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  • Interleukin-2  (3)
  • biochemical modulation  (2)
  • 1
    Electronic Resource
    Electronic Resource
    High- versus low-dose levo-leucovorin as a modulator of 5-fluorouracil in advanced colorectal cancer: A ‘GISCAD’ phase III study (1997)
    Springer
    Annals of oncology 8 (1997), S. 169-174 
    Details
    ISSN: 1569-8041
    Keywords: biochemical modulation ; colorectal cancer ; 5-fluorouracil ; high- versus low-dose ; L-leucovorin
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: Although leucovorin (LV) + 5-fluorouracil (5-FU) isconsidered the treatment of choice for advanced colorectal cancer in mostcountries, the optimal schedule of this combination has not yet beenestablished. Low-dose LV appears to be as active as high-dose LV in thedaily-times-five regimen, but no randomized study of the levorotatorystereoisomer (6S-LV) given at two different dose levels has been published. Patients and methods: Between November 1991 and June 1994, 422patients (all with measurable disease previously untreated with chemotherapy)were randomized to 6S-LV (100 mg/sqm/i.v.) + 5-FU (370 mg/sqm/15 min i.v.infusion), both administered for 5 days every 28 days (arm A), or to 6S-LV (10mg/sqm/i.v.) + 5-FU (doses as above), also given for 5 days every 28 days (armB). The primary endpoint of the study was the comparison of response rates(WHO criteria); the secondary endpoint was the assessment of survival andtolerability. No evaluation of the quality of life or the symptomatic effectof treatment was planned. Results: The response rate was 9.3% in arm A (95% CI:5.4–13.1), with 2 CR and 18 PR, and 10.7% in arm B (95%CI: 6.5–14.9), with 3 CR + 19 PR, without any significant difference(P = 0.78). The median time to progression was eight months in bothgroups and overall survival was 11 months, with no difference betweentreatments. Toxicity mainly consisted of gastrointestinal side effects(mucositis and diarrhoea), which were rarely severe (grade 3–4:5%–10% of patients) and similar in the two groups. Conclusions: In this large-scale multicentre trial, the low and highdoses of 6S-LV appeared to be equivalent in terms of the biochemicalmodulation of 5-FU in advanced colorectal cancer although, for several reasons(including the timing and the strict criteria of response evaluation, the highnumber of patients with unfavourable prognostic factors, themulti-institutional nature of the study, the dose and modality of 5-FUadministration), the response rate was lower than that reported in some of theother published studies. Given the considerable difference in economic costbetween the two dosages, the use of high-dose 6S-LV in the daily-times-fiveregimen is not recommended in clinical practice.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008200713533
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  • 2
    Electronic Resource
    Electronic Resource
    Intracavitary therapy of neoplastic effusions with cytokines: comparison among interferon α, β and interleukin-2 (1995)
    Springer
    Supportive care in cancer 3 (1995), S. 78-80 
    Details
    ISSN: 1433-7339
    Keywords: Interferon-α ; Interferon-β ; Interleukin-2 ; Neoplastic effusions
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Preliminary studies have suggested that the intracavitary administration of cytokines may represent a new effective palliative therapy of malignant effusions. To define further the therapeutic role of cytokines in the treatment of neoplastic fluid accumulation, 70 cancer patients with pleural, pericardial or peritoneal cytologically proven neoplastic effusions were randomized to receive intracavitary cycles with interleukin-2 (IL-2; 6x106 IU), interferon (IFNα; 2x107 U) or IFNβ (6x106 U) every week for 2 or 3 weeks. A clinical control of fluid accumulation was obtained in 39/70 (56%) patients. In patients with mesothelioma, the response rate was significantly higher with IL-2 than with IFNα or-β, while there was no difference in patients with tumors other than mesothelioma. Moreover, the duration of the period during which drainage was not required was significantly longer in patients treated with Il-2 than in the other groups. Toxicity was low in all patients. According to preliminary data, this study demonstrates that intracavitary administration of cytokines, including IL-2, IFNα and-β, is a new well-tolerated palliative therapy for malignant effusions, with an efficacy substantially comparable to that described with the most commonly used treatments with tetracyclines or cytostatic agents.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00343925
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    Paper (German National Licenses)
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  • 3
    Electronic Resource
    Electronic Resource
    A randomized study of neuroimmunotherapy with low-dose subcutaneous interleukin-2 plus melatonin compared to supportive care alone in patients with untreatable metastatic solid tumour (1995)
    Springer
    Supportive care in cancer 3 (1995), S. 194-197 
    Details
    ISSN: 1433-7339
    Keywords: Immunotherapy ; Interleukin-2 ; Melatonin
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Recent advances in our knowledge of psychoneuroimmune interactions involved in the control of tumour growth have shown the possibility of manipulating host anticancer defences through a neuroimmunotherapeutic strategy. In particular, our previous studies have demonstrated that the concomitant administration of the pineal neurohormone melatonin may amplify the antitumour efficacy of interleukin-2 (IL-2) in humans. On this basis, a study was planned to investigate the influence of neuroimmunotherapy with low-dose IL-2 plus melatonin on survival time and on performance status in untreatable metastatic cancer patients. The study included 100 patients with metastatic solid tumours, for whom no standard therapy was available. They were randomized to receive IL-2 (3 x 106 IU/day subcutaneously for 4 weeks) plus melatonin (40 mg/day orally) or supportive care alone. Partial tumour regressions were seen in 9/52 (17%) patients treated with the immunotherapy, and in none of the patients treated with supportive care alone. The percentage of survival at 1 year was significantly higher in patients treated with IL-2 and melatonin than in those receiving the supportive care alone (21/52 versus 5/48, P〈0.005). Moreover, the performence status improved in 22/52 patients of the immunotherapy group and in only 8.48 patients treated with supportive care (P〈0.01). This study shows that cancer neuroimmunotherapy with low-dose IL-2 and the pineal hormone melatonin may prolong the survival time and improve the quality of life of patients with metastatic solid tumours who do not respond to conventional therapies.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00368890
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    Paper (German National Licenses)
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  • 4
    Electronic Resource
    Electronic Resource
    Schedule specific biochemical modulation of 5-fluorouracil in advanced colorectal cancer: A randomized study (2000)
    Springer
    Annals of oncology 11 (2000), S. 1413-1420 
    Details
    ISSN: 1569-8041
    Keywords: advanced colorectal cancer ; biochemical modulation ; 5-fluorouracil ; schedule of administration
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:We have recently suggested that bolus 5-fluorouracil(5-FU) may work via a RNA directed mechanism while continuous infusion 5-FUmay kill cells via a thymidylate synthase related pathway. It may thus bepossible to selectively modulate each schedule biochemically. We have comparedan alternating regimen of bolus and continuous infusion 5-FU, selectivelymodulated for the schedule of administration, with modulated bolus 5-FU inadvanced colorectal cancer patients. Patients and methods:Two hundred fourteen patients from nineteenItalian centers were randomized to the control arm consisting of biweeklycycles of MTX, 200 mg/m2 on day 1, followed by bolus 5-FU 600mg/m2 on day 2 and 6-S-leucovorin rescue, or to the experimentalarm consisting of two biweekly cycles of the same regimen as in the controlarm alternated to three weeks of continuous infusion 5-FU (200mg/m2 day) + weekly bolus 6-S-leucovorin, 20 mg/m2. Results:Nine CR and twenty-seven PR were obtained on one hundredeleven evaluable patients treated in experimental arm (RR = 32%,95% confidence interval (95% CI): 24%–42%),while two CR and eleven PR were observed among one hunderd three evaluablepatients in control arm (RR = 13%, 95% CI:7%–21%). WHO grade 3–4 toxicity occurred in13% of cycles of experimental arm and in 8% of cycles in controlarm. The PFS was significantly longer in experimental arm (6.2 vs. 4.3 months,odds ratio 0.66, P = 0.003), while the overall survival was similarin both arms (14.8 months in experimental arm vs. 14.1 months in control arm);quality of life was similar as well. Eighty percent of patients receivingsecond-line chemotherapy in control arm were treated with continuous infusion5-FU. Conclusions:Alternating, schedule-specific biochemical modulationof FU is more active than MTX → 5-FU as first-line treatment of advancedcolorectal cancer. However, the overall survival was similar suggesting thatalternating bolus and infusional 5-FU upfront may be as effective as givingthem in sequence as first- and second-line treatment.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1026527605389
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  • 5
    Electronic Resource
    Electronic Resource
    Prevention of cytokine-induced hypotension in cancer patients by the pineal hormone melatonin (1996)
    Springer
    Supportive care in cancer 4 (1996), S. 313-316 
    Details
    ISSN: 1433-7339
    Keywords: Hypotension ; Immunotherapy ; Interleukin-2 ; Melatonin ; Nitric oxide ; Tumour necrosis factor α
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Hypotension is a frequent side-effect of cancer biotherapies with cytokines. Cytokine-induced hypotension would mainly depend on the stimulation of nitric oxide (NO) production, which represents the most effective endogenous vasodilator. Moreover, it has been proven that both biological activity and toxicity of cytokines are influenced by the psychoneuroendocrine system, in particular by the pineal hormone melatonin. To investigate the possible modulatory effect of melatonin on cytokine cardiovascular toxicity, we evaluated the influence of a concomitant melatonin administration on interleukin-2(IL-2)- and tumour-necrosis-factor-α(TNF)-induced hypotension in advanced cancer patients. The study included 116 patients with advanced solid tumour, for whom no effective standard anticancer therapy was available, who underwent cancer biotherapy with IL-2 (3 × 106 IU/day s.c. every day, 6 days/week for 4 weeks) or with TNF (0.75 mg/day i.v. for 5 days) as compassionate treatment for their disease. Patients were randomized to be treated with or without a concomitant melatonin administration (40 mg/day orally in the evening, starting 7 days prior to cytokine injection). The occurrence of hypotension was significantly less frequent in patients concomitantly treated by melatonin than in those who received the cytokine alone, during either IL-2 or TNF immunotherapy (IL-2: 11/45 versus 2/46,P〈0.05; TNF: 10/23 versus 1/12,P〈0.01). This study shows that melatonin may prevent hypotension occurring during cancer immunotherapy with IL-2 or TNF. Since the pineal hormone has appeared to inhibit the activity of NO synthase from the endothelial cells, we suggest that melatonin may prevent cytokine-induced hypotension by inhibiting NO production, which plays an essential role in inducing hypotension during IL-2 and TNF biotherapies.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01358887
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