Adjuvant active specific immunotherapy for stage II and III colon cancer with an autologous tumor cell vaccine: Eastern Cooperative Oncology Group study E5283

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

*Corresponding author for this work

Research output: Contribution to journalArticle

192 Citations (Scopus)

Abstract

Purpose: A randomized phase III clinical trial of adjuvant active specific immunotherapy (ASI) with an autologous tumor cell-bacillus Calmette- Guerin (BCG) vaccine was conducted to determine whether surgical resection plus ASI was more beneficial than resection alone in stage II and III colon cancer patients. Patients and Methods: Patients (n = 412) with colon cancer (297 with stage II disease, 115 with stage III disease) were randomly allocated to an observation arm or to a treatment arm in which they received three weekly intradermal vaccine injections of 107 irradiated autologous tumor cells beginning approximately 4 weeks after surgery. The first two weekly injections also contained 107 BCG organisms. Patients were observed for determination of time to recurrence and disease-free and overall survival. Results: This was a negative study in that after a 7.6-year median follow-up period, there were no statistically significant differences in clinical outcomes between the treatment arms. However, there were disease- free survival (P = .078) and overall survival (P = .12) trends in favor of ASI when treatment compliance was evaluated, ie, patients who received the intended treatment had a delayed cutaneous hypersensitivity (DCH) response to the third vaccination (induration ≥5 mm). Also, the magnitude of the DCH response correlated with improved prognosis. The 5-year survival proportion was 84.6% for those with indurations greater than 10 mm, compared with 45.0% for those with indurations less than 5 mm. Conclusions: When all randomized patients were evaluated, no significant clinical benefit was seen with ASI in surgically resected colon cancer patients with stage II or III colon cancer. However, there was an indication that treatment compliance with effective immunization results in disease-free and overall survival benefits.

Original languageEnglish (US)
Pages (from-to)148-157
Number of pages10
JournalJournal of Clinical Oncology
Volume18
Issue number1
StatePublished - Jan 1 2000

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Active Immunotherapy
Cancer Vaccines
Colonic Neoplasms
Disease-Free Survival
Delayed Hypersensitivity
BCG Vaccine
Intradermal Injections
Phase III Clinical Trials
Skin
Survival
Therapeutics
Mycobacterium bovis
Immunization
Neoplasms
Vaccination
Vaccines
Randomized Controlled Trials
Observation
Recurrence
Injections

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Harris, Jules E. ; Ryan, Louise ; Hoover, Herbert C. ; Stuart, Robert K. ; Oken, Martin M. ; Benson, Al B. ; Mansour, Edward ; Haller, Daniel G. ; Manola, Judith ; Hanna, Michael G. / Adjuvant active specific immunotherapy for stage II and III colon cancer with an autologous tumor cell vaccine : Eastern Cooperative Oncology Group study E5283. In: Journal of Clinical Oncology. 2000 ; Vol. 18, No. 1. pp. 148-157.
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title = "Adjuvant active specific immunotherapy for stage II and III colon cancer with an autologous tumor cell vaccine: Eastern Cooperative Oncology Group study E5283",
abstract = "Purpose: A randomized phase III clinical trial of adjuvant active specific immunotherapy (ASI) with an autologous tumor cell-bacillus Calmette- Guerin (BCG) vaccine was conducted to determine whether surgical resection plus ASI was more beneficial than resection alone in stage II and III colon cancer patients. Patients and Methods: Patients (n = 412) with colon cancer (297 with stage II disease, 115 with stage III disease) were randomly allocated to an observation arm or to a treatment arm in which they received three weekly intradermal vaccine injections of 107 irradiated autologous tumor cells beginning approximately 4 weeks after surgery. The first two weekly injections also contained 107 BCG organisms. Patients were observed for determination of time to recurrence and disease-free and overall survival. Results: This was a negative study in that after a 7.6-year median follow-up period, there were no statistically significant differences in clinical outcomes between the treatment arms. However, there were disease- free survival (P = .078) and overall survival (P = .12) trends in favor of ASI when treatment compliance was evaluated, ie, patients who received the intended treatment had a delayed cutaneous hypersensitivity (DCH) response to the third vaccination (induration ≥5 mm). Also, the magnitude of the DCH response correlated with improved prognosis. The 5-year survival proportion was 84.6{\%} for those with indurations greater than 10 mm, compared with 45.0{\%} for those with indurations less than 5 mm. Conclusions: When all randomized patients were evaluated, no significant clinical benefit was seen with ASI in surgically resected colon cancer patients with stage II or III colon cancer. However, there was an indication that treatment compliance with effective immunization results in disease-free and overall survival benefits.",
author = "Harris, {Jules E.} and Louise Ryan and Hoover, {Herbert C.} and Stuart, {Robert K.} and Oken, {Martin M.} and Benson, {Al B.} and Edward Mansour and Haller, {Daniel G.} and Judith Manola and Hanna, {Michael G.}",
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Harris, JE, Ryan, L, Hoover, HC, Stuart, RK, Oken, MM, Benson, AB, Mansour, E, Haller, DG, Manola, J & Hanna, MG 2000, 'Adjuvant active specific immunotherapy for stage II and III colon cancer with an autologous tumor cell vaccine: Eastern Cooperative Oncology Group study E5283', Journal of Clinical Oncology, vol. 18, no. 1, pp. 148-157.

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 C.; Stuart, Robert K.; Oken, Martin M.; Benson, Al B.; Mansour, Edward; Haller, Daniel G.; Manola, Judith; Hanna, Michael G.

In: Journal of Clinical Oncology, Vol. 18, No. 1, 01.01.2000, p. 148-157.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Adjuvant active specific immunotherapy for stage II and III colon cancer with an autologous tumor cell vaccine

T2 - Eastern Cooperative Oncology Group study E5283

AU - Harris, Jules E.

AU - Ryan, Louise

AU - Hoover, Herbert C.

AU - Stuart, Robert K.

AU - Oken, Martin M.

AU - Benson, Al B.

AU - Mansour, Edward

AU - Haller, Daniel G.

AU - Manola, Judith

AU - Hanna, Michael G.

PY - 2000/1/1

Y1 - 2000/1/1

N2 - Purpose: A randomized phase III clinical trial of adjuvant active specific immunotherapy (ASI) with an autologous tumor cell-bacillus Calmette- Guerin (BCG) vaccine was conducted to determine whether surgical resection plus ASI was more beneficial than resection alone in stage II and III colon cancer patients. Patients and Methods: Patients (n = 412) with colon cancer (297 with stage II disease, 115 with stage III disease) were randomly allocated to an observation arm or to a treatment arm in which they received three weekly intradermal vaccine injections of 107 irradiated autologous tumor cells beginning approximately 4 weeks after surgery. The first two weekly injections also contained 107 BCG organisms. Patients were observed for determination of time to recurrence and disease-free and overall survival. Results: This was a negative study in that after a 7.6-year median follow-up period, there were no statistically significant differences in clinical outcomes between the treatment arms. However, there were disease- free survival (P = .078) and overall survival (P = .12) trends in favor of ASI when treatment compliance was evaluated, ie, patients who received the intended treatment had a delayed cutaneous hypersensitivity (DCH) response to the third vaccination (induration ≥5 mm). Also, the magnitude of the DCH response correlated with improved prognosis. The 5-year survival proportion was 84.6% for those with indurations greater than 10 mm, compared with 45.0% for those with indurations less than 5 mm. Conclusions: When all randomized patients were evaluated, no significant clinical benefit was seen with ASI in surgically resected colon cancer patients with stage II or III colon cancer. However, there was an indication that treatment compliance with effective immunization results in disease-free and overall survival benefits.

AB - Purpose: A randomized phase III clinical trial of adjuvant active specific immunotherapy (ASI) with an autologous tumor cell-bacillus Calmette- Guerin (BCG) vaccine was conducted to determine whether surgical resection plus ASI was more beneficial than resection alone in stage II and III colon cancer patients. Patients and Methods: Patients (n = 412) with colon cancer (297 with stage II disease, 115 with stage III disease) were randomly allocated to an observation arm or to a treatment arm in which they received three weekly intradermal vaccine injections of 107 irradiated autologous tumor cells beginning approximately 4 weeks after surgery. The first two weekly injections also contained 107 BCG organisms. Patients were observed for determination of time to recurrence and disease-free and overall survival. Results: This was a negative study in that after a 7.6-year median follow-up period, there were no statistically significant differences in clinical outcomes between the treatment arms. However, there were disease- free survival (P = .078) and overall survival (P = .12) trends in favor of ASI when treatment compliance was evaluated, ie, patients who received the intended treatment had a delayed cutaneous hypersensitivity (DCH) response to the third vaccination (induration ≥5 mm). Also, the magnitude of the DCH response correlated with improved prognosis. The 5-year survival proportion was 84.6% for those with indurations greater than 10 mm, compared with 45.0% for those with indurations less than 5 mm. Conclusions: When all randomized patients were evaluated, no significant clinical benefit was seen with ASI in surgically resected colon cancer patients with stage II or III colon cancer. However, there was an indication that treatment compliance with effective immunization results in disease-free and overall survival benefits.

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