapy significantly increased OS compared to placebo (6.1 vs. 3.7 months, one-tailed log-rank, P=0.040) in a randomized phase II trial (29). However, a recently reported randomized phase III trial (FORTIS-M trial) didn't show a statistically significant benefit in OS, PFS or response rate for talactoferrin-α compared to placebo (27).…”

Section: Talactoferrin-amentioning

confidence: 99%

“…Talactoferrin-α is a recombinant form of human lactoferrin that binds to the gut epithelium, stimulating the digestive mucosa DCs and thus, the immune system via activation of the immunosurveillance mechanism (27). Digumarti et al showed that, when given in conjunction with carboplatin/ paclitaxel, talactoferrin-α increased response rates in stage IIIb/IV NSCLC patients when compared with placebo chemotherapy (47% vs. 29%, P=0.05) (28).…”

Section: Talactoferrin-amentioning

confidence: 99%

Immunotherapy in non-small cell lung cancer: the clinical impact of immune response and targeting

2016

View full text Add to dashboard Cite

Non-small cell lung cancer (NSCLC) remains the leading cause of cancer-related death worldwide.In recent years, through a better understanding of the interactions between the immune system and tumor cells (TC), immunotherapy has emerged as a promising therapeutic strategy. Chemotherapy has long been reported to interfere with the immune response to the tumor and conversely, anti-tumor immunity may add to those effects.Anti-tumor vaccines, such as MAGE-A3, Tecetomide, TG4010, CIMAvax, tumor cell vaccines and dendritic cell (DC) vaccines emerged as potent inducers of the immune response against the tumor. More recently the approval of the anti-programmed cell death 1 (anti-PD-1) monoclonal antibodies nivolumab and pembrolizumab for previously treated advanced squamous and non-squamous NSCLC, as well as other immune checkpoint inhibitors delivering promising results, has radically transformed the therapeutic landscape of NSCLC. Combination strategies now appear as the next step. Notwithstanding these successes, immunotherapy still holds significant drawbacks and currently several improvements are needed before routine use in clinical practice, including identification of robust biomarkers for optimal patient selection, as well as defining the best way to evaluate response.

show abstract

“…Neprokázal se ale žádný efekt tohoto typu imunoterapie. Střední doba OS byla 7,66 měsíce u placeba a 7,49 mě-síce v rameni s talaktoferrinem (HR 1,04; 95% CI 0,873-1,24; p = 0,6602) [5].…”

Section: Studie Fortis-munclassified

Present Experience and Perspectives of Immunotherapy of Lung Cancer

Havel¹

2015

Klin Onkol

View full text Add to dashboard Cite

SouhrnKarcinom plic je celosvětově nejčastější typ maligního procesu. Je také celosvětově nejčastější příčinou úmrtí na zhoubný nádor -poměr mortalita/ incidence je 0,87. Trvalého vyléčení je dnes možné dosáhnout pouze v raných stadiích choroby chirurgickou resekcí, popřípadě radikální radioterapií. To však přichází do úvahy pouze u asi 20 % nemocných. Výsledky léčby lokoregionálně pokročilého nebo metastatického karcinomu plic zůstávají i přes všechny dosažené pokroky neuspokojivé. I přes vylepšení ozařovacích technik, i přes zavedení nových cytostatik a nových tříd molekulárně cílených protinádorových léčiv se daří dosáhnout dlouhodobé kontroly nádorového procesu jen u malé části nemocných. Imunoterapie je léčebná modalita, která pro boj s nádorem využívá schopností vlastního imunitního systému. V článku jsou shrnuty autorovy 17leté zkušenosti s různými typy imunoterapie. Pozornost bude věnována velkým studiím s protinádorovými vakcínami START a MAGRIT, a zejména studiím z nastupující éry "checkpoint inhibitorů". Pokusíme se též nastínit možné nové směry ve vývoji imunoterapie a její kombinace se stávajícími léčebnými postupy. Klíčová slovakarcinom plic -imunoterapie -vakcíny -blokátory kontrolních bodů imunitních reakcí -protein 1 programované buněčné smrti SummaryLung cancer is the most common cancer in the world. Lung cancer is also the most common cause of death caused by cancer worldwide with fatality rate (the overall ratio of mortality to incidence) of 0.87. Nowadays, cure can be achieved only in early disease stages using surgical resection or radical radiotherapy. This approach can be considered only in 20% of patients. Outcome of therapy of loco-regionally advanced or metastatic lung cancer are unsatisfactory. Despite improvement of radiotherapy techniques, despite introduction of new cytostatics and new targeted therapies, long-term disease control could be achieved only in minority of patients. Immunotherapy is a therapeutic approach which uses the immune system itself against cancer. This article is a summary of the authors' 17-year experience with diff erent immunotherapeutic agents. It will be focused on big anti-cancer vaccines trials START and MAGRIT, and especially trials in the upcoming era of 'checkpoint inhibitors'. Future perspectives of immunotherapy and its combination of recent therapeutic approaches will be considered.

show abstract

Talactoferrin alfa versus placebo in patients with refractory advanced non-small-cell lung cancer (FORTIS-M trial)

Abstract: There was no improvement in efficacy with talactoferrin alfa in patients with advanced NSCLC whose disease had failed two or more previous regimens.

Cited by 47 publications

References 24 publications

Anticancer activities of bovine and human lactoferricin-derived peptides

Anticancer activities of bovine and human lactoferricin-derived peptides

Immunotherapy in non-small cell lung cancer: the clinical impact of immune response and targeting

Present Experience and Perspectives of Immunotherapy of Lung Cancer

Contact Info

Product

Resources

About