Gemcitabine plus conventional-dose epirubicin versus gemcitabine plus cisplatin as first-line chemotherapy for stage IIIB/IV non-small cell lung carcinoma-A randomized phase II trial

Lung Cancer

Volumn 62, Issue 3, 2008, Pages 334-343

  Hsu, Chiun ^a,b   Kuo, Sung Hsin ^a,b   Hu, Fu Chang ^a,c   Cheng, Ann Lii ^a,b,d   Shih, Jin Yuan ^a   Yu, Chong Jen ^a   Lin, Chia Chi ^a,b   Huang, Tsu Chen ^a,b   Yang, Pan Chyr ^a   Yang, Chih Hsin ^a,b  

^a NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

^b NATIONAL TAIWAN UNIVERSITY   (Taiwan)

^c NATIONAL TAIWAN UNIVERSITY   (Taiwan)

^d NATIONAL HEALTH RESEARCH INSTITUTES   (Taiwan)

Author keywords

Chemotherapy; Cisplatin; Epirubicin; Expression of excision repair cross complementing group 1 (ERCC1); Gemcitabine; Non small cell lung carcinoma; Topoisomerase II (TopoII )

Indexed keywords

CISPLATIN; DNA TOPOISOMERASE (ATP HYDROLYSING); EPIRUBICIN; EXCISION REPAIR CROSS COMPLEMENTING PROTEIN 1; GEMCITABINE;

ALOPECIA; ANEMIA; ARTICLE; BACKACHE; CANCER PATIENT; CANCER STAGING; CANCER SURVIVAL; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; FEBRILE NEUTROPENIA; FEVER; HICCUP; HUMAN; HUMAN TISSUE; IMMUNOHISTOCHEMISTRY; INFECTION; LEUKOPENIA; LUNG NON SMALL CELL CANCER; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROTOXICITY; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; SURVIVAL TIME; THROMBOCYTOPENIA; TREATMENT OUTCOME; VOMITING; WEIGHT REDUCTION;

ADENOCARCINOMA; ADULT; AGED; ANTIGENS, NEOPLASM; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, LARGE CELL; CARCINOMA, NON-SMALL-CELL LUNG; CARCINOMA, SQUAMOUS CELL; CISPLATIN; DEOXYCYTIDINE; DNA TOPOISOMERASES, TYPE II, EUKARYOTIC; DNA-BINDING PROTEINS; ENDONUCLEASES; EPIRUBICIN; FEMALE; HUMANS; IMMUNOENZYME TECHNIQUES; LUNG NEOPLASMS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM STAGING; PROGNOSIS; SURVIVAL RATE; TREATMENT OUTCOME;

EID: 45849137388     PISSN: 01695002     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.lungcan.2008.03.010     Document Type: Article

References (58)

1. American Society of Clinical Oncology. Clinical practice guidelines for the treatment of unresectable non-small-cell lung cancer. J Clin Oncol 1997;15:2996-3018.
2. Bunn Jr. P.A. Chemotherapy for advanced non-small-cell lung cancer: who, what, when, why?. J Clin Oncol 20 Suppl. (2002) 23s-33s
3. Pfister D.G., Johnson D.H., Azzoli C.G., Sause W., Smith T.J., Baker Jr. S., et al. American Society of Clinical Oncology: treatment of unresectable non-small-cell lung cancer guideline: update 2003. J Clin Oncol 22 (2004) 330-353
4. Martoni A., Melotti B., Guaraldi M., and Pannuti F. Activity of high-dose epirubicin in advanced non-small cell lung cancer. Eur J Cancer 27 (1991) 1231-1234
5. Feld R., Wierzbicki R., Walde P.L., Shepherd F.A., Evans W.K., Gupta S., et al. Phase I-II study of high-dose epirubicin in advanced non-small cell lung cancer. J Clin Oncol 10 (1992) 297-303
6. Wils J., Utama I., Sala L., Smeets J., and Riva A. Phase II study of high-dose epirubicin in nonsmall cell lung cancer. Eur J Cancer 26 (1990) 1140-1141
7. Smit E.F., Berendsen H.H., Piers D.A., Smeets J., Riva A., and Postmus P.E. A phase II study of high dose epirubicin in unresectable non small cell lung cancer. Br J Cancer 65 (1992) 405-408
8. Furuse K., Fukuoka M., Yamamoto M., Kawahara M., Tsuruta M., Kodama N., et al. A phase II study of epirubicin in advanced lung cancer (in Japanese). Gan to Kagaku Ryoho 13 (1986) 2835-2840
9. Kalman L.A., Kris M.G., and Gralla R.J. Phase II trial of 4-epidoxorubicin in patients with non small cell lung cancer. Cancer Treat Rep 67 (1983) 591-592
10. Yang C.H., Chen M.C., Cheng A.L., Hsu C.H., Yeh K.H., Yu Y.C., et al. Survival outcome of inoperable non-small cell lung cancer patients receiving conventional dose epirubicin and paclitaxel as first-line treatment. Oncology 68 (2005) 350-355
11. Chow K.U., Ries J., Weidmann E., Pourebrahim F., Napieralski S., Stieler M., et al. Induction of apoptosis using 2′,2′ difluorodeoxycytidine (gemcitabine) in combination with antimetabolites or anthracyclines on malignant lymphatic and myeloid cells. Antagonism or synergism depends on incubation schedule and origin of neoplastic cells. Ann Hematol 79 (2000) 485-492
12. Zoli W., Ricotti L., Tesei A., Ulivi P., Gasperi Campani A., et al. Schedule-dependent cytotoxic interaction between epidoxorubicin and gemcitabine in human bladder cancer cells in vitro. Clin Cancer Res 10 (2004) 1500-1507
13. Zielinski C.C. Gemcitabine/anthracycline combinations in metastatic breast cancer. Clin Breast Cancer 3 Suppl. (2002) 30-33
14. Galligioni E., Arcuri C., Sorio R., and Griso C. Gemcitabine and anthracyclines in platinum-resistant ovarian cancer. Ann Oncol 17 Suppl. (2006) v195-v198
15. Eickhoff A., Martin W., Hartmann D., Eickhoff J.C., Möhler M., Galle P.R., et al. A phase I/II multicentric trial of gemcitabine and epirubicin in patients with advanced pancreatic carcinoma. Br J Cancer 94 (2006) 1572-1574
16. Ricci S., Galli L., Chioni A., Iannopollo M., Antonuzzo A., Francesca F., et al. Gemcitabine plus epirubicin in patients with advanced urothelial carcinoma who are not eligible for platinum-based regimens. Cancer 95 (2002) 1444-1450
17. Rosell R., Cecere F., Santarpia M., Reguart N., and Taron M. Predicting the outcome of chemotherapy for lung cancer. Curr Opin Pharmacol 6 (2006) 323-331
18. Olaussen K.A., Dunant A., Fouret P., Brambilla E., André F., Haddad V., et al. DNA repair by ERCC1 in non-small-cell lung cancer and cisplatin-based adjuvant chemotherapy. N Engl J Med 355 (2006) 983-991
19. Buzdar A.U. Topoisomerase IIα gene amplification and response to anthracycline-containing adjuvant chemotherapy in breast cancer. J Clin Oncol 24 (2006) 2409-2411
20. Jarvinen T.A., and Liu E.T. HER-2/neu and topoisomerase IIalpha in breast cancer. Breast Cancer Res Treat 78 (2003) 299-311
21. In: Fleming I.D., Cooper J.S., Henson D.E., Hutter R.V., Kennedy B.J., Murphy G.P., et al. (Eds). American Joint Committee on Cancer Staging Manual. 5th ed. (1997), JB Lippincott, Philadelphia
22. Gralla R.J., Osoba D., Kris M.G., Kirkbride P., Hesketh P.J., Chinnery L.W., et al. Clinical practice guidelines for the use of antiemetics: Evidence-based report by the American Society of Clinical Oncology. J Clin Oncol 17 (1999) 2971-2994
23. Miller A.B., Hoogstraten B., Staquet M., and Winkler A. Reporting results of cancer treatment. Cancer 47 (1981) 207-214
24. Simon R. Design and conduct of clinical trials. In: DeVita V.T., Hellman S., and Rosenberg S.A. (Eds). Cancer: principle and practice of oncology (2001), Williams & Wilkins, Philadelphia: Lippincott 521-538
25. Hosmer D.W., and Lemeshow S. Applied logistic regression. 2nd ed. (2000), John Wiley & Sons, Hoboken, NJ
26. D'Addario G., Pintilie M., Leighl N.B., Feld R., Cerny T., and Shepherd F.A. Platinum-based versus non-platinum-based chemotherapy in advanced non-small-cell lung cancer: a meta-analysis of the published literature. J Clin Oncol 23 (2005) 2926-2936
27. Pujol J.L., Barlesi F., and Daures J.P. Should chemotherapy combinations for advanced non-small cell lung cancer be platinum-based? A meta-analysis of phase III randomized trials. Lung Cancer 51 (2006) 335-345
28. Rajeswaran A., Trojan A., Burnand B., and Giannelli M. Efficacy and side effects of cisplatin- and carboplatin-based doublet chemotherapeutic regimens versus non-platinum-based doublet chemotherapeutic regimens as first line treatment of metastatic non-small cell lung carcinoma: a systematic review of randomized controlled trials. Lung Cancer 59 (2008) 1-11
29. Pronzato P., Vigani A., Tognoni A., Vaira F., and Canessa P. Anthracyclines in non-small cell lung cancer. Lung Cancer 34 (2001) S57-S59
30. Martoni A., Guaraldi M., Piana E., Strocchi E., Petralia A., Busutti L., et al. Multicenter randomized clinical trial on high-dose epirubicin plus cis-platinum versus vinorelbine plus cis-platinum in advanced non small cell lung cancer. Lung Cancer 22 (1998) 31-38
31. Quantin X., Riviere A., Daures J.P., Oliver P., Comte-Bardonnet M., Khial F., et al. Phase I-II study of high dose epirubicin plus cisplatin in unresectable non-small-cell lung cancer: searching for the maximal tolerated dose. Am J Clin Oncol 23 (2000) 192-196
32. Huisman C., Biesma B., Postmus P.E., Giaccone G., Schramel F.M., and Smit E.F. Accelerated cisplatin and high-dose epirubicin with G-CSF support in patients with relapsed non-small-cell lung cancer: feasibility and efficacy. Br J Cancer 85 (2001) 1456-1461
33. van Putten J.W., Eppinga P., Erjavec Z., de Leede G., Nabers J., Smeets J.B., et al. Activity of high-dose epirubicin combined with gemcitabine in advanced non-small-cell lung cancer: a multicenter phase I and II study. Br J Cancer 82 (2000) 806-811
34. Smit E.F., Piers D.A., and Postmus P.E. Phase II study of high-dose epirubicin and etoposide in advanced non-small cell lung cancer. Eur J Cancer 28A (1992) 1965-1967
35. Bakker M., Groen H.J., Smit E.F., Smeets J., Riggi M., and Postmus P.E. Phase I study of high-dose epirubicin and vinorelbine in previously untreated non-small-cell lung cancer stage IIIB-IV. Br J Cancer 72 (1995) 1547-1550
36. Wachters F.M., van Putten J.W., Kramer H., Erjavec Z., Eppinga P., Strijbos J.H., et al. First-line gemcitabine with cisplatin or epirubicin in advanced non-small-cell lung cancer: a phase III trial. Br J Cancer 89 (2003) 1192-1199
37. Wachters F.M., Van Der Graaf W.T., and Groen H.J. Cardiotoxicity in advanced non-small cell lung cancer patients treated with platinum and non-platinum based combinations as first-line treatment. Anticancer Res 24 (2004) 2079-2083
38. Gandara D.R., Ohe Y., Kubota K., Nishwaki Y., Ariyoshi Y., Saijo N., et al. Japan-SWOG 'common-arm analysis of paclitaxel/carboplatin therapy in advanced NSCLC: a model for prospective comparison of cooperative group trials. Proc Am Soc Clin Oncol (2004) 7007 (abstract)
39. Crowley J., Furuse K., Kawahara M., Fukushima M., Williamson S., Lara P.N., et al. Second Japan-SWOG 'common arm analysis' of paclitaxel/carboplatin in advanced NSCLC: a model for testing population-related pharmacogenomics. Proc Am Soc Clin Oncol (2006) 7050 (abstract)
40. Bellmunt J., Paz-Ares L., Cuello M., Cecere F.L., Albiol S., Guillem V., et al. Gene expression of ERCC1 as a novel prognostic marker in advanced bladder cancer patients receiving cisplatin based chemotherapy. Ann Oncol 18 (2007) 522-528
41. Dabholkar M., Bostick-Bruton F., Weber C., Bohr V.A., Egwuagu C., and Reed E. ERCC1 and ERCC2 expression in malignant tissues from ovarian cancer patients. J Natl Cancer Inst 84 (1992) 1512-1517
42. Metzger R., Leichman C.G., Danenberg K.D., Danenberg P.V., Lenz H.J., Hayashi K., et al. ERCC1 mRNA levels complement thymidylate synthase mRNA levels in predicting response and survival for gastric cancer patients receiving combination cisplatin and fluorouracil chemotherapy. J Clin Oncol 16 (1998) 309-316
43. Cobo M., Isla D., Massuti B., Montes A., Sanchez J.M., Provencio M., et al. Customizing cisplatin based on quantitative excision repair cross-complementing 1 mRNA expression: a phase III trial in non-small-cell lung cancer. J Clin Oncol 25 (2007) 2747-2754
44. Soria J.C. ERCC1-tailored chemotherapy in lung cancer: the first prospective randomized trial. J Clin Oncol 25 (2007) 2648-2649
45. Depowski P.L., Rosenthal S.I., Brien T.P., Stylos S., Johnson R.L., and Ross J.S. Topoisomerase IIalpha expression in breast cancer: correlation with outcome variables. Mod Pathol 13 (2000) 542-547
46. Järvinen T.A., Kononen J., Pelto-Huikko M., and Isola J. Expression of topoisomerase IIalpha is associated with rapid cell proliferation, aneuploidy, and c-erbB2 overexpression in breast cancer. Am J Pathol 148 (1996) 2073-2082
47. Kreisholt J., Sorensen M., Jensen P.B., Nielsen B.S., Andersen C.B., and Sehested M. Immunohistochemical detection of DNA topoisomerase IIalpha, P-glycoprotein and multidrug resistance protein (MRP) in small-cell and non-small-cell lung cancer. Br J Cancer 77 (1998) 1469-1473
48. Giaccone G., van Ark-Otte J., Scagliotti G., Capranico G., van der Valk P., Rubio G., et al. Differential expression of DNA topoisomerases in non-small cell lung cancer and normal lung. Biochim Biophys Acta 1264 (1995) 337-346
49. Dingemans A.C., van Ark-Otte J., Span S., Scagliotti G.V., van der Valk P., Postmus P.E., et al. Topoisomerase IIalpha and other drug resistance markers in advanced non-small cell lung cancer. Lung Cancer 32 (2001) 117-128
50. Simon G., Sharma A., Li X., Hazelton T., Walsh F., Williams C., et al. Feasibility and efficacy of molecular analysis-directed individualized therapy in advanced non-small-cell lung cancer. J Clin Oncol 25 (2007) 2741-2746
51. Zheng Z., Chen T., Li X., Haura E., Sharma A., and Bepler G. DNA Synthesis and Repair Genes RRM1and ERCC1 in Lung Cancer. N Engl J Med 356 (2007) 800-808
52. Booton R., Ward T., Ashcroft L., Morris J., Heighway J., and Thatcher N. ERCC1 mRNA expression is not associated with response and survival after platinum-based chemotherapy regimens in advanced non-small cell lung cancer. J Thorac Oncol 2 (2007) 902-906
53. Niedernhofer L.J., Bhagwat N., and Wood R.D. ERCC1 and non-small-cell lung cancer. N Engl J Med 356 (2007) 2538-2540
54. Millward M.J., Boyer M.J., Lehnert M., Clarke S., Rischin D., Goh B.C., et al. Docetaxel and carboplatin is an active regimen in advanced non-small-cell lung cancer: a phase II study in Caucasian and Asian patients. Ann Oncol 14 (2003) 449-454
55. Huang S.F., Liu H.P., Li L.H., Ku Y.C., Fu Y.N., Tsai H.Y., et al. High frequency of epidermal growth factor receptor mutations with complex patterns in non-small cell lung cancers related to gefitinib responsiveness in Taiwan. Clin Cancer Res 10 (2004) 8195-8203
56. Shepherd F.A., Rodrigues Pereira J., Ciuleanu T., Tan E.H., Hirsh V., Thongprasert S., et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 353 (2005) 123-132
57. Thatcher N., Chang A., Parikh P., Rodrigues Pereira J., Ciuleanu T., von Pawel J., et al. Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer). Lancet 366 (2005) 1527-1537
58. Chang G.C., Tsai C.M., Chen K.C., Yu C.J., Shih J.Y., Yang T.Y., et al. Predictive factors of gefitinib antitumor activity in East Asian advanced non-small cell lung cancer patients. J Thorac Oncol 1 (2006) 520-525