Survival without toxicity for cisplatin plus pemetrexed versus cisplatin plus gemcitabine in chemonaïve patients with advanced non-small cell lung cancer: A risk-benefit analysis of a large phase III study

European Journal of Cancer

Volumn 45, Issue 13, 2009, Pages 2298-2303

  Scagliotti, Giorgio V ^a   Park, Keunchil ^b   Patil, Shekar ^c   Rolski, Janusz ^d   Goksel, Tuncay ^e   Martins, Renato ^f   Gans, Steven J M ^g   Visseren Grul, Carla ^h   Peterson, Patrick ⁱ  

^a UNIVERSITY OF TURIN   (Italy)

^b Sungkyunkwan University School of Medicine   (South Korea)

^c Bangalore Institute of Oncology   (India)

^d INSTITUTE OF ONCOLOGY   (Poland)

^e EGE UNIVERSITY   (Turkey)

^f UNIVERSITY OF WASHINGTON   (United States)

^g ST JANSDAL HOSPITAL   (Netherlands)

^h Eli Lilly Netherlands   (Netherlands)

ⁱ ELI LILLY AND COMPANY   (United States)

Author keywords

Cisplatin; Gemcitabine; Histology; NSCLC; Pemetrexed; Survival; Toxicity

Indexed keywords

CISPLATIN; GEMCITABINE; PEMETREXED;

ADULT; ADVANCED CANCER; AGED; ARTICLE; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; HISTOPATHOLOGY; HUMAN; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK BENEFIT ANALYSIS; SQUAMOUS CELL CARCINOMA; UNSPECIFIED SIDE EFFECT;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, NON-SMALL-CELL LUNG; CISPLATIN; DEOXYCYTIDINE; FEMALE; GLUTAMATES; GUANINE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; PRACTICE GUIDELINES AS TOPIC; PROGNOSIS; RISK ASSESSMENT; SURVIVAL ANALYSIS;

EID: 68749101759     PISSN: 09598049     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejca.2009.04.033     Document Type: Article

References (24)

1. Martins R., Kelly K., Socinski M.A., et al. Management of metastatic non-small cell lung cancer in 2006: innovations and unique clinical scenarios. In: Govindan R., Perry M.C., and Slowinski F.H. (Eds). American Society of Clinical Oncology 2006 Educational Book (2006), American Society of Clinical Oncology, Alexandria, VA 418-423
2. NCCN clinical practice guidelines in oncology: non-small cell lung cancer. National Comprehensive Cancer Network. ; 2009 [accessed 31.03.09].
3. D'Addario G., and Felip E. ESMO Guidelines Working Group. Non-small-cell lung cancer: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol 19 Suppl. 2 (2008) ii39-ii40
4. Manegold C., Gatzemeier U., von Pawel J., et al. Front-line treatment of advanced non-small-cell lung cancer with MTA (LY231514, pemetrexed disodium, ALIMTA) and cisplatin: a multicenter phase II trial. Ann Oncol 11 (2000) 435-440
5. Shepherd F.A., Dancey J., Arnold A., et al. Phase II study of pemetrexed disodium, a multitargeted antifolate, and cisplatin as first-line therapy in patients with advanced nonsmall cell lung carcinoma: a study of the National Cancer Institute of Canada Clinical Trials Group. Cancer 92 (2001) 595-600
6. Scagliotti G.V., Kortsik C., Dark G.G., 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 11 2 Pt. 1 (2005) 690-696
7. Zinner R.G., Fossella F.V., Gladish G.W., et al. Phase II study of pemetrexed in combination with carboplatin in the first-line treatment of advanced nonsmall cell lung cancer. Cancer 104 (2005) 2449-2456
8. Scagliotti G.V., De Marinis F., Rinaldi M., et al. Italian Lung Cancer Project. Phase III randomized trial comparing three platinum-based doublets in advanced non-small-cell lung cancer. J Clin Oncol 20 (2002) 4285-4291
9. 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 47 (2005) 69-80
10. Fossella F., Pereira J.R., von Pawel J., et al. Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: the TAX 326 study group. J Clin Oncol 21 (2003) 3016-3024
11. Kelly K., Crowley J., Bunn Jr. P.A., 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: a Southwest Oncology Group trial. J Clin Oncol 19 (2001) 3210-3218
12. Schiller J.H., Harrington D., Belani C.P., et al. Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 346 (2002) 92-98
13. Ohe Y., Ohashi Y., Kubota K., et al. Randomized phase III study of cisplatin plus irinotecan versus carboplatin plus paclitaxel, cisplatin plus gemcitabine, and cisplatin plus vinorelbine for advanced non-small-cell lung cancer: four-arm cooperative study in Japan. Ann Oncol 18 (2007) 317-323
14. Vogelzang N.J., Rusthoven J.J., Symanowski J., et al. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol 21 (2003) 2636-2644
15. Hanna N., Shepherd F.A., Fossella F.V., 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 22 (2004) 1589-1597
16. Scagliotti G.V., 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 26 (2008) 3543-3551
17. 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 14 (2009) 253-263
18. Pujol J.L., 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 2 (2007) 397-401
19. Therasse P., Arbuck S.G., Eisenhauer E.A., 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 92 (2000) 205-216
20. [NCI] National Cancer Institute. Common toxicity criteria (CTC). Version 2.0. ; 1998 [accessed 31.03.09].
21. ICH Efficacy Guidelines. E6(R1): good clinical practice. Consolidated guideline. ; 2009 [accessed 31.03.09].
22. Kaplan E.L., and Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 53 (1958) 457-481
23. Cox D.R. Regression models and life-tables (with discussion). J Roy Stat Soc Ser B 34 (1972) 187-220
24. Pimentel F.L., von Powel J., Martins R.G., et al. Resource utilization by non-small cell lung cancer histology: results from the randomized, phase III trial of pemetrexed/cisplatin versus gemcitabine/cisplatin. J Clin Oncol 16 (2008) 15S [suppl; abstr 8097]