Phase I-II trial of gemcitabine-based first-line chemotherapies for small cell lung cancer in elderly patients with performance status 0-2: The G-Step trial

Journal of Thoracic Oncology

Volumn 7, Issue 1, 2012, Pages 233-242

  Gridelli, Cesare ^a   Gallo, Ciro ^b   Morabito, Alessandro ^c   Iaffaioli, Rosario Vincenzo ^d   Favaretto, Adolfo ^e   Isa, Luciano ^f   Barbera, Santi ^g   Gamucci, Teresa ^h   Ceribelli, Anna ⁱ   Filipazzi, Virginio ^j   Maione, Paolo ^a   Rossi, Antonio ^a   Barletta, Emiddio ^d   Signoriello, Simona ^b   De Maio, Ermelinda ^c   Piccirillo, Maria Carmela ^c   Di Maio, Massimo ^c   Rocco, Gaetano ^c   Vecchione, Aldo ^c   Perrone, Francesco ^c  

^a S G MOSCATI HOSPITAL   (Italy)

^b SECOND UNIVERSITY OF NAPLES   (Italy)

^c NATIONAL CANCER INSTITUTE   (Italy)

^d National Cancer Institute   (Italy)

^e VENETO INSTITUTE OF ONCOLOGY IOV IRCCS   (Italy)

^f Serbelloni Hospital   (Italy)

^g Mariano Santo Hospital   (Italy)

^h Umberto I Hospital   (Italy)

ⁱ REGINA ELENA NATIONAL CANCER INSTITUTE   (Italy)

^j UNIVERSITY OF MILAN   (Italy)

more..

Author keywords

Elderly; Etoposide; Gemcitabine; Platinum compounds; SCLC; Vinorelbine

Indexed keywords

CARBOPLATIN; CISPLATIN; ETOPOSIDE; GEMCITABINE; NAVELBINE;

AGED; ANEMIA; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; BRAIN METASTASIS; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CANCER SURVIVAL; COMORBIDITY; COMPUTER ASSISTED TOMOGRAPHY; CONSTIPATION; DIARRHEA; DRUG FATALITY; DRUG HYPERSENSITIVITY; DRUG MEGADOSE; DRUG SAFETY; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; GENDER; GERIATRIC PATIENT; HAIR LOSS; HUMAN; INFECTION; LUNG SMALL CELL CANCER; MALE; MOTOR NEUROPATHY; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; OPTIMAL DRUG DOSE; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGNOSIS; PROGRESSION FREE SURVIVAL; SENSORY NEUROPATHY; SIDE EFFECT; STOMATITIS; SURVIVAL TIME; THORAX RADIOGRAPHY; THROMBOCYTOPENIA; TREATMENT OUTCOME; TREATMENT RESPONSE; VOMITING; WEIGHT REDUCTION;

EID: 84655170229     PISSN: 15560864     EISSN: 15561380     Source Type: Journal    
DOI: 10.1097/JTO.0b013e318233d6c2     Document Type: Article

References (43)

1. American Cancer Society. Cancer Facts & Figures 2010. Atlanta, GA: American Cancer Society, 2010.
2. Chute JP, Chen T, Feigal E, et al. Twenty years of phase III trials for patients with estensive-stage small-cell lung cancer. Perceptible progress. J Clin Oncol 1999;17:1794-1801. (Pubitemid 29269249)
3. Stephens RJ, Johnson DH. Treatment and outcomes for elderly patients with small cell lung cancer. Drugs Aging 2000;17:229-247.
4. Hutchins LF, Unger JM, Crowley JJ, et al. Underrepresentation of patients 65 years of age or older in cancer-treatment trials. N Engl J Med 1999;341:2061-2067. (Pubitemid 30035956)
5. Lewis JH, Kilgore ML, Goldman DP, et al. Participation of patients 65 years of age or older in cancer clinical trials. J Clin Oncol 2003;21: 1383-1389. (Pubitemid 46606420)
6. Talarico L, Chen G, Pazdur R. Enrollment of elderly patients in clinical trials for cancer drug registration: A 7-year experience by the US Food and Drug Administration. J Clin Oncol 2004;22:4626-4631. (Pubitemid 41185131)
7. Poplin E, Thompson B, Whitacre M, et al. Small cell carcinoma of the lung: influence of age on treatment outcome. Cancer Treat Rep 1987; 71:291-296. (Pubitemid 17051731)
8. Ludbrook JJ, Truong PT, MacNeil MV, et al. Do age and comorbidity impact treatment allocation and outcomes in limited stage small-cell lung cancer? A community-based population analysis. Int J Radiat Oncol Biol Phys 2003;55:1321-1330. (Pubitemid 36338300)
9. Safont MJ, Artal-Cortes A, Sirera R, et al. Retrospective study of efficacy and toxicity on patients older than 70 years within a randomized clinical trial of two cisplatin-based combinations in patients with smallcell lung cancer. Lung Cancer 2009;63:83-87.
10. Findlay MP, Griffin AM, Raghavan D, et al. Retrospective review of chemotherapy for small cell lung cancer in the elderly: does the end justify the means? Eur J Cancer 1991;27:1597-1601.
11. Radford JA, Ryder WD, Dodwell D, et al. Predicting septic complications of chemotherapy: An analysis of 382 patients treated for small cell lung cancer without dose reduction after major sepsis. Eur J Cancer 1992;29A:81-86.
12. Rossi A, Maione P, Colantuoni G, et al. Treatment of small cell lung cancer in the elderly. Oncologist 2005;10:399-411. (Pubitemid 40993568)
13. Cormier Y, Eisenhauer E, Muldal A, et al. Gemcitabine is an active new agent in previously untreated extensive small cell lung cancer. A study of the NCIC-CTG. Ann Oncol 1994;5:283-285. (Pubitemid 24097526)
14. Van der Lee I, Smit EF, van Putten JW, et al. Single-agent gemcitabine in patients with resistant small cell lung cancer: A phase II study. Ann Oncol 2001;12:557-561. (Pubitemid 32472114)
15. Vansteenkiste J, Gatzemeier U, Manegold C, et al. Gemcitabine plus etoposide in chemonaive extensive disease small-cell lung cancer: A multi-centre phase II study. Ann Oncol 2001;12:835-840. (Pubitemid 32655095)
16. De Marinis F, Migliorino MR, Paoluzzi L, et al. Phase I/II trial of gemcitabine plus cisplatin and etoposide in patients with small-cell lung cancer. Lung Cancer 2003;39:331-338. (Pubitemid 36279452)
17. Earle CC, Stewart DJ, Cormier Y, et al. A phase I study of gemcitabine/ cisplatin/etoposide in the treatment of small-cell lung cancer. Lung Cancer 1998;22:235-241. (Pubitemid 29067397)
18. Depierre A, Le Chavalier T, Quoix E, et al. Phase II study of Navelbine in small cell lung cancer. Proc Am Soc Clin Oncol 1995:14 (abstract 1050).
19. Gridelli C, Perrone F, Ianniello GP, et al. Carboplatin plus vinorelbine, a new well tolerated and active regimen for the treatment of extensivestage small cell lung cancer: A phase II study. J Clin Oncol 1998;16: 1414-1419. (Pubitemid 28175759)
20. Calvert AH, Newell DR, Gumbrell LA, et al. Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol 1989;7:1748-1756. (Pubitemid 19272848)
21. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000;92:205-216. (Pubitemid 30099779)
22. Charlson ME, Pompei P, Ales KL, et al. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis 1987;40:373-383. (Pubitemid 17055592)
23. Katz S. Assessing self maintenance: Activities of daily living, mobility and instrumental activities of daily living. J Am Geriatr Soc 1983;31: 721-727. (Pubitemid 14209563)
24. Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist 1969;9:179-186.
25. Maione P, Perrone F, Gallo C, et al. Pre-treatment quality of life and functional status assessment significantly predict survival of elderly patients with advanced non-small cell lung cancer receiving chemotherapy. A prognostic analysis of the MILES study. J Clin Oncol 2005;23: 6865-6872.
26. Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: A quality of life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993;85:365-376. (Pubitemid 23073154)
27. Bergman B, Aaronson NK, Ahmedzai S, et al. The EORTC QLQ-LC13: A modular supplement to the EORTC core quality of life questionnaire (QLQ-C30) for use in lung cancer clinical trials. Eur J Cancer 1994; 30A:635-642. (Pubitemid 24164250)
28. Gridelli C, Cigolari S, Gallo C, et al. Activity and toxicity of gemcitabine and gemcitabine vinorelbine in advanced non-small-cell lung cancer elderly patients. Phase II data from the Multicenter Italian Lung Cancer in the Elderly Study (MILES) randomized trial. Lung Cancer 2001;31:277-284. (Pubitemid 32107024)
29. Chen TT, Tie-Hua NG. Optimal flexible designs in phase II clinical trials. Stat Med 1998;17:2301-2312. (Pubitemid 28482675)
30. Thall P, Russell KE. A strategy for dose-finding and safety monitoring based on efficacy and adverse outcomes in phase I/II clinical trials. Biometrics 1998;54:251-264. (Pubitemid 28158800)
31. Thall PF, Lee JJ, Tseng C, et al. Accrual strategies for phase I trials with delayed patient outcome. Stat Med 1999;18:1155-1169. (Pubitemid 29229707)
32. Owonikoko TK, Ragin CC, Belani CP, et al. Lung cancer in elderly patients: An analysis of the surveillance, epidemiology, and end results database. J Clin Oncol 2007;25:5570-5577.
33. Camps C, Artal A, Gomez-Codina J, et al. Age as a prognostic factor in small cell lung cancer (SCLC): Randomized trial of high-dose epirubicincisplatin (HDEP) versus etoposide-cisplatin in SCLC. A retrospective analysis. Proc Am Soc Clin Oncol 2001;20:280b (abstract 2871).
34. Ardizzoni A, Favaretto A, Boni L, et al. Platinum-etoposide chemotherapy in elderly patients with small-cell lung cancer: Results of a randomized multicenter phase II study assessing attenuated-dose or full-dose with lenograstim prophylaxis: A Forza Operativa Nazionale Italiana Carcinoma Polmonare and Gruppo Studio Tumori Polmonari Veneto (FONICAP-GSTPV) study. J Clin Oncol 2005;23:569-575. (Pubitemid 46224234)
35. Souhami RL, Spiro SG, Rudd RM, et al. Five-day oral etoposide treatment for advanced small-cell lung cancer: Randomized comparison with intravenous chemotherapy. J Natl Cancer Inst 1997;89:577-580. (Pubitemid 27172948)
36. Girling DJ. Comparison of oral etoposide and standard intravenous multidrug chemotherapy for small-cell lung cancer: A stopped multicentre randomised trial. Medical Research Council Lung Cancer Working Party. Lancet 1996;348:563-566. (Pubitemid 26283886)
37. Quoix E, Breton JL, Daniel C, et al. Etoposide phosphate with carboplatin in the treatment of elderly patients with small-cell lung cancer: A phase II study. Ann Oncol 2001;12:957-962. (Pubitemid 32725769)
38. Larive S, Bombaron P, Riou R, et al. Carboplatin-etoposide combination in small cell lung cancer patients older than 70 years. A phase II rial. Lung Cancer 2002;35:1-7. (Pubitemid 34028083)
39. Okamoto H, Watanabe K, Kunikane H, et al. Randomised phase III trial of carboplatin plus etoposide vs split doses of cisplatin plus etoposide in elderly or poor-risk patients with extensive disease small-cell lung cancer: JCOG 9702. Br J Cancer 2007;97:162-169. (Pubitemid 47057464)
40. Pallis GA, Shepherd FA, Lacombe D, et al. Treatment of small cell lung cancer in elderly patients. Cancer 2010;116:1192-1200.
41. Hainsworth JD, Carrell D, Drengler RL, et al. Weekly combination chemotherapy with docetaxel and gemcitabine as first-line treatment for elderly patients and patients with poor performance status who have extensive-stage small cell lung carcinoma: A Minnie Pearl Cancer Research Network phase II trial. Cancer 2004;100:2437-2441. (Pubitemid 38657893)
42. Bonn O, Schmidt-Wolf G, Risse F, et al. Vindesine and etoposide: A practical and well-tolerated therapy for elderly patients or patients in reduced clinical condition with extensive-stage small-cell lung cancer (SCLC). Med Sci Monit 2005;11: PI19 -PI21.
43. Lee SM, James LE, Qian W, et al. Comparison of gemcitabine and carboplatin versus cisplatin and etoposide for patients with poor-prognosis small cell lung cancer. Thorax 2009;64:75-80