18F-FDG PET-CT response in a phase 1-2 trial of nab-paclitaxel plus gemcitabine for advanced pancreatic cancerReport as inadecuate




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Cancer Imaging

, 17:23

First Online: 03 August 2017Received: 07 March 2017Accepted: 06 July 2017

Abstract

BackgroundPositron emission tomography PET is poised to become a useful imaging modality in staging and evaluating therapeutic responses in patients with metastatic pancreatic cancer mPC. This analysis from a phase 1-2 study examined the utility of early PET imaging in patients with mPC treated with nab-paclitaxel plus gemcitabine.

MethodsTumors were measured by F2-fluoro-2-deoxyglucose PET-computed tomography CT in patients who received nab-paclitaxel 100 n = 13, 125 n = 38, or 150 n = 1 mg-m plus gemcitabine 1000 mg-m on days 1, 8, and 15 of a 28-day cycle. Lesion metabolic activity was evaluated at baseline and 6 and 12 weeks postbaseline.

ResultsFifty-two patients had baseline and ≥1 follow-up PET scan. The median maximum standardized uptake values per pancreatic lesion in the nab-paclitaxel 100 mg-m and 125 mg-m cohorts were 5.1 and 6.5, respectively. Among patients who had a metabolic response by PET, those who received nab-paclitaxel 125 mg-m had a 4-month survival advantage over those who received 100 mg-m. All patients in the nab-paclitaxel 125 mg-m cohort experienced an early complete metabolic response CMR; 34% or partial metabolic response PMR; 66%. In the nab-paclitaxel 125 mg-m cohort, investigator-assessed objective response rates were 77% and 44% among patients with a CMR and PMR, respectively, with no correlation between PET and CT response Spearman rs = 0.22; P = 0.193. Patients in the nab-paclitaxel 125 mg-m cohort with a CMR experienced a significantly longer overall survival vs those with a PMR median, 23.0 vs 11.2 months; P = 0.011, and a significant correlation was found between best percentage change in tumor burden by PET and survival: for each 1% decrease in PET score, the risk of death decreased by 2%.

ConclusionsThe majority of primary pancreatic tumors and their metastases were PET avid, and PET effectively measured changes in tumor metabolic activity at 6 and 12 weeks. These results support the antitumor activity of nab-paclitaxel 125 mg-m plus gemcitabine 1000 mg-m for treating mPC and the utility of PET for measuring treatment response. Treatment response by PET analysis may be considered when evaluating investigational agents in mPC.

Trial registrationNCT00398086.

KeywordsPancreatic cancer nab-Paclitaxel Gemcitabine Phase 1-2 clinical trial Positron emission tomography AbbreviationsF-FDGF2-fluoro-2-deoxyglucose

CA 19–9Carbohydrate antigen 19–9

CMRComplete metabolic response

CTComputed tomography

ECOG PSEastern Cooperative Oncology Group performance status

EORTCEuropean Organisation for Research and Treatment of Cancer

FOLFIRINOXFolinic acid, 5-fluorouracil, irinotecan, and oxaliplatin

mPCMetastatic pancreatic cancer

nab-Pnab-paclitaxel

OSOverall survival

pCRPathological complete response

PETPositron emission tomography

PMDProgressive metabolic disease

PMRPartial metabolic response

RECISTResponse Evaluation Criteria In Solid Tumors

ROIRegion of interest

SMDStable metabolic disease

SUVStandardized uptake values

SUVmaxMaximum standardized uptake values

SUVmax TotalStandardized uptake values of all target lesions

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