Folinic Acid and 5-Fluorouracil ± Interferon Alfa-2b in the Treatment of Advanced Colorectal Cancer: Preliminary Results of a Randomized Study

1993 ◽  
pp. 353-358
Author(s):  
C. Barone ◽  
A. Astone ◽  
A. Cassano
Keyword(s):  
Colorectal Cancer ◽  
Folinic Acid ◽  
Advanced Colorectal Cancer ◽  
Randomized Study ◽  
Interferon Alfa ◽  
Preliminary Results

scholarly journals Phase III randomized study of two fluorouracil combinations with either interferon alfa-2a or leucovorin for advanced colorectal cancer. Corfu-A Study Group.

1995 ◽  
Vol 13 (4) ◽  
pp. 921-928 ◽  
Keyword(s):  
Colorectal Cancer ◽  
Advanced Colorectal Cancer ◽  
Randomized Study ◽  
Gastrointestinal Symptoms ◽  
Interferon Alfa ◽  
Phase Iii ◽  
Human Interferon ◽  
Biochemical Modulation ◽  
Survival Times ◽  
Colorectal Cancer Patients

PURPOSE To compare the efficacy and toxicity profiles of a combination of fluorouracil (5-FU) with recombinant human interferon alfa-2a (Roferon-A; Hoffman La-Roche AG, Basel, Switzerland) versus the combination of 5-FU with leucovorin (LV) in the treatment of advanced colorectal cancer. PATIENTS AND METHODS A total of 496 previously untreated colorectal cancer patients were randomized to receive either Roferon-A (9 MIU) subcutaneously three times per week, with 5-FU (750 mg/m2/d) by continuous intravenous (i.v.) infusion (CIV) on days 1 to 5, then, after a 9-day hiatus, as a weekly i.v. bolus at the same dose (IFN/5-FU); or LV (200 mg/m2/d) by i.v. infusion plus 5-FU (370 mg/m2/d) by i.v. bolus on days 1 to 5, repeated every 4 weeks (LV/5-FU). RESULTS There were no significant differences between IFN/5-FU and LV/5-FU in the overall response rate (21% v 18%), duration of response (7.3 v 6.2 months), or survival time (median, 11.0 v 11.3 months). Toxicity profiles differed; constitutional symptoms and myelosuppression were more frequent and more severe with IFN/5-FU, and gastrointestinal symptoms with LV/5-FU. More patients interrupted treatment for adverse events (AEs) with IFN/5-FU than with LV/5-FU. Five treatment-related deaths occurred with each regimen. CONCLUSION The combination IFN/5-FU produced response rates, response durations, and survival times similar to those with LV/5-FU. Biochemical modulation of 5-FU by either IFN or LV appears to result in equivalent efficacy; however, fewer patients were able to tolerate the specified IFN/5-FU combination used in this study.

scholarly journals Phase III Randomized Study of Two Fluorouracil Combinations With Either Interferon Alfa-2a or Leucovorin for Advanced Colorectal Cancer

1996 ◽  
Vol 14 (3) ◽  
pp. 1044-1044
Author(s):  
Keyword(s):  
Colorectal Cancer ◽  
Clin Oncol ◽  
Advanced Colorectal Cancer ◽  
Randomized Study ◽  
Interferon Alfa ◽  
Phase Iii ◽  
Study Group ◽  
The Third ◽  
Group Member

The name of a Corfu-A Study Group member listed in the Appendix of the report entitled, "Phase III Randomized Study of Two Fluorouracil Combinations With Either Interferon Alfa-2a or Leucovorin for Advanced Colorectal Cancer" by the Corfu-A Study Group (J Clin Oncol 13:921–928, 1995) appeared incorrectly. The third name listed should have appeared as "R. Bell."

Fluorouracil and leucovorin with or without interferon alfa-2b in advanced colorectal cancer: analysis of a prospective randomized phase III trial. Hellenic Cooperative Oncology Group.

1996 ◽  
Vol 14 (10) ◽  
pp. 2682-2687 ◽  
Author(s):  
P A Kosmidis ◽  
N Tsavaris ◽  
D Skarlos ◽  
D Theocharis ◽  
E Samantas ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Advanced Colorectal Cancer ◽  
Positive Impact ◽  
Performance Status ◽  
Final Analysis ◽  
Interferon Alfa ◽  
Phase Iii ◽  
Psychological Reactions ◽  
Group A ◽  
Group B

PURPOSE To investigate if double modulation of fluorouracil (5-FU) with leucovorin (folinic acid [FA]) and interferon alfa-2b (IFN 2b) improves responses and survival in comparison to single modulation of 5-FU with FA. PATIENTS AND METHODS One hundred six patients with histologically confirmed advanced colorectal cancer, measurable disease, and without previous chemotherapy were prospectively randomized into two groups. Patients in group A received 5-FU 450 mg/m2 as an intravenous bolus in the midinfusion of FA weekly. FA was given at a dose of 200 mg/m2 in 500 mL 0.9% normal saline solution in 2-hour infusion. Patients in group B received exactly the same regimen plus IFN 2b 5 million units subcutaneously three times weekly. RESULTS All patients were well balanced in both groups regarding age, sex, performance status, number, and site of metastasis. One hundred two patients were assessable. All patients have died. There was no difference in response between the two groups (7.8% v 9.8%). Median survival was 10.1 months in group A, and 7.2 months in group B (P = .00189). Median time to progression was 8.4 and 5.2 months, respectively (P = .00196). Overall, better performance status and older age had a positive impact on survival. Toxicity was the most important and catastrophic aspect of this study. Patients who received IFN 2b had significantly worse anemia, neutropenia, diarrhea, anorexia, weight loss, flu-like syndrome, and psychological reactions. CONCLUSION Based on this final analysis, the addition of IFN 2b to the combination of 5-FU and FA enhances toxicity and contributes to decreased survival.

Impact of protracted venous infusion fluorouracil with or without interferon alfa-2b on tumor response, survival, and quality of life in advanced colorectal cancer.

1995 ◽  
Vol 13 (9) ◽  
pp. 2317-2323 ◽  
Author(s):  
M Hill ◽  
A Norman ◽  
D Cunningham ◽  
M Findlay ◽  
M Watson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Advanced Colorectal Cancer ◽  
Symptomatic Improvement ◽  
Interferon Alfa ◽  
Life Questionnaire ◽  
European Organization ◽  
Significant Difference ◽  
Venous Infusion

PURPOSE The aim of this study was to investigate the effects of adding interferon alfa-2b (IFN) to protracted venous infusion fluorouracil (PVI 5-FU) from the start of treatment in patients with advanced colorectal cancer. PATIENTS AND METHODS Patients who attended our unit with histologically confirmed advanced colorectal cancer were randomized to receive either PVI 5-FU 300 mg/m2/d via Hickman line, and IFN 5 MU subcutaneously three times weekly, or PVI 5-FU alone. Treatment was given for a maximum of two 10-week blocks, with a 2-week gap for reassessment of all parameters. Quality of life (QL) was measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) pretreatment and every 6 weeks thereafter. RESULTS A total of 160 patients were randomized, with 155 eligible for assessment. Radiologic response was observed in 43 patients (28%): 17 of 77 (22%) in the 5-FU-plus-IFN arm (all partial responses [PRs]) and 26 of 78 (33%) in the 5-FU-alone group (complete responses [CRs] and 22 PRs) (difference not significant). Symptomatic improvement occurred in the majority of patients, and equally in both arms: 61% to 80% depending on the symptom. There was no significant difference between the two groups in failure-free survival (median, 161 v 193 days) or overall survival (median, 328 v 357 days). However, patients who received IFN did experience significantly more toxicity in the form of leukopenia (P = .001), neutropenia (P = .04), mucositis (P = .008), and alopecia (P = .0002). There were no toxic deaths and few notable differences in QL between the two arms. CONCLUSION This study confirms that PVI 5-FU is effective in treating the symptoms associated with metastatic colorectal carcinoma, with only mild to moderate toxicity and maintenance of QL. IFN 5 MU three times weekly does not enhance these palliative benefits.

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