A randomized phase II study of ifosfamide/mesna/cisplatin plus G-CSF or etoposide/cisplatin plus G-CSF in advanced non-small cell lung cancer: A cancer and leukemia group B study

Lung Cancer

Volumn 14, Issue 2-3, 1996, Pages 315-329

  Graziano, Stephen L ^a,h   Valone, Frank H ^b   Herndon II, James E ^c   Crawford, Jeffrey ^c   Richards II, Frederick ^d   Rege, Vishram B ^e   Clamon, Gerald ^f   Green, Mark R ^g  

^a State University of New York Upstate Medical University: College of Medicine   (United States)

^b DARTMOUTH HITCHCOCK MEDICAL CENTER   (United States)

^c DUKE UNIVERSITY MEDICAL CENTER   (United States)

^d WAKE FOREST SCHOOL OF MEDICINE   (United States)

^e BROWN UNIVERSITY   (United States)

^f UNIVERSITY OF IOWA HOSPITALS AND CLINICS   (United States)

^g UNIVERSITY OF CALIFORNIA SAN DIEGO   (United States)

^h SUNY UPSTATE MEDICAL UNIVERSITY   (United States)

Author keywords

Chemotherapy; Cisplatin; Etoposide; Granulocyte colony stimulating factor; Lung cancer; Non small cell lung cancer; Phase II study

Indexed keywords

CISPLATIN; ETOPOSIDE; GRANULOCYTE COLONY STIMULATING FACTOR; IFOSFAMIDE; MESNA;

ADULT; ADVANCED CANCER; AGED; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER STAGING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG INDUCED DISEASE; DRUG SCREENING; FEMALE; HUMAN; INFECTION; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; THROMBOCYTOPENIA;

EID: 0030014973     PISSN: 01695002     EISSN: None     Source Type: Journal    
DOI: 10.1016/0169-5002(96)00556-9     Document Type: Article

References (38)

1. Boring CC, Squires TS, Tong T, Montgomery S. Cancer statistics, 1994. CA Cancer J Clin 1994; 44: 7-26.
2. Ginsberg RJ, Kris MG, Armstrong JG. Non-small cell lung cancer. In DeVita VT Jr, Hellman S, Rosenberg SA, editors. Cancer: principles and practice of oncology (4th edn.). Philadelphia, PA: Lippincott, 1993; 673-723.
3. Liu RJ. Chemotherapy outcomes in advanced non-small-cell lung carcinoma. Semin Oncol 1993; 20: 296-301.
4. Weick JK, Crowley J, Natale RB, Horn BL, Rivkin S, Coltman Jr CA, Taylor SA, Livingston RB. A randomized trial of five cisplatin-containing treatments in patients with metastatic non-small-cell lung cancer: a Southwest Oncology Group Study. J Clin Oncol 1991; 9: 1157-1162.
5. Rapp E, Pater JL, Willan A, Cormier Y, Murray N, Evans WK, Hodson DI, Clark DA, Feld R, Arnold AM, Ayoub JI, Wilson KS, Latreille J, Wierzbicki RF, Hill DP. Chemotherapy can prolong survival in patients with advanced non-small-cell lung cancer - report of a Canadian multicenter randomized trial. J Clin Oncol 1988; 6: 633-641.
6. Grilli R, Oxman AD, Julian JA. Chemotherapy for advanced non-small-cell lung cancer: how much benefit is enough? J Clin Oncol 1993; 11: 1866-1872.
7. Stewart LA, Pignon JP, Parmar MKB, Le Chevalier T, Souhami RL. A meta-analysis using individual patient data from randomized clinical trials (RCTS) of chemotherapy (CT) in non-small cell lung cancer (NSCLC): survival in the supportive care (SC) setting. Proc Am Soc Clin Oncol 1994; 13: 337 (Abstr 1118).
8. Ihde DC. Chemotherapy combined with chest irradiation for locally advanced non-small cell lung cancer. Ann Intern Med 1991; 115: 737-739.
9. Dillman RO, Seagren SL, Propert KJ, Guerra J, Eaton WL, Perry MC, Carey RW, Frei III EF, Green MR. A randomized trial of induction chemotherapy plus high-dose radiation versus radiation alone in stage III non-small cell lung cancer. New Engl J Med 1990; 323: 940-945.
10. Le Chevalier T, Arriagada R, Quoix E, Ruffie P, Martin M, Tarayre M, Lacombe-Terrier MJ, Douillard JY, Laplanche A. Radiotherapy alone versus combined chemotherapy and radiotherapy in nonresectable non-small-cell lung cancer: first analysis of a randomized trial in 353 patients. J Natl Cancer Inst 1991; 83: 417-423.
11. Pignon JP, Stewart LA, Souhami RL, Arriagada R. A meta-analysis using individual patient data from randomised clinical trials (RCTS) of chemotherapy (CT) in non-small cell lung cancer (NSCLC): Survival in the locally advanced setting. Proc Am Soc Clin Oncol 1994; 13: 334 (Abstr 1109).
12. Bunn PA Jr. The expanding role of cisplatin in the treatment of non-small-cell lung cancer. Semin Oncol 1989; 16 Suppl 4: 10-21.
13. Ettinger DS. Ifosfamide in the treatment of non-small cell lung cancer. Semin Oncol 1989; 16 Suppl 3: 31-38.
14. Johnson DH. Overview of ifosfamide in small cell and non-small cell lung cancer. Semin Oncol 1990; 17 Suppl 4: 24-30.
15. Brade WP, Herdrich K, Varini M. Ifosfamide-pharmacology, safety and therapeutic potential. Cancer Treat Rev 1985; 12: 1-47.
16. Rodriguez V, Bodey GP, Freireich EJ. Reduction of ifosfamide toxicity using dose fractionation. Cancer Res 1976; 36: 2945-2948.
17. Costanzi JJ, Gagliano R, Loukas D, Panctticrc FJ, Hokanson JA. Ifosfamide in the treatment of recurrent or disseminated lung cancer. A phase II study of two dose schedules. Cancer 1978; 41: 1715-1719.
18. Scheef W, Klein HO, Burkert H, Gunther U, Hoefer-Janker H, Mitrenga D, Schnitker J, Voigtmann R. Controlled clinical studies with an antidote against the urotoxicity of oxazaphosphorines: preliminary results. Cancer Treat Rep 1979; 63: 501-505.
19. Burkert H. Clinical overview of mesna. Cancer Treat Rev 1983; 10 Suppl A: 175-181.
20. Drings P, Stiefel P, Dirks HP, Grimm V, Kleckow M, Manke HG, Queiffer W, Abel U, Heinrich S. Ifosfamide and cisplatin in the chemotherapy of non-small cell carcinoma of the lung. Dtsch Med Wschr 1984; 109: 1059-1064.
21. Drings P, Abel V, Bulzebruck H, Stiefel P, Kleckow M, Manke HG. Experience with ifosfamide combinations (etoposide or DDP) in non-small cell lung cancer. Cancer Chemother Pharmacol 1986; 18 Suppl 2: S34-S39.
22. Graziano SL, Herndon JE, Richards F, DiFino S, Modeas C, Duggan DB, Green MR. A phase I trial of ifosfamide, mesna, and cisplatin in advanced non-small cell lung cancer. A Cancer and Leukemia Group B study. Cancer 1993; 72: 62-68.
23. Klatersky J. Therapy with cisplatin and etoposide for non-small-cell lung cancer. Semin Oncol 1986; 13 Suppl 3: 104-114.
24. Klatersky J, Sculier JP, Lacroix J, Dabouis G, Bureau G, Libert P, Richez M, Ravez P, Vandermoten G, Thiriaux J, Cordier R, Finet C, Berchier MC, Sergysels R, Mommen P, Paesmans M. A randomized study comparing cisplatin or carboplatin with etoposide in patients with advanced non-small-cell lung cancer: European Organization for Research and Treatment of Cancer Protocol 07861. J Clin Oncol 1990; 8: 1556-1562.
25. Klatersky J, Sculier JP, Bureau G, Libert P, Ravez P, Vandermoten G, Thiriaux J, Lecomte J, Cordier R, Dabouis G, Brohee D, Themelin L, Mommen P. Cisplatin versus cisplatin plus etoposide in the treatment of advanced non-small-cell lung cancer. J Clin Oncol 1989; 7: 1087-1092.
26. Muscato J, Clamon G, Perry M, Omura G, Berkowitz I, Reid T, Green MR. Etoposide (VP-16) and cisplatin (DDP) at maximum tolerated dose (MTD) in non-small cell lung carcinoma (NSCLC): A CALGB study. Proc Am Soc Clin Oncol 1991; 10: 243 (Abstr 830).
27. Crawford J, Ozer H, Stoller R, Johnson D, Lyman G, Tabbara I, Kris M, Grous J, Picozzi V, Rausch G, Smith R, Gradishar W, Yahanda A, Vincent M, Stewart M, Glaspy J. Reduction by granulocyte colony-stimulating factor of fever and neutropenia induced by chemotherapy in patients with small-cell lung cancer. New Engl J Med 1991; 325: 164-170.
28. Oken MM, Creech RH, Tormey DC, Horton J. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982; 5: 649-655.
29. Division of Cancer Treatment, National Cancer Institute. Common toxicity criteria. Bethesda, MD: National Cancer Institute, July, 1989.
30. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53: 457-481.
31. Hollander M, Wolfe DA. Nonparametric statistical methods. New York: Wiley, 1973.
32. Green MR, Kramer A, Schilsky R, Stoople M, Zimmer B, Richards F, Skarin A, Anderson JR. Platinum-based combination chemotherapy in advanced non-small cell lung cancer: a randomized phase II trial of the Cancer and Leukemia Group B. Med Pediatr Oncol 1990; 18: 197-202.
33. Lyss AR, Vokes EE, Goutsou M, Mason Coughlin K, Green MR. Cisplatin/5FU/leucovorin (PFL) or intravenous 6-thioguanine (6TG) in advanced non-small cell lung cancer (NSCLC): a randomized phase II study (Abstr 923). Proc Am Soc Clin Oncol 1990; 9: 239.
34. Mitchell EP, Luikart SD, Van Echo DA, Propert K, Modeas C, Perry MC, Green M. Etoposide (VP-16) and cisplatin (DDP) in untreated extensive small cell lung cancer (SCLC): a dose-escalation study. Proc Am Soc Clin Oncol 1988; 7: 206 (Abstr 796).
35. Schuchter LM, Luginbuhl WE, Meropol NJ. The current status of toxicity protectants in cancer therapy. Semin Oncol 1992; 19: 742-751.
36. Le Chevalier T, Pujol JL, Douillard JY, Alberola V, Monnier A, Riviere A, Lianes P, Chomy P, Cigolari S, Besson F, Berthaud P, Brisgand D. A three-arm trial of vinorelbine (navelbine) plus cisplatin, vindesin plus cisplatin, and single-agent vinorelbine in the treatment of non-small cell lung cancer: and expanded analysis. Semin Oncol 1994; 21 Suppl 10: 28-34.
37. Rosso R, Salvati F, Ardizzoni A, Curcio CG, Rubagotti A, Belli M, Castagneto B, Fusco V, Sassi M, Ferrara G, Pizza A, Pedicini T, Soresi E, Scoditti S, Cioffi R, Folco U, Monaco M, Merlano M, Rimoldi R, Tonachella R, Cruciani A, Colantuoni G, Rinaldi M, Portalone L, Bruzzi P, Santi L. Etoposide versus etoposide plus high-dose cisplatin in the management of advanced non-small cell lung cancer. Cancer 1990; 66: 130-134.
38. Luedke DW, Einhorn L, Omura GA, Sarma PR, Bartolucci AA, Birch R, Greco FA. Randomized comparison of two combination regimens versus minimal chemotherapy in non-small-cell lung cancer: a Southeastern Cancer Study Group Trial. J Clin Oncol 1990; 8: 886-891.