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

Autor: Chiorean, E. G., Von Hoff, D. D., Reni, M., Arena, F. P., Infante, J. R., Bathini, V. G., Wood, T. E., Mainwaring, P. N., Muldoon, R. T., Clingan, P., Kunzmann, V., Ramanathan, R. K., Tabernero, Josep, Goldstein, D., McGovern, D., Lu, B., Ko, A., Universitat Autònoma de Barcelona
Jazyk: angličtina
Rok vydání: 2016
Předmět:
0301 basic medicine
Oncology
medicine.medical_specialty
CA-19-9 Antigen
endocrine system diseases
medicine.medical_treatment
pancreatic cancer
chemotherapy
Gastroenterology
Nab -paclitaxel
03 medical and health sciences
chemistry.chemical_compound
nab-paclitaxel
0302 clinical medicine
Fluorodeoxyglucose F18
Predictive Value of Tests
Internal medicine
Pancreatic cancer
Metastatic pancreatic cancer
Gastrointestinal Tumors
MPACT
medicine
Chemotherapy
Humans
In patient
ddc:610
business.industry
Hematology
Original Articles
medicine.disease
CA19-9
Gemcitabine
digestive system diseases
Pancreatic Neoplasms
030104 developmental biology
chemistry
030220 oncology & carcinogenesis
Positron-Emission Tomography
Adenocarcinoma
Deoxycytidine
Radiopharmaceuticals
business
Tomography
X-Ray Computed
medicine.drug
Zdroj: Annals of Oncology
Dipòsit Digital de Documents de la UAB
Universitat Autònoma de Barcelona
Popis: 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.
Background 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. Patients and methods Untreated patients with MPC (N = 861) received nab-P + Gem or Gem alone. CA19-9 was evaluated at baseline and every 8 weeks. Results 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. Conclusion 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.
Databáze: OpenAIRE
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