Phase II trial of neoadjuvant docetaxel and CG1940/CG8711 followed by radical prostatectomy in patients with high-risk clinically localized prostate cancer

Jacqueline Vuky, John M. Corman, Christopher Porter, Semra Olgac, Evan Auerbach, Kathryn Dahl

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Background. Prostate cancer (PC) is the most commonly diagnosed noncutaneous malignancy in American men. PC, which exhibits a slow growth rate and multiple potential target epitopes, is an ideal candidate for immunotherapy. GVAX for prostate cancer is a cellular immunotherapy, composed of PC-3 cells (CG1940) and LNCaP cells (CG8711). Each of the components is a prostate adenocarcinoma cell line that has been genetically modified to secrete granulocyte-macrophage colony-stimulating factor. Hypothesizing that GVAX for prostate cancer could be effective in a neoadjuvant setting in patients with locally advanced disease, we initiated a phase II trial of neoadjuvant docetaxelandGVAX.For the trial, the clinical effects ofGVAXwere assessed in patients undergoing radical prostatectomy (RP). Methods. Patients received docetaxel administered at a dose of 75 mg/m82 every 3 weeks for 4 cycles. GVAX was administered 2-3 days after chemotherapy preoperatively for four courses of immunotherapy. The first dose of GVAX was a prime immunotherapy of 5×108 cells. The subsequent boost immunotherapies consisted of 3×108 cells. After RP, patients received an additional six courses of immunotherapy. Pathologic complete response, toxicity, and clinical response were assessed. The primary endpoint of the trial was a pathologic state of pT0, which is defined as no evidence of cancer in the prostate. Results. Six patients completed neoadjuvant docetaxel and GVAX therapy. No serious drug-related adverse events were observed. Median change in prostate-specific antigen (PSA) following neoadjuvant therapy was 1.47 ng/ml. One patient did not undergo RP due to the discovery of positive lymph nodes during exploration. Of the five patients completing RP, four had a downstaging of their Gleason score. Undetectable PSA was achieved in three patients at 2 months after RP and in two patients at 3 years after RP. Conclusions. Neoadjuvant docetaxel/GVAX is safe and well toleratedinpatientswithhigh- risklocallyadvancedPC.Noevidence of increased intraoperative hemorrhage or increased length of hospital stay postoperatively was noted. These results justify further study of neoadjuvant immunotherapy.

Original languageEnglish (US)
Pages (from-to)687-688
Number of pages2
JournalOncologist
Volume18
Issue number6
DOIs
StatePublished - 2013

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docetaxel
Prostatectomy
Prostatic Neoplasms
Immunotherapy
Prostate-Specific Antigen
Length of Stay
Neoadjuvant Therapy
Neoplasm Grading
Granulocyte-Macrophage Colony-Stimulating Factor
Drug-Related Side Effects and Adverse Reactions

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase II trial of neoadjuvant docetaxel and CG1940/CG8711 followed by radical prostatectomy in patients with high-risk clinically localized prostate cancer. / Vuky, Jacqueline; Corman, John M.; Porter, Christopher; Olgac, Semra; Auerbach, Evan; Dahl, Kathryn.

In: Oncologist, Vol. 18, No. 6, 2013, p. 687-688.

Research output: Contribution to journalArticle

Vuky, Jacqueline ; Corman, John M. ; Porter, Christopher ; Olgac, Semra ; Auerbach, Evan ; Dahl, Kathryn. / Phase II trial of neoadjuvant docetaxel and CG1940/CG8711 followed by radical prostatectomy in patients with high-risk clinically localized prostate cancer. In: Oncologist. 2013 ; Vol. 18, No. 6. pp. 687-688.
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abstract = "Background. Prostate cancer (PC) is the most commonly diagnosed noncutaneous malignancy in American men. PC, which exhibits a slow growth rate and multiple potential target epitopes, is an ideal candidate for immunotherapy. GVAX for prostate cancer is a cellular immunotherapy, composed of PC-3 cells (CG1940) and LNCaP cells (CG8711). Each of the components is a prostate adenocarcinoma cell line that has been genetically modified to secrete granulocyte-macrophage colony-stimulating factor. Hypothesizing that GVAX for prostate cancer could be effective in a neoadjuvant setting in patients with locally advanced disease, we initiated a phase II trial of neoadjuvant docetaxelandGVAX.For the trial, the clinical effects ofGVAXwere assessed in patients undergoing radical prostatectomy (RP). Methods. Patients received docetaxel administered at a dose of 75 mg/m82 every 3 weeks for 4 cycles. GVAX was administered 2-3 days after chemotherapy preoperatively for four courses of immunotherapy. The first dose of GVAX was a prime immunotherapy of 5×108 cells. The subsequent boost immunotherapies consisted of 3×108 cells. After RP, patients received an additional six courses of immunotherapy. Pathologic complete response, toxicity, and clinical response were assessed. The primary endpoint of the trial was a pathologic state of pT0, which is defined as no evidence of cancer in the prostate. Results. Six patients completed neoadjuvant docetaxel and GVAX therapy. No serious drug-related adverse events were observed. Median change in prostate-specific antigen (PSA) following neoadjuvant therapy was 1.47 ng/ml. One patient did not undergo RP due to the discovery of positive lymph nodes during exploration. Of the five patients completing RP, four had a downstaging of their Gleason score. Undetectable PSA was achieved in three patients at 2 months after RP and in two patients at 3 years after RP. Conclusions. Neoadjuvant docetaxel/GVAX is safe and well toleratedinpatientswithhigh- risklocallyadvancedPC.Noevidence of increased intraoperative hemorrhage or increased length of hospital stay postoperatively was noted. These results justify further study of neoadjuvant immunotherapy.",
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T1 - Phase II trial of neoadjuvant docetaxel and CG1940/CG8711 followed by radical prostatectomy in patients with high-risk clinically localized prostate cancer

AU - Vuky, Jacqueline

AU - Corman, John M.

AU - Porter, Christopher

AU - Olgac, Semra

AU - Auerbach, Evan

AU - Dahl, Kathryn

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N2 - Background. Prostate cancer (PC) is the most commonly diagnosed noncutaneous malignancy in American men. PC, which exhibits a slow growth rate and multiple potential target epitopes, is an ideal candidate for immunotherapy. GVAX for prostate cancer is a cellular immunotherapy, composed of PC-3 cells (CG1940) and LNCaP cells (CG8711). Each of the components is a prostate adenocarcinoma cell line that has been genetically modified to secrete granulocyte-macrophage colony-stimulating factor. Hypothesizing that GVAX for prostate cancer could be effective in a neoadjuvant setting in patients with locally advanced disease, we initiated a phase II trial of neoadjuvant docetaxelandGVAX.For the trial, the clinical effects ofGVAXwere assessed in patients undergoing radical prostatectomy (RP). Methods. Patients received docetaxel administered at a dose of 75 mg/m82 every 3 weeks for 4 cycles. GVAX was administered 2-3 days after chemotherapy preoperatively for four courses of immunotherapy. The first dose of GVAX was a prime immunotherapy of 5×108 cells. The subsequent boost immunotherapies consisted of 3×108 cells. After RP, patients received an additional six courses of immunotherapy. Pathologic complete response, toxicity, and clinical response were assessed. The primary endpoint of the trial was a pathologic state of pT0, which is defined as no evidence of cancer in the prostate. Results. Six patients completed neoadjuvant docetaxel and GVAX therapy. No serious drug-related adverse events were observed. Median change in prostate-specific antigen (PSA) following neoadjuvant therapy was 1.47 ng/ml. One patient did not undergo RP due to the discovery of positive lymph nodes during exploration. Of the five patients completing RP, four had a downstaging of their Gleason score. Undetectable PSA was achieved in three patients at 2 months after RP and in two patients at 3 years after RP. Conclusions. Neoadjuvant docetaxel/GVAX is safe and well toleratedinpatientswithhigh- risklocallyadvancedPC.Noevidence of increased intraoperative hemorrhage or increased length of hospital stay postoperatively was noted. These results justify further study of neoadjuvant immunotherapy.

AB - Background. Prostate cancer (PC) is the most commonly diagnosed noncutaneous malignancy in American men. PC, which exhibits a slow growth rate and multiple potential target epitopes, is an ideal candidate for immunotherapy. GVAX for prostate cancer is a cellular immunotherapy, composed of PC-3 cells (CG1940) and LNCaP cells (CG8711). Each of the components is a prostate adenocarcinoma cell line that has been genetically modified to secrete granulocyte-macrophage colony-stimulating factor. Hypothesizing that GVAX for prostate cancer could be effective in a neoadjuvant setting in patients with locally advanced disease, we initiated a phase II trial of neoadjuvant docetaxelandGVAX.For the trial, the clinical effects ofGVAXwere assessed in patients undergoing radical prostatectomy (RP). Methods. Patients received docetaxel administered at a dose of 75 mg/m82 every 3 weeks for 4 cycles. GVAX was administered 2-3 days after chemotherapy preoperatively for four courses of immunotherapy. The first dose of GVAX was a prime immunotherapy of 5×108 cells. The subsequent boost immunotherapies consisted of 3×108 cells. After RP, patients received an additional six courses of immunotherapy. Pathologic complete response, toxicity, and clinical response were assessed. The primary endpoint of the trial was a pathologic state of pT0, which is defined as no evidence of cancer in the prostate. Results. Six patients completed neoadjuvant docetaxel and GVAX therapy. No serious drug-related adverse events were observed. Median change in prostate-specific antigen (PSA) following neoadjuvant therapy was 1.47 ng/ml. One patient did not undergo RP due to the discovery of positive lymph nodes during exploration. Of the five patients completing RP, four had a downstaging of their Gleason score. Undetectable PSA was achieved in three patients at 2 months after RP and in two patients at 3 years after RP. Conclusions. Neoadjuvant docetaxel/GVAX is safe and well toleratedinpatientswithhigh- risklocallyadvancedPC.Noevidence of increased intraoperative hemorrhage or increased length of hospital stay postoperatively was noted. These results justify further study of neoadjuvant immunotherapy.

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