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Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria

Wolchok, Jedd D; Hoos, Axel; O'Day, Steven; Weber, Jeffrey S; Hamid, Omid; Lebbe, Celeste; Maio, Michele; Binder, Michael; Bohnsack, Oliver; Nichol, Geoffrey; Humphrey, Rachel; Hodi, F Stephen
PURPOSE: Immunotherapeutic agents produce antitumor effects by inducing cancer-specific immune responses or by modifying native immune processes. Resulting clinical response patterns extend beyond those of cytotoxic agents and can manifest after an initial increase in tumor burden or the appearance of new lesions (progressive disease). Response Evaluation Criteria in Solid Tumors or WHO criteria, designed to detect early effects of cytotoxic agents, may not provide a complete assessment of immunotherapeutic agents. Novel criteria for the evaluation of antitumor responses with immunotherapeutic agents are required. EXPERIMENTAL DESIGN: The phase II clinical trial program with ipilimumab, an antibody that blocks CTL antigen-4, represents the most comprehensive data set available to date for an immunotherapeutic agent. Novel immune therapy response criteria proposed, based on the shared experience from community workshops and several investigators, were evaluated using data from ipilimumab phase II clinical trials in patients with advanced melanoma. RESULTS: Ipilimumab monotherapy resulted in four distinct response patterns: (a) shrinkage in baseline lesions, without new lesions; (b) durable stable disease (in some patients followed by a slow, steady decline in total tumor burden); (c) response after an increase in total tumor burden; and (d) response in the presence of new lesions. All patterns were associated with favorable survival. CONCLUSION: Systematic criteria, designated immune-related response criteria, were defined in an attempt to capture additional response patterns observed with immune therapy in advanced melanoma beyond those described by Response Evaluation Criteria in Solid Tumors or WHO criteria. Further prospective evaluations of the immune-related response criteria, particularly their association with overall survival, are warranted.
PMID: 19934295
ISSN: 1078-0432
CID: 2201842

Long-term survival of patients (pts) with advanced melanoma treated with ipilimumab with or without dacarbazine [Meeting Abstract]

Hersh, E.; Weber, J.; Powderly, J.; Pavlik, A.; Nichol, G.; Yellin, M.; Cranmer, L.; Urba, W.; O'Day, S.
ISI:000276606606054
ISSN: 0732-183x
CID: 3158962

Association between intraepithelial Escherichia coli and colorectal cancer

Swidsinski, A; Khilkin, M; Kerjaschki, D; Schreiber, S; Ortner, M; Weber, J; Lochs, H
BACKGROUND & AIMS/OBJECTIVE:Although multiple studies have focused on Helicobacter pylori, little is known about the mucosa-associated flora of the colon. The aim of this study was to detect bacteria directly in colonic mucosa from patients screened for colorectal cancer. METHODS:Bacteria were quantified with the polymerase chain reaction and identified by comparative sequence analysis in colonoscopic biopsy specimens from 31 asymptomatic and 34 symptomatic controls with normal colonoscopic findings, 29 patients with colonic adenoma, and 31 patients with colorectal carcinoma. In 41 patients, intra- and extracellular location of bacteria was confirmed with the gentamicin protection assay. RESULTS:No bacteria were detected in biopsy specimens from 97% of asymptomatic and 69% of symptomatic controls. In contrast, bacterial concentrations of 10(3)-10(5) colony-forming units per microliter were detected in biopsy specimens from both malignant and macroscopically normal tissue in 90% and 93% of patients with adenoma and carcinoma, respectively. E. coli and coli-like bacteria were shown to colonize the colonic mucosa in 82% of these patients. The gentamicin protection assay indicated that E. coli was partially intracellular in 87% of patients with adenoma and carcinoma and in none of the controls. CONCLUSIONS:The colonic mucosa of patients with colorectal carcinoma but not normal colonic mucosa is colonized by intracellular E. coli.
PMID: 9679033
ISSN: 0016-5085
CID: 4637272