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60. Impact of Primary Tumour Location and Early Tumour Shrinkage on Outcomes in Patients with RAS Wild-Type Metastatic Colorectal Cancer Following First-Line FOLFIRI Plus Panitumumab

Author

Köhne CH, Karthaus M, Mineur L, Thaler J, Van den Eynde M, Gallego J, Koukakis R, Berkhout M, and Hofheinz RD

Abstract

Objective Data from a trial of first-line panitumumab plus FOLFIRI (folinic acid, infusional 5-fluorouracil and irinotecan) in metastatic colorectal cancer were retrospectively analysed to investigate the effects of primary tumour location and early tumour shrinkage on outcomes. Methods Patients with RAS wild-type metastatic colorectal cancer from a single-arm, open-label phase II study (NCT00508404) were included. Tumours located from the splenic flexure to rectum and in the caecum to transverse colon were defined as left- and right-sided, respectively. Baseline characteristics were summarised by primary tumour location and the effects of primary tumour location on outcomes-including objective response rate, resection rate, depth of response, duration of response and progression-free survival-were analysed. Progression-free survival and objective response rate were analysed by early tumour shrinkage status. Results Primary tumour location was determined in 52/69 (75%) patients with RAS wild-type metastatic colorectal cancer; 45 (87%) had left-sided disease. Median progression-free survival was longer in patients with left-sided tumours (11.2 vs. 7.2 months for right-sided disease) and more of these patients experienced early tumour shrinkage >= 30% (53% vs. 29%). Early tumour shrinkage >= 30% was associated with improved progression-free survival irrespective of tumour location. More patients with early tumour shrinkage >= 30% achieved a partial or complete response. Objective response rate, duration of response, depth of response and resection rates were similar in patients with left- and right-sided tumours. Conclusions This analysis has confirmed a prognostic effect of primary tumour location in patients with RAS wild-type metastatic colorectal cancer receiving first-line panitumumab plus FOLFIRI. Early tumour shrinkage was associated with improved progression-free survival irrespective of tumour location. In right-sided disease, early tumour shrinkage may identify a subgroup of patients who might respond to panitumumab. ClinicalTrials.gov identifier NCT00508404.

Published
2019

61. Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation A Randomized Clinical Trial

Author

Bastidas, A, de la Serna, J, El Idrissi, M, Oostvogels, L, Quittet, P, Lopez-Jimenez, J, Vural, F, Pohlreich, D, Zuckerman, T, Issa, NC, Gaidano, G, Lee, JJ, Abhyankar, S, Solano, C, de Oteyza, JP, Satlin, MJ, Schwartz, S, Campins, M, Rocci, A, Llamas, CV, Lee, DG, Tan, SM, Johnston, AM, Grigg, A, Boeckh, MJ, Campora, L, Lopez-Fauqued, M, Heineman, TC, Stadtmauer, EA, Sullivan, KM, Alonso, AA, Anagnostopoulos, A, Andreadis, C, Angelopoulou, M, Anttila, VJ, Aoun, M, Barista, I, Berkahn, L, Bloor, AJC, Broady, R, Brossart, P, Buadi, FK, Bulabois, CE, Cantin, G, Cellini, C, Chandrasekar, PH, Chauncey, T, Cuneo, A, Dadwal, SS, Dickinson, M, Eom, H, Sanfeliu, AE, Coll, CF, Flomenberg, PR, Gonzalez-Rodriguez, AP, Gottlieb, DJ, Grisariu, S, Guenther, A, Gutman, J, Hahn, U, Heinz, WJ, Heras, I, Ikeda, T, Jarque, I, Karthaus, M, Kerre, T, Kiani, A, Klein, AK, Kofla, G, Kryuchkova, IV, Kuo, CY, Kuruvilla, J, Kuvshinov, A, Kwak, JY, Lee, JH, Lepretre, S, Lie, AKW, Lucchesi, A, Maertens, J, Marijt, EWA, Munoz, CM, Michieli, M, Milliken, ST, Milpied, N, Coll, JM, Mossad, SB, Murphy, J, Matilla, MBN, Novak, J, Olney, HJ, Navarrete, RO, Cascon, MJP, Peniket, A, Penka, G, Piatkowska-Jakubas, B, Zarzuela, MP, Quiel, D, Rowley, SD, Sabry, W, Salmi, TM, Selleslag, DLD, Shea, TC, Silling, G, Sinisalo, UM, Sohn, SK, Staib, P, Szer, J, Theunissen, K, Topcuoglu, P, Tyurina, NG, Uvarov, M, Wahid, FSA, San Segundo, LY, Yegin, ZA, Yeh, SP, Yip, SF, Yoon, SS, Young, JAH, Zachee, P, Zaja, F, and ZOE-HSCT Study Grp Collaborators

Abstract

IMPORTANCE Herpes zoster, a frequent complication following autologous hematopoietic stem cell transplantation (HSCT), is associated with significant morbidity. A nonlive adjuvanted recombinant zoster vaccine has been developed to prevent posttransplantation zoster. OBJECTIVE To assess the efficacy and adverse event profile of the recombinant zoster vaccine in immunocompromised autologous HSCT recipients. DESIGN, SETTING, AND PARTICIPANTS Phase 3, randomized, observer-blinded study conducted in 167 centers in 28 countries between July 13, 2012, and February 1, 2017, among 1846 patients aged 18 years or older who had undergone recent autologous HSCT. INTERVENTIONS Participants were randomized to receive 2 doses of either recombinant zoster vaccine (n=922) or placebo (n=924) administered into the deltoid muscle; the first dose was given 50 to 70 days after transplantation and the second dose 1 to 2 months thereafter. MAIN OUTCOMES AND MEASURES The primary end point was occurrence of confirmed herpes zoster cases. RESULTS Among 1846 autologous HSCT recipients (mean age, 55 years; 688 [37%] women) who received 1 vaccine or placebo dose, 1735 (94%) received a second dose and 1366 (74%) completed the study. During the 21-month median follow-up, at least 1 herpes zoster episode was confirmed in 49 vaccine and 135 placebo recipients (incidence, 30 and 94 per 1000 person-years, respectively), an incidence rate ratio (IRR) of 0.32 (95% CI, 0.22-0.44; P

Published
2019

62. Thromboseprophylaxe (II)

Author

Gösling, T., primary, Schmidt, U., additional, Depka-Prondzinski, M. V., additional, Karthaus, M., additional, Barthels, M., additional, and Blauth, M., additional

Published
2000
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82. Secondary antifungal prophylaxis: 953

Author

Cornely, O. A., Sieniawski, M., Böhme, A., Maschmeyer, G., Reichert, D., Karthaus, M., Buchheidt, D., Martino, R., Einsele, H., Silling, G., Öhler, L., Schiel, X., Ullmann, A. J., Glasmacher, A., Krüger, W., Gratwohl, A., Lövenich, H., and Fätkenheuer, G.

Published
2002

86. Exploratory analyses assessing the impact of early tumour shrinkage and depth of response on survival outcomes in patients with RAS wild-type metastatic colorectal cancer receiving treatment in three randomised panitumumab trials

Author

Taieb J, Rivera F, Siena S, Karthaus M, Valladares-Ayerbes M, Gallego J, Geissler M, Koukakis R, Demonty G, and Peeters M

Subjects
Depth of response, Early tumour shrinkage, Metastatic colorectal cancer, Panitumumab, Survival
Abstract

To report exploratory analyses of early tumour shrinkage (ETS) and depth of response (DpR) in patients with RAS wild-type (WT) metastatic colorectal cancer (mCRC), receiving the first-line treatment in three randomised panitumumab trials.

Published
2018

87. New AGIHO-guideline for diagnosis and therapy of CVC-associated infections

Author

Böll, B., Buchheidt, D., Hasenkamp, J., Kiehl, M., Kiderlen, T., Kochanek, M., Koldehoff, Michael, Kostrewa, P., Löhnert, A., Mellinghoff, Sibylle C., Metzner, B., Penack, O., Ruhnke, M., Enrico, S., Vehreschild, M., Weißinger, F., Wolf, H.-H., Hentrich, M., and Karthaus, M.

Subjects
Medizin
Published
2018

93. Prophylaxis and treatment of invasive aspergillosis with voriconazole, posaconazole and caspofungin - review of the literature

Author

Karthaus M

Subjects
Medicine
Abstract

Abstract Major progress for the management of invasive aspergillosis has come from the introduction of new antifungals since the late 1990s. Although mortality of invasive aspergillosis remains as high as 30-50%. Backbone of management are prophylaxis, early diagnosis and early initiation of antifungals for reduction of invasive aspergillosis related mortality. Randomized trials have been undertaken for the prophylaxis as well as treatment of invasive aspergillosis in the last two decades. Posaconazole is recommended for prophylaxis against aspergillosis in patients treated for acute myelogenous leukemia, myelodysplastic syndrome or patients with graft versus host disease after allogeneic transplantation. Efficacy has been shown for first-line therapy of invasive aspergillosis with voriconazole and liposomal amphotericin B. Gastrointestinal resorption for the azoles posaconazole, voriconazole and itraconazole differ considerably. While oral voriconazole resportion is reduced when taken with food, posaconazole has to be taken with fatty food for optimal intestinal resorption. Beside all advances in the management of invasive aspergillosis important questions remain unresolved. This article reviews the current state of prophylaxis and treatment of invasive aspergillosis and points out clinicians unmet needs.

Published
2011
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97. New AGIHO-guideline for diagnosis and therapy of CVC-associated infections

Author

Boell, B., Buchheidt, D., Hasenkamp, J., Kiehl, M., Kiderlen, T., Kochanek, M., Koldehoff, M., Kostrewa, P., Loehnert, A., Mellinghoff, S. C., Metzner, B., Penack, O., Ruhnke, M., Enrico, S., Vehreschild, M., Weissinger, F., Wolf, H. -H, Hentrich, M., Karthaus, M., Boell, B., Buchheidt, D., Hasenkamp, J., Kiehl, M., Kiderlen, T., Kochanek, M., Koldehoff, M., Kostrewa, P., Loehnert, A., Mellinghoff, S. C., Metzner, B., Penack, O., Ruhnke, M., Enrico, S., Vehreschild, M., Weissinger, F., Wolf, H. -H, Hentrich, M., and Karthaus, M.

Published
2018

98. Bezlotoxumab for Prevention of Recurrent Clostridium difficile Infection

Author

Wilcox, M. H., Gerding, D. N., Poxton, I. R., Kelly, C., Nathan, R., Birch, T., Cornely, O. A., Rahav, G., Bouza, E., Lee, C., Jenkin, G., Jensen, W., Kim, Y. -S., Yoshida, J., Gabryelski, L., Pedley, A., Eves, K., Tipping, R., Guris, D., Kartsonis, N., Playford G, Dorr M. -B., Mcgechie, D, Iredell, J, Allworth, A, Cheng, A, Choi, Nj, Thalhammer, F, Maieron, A, Wenisch, C, Meyer, B, Jacobs, F, Delmee, M, Peetermans, W, Giot, Jb, Munhoz, Al, Kallas, Eg, Ladeira, Jp, Bernstein, Cn, Grimard, D, Mcgeer, A, Poirier, A, Valiquette, L, Miller, M, Oughton, M, Trottier, S, Dolce, P, Smyth, D, Gambra, P, Palma, S, Rojas, L, Northland, R, Arellano, Mc, Perez, J, Barreto, Mf, Gomez, Jm, Ramirez, I, Correa, A, Onate, J, Rohacova, H, Stastnik, M, Zjevikova, A, Blazek, J, Kumpel, P, Petersen, Am, Gluud, Ll, Staugaard, Hm, Tvede, M, Glerup, H, Madsen, Sm, Helms, M, Naumann, R, Karthaus, M, Reinshagen, M, Raz, R, Giladi, M, Chowers, M, Bishara, J, Quirino, T, Castelli, F, Bassetti, M, Rizzardini, G, Vismara, E, Puoti, M, Viale, P, Menichetti, F, Cauda, R, Bonfanti, P, Franzetti, F, Gori, A, Minoli, L, Noriega, Er, Mills, Gd, Ritchie, S, Burns, A, Pithie, A, dos Santos RM, Aldomiro, F, Fernando, Pb, Rola, J, Reis, E, Van Zyl JH, Aboo, N, Richards, G, Hernandez, Mj, de Medrano VA, Prunonosa, Lm, Gonzalez, Jl, Reinoso, Jc, Martinez, Ar, Cisneros, Jd, Banos, Jr, Sheridan, R, Minton, J, Williams, J, Stanley, P, Guleri, A, Llewelyn, M, Todd, N, Barlow, G, Bacon, Ae, Baird, Im, Baxter, R, Zenilman, Jm, Beshay, M, Betts, Rf, Brettholz, Em, Buitrago, Mi, Carlson, Rw, Cook, Pp, Dupont, Hl, Foley, C, Freilich, B, Giron, Ja, Golan, Y, Green, S, Hall, Mc, Johnson, Dj, Jones, Rk, Graham, Dr, Kazimir, M, Keating, M, Brumble, Lm, Kumar, Pn, Liappis, Ap, Libke, R, Mehra, Pk, Overcash, Sj, Mullane, Km, Nguyen, Mh, Patel, Mc, Powers, Ck, Pullman, J, Keegan, J, Nepal, S, English, G, Ricci, Rl, Risi, Gf, Rodriguez, M, Schmitt, Cm, Sims, Md, Kamepalli, R, Tural, A, Vazquez, Ja, Alangaden, Gj, Weavind, Lm, Young, Ma, Chen, St, Liu, E, Nguyen, Hh, Alfonso, Tb, Muse, Dd, Orenstein, R, Yacyshyn, B, Gebhard, Re, Dinges, W, Bolton, M, Rubin, M, Kuemmerle, Jf, Limaye, Ap, Friedenberg, Ka, Hiemenz, Jw, Quadri, A, Martinez, Jv, Barcan, La, Cordova, E, Mykietiuk, A, Losso, M, Fedorak, Rn, Steiner, T, Gerson, M, Weiss, K, Dlouhy, P, Vitous, A, Benes, J, Husa, P, Knizek, P, Anttila, Vj, Broas, M, Camou, F, Postil, D, Launay, O, Corroyer-Simovic, B, Meynard, Jl, Schneider, S, Molina, Jm, Neau, D, Zalcman, G, Boutoille, D, Ostermann, H, Heinz, W, Reuter, S, Oren, I, Schiff, E, Umemoto, T, Masubuchi, T, Mukawa, K, Yasuda, K, Imokawa, S, Fukuda, K, Ohta, H, Harada, N, Fujii, S, Tamaki, S, Yasui, S, Furukawa, K, Takahashi, M, Uraoka, T, Watanabe, M, Ikehara, Y, Kodaira, M, Komatsu, H, Higashi, K, Taguchi, F, Ura, N, Serizawa, Y, Fukuchi, T, Ashikawa, T, Shabana, M, Okubo, M, Matsumoto, M, Kurihara, A, Miyasaka, E, Shimizu, M, Tominaga, H, Kubota, T, Kashiwazaki, M, Masuda, Y, Terasaki, S, Okafuji, H, Mieno, H, Urabe, T, Okamoto, E, Kajimura, M, Yamagishi, Y, Rydzewska, G, Mach, T, Ciechanowski, K, Podlasin, R, Tomasiewicz, K, Janczewska-Kazek, E, Czarnobilski, K, Halota, W, Gryglewska, B, Plesniak, R, Dabrowiecki, P, Lipowski, D, Simanenkov, V, Shcheglova, L, Uspenskiy, Y, Cheganov, A, Han, Ds, Kim, Js, Hong, Sp, Kim, Ti, Jang, Bi, Byeon, Js, Kim, E, Kim, Mj, Lee, J, Pai, H, Cheong, Hj, Lee, S, Loyarte, Ja, Gonzalez, Jc, Santiago, Eb, Lopez, Jr, Baranda, Jm, Viladomiu, As, Calbo, E, Lannergard, A, Falt, J, Gardlund, B, Andersson, Lm, Fraenkel, Cj, Rombo, L, Widmer, A, Chen, Yc, Sheng, Wh, Wang, Fd, Wang, Nc, Lee, Ch, Chen, Yh, Chuang, Yc, Unal, S, Ozaras, R, Esen, S, Ural, O, Ayaz, C, Sakarya, S, Celebi, A, Mistik, R, Bedimo, R, Bressler, A, Mckinley, Mj, Quirk, D, Talansky, Al, Agronin, Me, Akhrass, Fa, Ali, M, Alrabaa, Sf, Assi, Ma, Calfee, Dp, Carson, P, Mariani, Pg, Guerrero, D, Dubberke, Er, Hardi, R, Hazan-Steinberg, S, Itani, Km, Jauregui-Peredo, El, Kasabji, A, Hameed, M, Murillo, A, Odio, Aj, Shah, P, Braun, Ti, Slim, J, Sloan, L, Srinivasan, S, Tan, Mj, Clough, La, Herr, D, Miller, Lg, Dorfmeister, J, Khan, O, and Melik-Abrahamian, F.

Subjects
0301 basic medicine, Male, Adolescent, Adult, Aged, Aged, 80 and over, Anti-Bacterial Agents, Antibodies, Monoclonal, Antibodies, Neutralizing, Clostridium Infections, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Infusions, Intravenous, Intention to Treat Analysis, Kaplan-Meier Estimate, Middle Aged, Secondary Prevention, Young Adult, Clostridium difficile, Clinical Trial, Phase III, Antibiotics, 0302 clinical medicine, Monoclonal, 80 and over, 030212 general & internal medicine, Medicine (all), Neutralizing, education.field_of_study, Research Support, Non-U.S. Gov't, General Medicine, Multicenter Study, Randomized Controlled Trial, Combination, Broadly Neutralizing Antibodies, Intravenous, medicine.medical_specialty, Infusions, medicine.drug_class, 030106 microbiology, Population, Placebo, Antibodies, 03 medical and health sciences, Pharmacotherapy, Drug Therapy, Internal medicine, Journal Article, medicine, education, Intention-to-treat analysis, Clostridioides difficile, business.industry, Interim analysis, Surgery, Bezlotoxumab, business
Abstract

BACKGROUND: Clostridium difficile is the most common cause of infectious diarrhea in hospitalized patients. Recurrences are common after antibiotic therapy. Actoxumab and bezlotoxumab are human monoclonal antibodies against C. difficile toxins A and B, respectively.METHODS: We conducted two double-blind, randomized, placebo-controlled, phase 3 trials, MODIFY I and MODIFY II, involving 2655 adults receiving oral standard-of-care antibiotics for primary or recurrent C. difficile infection. Participants received an infusion of bezlotoxumab (10 mg per kilogram of body weight), actoxumab plus bezlotoxumab (10 mg per kilogram each), or placebo; actoxumab alone (10 mg per kilogram) was given in MODIFY I but discontinued after a planned interim analysis. The primary end point was recurrent infection (new episode after initial clinical cure) within 12 weeks after infusion in the modified intention-to-treat population.RESULTS: In both trials, the rate of recurrent C. difficile infection was significantly lower with bezlotoxumab alone than with placebo (MODIFY I: 17% [67 of 386] vs. 28% [109 of 395]; adjusted difference, -10.1 percentage points; 95% confidence interval [CI], -15.9 to -4.3; PCONCLUSIONS: Among participants receiving antibiotic treatment for primary or recurrent C. difficile infection, bezlotoxumab was associated with a substantially lower rate of recurrent infection than placebo and had a safety profile similar to that of placebo. The addition of actoxumab did not improve efficacy. (Funded by Merck; MODIFY I and MODIFY II ClinicalTrials.gov numbers, NCT01241552 and NCT01513239 .).

Published
2017
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99. Amisulpride prevents nausea and vomiting associated with highly emetogenic chemotherapy: a randomised, double-blind, placebo-controlled, dose-ranging trial

Author

Herrstedt, J., primary, Summers, Y., additional, Jordan, K., additional, von Pawel, J., additional, Jakobsen, A. H., additional, Ewertz, M., additional, Chan, S., additional, Naik, J. D., additional, Karthaus, M., additional, Dubey, S., additional, Davis, R., additional, and Fox, G. M., additional

Published
2018
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100. Early tumour shrinkage (ETS) and its impact on tumour-related symptoms in patients with previously untreated RAS wild-type metastatic colorectal cancer (mCRC): A retrospective analysis of three panitumumab studies

Author

Taieb, J., primary, Geissler, M., additional, Rivera, F., additional, Karthaus, M., additional, Wilson, R., additional, Loupakis, F., additional, Price, T., additional, Tracy, M., additional, Burdon, P., additional, and Peeters, M., additional

Published
2018
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