Dose selection trial of metronomic oral vinorelbine monotherapy in patients with metastatic cancer: A hellenic cooperative oncology group clinical translational study

BMC Cancer

Volumn 13, Issue , 2013, Pages

  Briasoulis, Evangelos ^a   Aravantinos, Gerasimos ^b   Kouvatseas, George ^c   Pappas, Periklis ^a   Biziota, Eirini ^a   Sainis, Ioannis ^d   Makatsoris, Thomas ^e   Varthalitis, Ioannis ^f   Xanthakis, Ioannis ^g   Vassias, Antonios ^h   Klouvas, George ⁱ   Boukovinas, Ioannis ^j   Fountzilas, George ^g   Syrigos, Kostantinos N ^h   Kalofonos, Haralambos ^e   Samantas, Epaminontas ^b  

^a UNIVERSITY OF IOANNINA   (Greece)

^b AGII ANARGIRI CANCER HOSPITAL   (Greece)

^c Health Data Specialists Ltd   (Greece)

^d UNIVERSITY OF IOANNINA   (Greece)

^e UNIVERSITY OF PATRAS   (Greece)

^f Chania General Hospital St George   (Greece)

^g ARISTOTLE UNIVERSITY OF THESSALONIKI   (Greece)

^h SOTIRIA GENERAL HOSPITAL   (Greece)

ⁱ METROPOLITAN HOSPITAL   (Greece)

^j THEAGENIO CANCER HOSPITAL   (Greece)

more..

Author keywords

Antiangiogenic; Cancer; Metronomic chemotherapy; Vinorelbine

Indexed keywords

FIBROBLAST GROWTH FACTOR 2; INTERLEUKIN 8; NAVELBINE; THROMBOSPONDIN 1; TUMOR MARKER; VASCULOTROPIN; VASCULOTROPIN RECEPTOR 2; ANTINEOPLASTIC AGENT; MESSENGER RNA; VINBLASTINE;

ABNORMAL LABORATORY RESULT; ADOLESCENT; ADULT; AGED; ARTICLE; BREAST CANCER; CANCER CHEMOTHERAPY; CANCER GROWTH; CANCER PATIENT; CANCER RESISTANCE; CANCER SURVIVAL; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DISEASE SEVERITY; DRUG ACCUMULATION; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG FEVER; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; GASTROINTESTINAL TOXICITY; GENETIC TRANSCRIPTION; HEMOPTYSIS; HUMAN; HUMAN CELL; LEUKOCYTE; LOW DRUG DOSE; LUNG NON SMALL CELL CANCER; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; METABOLIC DISORDER; METASTASIS POTENTIAL; METRONOMIC DRUG ADMINISTRATION; MONOTHERAPY; MULTICENTER STUDY; NEUTROPHIL; ONCOLOGY; OPEN STUDY; PAIN; PERIPHERAL EDEMA; PREDICTION; PROGRESSION FREE SURVIVAL; PROSTATE CANCER; RANDOMIZED CONTROLLED TRIAL; RECURRENT CANCER; RESPIRATORY TRACT DISEASE; SENSORY NEUROPATHY; SIDE EFFECT; STEADY STATE; TEK GENE; THROMBOCYTE; TREATMENT RESPONSE; TUMOR VASCULARIZATION; WEIGHT GAIN; WEIGHT REDUCTION; ANALOGS AND DERIVATIVES; BONE NEOPLASMS; BREAST NEOPLASMS; CANCER STAGING; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIAL; DOSE RESPONSE; ENZYME LINKED IMMUNOSORBENT ASSAY; FOLLOW UP; GENETICS; LIVER NEOPLASMS; LUNG NEOPLASMS; METABOLISM; MIDDLE AGED; MORTALITY; ORAL DRUG ADMINISTRATION; PATHOLOGY; PHASE 1 CLINICAL TRIAL; PROGNOSIS; PROSTATIC NEOPLASMS; REAL TIME POLYMERASE CHAIN REACTION; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; SECONDARY; SURVIVAL RATE; TIME TO TREATMENT; TRANSLATIONAL RESEARCH; YOUNG ADULT;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; AGED; ANTINEOPLASTIC AGENTS, PHYTOGENIC; BONE NEOPLASMS; BREAST NEOPLASMS; CARCINOMA, NON-SMALL-CELL LUNG; DOSE-RESPONSE RELATIONSHIP, DRUG; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; FOLLOW-UP STUDIES; HUMANS; LIVER NEOPLASMS; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM STAGING; PROGNOSIS; PROSTATIC NEOPLASMS; REAL-TIME POLYMERASE CHAIN REACTION; REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION; RNA, MESSENGER; SURVIVAL RATE; TIME-TO-TREATMENT; TRANSLATIONAL MEDICAL RESEARCH; TUMOR MARKERS, BIOLOGICAL; VINBLASTINE; YOUNG ADULT;

EID: 84878235787     PISSN: None     EISSN: 14712407     Source Type: Journal    
DOI: 10.1186/1471-2407-13-263     Document Type: Article

References (43)

1. Kosmidis PA, Fountzilas G, Eleftheraki AG, Kalofonos HP, Pentheroudakis G, Skarlos D, Dimopoulos MA, Bafaloukos D, Pectasides D, Samantas E, et al. Paclitaxel and gemcitabine versus paclitaxel and vinorelbine in patients with advanced non-small-cell lung cancer. A phase III study of the hellenic cooperative oncology group (HeCOG). Ann Oncol 2011, 22(4):827-834. 10.1093/annonc/mdq445, 20880999.
2. Saltz LB. Progress in cancer care: the hope, the hype, and the gap between reality and perception. J Clin Oncol 2008, 26(31):5020-5021. 10.1200/JCO.2008.17.6198, 18794538.
3. Fojo T, Parkinson DR. Biologically targeted cancer therapy and marginal benefits: are we making too much of too little or are we achieving too little by giving too much?. Clin Cancer Res 2010, 16(24):5972-5980. 10.1158/1078-0432.CCR-10-1277, 21169250.
4. Richards L. Targeted therapies: disappointing outcomes for anti-VEGF therapy. Nat Rev Clin Oncol 2011, 8(4):194.
5. Gebbia V, Serretta V, Borsellino N, Valerio MR. Salvage therapy with oral metronomic cyclophosphamide and methotrexate for castration-refractory metastatic adenocarcinoma of the prostate resistant to docetaxel. Urology 2011, 78(5):1125-1130. 10.1016/j.urology.2011.08.010, 22054386.
6. Kerbel RS, Klement G, Pritchard KI, Kamen B. Continuous low-dose anti-angiogenic/ metronomic chemotherapy: from the research laboratory into the oncology clinic. Ann Oncol 2002, 13(1):12-15. 10.1093/annonc/mdf093, 11863092.
7. Mir O, Domont J, Cioffi A, Bonvalot S, Boulet B, Le Pechoux C, Terrier P, Spielmann M, Le Cesne A. Feasibility of metronomic oral cyclophosphamide plus prednisolone in elderly patients with inoperable or metastatic soft tissue sarcoma. Eur J Cancer 2011, 47(4):515-519. 10.1016/j.ejca.2010.11.025, 21251814.
8. Penel N, Clisant S, Dansin E, Desauw C, Degardin M, Mortier L, Vanhuyse M, Bonodeau F, Fournier C, Cazin JL, et al. Megestrol acetate versus metronomic cyclophosphamide in patients having exhausted all effective therapies under standard care. Br J Cancer 2010, 102(8):1207-1212. 10.1038/sj.bjc.6605623, 2856003, 20354522.
9. Wong NS, Buckman RA, Clemons M, Verma S, Dent S, Trudeau ME, Roche K, Ebos J, Kerbel R, Deboer GE, et al. Phase I/II trial of metronomic chemotherapy with daily dalteparin and cyclophosphamide, twice-weekly methotrexate, and daily prednisone as therapy for metastatic breast cancer using vascular endothelial growth factor and soluble vascular endothelial growth factor receptor levels as markers of response. J Clin Oncol 2010, 28(5):723-730. 10.1200/JCO.2009.24.0143, 20026801.
10. Hahnfeldt P, Folkman J, Hlatky L. Minimizing long-term tumor burden: the logic for metronomic chemotherapeutic dosing and its antiangiogenic basis. J Theor Biol 2003, 220(4):545-554. 10.1006/jtbi.2003.3162, 12623285.
11. Kerbel RS, Kamen BA. The anti-angiogenic basis of metronomic chemotherapy. Nat Rev Cancer 2004, 4:423-436. 10.1038/nrc1369, 15170445.
12. Yancopoulos GD. Clinical application of therapies targeting VEGF. Cell 2010, 143(1):13-16. 10.1016/j.cell.2010.09.028, 20887885.
13. Tejpar S, Prenen H, Mazzone M. Overcoming resistance to antiangiogenic therapies. Oncologist 2012, 17(8):1039-1050. 10.1634/theoncologist.2012-0068, 22773560.
14. Huang D, Ding Y, Zhou M, Rini BI, Petillo D, Qian CN, Kahnoski R, Futreal PA, Furge KA, Teh BT. Interleukin-8 mediates resistance to antiangiogenic agent sunitinib in renal cell carcinoma. Cancer Res 2010, 70(3):1063-1071. 10.1158/0008-5472.CAN-09-3965, 20103651.
15. Ellis LM, Hicklin DJ. VEGF-targeted therapy: mechanisms of anti-tumour activity. Nat Rev Cancer 2008, 8(8):579-591. 10.1038/nrc2403, 18596824.
16. Bergers G, Hanahan D. Modes of resistance to anti-angiogenic therapy. Nat Rev Cancer 2008, 8(8):592-603. 10.1038/nrc2442, 2874834, 18650835.
17. Shaked Y, Kerbel RS. Antiangiogenic strategies on defense: on the possibility of blocking rebounds by the tumor vasculature after chemotherapy. Cancer Res 2007, 67(15):7055-7058. 10.1158/0008-5472.CAN-07-0905, 17671170.
18. Frei E, Canellos GP. Dose: a critical factor in cancer chemotherapy. Am J Med 1980, 69(4):585-594. 10.1016/0002-9343(80)90472-6, 6999898.
19. Pasquier E, Kavallaris M, Andre N. Metronomic chemotherapy: new rationale for new directions. Nat Rev Clin Oncol 2010, 7(8):455-465. 10.1038/nrclinonc.2010.82, 20531380.
20. Chen CA, Ho CM, Chang MC, Sun WZ, Chen YL, Chiang YC, Syu MH, Hsieh CY, Cheng WF. Metronomic chemotherapy enhances antitumor effects of cancer vaccine by depleting regulatory T lymphocytes and inhibiting tumor angiogenesis. Mol Ther 2010, 18(6):1233-1243. 10.1038/mt.2010.34, 2889744, 20372107.
21. Andre N, Padovani L, Pasquier E. Metronomic scheduling of anticancer treatment: the next generation of multitarget therapy?. Future Oncol 2011, 7(3):385-394. 10.2217/fon.11.11, 21417902.
22. Briasoulis E, Pappas P, Puozzo C, Tolis C, Fountzilas G, Dafni U, Marselos M, Pavlidis N. Dose-ranging study of metronomic oral vinorelbine in patients with advanced refractory cancer. Clin Cancer Res 2009, 15(20):6454-6461. 10.1158/1078-0432.CCR-09-0970, 19808873.
23. Skipper HE, Schabel FM, Mellett LB, Montgomery JA, Wilkoff LJ, Lloyd HH, Brockman RW. Implications of biochemical, cytokinetic, pharmacologic, and toxicologic relationships in the design of optimal therapeutic schedules. Cancer Chemother Rep 1970, 54(6):431-450.
24. DeVita VT, Chu E. A history of cancer chemotherapy. Cancer Res 2008, 68(21):8643-8653. 10.1158/0008-5472.CAN-07-6611, 18974103.
25. Maraveyas A, Lam T, Hetherington JW, Greenman J. Can a rational design for metronomic chemotherapy dosing be devised?. Br J Cancer 2005, 92(8):1588-1590. 10.1038/sj.bjc.6602474, 2362004, 15846302.
26. Shaked Y, Emmenegger U, Man S, Cervi D, Bertolini F, Ben-David Y, Kerbel RS. Optimal biologic dose of metronomic chemotherapy regimens is associated with maximum antiangiogenic activity. Blood 2005, 106(9):3058-3061. 10.1182/blood-2005-04-1422, 1895327, 15998832.
27. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, 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(3):205-216. 10.1093/jnci/92.3.205, 10655437.
28. Bubley GJ, Carducci M, Dahut W, Dawson N, Daliani D, Eisenberger M, Figg WD, Freidlin B, Halabi S, Hudes G, et al. Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: recommendations from the prostate-specific antigen working group. Journal of clinical oncology : official journal of the American Society of Clinical Oncology 1999, 17(11):3461-3467.
29. McShane LM, Altman DG, Sauerbrei W, Taube SE, Gion M, Clark GM. Reporting recommendations for tumor marker prognostic studies (REMARK). J Natl Cancer Inst 2005, 97(16):1180-1184. 10.1093/jnci/dji237, 16106022.
30. Pectasides D, Papaxoinis G, Kotoula V, Fountzilas H, Korantzis I, Koutras A, Dimopoulos AM, Papakostas P, Aravantinos G, Varthalitis I, et al. Expression of angiogenic markers in the peripheral blood of docetaxel-treated advanced breast cancer patients: A Hellenic Cooperative Oncology Group (HeCOG) study. Oncol Rep 2012, 27(1):216-224.
31. Livak K, Schmittgen T. Analysis of relative gene expression data using real-time quantitative PCR and the 2(-DeltaDeltaCt) Method. Methods 2001, 25(4):402-408. 10.1006/meth.2001.1262, 11846609.
32. Van Heugen JC, De Graeve J, Zorza G, Puozzo C. New sensitive liquid chromatography method coupled with tandem mass spectrometric detection for the clinical analysis of vinorelbine and its metabolites in blood, plasma, urine and faeces. J Chromatogr A 2001, 926(1):11-20. 10.1016/S0021-9673(01)00993-1, 11554404.
33. Cohen J. Statistical Power Analysis for the Behavioral Sciences 1977, New York, NY: Academic Press.
34. Thall PF, Cook JD. Dose-finding based on efficacy-toxicity trade-offs. Biometrics 2004, 60(3):684-693. 10.1111/j.0006-341X.2004.00218.x, 15339291.
35. Verheul HM, Pinedo HM. Possible molecular mechanisms involved in the toxicity of angiogenesis inhibition. Nat Rev Cancer 2007, 7(6):475-485. 10.1038/nrc2152, 17522716.
36. Eskens FA, Verweij J. The clinical toxicity profile of vascular endothelial growth factor (VEGF) and vascular endothelial growth factor receptor (VEGFR) targeting angiogenesis inhibitors; a review. Eur J Cancer 2006, 42(18):3127-3139. 10.1016/j.ejca.2006.09.015, 17098419.
37. Folkman J. Angiogenesis: an organizing principle for drug discovery?. Nat Rev Drug Discov 2007, 6(4):273-286. 10.1038/nrd2115, 17396134.
38. Pappas P, Biziota I, Marselos M, Brasoulis E. Evaluation of antiproliferative and molecular effects of vinorelbine and its active metabolite 4-O-deacetyl-vinorelbine on human endothelial cells in an in vitro simulation model of metronomic chemotherapy. Eur J Cancer 2008, 6(Supplement 9s):138-139. Abstract 533.
39. Hamaguchi I, Huang XL, Takakura N, Tada J, Yamaguchi Y, Kodama H, Suda T. In vitro hematopoietic and endothelial cell development from cells expressing TEK receptor in murine aorta-gonad-mesonephros region. Blood 1999, 93(5):1549-1556.
40. Dales JP, Garcia S, Bonnier P, Duffaud F, Meunier-Carpentier S, Andrac-Meyer L, Lavaut MN, Allasia C, Charpin C. Tie2/Tek expression in breast carcinoma: correlations of immunohistochemical assays and long-term follow-up in a series of 909 patients. Int J Oncol 2003, 22(2):391-397.
41. Dumont DJ, Yamaguchi TP, Conlon RA, Rossant J, Breitman ML. tek, a novel tyrosine kinase gene located on mouse chromosome 4, is expressed in endothelial cells and their presumptive precursors. Oncogene 1992, 7(8):1471-1480.
42. Laquente B, Vinals F, Germa JR. Metronomic chemotherapy: an antiangiogenic scheduling. Clin Transl Oncol 2007, 9(2):93-98. 10.1007/s12094-007-0018-3, 17329220.
43. Gasparini G. Metronomic scheduling: the future of chemotherapy?. Lancet Oncol 2001, 2(12):733-740. 10.1016/S1470-2045(01)00587-3, 11902515.