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PubMed1994

Improving adjuvant therapy for rectal cancer by combining protracted-infusion fluorouracil with radiation therapy after curative surgery.

BACKGROUND: The combination of radiation therapy and chemotherapy with fluorouracil plus semustine after surgery has been established as an effective approach to decreasing the risk of tumor relapse and improving survival in patients with rectal cancer who are at high risk for relapse or death. We sought to determine whether the efficacy of chemotherapy could be improved by administering fluorouracil by protracted infusion throughout the duration of radiation therapy and whether the omission of semustine would reduce the toxicity and delayed complications of chemotherapy without decreasing its antitumor efficacy. METHODS: Six hundred sixty patients with TNM stage II or III rectal cancer received intermittent bolus injections or protracted venous infusions of fluorouracil during postoperative radiation to the pelvis. They also received systemic chemotherapy with semustine plus fluorouracil or with fluorouracil alone in a higher dose, administered before and after the pelvic irradiation. RESULTS: With a median follow-up of 46 months among surviving patients, patients who received a protracted infusion of fluorouracil had a significantly increased time to relapse (P = 0.01) and improved survival (P = 0.005). There was no evidence of a beneficial effect in the patients who received semustine plus fluorouracil. CONCLUSIONS: A protracted infusion of fluorouracil during pelvic irradiation improved the effect of combined-treatment postoperative adjuvant therapy in patients with high-risk rectal cancer. Semustine plus fluorouracil was not more effective than a higher dose of systemic fluorouracil given alone.

Adenocarcinoma↗

PubMed1980

Randomized comparisons of radiotherapy and nitrosoureas for the treatment of malignant glioma after surgery.

Within three weeks of definitive surgical intervention, 467 patients with histologically proved malignant glioma were randomized to receive one of four treatment regimens: semustine (MeCCNU), radiotherapy, carmustine (BCNU) plus radiotherapy, or semustine plus radiotherapy. We analyzed the data for the total randomized population and for the 358 patients in whom the initial protocol specifications were met (the valid study group). Observed toxicity included acceptable skin reactions secondary to radiotherapy and reversible leukopenia and thrombocytopenia due to chemotherapy. Radiotherapy used alone or in combination with a nitrosourea significantly improved survival in comparison with semustine alone. The group receiving carmustine plus radiotherapy had the best survival, but the difference in survival between the groups receiving carmustine plus radiotherapy and semustine plus radiotherapy was not statistically significant. The combination of carmustine plus radiotherapy produced a modest benefit in long-term (18-month) survival as compared with radiotherapy alone, although the difference between survival curves was not significiant at the 0.05 level. This study suggests that it is best to use radiotherapy in the post-surgical treatment of malignant glioma and to continue the search for an effective chemotherapeutic regimen to use in addition to radiotherapy.

Aged↗

PubMed1984

Adjuvant therapy of colon cancer--results of a prospectively randomized trial.

After curative surgical resection, 621 patients with modified Dukes' stage B2, C1, or C2 colon carcinoma were randomly assigned to one of four treatment programs. These included chemotherapy with fluorouracil and semustine, immunotherapy with methanol extraction residue of bacillus Calmette-Guérin (BCG), combination therapy with fluorouracil, semustine, and immunotherapy, or close follow-up without adjuvant treatment. Treatment continued for 70 weeks. After a median of 51/2 years of follow-up, no significant differences were noted in either recurrence or survival rates among the four treatment programs. Leukemia developed in seven patients, all of whom had received fluorouracil and semustine. The results of this study do not support the use of chemotherapy with fluorouracil and semustine, immunotherapy with methanol extraction residue of BCG, or their combination as an adjuvant treatment program for patients at high risk for recurrent colon carcinoma. The data do, however, demonstrate the necessity for an untreated control group in a trial of adjuvant therapy for colon cancer.

BCG Vaccine↗

PubMed1991

Current treatment approaches in colorectal cancer.

Fluorouracil (5-FU) is still the mainstay of adjuvant treatment for colorectal cancer. Two trials have shown a disease-free and overall survival benefit for 5-FU combined with levamisole in patients with node-positive colon cancer. This regimen is fairly well tolerated and devoid of long-term sequelae, and is now considered standard treatment for node-positive colon cancer. One trial showed a modest improvement in disease-free survival for the semustine/vincristine/5-FU combination; the leukemogenicity and renal toxicity caused by semustine have prevented this regimen from being adopted. Although administering 5-FU directly into the portal vein may improve disease-free survival, most trials have failed to demonstrate a reduction in the incidence of hepatic metastases. This technique, therefore, remains investigational. Several trials in rectal cancer show an advantage for 5-FU combined with semustine and radiation therapy in terms of disease-free survival, overall survival, or both; the contribution of semustine has been questioned and is currently being investigated. In patients with metastatic disease, hepatic arterial infusion of floxuridine produces a higher objective response rate than intravenous administration, but has not resulted in a survival benefit; hepatobiliary toxicity limits the duration of therapy. Biochemical modulation of 5-FU with leucovorin increases the response rate produced by 5-FU alone; a survival benefit has also been observed. N-(phosphonacetyl)-L-aspartate has shown initial promise in combination with high-dose 5-FU infusions. Among the many new drugs tested, only tauromustine seems worthy of further study.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1985

Clinical trial of adjuvant chemotherapy after surgical resection of colorectal cancer metastatic to the liver.

Adjuvant chemotherapy consisting of 5-fluorouracil and semustine was given to 26 patients who had undergone resection (with curative intent) of hepatic metastatic lesions from a primary colorectal carcinoma. Our objective was to obtain preliminary observations regarding the effectiveness of this regimen for improving the long-term survival associated with hepatic resection alone in these patients (the overall 5-year survival after hepatic resection is 25% at our institution). At the time of analysis, the malignant disease had progressed in 19 of our patients, and 17 patients had died. For all patients who receive adjuvant chemotherapy, the median duration of survival is 34 months, and the estimated 5-year survival is 15%. Statistical analysis indicated no significant advantage in survival for the study patients in comparison with 26 control patients who were treated with hepatic resection only and were closely matched for prognostic factors. Because 5-fluorouracil plus semustine conferred no apparent beneficial effects as an adjuvant treatment in this exploratory study, we do not recommend a definitive randomized trial of this regimen.

Adult↗

PubMed1988

An update of two randomized trials in previously untreated multiple myeloma comparing melphalan and prednisone versus three- and five-drug combinations: an Argentine Group for the Treatment of Acute Leukemia Study.

An update of two consecutive randomized studies in previously untreated multiple myeloma was performed. The first study (10-M-73) began in 1973; 150 patients were treated with melphalan and prednisone (MP) or semustine, cyclophosphamide, and prednisone (MeCP). In a second randomized study (3-M-77), begun in 1977, 260 patients were treated with MP or melphalan, prednisone, cyclophosphamide, semustine, and vincristine (MPCCV). A total of 27 of the 67 patients (40%) treated with MP and 33 of the 83 patients (40%) treated with MeCP showed a good response in protocol 10-M-73; 48 of 145 patients (33%) treated with MP and 51 of the 115 patients (44%) treated with MPCCV in protocol 3-M-77 obtained a good response (P is not significant). Median survival in protocol 10-M-73 was 30 months for MeCP and 38 months for MP. At 84 months, 19% and 9% remain alive, respectively. Median survival for protocol 3-M-77 was 44 months for those treated with MPCCV and 42 months for MP. At 60 months, 9% and 11% remain alive; this difference was not significant. Also, there was no survival difference for favorable or unfavorable prognostic groups among the four treatment arms of both protocols. It can be concluded, with a long-term follow-up of both protocols, that the combination of MP is as effective as the three- and five-drugs combinations, and in view of its simplicity and cost-saving advantages, it should be favored for initial therapy of multiple myeloma patients.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1976

Adjuvant nitrosourea therapy for glioblastoma.

An attempt was made to evaluate the potential advantages of chemotherapy in the treatment of 62 patients with glioblastoma. Twenty-four of the 62 patients received adjuvant nitrosourea chemotherapy with carmustine (BCNU), lomustine (CCNU), or semustine (methyl CCCNU) in addition to surgery and radiotherapy. Thirty-three of the 62 patients were involved in a controlled, prospective, randomly allocated study. Quality or quantity of survival was not prolonged in patients who received chemotherapy. Age greater than 64 years, a severe postoperative neurological deficit, or the onset of symptoms less than 12 months prior to surgery were associated with a worse prognosis. The valid evaluation of the effect of a form of treatment on survival in patients with glioblastoma is contingent on the regorous avoidance of preselected factors that may predispose the treated group to a more favorable prognosis.

Adolescent↗

PubMed1975

Chemotherapy, BCG, and serum from tumor-bearing mice: comparative effects on growth and spread of mouse Lewis lung cancer.

In 101 mice, Lewis lung tumor (25 mg apiece) was implanted subcutaneously in the right hind limb and the mice separated into various groups and protocols to test treatment with immunotherapeutic and chemotherapeutic agents. In those treated intralesionally with BCG, the growth of primary tumor was retarded (P smaller than or equal to .05). Tumor growth in animals treated with systemic BCG and serum from tumor-bearing mice was not different from controls. In 14 of 20 mice treated with chemotherapy (semustine and cyclophosphamide), there was no primary or metastatic growth (P smaller than or equal to .01). The observations show that this sort of systemic immunotherapy had no effect on mouse Lewis lung tumor, that intralesionally there was a retarding effect of BCG (although it did not influence metastases), and that this protocol of chemotherapy was strikingly effective.

Animals↗

PubMed1983

Metastatic colorectal carcinoma. A prospective randomized trial of Methyl-CCNU, 5-Fluorouracil (5-FU) and vincristine (MOF) versus MOF plus streptozotocin (MOF-Strep).

A prospective randomized trial evaluated semustine (Methyl CCNU) 5-Fluorouracil (5-FU) and vincristine (MOF) versus MOF plus streptozotocin (MOF-Strep) in 75 patients with advanced, measurable colorectal carcinoma. The complete and partial remission rate with MOF-Strep was significantly better, 34 versus 5% with MOF (P = 0.003). Gastrointestinal toxicity was increased with the addition of streptozotocin. Initial patient characteristics such as age, sex, performance status, time from diagnosis to metastatic disease, site of metastatic disease, and most initial laboratory values were not predictive of response. However, certain initial laboratory values (lactic dehydrogenace and leukocyte count) and one tumor site pulmonary metastases did influence survival regardless of response.

Adult↗

PubMed1985

Postoperative adjuvant 5-fluorouracil plus methyl-CCNU therapy for gastric cancer patients. Eastern Cooperative Oncology Group study (EST 3275).

After en bloc resection of gastric adenocarcinoma, 180 patients were randomized to 2 years of 5-fluorouracil (5-FU) + semustine (MeCCNU) chemotherapy or to observation only. After a median follow-up time of 64 months, 48 of 89 control patients and 51/91 treated patients recurred (P less than 0.71). The sites of recurrent cancer were similar for both groups: liver, 32%; local esophagus or stomach, 51%; abdominal nodes and peritoneum, 38%; and extra-abdominal nodes, 14%. The survival curves overlap; 51/89 controls and 57/91 treated patients died with a median survival of 32.7 and 36.6 months, respectively (P less than 0.73). Treated patients experienced clinically important hematologic toxicity and two treated patients died of marrow failure with leukemia. Because of the toxicity and the lack of effectiveness, adjuvant 5-FU + MeCCNU is not recommended for patients with resectable gastric cancer.

Adenocarcinoma↗

PubMed1988

Genotoxic effects of MeCCNU on human peripheral blood lymphocytes.

MeCCNU (semustine, 1-(2-chloroethyl)-3-(4-methylcyclohexyl)-1-nitrosourea, NSC 95441) is successfully used in the treatment of various human malignancies. The drug was tested for its in vitro genotoxic effects on human peripheral blood lymphocytes. Several drug concentrations were studied considering mean plasma level achieved in patients after the receipt of MeCCNU therapy. Induction of chromosome aberrations and sister chromatid exchange frequency had shown dose-effect relationship. Reduced mitotic activity and prolonged average generation time was observed in MeCCNU treated cultures. The results suggest that 'therapeutic' MeCCNU concentrations have genotoxic effects on human peripheral blood lymphocytes.

Administration, Oral↗

PubMed1985

Prolongation of the disease-free interval in surgically treated rectal carcinoma.

To assess the effects of postoperative radiation therapy and chemotherapy on tumor recurrence and patient survival, 227 patients (data on 202 of whom were analyzed) who had undergone "curative" surgical resection for rectal adenocarcinoma were prospectively and randomly assigned to one of four treatments: no adjuvant therapy (concurrent controls, 58 patients), postoperative radiotherapy with 4000 or 4800 rad (50 patients), postoperative chemotherapy (fluorouracil and semustine [methyl-CCNU], 48 patients), or a combination of radiation therapy and chemotherapy (46 patients). Five years after the entry of the last patient and with a median follow-up of all survivors for 80 months, the recurrence rate was highest among the control patients (55 per cent) and lowest among the patients receiving a combination of adjuvant radiation and chemotherapy (33 per cent). Time to tumor recurrence differed significantly among the four treatment groups (P less than 0.04); it was significantly prolonged by combined radiation and chemotherapy as compared with resection alone (P less than 0.009). Overall survival did not differ significantly among the treatment groups. The superiority of the combined-modality regimen appeared to be attributable to the effects of radiation therapy and chemotherapy in controlling local and distant recurrences, respectively. We conclude that this study provides evidence supporting the use of postoperative radiation therapy in conjunction with chemotherapy in patients who have had "curative" resection of rectal cancer with involvement of perirectal fat or regional nodes or both (Stages B2 and C).

Adenocarcinoma↗

PubMed1991

Effective surgical adjuvant therapy for high-risk rectal carcinoma.

BACKGROUND: Radiation therapy as an adjunct to surgery for rectal cancer has been shown to reduce local recurrence but has not improved survival. In a previous study, combined radiation and chemotherapy improved survival significantly as compared with surgery alone, but not as compared with adjuvant radiation, which many regard as standard therapy. We designed a combination regimen to optimize the contribution of chemotherapy, decrease recurrence, and improve survival as compared with adjuvant radiation alone. METHODS: Two hundred four patients with rectal carcinoma that was either deeply invasive or metastatic to regional lymph nodes were randomly assigned to postoperative radiation alone (4500 to 5040 cGy) or to radiation plus fluorouracil, which was both preceded and followed by a cycle of systemic therapy with fluorouracil plus semustine (methyl-CCNU). RESULTS: After a median follow-up of more than seven years, the combined therapy had reduced the recurrence of rectal cancer by 34 percent (P = 0.0016; 95 percent confidence interval, 12 to 50 percent). Initial local recurrence was reduced by 46 percent (P = 0.036; 95 percent confidence interval, 2 to 70 percent), and distant metastasis by 37 percent (P = 0.011; 95 percent confidence interval, 9 to 57 percent). In addition, combined therapy reduced the rate of cancer-related deaths by 36 percent (P = 0.0071; 95 percent confidence interval, 14 to 53 percent) and the overall death rate by 29 percent (P = 0.025; 95 percent confidence interval, 7 to 45 percent). Its acute toxic effects included nausea, vomiting, diarrhea, leukopenia, and thrombocytopenia. These effects were seldom severe. Severe, delayed treatment-related reactions, usually small-bowel obstruction requiring surgery, occurred in 6.7 percent of all patients receiving radiation, and the frequencies of these complications were comparable in both treatment groups. CONCLUSIONS: The combination of postoperative local therapy with radiation plus fluorouracil and systemic therapy with a fluorouracil-based regimen significantly and substantively improves the results of therapy for rectal carcinoma with a poor prognosis, as compared with postoperative radiation alone.

Adenocarcinoma↗

PubMed1988

Postoperative adjuvant chemotherapy or radiation therapy for rectal cancer: results from NSABP protocol R-01.

Information is presented from 555 patients with Dukes B and C rectal cancers treated by curative resection who were entered into the National Surgical Adjuvant Breast and Bowel Project (NSABP) protocol R-01 between November 1977 and October 1986. Their average time on study was 64.1 months. The patients were randomized to receive no further treatment (184 patients), postoperative adjuvant chemotherapy with 5-fluorouracil, semustine, and vincristine (MOF) (187 patients), or postoperative radiation therapy (184 patients). The chemotherapy group, when compared with the group treated by surgery alone, demonstrated an overall improvement in disease-free survival (P = .006) and in survival (P = .05). Employing the proportional hazards model, a global test was used to determine the presence of treatment interactions. Investigation of stratification variables employed in this study indicated that sex, and to a lesser extent age and Dukes stage, made individual contributions to the disease-free survival and the survival benefit from chemotherapy. When evaluated according to sex, the benefit for chemotherapy at 5 years, both in disease-free survival (29% vs. 47%; P less than .001; relative odds, 2.00) and in survival (37% vs. 60%; P = .001; relative odds, 1.93), was restricted to males. When males were tested for age trend with the use of a logistic regression analysis, chemotherapy was found to be more advantageous in younger patients. When the group receiving post-operative radiation (4,600-4,700 rad in 26-27 fractions; 5,100-5,300 rad maximum at the perineum) was compared to the group treated only by surgery, there was an overall reduction in local-regional recurrence from 25% to 16% (P = .06). No significant benefit in overall disease-free survival (P = .4) or survival (P = .7) from the use of radiation has been demonstrated. The global test for interaction to identify heterogeneity of response to radiation within subsets of patients was not significant. In conclusion, this investigation has demonstrated a benefit from adjuvant chemotherapy (MOF) for the management of rectal cancer. The observed advantage was restricted to males. Postoperative radiation therapy reduced the incidence of local-regional recurrence, but it failed to affect overall disease-free survival and survival.

Aged↗

PubMed1988

Postoperative adjuvant chemotherapy or BCG for colon cancer: results from NSABP protocol C-01.

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.

Aged↗

PubMed2000

Randomized trial of postoperative adjuvant chemotherapy with or without radiotherapy for carcinoma of the rectum: National Surgical Adjuvant Breast and Bowel Project Protocol R-02.

BACKGROUND: The conviction that postoperative radiotherapy and chemotherapy represent an acceptable standard of care for patients with Dukes' B (stage II) and Dukes' C (stage III) carcinoma of the rectum evolved in the absence of data from clinical trials designed to determine whether the addition of radiotherapy results in improved disease-free survival and overall survival. This study was carried out to address this issue. An additional aim was to determine whether leucovorin (LV)-modulated 5-fluorouracil (5-FU) is superior to the combination of 5-FU, semustine, and vincristine (MOF) in men. PATIENTS AND METHODS: Eligible patients (n = 694) with Dukes' B or C carcinoma of the rectum were enrolled in National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol R-02 from September 1987 through December 1992 and were followed. They were randomly assigned to receive either postoperative adjuvant chemotherapy alone (n = 348) or chemotherapy with postoperative radiotherapy (n = 346). All female patients (n = 287) received 5-FU plus LV chemotherapy; male patients received either MOF (n = 207) or 5-FU plus LV (n = 200). Primary analyses were carried out by use of a stratified log-rank statistic; P values are two-sided. RESULTS: The average time on study for surviving patients is 93 months as of September 30, 1998. Postoperative radiotherapy resulted in no beneficial effect on disease-free survival (P =.90) or overall survival (P =.89), regardless of which chemotherapy was utilized, although it reduced the cumulative incidence of locoregional relapse from 13% to 8% at 5-year follow-up (P =.02). Male patients who received 5-FU plus LV demonstrated a statistically significant benefit in disease-free survival at 5 years compared with those who received MOF (55% versus 47%; P =.009) but not in 5-year overall survival (65% versus 62%; P =.17). CONCLUSIONS: The addition of postoperative radiation therapy to chemotherapy in Dukes' B and C rectal cancer did not alter the subsequent incidence of distant disease, although there was a reduction in locoregional relapse when compared with chemotherapy alone.

Antimetabolites, Antineoplastic↗

PubMed2004

Randomized trial of adjuvant therapy in colon carcinoma: 10-year results of NSABP protocol C-01.

BACKGROUND: The National Surgical Adjuvant Breast and Bowel Project C-01 trial reported in 1988 that, for patients with adenocarcinoma of the colon, compared with surgery alone, 1) postoperative chemotherapy with 1-(2-chloroethyl)-3-(4-trans-methylcyclohexyl)-1-nitrosourea (i.e., MeCCNU or semustine), vincristine, and 5-fluorouracil was associated with better 5-year disease-free and overall survival and 2) postoperative immunotherapy with bacillus Calmette-Guérin was associated with better 5-year overall, but not disease-free, survival. We now provide a 10-year update of this trial. METHODS: Between November 11, 1977, and February 28, 1983, 1166 patients with resected Dukes' stage B and C adenocarcinoma of the colon were stratified by Dukes' stage, sex, and age (<65 years or > or =65 years) and then randomly assigned to receive no further treatment (surgery alone; 394 patients), adjuvant chemotherapy (379 patients), or adjuvant immunotherapy (393 patients). Those eligible for follow-up included 375 (95.2%) patients in the surgery-alone group, 349 (92.1%) patients in the adjuvant-chemotherapy group, and 372 (94.7%) patients in the adjuvant-immunotherapy group. All statistical tests were two-sided. RESULTS: No difference was observed between patients in the chemotherapy group and those in the surgery-alone group in 10-year disease-free survival (hazard ratio [HR] = 1.14, 95% confidence interval [CI] = 0.94 to 1.39;P =.17) or overall survival (HR = 1.12, 95% CI = 0.91 to 1.38; P=.27). Immunotherapy did not appear to prevent tumor relapse after 10 years (for surgery alone versus immunotherapy, relative risk [RR] = 0.99, 95% CI = 0.78 to 1.25; P =.93) but had a beneficial effect on 10-year overall survival (for surgery alone versus immunotherapy, RR = 1.27, 95% CI = 1.03 to 1.56; P =.02) that apparently results from a reduction in deaths associated with comorbidities in the immunotherapy group. CONCLUSION: The disease-free and overall survival benefit associated with chemotherapy in this patient population is of limited duration, disappearing after 10 years.

Adenocarcinoma↗

PubMed1999

Comparative efficacy of adjuvant chemotherapy in patients with Dukes' B versus Dukes' C colon cancer: results from four National Surgical Adjuvant Breast and Bowel Project adjuvant studies (C-01, C-02, C-03, and C-04)

PURPOSE: Although the benefit from adjuvant chemotherapy has been clearly established in patients with Dukes' C colon cancer, such benefit has been questioned in patients with Dukes' B disease. To determine whether patients with Dukes' B disease benefit from adjuvant chemotherapy and to evaluate the magnitude of the benefit, compared with that observed in Dukes' C patients, we examined the relative efficacy of adjuvant chemotherapy according to Dukes' stage in four sequential National Surgical Adjuvant Breast and Bowel Project trials (C-01, C-02, C-03, and C-04) that compared different adjuvant chemotherapy regimens with each other or with no adjuvant treatment. PATIENTS AND METHODS: The four trials included Dukes' B and C patients and were conducted between 1977 and 1990. The eligibility criteria and follow-up requirements were similar for all four trials. Protocol C-01 compared adjuvant semustine, vincristine, and fluorouracil (5-FU) (MOF regimen) with operation alone. Protocol C-02 compared the perioperative administration of a portal venous infusion of 5-FU with operation alone. Protocol C-03 compared adjuvant 5-FU and leucovorin (LV) with adjuvant MOF. Protocol C-04 compared adjuvant 5-FU and LV with 5-FU and levamisole (LEV) and with the combination of 5-FU, LV, and LEV. RESULTS: Forty-one percent of the patients included in these four trials had resected Dukes' B tumors. In all four studies, the overall, disease-free, and recurrence-free survival improvement noted for all patients was evident in both Dukes' B and Dukes' C patients. When the relative efficacy of chemotherapy was examined, there was always an observed reduction in mortality, recurrence, or disease-free survival event, irrespective of Dukes' stage, and in most instances, the reduction was as great or greater for Dukes' B patients as for Dukes' C patients. When data from all four trials were examined in a combined analysis, the mortality reduction was 30% for Dukes' B patients versus 18% for Dukes' C patients. The mortality reduction in Dukes' B patients occurred irrespective of the presence or absence of adverse prognostic factors. CONCLUSION: Patients with Dukes' B colon cancer benefit from adjuvant chemotherapy and should be presented with this treatment option. Regardless of the presence or absence of other clinical prognostic factors, Dukes' B patients seem to benefit from chemotherapy administration.

Adenocarcinoma↗