Adjuvant Active  Specific Immunotherapy for Stage II  and III Colon Cancer With an Autologous Tumor Cell Vaccine: Eastern  Cooperative Oncology Group Study  E5283

Harris, Jules E.; Ryan, Louise; Hoover, Herbert; Stuart, Robert K.; Oken, Martin M.; Benson, Al B.; Mansour, Edward G.; Haller, Daniel G.; Manola, Judith; Hanna, Michael G.

doi:10.1200/jco.2000.18.1.148

Cited by 244 publications

(100 citation statements)

References 18 publications

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“…This is important because DTH-reactions indicate the development of specific cellular immunity and correlate strongly with survival (McCune et al, 1990;Baars et al, 2000;Harris et al, 2000). A recently published study with autologous colon tumour vaccines has shown that DTH-reactions with a diameter exceeding 10 mm should be considered to reflect successful vaccination therapy and predict relatively good survival rates (Harris et al, 2000).…”

Section: -Fu+asi For Stage III Colon Cancer a Baars Et Almentioning

confidence: 99%

“…The presence of a DTH response to tumour cells, 48 h after the vaccination regimen, is a measure of immunogenicity and reflects the adequacy of the vaccination and the general immune status of the patient. So far, DTH has been the only suitable parameter for the evaluation of anti-tumour immunity and the best early predictor of clinical efficacy of vaccination therapies (McCune et al, 1990;Harris et al, 2000;Baars et al, 2000;Clay et al, 2001).…”

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A phase II study of active specific immunotherapy and5-FU/Leucovorin as adjuvant therapy for stage III colon carcinoma

et al. 2002

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Active specific immunotherapy, using vaccines with autologous tumour cells and BCG, significantly reduces the rate of tumour recurrence in stage II colon cancer patients, while no clinical benefit has yet been observed in stage III patients. Adjuvant treatment with 5-Fluorouracil/Leucovorin is now considered standard therapy for stage III colon carcinoma and results in an absolute survival benefit of approximately 10%. Yet, the 5-year overall survival rate of stage III colon cancer patients is only 40 -50%. Combining chemotherapy and immunotherapy might improve prognosis for stage III patients, especially when considering that active specific immunotherapy and chemotherapy have shown synergistic effects in pre-clinical tumour models. We performed a phase II study with 56 patients, using the combination of active specific immunotherapy and chemotherapy as an adjuvant therapy in stage III colon cancer patients to assess the influence of 5-Fluorouracil/Leucovorin on anti-tumour immunity induced by autologous tumour cell vaccinations. Anti-tumour immunity was measured before and after chemotherapy by means of delayed type hypersensitivity reactions, taken 48 h after the third and the fourth vaccination. We also investigated the toxicity of this combined immuno-chemotherapy treatment. Delayed type hypersensitivity reactions before chemotherapy had a median size of 20.3 mm, while after chemotherapy delayed type hypersensitivity size was 18.4 mm (P=0.01), indicating that chemotherapy hardly affected anti-tumour immunity. The severity of ulcers at the BCG vaccination sites was comparable to previous studies. In 30% of the patients grade III or grade IV chemotherapy related toxicity was seen; this is comparable to what is normally observed after adjuvant chemotherapy alone. This study shows that the active specific immunotherapy-induced anti-tumour immune response is only minimally impaired by consecutive chemotherapy and that the combined treatment of stage III colon cancer patients with active specific immunotherapy and 5-Fluorouracil/Leucovorin does not cause unexpected toxicity. Colon cancer is one of the most prevalent malignancies in the industrialised world, with approximately 240 000 new cases diagnosed each year in the USA and Western Europe. When colon cancer is detected early, in stages I or II (Dukes A or B), the 5 year survival rate with surgery alone is 60 -90%, depending on the depth of invasion of the tumour into the bowel wall. When the cancer has spread to the regional lymph nodes, or stage III (Dukes C), the 5 year survival rate is 25 -60%. Important prognostic factors in stage III colon carcinoma include the number of positive nodes, extra-nodal growth, invasion of adjacent organs, grade of histologic differentiation and post-operative CEA level. When distant metastases are diagnosed, stage IV (Dukes D), the 5 year survival rate is less than 5% (Cohen et al, 1997).Currently most patients with stage III colon carcinoma receive an adjuvant treatment with 5-Fluorouracil (5-FU) and Leucovorin. Several lar...

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Section: -Fu+asi For Stage III Colon Cancer a Baars Et Almentioning

confidence: 99%

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confidence: 99%

A phase II study of active specific immunotherapy and5-FU/Leucovorin as adjuvant therapy for stage III colon carcinoma

et al. 2002

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“…Assays such as the enzyme-linked immunospot (ELISpot), an interferon-γ-release assay which can detect the frequency of specific cytotoxic lymphocytes, are gaining popularity, but the relative importance of any positive result to clinical outcome remains unclear. The assay which currently appears in a number of trials to correlate most strongly with a clinical response is delayed-type hypersensitivity (DTH) testing (Berd et al, 1990;Simons et al, 1997;Harris et al, 2000).…”

Section: Evaluation Of Vaccine Therapy: the Importance Of Immunologicmentioning

confidence: 99%

Developing effective cancer vaccines: design and monitoring are critical

Armstrong

Dermime

2001

Br J Cancer

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“…Whole tumor cell vaccines combined with bacilli Calmette-Guerin (BCG), an attenuated strain of mycobacterium bovis, was the first colorectal tumor cell vaccine. Then three randomized trials of this tumor cell BCG vaccine have been carried out (Hoover et al, 1993;Vermorken et al, 1999;Harris et al, 2000). Regrettably, a meta-analysis of these three trials showed that overall survival trended towards improvement but failed to reach statistical significance.…”

Section: Introductionmentioning

confidence: 99%

HOCl Oxidation-modified CT26 Cell Vaccine Inhibits Colon Tumor Growth in a Mouse Model

Huang¹,

Ma²,

Zhou³

et al. 2012

Asian Pacific Journal of Cancer Prevention

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Adjuvant Active Specific Immunotherapy for Stage II and III Colon Cancer With an Autologous Tumor Cell Vaccine: Eastern Cooperative Oncology Group Study E5283

Cited by 244 publications

References 18 publications

A phase II study of active specific immunotherapy and5-FU/Leucovorin as adjuvant therapy for stage III colon carcinoma

A phase II study of active specific immunotherapy and5-FU/Leucovorin as adjuvant therapy for stage III colon carcinoma

Developing effective cancer vaccines: design and monitoring are critical

HOCl Oxidation-modified CT26 Cell Vaccine Inhibits Colon Tumor Growth in a Mouse Model

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