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Title: | nab-Paclitaxel plus gemcitabine in metastatic pancreatic adenocarcinoma: Australian subset analyses of the phase III MPACT trial. | Authors: | Botteman M.;Romano A.;Ferrara S.;Margunato-Debay S.;Harris M. ;Aly A.;Beale P.;Asghari G.;Parnis F.X.;Clingan P.;Mainwaring P.;Young R. | Institution: | (Young) Medical Oncology, Royal Hobart Hospital, Hobart, TAS, Australia (Mainwaring) Oncology Unit, Canossa Private Hospital, Oxley, QLD, Australia (Clingan) Medical Oncology, Southern Medical Day Care Centre, Wollongong, NSW, Australia (Parnis) Department of Medical Oncology, Adelaide Cancer Centre (T/A Ashford Cancer Centre), Kurralta Park, SA, Australia (Asghari) Bankstown Cancer Centre, Bankstown-Lidcombe Hospital, Bankstown, NSW, Australia (Beale) Cancer Services and Palliative Care, Sydney Cancer Centre, Concord, NSW, Australia (Aly, Botteman) Real-World Evidence and Data Analytics Center of Excellence, Pharmerit International, Bethesda, MD, United States (Romano, Ferrara, Margunato-Debay) Celgene R&D Sarl, Celgene Corporation, Summit, NJ, United States (Harris) Familial Cancer Centre, Monash Health, East Bentleigh, VIC, Australia | Issue Date: | 27-Sep-2018 | Copyright year: | 2018 | Publisher: | Blackwell Publishing Ltd | Place of publication: | United Kingdom | Publication information: | Asia-Pacific Journal of Clinical Oncology. 14 (5) (pp e325-e331), 2018. Date of Publication: October 2018. | Journal: | Asia-Pacific Journal of Clinical Oncology | Abstract: | Aim: The phase III MPACT trial (N = 861) demonstrated superior overall survival (OS) with first-line nab-paclitaxel plus gemcitabine versus gemcitabine alone (median, 8.7 months vs 6.6 months; hazard ratio [HR], 0.72; 95% confidence interval [CI], 0.62-0.83; P < 0.001) in patients with metastatic pancreatic cancer. The efficacy benefit of the combination over gemcitabine alone was observed across patient subgroups, including those based on region. This subset analysis was designed to examine the safety and efficacy of nab-paclitaxel plus gemcitabine in patients treated in Australia to understand whether differences in patient population or regional variations in patient care had any impact on clinical outcomes. Method(s): Patients with metastatic pancreatic cancer received first-line nab-paclitaxel plus gemcitabine or gemcitabine alone in the MPACT study; this analysis focused on those treated in Australia. Result(s): In the Australian cohort, 120 patients were randomized to receive nab-paclitaxel plus gemcitabine (n = 61) or gemcitabine alone (n = 59). Median OS was 9.4 months with nab-paclitaxel plus gemcitabine versus 6.7 months with gemcitabine alone (HR, 0.64; 95% CI, 0.44-0.94; P = 0.022). Progression-free survival (median, 5.5 months vs 3.6 months; HR, 0.65; 95% CI, 0.42-1.00; P = 0.049) and the overall response rate (23% vs 2%; P < 0.001) were significantly improved with the combination. No new safety signals were observed. Conclusion(s): The results of this subset analysis confirm the efficacy and manageable safety profile of nab-paclitaxel plus gemcitabine in patients with metastatic pancreatic cancer treated in Australia.Copyright © 2018 John Wiley & Sons Australia, Ltd | DOI: | http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1111/ajco.12999 | Link to associated publication: | Click here for full text options | PubMed URL: | 29932294 [http://www.ncbi.nlm.nih.gov/pubmed/?term=29932294] | ISSN: | 1743-7555 | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/37024 | Type: | Article | Subjects: | multicenter study neutropenia/si [Side Effect] outcome assessment *pancreas adenocarcinoma/di [Diagnosis] *pancreas adenocarcinoma/dt [Drug Therapy] patient care peripheral neuropathy/si [Side Effect] phase 3 clinical trial priority journal progression free survival thrombocytopenia/si [Side Effect] tumor localization very elderly vomiting/si [Side Effect] *antineoplastic agent/ae [Adverse Drug Reaction] *antineoplastic agent/ct [Clinical Trial] *antineoplastic agent/an [Drug Analysis] *antineoplastic agent/cm [Drug Comparison] *antineoplastic agent/dt [Drug Therapy] *antineoplastic agent/pd [Pharmacology] CA 19-9 antigen/ec [Endogenous Compound] gemcitabine/ae [Adverse Drug Reaction] gemcitabine/ct [Clinical Trial] gemcitabine/an [Drug Analysis] gemcitabine/cm [Drug Comparison] gemcitabine/dt [Drug Therapy] gemcitabine/pd [Pharmacology] unclassified drug *gemcitabine plus paclitaxel/ae [Adverse Drug Reaction] *gemcitabine plus paclitaxel/ct [Clinical Trial] *gemcitabine plus paclitaxel/an [Drug Analysis] *gemcitabine plus paclitaxel/cm [Drug Comparison] *gemcitabine plus paclitaxel/dt [Drug Therapy] *gemcitabine plus paclitaxel/pd [Pharmacology] overall survival adult aged anemia/si [Side Effect] antigen detection *antineoplastic activity article Australia cancer survival cohort analysis controlled study drug efficacy drug safety fatigue/si [Side Effect] female hematologic disease/si [Side Effect] human human tissue informed consent leukopenia/si [Side Effect] lung metastasis/co [Complication] major clinical study male *metastasis potential middle aged drug efficacy drug safety fatigue / side effect female hematologic disease / side effect human lung metastasis / complication major clinical study male *metastasis potential middle aged multicenter study neutropenia / side effect outcome assessment overall survival *pancreas adenocarcinoma / *diagnosis / *drug therapy patient care peripheral neuropathy / side effect phase 3 clinical trial priority journal progression free survival thrombocytopenia / side effect tumor localization aged vomiting / side effect adult leukopenia / side effect very elderly anemia / side effect antigen detection *antineoplastic activity Article Australia cancer survival cohort analysis controlled study informed consent human tissue |
Type of Clinical Study or Trial: | Observational study (cohort, case-control, cross sectional or survey) |
Appears in Collections: | Articles |
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