Abstract
Purpose: This study had two major goals: (1) to assess the effectiveness of a regimen of fluorouracil (5-FU) plus levamisole plus leucovorin as postoperative surgical adjuvant therapy for patients with high-risk colon cancer, and (2) to evaluate 6 months versus 12 months of chemotherapy. Patients and Methods: Patients with poor-prognosis stage II or III colon cancer were randomly assigned to receive adjuvant chemotherapy with either intensive-course 5-FU and leucovorin combined with levamisole, or a standard regimen of 5-FU plus levamisole. Patients were also randomly assigned to receive either 12 months or 6 months of chemotherapy, which resulted in four treatment groups. Results: Eight hundred ninety-one of 915 patients entered (97.4%) were eligible. The median follow-up duration is 5.1 years for patients still alive. There was a difference among the four treatment groups with re- spect to patient survival, and a significant duration-by-regimen interaction was observed. Specifically, standard 5-FU plus levamisole was inferior to 5-FU plus leucovorin plus levamisole when treatment was given for 6 months (5-year survival rate, 60% v 70%; P <.01). Conclusion: There was no significant improvement in patient survival when chemotherapy was given for 12 months compared with 6 months. When chemotherapy was given for 6 months, standard 5-FU plus levamisole was associated with inferior patient survival compared with intensive-course 5-FU plus leucovorin plus levamisole. These data suggest that 5-FU plus levamisole for 6 months should not be used in clinical practice, whereas 6 months of treatment with 5-FU plus leucovorin plus levamisole is effective.
| Original language | English |
|---|---|
| Pages (from-to) | 295-300 |
| Number of pages | 6 |
| Journal | Journal of Clinical Oncology |
| Volume | 16 |
| Issue number | 1 |
| State | Published - Jan 1998 |
| Externally published | Yes |
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All Science Journal Classification (ASJC) codes
- Cancer Research
- Oncology
Cite this
Prospectively randomized trial of postoperative adjuvant chemotherapy in patients with high-risk colon cancer. / O'Connell, Michael J.; Laurie, John A.; Kahn, Michael; Fitzgibbons, Robert Joseph; Erlichman, Charles; Shepherd, Lois; Moertel, Charles G.; Kocha, Walter I.; Pazdur, Richard; Wieand, H. Sam; Rubin, Joseph; Vukov, Allen M.; Donohue, John H.; Krook, James E.; Figueredo, Alvaro.
In: Journal of Clinical Oncology, Vol. 16, No. 1, 01.1998, p. 295-300.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Prospectively randomized trial of postoperative adjuvant chemotherapy in patients with high-risk colon cancer
AU - O'Connell, Michael J.
AU - Laurie, John A.
AU - Kahn, Michael
AU - Fitzgibbons, Robert Joseph
AU - Erlichman, Charles
AU - Shepherd, Lois
AU - Moertel, Charles G.
AU - Kocha, Walter I.
AU - Pazdur, Richard
AU - Wieand, H. Sam
AU - Rubin, Joseph
AU - Vukov, Allen M.
AU - Donohue, John H.
AU - Krook, James E.
AU - Figueredo, Alvaro
PY - 1998/1
Y1 - 1998/1
N2 - Purpose: This study had two major goals: (1) to assess the effectiveness of a regimen of fluorouracil (5-FU) plus levamisole plus leucovorin as postoperative surgical adjuvant therapy for patients with high-risk colon cancer, and (2) to evaluate 6 months versus 12 months of chemotherapy. Patients and Methods: Patients with poor-prognosis stage II or III colon cancer were randomly assigned to receive adjuvant chemotherapy with either intensive-course 5-FU and leucovorin combined with levamisole, or a standard regimen of 5-FU plus levamisole. Patients were also randomly assigned to receive either 12 months or 6 months of chemotherapy, which resulted in four treatment groups. Results: Eight hundred ninety-one of 915 patients entered (97.4%) were eligible. The median follow-up duration is 5.1 years for patients still alive. There was a difference among the four treatment groups with re- spect to patient survival, and a significant duration-by-regimen interaction was observed. Specifically, standard 5-FU plus levamisole was inferior to 5-FU plus leucovorin plus levamisole when treatment was given for 6 months (5-year survival rate, 60% v 70%; P <.01). Conclusion: There was no significant improvement in patient survival when chemotherapy was given for 12 months compared with 6 months. When chemotherapy was given for 6 months, standard 5-FU plus levamisole was associated with inferior patient survival compared with intensive-course 5-FU plus leucovorin plus levamisole. These data suggest that 5-FU plus levamisole for 6 months should not be used in clinical practice, whereas 6 months of treatment with 5-FU plus leucovorin plus levamisole is effective.
AB - Purpose: This study had two major goals: (1) to assess the effectiveness of a regimen of fluorouracil (5-FU) plus levamisole plus leucovorin as postoperative surgical adjuvant therapy for patients with high-risk colon cancer, and (2) to evaluate 6 months versus 12 months of chemotherapy. Patients and Methods: Patients with poor-prognosis stage II or III colon cancer were randomly assigned to receive adjuvant chemotherapy with either intensive-course 5-FU and leucovorin combined with levamisole, or a standard regimen of 5-FU plus levamisole. Patients were also randomly assigned to receive either 12 months or 6 months of chemotherapy, which resulted in four treatment groups. Results: Eight hundred ninety-one of 915 patients entered (97.4%) were eligible. The median follow-up duration is 5.1 years for patients still alive. There was a difference among the four treatment groups with re- spect to patient survival, and a significant duration-by-regimen interaction was observed. Specifically, standard 5-FU plus levamisole was inferior to 5-FU plus leucovorin plus levamisole when treatment was given for 6 months (5-year survival rate, 60% v 70%; P <.01). Conclusion: There was no significant improvement in patient survival when chemotherapy was given for 12 months compared with 6 months. When chemotherapy was given for 6 months, standard 5-FU plus levamisole was associated with inferior patient survival compared with intensive-course 5-FU plus leucovorin plus levamisole. These data suggest that 5-FU plus levamisole for 6 months should not be used in clinical practice, whereas 6 months of treatment with 5-FU plus leucovorin plus levamisole is effective.
UR - http://www.scopus.com/inward/record.url?scp=0031982505&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0031982505&partnerID=8YFLogxK
M3 - Article
C2 - 9440756
AN - SCOPUS:0031982505
VL - 16
SP - 295
EP - 300
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 1
ER -