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1. Fluoropyrimidine type, patient age, tumour sidedness and mutation status as determinants of benefit in patients with metastatic colorectal cancer treated with EGFR monoclonal antibodies: individual patient data pooled analysis of randomised trials from the ARCAD database

Author

Karapetis, C. S., Liu, H., Sorich, M. J., Pederson, L. D., Van Cutsem, E., Maughan, T., Douillard, J. Y., O’Callaghan, C. J., Jonker, D., Bokemeyer, C., Sobrero, A., Cremolini, C., Chibaudel, B., Zalcberg, J., Adams, R., Buyse, M., Peeters, M., Yoshino, T., de Gramont, A., and Shi, Q.

Published
2024
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3. Efficacy and safety of short-course radiotherapy versus total neoadjuvant therapy in older rectal cancer patients: a randomised pragmatic trial (SHAPERS)

Author

Saúde-Conde, R., primary, Vandamme, T., additional, De Backer, M., additional, Martinive, P., additional, Covas, A., additional, Deleporte, A., additional, Dermine, A., additional, Forget, F., additional, Geboes, K., additional, Gilliaux, Q., additional, Gokburun, Y., additional, Gonne, E., additional, Joye, I., additional, Lecomte, S., additional, Liberale, G., additional, Lybaert, W., additional, Moretti, L., additional, Mortier, L., additional, Mupingu Mwanawa, S., additional, Puleo, F., additional, Saad, E.D., additional, Sinapi, I., additional, Annemans, L., additional, Buyse, M., additional, and Sclafani, F., additional

Published
2024
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5. Efficacy and safety of short-course radiotherapy versus total neoadjuvant therapy in older rectal cancer patients: a randomised pragmatic trial (SHAPERS)

Author

Saúde Conde, Rita, Vandamme, T., De Backer, M., Martinive, P., Covas, Angélique, Deleporte, Amélie, Dermine, A., Forget, Frédéric, Geboes, K., Gilliaux, Q., Gokburun, Yeter, Gonne, E., Joye, Ines, Lecomte, Sylvie, Liberale, Gabriel, Lybaert, Willem, Moretti, Luigi, Mortier, Laurent, Mupingu Mwanawa, Sandra, Puleo, Francesco, Saad, E.D., Sinapi, Isabelle, Annemans, Lieven, Buyse, M., Sclafani, Francesco, Saúde Conde, Rita, Vandamme, T., De Backer, M., Martinive, P., Covas, Angélique, Deleporte, Amélie, Dermine, A., Forget, Frédéric, Geboes, K., Gilliaux, Q., Gokburun, Yeter, Gonne, E., Joye, Ines, Lecomte, Sylvie, Liberale, Gabriel, Lybaert, Willem, Moretti, Luigi, Mortier, Laurent, Mupingu Mwanawa, Sandra, Puleo, Francesco, Saad, E.D., Sinapi, Isabelle, Annemans, Lieven, Buyse, M., and Sclafani, Francesco

Abstract

info:eu-repo/semantics/published

Published
2024

7. Validation of metastasis-free survival as a surrogate endpoint for overall survival in localized prostate cancer in the era of docetaxel for castration-resistant prostate cancer

Author

Xie, W., primary, Ravi, P., additional, Buyse, M., additional, Halabi, S., additional, Kantoff, P., additional, Sartor, O., additional, Soule, H., additional, Clarke, N., additional, Dignam, J., additional, James, N., additional, Fizazi, K., additional, Gillessen, S., additional, Mottet, N., additional, Murphy, L., additional, Parulekar, W., additional, Sandler, H., additional, Tombal, B., additional, Williams, S., additional, and Sweeney, C.J., additional

Published
2023
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8. Effects of neratinib on health-related quality of life in women with HER2-positive early-stage breast cancer: longitudinal analyses from the randomized phase III ExteNET trial

Author

Delaloge, S., Cella, D., Ye, Y., Buyse, M., Chan, A., Barrios, C.H., Holmes, F.A., Mansi, J., Iwata, H., Ejlertsen, B., Moy, B., Chia, S.K.L., Gnant, M., Smichkoska, S., Ciceniene, A., Martinez, N., Filipović, S., Ben-Baruch, N.E., Joy, A.A., Langkjer, S.T., Senecal, F., de Boer, R.H., Moran, S., Yao, B., Bryce, R., Auerbach, A., Fallowfield, L., and Martin, M.

Published
2019
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28. Survival following early-stage colon cancer: an ACCENT-based comparison of patients versus a matched international general population†

Author

Renfro, L. A., Grothey, A., Kerr, D., Haller, D. G., André, T., Van Cutsem, E., Saltz, L., Labianca, R., Loprinzi, C. L., Alberts, S. R., Schmoll, H., Twelves, C., Yothers, G., Sargent, D. J., Sargent, D.J., Green, E., Grothey, A., Alberts, S.R., Shi, Q., Renfro, L.A., Yothers, G., OʼConnell, M.J., Wolmark, N., de Gramont, A., Gray, R., Kerr, D., Haller, D.G., Guthrie, K., Buyse, M., Labianca, R., Seitz, J.F., OʼCallaghan, C.J., Francini, G., Catalano, P.J., Blanke, C.D., Andre, T., Goldberg, R.M., Benson, A., Twelves, C., Sirzen, F., Cisar, L., Van Cutsem, E., and Saltz, L.

Published
2015
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29. International consensus recommendations on key outcome measures for organ preservation after (chemo)radiotherapy in patients with rectal cancer

Author

Fokas, E., Fokas, E., Appelt, A., Glynne-Jones, R., Beets, G., Perez, R., Garcia-Aguilar, J., Rullier, E., Smith, J.J., Marijnen, C., Peters, F.P., van der Valk, M., Beets-Tan, R., Myint, A.S., Gerard, J.P., Bach, S.P., Ghadimi, M., Hofheinz, R.D., Bujko, K., Gani, C., Haustermans, K., Minsky, B.D., Ludmir, E., West, N.P., Gambacorta, M.A., Valentini, V., Buyse, M., Renehan, A.G., Gilbert, A., Sebag-Montefiore, D., Rodel, C., Fokas, E., Fokas, E., Appelt, A., Glynne-Jones, R., Beets, G., Perez, R., Garcia-Aguilar, J., Rullier, E., Smith, J.J., Marijnen, C., Peters, F.P., van der Valk, M., Beets-Tan, R., Myint, A.S., Gerard, J.P., Bach, S.P., Ghadimi, M., Hofheinz, R.D., Bujko, K., Gani, C., Haustermans, K., Minsky, B.D., Ludmir, E., West, N.P., Gambacorta, M.A., Valentini, V., Buyse, M., Renehan, A.G., Gilbert, A., Sebag-Montefiore, D., and Rodel, C.

Abstract

Multimodal treatment strategies for patients with rectal cancer are increasingly including the possibility of organ preservation, through nonoperative management or local excision. Organ preservation strategies can enable patients with a complete response or near-complete clinical responses after radiotherapy with or without concomitant chemotherapy to safely avoid the morbidities associated with radical surgery, and thus to maintain anorectal function and quality of life. However, standardization of the key outcome measures of organ preservation strategies is currently lacking; this includes a lack of consensus of the optimal definitions and selection of primary end points according to the trial phase and design; the optimal time points for response assessment; response-based decision-making; follow-up schedules; use of specific anorectal function tests; and quality of life and patient-reported outcomes. Thus, a consensus statement on outcome measures is necessary to ensure consistency and facilitate more accurate comparisons of data from ongoing and future trials. Here, we have convened an international group of experts with extensive experience in the management of patients with rectal cancer, including organ preservation approaches, and used a Delphi process to establish the first international consensus recommendations for key outcome measures of organ preservation, in an attempt to standardize the reporting of data from both trials and routine practice in this emerging area.Patients with early-stage rectal cancer might potentially benefit from treatment with an organ-sparing approach, which preserves quality of life owing to avoidance of the need for permanent colostomy. Trials conducted to investigate this have so far been hampered by considerable inter-trial heterogeneity in several key features. In this Consensus Statement, the authors provide guidance on the optimal end points, response assessment time points, follow-up procedures and quality of life measu

Published
2021

30. Effect of pegaptanib sodium 0.3□mg intravitreal injections (Macugen) in intraocular pressure: posthoc analysis from V.I.S.I.O.N. study

Author

Boyer, David S, Goldbaum, Mauro, Leys, Anita M, Starita, Carla, Blumenkranz, M, Buyse, M, Goldberg, M, Gragoudas, E S, Miller, J, Schwartz, S D, Singerman, L, Yannuzzi, L, Adamis, A P, Guyer, D R, OʼShaughnessy, D, de Gronckel, S, Fesneau, G, Quinaux, E, Tremolet, D, Wang, K, Brailey, A, Finman, J, Ting, N, Bressler, N M, Bressler, S B, Denblow, R, Schein, O D, Seabrook, S, Solomon, S, Schachat, A P, Philips, D, Altaweel, M, Davis, M D, Blodi, B A, Danis, R P, Ip, M S, Hiner, C, Elledge, J, Webster, M, Hannan, C, Ficken, J, Alexander, S, Neider, M, Wabers, H, Vargo, P, Lambert, E, Kastorff, L, Carr, A, Shkiele, A, Baliker, J, Guymer, R, Constable, I, Arnold, J, Sarks, S, Chang, A, Gillies, M, Mitchell, P, Haas, A, Stur, M, Leys, A, Moreira, C, Portella, E, de Avila, M, Taleb, A C, Lavinsky, J, Lavinsky, D, Farah, M E, Williams, G, Leonard, B, Garcia, R, Maberley, D, Lopez, J M, Rodriguez, F J, Fiser, I, Larsen, M, Korobelnik, J-F, Soubrane, G, Koenig, F, Gaudric, A, Dithmar, S, Holz, F G, Joussen, A, Kirchhof, B, Wiedemann, P, Pauleikhoff, D, Schneider, U, Suveges, I, Gyory, J, Pollack, A, Loewenstein, A, Rosenblatt, I, Giovannini, A, Menchini, U, Brancato, R, Piccolino, Cardillo F, Grignolo, F M, Bandello, F, Schlingemann, R O, Deutman, A, Kaluzny, J, Pecold, K, Cunha-Vaz, J, da Silva, R, Ruiz Moreno, J M, Mones, J, Figueroa, M, Pournaras, C, Zografos, L, Lois, N, Chakravarthy, U, Hykin, P, Chisholm, I, Johnson, M W, Marcus, D M, Mandava, N, Haller, J A, Cangemi, F, Boyer, D, Kim, I, Loewenstein, J, Heier, J, Reichel, E, Falcone, P M, Weissgold, D J, Conway, B P, Garfinkel, R, Glaser, B, Lyon, A T, Lewis, H, Wells, J A, Wilcox, L, Fish, G, Eliott, D, Fekrat, S, Taney, B, Eaton, A M, Deramo, V, Wroblewski, J, Tom, D, Chow, D R, Orth, D H, Packo, K H, Holz, E, Mieler, W, Kuppermann, B, Sabates, N, Cummings, H, Pendergast, S D, Gonzales, C, Lim, J I, Charles, S, Sanislo, S, Rosenfeld, P, Connor, T, Cantrill, H, Willson, R, Bailey-Freund, K, Rosen, R, Leonard, R, Brucker, A, Ho, A, Sneed, S, Friberg, T, Klein, M, Tornambe, P, Stoller, G, Capone, A, Jr, Bernstein, P S, McDonald, H R, Schatz, H, Johnson, R N, Nanda, M, Avery, R, Wong, K, Grizzard, W S, Higgins, P, Hudson, H, Joffe, L, Varenhorst, M, Slusher, M M, Betts, F, Cunningham, E, Jr, Curtiss, K, Harrison, E, Katz, B, Masonson, H N, DeMarco, R, Beals, C, Patel, M, Rodriguez, I, and Starita, C

Published
2014
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33. How to Anticipate the Assessment of the Public Health Benefit of New Medicines?

Author

Alperovitch, A., Bamberger, M., Begaud, B., Blin, O., Blin, P., Breart, G., Brun Strang, C., Buyse, M., Castot, A., Chauvenet, M., Chicoye, A., David, N., De Bels, F., De Sahb Berkovitch, R., Dohin, E., Fagnani, F., Falissard, B., Gastaldi-Menager, C., Giri, I., Haim, M., Joubert, J.M., Lapeyre-Mestre, M., Lassale, C., Marchant Ramirez, I., Meyer, F., Micallef, J., Mollimard, M., Moreau-Defarges, T., Pazart, L., Perret, L., Pigeon, M., Rumeau Pichon, C., Tcheng, Ph., Woler, M., Zanetti, L., Zylberman, M., Massol, Jacques, Puech, Alain, and Boissel, Jean-Pierre

Published
2007
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34. Comment anticiper l’évaluation de l’intérêt de santé publique des médicaments ?

Author

Alperovitch, A., Bamberger, M., Bégaud, B., Blin, O., Blin, P., Bréart, G., Brun Strang, C., Buyse, M., Castot, A., Chauvenet, M., Chicoye, A., David, N., De Bels, F., De Sahb Berkovitch, R., Dohin, E., Fagnani, F., Falissard, B., Gastaldi-Menager, C., Giri, I., Haim, M., Joubert, J.M., Lapeyre-Mestre, M., Lassale, C., Marchant Ramirez, I., Meyer, F., Micallef, J., Mollimard, M., Moreau-Defarges, T., Pazart, L., Perret, L., Pigeon, M., Rumeau Pichon, C., Tcheng, Ph., Woler, M., Zanetti, L., Zylberman, M., Massol, Jacques, Puech, Alain, and Boissel, Jean-Pierre

Published
2007
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35. Outcome measures in multimodal rectal cancer trials

Author

Fokas, E., Glynne-Jones, R., Appelt, A., Beets-Tan, R., Beets, G., Haustermans, K., Marijnen, C., Minsky, B. D., Ludmir, E., Quirke, P., Sebag-Montefiore, D., Garcia-Aguilar, J., Gambacorta, M. A., Valentini, V., Buyse, M., Rodel, C., Gambacorta M. A. (ORCID:0000-0001-5455-8737), Valentini V. (ORCID:0000-0003-4637-6487), Fokas, E., Glynne-Jones, R., Appelt, A., Beets-Tan, R., Beets, G., Haustermans, K., Marijnen, C., Minsky, B. D., Ludmir, E., Quirke, P., Sebag-Montefiore, D., Garcia-Aguilar, J., Gambacorta, M. A., Valentini, V., Buyse, M., Rodel, C., Gambacorta M. A. (ORCID:0000-0001-5455-8737), and Valentini V. (ORCID:0000-0003-4637-6487)

Abstract

There is a large variability regarding the definition and choice of primary endpoints in phase 2 and phase 3 multimodal rectal cancer trials, resulting in inconsistency and difficulty of data interpretation. Also, surrogate properties of early and intermediate endpoints have not been systematically assessed. We provide a comprehensive review of clinical and surrogate endpoints used in trials for non-metastatic rectal cancer. The applicability, advantages, and disadvantages of these endpoints are summarised, with recommendations on clinical endpoints for the different phase trials, including limited surgery or non-operative management for organ preservation. We discuss how early and intermediate endpoints, including patient-reported outcomes and involvement of patients in decision making, can be used to guide trial design and facilitate consistency in reporting trial results in rectal cancer.

Published
2020

36. Event-Free Survival, a Prostate-Specific Antigen-Based Composite End Point, Is Not a Surrogate for Overall Survival in Men With Localized Prostate Cancer Treated With Radiation.

Author

Xie W, Regan MM, Buyse M, Halabi S, Kantoff PW, Sartor O, Soule H, Berry D, Clarke N, Collette L, D'Amico A, Lourenco RDA, Dignam J, Eisenberger M, James N, Fizazi K, Gillessen S, Loriot Y, Mottet N, Parulekar W, Sandler H, Spratt DE, Sydes MR, Tombal B, Williams S, Sweeney CJ, ICECaP Working Group, Xie W, Regan MM, Buyse M, Halabi S, Kantoff PW, Sartor O, Soule H, Berry D, Clarke N, Collette L, D'Amico A, Lourenco RDA, Dignam J, Eisenberger M, James N, Fizazi K, Gillessen S, Loriot Y, Mottet N, Parulekar W, Sandler H, Spratt DE, Sydes MR, Tombal B, Williams S, Sweeney CJ, and ICECaP Working Group

Abstract

Purpose

Recently, we have shown that metastasis-free survival is a strong surrogate for overall survival (OS) in men with intermediate- and high-risk localized prostate cancer and can accelerate the evaluation of new (neo)adjuvant therapies. Event-free survival (EFS), an earlier prostate-specific antigen (PSA)-based composite end point, may further expedite trial completion.

Methods

EFS was defined as the time from random assignment to the date of first evidence of disease recurrence, including biochemical failure, local or regional recurrence, distant metastasis, or death from any cause, or was censored at the date of last PSA assessment. Individual patient data from trials within the Intermediate Clinical Endpoints in Cancer of the Prostate-ICECaP-database with evaluable PSA and disease follow-up data were analyzed. We evaluated the surrogacy of EFS for OS using a 2-stage meta-analytic validation model by determining the correlation of EFS with OS (patient level) and the correlation of treatment effects (hazard ratios [HRs]) on both EFS and OS (trial level). A clinically relevant surrogacy was defined a priori as an R2 ≥ 0.7.

Results

Data for 10,350 patients were analyzed from 15 radiation therapy-based trials enrolled from 1987 to 2011 with a median follow-up of 10 years. At the patient level, the correlation of EFS with OS was 0.43 (95% CI, 0.42 to 0.44) as measured by Kendall's tau from a copula model. At the trial level, the R2 was 0.35 (95% CI, 0.01 to 0.60) from the weighted linear regression of log(HR)-OS on log(HR)-EFS.

Conclusion

EFS is a weak surrogate for OS and is not suitable for use as an intermediate clinical end point to substitute for OS to accelerate phase III (neo)adjuvant trials of prostate cancer therapies for primary radiation therapy-based trials.

Published
2020

37. Overall survival benefit for sequential doxorubicin–docetaxel compared with concurrent doxorubicin and docetaxel in node-positive breast cancer—8-year results of the Breast International Group 02-98 phase III trial†

Author

Oakman, C., Francis, P. A., Crown, J., Quinaux, E., Buyse, M., De Azambuja, E., Margeli Vila, M., Andersson, M., Nordenskjöld, B., Jakesz, R., Thürlimann, B., Gutiérrez, J., Harvey, V., Punzalan, L., DellʼOrto, P., Larsimont, D., Steinberg, I., Gelber, R. D., Piccart-Gebhart, M., Viale, G., and Di Leo, A.

Published
2013
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42. Metastasis-Free Survival Is a Strong Surrogate of Overall Survival in Localized Prostate Cancer

Author

Xie, W, Regan, M, Buyse, M, Halabi, S, Kantoff, P, Sartor, O, Soule, H, Clarke, N, Collette, L, Dignam, J, Fizazi, K, Paruleker, W, Sandler, H, Sydes, M, Tombal, B, Williams, S, Sweeney, C, Andren, O, Armstrong, J, Berry, D, Bolla, M, Chin, J, Chowdhury, S, Cooperberg, M, Denham, J, Di Stasi, S, Eisenberger, M, Freidlin, B, Gillessen, S, Gleave, M, Habibian, M, James, N, Jarow, J, Keating, N, Keloff, G, Klotz, L, Lukka, H, Mason, M, Miyahira, A, Mottet, N, Nakabayashi, M, Parulekar, W, Scardino, P, Scher, H, Simon, R, Simons, J, Small, E, Tangen, C, Thompson, I, Widmark, A, Wiegel, T, Wirth, M, Yeoh, E, and Zapatero, A

Subjects
Male, Oncology, Cancer Research, cancer surgery controlled study, medicine.medical_treatment, 030232 urology & nephrology, androgen deprivation therapy, localization cancer, Settore MED/24 - Urologia, law.invention, Prostatic Neoplasms randomized controlled trial (topic), Prostate cancer, 0302 clinical medicine, Randomized controlled trial, Risk Factors, law, risk factor survival analysis, Neoplasm Metastasis, skin and connective tissue diseases, disease free survival, Randomized Controlled Trials as Topic, follow up high risk patient, aged, Article, cancer, radiotherapy, correlational study, human intermediate risk patient, major clinical study, male metastasis free survival, overall survival, patient coding priority, journal prostate cancer prostatectomy treatment, duration, bio assay meta analysis, metastasis multimodality, cancer therapy, pathology, ORIGINAL REPORTS, Combined Modality Therapy, Darolutamide, 030220 oncology & carcinogenesis, Meta-analysis, Adjuvant, medicine.medical_specialty, Endpoint Determination, Disease-Free Survival, 03 medical and health sciences, Internal medicine, medicine, Adjuvant therapy, Overall survival, Humans, Survival analysis, business.industry, Prostatic Neoplasms, medicine.disease, Survival Analysis, Surgery, business
Abstract

Purpose Adjuvant therapy for intermediate-risk and high-risk localized prostate cancer decreases the number of deaths from this disease. Surrogates for overall survival (OS) could expedite the evaluation of new adjuvant therapies. Methods By June 2013, 102 completed or ongoing randomized trials were identified and individual patient data were collected from 28 trials with 28,905 patients. Disease-free survival (DFS) and metastasis-free survival (MFS) were determined for 21,140 patients from 24 trials and 12,712 patients from 19 trials, respectively. We evaluated the surrogacy of DFS and MFS for OS by using a two-stage meta-analytic validation model by determining the correlation of an intermediate clinical end point with OS and the correlation of treatment effects on both the intermediate clinical end point and OS. Results Trials enrolled patients from 1987 to 2011. After a median follow-up of 10 years, 45% of 21,140 men and 45% of 12,712 men experienced a DFS and MFS event, respectively. For DFS and MFS, 61% and 90% of the patients, respectively, were from radiation trials, and 63% and 66%, respectively, had high-risk disease. At the patient level, Kendall’s τ correlation with OS was 0.85 and 0.91 for DFS and MFS, respectively. At the trial level, R2 was 0.86 (95% CI, 0.78 to 0.90) and 0.83 (95% CI, 0.71 to 0.88) from weighted linear regression of 8-year OS rates versus 5-year DFS and MFS rates, respectively. Treatment effects—measured by log hazard ratios—for the surrogates and OS were well correlated ( R2, 0.73 [95% CI, 0.53 to 0.82] for DFS and 0.92 [95% CI, 0.81 to 0.95] for MFS). Conclusion MFS is a strong surrogate for OS for localized prostate cancer that is associated with a significant risk of death from prostate cancer.

Published
2017

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