A model to select regimens for Phase III trials for patients with advanced-stage non-small cell lung cancer

Clinical Cancer Research

Volumn 9, Issue 3, 2003, Pages 917-922

  Freidlin, Boris ^a   Breathnach, Oscar S ^b   Johnson, Bruce E ^c,d  

^a NATIONAL CANCER INSTITUTE   (United States)

^b University College Cork and INFANT Centre   (Ireland)

^c BRIGHAM AND WOMEN S HOSPITAL   (United States)

^d DANA FARBER CANCER INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CARBOPLATIN; CISPLATIN; CYCLOPHOSPHAMIDE; DOXORUBICIN; ETOPOSIDE; FLUOROURACIL; METHOTREXATE; MITOMYCIN; NAVELBINE; PACLITAXEL; PROCARBAZINE; VINBLASTINE; VINDESINE;

ADOLESCENT; ADULT; ADVANCED CANCER; AGED; ARTICLE; CANADA; CANCER CHEMOTHERAPY; CANCER PATIENT; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEATH; FEMALE; HUMAN; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; OUTCOMES RESEARCH; PHASE 3 CLINICAL TRIAL; PILOT STUDY; PRIORITY JOURNAL; STATISTICAL SIGNIFICANCE; UNITED STATES;

CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIALS; CLINICAL TRIALS, PHASE II; CLINICAL TRIALS, PHASE III; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MODELS, STATISTICAL; RANDOM ALLOCATION; TREATMENT OUTCOME;

EID: 0037342266     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (40)

1. Breathnach, O. S., Freidlin, B., Conley, B., Green, M. R., Johnson, D. H., Gandara, D. R., O'Connell, M., Shepherd, F. A., and Johnson, B. E. Twenty-two years of Phase III trials for patients with advanced non-small-cell lung cancer: sobering results. J. Clin. Oncol., 19: 1734-1742, 2001.
2. Chute, J. P., Chen, T., Feigal, E., Simon, R., and Johnson, B. E. Twenty years of Phase III trials for patients with extensive-stage small-cell lung cancer: perceptible progress. J. Clin. Oncol., 17: 1794-1801, 1999.
3. Chen, T. T., Chute, J. P., Feigal, E., Johnson, B. E., and Simon, R. A model to select chemotherapy regimens for Phase III trials for extensive-stage small-cell lung cancer. J. Natl. Cancer Inst. (Bethesda), 92: 1601-1607, 2000.
4. Bonomi, P., Kim, K., Fairclough, D., Cella, D., Kugler, J., Rowinsky, E., Jiroutek, M., and Johnson, D. Comparison of survival and quality of life in advanced non-small-cell lung cancer patients treated with two dose levels of paclitaxel combined with cisplatin versus etoposide with cisplatin: results of an Eastern Cooperative Oncology Group trial. J. Clin. Oncol., 18: 623-631, 2000.
5. Crawford, J., O'Rourke, M., Schiller, J. H., Spiridonidis, C. H., Yanovich, S., Ozer, H., Langleben, A., Hutchins, L., Koletsky, A., Clamon, G., Burman, S., White, R., Hohneker, J., and Spiridonitis, C. H. Randomized trial of vinorelbine compared with fluorouracil plus leucovorin in patients with stage IV non-small-cell lung cancer. J. Clin. Oncol., 14: 2774-2784, 1996.
6. Rapp, E., Pater, J. L., Willan, A., Cormier, Y., Murray, N., Evans, W. K., Hodson, D. I., Clark, D. A., Feld, R., Arnold, A. M., et al. Chemotherapy can prolong survival in patients with advanced non-small-cell lung cancer-report of a Canadian multicenter randomized trial. J. Clin. Oncol., 6: 633-641, 1988.
7. Miller, T. P., Chen, T. T., Coltman, C. A., Jr., O'Bryan, R. M., Vance, R. B., Weiss, G. B., Fletcher, W. S., Stephens, R. L., and Livingston, R. B. Effect of alternating combination chemotherapy on survival of ambulatory patients with metastatic large-cell and adenocarcinoma of the lung. A Southwest Oncology Group Study. J. Clin. Oncol., 4: 502-508, 1986.
8. Wozniak, A. J., Crowley, J. J., Balcerzak, S. P., Weiss, G. R., Spiridonidis, C. H., Baker, L. H., Albain, K. S., Kelly, K., Taylor, S. A., Gandara, D. R., and Livingston, R. B. Randomized trial comparing cisplatin with cisplatin plus vinorelbine in the treatment of advanced non-small-cell lung cancer: a Southwest Oncology Group study. J. Clin. Oncol., 16: 2459-2465, 1998.
9. Bitran, J. D., Desser, R. K., DeMeester, T., and Golomb, H. M. Metastatic non-oat-cell bronchogenic carcinoma. Therapy with cyclophosphamide, doxorubicin, methotrexate, and procarbazine (CAMP). JAMA, 240: 2743-2746, 1978.
10. Woodcock, T. M., Blumenreich, M. S., Richman, S. P., Kubota, T. T., Gentile, P. S., and Allegra, J. C. Combination chemotherapy with cis-diamminedichloroplatinum and vinblastine in advanced non-small cell lung cancer. J. Clin. Oncol., 1: 247-250, 1983.
11. Hainsworth, J. D., Porter, L. L., III, Johnson, D. H., Hande, K. R., Wolff, S. N., Birch, R., Enas, G., and Greco, F. A. Combination chemotherapy with vindesine, etoposide, and cisplatin in non-small cell lung cancer: a pilot study of the Southeastern Cancer Study Group. Cancer Treat. Rep., 70: 339-341, 1986.
12. Butler, T. P., MacDonald, J. S., Smith, F. P., Smith, L. F., Woolley, P. V., and Schein, P. S. 5-Fluorouracil, Adriamycin, and mitomycin-C (FAM) chemotherapy for adenocarcinoma of the lung. Cancer (Phila.), 43: 1183-1188, 1979.
13. Ruckdeschel, J. C., Finkelstein, D. M., Ettinger, D. S., Creech, R. H., Mason, B. A., Joss, R. A., and Vogl, S. A randomized trial of the four most active regimens for metastatic non-small-cell lung cancer. J. Clin. Oncol., 4: 14-22, 1986.
14. Krook, J. E., Jett, J. R., and Little, C. A Phase I-II study of sequential infusion VP-16 and cisplatin therapy in advanced lung cancer. Am. J. Clin. Oncol., 12: 114-117, 1989.
15. Gandara, D. R., Perez, E. A., Wold, H., Caggiano, V., Malec, M., Ahn, D. K., Meyers, F., and Carlson, R. W. High-dose cisplatin and mitomycin C in advanced non-small cell lung cancer: a Phase II study of the Northern California Oncology Group. Cancer Chemother. Pharmacol., 27: 243-247, 1990.
16. Depierre, A., Lemarie, E., Dabouis, G., Gamier, G., Jacoulet, P., and Dalphin, J. C. A Phase II study of Navelbine (vinorelbine) in the treatment of non-small-cell lung cancer. Am. J. Clin. Oncol., 14: 115-119, 1991.
17. Johnson, D. H., Paul, D. M., Hande, K. R., Shyr, Y., Blanke, C., Murphy, B., Lewis, M., and De Vore, R. F., III. Paclitaxel plus carboplatin in advanced non-small-cell lung cancer: a Phase II trial. J. Clin. Oncol., 14: 2054-2060, 1996.
18. Berthaud, P., Le Chevalier, T., Ruffle, P., Baldeyrou, P., Arriagada, R., Besson, F., and Tursz, T. Phase I-II study of vinorelbine (Navelbine) plus cisplatin in advanced non-small cell lung cancer. Eur. J. Cancer, 28A: 1863-1865, 1992.
19. Bhasker, B. Phase II study of vinblastine (V) and mitomycin c (M) in advanced adenocarcinoma (AC) and undifferentiated large cell (LCC) of the lung. Proc. Am. Assoc. Cancer Res., 19: 229, 1978.
20. Eagan, R. T., Ingle, J. N., Frytak, S., Rubin, J., Kvols, L. K., Carr, D. T., Coles, D. T., and O'Fallon, J. R. Platinum-based polychemotherapy versus dianhydrogalactitol in advanced non-small cell lung cancer. Cancer Treat. Rep., 61: 1339-1345, 1977.
21. Gralla, R. J., Casper, E. S., Kelsen, D. P., Braun, D. W., Jr., Dukeman, M. E., Martini, N., Young, C. W., and Golbey, R. B. Cisplatin and vindesine combination chemotherapy for advanced carcinoma of the lung: a randomized trial investigating two dosage schedules. Ann. Intern. Med., 95: 414-420, 1981.
22. Kenis, Y., Michel, J., Rimoldi, R., Levy, P., and Israel, L. Results of a clinical trial with intermittent doses of Adriamycin in lung cancer. Eur. J. Cancer, 8: 485-489, 1972.
23. Kreisman, H., Ginsberg, S., Propert, K. J., Richards, F., Graziano, S., and Green, M. Carboplatin or iproplatin in advanced non-small cell lung cancer: a Cancer and Leukemia Group B Study. Cancer Treat. Rep., 71: 1049-1052, 1987.
24. Longeval, E., and Klastersky, J. Combination chemotherapy with cisplatin and etoposide in bronchogenic squamous cell carcinoma and adenocarcinoma. A study by the EORTC lung cancer working party (Belgium). Cancer (Phila.), 50: 2751-2756, 1982.
25. Luedke, D. W., Luedke, S. L., Martelo, O., Quesenberry, P., Birch, R., Schlueter, J., Hake, J., and Logan, T. Vindesine and mitomycin in the treatment of advanced non-small cell lung cancer: a Southeastern Cancer Study Group Trial. Cancer Treat. Rep., 70: 651-653, 1986.
26. Robert, F., Omura, G., and Bartolucci, A. A. Combination chemotherapy with cyclophosphamide, Adriamycin, intermediate dose methotrexate, and folinic acid rescue (CAMF) in advanced lung cancer. Cancer (Phila.), 45: 1-5, 1980.
27. Chahinian, A. P., Mandel, E. M., Holland, J. F., Jaffrey, I. S., and Teirstein, A. S. MACC (methotrexate, Adriamycin, cyclophosphamide and CCNU) in advanced lung cancer. Cancer (Phila.), 43: 1590-1597, 1979.
28. Herbst, R. S., Maddox, A. M., Rothenberg, M. L., Small, E. J., Rubin, E. H., Baselga, J., Rojo, F., Hong, W. K., Swaisland, H., Averbuch, S. D., Ochs, J., and LoRusso, P. M. Selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 is generally well-tolerated and has activity in non-small-cell lung cancer and other solid tumors: results of a Phase I trial. J. Clin. Oncol., 20: 3815-3825, 2002.
29. Ranson, M., Hammond, L. A., Ferry, D., Kris, M., Tullo, A., Murray, P. I., Miller, V., Averbuch, S., Ochs, J., Morris, C., Feyereislova, A., Swaisland, H., and Rowinsky, E. K. ZD1839, a selective oral epidermal growth factor receptor-tyrosine kinase inhibitor, is well tolerated and active in patients with solid, malignant tumors: results of a Phase I trial. J. Clin. Oncol., 20: 2240-2250, 2002.
30. Hidalgo, M., Siu, L. L., Nemunaitis, J., Rizzo, J., Hammond, L. A., Takimoto, C., Eckhardt, S. G., Tolcher, A., Britten, C. D., Denis, L., Ferrante, K., Von Hoff, D. D., Silberman, S., and Rowinsky, E. K. Phase I and pharmacologic study of OSI-774, an epidermal growth factor receptor tyrosine kinase inhibitor, in patients with advanced solid malignancies. J. Clin. Oncol., 19: 3267-3279, 2001.
31. Norton, L. High-dose chemotherapy for breast cancer: "how do you know?" J. Clin. Oncol., 19: 2769-2770, 2001.
32. Green, S., Benedetti, J., and Crawley J. Clinical Trials in Oncology. London: Chapman and Hall, 1997.
33. Kris, M. G., Gralla, R. J., Kalman, L. A., Kelsen, D. P., Casper, E. S., Burke, M. T., Groshen, S., Cibas, I. R., Bagin, R., and Heelan, R. T. Randomized trial comparing vindesine plus cisplatin with vinblastine plus cisplatin in patients with non-small cell lung cancer, with an analysis of methods of response assessment. Cancer Treat. Rep., 69: 387-395, 1985.
34. Zelen, M. Guidelines for publishing papers on cancer clinical trials: responsibilities of editors and authors. J. Clin. Oncol., 1: 164-169, 1983.
35. Dhingra, H. M., Valdivieso, M., Carr, D. T., Chiuten, D. F., Farha, P., Murphy, W. K., Spitzer, G., and Umsawasdi, T. Randomized trial of three combinations of cisplatin with vindesine and/or VP-16-213 in the treatment of advanced non-small-cell lung cancer. J. Clin. Oncol., 3: 176-183, 1985.
36. Krook, J. E., Jett, J. R., Fleming, T. R., Dalton, R. J., Marschke, R. F., Cullinan, S. A., Windschitl, H. E., Everson, L. K., Brunk, F. S., Laurie, J. A., et al. A controlled evaluation of combined 5-fluorouracil, doxorubicin, and mitomycin C (FAM) for the treatment of advanced non-small-cell lung cancer. J. Clin. Oncol., 3: 842-848, 1985.
37. Weick, J. K., Crowley, J., Natale, R. B., Hom, B. L., Rivkin, S., Coltman, C. A., Jr., Taylor, S. A., and Livingston, R. B. 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., 9: 1157-1162, 1991.
38. Veeder, M. H., Jett, J. R., Su, J. Q., Mailliard, J. A., Foley, J. F., Dalton, R. J., Etzell, P. S., Marschke, R. F., Jr., Kardinal, C. G., Maksymiuk, A. W., et al. A Phase III trial of mitomycin C alone versus mitomycin C, vinblastine, and cisplatin for metastatic squamous cell lung carcinoma. Cancer (Phila.), 70: 2281-2287, 1992.
39. Goldberg, R. M., Jett, J. R., Therneau, T. M., Johnson, P. S., Tschetter, L. K., Krook, J. E., Veeder, M. H., Owen, D., Etzell, P. S., and Andres, D. F. Bolus versus infusion regimens of etoposide and cisplatin in treatment of non-small cell lung cancer: a study of the North Central Cancer Treatment group. J. Natl. Cancer Inst. (Bethesda), 82: 1899-1903, 1990.
40. Gandara, D. R., Crowley, J., Livingston, R. B., Perez, E. A., Taylor, C. W., Weiss, G., Neefe, J. R., Hutchins, L. F., Roach, R. W., Grunberg, S. M., et al. Evaluation of cisplatin intensity in metastatic non-small-cell lung cancer: a Phase III study of the Southwest Oncology Group. J. Clin. Oncol., 11: 873-878, 1993.