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Old 03-03-2014, 10:41 AM   #1
'lizbeth
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Fighting fire's GP2 info request

Randomized phase II clinical trial of the anti-HER2 (GP2) vaccine to prevent recurrence in high-risk breast cancer patients: A planned interim analysis.




Subcategory:
Vaccines




Category:
Developmental Therapeutics - Immunotherapy




Meeting:
2013 ASCO Annual Meeting




Session Type and Session Title:
Oral Abstract Session, Developmental Therapeutics - Immunotherapy




Abstract Number:
3005



Citation:
J Clin Oncol 31, 2013 (suppl; abstr 3005)



Author(s):
Francois Trappey, John S. Berry, Timothy J Vreeland, Diane F. Hale, Alan K. Sears, Sathibalan Ponniah, Sonia A. Perez, Guy T. Clifton, Michael Papamichail, George Earl Peoples, Elizabeth Ann Mittendorf; Brooke Army Medical Center, San Antonio, TX; Cancer Vaccine Development Program, United States Military Cancer Institute, USUHS, Bethesda, MD; St. Savas Cancer Hospital, Athens, Greece; Department of Surgery, Brooke Army Medical Center, Fort Sam Houston, TX; Cancer Immunology and Immunotherapy Center, Athens, Greece; The University of Texas MD Anderson Cancer Center, Houston, TX




Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
Abstract Disclosures
2013 ASCO Annual Meeting Proceedings Errata




Abstract:

Background: A prospective, randomized, multi-center, placebo-controlled, single-blinded, phase II trial was designed to evaluate the safety and clinical efficacy of GP2, a HER2-derived peptide vaccine, in breast cancer patients. Methods: Clinically disease-free, node-positive or high-risk node-negative patients (pts) with any level of HER2 expression were enrolled after standard of care therapy. HLA-A2+ pts were randomized to receive GP2 + GM-CSF (VG) or GM-CSF alone (CG). HLA A2- controls from a parallel arm of the study were also eligible for evaluation, the extended CG (ECG). Pts receive 6 monthly intradermal inoculations (R0-R6) during the primary vaccine series followed by four boosters every 6 mos. Immune responses (IR) were measured by delayed type hypersensitivity (DTH) at R0 and R6. This planned interim analysis was performed at 24 months median follow-up. Results: We have currently enrolled 172 pts (46, VG; 43, CG; 83 extended CG). There are no differences between groups with respect to age, rate of node positivity, tumor grade, tumor size, ER/PR status, and HER2 over-expression (all p > 0.05). Maximum local toxicity (tox) was similar between the two groups (grade (Gr) 1 and 2: VG 93%, CG 98%; Gr 3: VG 2%, CG 1%). Maximum systemic tox was also similar between the groups (Gr 1 and 2: VG 91%, CG 85%). No Gr 3 systemic tox has been reported. The most frequent systemic reactions are fatigue, headache, and myalgias. IR to GP2 has been robust. DTH is increased from R0 to R6 in the VG (3.0±0.98 to 21.5±4.04 mm, p < 0.01) vs. the smaller increase in CG (2.6±0.89 to 6.0±1.6 mm, p = 0.01). VG DTH at R6 is significantly higher than the CG (21.5 vs 6.0 mm, p < 0.01). The recurrence rate (RR) is decreased in the VG vs CG (4.3% vs. 11.6%, p = 0.41) and VG vs ECG (4.3% vs 9.5%, p = 0.41). In pts with HER2-overexpressing (IHC3+ or FISH+) tumors, the RR is decreased in the VG (0% vs 5% CG, p = 0.28). For TNBC (HER2 low, ER/PR-) pts, the RR is reduced in the VG vs ECG (0% vs 10.6%, p = 0.251). Conclusions: The GP2 vaccine is safe and the minimal toxicity is comparable between the VG and CG, suggesting that it is due to GM-CSF. Robust in vivo immune response has correlated with a >50% reduction in breast cancer recurrences in the VG. Clinical trial information: NCT00524277.
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Stage IIb Invasive Ductal Carcinoma, Pagets, 3 of 15 positive nodes

Traditional Treatment: Mastectomy and Axillary Node Dissection followed by Taxotere, 6 treatments and 1 year of Herceptin, no radiation
Former Chemo Ninja "Takizi Zukuchiri"

Additional treatments:
GP2 vaccine, San Antonio Med Ctr
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ENERGY Study, UCSD La Jolla

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The content of my posts are meant for informational purposes only. The medical information is intended for general information only and should not be used in any way to diagnose, treat, cure, or prevent disease

Last edited by 'lizbeth; 03-03-2014 at 10:43 AM.. Reason: delete duplicate pasting
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Old 03-04-2014, 07:14 PM   #2
anna4969
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Re: Fighting fire's GP2 info request

Lizbeth,

Thank you for posting. I did the GP2 and GM-CSF with my last 6 Herceptins in a Phase 1 trail(I did not get the boosters as that was not a part of the trial). These results must be good as you posted them. Can you decipher a bit for me? I was ER/PR - and Her2 +(of course). What exactly does this mean for me?

I'm so happy you keep so informed about this. I should really email my trial nurse and ask her point blank if there have been any recurrences in my study, just don't really know if I want to hear the answer!!

Thanks a bunch
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1/10 rt. breast IDC er/pr - Her +++
9cm. tumor, 8-9 + nodes
Neoadj. FACT & beloved H!!, radiation, Dbl. Mast. Diep recons.
GP2 Vaccine completed 5/11
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Old 03-05-2014, 11:00 AM   #3
'lizbeth
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Re: Fighting fire's GP2 info request

Here is the PubMed information on Phase I:

Cancer. 2010 Jan 15;116(2):292-301. doi: 10.1002/cncr.24756.
Results of the first phase 1 clinical trial of the HER-2/neu peptide (GP2) vaccine in disease-free breast cancer patients: United States Military Cancer Institute Clinical Trials Group Study I-04.

Carmichael MG1, Benavides LC, Holmes JP, Gates JD, Mittendorf EA, Ponniah S, Peoples GE.
Author information


Abstract

BACKGROUND:

HER-2/neu, overexpressed in breast cancer, is a source of immunogenic peptides that include GP2 and E75. Phase 2 testing of E75 as an adjuvant vaccine has suggested a clinical benefit. GP2, derived from the transmembrane portion of HER-2/neu, has differing binding characteristics and may be more immunogenic than E75. Results of the first phase 1 trial of GP2 peptide vaccine are presented.
METHODS:

Disease-free, lymph node-negative, human leukocyte antigen (HLA)-A2(+) breast cancer patients were enrolled. This dose escalation trial included 4 groups to determine safety and optimal GP2 peptide/granulocyte-macrophage colony-stimulating factor (GM-CSF) dose. Toxicities were monitored. Immunologic response was assessed ex vivo via the HLA-A2:immunoglobulin dimer assay to detect GP2-specific CD8(+) T cells (and E75-specific CD8(+) T cells to assess epitope spreading) and in vivo via delayed type hypersensitivity (DTH) reaction (medians/ranges).
RESULTS:

Eighteen patients were enrolled. All toxicities were grade < or =2. Eight (88.9%) of 9 patients in the first 3 dose groups required GM-CSF dose reductions for local reactions > or =100 mm or grade > or =2 systemic toxicity. GM-CSF dose was reduced to 125 microg for the final dose group. All patients responded immunologically ex vivo (GP2-specific CD8(+) T cells from prevaccination to maximum, 0.4% [0.0%-2.0%] to 1.1% [0.4%-3.6%], P < .001) and in vivo (GP2 pre- to postvaccination DTH, 0 mm [0.0-19.5 mm] to 27.5 mm [0.0-114.5 mm, P < .001). E75-specific CD8(+) T cells also increased in response to GP2 from prevaccination to maximum (0.8% [0.0%-2.41%] to 1.6% [0.86%-3.72%], P < .001).
CONCLUSIONS:

The GP2 peptide vaccine appears safe and well tolerated with minimal local/systemic toxicity. GP2 elicited HER-2/neu-specific immune responses, including epitope spreading, in high-risk, lymph node-negative breast cancer patients. These findings support further investigation of the GP2 vaccine for the prevention of breast cancer recurrence.
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Old 03-05-2014, 11:33 AM   #4
anna4969
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Re: Fighting fire's GP2 info request

Lizbeth,

Thanks for this. I believe, based on the phase 1 in 2010, they then expanded and included the Herceptin factor as well, as I participated in the GP2 + GM-CSF + Herceptin in Jan. of 2011. I'm not seeing any more information regarding ongoing studies with all 3. Thanks for all you investigations in these vaccines. I am a firm believer that they will be of major benefit to us. When I see StephN post, I am so excited because I know she was one of the first vaccine participants in Washington and she is NED. Wonderful!!

Be well.
__________________
1/10 rt. breast IDC er/pr - Her +++
9cm. tumor, 8-9 + nodes
Neoadj. FACT & beloved H!!, radiation, Dbl. Mast. Diep recons.
GP2 Vaccine completed 5/11
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