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CA19-9 decrease at 8 weeks as a predictor of overall survival in a randomized phase III trial (MPACT) of weekly nab -paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic pancreatic cancer
Chiorean, E. G. (University of Washington. Department of Medicine)
Von Hoff, D. D. (Translational Genomics Research Institute)
Reni, M. (Ospedale San Raffaele. Servizio di Oncologia Medica)
Arena, F. P. (NYU Langone Arena Oncology. Department of Oncology)
Infante, J. R. (Sarah Cannon Research Institute)
Bathini, V. G. (University of Massachusetts Medical School. Cancer Center of Excellence)
Wood, T. E. (University of Alabama at Birmingham. Comprehensive Cancer Center)
Mainwaring, P. N. (Centre for Haematology & Oncology (Brisbane, Austràlia))
Muldoon, R. T. (Genesis Cancer Center. Department of Oncology)
Clingan, P. R. (Southern Medical Day Care Centre)
Kunzmann, V. (Universitätsklinikum Würzburg. Medizinischen Klinik und Poliklinik II)
Ramanathan, R. K. (Translational Genomics Research Institute)
Tabernero Caturla, Josep (Hospital Universitari de la Vall d'Hebron)
Goldstein, D. (Prince of Wales Hospital. Department of Oncology)
McGovern, D. (Celgene Corporation)
Lu, B. (Celgene Corporation)
Ko, A. (Celgene Corporation)
Universitat Autònoma de Barcelona

Fecha: 2016
Resumen: Any CA19-9 decline at week 8 and radiologic response by week 8 each predicted longer OS in both treatment arms. In the nab- P + Gem arm, the higher proportion of patients with week 8 CA19-9 decrease [82% (206/252); median OS 13. 2 months] than a RECIST-defined response [16% (40/252); median OS 13. 7 months] suggests that CA19-9 decline is a predictor of OS applicable to a larger population. A phase I/II study and subsequent phase III study (MPACT) reported significant correlations between CA19-9 decreases and prolonged overall survival (OS) with nab -paclitaxel plus gemcitabine (nab -P + Gem) treatment for metastatic pancreatic cancer (MPC). CA19-9 changes at week 8 and potential associations with efficacy were investigated as part of an exploratory analysis in the MPACT trial. Untreated patients with MPC (N = 861) received nab -P + Gem or Gem alone. CA19-9 was evaluated at baseline and every 8 weeks. Patients with baseline and week-8 CA19-9 measurements were analyzed (nab -P + Gem: 252; Gem: 202). In an analysis pooling the treatments, patients with any CA19-9 decline (80%) versus those without (20%) had improved OS (median 11. 1 versus 8. 0 months; P = 0. 005). In the nab -P + Gem arm, patients with (n = 206) versus without (n = 46) any CA19-9 decrease at week 8 had a confirmed overall response rate (ORR) of 40% versus 13%, and a median OS of 13. 2 versus 8. 3 months (P = 0. 001), respectively. In the Gem-alone arm, patients with (n = 159) versus without (n = 43) CA19-9 decrease at week 8 had a confirmed ORR of 15% versus 5%, and a median OS of 9. 4 versus 7. 1 months (P = 0. 404), respectively. In the nab -P + Gem and Gem-alone arms, by week 8, 16% (40/252) and 6% (13/202) of patients, respectively, had an unconfirmed radiologic response (median OS 13. 7 and 14. 7 months, respectively), and 79% and 84% of patients, respectively, had stable disease (SD) (median OS 11. 1 and 9 months, respectively). Patients with SD and any CA19-9 decrease (158/199 and 133/170) had a median OS of 13. 2 and 9. 4 months, respectively. This analysis demonstrated that, in patients with MPC, any CA19-9 decrease at week 8 can be an early marker for chemotherapy efficacy, including in those patients with SD. CA19-9 decrease identified more patients with survival benefit than radiologic response by week 8.
Derechos: Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. Creative Commons
Lengua: Anglès.
Documento: article ; recerca ; publishedVersion
Materia: CA19-9 ; Pancreatic cancer ; Chemotherapy ; Nab -paclitaxel ; MPACT
Publicado en: Annals of oncology, Vol. 27, issue 4 (April 2016) , p. 654-660, ISSN 1569-8041

PMID: 26802160
DOI: 10.1093/annonc/mdw006


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