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One prospective randomised study in patients with malignant melanoma, thymus peptides caused an increased tumour-free period, a longer survival time and increased quality of life (4). One prospective, randomised study in intermediate- and high-grade Non-Hodgkin?fs lymphoma, patients were treated with thymus peptides in addition to standard chemotherapy. The treated patients tolerated thymus peptides quite well and had a significantly higher complete response rate than those patients who did not receive thymus peptides (5). One prospective, randomised study in patients undergoing colorectal surgery showed, that the patients, who received thymus peptides in addition to Cefotetan, did significantly better in lowering the rate of abdominal abscesses and upper respiratory tract infections (6). One prospective, randomised study in women with advanced breast cancer could document, that those women, receiving thymus peptides in addition to their chemotherapy regimen, tolerated the chemotherapy significantly better and reduced the rate of secondary infections (7,8). One prospective, randomised study in breast cancer patients showed that thymus peptides protect the bone marrow functions against the haematological toxicities and recovery during and after high dose of Mitoxantrone (9). Another study also showed significant benefit in complete response rate to therapy and prevention of myelosuppression and secondary infections when thymus peptides were added to the regimen (10,11). Therefore, in the Cologne Model, thymus peptides are used:

1) To enhance bone marrow function and protect the patient against myelosuppression of standard chemotherapy;
2) To support bone marrow recovery after radiation and chemotherapy;
3) To prevent secondary infections due to immunosuppression caused by standard chemotherapy and surgical interventions;
4 )To increase complete and partial response rate to anticancer therapies;
5) To improve lymphocyte function and biological defence mechanisms.

1. Maurer, HR, Eckert, K, Stange, R.: Einfluss der Therapie mit Thymoject auf die antitumorale Immunotoxizitaet der Leukozyten von Mamma- Tumorpatientinnen. Pers.Mitt 1999.
2. Mustacchi, G, Paves, L, Milani, S. et al.: High-dose folinic acid and fluouracil plus or minus thymostimulin for the treatment of metastatic colorectal cancer: 619.
3. Schulof, RS, Loyd, MJ, Cleary, PA, et al.: A randomized trial to evaluate the immunorestorative properties of synthetic thymosin-alpha1 in patients with lung cancer. J Biol Resp Modif 4 (1985) 147-158.
4. Azizi A, Brenner HJ, Shoham J: Postoperative adjuvante Behandlung von Patienten mit malignem Melanom durch den Thymusfaktor Thymostimulin. Arzneim-Forsch/Drg Res 34(II): 1043-1046 (1984).
5. Massimo F, Gobbi P, Moretti G, Avanzini P, Italian Lymphoma Study Group: Effects of Thymostimulin with combination Chemotherapy in patients with aggressive non-Hogkin?fs lymphoma. Am J Clin Oncol (CCT) 18(1): 8-14 (1995).
6. Peretti P, Tonelli F, Mazzei T, Ficari F, Italian study group on antimicrobal prophylaxis in abdominal surgery. J Chemotherapy 5(1): 37-42 (1993).
7. Gonelli S, Petrioli R, Cepollaro C, Palmieri R, Aquino A, Gennari C: Thymostimulin in association with chemotherapy in breast cancer patients with bone metastases. Clin Drug Invest 9(2): 79-87 (1995).
8. Iaffaioli RV, Frasci G, Tortora G, Ciardiello F, Nuzzo F, Scala S, Pacelli R, Bianco AR: Effect of thymic extract Thymostimulin on the incidence of infections and myelotoxicity during adjuvant chemotherapy for breast cancer. Thymus 12: 69-75 (1988). Kluwer Academic Publishers.
9. Sanchiz F, Milla A: A randomised study comparing granulocyte-colony stimulating factor (G-CSF) with G-CSF plus Thymostimulin in the treatment of haematological toxicity in patients with advanced breast cancer after high dose Mitoxantrone therapy. Eur J Cancer 32A(1): 52-56 (1996).
10. Macchaiarini P, Danesi R, Del Tacca M, Angeletti CA: Effects of Thymostimulin on chemotherapy-induced toxicity and long-term survival in small cell lung cancer patients. Anticancer Res 9: 193-196 (1989).
11. Mustacchi G, Pavesi L, Milani S, Caraco A, et al: High-dose folinic acid and fluorouracil plus or minus Thymostimulin for treatment of metastatic colorectal cancer: results of a randomised multicenter clinical trail. Anticancer Res 14: 617-620 (1994).

the thymus plays an important role in the immune system

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