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GM‐CSF as a systemic adjuvant in a phase II prostate cancer vaccine trial
Author(s) -
Simmons S.J.,
Tjoa B.A.,
Rogers M.,
Elgamal A.,
Kenny G.M.,
Ragde H.,
Troychak M.J.,
Boynton A.L.,
Murphy G.P.
Publication year - 1999
Publication title -
the prostate
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.295
H-Index - 123
eISSN - 1097-0045
pISSN - 0270-4137
DOI - 10.1002/(sici)1097-0045(19990601)39:4<291::aid-pros10>3.0.co;2-9
Subject(s) - medicine , granulocyte macrophage colony stimulating factor , adjuvant , prostate cancer , discontinuation , clinical trial , immune system , immunotherapy , granulocyte colony stimulating factor , subcutaneous injection , gastroenterology , cancer , immunology , cytokine , chemotherapy
BACKGROUND Recombinant human granulocyte‐macrophage colony‐stimulating factor (GM‐CSF; Leukine® [sargramostim], Immunex Corp., Seattle, WA) was administered to a subgroup of 44 patients in a phase II clinical trial for prostate cancer using DC pulsed with HLA‐A2‐specific prostate‐specific membrane antigen (PSMA) peptides. Our purpose was to determine if GM‐CSF caused any enhancement of patients' immune responses, including enhancement of clinical response to the DC‐peptide treatment. This report compares the clinical responses to DC‐peptide infusions with and without systemic GM‐CSF treatment. METHODS GM‐CSF was administered by subcutaneous injection at a dose of 75 μg/m 2 /day for 7 days with each of six infusion cycles. Prefilled syringes were supplied to the patients for self‐administration. RESULTS One complete and 8 partial responders were identified among 44 patients who received GM‐CSF, as compared to 2 complete and 17 partial responders among 51 patients who did not receive GM‐CSF. For patients who received GM‐CSF and were tested by delayed‐type hypersensitivity (DTH) skin test, 3 cases of improved immune response were identified, compared to 5 cases of improvement in patients who did not receive GM‐CSF. The main GM‐CSF side effects reported were local reactions at the site of injection, fatigue, pain, and fever. Most reported side effects were of mild severity, with some cases of moderate severity leading to discontinuation of GM‐CSF. CONCLUSIONS Our results suggest GM‐CSF as employed in this trial did not detectably enhance clinical response to DC‐peptide infusions, or significantly enhance the measured immune response. Prostate 39:291–297, 1999. © 1999 Wiley‐Liss, Inc.