Predictive values of serum insulin kinetics for reversion of impaired glucose tolerance to normal glucose tolerance and the effects of voglibose treatment: a retrospective post hoc analysis of a Japanese phase III study

2012 ◽  
Vol 3 (4) ◽  
pp. 209-216 ◽  
Author(s):  
Ryuzo Kawamori ◽  
Naoko Tajima ◽  
Yasuhiko Iwamoto ◽  
Atsunori Kashiwagi ◽  
Kazuaki Shimamoto ◽  
...  
Keyword(s):  
Glucose Tolerance ◽  
Serum Insulin ◽  
Normal Glucose Tolerance ◽  
Phase Iii ◽  
Predictive Values ◽  
Post Hoc Analysis ◽  
Insulin Kinetics ◽  
Normal Glucose ◽  
Phase Iii Study ◽  
Post Hoc

scholarly journals Pain Progression at Initiation of Cabazitaxel in Metastatic Castration-Resistant Prostate Cancer (mCRPC): A Post Hoc Analysis of the PROSELICA Study

Cancers ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1284
Author(s):  
Nicolas Delanoy ◽  
Debbie Robbrecht ◽  
Mario Eisenberger ◽  
Oliver Sartor ◽  
Ronald de Wit ◽  
...  
Keyword(s):  
Progression Free Survival ◽  
Phase Iii ◽  
Castration Resistant Prostate Cancer ◽  
Radiological Progression ◽  
Post Hoc Analysis ◽  
Psa Response ◽  
Phase Iii Study ◽  
Psa Progression ◽  
Previously Treated ◽  
Post Hoc

Background: In the PROSELICA phase III trial (NCT01308580), cabazitaxel 20 mg/m2 (CABA20) was non-inferior to cabazitaxel 25 mg/m2 (CABA25) in mCRPC patients previously treated with docetaxel (DOC). The present post hoc analysis evaluates how the type of progression at randomization affected outcomes. Methods: Progression type at randomization was defined as follows: PSA progression only (PSA-p; no radiological progression (RADIO-p), no pain), RADIO-p (±PSA-p, no pain), or pain progression (PAIN-p, ±PSA-p, ±RADIO-p). Relationships between progression type and overall survival (OS), radiological progression-free survival (rPFS), and PSA response (confirmed PSA decrease ≥ 50%) were analyzed. Results: All randomized patients (n = 1200) had received prior DOC, and 25.7% had received prior abiraterone or enzalutamide. Progression type at randomization was evaluable in 1075 patients (PSA-p = 24.4%, RADIO-p = 20.8%, PAIN-p = 54.8%). Pain progression was associated with clinical and biological features of aggressive disease. Median OS from CABA initiation or date of mCRPC diagnosis, all arms combined, was shorter in the PAIN-p group than in the RADIO-p or the PSA-p groups (12.0 versus 16.8 and 18.4 months, respectively, p < 0.001). In multivariate analysis, all arms combined, PAIN-p was an independent predictor of poor OS (HR = 1.44, p < 0.001). PSA response, rPFS, and OS were numerically higher with CABA25 versus CABA20 in patients with PAIN-p. Conclusions: This post hoc analysis of the PROSELICA phase III study shows that pain progression at initiation of CABA in mCRPC patients previously treated with DOC is associated with a poor prognosis. Disease progression should be carefully monitored, even in the absence of PSA rise.

Understanding the Prognostic Value of Primary Tumor Location and KRAS in Metastatic Colorectal Cancer: A Post Hoc Analysis of the OPTIMOX3 DREAM Phase III Study

2020 ◽  
Vol 19 (3) ◽  
pp. 200-208.e1 ◽  
Author(s):  
Benoist Chibaudel ◽  
Thierry André ◽  
Christophe Tournigand ◽  
Christophe Louvet ◽  
Magdalena Benetkiewicz ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Primary Tumor ◽  
Prognostic Value ◽  
Tumor Location ◽  
Phase Iii ◽  
Primary Tumor Location ◽  
Post Hoc Analysis ◽  
Phase Iii Study ◽  
Post Hoc

Post hoc analysis of a phase III study to test the association between circulating methylated glutathione s transferase (mGSTP1) DNA levels and response to docetaxel (DTX) in metastatic castration resistant prostate cancer (mCRPC).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 5014-5014
Author(s):  
Kate Lynette Mahon ◽  
Wenjia Qu ◽  
Hui-Ming Lin ◽  
Calan Spielman ◽  
Daniel Cain ◽  
...  
Keyword(s):  
Cpg Island ◽  
Multivariable Analysis ◽  
Phase Iii ◽  
Castration Resistant Prostate Cancer ◽  
Serum Samples ◽  
Full Cohort ◽  
Post Hoc Analysis ◽  
Time Points ◽  
Phase Iii Study ◽  
Post Hoc

5014 Background: GSTP1 inactivation is associated with CpG island hypermethylation in > 99% prostate cancers. Detection of circulating mGSTP1 DNA predicts response to DTX and overall survival (OS) in phase I/II mCRPC cohorts. This post hoc analysis of a phase III study aims to test the association between circulating mGSTP1 DNA levels and outcomes. Methods: The phase III SYNERGY study tested DTX +/- custirsen as 1st line chemotherapy in mCRPC (n = 1022) with no OS benefit in the experimental arm. Serum samples were taken at baseline (BL) and preC3 of DTX +/- custirsen from 600 patients (pts) enrolled on the SYNERGY study. mGSTP1levels in free DNA were measured using a sensitive methylation specific PCR assay and correlated with PSA response, time to PSA progression (TTP) and OS. Results: On interim analysis of 300 pts, serum mGSTP1 was detectable at BL in 80% and preC3 in 44%. Undetectable preC3 mGSTP1 correlated with a ≥30% fall in PSA within 3m of starting DTX (p < 0.001). Detectable BL and preC3 mGSTP1 predicted shorter TTP after DTX (BL; HR 1.6 95%CI 1.1-2.3; p = 0.01 and preC3 HR 2.2 95%CI 1.6-2.9; p < 0.001). Detectable mGSTP1 at both time points predicted shorter OS (BL; median OS 18.4 vs 33.1m, HR 2.4 95%CI 1.6-3.7; p < 0.001 and preC3; median OS 13.9 vs 29m, HR 2.7 95%CI 2.0-3.6; p < 0.001). In those with detectable BL mGSTP1, 50% had undetectable preC3 mGSTP1 predicting > 30% fall in PSA within 3m (p < 0.001), improved TTP (HR 0.40 95%CI 0.29-0.57; p < 0.001) and improved OS (25.2 vs 13.9 m HR 0.38 95%CI 0.28-0.51; p < 0.001). On multivariable analysis including Hb, Karnofsky PS, LDH, PSA and visceral metastases, detectable preC3 mGSTP1 independently predicted shorter TTP (HR 1.9 95%CI 1.4-2.6; p < 0.001). Detectable mGSTP1at both time points independently predicted OS (BL; HR1.8 95%CI 1.2-2.8; p = 0.006 and preC3; HR 2.2 95%CI 1.6-3.0; p < 0.001). Results from the full cohort of 600 pts will be available for presentation at the meeting. Conclusions: This study should validate circulating mGSTP1 DNA as a marker of therapeutic benefit and prognosis in men with mCRPC receiving DTX and could be utilized for clinical management.

Diminished Serum Insulin Response to Glucose in Genetic Prediabetic Males with Normal Glucose Tolerance

Diabetes ◽  
1968 ◽  
Vol 17 (1) ◽  
pp. 17-26 ◽  
Author(s):  
J. S. Soeldner ◽  
R. E. Gleason ◽  
R. F. Williams ◽  
M. J. Garcia ◽  
D. M. Beardwood ◽  
...  
Keyword(s):  
Glucose Tolerance ◽  
Serum Insulin ◽  
Insulin Response ◽  
Normal Glucose Tolerance ◽  
Normal Glucose ◽  
Insulin Response To Glucose
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