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3. Clinically relevant bleeding in cancer patients treated for venous thromboembolism from the CATCH study

Author

Kamphuisen, P.W., Lee, A.Y.Y., Meyer, G., Bauersachs, R., Janas, M.S., Jarner, M.F., Khorana, A.A., Bella Santiago, R., Cerana, S., Zarbá, J.J., Andel, J., Barrios, C.H., Borba Reiriz, A., Cesario, F., de Azevedo, S., Ferreira Filho, A.F., Franke, F.A., Padilha, S., Paiva Queiroz, R., Pimenta, A., Rerin, J., Rigo, R., van Eyll Rocha, S.B., Santos Borges, G., Vacaro, G., Anastasov, V., Dragneva, T., Georgiev, G., Champion, P., Kuruvilla, P., Gonzalez, C., Ditl, P., Förster, J., Lubomir, B., Vydra, J., El Hassan, R.A., Sabri, S., Allahloubi, N., Elzawawy, A., Ezzat, S.S., El Kady, M.S., Bacchus, L., Beyer‐Westendorf, J., Kamphausen, U., Niederwieser, D., Ostermann, H., Sosada, M., Anagnostopoulos, N., Fountzilas, G., Ioannou, C., Liapis, C., Schaeffer, J.F.B., Atilli, S., Balsubramanian, S., Bondarde, S., Desai, S.C., Deshmukh, C., Singh, D.P., Gharami, F., Goyal, L., Gupta, S., Gupte, S., Mukherjee, K.K., Krishnan, S., Kumar, K., Mehta, A., Mishra, K., Naik, R., Pawar, S., Nagarkar, R.V., Warrier, N., Brenner, B., Gavish, I., Lugassy, G., Kolin, M., Enrico, B., Mazzucconi, M.G., Visani, G., Awidi, A., Novikovs, N., Miscuks, J., Abigerges, D., Farhat, F., Khoueiry, P., Makarem, J., Alvarez Ordorica, O., Anaya Santacruz, E., Calderillo Ruiz, G., de la Concha Ureta, J.H., Pantigoso, W.S.R., Philco, M., Pineda, A.R., Queszada, E.A.V., Gawrychowski, K., Witkiewicz, W., Macias, E., Teixeira, E., Ciuleanu, T.‐E., Ligia, C.C., Lungulescu, D., Manolescu, I.G., Rodica, A., Volovat, C., Burov, Y., Katelnitsky, I., Svistov, D., Ahmad, K., Algahtani, F., Al‐Zahrani, H., Qari, M., Jovanovic, D., Milanovic, N., Perin, B., Stojanovic, V., Tomasic, L., Chovanec, J., Herman, O., Kissova, V., Sasvary, F., Špánik, S., Szentivanyi, M., Barón, F., Gallardo, E., Jiménez, D., Remedios, O., Sanchez, A., Engelbrecht, J., Jonas, N., McAdam, G., Patel, M., Rapoport, B., Robertson, B., Oh, D., Kim, H., Kim, H.‐K., Kim, H.J., Kim, H.S., Ahn, J.S., Chung, J., Jang, J., Park, K.U., Shin, S.‐W., Kim, S.H., Yoon, S‐S., Kim, Y.‐K., Chiu, C.‐F., Chang, C.‐S., Liu, J.‐H., Rau, K.‐M., Chen, S.‐W., Chittima, S., Ekkapong, T., Nonglak, K., Pantep, A., Pramook, M., Thanakrit, S., Patrapim, S., Sumitra, T., Udomluck, C., Kobza, I., Nykonenko, O., Prasol, V., and Vladychuk, I.

Published
2018
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5. The clinical landscape of cell-free DNA alterations in 1671 patients with advanced biliary tract cancer

Author

Berchuck, J.E., primary, Facchinetti, F., additional, DiToro, D.F., additional, Baiev, I., additional, Majeed, U., additional, Reyes, S., additional, Chen, C., additional, Zhang, K., additional, Sharman, R., additional, Uson Junior, P.L.S., additional, Maurer, J., additional, Shroff, R.T., additional, Pritchard, C.C., additional, Wu, M.-J., additional, Catenacci, D.V.T., additional, Javle, M., additional, Friboulet, L., additional, Hollebecque, A., additional, Bardeesy, N., additional, Zhu, A.X., additional, Lennerz, J.K., additional, Tan, B., additional, Borad, M., additional, Parikh, A.R., additional, Kiedrowski, L.A., additional, Kelley, R.K., additional, Mody, K., additional, Juric, D., additional, and Goyal, L., additional

Published
2022
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6. 76MO Efficacy of RLY-4008, a highly selective FGFR2 inhibitor in patients (pts) with an FGFR2-fusion or rearrangement (f/r), FGFR inhibitor (FGFRi)-naïve cholangiocarcinoma (CCA): ReFocus trial

Author

Park, J.O., primary, Wai Meng, D.T., additional, Hollebecque, A., additional, Borad, M., additional, Goyal, L., additional, Schram, A., additional, Cassier, P., additional, Kamath, S.D., additional, Dotan, E., additional, Kim, R., additional, Sahai, V., additional, Liao, C-Y., additional, Millward, M., additional, Roda Perez, D., additional, Blakesley, R., additional, Wolf, B., additional, Subbiah, V., additional, Kelley, R.K., additional, and Oh, D-Y., additional

Published
2022
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7. Long-Term Results of a Multi-Institutional Phase II Study of Hypofractionated Proton Beam Irradiation of Unresectable Primary Liver Tumors

Author

Roberts, H.J., primary, Hong, T.S., additional, Ly, L., additional, Yeap, B.Y., additional, Ben-Josef, E., additional, Zhu, A.X., additional, Goyal, L., additional, Franses, J., additional, Ryan, D.P., additional, Allen, J.N., additional, Clark, J.W., additional, Drapek, L.C., additional, Tanabe, K., additional, Ferrone, C.R., additional, Koay, E.J., additional, Crane, C.H., additional, DeLaney, T.F., additional, and Wo, J.Y., additional

Published
2022
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8. Identifying FGFR2 fusions/rearrangements in cholangiocarcinoma patients using a novel cfDNA algorithm for treatment with RLY-4008, a highly selective irreversible FGFR2 inhibitor

Author

Schram, A., primary, Borad, M., additional, Sahai, V., additional, Kamath, S., additional, Kim, R., additional, Liao, C.Y.A., additional, Oh, D.Y., additional, Ponz-Sarvisé, M., additional, Yachnin, J., additional, Shell, S.A., additional, Cassier, P., additional, Dotan, E., additional, Florou, V., additional, Moreno, V., additional, Park, J.O., additional, Tai, D., additional, Schmidt-Kittler, O., additional, Ferté, C., additional, Goyal, L., additional, and Subbiah, V., additional

Published
2022
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9. Treatment of Cholangiocarcinoma with a Humanized Anti-Claudin-1 Monoclonal Antibody

Author

Muller, M., primary, Nehme, Z., additional, Röhlen, N., additional, Juehling, F., additional, Crouchet, E., additional, Pessaux, P., additional, Felli, E., additional, Goyal, L., additional, Meyer, M., additional, Iacone, R., additional, Toso, A., additional, Bardeesy, N., additional, Schuster, C., additional, Mailly, L., additional, and Baumert, T., additional

Published
2022
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10. LBA12 Efficacy of RLY-4008, a highly selective FGFR2 inhibitor in patients (pts) with an FGFR2-fusion or rearrangement (f/r), FGFR inhibitor (FGFRi)-naïve cholangiocarcinoma (CCA): ReFocus trial

Author

Hollebecque, A., primary, Borad, M., additional, Goyal, L., additional, Schram, A., additional, Park, J.O., additional, Cassier, P.A., additional, Kamath, S.D., additional, Meng, D.T. Wai, additional, Dotan, E., additional, Kim, R., additional, Sahai, V., additional, Oh, D-Y., additional, Liao, C-Y., additional, Millward, M., additional, Perez, D. Roda, additional, Ferté, C., additional, Blakesley, R., additional, Wolf, B., additional, Subbiah, V., additional, and Kelley, R.K., additional

Published
2022
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11. Automatic Segmentation of Intra-treatment CT Images for Adaptive Radiation Therapy of the Prostate

Author

Davis, B. C., Foskey, M., Rosenman, J., Goyal, L., Chang, S., Joshi, S., Hutchison, David, editor, Kanade, Takeo, editor, Kittler, Josef, editor, Kleinberg, Jon M., editor, Mattern, Friedemann, editor, Mitchell, John C., editor, Naor, Moni, editor, Nierstrasz, Oscar, editor, Pandu Rangan, C., editor, Steffen, Bernhard, editor, Sudan, Madhu, editor, Terzopoulos, Demetri, editor, Tygar, Dough, editor, Vardi, Moshe Y., editor, Weikum, Gerhard, editor, Duncan, James S., editor, and Gerig, Guido, editor

Published
2005
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12. P-16 PROOF 301: A multicenter, open-label, randomized, phase 3 trial of infigratinib vs gemcitabine + cisplatin in patients with advanced cholangiocarcinoma with an FGFR2 gene fusion/rearrangement

Author

Abou-Alfa, G., primary, Borbath, I., additional, Goyal, L., additional, Lamarca, A., additional, Macarulla, T., additional, Oh, D., additional, Roychowdhury, S., additional, Sadeghi, S., additional, Shroff, R., additional, Soto, J., additional, Pedrioli, G., additional, Fumagalli, L., additional, Dambkowski, C., additional, and Javle, M., additional

Published
2022
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13. Recommendations from the ICM-VTE: General

Author

Parvizi, J., Abbas, A. A., Abcha, O., Abdelaal, M. S., Ackermann, P. W., Acuna, A. J., Ageno, W., Aguilar Ramirez, J. J., Akkaya, M., Alameddine, D., Alfaro, D. O., Alvand, A., Alzeedi, M., Andrade, A. J., Arnold, W. V., Arish, A., Austin, M. S., Ay, C., Azboy, I., Babis, G. C., Baker, C. M., Barrack, R. L., Barragan, E., Beaton-Comulada, D., Bedair, H. S., Bell, J. A., Beverland, D. E., Bhatia, N., Bialecki, J., Bondarenko, S., Bonilla, G., River Boschert, S. O., Bracho, C., Brooks, D., Buttaro, M., Cacan Daniel Caldeira, M. A., Callaghan, J., Campbell, D. G., Cancienne, J. M., Cannegieter, S. C., Canseco, J. A., Caprini, J. A., Carrier, M., Castro Bejarano, J. C., Catani, F., Ceylan, H. H., Cha, Y. -H., Chan, C. K., Chan, N., Cheung, M. H., Chisari, E., Cimminiello, C., Citak, M., Colon-Miranda, R. G., Colwell, C., Combs, K., Cordeiro, M., Corvi, J. J., Courtney Crispiana Cozowicz, P. M., Crawford, R. W., Cruz, E., D'Amore, T., Dantas, P., Della Valle, A. G., Deltour, C., Demanes, A. C., Djaja, Y. P., Dunbar, M. J., Egoavil, M. S., Egol, K. A., Eichinger, S., Elias, L. F., Emmerson, B. R., Ettema, H. B., Al Farii, H., Fernandez-Rodriguez, D., Fillingham, Y. A., Fu, H., Gallagher, N., Gary, J. L., Geerts, W. H., Ghazavi, M. T., Gleason, B., Goh, G. S., Goncalves, S., Goriainov, V., Goswami, K., Goyal, L., Granqvist, M., Grenho, A., Griffin, X., Hafez, M. A., Hakyemez, O. S., Hamdi, S., Hansen, E. N., Hansen, H., Hasegawa, M., Higuera, C. A., Hobohm, L. M. A., Holc, F., Hollingsworth, N., Hozack, W. J., Hughes, A. J., Humphrey, T. J., Huo, M. H., Inaba, Y., Jenny, J. -Y., Jiranek, W., Kaila, R., Kallel, S., Kamath, A. F., Karachalios, T., Karas, V., Kelkar, A. H., Keller, K., Kenanidis, E., Khan, I. A., Khan, Y., Kim, J. -H., Kim, K. -I., Klein, G. R., Kleiner, J. E., Komnos, G., Konstantinides, S. V., Koo, K. -H., Kopenitz, J., Krasinski, Z., Krueger, C. A., Kuo, A., Kvederas, G., Kwong, L. M., Lachiewicz, P. F., De Ladoucette, A., Larco, E., Larkin, J. A., Levine, B. R., W. T., Li, Lieberman, J. R., Lip, G. Y. H., Lizarraga, M. M., Llinas, A., Lobastov, K., Lobo, C. A., Ludwick, L., Julian, F., Maempel, Magnuson, J., Maini, L., Maltseva, V., Mamczak, C. N., Garcia-Mansilla, A., Manzaneda, M. E., Martino, V., Al Maskari, S., Matharu, G. S., Mead, M., Meghpara, M. M., Mehta, S., Memtsoudis, S. G., Menon, D., Merli Nikolaos Milonakis, G. J., Mirkazemi, C., Mojica, J. J., Moka, E., Moncman, T. G., Monsalvo, D., Mortazavi, S. M. J., Morton, J., Mulcahey, M. K., Najafi, F., Nam, D., Namdari, S., Navarro, R., Nazarian, D. G., Niikura, T., Noyez, J. F., Ochoa Chaar, C. I., Ong, C. B., Otero-Lopez, A., Ozaki, T., Pandit, H., Pannu, T. S., Parvizi, N., Poeran, J., Poolman, R. W., Purtill, J. J., Radoicic, D. K., Rajasekaran, R. B., Rajasekhar, A., Randelli, F., Reed, M., Restrepo, C., Riva, N., Romanini, E., Sadek, M., Saglam, Y., Salazar, G., Salazar, M., Salvati, E. A., Samama, C. M., Sanchez-Osorio, J. S., Santoso, A., Sattarzadeh, R., Saxena, A., Schemitsch, E., Schulman, S., Schwenk, E. S., Shahi, A., Sharkey, P. F., Sharrock, N., Shivakumar, S., Shohat, N., Siegel, N. M., Sievers, D. A., Smailys, A., Smith, E. B., Somers, J. F. A., Souissi, M., Sousa, P., Sousa, R., Spyropoulos, A. C., Squizzato, A., Srivastava, A., Suarez, C., Suresh, S., Tannoury, T., Tarabichi, M., Tarabichi, S., Taylor, J., Terhune, E. B., Thienpont, E., Thomas, T. L., Top, A. C., Tornetta, P., Torres, A., Torres-Lugo, N. J., Tort-Saade, P., Tresgallo-Pares, R., Tsiridis, E., Tuncay, I., Urbanek, T., Urish, K. L., Vendittoli, P. -A., Victor, K., Vilchez, F., Villa, J. M., Viscusi, E. R., Volk, T., Vosooghi, F., Vysotskyi, O., Walsh, M., Warren, J., Werner, B. C., Westrich, G., Whitehouse, M. R., Whitehouse, S. L., Winters, B. S., Wouthuyzen-Bakker, M., Yamada, K., Yates, A. J., Yoo, J. -I., Yoon, U., Zambianchi, F., UCL - SSS/IREC/NMSK - Neuro-musculo-skeletal Lab, UCL - (SLuc) Service d'orthopédie et de traumatologie de l'appareil locomoteur, and Delegates, ICM-VTE General

Subjects
Risk Factors, Anticoagulants, Humans, Orthopedics and Sports Medicine, Surgery, General Medicine, Venous Thromboembolism
Published
2022

14. Futibatinib, an Irreversible FGFR1-4 Inhibitor, in Patients with Advanced Solid Tumors Harboring FGF/FGFR Aberrations: A Phase I Dose-Expansion Study

Author

Meric-Bernstam, F, Bahleda, R, Hierro, C, Sanson, M, Bridgewater, J, Arkenau, H-T, Tran, B, Kelley, RK, Park, JO, Javle, M, He, Y, Benhadji, KA, Goyal, L, Meric-Bernstam, F, Bahleda, R, Hierro, C, Sanson, M, Bridgewater, J, Arkenau, H-T, Tran, B, Kelley, RK, Park, JO, Javle, M, He, Y, Benhadji, KA, and Goyal, L

Abstract

Futibatinib, a highly selective, irreversible FGFR1-4 inhibitor, was evaluated in a large multihistology phase I dose-expansion trial that enrolled 197 patients with advanced solid tumors. Futibatinib demonstrated an objective response rate (ORR) of 13.7%, with responses in a broad spectrum of tumors (cholangiocarcinoma and gastric, urothelial, central nervous system, head and neck, and breast cancer) bearing both known and previously uncharacterized FGFR1-3 aberrations. The greatest activity was observed in FGFR2 fusion/rearrangement-positive intrahepatic cholangiocarcinoma (ORR, 25.4%). Some patients with acquired resistance to a prior FGFR inhibitor also experienced responses with futibatinib. Futibatinib demonstrated a manageable safety profile. The most common treatment-emergent adverse events were hyperphosphatemia (81.2%), diarrhea (33.5%), and nausea (30.4%). These results formed the basis for ongoing futibatinib phase II/III trials and demonstrate the potential of genomically selected early-phase trials to help identify molecular subsets likely to benefit from targeted therapy. SIGNIFICANCE: This phase I dose-expansion trial demonstrated clinical activity and tolerability of the irreversible FGFR1-4 inhibitor futibatinib across a broad spectrum of FGFR-aberrant tumors. These results formed the rationale for ongoing phase II/III futibatinib trials in cholangiocarcinoma, breast cancer, gastroesophageal cancer, and a genomically selected disease-agnostic population.This article is highlighted in the In This Issue feature, p. 275.

Published
2022

15. POSA354 Patient-Reported Outcomes in Futibatinib-Treated Intrahepatic Cholangiocarcinoma Patients with FGFR2 Fusions/Rearrangements: Results from the Foenix-CCA2 Study

Author

Bridgewater, JA, primary, Hollebecque, A, additional, Furuse, J, additional, Goyal, L, additional, Meric-Bernstam, F, additional, Epstein, RS, additional, Morlock, R, additional, Salimi, T, additional, Wacheck, V, additional, Liu, M, additional, Benhadji, K, additional, and Valle, JW, additional

Published
2022
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16. Futibatinib for FGFR2-Rearranged Intrahepatic Cholangiocarcinoma.

Author

Goyal, L., Meric-Bemstam, F., Hollebecque, A., Valle, J. W., Morizane, C., Karasic, T. B., Abrams, T. A., Furuse, J., Kelley, R. K., Cassier, P. A., Klümpen, H.-J., Chang, H.-M., Chen, L.-T., Tabernero, J., Oh, D.-Y., Mahipal, A., Moehler, M., Mitchell, E. P., Komatsu, Y., and Masuda, K.

Subjects
*FIBROBLAST growth factor 2, *FIBROBLAST growth factor receptors, *CHOLANGIOCARCINOMA, *ADVERSE health care events, *CANCER fatigue
Abstract

BACKGROUND Alterations in fibroblast growth factor receptor 2 (FGFR2) have emerged as promising drug targets for intrahepatic cholangiocarcinoma, a rare cancer with a poor prognosis. Futibatinib, a next-generation, covalently binding FGFR1-4 inhibitor, has been shown to have both antitumor activity in patients with FGFR-altered tumors and strong preclinical activity against acquired resistance mutations associated with ATP-competitive FGFR inhibitors. METHODS In this multinational, open-label, single-group, phase 2 study, we enrolled patients with unresectable or metastatic FGFR2 fusion-positive or FGFR2 rearrangement-positive intrahepatic cholangiocarcinoma and disease progression after one or more previous lines of systemic therapy (excluding FGFR inhibitors). The patients received oral futibatinib at a dose of 20 mg once daily in a continuous regimen. The primary end point was objective response (partial or complete response), as assessed by independent central review. Secondary end points included the response duration, progression-free and overall survival, safety, and patient-reported outcomes. RESULTS Between April 16, 2018, and November 29, 2019, a total of 103 patients were enrolled and received futibatinib. A total of 43 of 103 patients (42%; 95% confidence interval, 32 to 52) had a response, and the median duration of response was 9.7 months. Responses were consistent across patient subgroups, including patients with heavily pretreated disease, older adults, and patients who had co-occurring TP53 mutations. At a median follow-up of 17.1 months, the median progression-free survival was 9.0 months and overall survival was 21.7 months. Common treatment-related grade 3 adverse events were hyperphosphatemia (in 30% of the patients), an increased aspartate aminotransferase level (in 7%), stomatitis (in 6%), and fatigue (in 6%). Treatment-related adverse events led to permanent discontinuation of futibatinib in 2% of the patients. No treatment-related deaths occurred. Quality of life was maintained throughout treatment. CONCLUSIONS In previously treated patients with FGFR2 fusion or rearrangement-positive intrahepatic cholangiocarcinoma, the use of futibatinib, a covalent FGFR inhibitor, led to measurable clinical benefit. (Funded by Taiho Oncology and Taiho Pharmaceutical; FOENIX-CCA2 ClinicalTrials.gov number, NCT02052778.) [ABSTRACT FROM AUTHOR]

Published
2023
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19. 59TiP Phase III study of NUC-1031 + cisplatin vs gemcitabine + cisplatin for first-line treatment of patients with advanced biliary tract cancer (NuTide:121)

Author

Knox, J., primary, McNamara, M.G., additional, Goyal, L., additional, Cosgrove, D., additional, Springfeld, C., additional, Sjoquist, K., additional, Park, J.O., additional, Verdaguer, H., additional, Braconi, C., additional, Ross, P., additional, Oh, D-Y., additional, De Gramont, A., additional, Shroff, R.T., additional, Zalcberg, J.R., additional, Palmer, D., additional, and Valle, J.W., additional

Published
2021
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21. Ramucirumab for patients with advanced hepatocellular carcinoma and elevated alpha fetoprotein following a non-sorafenib based systemic therapy: interim results from an expansion cohort of the phase 3 REACH-2 study

Author

Pinter non-author presenter, M, additional, Finn, R, additional, De Toni, E, additional, Chung Cheung Yau, T, additional, Yen, C, additional, Hsu, C, additional, Chan, S, additional, He, A, additional, Galle, P, additional, Trojan, J, additional, Stirnimann, G, additional, Baron, A, additional, Acosta-Rivera, M, additional, Goyal, L, additional, Wang, C, additional, Abada, P, additional, Widau, R, additional, and Zhu, A, additional

Published
2021
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22. P-70 First-in-human study of highly selective FGFR2 inhibitor, RLY-4008, in patients with intrahepatic cholangiocarcinoma and other advanced solid tumors

Author

Goyal, L., primary, Subbiah, V., additional, Mahipal, A., additional, Kamath, S., additional, Mody, K., additional, Borad, M., additional, El-Khoueiry, A., additional, Sahai, V., additional, Kim, R., additional, Kelley, R., additional, Schmidt-Kittler, O., additional, Shen, J., additional, Jen, K., additional, Deary, A., additional, Padval, M., additional, Sherwin, C., additional, Wolf, B., additional, and Schram, A., additional

Published
2021
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27. Phase I, first-in-human study of futibatinib, a highly selective, irreversible FGFR1-4 inhibitor in patients with advanced solid tumors.

Author

Bahleda, R, Meric-Bernstam, F, Goyal, L, Tran, B, He, Y, Yamamiya, I, Benhadji, KA, Matos, I, Arkenau, H-T, Bahleda, R, Meric-Bernstam, F, Goyal, L, Tran, B, He, Y, Yamamiya, I, Benhadji, KA, Matos, I, and Arkenau, H-T

Abstract

BACKGROUND: Futibatinib is an oral, irreversible, highly selective fibroblast growth factor receptor (FGFR)1-4 inhibitor with potent preclinical activity against tumors harboring FGFR aberrations. This first-in-human, phase I dose-escalation trial (NCT02052778) evaluates the safety and pharmacokinetics/pharmacodynamics of futibatinib in advanced solid tumors. PATIENTS AND METHODS: Following a standard 3+3 dose-escalation design, eligible patients with advanced solid tumors refractory to standard therapies received 8-200 mg futibatinib three times a week (t.i.w.) or 4-24 mg once daily (q.d.). RESULTS: A total of 86 patients were enrolled in the nine t.i.w. (n = 42) and five q.d. cohorts (n = 44); 71 patients (83%) had tumors harboring FGF/FGFR aberrations. Three of nine patients in the 24-mg q.d. cohort experienced dose-limiting toxicities, including grade 3 increases in alanine transaminase, aspartate transaminase, and blood bilirubin (n = 1 each). The maximum tolerated dose (MTD) was determined to be 20 mg q.d.; no MTD was defined for the t.i.w. schedule. Across cohorts (n = 86), the most common treatment-emergent adverse events (TEAEs) were hyperphosphatemia (59%), diarrhea (37%), and constipation (34%); 48% experienced grade 3 TEAEs. TEAEs led to dose interruptions, dose reductions, and treatment discontinuations in 55%, 14%, and 3% of patients, respectively. Pharmacokinetics were dose proportional across all q.d. doses but not all t.i.w. doses evaluated, with saturation observed between 80 and 200 mg t.i.w. Serum phosphorus increased dose dependently with futibatinib on both schedules, but a stronger exposure-response relationship was observed with q.d. dosing, supporting 20 mg q.d. as the recommended phase II dose (RP2D). Overall, partial responses were observed in five patients [FGFR2 fusion-positive intrahepatic cholangiocarcinoma (n = 3) and FGFR1-mutant primary brain tumor (n = 2)], and stable disease in 41 (48%). CONCLUSIONS: Futibatinib treatment resulted

Published
2020

28. Long Term Follow-up of a Phase II Study of Autophagy Inhibition with Hydroxychloroquine (HCQ) and Preoperative (Preop) Short Course Chemoradiation (SCRT) Followed by Early Surgery for Resectable Ductal Adenocarcinoma of the Head of Pancreas (PDAC)

Author

Hong, T.S., primary, Lennerz, J.K., additional, Wo, J.Y., additional, Ulysse, C., additional, Yeap, B.Y., additional, Clark, J.W., additional, Ryan, D.P., additional, Blaszkowsky, L.S., additional, Drapek, L.C., additional, Ting, D., additional, Murphy, J., additional, Faris, J., additional, Allen, J.N., additional, Zhu, A.X., additional, Goyal, L., additional, Lillemoe, K., additional, Ferrone, C.R., additional, DeLaney, T.F., additional, Fernandez-del Casti, C., additional, and Kimmelman, A.C., additional

Published
2020
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29. 116MO Efficacy, safety, and quality of life (QoL) with futibatinib in patients (pts) with intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 fusions/rearrangements: FOENIX-CCA2

Author

Furuse, J., primary, Goyal, L., additional, Meric-Bernstam, F., additional, Hollebecque, A., additional, Valle, J.W., additional, Morizane, C., additional, Karasic, T.B., additional, Abrams, T.A., additional, Kelley, R.K., additional, Cassier, P.A., additional, Klumpen, H-J., additional, Uboha, N., additional, Mahipal, A., additional, Mitchell, E., additional, Ahn, E., additional, Chang, H-M., additional, Masuda, K., additional, He, Y., additional, Benhadji, K.A., additional, and Bridgewater, J.A., additional

Published
2020
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34. 1014TiP PROOF: A multicenter, open-label, randomized, phase III trial of infigratinib vs gemcitabine + cisplatin in patients with advanced cholangiocarcinoma with FGFR2 gene rearrangements

Author

Abou-Alfa, G.K., primary, Borbath, I., additional, Cohn, A.L., additional, Goyal, L., additional, Lamarca, A., additional, Macarulla, T., additional, Oh, D-Y., additional, Roychowdhury, S., additional, Sadeghi, S., additional, Shroff, R.T., additional, Howland, M., additional, Li, A., additional, Cho, T., additional, Pande, A., additional, and Javle, M., additional

Published
2020
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35. 54P Efficacy and safety of futibatinib in intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 fusions/other rearrangements: Subgroup analyses of a phase II study (FOENIX-CCA2)

Author

Bridgewater, J., primary, Meric-Bernstam, F., additional, Hollebecque, A., additional, Valle, J.W., additional, Morizane, C., additional, Karasic, T., additional, Abrams, T., additional, Furuse, J., additional, Kelley, R.K., additional, Cassier, P., additional, Klümpen, H-J., additional, Uboha, N., additional, Mahipal, A., additional, Mitchell, E., additional, Ahn, E.R., additional, Chang, H-M., additional, Masuda, K., additional, He, Y., additional, Benhadji, K., additional, and Goyal, L., additional

Published
2020
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36. 80TiP Global phase III study of NUC-1031 plus cisplatin vs gemcitabine plus cisplatin for first-line treatment of patients with advanced biliary tract cancer (NuTide:121)

Author

Knox, J.J., primary, McNamara, M.G., additional, Goyal, L., additional, Doherty, M., additional, Cosgrove, D., additional, Springfeld, C., additional, Sjoquist, K., additional, Park, J.O., additional, Verdaguer, H., additional, Braconi, C., additional, Ross, P., additional, De Gramont, A., additional, Zalcberg, J.R., additional, Palmer, D., additional, and Valle, J.W., additional

Published
2020
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37. SO-5 Efficacy of second-line chemotherapy in patients with advanced or metastatic cholangiocarcinoma and FGFR2 fusions: A retrospective analysis

Author

Javle, M., primary, Sadeghi, S., additional, Roychowdhury, S., additional, El-Khoueiry, A., additional, Goyal, L., additional, Philip, P., additional, Kelley, R., additional, Borbath, I., additional, Macarulla, T., additional, Yong, W., additional, Tanasanvimon, S., additional, Li, A., additional, Howland, M., additional, Pande, A., additional, and Abou-Alfa, G., additional

Published
2020
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38. P-144 Infigratinib versus gemcitabine plus cisplatin as first-line therapy in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations: phase 3 PROOF trial

Author

Abou-Alfa, G., primary, Borbath, I., additional, Cohn, A., additional, Goyal, L., additional, Lamarca, A., additional, Macarulla, T., additional, Oh, D., additional, Roychowdhury, S., additional, Sadeghi, S., additional, Shroff, R., additional, Howland, M., additional, Li, A., additional, Cho, T., additional, Pande, A., additional, and Javle, M., additional

Published
2020
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43. 326 (PB106) - Identifying FGFR2 fusions/rearrangements in cholangiocarcinoma patients using a novel cfDNA algorithm for treatment with RLY-4008, a highly selective irreversible FGFR2 inhibitor

Author

Schram, A., Borad, M., Sahai, V., Kamath, S., Kim, R., Liao, C.Y.A., Oh, D.Y., Ponz-Sarvisé, M., Yachnin, J., Shell, S.A., Cassier, P., Dotan, E., Florou, V., Moreno, V., Park, J.O., Tai, D., Schmidt-Kittler, O., Ferté, C., Goyal, L., and Subbiah, V.

Published
2022
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46. Patterns of Care and Outcomes of Definitive External Beam Radiotherapy and Radioembolization for Localized Hepatocellular Carcinoma: A Propensity Score-Adjusted Analysis

Author

Bitterman, D.S., primary, Sanford, N.N., additional, Niemierko, A., additional, Mahal, B.A., additional, Qadan, M., additional, Ganguli, S., additional, Blaszkowsky, L.S., additional, Zhu, A.X., additional, Hong, T.S., additional, Devlin, P.M., additional, Goyal, L., additional, and Wo, J.Y., additional

Published
2019
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48. PARP-ness in metastatic colorectal cancer

Author

Mauri, G., primary, Kanter, K., additional, Fish, M., additional, Horick, N., additional, Allen, J., additional, Blaszkowsky, L., additional, Clark, J., additional, Ryan, D., additional, Nipp, R., additional, Giantonio, B., additional, Goyal, L., additional, Dubois, J., additional, Murphy, J., additional, Roeland, E., additional, Weekes, C., additional, Wo, J., additional, Hong, T., additional, Zhu, A., additional, Van Seventer, E., additional, Corcoran, R., additional, and Parikh, A., additional

Published
2019
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49. Debio 1347 in patients with gastrointestinal cancers harboring an FGFR gene fusion: preliminary results

Author

Matos, I., primary, Goyal, L., additional, Cleary, J., additional, Voss, M., additional, Oh, D., additional, Bernstam, F. Meric, additional, Ng, C., additional, Iyer, G., additional, Ishii, N., additional, Hu, Y., additional, Chessex, A. Vaslin, additional, Pokorska-Bocci, A., additional, Nicolas, V., additional, Kirpicheva, Y., additional, Zanna, C., additional, Flaherty, K., additional, Tabernero, J., additional, and Hyman, D., additional

Published
2019
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50. Serial circulating tumor DNA (ctDNA) monitoring to predict response to treatment in metastatic gastrointestinal cancers

Author

Parikh, A., primary, Kanter, K., additional, Mojtahed, A., additional, Schneider, J., additional, Van Seventer, E., additional, Fish, M., additional, Allen, J., additional, Blaszkowsky, L., additional, Wo, J., additional, Clark, J., additional, Giantonio, B., additional, Goyal, L., additional, Hong, T., additional, Nipp, R., additional, Roeland, E., additional, Weekes, C., additional, Zhu, A., additional, Ryan, D., additional, Fetter, I., additional, Horick, N., additional, and Corcoran, R., additional

Published
2019
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