Journal of Clinical Oncology, Vol 10, 549-557, Copyright © 1992 by American Society of Clinical Oncology
Radiation therapy and fluorouracil with or without semustine for the treatment of patients with surgical adjuvant adenocarcinoma of the rectum. Gastrointestinal Tumor Study Group
PURPOSE: To evaluate the contribution of semustine (MeCCNU) to adjuvant
benefit, previously untreated patients with histologically proven
adenocarcinoma of the rectum who had undergone curative resection were
randomized to treatment with combination radiation therapy and fluorouracil
(5-FU) followed by either 12 months of 5-FU and MeCCNU or 6 months of
escalating 5-FU. PATIENTS AND METHODS: Between March 1981 and November
1985, 210 patients were randomized by Gastrointestinal Tumor Study Group
(GITSG) investigators. Subsequent to randomization, 11 (5%) patients (six
treated with 5-FU and MeCCNU; five with escalating 5-FU) were found to be
ineligible and are excluded from survival analyses. RESULTS: About half the
patients on each of the two treatment arms experienced at least one episode
of severe or worse toxicity, and there was one treatment-related death on
each arm. No episodes of leukemia have been reported. Median follow-up time
for surviving patients is 5.8 years, and 3-year follow-up is available for
all but five surviving patients. Recurrent disease has been reported in 54%
(51 of 95) of 5-FU- and MeCCNU-treated patients compared with 43% (45 of
104) of escalating 5-FU-treated patients. Probability of 3-year
disease-free survival for the two treatment cohorts is 54% and 68%,
respectively. Ninety-one deaths have occurred: 46% (44 of 95) of 5-FU- and
MeCCNU-treated patients and 45% (47 of 104) of escalating 5-FU- treated
patients. Three-year postsurgery survival probabilities are 66% and 75%.
CONCLUSION: Substantial differences in survival or recurrence results
between the two study arms are unlikely to be observed. We conclude that
MeCCNU is not an essential component of effective postoperative combined
modality treatment of adjuvant rectal cancer.
This article has been cited by other articles:
|
|
|
|
 
I. J. Park, H. C. Kim, C. S. Yu, T. W. Kim, S. J. Jang, and J. C. Kim
Effect of Adjuvant Radiotherapy on Local Recurrence in Stage II Rectal Cancer
Ann. Surg. Oncol.,
February 1, 2008;
15(2):
519 - 525.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J-P Machiels, C Sempoux, P Scalliet, J-C Coche, Y Humblet, E Van Cutsem, J Kerger, J-L Canon, M Peeters, S Aydin, et al.
Phase I/II study of preoperative cetuximab, capecitabine, and external beam radiotherapy in patients with rectal cancer
Ann. Onc.,
April 1, 2007;
18(4):
738 - 744.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
C. Ratto, R. Ricci, V. Valentini, F. Castri, A. Parello, M. A. Gambacorta, N. Cellini, F. M. Vecchio, and G. B. Doglietto
Neoplastic Mesorectal Microfoci (MMF) following Neoadjuvant Chemoradiotherapy: Clinical and Prognostic Implications
Ann. Surg. Oncol.,
February 1, 2007;
14(2):
853 - 861.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
C. Rodel, T. Liersch, R. M. Hermann, D. Arnold, T. Reese, M. Hipp, A. Furst, N. Schwella, M. Bieker, G. Hellmich, et al.
Multicenter Phase II Trial of Chemoradiation With Oxaliplatin for Rectal Cancer
J. Clin. Oncol.,
January 1, 2007;
25(1):
110 - 117.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
C. Ratto, R. Ricci, V. Valentini, F. Castri, A. Parello, M. A. Gambacorta, N. Cellini, F. M. Vecchio, and G. B. Doglietto
Neoplastic Mesorectal Microfoci (MMF) Following Neoadjuvant Chemoradiotherapy: Clinical and Prognostic Implications
Ann. Surg. Oncol.,
November 1, 2006;
13(11):
1393 - 1402.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
R. Glynne-Jones, J. Dunst, and D. Sebag-Montefiore
The integration of oral capecitabine into chemoradiation regimens for locally advanced rectal cancer: how successful have we been?
Ann. Onc.,
March 1, 2006;
17(3):
361 - 371.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. De Paoli, S. Chiara, G. Luppi, M. L. Friso, G. D. Beretta, S. Del Prete, L. Pasetto, M. Santantonio, E. Sarti, G. Mantello, et al.
Capecitabine in combination with preoperative radiation therapy in locally advanced, resectable, rectal cancer: a multicentric phase II study
Ann. Onc.,
February 1, 2006;
17(2):
246 - 251.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J.-P. Machiels, L. Duck, B. Honhon, B. Coster, J.-C. Coche, P. Scalliet, Y. Humblet, S. Aydin, J. Kerger, V. Remouchamps, et al.
Phase II study of preoperative oxaliplatin, capecitabine and external beam radiotherapy in patients with rectal cancer: the RadiOxCape study
Ann. Onc.,
December 1, 2005;
16(12):
1898 - 1905.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
L. L. Gunderson, D. J. Sargent, J. E. Tepper, N. Wolmark, M. J. O'Connell, M. Begovic, C. Allmer, L. Colangelo, S. R. Smalley, D. G. Haller, et al.
Impact of T and N Stage and Treatment on Survival and Relapse in Adjuvant Rectal Cancer: A Pooled Analysis
J. Clin. Oncol.,
May 15, 2004;
22(10):
1785 - 1796.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. J. Telford, J. R. Saltzman, K. M. Kuntz, and S. Syngal
Impact of Preoperative Staging and Chemoradiation Versus Postoperative Chemoradiation on Outcome in Patients With Rectal Cancer: A Decision Analysis
J Natl Cancer Inst,
February 4, 2004;
96(3):
191 - 201.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
C. Rodel, Gerhard. G. Grabenbauer, T. Papadopoulos, W. Hohenberger, H.-J. Schmoll, and R. Sauer
Phase I/II Trial of Capecitabine, Oxaliplatin, and Radiation for Rectal Cancer
J. Clin. Oncol.,
August 15, 2003;
21(16):
3098 - 3104.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. Z. Ayanian, A. M. Zaslavsky, C. S. Fuchs, E. Guadagnoli, C. M. Creech, R. D. Cress, L. C. O'Connor, D. W. West, M. E. Allen, R. E. Wolf, et al.
Use of Adjuvant Chemotherapy and Radiation Therapy for Colorectal Cancer in a Population-Based Cohort
J. Clin. Oncol.,
April 1, 2003;
21(7):
1293 - 1300.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. L. Potosky, L. C. Harlan, R. S. Kaplan, K. A. Johnson, and C. F. Lynch
Age, Sex, and Racial Differences in the Use of Standard Adjuvant Therapy for Colorectal Cancer
J. Clin. Oncol.,
March 1, 2002;
20(5):
1192 - 1202.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
H.-S. Hwang, T. W. Davis, J. A. Houghton, and T. J. Kinsella
Radiosensitivity of Thymidylate Synthase-deficient Human Tumor Cells Is Affected by Progression through the G1 Restriction Point into S-Phase: Implications for Fluoropyrimidine Radiosensitization
Cancer Res.,
January 1, 2000;
60(1):
92 - 100.
[Abstract]
[Full Text]
|
|
|
|
|
|
|
M. J. O'Connell, J. A. Martenson, H. S. Wieand, J. E. Krook, J. S. Macdonald, D. G. Haller, R. J. Mayer, L. L. Gunderson, and T. A. Rich
Improving Adjuvant Therapy for Rectal Cancer by Combining Protracted-Infusion Fluorouracil with Radiation Therapy after Curative Surgery
N. Engl. J. Med.,
August 25, 1994;
331(8):
502 - 507.
[Abstract]
[Full Text]
|
|
|
|
|
|
|
C. G. Moertel
Chemotherapy for Colorectal Cancer
N. Engl. J. Med.,
April 21, 1994;
330(16):
1136 - 1142.
[Full Text]
|
|
|
|
