Sequential vinorelbine and docetaxel in advanced non-small cell lung cancer patients age 70 and older and/or with a performance status of 2: A phase II trial of the Southwest Oncology Group (S0027)

Journal of Thoracic Oncology

Volumn 1, Issue 6, 2006, Pages 537-544

  Hesketh, Paul J ^a   Chansky, Kari ^b   Lau, Derick H M ^c   Doroshow, James H ^d   Moinpour, Carol M ^b   Chapman, Robert A ^e   Goodwin, J Wendall ^f   Gross, Howard M ^g   Crowley, John J ^b   Gandara, David R ^c  

^a ST ELIZABETH'S MEDICAL CENTER   (United States)

^b SOUTHWEST ONCOLOGY GROUP STATISTICAL CENTER   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d CITY OF HOPE NATIONAL MEDICAL CENTER   (United States)

^e HENRY FORD HOSPITAL   (United States)

^f Ozarks Regional Community Clinical Oncology Program   (United States)

^g Dayton Community Clinical Oncology Program   (United States)

Author keywords

Chemotherapy; Elderly; Lung cancer; Performance status 2; Phase II clinical trial

Indexed keywords

DEXAMETHASONE; DIURETIC AGENT; DOCETAXEL; ERYTHROPOIETIN; NAVELBINE; DRUG DERIVATIVE; TAXOID; VINBLASTINE;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ARTICLE; CANCER CHEMOTHERAPY; CANCER SURVIVAL; CHRONOSEQUENCE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG TOLERABILITY; DYSPNEA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HEART MUSCLE CONDUCTION DISTURBANCE; HUMAN; KIDNEY FAILURE; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALAISE; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OUTCOME ASSESSMENT; PERFORMANCE; PHASE 2 CLINICAL TRIAL; PLEURA EFFUSION; PRIORITY JOURNAL; RESPIRATORY FAILURE; SENSORY NEUROPATHY; SURVIVAL RATE; THROMBOCYTOPENIA; TREATMENT RESPONSE; AGE; CANCER INVASION; CANCER STAGING; DOSE RESPONSE; DRUG ADMINISTRATION; INTRAVENOUS DRUG ADMINISTRATION; KARNOFSKY PERFORMANCE STATUS; LUNG TUMOR; MAXIMUM TOLERATED DOSE; MORTALITY; PATHOLOGY; PROGNOSIS; SURVIVAL; TREATMENT OUTCOME;

AGE FACTORS; AGED; AGED, 80 AND OVER; CARCINOMA, NON-SMALL-CELL LUNG; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; KARNOFSKY PERFORMANCE STATUS; LUNG NEOPLASMS; MALE; MAXIMUM TOLERATED DOSE; NEOPLASM INVASIVENESS; NEOPLASM STAGING; PROGNOSIS; SURVIVAL ANALYSIS; TAXOIDS; TREATMENT OUTCOME; VINBLASTINE;

EID: 34247871475     PISSN: 15560864     EISSN: 15561380     Source Type: Journal    
DOI: 10.1097/01243894-200607000-00007     Document Type: Article

References (50)

1. Grilli R, Oxman A, Julian J. Chemotherapy for advanced non-small cell lung cancer: how much benefit is enough? J Clin Oncol 1993;11:1866-1872.
2. 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.
3. Souquet PJ, Chauvin F, Boissel J, et al. Polychemotherapy in advanced non-small cell lung cancer: a meta-analysis. Lancet 1993;342:19-21.
4. Marino P, Pampallona S, Preatoni A, et al. Chemotherapy vs. supportive care in advanced non-small cell lung cancer: results of a meta-analysis of the literature. Chest 1994;106:861-865.
5. Hutchins LF, Unger JM, Crowley JJ, et al. Under representation of patients 65 years of age or older in cancer-treatment trials. N Engl J Med 1999;341:2061-2067.
6. Langer CJ, Manola J, Bernardo P, et al. Cisplatin-based therapy for elderly patients with advanced non-small cell lung cancer: implications of the Eastern Cooperative Oncology Group 5592, a randomized trial. J Natl Cancer Inst 2002;94:173-181.
7. Langer CJ, Vangel M, Schiller J, et al. Age-specific subanalysis of ECOG 1594: fit elderly patients (70-80 yrs) with NSCLC do as well as younger patients (<70). Proc Am Soc Clin Oncol 2003;22:639a.
8. Kelly K, Giarritta S, Hayes S, et al. Should older patients receive combination chemotherapy for advanced stage non-small cell lung cancer? An analysis of Southwest Oncology Trials 9509 and 9308. Proc Am Soc Clin Oncol 2001;20:329a.
9. Lilenbaum R, Herndon J, List M, et al. Single-agent versus combination chemotherapy in advanced non-small cell lung cancer: the cancer and leukemia group B (study 9730). J Clin Oncol 2006;23:190-196.
10. The Elderly Lung Cancer Vinorelbine Italian Study Group. Effect of vinorelbine on quality of life and survival of elderly patients with advanced non-small cell lung cancer. J Natl Cancer Inst 1999;91:66-72.
11. Frasci G, Lorusso V, Panza N, et al. Gemcitabine plus vinorelbine versus vinorelbine alone in elderly patients with advanced non-small cell lung cancer. J Clin Oncol 2000;18:2529-2536.
12. Gridelli C, Perrone F, Gallo C, et al. Chemotherapy for elderly patients with advanced non-small cell lung cancer: the multicenter Italian lung cancer in the elderly study (MILES) phase III randomized. J Natl Cancer Inst 2003;95:362-372.
13. Fidias P, Supko JG, Marrins R, et al. A phase II study of weekly paclitaxel in elderly patients with advanced non-small cell lung cancer. Clin Cancer Res 2001;7:3942-3949.
14. Hainsworth JD, Burris HA, Litchy S, et al. Weekly docetaxel in the treatment of elderly patients with advanced non-small cell lung carcinoma. Cancer 2000;89:328-333.
15. Ruckdeschel JC, Finkelstein DM, Ettinger DS, et al. A randomized trial of the four most active regimens for metastatic non-small cell lung cancer. J Clin Oncol 1986;4:14-22.
16. Buccheri G, Ferrigno D. Vinorelbine in elderly patients with inoperable non-small cell lung carcinoma: a phase II study. Cancer 2000;12:2677-2685.
17. Perrone F. Personal Communication. November 1999.
18. Masotti A, Zannini G, Poggi R, Morandini GC. Vinorelbine monochemotherapy in non-small-cell lung cancer: experience in patients with low performance status. Monaldi Arch Chest Dis 1994;49:197-200.
19. Day RS. Treatment sequencing, asymmetry, and uncertainty: protocol strategies for combination chemotherapy. Cancer Res 1986;46:3876-3885.
20. Norton L, Simon R. Tumor size, sensitivity to therapy, and design of treatment schedules. Cancer Treat Rep. 1977;61:1307-1317.
21. Edelman MJ, Gandara DR. Sequential chemotherapy: rationale and clinical trial design in advanced non-small cell carcinoma. Clin Lung Cancer 1999;1:122-127.
22. Edelman MJ, Gandara DR, Lau D, et al. Sequential combination chemotherapy in advanced non-small cell lung cancer: carboplatin and gemcitabine followed by paclitaxel. Cancer 2001;92:146-152.
23. Edelman MJ, Clark JI, Chansky K, et al. Randomized phase II trial of sequential chemotherapy in advanced non-small cell lung cancer (SWOG 9806): carboplatin/gemcitabine followed by paclitaxel or cisplatin/vinorelbine followed by docetaxel. Clin Cancer Res 2004;10:5022-5026.
24. Henderson IC, Berry DA, Demetri GD, et al. Improved outcomes from adding sequential paclitaxel but not from escalating doxorubicin dose in an adjuvant chemotherapy regimen for patients with node-positive primary breast cancer. J Clin Oncol 2003;21:976-983.
25. Gandara DR, Chansky K, Albain KS, et al. Consolidation docetaxel after concurrent chemoradiotherapy in stage IIIB non-small cell lung cancer: phase II Southwest Oncology Group Study S9504. J Clin Oncol 2003;10:2004-2010.
26. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000;3:205-216.
27. National Cancer Institute [homepage on the Internet]. Maryland: NCI Common Toxicity Criteria. Available from: http://ctep.cancer.gov.
28. Cella DF, Tulsky DS, Gray G, et al. The functional assessment of cancer therapy scale: development and validation of the general measure. J Clin Oncol 1993;11:570-579.
29. Cella DF, Bonomi AE, Lloyd SR, et al. Reliability and validity of the Functional Assessment of Cancer Therapy-Lung (FACT-L) quality of life instrument. Lung Cancer 1995;12:199-200.
30. Cella DF. Manual of the Functional Assessment of Chronic Illness Therapy (FACIT Scales)-Version 4. Center on Outcomes Research and Education (CORE). Evanston, IL: Evanston Northwestern Healthcare and Northwestern University, 1997.
31. Bonomi P, Kim K-M, Fairclough D, et al. 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 2000;18:623-631.
32. Cella D, Eton DT, Fairclough DL, et al. What is a clinically meaningful change on the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) Study 5592. J Clin Epidemiol 2002;55:285-295.
33. Katz JN, Chang LC, Sangha O, et al. Can comorbidity be measured by questionnaire rather than medical record review? Med Care 1996;34:73-84.
34. Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics 1982;38:963-974.
35. Wozniak AJ, Crowley JJ, Balcerzak SP, et al. Randomized trial comparing cisplatin with cisplatin plus vinorelbine in the treatment of advanced non-small cell lung cancer. J Clin Oncol 1998;7:2459-2465.
36. Kelly K, Crowley J, Bunn Jr, PA et al. Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non-small cell lung cancer. J Clin Oncol 2001;13:3210-3218.
37. Schiller JH, Harrington D, Belani CP, et al. Comparison of four chemotherapy regimens for advanced non-small cell lung cancer. N Engl J Med 2002;2:92-98.
38. Firat S, Byhardt RW, Gore E. Comorbidity and Karnofsky performance score are independent prognostic factors in stage III non-small-cell lung cancer: an institutional analysis of patients treated on four RTOG studies. Radiation Therapy Oncology Group. Int J Radiat Oncol Biol Phys 2002;54:357-364.
39. Tammemagi CM, Neslund-Dudas C, Simoff M, et al. Impact of comorbidity on lung cancer survival. Int J Cancer 2004;103:792-802.
40. Tammemagi CM, Neslund-Dudas C, Simoff M, et al. In lung cancer patients, age, race-ethnicity, gender and smoking predict adverse comorbidity, which in turn predicts treatment and survival. J Clin Epidemiol 2004;57:597-609.
41. Cullen MH, Billingham LJ, Woodroffe CM, et al. Mitomycin, ifosfamide, and cisplatin in unresectable non-small-cell lung cancer: effects on survival and quality of life. J Clin Oncol 1999;17:3188-3194.
42. Anderson H, Hopwood P, Stephens RJ, et al. Gemcitabine plus best supportive care (BSC) vs. BSC in inoperable non-small-cell lung cancer - a randomized trial with quality of life as the primary outcome.UK NSCLC Gemcitabine Group. Non-Small Cell Lung Cancer. Br J Cancer 2000;83:447-453.
43. Albain KS, Crowley JJ, LeBlanc M, et al. Survival determinants in extensive-stage non-small cell lung cancer. J Clin Oncol 1991;9:1618-1626.
44. Sweeney CJ, Zhu J, Sandler AB, et al. Outcome of patients with a performance status of 2 in Eastern Cooperative Oncology Group Study E1594: a phase II trial in patients with metastatic non-small cell lung carcinoma. Cancer 2001;92:2639-2647.
45. Kosmidis PA, Dimopoulos MA, Syrigos C, et al. Gemcitabine vs. gemcitabine-carboplatin (GCB) for patients with advanced non-small cell lung cancer and PS: 2. A prospective randomized phase II study of the Hellenic Co-Operative Oncology Group (Abstract 7058). J Clin Oncol 2004;22(Suppl):630.
46. Tester WJ, Stephenson P, Langer CJ, et al. ECOG 1599: Randomized phase II study of paclitaxel/carboplatin or gemcitabine/cisplatin in performance status 2 patients with advanced non-small cell lung cancer (Abstract 7055). J Clin Oncol 2004;22(Suppl):630.
47. Billingham LJ, Cullen MH. The benefits of chemotherapy in patient subgroups with unresectable non-small cell lung cancer. Ann Oncol 2001;12:1671-1675.
48. Vansteenkiste JF, Vandebroek J, Nackaerts KL, et al. Influence of cisplatin-use, age, performance status and duration of chemotherapy on symptom control in advanced non-small cell lung cancer: detailed symptom analysis of a randomized study comparing cisplatin-vindesine to gemcitabine. Lung Cancer 2003;40:191-199.
49. Vansteenkiste JF, Vandebroek JE, Nackaerts KL, et al. Clinical-benefit response in advanced non-small cell lung cancer: a multicenter prospective randomized phase III study of single agent gemcitabine versus cisplatin-vindesine. Ann Oncol 2001;12:1221-1230.
50. Hickish TF, Smith IE, O'Brien ME, et al. Clinical benefit from palliative chemotherapy in non-small cell lung cancer extends to the elderly and those with poor prognostic factors. Br J Cancer 1998;78:28-33.