A reexamination of the stable category for evaluating response in patients with advanced prostate cancer

Abstract

Stable response to therapy in patients with advanced prostate cancer, as experienced in clinical trials of the National Prostatic Cancer Project (NPCP) has been re‐examined. Data from 10 completed trials, totaling over 1300 patients, have been examined for survival patterns within categories of response to therapy. Survival patterns, for patients alive at 12 weeks, were significantly poorer for patients who were categorized as progressors after 12 weeks on treatment than for those who were categorized as stable or as partial regressions. Furthermore, comparisons of survival patterns for those patients who were categorized as stable or partial regression revealed no statistically significant differences between them. The concerns over the use of stable as an indicator of response and the problems in establishing its true meaning are discussed. All things considered, the use of stable is a valid means to evaluate the status of patients in clinical trials of treatment modalities for advanced cancer of the prostate.

Chemohormonal therapy as primary treatment for metastatic prostate cancer: A randomized study of estramustine phosphate plus luteinizing hormone‐releasing hormone agonist versus flutamide plus luteinizing hormone‐releasing hormone agonist

“…Objective responses were evaluated according to the modified National Prostatic Cancer Project criteria to include a decrease of PSA by ≥ 50% in the partial response (PR) category 9 . A complete response (CR) was defined as normalization of the PSA level and, in patients with measurable disease, disappearance of all lesions without the occurrence of new ones.…”

“…Objective responses were evaluated according to the modified National Prostatic Cancer Project criteria to include a decrease of PSA by ≥50% in the partial response (PR) category. 9 A complete response (CR) was defined as normalization of the PSA level and, in patients with measurable disease, disappearance of all lesions without the occurrence of new ones. PR was defined as a decrease of ≥50% in the sum of the products of the longest diameters of all measurable lesions persisting for ≥4 weeks, improvement in bone scan findings, and reossification of lytic lesions, in addition to no increase in the size of any existing lesions and no appearance of new lesions.…”

Vaccination of advanced prostate cancer patients with PSCA and PSA peptide‐loaded dendritic cells induces DTH responses that correlate with superior overall survival

“…Progression was defined according to the criteria of the National Prostatic Cancer Project, 19 i.e. by a rise in PSA >50% on 2 occasions at least 1 week apart.…”

“…bone radioisotope scan or CT scan) was performed before the first and 2 weeks after the last vaccination. Since several patients did not present with measurable target lesions, clinical outcome was defined based on the criteria of the National Prostatic Cancer Project 19 and the recommendations of the Prostate-Specific Antigen Working Group. 20 In contrast to the RECIST criteria, 21 these follow-up criteria take changes in serum PSA into account.…”

“…DC maturation was induced with 20 ng/mL TNFa and 1 lg/mL Prostaglandin-E2 (all supplements from CellGenix) for 2 days. GMP-grade, HLA-A*0201-restricted peptides PSCA [14][15][16][17][18][19][20][21][22] (ALQPGTALL), CPP-PSCA (AAVLLPVLL-AAP-ALQPGTALL), PSA1 141-150 (FLTPKKLQCV), PSA2 [146][147][148][149][150][151][152][153][154] (KLQCVDLHV), PSA3 154-163 (VISNDVCAQV), and the HIVgag peptide HIVp17.A2.1 (SLYNTVATL) were purchased from Calbiochem-Novachem (Schwalbach, Germany). After maturation, DC were split into 3 aliquots.…”