Surrogate endpoints for overall survival in randomized clinical trials testing antibody-drug conjugates

Breast Cancer

Surrogate End Points for Overall Survival in Neoadjuvant Randomized Clinical Trials for Early Breast Cancer

J Clin Oncol

Conforti F, Nekljudova V, Sala I, Ascari R, Solbach C, Untch M, Denkert C, Bagnardi V, Pala L, Fasching PA, Schneeweiss A, Lück HJ, Pagan E, De Pas T, van Mackelenbergh M, Huober J, Müller V, Link T, Karn T, Reinisch M, Marmé F, Bjelic-Radisic V, Schem C, Hartkopf A, Stickeler E, Hanusch C, Blohmer JU, Fehm T, Rhiem K, Holtschmidt J, Gelber RD, Loibl S

doi: 10.1200/JCO-24-01360

Further Publications

Overall survival benefits of cancer drugs initially approved by the US Food and Drug Administration on the basis of immature survival data: a retrospective analysis

Lancet Oncol

Naci H, Zhang Y, Woloshin S, Guan X, Xu Z, Wagner AK

doi: 10.1016/S1470-2045(24)00152-9

Gynecologic Cancer

Overall Survival in Patients with Endometrial Cancer Treated with Dostarlimab plus Carboplatin-Paclitaxel in the Randomized ENGOT-EN6/GOG-3031/RUBY Trial

Ann Oncol

Powell MA, Bjørge L, Willmott L, Novák Z, Black D, Gilbert L, Sharma S, Valabrega G, Landrum LM, Gropp-Meier M, Stuckey A, Boere I, Gold MA, Segev Y, Gill SE, Gennigens C, Sebastianelli A, Shahin MS, Pothuri B, Monk BJ, Buscema J, Coleman RL, Slomovitz BM, Ring KL, Herzog TJ, Balas MM, Grimshaw M, Stevens S, Lai DW, McCourt C, Mirza MR

doi: 10.1016/j.annonc.2024.05.546

Breast Cancer

Tumor-Infiltrating Lymphocytes and Survival Outcomes in Early ERBB2-Positive Breast Cancer: 10-Year Analysis of the ShortHER Randomized Clinical Trial

JAMA Oncol

Dieci MV, Bisagni G, Bartolini S, Schirone A, Cavanna L, Musolino A, Giotta F, Rimanti A, Garrone O, Bertone E, Cagossi K, Sarti S, Ferro A, Piacentini F, Orvieto E, Sanders M, Miglietta F, Massa D, Balduzzi S, Conte P, D'Amico R, Guarneri V

doi: 10.1001/jamaoncol.2024.6872

Multiple Myeloma (MM)

Evaluating Minimal Residual Disease Negativity as a Surrogate Endpoint for Treatment Efficacy in Multiple Myeloma: A Meta-Analysis of Randomized Controlled Trials

Am J Hematol

Ntanasis-Stathopoulos I, Filippatos C, Ntanasis-Stathopoulos A, Malandrakis P, Kastritis E, Tsitsilonis OE, Dimopoulos MA, Terpos E, Gavriatopoulou M

doi: 10.1002/ajh.27582

Multiple Myeloma (MM)

Minimal Residual Disease-Based End Point for Accelerated Assessment of Clinical Trials in Multiple Myeloma: A Pooled Analysis of Individual Patient Data From Multiple Randomized Trials

J Clin Oncol

Shi Q, Paiva B, Pederson LD, Dimier N, Talpes E, Prior TJ, Orfao A, Moreau P, Sonneveld P, Kumar SK, Dixon JG, Patel R, Bartlett BJ, Schecter J, McCarthy P, Hose D, Seckinger A, Mattia D, Goldschmidt H, Oliva S, Owen RG, Anderson KC, San-Miguel J, Durie BGM, Munshi N, International Independent Team for Endpoint Approval of Myeloma Minimal Residual Disease (i2TEAMM) Group

doi: 10.1200/JCO-24-02020

Breast Cancer

Correlation Between Disease-Free Survival Endpoints and Overall Survival in Elderly Patients with Early-Stage HER2-Negative Breast Cancer: A SEER-Medicare Analysis

Adv Ther

Earla JR, Kurian AW, Kponee-Shovein K, Mahendran M, Song Y, Hua Q, Hilts A, Sun Y, Hirshfield KM, Robson M, Mejia JA

doi: 10.1007/s12325-024-03074-7

Head and Neck Cancer

A systematic review of antibody-drug conjugates and bispecific antibodies in head and neck squamous cell carcinoma and nasopharyngeal carcinoma: Charting the course of future therapies

Cancer Treat Rev

Jiménez-Labaig P, Rullan A, Hernando-Calvo A, Llop S, Bhide S, O'Leary B, Braña I, Harrington KJ

doi: 10.1016/j.ctrv.2024.102772

Lymphoma

Progression-free survival is a weakly predictive surrogate end-point for overall survival in follicular lymphoma: A systematic review and meta-analysis

Br J Haematol

Milrod CJ, Kim KW, Raker C, Ollila TA, Olszewski AJ, Pelcovits A

doi: 10.1111/bjh.19449

Related content

Surrogate End Points for Overall Survival in Neoadjuvant Randomized Clinical Trials for Early Breast Cancer

Overall survival benefits of cancer drugs initially approved by the US Food and Drug Administration on the basis of immature survival data: a retrospective analysis

Overall Survival in Patients with Endometrial Cancer Treated with Dostarlimab plus Carboplatin-Paclitaxel in the Randomized ENGOT-EN6/GOG-3031/RUBY Trial

Tumor-Infiltrating Lymphocytes and Survival Outcomes in Early ERBB2-Positive Breast Cancer: 10-Year Analysis of the ShortHER Randomized Clinical Trial

Evaluating Minimal Residual Disease Negativity as a Surrogate Endpoint for Treatment Efficacy in Multiple Myeloma: A Meta-Analysis of Randomized Controlled Trials

Minimal Residual Disease-Based End Point for Accelerated Assessment of Clinical Trials in Multiple Myeloma: A Pooled Analysis of Individual Patient Data From Multiple Randomized Trials

Correlation Between Disease-Free Survival Endpoints and Overall Survival in Elderly Patients with Early-Stage HER2-Negative Breast Cancer: A SEER-Medicare Analysis

A systematic review of antibody-drug conjugates and bispecific antibodies in head and neck squamous cell carcinoma and nasopharyngeal carcinoma: Charting the course of future therapies

Progression-free survival is a weakly predictive surrogate end-point for overall survival in follicular lymphoma: A systematic review and meta-analysis