A randomized phase 3 trial comparing pemetrexed/carboplatin and docetaxel/carboplatin as first-line treatment for advanced, nonsquamous non-small cell lung cancer

Journal of Thoracic Oncology

Volumn 6, Issue 11, 2011, Pages 1907-1914

  Rodrigues Pereira, José ^a   Kim, Joo Hang ^b   Magallanes, Manuel ^c   Lee, Dae Ho ^d   Wang, Jie ^e   Ganju, Vinod ^f   Martínez Barrera, Luis ^g   Barraclough, Helen ^h   Van Kooten, Maximiliano ^h   Orlando, Mauro ⁱ  

^a Instituto do Cancer Dr Arnaldo   (Brazil)

^b Yonsei University College of Medicine   (South Korea)

^c Department of Medical Oncology   (Mexico)

^d University of Ulsan College of Medicine   (South Korea)

^e PEKING UNIVERSITY CANCER HOSPITAL AND INSTITUTE   (China)

^f Frankston Private   (Australia)

^g INSTITUTO NACIONAL DE ENFERMEDADES RESPIRATORIAS   (Mexico)

^h ELI LILLY AUSTRALIA PTY LTD   (Australia)

ⁱ Edificio Panamericana Plaza   (Argentina)

Author keywords

Carboplatin; Docetaxel; First line therapy; Non small cell lung carcinoma; Nonsquamous; Pemetrexed

Indexed keywords

CARBOPLATIN; CISPLATIN; DOCETAXEL; GEMCITABINE; PEMETREXED;

ABDOMINAL PAIN; ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANAPHYLACTIC SHOCK; ANEMIA; ARTICLE; ASTHENIA; BLOOD TOXICITY; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CONSTIPATION; DECREASED APPETITE; DEVICE INFECTION; DIARRHEA; DRUG EFFECT; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSGEUSIA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; GLOMERULUS FILTRATION RATE; HUMAN; LEUKOPENIA; LUNG INFECTION; LUNG NON SMALL CELL CANCER; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROTOXICITY; NEUTROPENIA; OPEN STUDY; OVERALL SURVIVAL; PARALLEL DESIGN; PERIPHERAL NEUROPATHY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; RISK BENEFIT ANALYSIS; SENSORY NEUROPATHY; SIDE EFFECT; STOMATITIS; SURVIVAL TIME; THROMBOCYTOPENIA; TREATMENT OUTCOME; VOMITING;

ADENOCARCINOMA; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARBOPLATIN; CARCINOMA, LARGE CELL; CARCINOMA, NON-SMALL-CELL LUNG; FEMALE; FOLLOW-UP STUDIES; GLUTAMATES; GUANINE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM STAGING; PROGNOSIS; SURVIVAL RATE; TAXOIDS;

EID: 80054911223     PISSN: 15560864     EISSN: 15561380     Source Type: Journal    
DOI: 10.1097/JTO.0b013e318226b5fa     Document Type: Article

References (34)

1. Azzoli CG, Baker S Jr, Temin S, et al. American Society of Clinical Oncology Clinical Practice Guideline update on chemotherapy for stage IV non-small-cell lung cancer. J Clin Oncol 2009;27:6251-6266.
2. Crino L, Weder W, van Meerbeeck J, et al. Early stage and locally advanced (non-metastatic) non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2010;21(Suppl 5):v103-v115.
3. D'Addario G, Fruh M, Reck M, et al. Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2010;21(Suppl 5):v116-v119.
4. Socinski MA, Crowell R, Hensing TE, et al. Treatment of non-small cell lung cancer, stage IV: ACCP evidence-based clinical practice guidelines (2nd edition). Chest 2007;132:277S-289S. (Pubitemid 47502813)
5. Jett JR, Schild SE, Keith RL, et al. Treatment of non-small cell lung cancer, stage IIIB: ACCP evidence-based clinical practice guidelines (2nd edition). Chest 2007;132:266S-276S. (Pubitemid 47502812)
6. Ardizzoni A, Boni L, Tiseo M, et al. Cisplatin- versus carboplatin-based chemotherapy in first-line treatment of advanced non-small-cell lung cancer: an individual patient data meta-analysis. J Natl Cancer Inst 2007;99:847-857.
7. Jiang J, Liang X, Zhou X, et al. A meta-analysis of randomized controlled trials comparing carboplatin-based to cisplatin-based chemotherapy in advanced non-small cell lung cancer. Lung Cancer 2007;57: 348-358. (Pubitemid 47285418)
8. Cohen MH, Johnson JR, Wang YC, et al. FDA drug approval summary: pemetrexed for injection (Alimta) for the treatment of non-small cell lung cancer. Oncologist 2005;10:363-368. (Pubitemid 40993563)
9. Scagliotti G, Hanna N, Fossella F, et al. The differential efficacy of pemetrexed according to NSCLC histology: a review of two Phase III studies. Oncologist 2009;14:253-263.
10. Hanna N, Shepherd FA, Fossella FV, et al. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 2004;22:1589-1597. (Pubitemid 41079796)
11. Pujol JL, Paul S, Chouaki N, et al. Survival without common toxicity criteria grade 3/4 toxicity for pemetrexed compared with docetaxel in previously treated patients with advanced non-small cell lung cancer (NSCLC): a risk-benefit analysis. J Thorac Oncol 2007;2:397-401. (Pubitemid 47181693)
12. Fossella F, Pereira JR, von Pawel J, et al. Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinore-lbine plus cisplatin for advanced non-small-cell lung cancer: the TAX 326 study group. J Clin Oncol 2003;21:3016-3024. (Pubitemid 46606280)
13. Jiang L, Wang DY, Zhu ZH, et al. Phase II study of carboplatin combined with weekly docetaxel in patients with advanced non-small cell lung cancer. Cancer Chemother Pharmacol 2010;66:449-453.
14. Kataoka K, Suzuki R, Taniguchi H, et al. Phase I/II trial of docetaxel and carboplatin as a first-line therapy in patients with stage IV non-small-cell lung cancer. Lung 2006;184:133-139. (Pubitemid 44222460)
15. Kim HJ, Kim TG, Lee HJ, et al. A phase II study of combination chemotherapy with docetaxel and carboplatin for elderly patients with advanced non-small cell lung cancer. Lung Cancer 2010;68:248-252.
16. Millward MJ, Boyer MJ, Lehnert M, et al. Docetaxel and carboplatin is an active regimen in advanced non-small-cell lung cancer: a phase II study in Caucasian and Asian patients. Ann Oncol 2003;14:449-454. (Pubitemid 36367424)
17. Ramalingam S, Dobbs TW, Einzig AI, et al. Carboplatin and docetaxel in advanced non-small-cell lung cancer: results of a multicenter phase II study. Cancer Chemother Pharmacol 2004;53:439-444. (Pubitemid 38553667)
18. Thongprasert S, Soorraritchingchai S, Chewaskulyong B, et al. A phase II study of docetaxel and carboplatin in Thai patients with advanced non-small-cell lung cancer. J Med Assoc Thai 2006;89:152-159. (Pubitemid 44743404)
19. Tsavaris N, Kosmas C, Skopelitis E, et al. A phase II study of the docetaxel-carboplatin chemotherapy regimen in advanced non-small-cell lung cancer. Lung 2005;183:405-416. (Pubitemid 43213983)
20. Yoshimura N, Kudoh S, Kimura T, et al. Phase II study of docetaxel and carboplatin in elderly patients with advanced non-small cell lung cancer. J Thorac Oncol 2009;4:371-375.
21. Grønberg BH, Bremnes RM, Fløtten O, et al. Phase III study by the Norwegian lung cancer study group: pemetrexed plus carboplatin compared with gemcitabine plus carboplatin as first-line chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol 2009;27:3217-3224.
22. Obasaju CK, Raju R, Stinchcombe T, et al. Final results of a randomized phase II trial of pemetrexed (P) + carboplatin (Cb) ± enzastaurin (E) versus docetaxel (D) + Cb as first-line treatment of patients (pts) with stage IIIB/IV non-small cell lung cancer (NSCLC). J Clin Oncol 2009;27:ASCO Meeting Abstract 8037.
23. Scagliotti GV, Kortsik C, Dark GG, et al. Pemetrexed combined with oxaliplatin or carboplatin as first-line treatment in advanced non-small cell lung cancer: a multicenter, randomized, phase II trial. Clin Cancer Res 2005;11:690-696. (Pubitemid 40116896)
24. Zinner RG, Fossella FV, Gladish GW, et al. Phase II study of pemetrexed in combination with carboplatin in the first-line treatment of advanced nonsmall cell lung cancer. Cancer 2005;104:2449-2456. (Pubitemid 41691567)
25. Zinner RG, Saxman SB, Peng G, et al. Treatment rationale and study design for a randomized trial of pemetrexed/carboplatin followed by maintenance pemetrexed versus paclitaxel/carboplatin/bevacizumab followed by maintenance bevacizumab in patients with advanced non-small-cell lung cancer of nonsquamous histology. Clin Lung Cancer 2010;11:352-357.
26. Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982;5: 649-655. (Pubitemid 13149996)
27. Fleming I, Cooper J, Henson D, et al. eds. AJCC Cancer Staging Manual, 5th ed. Philadelphia, PA: Lippincott-Raven Publishers, 1997.
28. Mountain CF. Revisions in the International System for Staging Lung Cancer. Chest 1997;111:1710-1717. (Pubitemid 27260107)
29. Ciuleanu T, Brodowicz T, Zielinski C, et al. Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study. Lancet 2009;374:1432-1440.
30. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000;92:205-216.
31. Cancer Therapy Evaluation Program. Common Terminology Criteria for Adverse Events, Version 3.0. [National Cancer Institute, US National Institutes of Health Web Site]. August 9;2006. Available at: http://ctep.info. nih.gov/protocolDevelopment/electronic-applications/ctc.htm. Accessed September 7, 2010.
32. Scagliotti GV, Park K, Patil S, et al. Survival without toxicity for cisplatin plus pemetrexed versus cisplatin plus gemcitabine in chemona-ive patients with advanced non-small cell lung cancer: a risk-benefit analysis of a large phase III study. Eur J Cancer 2009;45:2298-2303.
33. Scagliotti GV, Parikh P, von Pawel J, et al. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol 2008;26:3543-3551.
34. Center for Drug Evaluation and Research. Communication: Carboplatin dosing. [U.S. Food and Drug Administration Website]. 10 August, 2010. Available at: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm228974.htm. Accessed December 13, 2010.