TY - JOUR
T1 - Postoperative adjuvant chemotherapy or BCG for colon cancer
T2 - Results from NSABP protocol C-01
AU - Wolmark, Norman
AU - Fisher, Bernard
AU - Rockette, Howard
AU - Redmond, Carol
AU - Wickerham, D. Lawrence
AU - Fisher, Edwin R.
AU - Jones, Judith
AU - Glass, Andrew
AU - Lerner, Harvey
AU - Lawrence, Walter
AU - Prager, David
AU - Wexler, Marvin
AU - Evans, James
AU - Cruz, Anatolio
AU - Dimitrov, Nikolay
AU - Jochimsen, Peter
N1 - Funding Information:
Supported by Public Health Service grant CA-34212 from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services; and by grant RC-13 from the American Cancer Society. Other NSABP investigators include: R Sponzo (Albany Regional Cancer Center, Albany, NY); R Rosen (Albert Einstein College of Medicine, Bronx, NY); D. Prager (Allentown Hospital, Allentown, PA); J. Spector (Berkshire Medical Center, Pittsfield, MA); B. Marchelb (Billings Interhospital Oncology Project, Billings, MT); M. Feldman (Boston University, Boston, MA); J. M. Sterchi (Bowman Gray School of Medicine, Winston-Salem, NC); M. Morrow (Downstate Medical Center, Brooklyn, NY); J. Evans (Geisinger Medical Center, Danville, PA); D. State (Harbor General Hospital, Torrance, CA); A. Robidoux Hotel-Dieu, Montreal, PQ, Canada); R Margolese (Jewish General Hospital, Montreal, PQ, Canada); A. Glass (Kaiser Permanente, Portland, OR); H. Wold (Letterman Army Medical Center, San Francisco, CA); /. Cohn (Louisiana State University, New Orleans, LA); D. Bowman (Manitoba Cancer Foundation, Winnipeg, MB, Canada); T. Banerjee (Marsh-field Clinic, Marshfield, WI); T. Wozniak (Medical Center of Delaware, Inc., Newark, DE); W. Lawrence (Medical College of Virginia, Richmond, VA); D. Plbtkin (Memorial Cancer Research Foundation, Los Angeles, CA); R Dresser (Michael Reese Hospital, Chicago, IL); N. Dimitrov (Michigan State University, E. Lansing, MI); M. Thirlweli (Montreal General Hospital, Montreal, PQ, Canada); J. Guzik (Naval Hospital, San Diego, CA); H. Lerner (Pennsylvania Hospital, Philadelphia, PA); H. ShibatalMarvin Wexler (Royal Victoria Hospital, Montreal, PQ, Canada); R Poisson/S. Legaull-Poisson (St. Luc Hospital, Montreal, PQ, Canada); P. Koontz (St. Luke's Hospital, Kansas City, MO); 7. Keysertingk (St. Mary's Hospital Center, Montreal, PQ, Canada); L Mahoney (St. Michael's Hospital, Toronto, ON, Canada); M. Kemeny (St. Vincent's Hospital, New York, NY); / Berry (Tom Baker Cancer Centre, Calgary, AB, Canada); C. Sutherland (Tulane University, New Orleans, LA); R Oishi (University of Hawaii, Honolulu, HI); P. Jochimsen (University of Iowa, Iowa City, IA); £ G. EUas (University of Maryland, Baltimore, MD); B. Fisher (University of Pittsburgh, Pittsburgh, PA); A. Cruz (University of Texas, San Antonio, TX); J. Bledsoe (Washington Regional Medical Center, Rogers, AR); M. Tan (White Memorial Medical Center, Los Angeles, CA).
PY - 1988/3/2
Y1 - 1988/3/2
N2 - Data are presented from 1,166 patients with Dukes B and C carcinoma of the colon who were entered into the National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol C-01 between November 1977 and February 1983. Patients were randomized to one of three therapeutic categories: 1) no further treatment following curative resection (394 patients); 2) postoperative chemotherapy consisting of 5-fluorouracil, semustine, and vincristine (379 patients); or 3) postoperative BCG (393 patients). The average time on study was 77.3 months. A comparison between patients receiving postoperative adjuvant chemotherapy and those treated with surgery alone indicated that there was an overall improvement in disease-free survival (P=.02) and survival (P=.05) in favor of the chemotherapy-treated group. At 5 years of follow-up, patients treated with surgery alone were at 1.29 times the risk of developing a treatment failure and at 1.31 times the likelihood of dying as were similar patients treated with combination adjuvant chemotherapy. Comparison of the BCG-treated group with the group treated with surgery alone indicated that there was no statistically significant difference in disease-free survival (P=.09). There was, however, a survival advantage in favor of the BCG-treated group (P=.03). At 5 years of follow-up, patients randomized to the surgery-alone arm were at 1.28 times the risk of dying as were similar patients treated with BCG. Further investigation disclosed that this survival advantage in favor of BCG was a result of a diminution in deaths that were non-cancer related. When analyses were conducted on which events not related to cancer recurrence were eliminated, the survival difference between the BCG and control groups became nonsignificant (P=.40); the cumulative odds at 5 years decreased from 1.28 to 1.10. The findings from this study are the first from a randomized prospective clinical trial to demonstrate that a significant disease-free survival and survival benefit can be achieved with postoperative adjuvant chemotherapy in patients with Dukes B and C carcinoma of the colon who have undergone curative resection. [J Natl Cancer Inst 1988;80:30-36]
AB - Data are presented from 1,166 patients with Dukes B and C carcinoma of the colon who were entered into the National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol C-01 between November 1977 and February 1983. Patients were randomized to one of three therapeutic categories: 1) no further treatment following curative resection (394 patients); 2) postoperative chemotherapy consisting of 5-fluorouracil, semustine, and vincristine (379 patients); or 3) postoperative BCG (393 patients). The average time on study was 77.3 months. A comparison between patients receiving postoperative adjuvant chemotherapy and those treated with surgery alone indicated that there was an overall improvement in disease-free survival (P=.02) and survival (P=.05) in favor of the chemotherapy-treated group. At 5 years of follow-up, patients treated with surgery alone were at 1.29 times the risk of developing a treatment failure and at 1.31 times the likelihood of dying as were similar patients treated with combination adjuvant chemotherapy. Comparison of the BCG-treated group with the group treated with surgery alone indicated that there was no statistically significant difference in disease-free survival (P=.09). There was, however, a survival advantage in favor of the BCG-treated group (P=.03). At 5 years of follow-up, patients randomized to the surgery-alone arm were at 1.28 times the risk of dying as were similar patients treated with BCG. Further investigation disclosed that this survival advantage in favor of BCG was a result of a diminution in deaths that were non-cancer related. When analyses were conducted on which events not related to cancer recurrence were eliminated, the survival difference between the BCG and control groups became nonsignificant (P=.40); the cumulative odds at 5 years decreased from 1.28 to 1.10. The findings from this study are the first from a randomized prospective clinical trial to demonstrate that a significant disease-free survival and survival benefit can be achieved with postoperative adjuvant chemotherapy in patients with Dukes B and C carcinoma of the colon who have undergone curative resection. [J Natl Cancer Inst 1988;80:30-36]
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U2 - 10.1093/jnci/80.1.30
DO - 10.1093/jnci/80.1.30
M3 - Article
C2 - 3276901
AN - SCOPUS:0023855192
SN - 0027-8874
VL - 80
SP - 30
EP - 36
JO - Journal of the National Cancer Institute
JF - Journal of the National Cancer Institute
IS - 1
ER -