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A phase III randomized trial of chemoimmunotherapy comprising gemcitabine and capecitabine with or without telomerase vaccine GV1001 in patients with locally advanced or metastatic pancreatic cancer.
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
Background: GV1001, a promiscuous class II epitope encompassing aa 611-626 of hTERT led to the development of CD4+ clones recognizing hTERT in patients with advanced pancreatic cancer (APC). Preclinically gemcitabine increases antigen cross-presentation, enhances T cell trafficking/activation, and reduces MDSCs and Tregs. Methods: Patients with APC were randomized 1:1:1 to: Arm 1 GemCap; 2 GemCap for 8/52 followed by GV1001 followed by further GemCap if no PD at week 8; 3 concurrent administration of GemCap and GV1001. 735 (69.2%) had metastatic disease and 948 (89.3%) had ECOG PS=0 or 1. Randomization was stratified by stage and PS. Primary endpoint was overall survival (OS); secondary endpoints included ORR, TTP, and AEs. Recruitment target was 1,110 patients (780 deaths) to permit detection of a hazard ratio of 0.748 between either GV1001 arm and Arm 1 using a 2-sided α=0.025 level of significance with at least 80% power. Results: 1,062 pts from 51 centers were randomized. Trial maturity was high (72.7% patients died): median follow-up was 6.11 months. The overall response rates were Arm 1=17.6%; Arm 2=8.9% (p=0.001); Arm 3: 15.5% (p=0.460 compared with Arm 1). Conclusions: OS with concurrent GemCap/GV1001 was not different to that with GemCap alone. OS with sequential GV1001 was not statistically different to GemCap alone as it did not meet the criterion for statistical significance (p<0.0175). The addition of a T helper epitope vaccine to GemCap did not improve outcome compared to GemCap alone. Clinical trial information: 43482138.
|No. of deaths
(% of N)
|Arm 1||358||245 (68%)||7.89||33.7%||1||N/A|
|Arm 2||350||268 (77%)||(7.07 to 8.85)||(28.2 to 39.2)||1.19||0.0466|
|Arm 3||354||259 (73%)||6.94||25.3%||(0.97 to 1.48)||0.6378|
|(6.35 to 7.60)||(20.4 to 30.6)||1.05|
|8.36||32.3%||(0.85 to 1.29)|
|(7.30 to 9.74)||(26.9 to 37.8)|
* ITT analysis using Cox regression and log-rank test stratified on ECOG and stage at randomization. Confidence level reflects the O’Brien-Fleming boundary and has the force of a 95% interval.
Abstracts by G. W. Middleton:
Addition of panitumumab to irinotecan: Results of PICCOLO, a randomized controlled trial in advanced colorectal cancer (aCRC).Meeting: 2011 ASCO Annual Meeting | Abstract No: 3523
Biomodulation of irinotecan using ciclosporin: Results of PICCOLO, a randomized controlled trial in advanced colorectal cancer (aCRC).Meeting: 2011 ASCO Annual Meeting | Abstract No: 3566