Multicenter phase 2 study of interleukin-2 and 13-cis retinoic acid as maintenance therapy in advanced non-small-cell lung cancer

Journal of Immunotherapy

Volumn 29, Issue 1, 2006, Pages 87-94

  Recchia, Francesco ^a,b,e   Saggio, Gaetano ^a   Nuzzo, Antonio ^c   Biondi, Edoardo ^c   Di Blasio, Anna ^a   Cesta, Alisia ^a   Candeloro, Giampiero ^a   Alesse, Edoardo ^d   Reaf, Silvio ^b,d  

^a Ospedale Civile di Avezzano   (Italy)

^b Fondazione Carlo Ferri   (Italy)

^c Ospedale Civile di Lanciano   (Italy)

^d UNIVERSITY OF L'AQUILA   (Italy)

^e NONE   (Italy)

Author keywords

13 cis retinoic acid; Advanced non small cell lung cancer; Interleukin 2; Maintenance therapy; Vascular endothelial growth factor

Indexed keywords

C REACTIVE PROTEIN; CARBOPLATIN; CISPLATIN; GEMCITABINE; INTERLEUKIN 12; NAVELBINE; PACLITAXEL; RETINOIC ACID; RHEUMATOID FACTOR; VASCULOTROPIN; ANTINEOPLASTIC AGENT; INTERLEUKIN 2; ISOTRETINOIN; VASCULOTROPIN A;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ARTICLE; CANCER SURVIVAL; CD4 CD8 RATIO; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; FEVER; HUMAN; HYPERTRIGLYCERIDEMIA; HYPOTHYROIDISM; LEUKOPENIA; LUNG CANCER; LUNG NON SMALL CELL CANCER; LYMPHOCYTE COUNT; MAJOR CLINICAL STUDY; MULTICENTER STUDY; NATURAL KILLER T CELL; NEUTROPENIA; PATIENT MONITORING; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGNOSIS; RASH; THROMBOCYTOPENIA; TREATMENT OUTCOME; TUMOR RECURRENCE; BLOOD; DRUG EFFECT; IMMUNOLOGY; LUNG TUMOR; LYMPHOCYTE; MIDDLE AGED; MORTALITY; NATURAL KILLER CELL; SURVIVAL;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; CARCINOMA, NON-SMALL-CELL LUNG; HUMANS; INTERLEUKIN-2; ISOTRETINOIN; KILLER CELLS, NATURAL; LUNG NEOPLASMS; LYMPHOCYTES; MIDDLE AGED; SURVIVAL ANALYSIS; TREATMENT OUTCOME; VASCULAR ENDOTHELIAL GROWTH FACTOR A;

EID: 33644832319     PISSN: 15249557     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.cji.0000186244.85058.1b     Document Type: Article

References (36)

1. Parkin DM, Bray F, Ferlay J, et al. Estimating the world cancer burden: Globocan 2000. Int J Cancer. 2001;94:153-156.
2. Ginsberg RG, Vokes EE, Raben A. Non small cell lung cancer. In: De Vita VT, Hellman S, Rosemberg SA, eds. Principles and Practice of Oncology. 5th ed. Philadelphia: Lippincott-Raven; 1997:858-911.
3. Non Small Cell Lung Cancer Collaborative Group. Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomized clinical trials. BMJ. 1995;311:899-909.
4. D'Addario G, Pintilie M, Leighl NB, et al. Platinum-based versus non-platinum-based chemotherapy in advanced non-small-cell lung cancer: a meta-analysis of the published literature. J Clin Oncol. 2005;23:2926-2936.
5. Folkman J. The role of angiogenesis in tumor growth. Semin Cancer Biol. 1992;3:65-71.
6. Mackall CL, Fleisher TA, Brown MR, et al. Lymphocyte depletion during treatment with intensive chemotherapy for cancer. Blood. 1994;84:2221-2228.
7. Wise JA, Mokyr MB, Dray S. Effect of low-dose cyclophosphamide therapy on specific and nonspecific T cell-dependent immune responses of spleen cells from mice bearing large MOPC-315 plasmacytomas. Cancer Immunol Immunother. 1988;27:191-197.
8. Stanley KE. Prognostic factors for survival in patients with inoperable lung cancer. J Natl Cancer Inst. 1980;65:25-32.
9. Arinaga M, Noguchi T, Takeno S, et al. Clinical significance of vascular endothelial growth factor C and vascular endothelial growth factor receptor 3 in patients with nonsmall cell lung carcinoma. Cancer. 2003;97:457-464.
10. Brattstrom D, Bergqvist M, Hesselius P, et al. Elevated preoperative serum levels of angiogenic cytokines correlate to larger primary tumours and poorer survival in non-small cell lung cancer patients. Lung Cancer. 2002;37:57-63.
11. Fox FE, Kubin M, Cassin M, et al. Retinoids synergize with interleukin-2 to augment IFN-gamma and interleukin-12 production by human peripheral blood mononuclear cells. J Interferon Cytokine Res. 1999;19:407-415.
12. Recchia F, De Filippis S, Rosselli M, et al. Phase IB study of subcutaneously administered interleukin-2 in combination with 13-cis retinoic acid as maintenance therapy in advanced cancer. Clin Cancer Res. 2001;7:1251-1257.
13. Fyfe G, Fisher RI, Rosenberg SA, et al. Results of treatment of 255 patients with metastatic renal cell carcinoma who received high-dose recombinant interleukin-2 therapy. J Clin Oncol. 1995;13:688-696.
14. Recchia F, De Filippis S, Rosselli M, et al. Interleukin-2 and 13-cis retinoic acid in the treatment of minimal residual disease. A phase II study. Int J Oncol. 2002;20:1275-1282.
15. Recchia F, Saggio G, Cesta A, et al. Phase II randomized study of interleukin-2 with or without 13-cis retinoic acid as maintenance therapy in patients with advanced cancer responsive to chemotherapy. Anticancer Res. 2005;25:3149-3157.
16. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors: European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000;92:205-216.
17. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958;53:457-481.
18. Recchia F, Lalli A, Lombardo M, et al. Ifosfamide, cisplatin and 13-cis retinoic acid for patients with advanced or recurrent squamous cell carcinoma of the head and neck. A phase I-II study. Cancer. 2001;92:814-821.
19. Recchia F, Sica G, De Filippis S, et al. Cisplatin, vindesine, mitomycin-c and 13-cis retinoic acid in the treatment of advanced non-small cell lung cancer. A phase II pilot study. Anticancer Res. 2000;20:1985-1990.
20. Chalmers TC, Celano P, Sacks HS, et al. Bias treatment assignment in controlled clinical trials. N Engl J Med. 1983;309:1358-1361.
21. Sacks H, Chalmers TC, Smith H Jr. Randomized versus historical controls for clinical trials. Am J Med. 1982;72:233-240.
22. Coldiz GA, Miller JN, Mosteller F. How study design affects outcome in comparisons of therapy I. Surg Stat Med. 1989;8:441-454.
23. Miller JN, Coldiz GA, Mosteller F. How study design affects outcome in comparisons of therapy II. Surg Stat Med. 1989;8:455-466.
24. Concato J, Shah N, Horwitz RI. Randomized controlled trials, observational studies and the hierarchy of research designs. N Engl J Med. 2000;342:1887-1892.
25. Benson BA, Hartz A. A comparison of observation studies and randomized, controlled trials. N Engl J Med. 2000;342:1878-1886.
26. Westeel V, Quoix E, Moro-Sibilot D, et al. French Thoracic Oncology Collaborative Group (GCOT). Randomized study of maintenance vinorelbine in responders with advanced non-small-cell lung cancer. J Natl Cancer Inst. 2005;97:499-506.
27. Pasquier E, Honore S, Pourroy B, et al. Antiangiogenic concentrations of paclitaxel induce an increase in microtubule dynamics in endothelial cells but not in cancer cells. Cancer Res. 2005;65:2433-2440.
28. Belani CP, Barstis J, Perry MC, et al. Multicenter, randomized trial for stage IIIB or IV non-small-cell lung cancer using weekly paclitaxel and carboplatin followed by maintenance weekly paclitaxel or observation. J Clin Oncol. 2003;21:2933-2939.
29. Prior C, Oroszy S, Oberaigner W, et al. Advanced non-small-cell lung cancer: adjunctive interferon gamma in induction and maintenance therapy. J Cancer Res Clin Oncol. 1999;125:42-46.
30. Ardizzoni A, Bonavia M, Viale M, et al. Biologic and clinical effects of continuous infusion interleukin-2 in patients with non-small cell lung cancer. Cancer. 1994;73:1353-1360.
31. Orditura M, Romano C, De Vita F, et al. Behaviour of interleukin-2 serum levels in advanced non-small-cell lung cancer patients: relationship with response to therapy and survival. Cancer Immunol Immunother. 2000;49:530-536.
32. Fontanini G, Lucchi M, Vignati S, et al. Angiogenesis as a prognostic indicator of survival in non-small-cell lung carcinoma: a prospective study. J Natl Cancer Inst. 1997;89:881-886.
33. Hilbe W, Dirnhofer S, Oberwasserlechner F, et al. CD133 positive endothelial progenitor cells contribute to the tumour vasculature in non-small cell lung cancer. J Clin Pathol. 2004;57:965-969.
34. Fumagalli LA, Vinke J, Hoff W, et al. Lymphocytes independently predict overall survival in advanced cancer patients: a biomarker for IL-2 immunotherapy. J Immunother. 2003;26:394-402.
35. Blay JY, Negrier S, Combaret V. Serum levels of IL-6 as a prognostic factor in metastatic renal cell carcinoma. Cancer Res. 1992;52:3317-3322.
36. Kaul R, Sharma A, Lisse JR, et al. Human recombinant IL-2 augments immunoglobulin and induces rheumatoid factor production by rheumatoid arthritis lymphocytes engrafted into severe combined immunodeficient mice. Clin Immunol Immunopathol. 1995;74:271-282.