Adjuvant 5-Fluorouracil and Leucovorin With or Without Interferon Alfa-2a in Colon Carcinoma: National Surgical Adjuvant Breast and Bowel Project Protocol C-05

Wolmark, Norman; Bryant, John; Smith, Roy E.; Grem, Jean L.; Allegra, Carmen J.; Hyams, David M.; Atkins, James; Dimitrov, Nikolay V.; Oishi, Robert H.; Prager, David; Fehrenbacher, Louis; Romond, Edward H.; Colangelo, Linda H.; Fisher, Bernard

doi:10.1093/jnci/90.23.1810

Cited by 94 publications

(42 citation statements)

References 9 publications

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“…Thus, the improved OS hazard ratio for the IFN treatment group in the 5-FU adjusted model could be explained by age or other unobserved nontreatment-related prognostic factors also. These findings confirm the results of other trials that the addition of IFN to 5-FU does not confer a survival benefit (Wolmark et al, 1998). Frequency of grade 3 and 4 toxicities was increased in therapy arms including LEV or IFN.…”

Section: Discussionsupporting

confidence: 89%

“…The NSABP protocol C-05 evaluated the efficacy of the addition of interferon alfa-2a to 5-FU and leucovorin in the adjuvant treatment of colon cancer. The results of this trial showed no significant difference either in DFS or in OS for the IFN arm (Wolmark et al, 1998). Owing to the absence of significant differences in OS in these trials examining the role of LEV and IFN in the adjuvant setting of colon cancer, continuation of accrual in the present trial was considered as ethically justifiable until the end of the accrual period in 1999.…”

Section: Discussionmentioning

confidence: 78%

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A prospective randomised trial to study the role of levamisole and interferon alfa in an adjuvant therapy with 5-FU for stage III colon cancer

Schippinger

Jagoditsch²,

Sorré³

et al. 2005

Br J Cancer

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The purpose of this trial was to examine the efficacy of the addition of levamisole (LEV) or interferon alfa (IFN) to an adjuvant chemotherapy with 5-fluorouracil (5-FU) in patients with stage III colon cancer. According to a 2 Â 2 factorial study design, 598 patients were randomly assigned to one of four adjuvant treatment arms. Patients in arm one received 5-FU weekly for 1 year, patients in arm two 5-FU plus LEV, in arm three 5-FU plus IFN and patients in arm four 5-FU, LEV and IFN. The relative risk of relapse and the relative risk of death were significantly higher for patients treated with LEV compared with those without LEV treatment (HR 1.452, 95% CI 1.135 -1.856, P ¼ 0.0028; HR 1.506, 95% CI 1.150 -1.973, P ¼ 0.0027, respectively). No significant impact on survival was observed for therapy with IFN in the univariate analysis. The addition of LEV to adjuvant 5-FU significantly worsened the prognosis of patients with stage III colon cancer. Interferon alfa had no significant influence on survival when combined with adjuvant 5-FU, but increased the toxicity of therapy substantially.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 78%

A prospective randomised trial to study the role of levamisole and interferon alfa in an adjuvant therapy with 5-FU for stage III colon cancer

Schippinger

Jagoditsch²,

Sorré³

et al. 2005

Br J Cancer

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“…Two treatment trials and three prevention trials stated that gender subgroup analyses were based on data from previously published reports, and two treatment trials and three prevention trials stated that specific gender hypotheses were being tested. The reports of gender subgroup analyses of treatment outcome showed a higher rate of toxicity among women, 26 higher levels of pretreatment psychological distress among women, 27 a greater proportion of recurrences and treatment failures among women, 28 lower levels of recurrence among women, 29 better response to therapy among women, 30 worse survival among men, 24 and a lower mortality rate among women. 26 One report recommended caution in the interpretation of the subgroup analyses, because the gender analysis was not planned in advance.…”

Section: Resultsmentioning

confidence: 99%

Selection and description of cancer clinical trials participants—Science or happenstance?

Swanson

Bailar

2002

Cancer

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BACKGROUNDThe selection of clinical trials participants is a critical step in study design, because it affects the generalizability of recommendations made on the basis of trial results and public acceptance of medical research. The authors assessed the heterogeneity of subgroups in cancer treatment and prevention trials and the analysis of subgroups in the evaluation of trial outcomes.METHODSThe authors reviewed published reports (1990–2000) of cancer prevention and treatment trials from 11 journals. They report here on all Phase III cancer treatment and prevention trials that had at least 100 participants and were conducted among adults in the United States. A structured abstract was developed and used to extract data from the 261 published reports. Descriptive summaries of the abstracted data provided the information included in this systematic review.RESULTSAge and gender of study participants were reported in more than 90% of these trials, whereas fewer than 30% of the trials reported race or ethnicity. Gender was reported as an explicit criterion for participant selection primarily in studies of gender specific malignancies. Race and ethnicity were reported as explicit selection criteria for participant selection for five of the prevention trials and for none of the cancer treatment trials. The 105 treatment trials that reported including both men and women had 42,355 participants, and 38.6% of those participants were women. The 26 prevention trials that reported including both men and women had 73,995 participants, and 34.7% of those participants were women. Fifty‐seven treatment trials reported participant ethnic diversity: There were 45,815 participants, with 10.5% African‐American participants and with less than 1% Hispanic, Asian, or Native American participants. Seventeen prevention trials reported participant ethnic diversity: There were 91,741 participants, with 5.5% African‐American participants, 1.7% Hispanic participants, and less than 1% Asian or Native American participants.CONCLUSIONSCancer treatment and prevention trial reports provide scant information about participant race and ethnicity. Such studies use participant selection criteria that do not define diverse subgroups, and few subgroup analyses are conducted. Improvements in the selection, reporting, and analysis of clinical trials participants are needed. Cancer 2002;95:950–9. © 2002 American Cancer Society.DOI 10.1002/cncr.10785

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“…Nevertheless, several large-scale studies conducted to demonstrate the efficacy of adjuvant chemotherapy started treatment within 42 days [19][20][21][22]. Only 10 % of all patients with breast cancer in the SEER-Medicare database received chemotherapy 3 months after surgery, and their overall mortality hazard ratio (HR) was 1.…”

Section: Discussionmentioning

confidence: 99%

Association Between Time (Initiation and Length) and Oncological Outcomes for the Patients with Colon Cancer Treated with Adjuvant Chemotherapy

et al. 2015

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Adjuvant chemotherapy is benefit for high-risk stage II and stage III colon cancer after curative resection. But, the optimal time between surgical and initiation of adjuvant chemotherapy remains unclear. Moreover, no study of efficacy with different lengths of adjuvant chemotherapy has appeared. This study was aimed to identify association between time (initiation and length) and oncological outcomes of adjuvant chemotherapy on the stages II and III colon cancer patients. A total of 406 high-risk stages II and III colon cancer patients were retrospectively enrolled in prospectively collected data. They were categorized into three groups representing chemotherapy initiation time: less than 4 weeks (group 1), 4 to 6 weeks (group 2), and more than 6 weeks (group 3). They were categorized into two groups representing chemotherapy length time : less than 200 days (group 1a) and more than 200 days (group 2a). The 5-year disease-free survival (DFS) rates were 74.97 % in group 1, 76.94 % in group 2, and 63.97 % in group 3 (p>0.05). The 5-year DFS rates were 75.49 % in the group that received adjuvant chemotherapy within 6 weeks and 63.97 % in the group that received adjuvant chemotherapy >6 weeks (p=0.0539). The 5-year DFS rates were 77.21 % in group 1a and 81.82 % in group 2a (p>0.05). Adjuvant chemotherapy should be safely offered within 6 weeks after surgical excision in patients with colon cancer after considering the patient's general physical condition and hematological factors, even if the chemotherapy length is prolonged.

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Adjuvant 5-Fluorouracil and Leucovorin With or Without Interferon Alfa-2a in Colon Carcinoma: National Surgical Adjuvant Breast and Bowel Project Protocol C-05

Abstract: The addition of IFN to 5-FU + LV adjuvant therapy confers no statistically significant benefit, but it does increase toxicity.

Cited by 94 publications

References 9 publications

A prospective randomised trial to study the role of levamisole and interferon alfa in an adjuvant therapy with 5-FU for stage III colon cancer

A prospective randomised trial to study the role of levamisole and interferon alfa in an adjuvant therapy with 5-FU for stage III colon cancer

Selection and description of cancer clinical trials participants—Science or happenstance?

Association Between Time (Initiation and Length) and Oncological Outcomes for the Patients with Colon Cancer Treated with Adjuvant Chemotherapy

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