Positron emission tomography response evaluation from a randomized phase III trial of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas
| Autor: | Ramanathan, R. K., Goldstein, D., Korn, R. L., Arena, F. P, Moore, M., Siena, S., Teixeira, L., Tabernero, Josep, Van Laethem, J.-L., Liu, H., McGovern, D., Lu, B., Von Hoff, D. D., Universitat Autònoma de Barcelona |
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| Rok vydání: | 2015 |
| Předmět: |
0301 basic medicine
Oncology Male positron emission tomography endocrine system diseases pancreatic cancer metabolic response Deoxycytidine nab-paclitaxel chemistry.chemical_compound 0302 clinical medicine Antineoplastic Combined Chemotherapy Protocols Neoplasm Metastasis Aged 80 and over medicine.diagnostic_test Hematology Middle Aged medicine.anatomical_structure Treatment Outcome Paclitaxel Positron emission tomography Response Evaluation Criteria in Solid Tumors 030220 oncology & carcinogenesis Adenocarcinoma Female Pancreas medicine.drug Adult medicine.medical_specialty Nab-paclitaxel Disease-Free Survival Drug Administration Schedule Nab -paclitaxel 03 medical and health sciences Internal medicine Pancreatic cancer Albumins Gastrointestinal Tumors medicine Humans Letters to the Editor Aged business.industry Metabolic response Original Articles medicine.disease Gemcitabine Cancérologie Pancreatic Neoplasms 030104 developmental biology chemistry Positron-Emission Tomography business Hématologie |
| Zdroj: | Annals of Oncology Annals of oncology, 27 (4 Dipòsit Digital de Documents de la UAB Universitat Autònoma de Barcelona |
| ISSN: | 1569-8041 |
| Popis: | In the phase III MPACT trial, nab-paclitaxel plus gemcitabine (nab-P + Gem) demonstrated superior efficacyversus Gem alone for patients with metastatic pancreatic cancer. We sought to examine the feasibility of positron emissiontomography (PET) and to compare metabolic response rates and associated correlations with efficacy in the MPACT trial.Patients and methods: Patients with previously untreated metastatic adenocarcinoma of the pancreas were randomized1:1 to receive nab-P + Gem or Gem alone. Treatment continued until disease progression by RECIST or unacceptable toxicity.Results: PET scans were carried out on the first 257 patients enrolled at PET-equipped centers (PET cohort). Most patients(252 of 257) had ≥ 2 PET-avid lesions, and median maximum standardized uptake values at baseline were 4.6 and 4.5 in thenab-P + Gem and Gem-alone arms, respectively. In a pooled treatment arm analysis, a metabolic response by PET (best responseat any time during study) was associated with longer overall survival (OS) (median 11.3 versus 6.9 months; HR, 0.56;P < 0.001). Efficacy results within each treatment arm appeared better for patients with a metabolic response. The metabolicresponse rate (best response and week 8 response) was higher for nab-P + Gem (best response: 72% versus 53%,P = 0.002; week 8: 67% versus 51%; P = 0.014). Efficacy in the PET cohort was greater for nab-P + Gem versus Gem alone,including for OS (median 10.5 versus 8.4 months; hazard ratio [HR], 0.71; P = 0.009) and ORR by RECIST (31% versus 11%;P < 0.001).Conclusion: Pancreatic lesions were PET avid at baseline, and the rate of metabolic response was significantly higher fornab-P + Gem versus Gem alone at week 8 and for best response during study. Having a metabolic response was associatedwith longer survival, and more patients experienced a metabolic response than a RECIST-defined response.ClinicalTrials.gov: NCT00844649. SCOPUS: ar.j info:eu-repo/semantics/published |
| Databáze: | OpenAIRE |
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