Randomized, multicenter, open-label phase II study of gemcitabine plus single-dose versus split-dose carboplatin in the treatment of patients with advanced-stage non-small-cell lung cancer

Clinical Lung Cancer

Volumn 8, Issue 2, 2006, Pages 135-139

  Schuette, Wolfgang ^a   Blankenburg, Thomas ^a   Schneider, Claus Peter ^b   von Weikersthal, Ludwig Fischer ^c   Guetz, Sylvia ^d   Laier Groeneveld, Gerhard ^e   Virchow, Johann Christian ^f   Chemaissani, Assnad ^g   Reck, Martin ^h  

^a D 06120 Halle Germany   (Germany)

^b Central Clinic Bad Berka   (Germany)

^c KLINIKUM ST MARIEN   (Germany)

^d Robert Koch Klinik   (Germany)

^e HELIOS KLINIKUM ERFURT   (Germany)

^f UNIVERSITY OF ROSTOCK   (Germany)

^g UNIVERSITY HOSPITAL OF COLOGNE   (Germany)

^h KRANKENHAUS GROSSHANSDORF   (Germany)

Author keywords

Chemotherapy; Thrombocytopenia; Toxicity

Indexed keywords

ANTIANEMIC AGENT; CARBOPLATIN; GEMCITABINE;

ADULT; ADVANCED CANCER; AGED; ANEMIA; AREA UNDER THE CURVE; ARTICLE; BLOOD TOXICITY; CANCER COMBINATION CHEMOTHERAPY; CANCER STAGING; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG EFFICACY; FEBRILE NEUTROPENIA; FEMALE; FUNCTIONAL ASSESSMENT; GERMANY; GRANULOCYTOPENIA; HUMAN; INCIDENCE; LEUKOPENIA; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MUSCULOSKELETAL PAIN; NEUROTOXICITY; NEUTROPENIA; OPEN STUDY; OTOTOXICITY; OVERALL SURVIVAL; PAIN; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; STATISTICAL SIGNIFICANCE; SURVIVAL TIME; TREATMENT RESPONSE;

EID: 33750191796     PISSN: 15257304     EISSN: None     Source Type: Journal    
DOI: 10.3816/CLC.2006.n.042     Document Type: Article

References (24)

1. Lilenbaum RC, Langenberg P, Dickersin K. Single agent versus combination chemotherapy in patients with advanced nonsmall cell lung carcinoma: a meta-analysis of response, toxicity, and survival. Cancer 1998; 82:116-126.
2. Sörenson S, Glimelius B, Nygren P, et al. A systematic overview of chemotherapy effects in non-small cell lung cancer. Swedish Council of Technology Assessment in Health Care. Acta Oncol 2001; 40:327-339.
3. Hotta K, Matsuo K, Ueoka H, et al. Addition of platinum compounds to a new agent in patients with advanced non-small-cell lung cancer: a literature based meta-analysis of randomised trials. Ann Oncol 2004; 15:1782-1789.
4. D'Addario G, Pintilie M, Leighl NB, et al. Platinum-based versus non-platinum-based chemotherapy in advanced non-small-cell lung cancer: a meta-analysis of the published literature. J Clin Oncol 2005; 23:2926-2936.
5. Pfister DG, Johnson DH, Azzoli CG, et al. American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003. J Clin Oncol 2004; 22:330-353.
6. ESMO minimum clinical recommendations for diagnosis, treatment and follow-up of non-small-cell lung cancer (NSCLC). Ann Oncol 2001; 12:1049-1050.
7. Ettinger DS. Is there a Preferred combination chemotherapy regimen for metastastic non-small cell lung cancer? Oncologist 2002; 7:226-233.
8. Le Chevalier T, Scagliotti G, Natale R, et al. Efficacy of gemcitabine plus platinum chemotherapy compared with other platinum containing regimens in advanced non-small-cell lung cancer: a meta-analysis of survival outcomes. Lung Cancer 2005; 47:69-80.
9. van Moorsel CJ, Pinedo HM, Veerman G, et al. Mechanisms of synergism between cisplatin and gemcitabine in ovarian and non-small-cell lung cancer cell lines. Br J Cancer 1999; 80:981-990.
10. Danson S, Middleton MR, O'Byrne KJ, et al. Phase III trial of gemcitabine and carboplatin versus mitomycin, ifosfamide, and cisplatin or mitomycin, vinblastine, and cisplatin in patients with advanced nonsmall cell lung carcinoma. Cancer 2003; 98:542-553.
11. Grigorescu AC, Draghici IN, Nitipir C, et al. Gemcitabine (GEM) and carboplatin (CBDCA) versus cisplatin (CDDP) and vinblastine (VLB) in advanced non-small-cell lung cancer (NSCLC) stages III and IV: a phase III randomised trial. Lung Cancer 2002; 37:9-14.
12. Rudd RM, Gower NH, Spiro SG, et al. Gemcitabine plus carboplatin versus mitomycin, ifosfamide, and cisplatin in patients with stage IIIB or IV non-small-cell lung cancer: a phase III randomized study of the London Lung Cancer Group. J Clin Oncol 2005; 23:142-153.
13. Sederholm C, Hillerdal G, Lamberg K, et al. Phase III trial of gemcitabine plus carboplatin versus single-agent gemcitabine in the treatment of locally advanced or metastatic non-small-cell lung cancer: the Swedish Lung Cancer Study Group. J Clin Oncol 2005; 23:8380-8388.
14. Treat J, Belani CP, Edelman M, et al. A randomized phase III trial of gemcitabine (G) in combination with carboplatin (C) or paclitaxel (P) versus paclitaxel plus carboplatin in advanced (stage IIIB, IV) non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol 2003; 22:624 (Abstract #2511).
15. Zatloukal P, Petruzelka L, Zemanova M, et al. Gemcitabine plus cisplatin vs. gemcitabine plus carboplatin in stage IIIb and IV non-small cell lung cancer: a phase III randomized trial. Lung Cancer 2003; 41:321-331.
16. Mazzanti P, Massacesi C, Rocchi MB, et al. Randomized, multicenter, phase II study of gemcitabine plus cisplatin versus gemcitabine plus carboplatin in patients with advanced non-small cell lung cancer. Lung Cancer 2003; 41:81-89.
17. Carrato A, Garcia-Gomez J, Alberola V, et al. Carboplatin (CARBO) in combination with gemcitabine (GEM) in advanced non-small cell lung cancer (NSCLC). Comparison of two consecutive phase II trials using different schedules. Proc Am Soc Clin Oncol 1999; 18:498a (Abstract #1922).
18. Ng EW, Sandler AB, Robinson L, et al. A phase II study of carboplatin plus gemcitabine in advanced non-small-cell lung cancer (NSCLC): a Hoosier oncology group study. Am J Clin Oncol 1999; 22:550-553.
19. Calvert AH, Newell DR, Gumbrell LA, et al. Carboplatin dosage: pospective evaluation of a simple formula based on renal function. J Clin Oncol 1989; 7:1748-1756.
20. Sculier JP, Paesmans M, Thiriaux J, et al. A comparison of methods of calculation for estimating carboplatin AUC with a retrospective pharmacokinetic-pharmacodynamic analysis in patients with advanced non-small cell lung cancer. Eur J Cancer 1999; 35:1314-1319.
21. Jodrell DI, Egorin MJ, Canetta RM, et al. Relationships between carboplatin exposure and tumor response and toxicity in patients with ovarian cancer. J Clin Oncol 1992; 10:520-528.
22. van der Vijgh WJ. Clinical pharmacokinetics of carboplatin. Clin Pharmacokinet 1991; 21:242-261.
23. Yanagihara RH, Beck M, McLarty J. Low dose gemcitabine (G) and carboplatin (C) in advanced non small cell lung cancer (NSCLC): an update. Proc Am Soc Clin Oncol 2001; 20:278b (Abstract #2864).
24. Blackhall FH, Shepherd FA, Albain KS. Improving survival and reducing toxicity with chemotherapy in advanced non-small cell lung cancer: a realistic goal? Treat Respir Med 2005; 4:71-84.