A multicenter international randomized phase III study comparing cisplatin in combination with irinotecan or etoposide in previously untreated small-cell lung cancer patients with extensive disease

Annals of Oncology

Volumn 21, Issue 9, 2010, Pages 1810-1816

  Zatloukal, P ^a   Cardenal, F ^b   Szczesna, A ^c   Gorbunova, V ^d   Moiseyenko, V ^e   Zhang, X ^f   Cisar, L ^f   Soria, J C ^g   Domine, M ^h   Thomas, M ⁱ  

^a UNIVERSITY HOSPITAL BULOVKA   (Czech Republic)

^b CATALAN INSTITUTE OF ONCOLOGY   (Spain)

^c Regional Lung Diseases Hospital   (Poland)

^d N N BLOKHIN RUSSIAN CANCER RESEARCH CENTER   (Russian Federation)

^e N N PETROV RESEARCH INSTITUTE OF ONCOLOGY   (Russian Federation)

^f PFIZER INC   (United States)

^g INSTITUT GUSTAVE ROUSSY   (France)

^h HOSPITAL UNIVERSITARIO FUNDACIÓN JIMÉNEZ DÍAZ   (Spain)

ⁱ UNIVERSITY OF HEIDELBERG   (Germany)

Author keywords

Cisplatin; Etoposide; Irinotecan; Small cell lung cancer with extensive disease

Indexed keywords

CISPLATIN; ETOPOSIDE; IRINOTECAN;

ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTICLE; CANCER GROWTH; CANCER PATIENT; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED STUDY; DATA ANALYSIS; DIARRHEA; DRUG RESPONSE; FATIGUE; FEMALE; HAZARD RATIO; HUMAN; LEUKOPENIA; LUNG SMALL CELL CANCER; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OPEN STUDY; OVERALL SURVIVAL; PARALLEL DESIGN; PARESTHESIA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STOMATITIS; SURVIVAL RATE; THROMBOCYTOPENIA; VOMITING; WEIGHT REDUCTION;

ADOLESCENT; ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; CISPLATIN; ETOPOSIDE; FEMALE; HUMANS; INTERNATIONAL AGENCIES; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; NEOPLASM STAGING; PROGNOSIS; SMALL CELL LUNG CARCINOMA; SURVIVAL RATE; YOUNG ADULT;

EID: 77953239393     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdq036     Document Type: Article

References (28)

1. Garcia M, Jemal A, Ward E et al. Global Cancer Facts and Figures 2007. Atlanta, GA: American Cancer Society 2007.
2. Sher T, Dy GK, Adjei AA. Small cell lung cancer. Mayo Clin Proc 2008; 83: 355-367.
3. Saijo N. Progress in treatment of small-cell lung cancer: role of CPT-11. Br J Cancer 2003; 89: 2178-2183.
4. Hanna N. Optimal treatment of extensive-stage small cell lung cancer In 42nd Annual Meeting of the American Society of Clinical Oncology, 2-6 June 2006, Atlanta, GA.
5. Fukuda M, Nishio K, Kanzawa F et al. Synergism between cisplatin and topoisomerase I inhibitors, NB-506 and SN-38, in human small cell lung cancer cells. Cancer Res 1996; 56: 789-793.
6. Masuda N, Kudoh S, Fukuoka M. Irinotecan (CPT-11): pharmacology and clinical applications. Crit Rev Oncol Hematol 1996; 24: 3-26.
7. Noda K, Nishiwaki Y, Kawahara M et al. Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive small-cell lung cancer. N Engl J Med 2002; 346: 85-91.
8. Hanna N, Bunn PA Jr., Langer C et al. Randomized phase III trial comparing irinotecan/cisplatin with etoposide/cisplatin in patients with previously untreated extensive-stage disease small-cell lung cancer. J Clin Oncol 2006; 24: 2038-2043.
9. Lara PN Jr., Natale R, Crowley J et al. Phase III trial of irinotecan/cisplatin compared with etoposide/cisplatin in extensive-stage small-cell lung cancer: clinical and pharmacogenomic results from SWOG S0124. J Clin Oncol 2009; 27: 2530-2535.
10. Therasse P, Arbuck S, Eisenhauer E 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: 2005-2016.
11. Morikawa T, Yoshida M. A useful testing strategy in phase III trials: combined test of superiority and test of equivalence. J Biopharm Stat 1995; 5: 297-306.
12. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53: 457-481.
13. Lara P, Redman M, Lenz H et al. Cisplatin (Cis)/etoposide (VP16) compared to cis/irinotecan (CPT11) in extensive-stage small cell lung cancer (E-SCLC): pharmacogenomic (PG) and comparative toxicity analysis of JCOG 9511 and SWOG 0124. J Clin Oncol 2007; 25: 18s.
14. Hermes A, Bergman B, Bremnes R et al. Irinotecan plus carboplatin versus oral etoposide plus carboplatin in extensive small-cell lung cancer: a randomized phase III trial. J Clin Oncol 2008; 26: 4261-4267.
15. Schmittel A, Fischer von Weikersthal L, Sebastian M et al. A randomized phase II trial of irinotecan plus carboplatin versus etoposide plus carboplatin treatment in patients with extended disease small-cell lung cancer. Ann Oncol 2006; 17: 663-667.
16. Schmittel AH, Sebastian M, Fischer von Weikersthal L et al. Irinotecan plus carboplatin versus etoposide plus carboplatin in extensive disease small cell lung cancer: results of the German randomized phase III trial. J Clin Oncol 2009; 27 (Suppl): 15s (Abstr 8029).
17. Eckardt JR, von Pawel J, Papai Z et al. Open-label, multicenter, randomized, phase III study comparing oral topotecan/cisplatin versus etoposide/cisplatin as treatment for chemotherapy-naive patients with extensive-disease small-cell lung cancer. J Clin Oncol 2006; 24: 2044-2051.
18. Heigener DF, Freitag L, Eschbach C et al. Topotecan/cisplatin (TP) compared to cisplatin/etoposide (PE) for patients with extensive disease-small cell lung cancer (ED-SCLC): final results of a randomised phase III trial. J Clin Oncol 2008; 26 (Suppl): (Abstr 7513).
19. Maitland ML, DiRienzo A, Ratain MJ. Interpreting disparate responses to cancer therapy: the role of human population genetics. J Clin Oncol 2006; 24: 2151-2157.
20. Beutler E. Targeted disruption of the HFE gene. Proc Natl Acad Sci U S A 1998; 95: 2033-2034.
21. Mathijssen RH, van Alphen RJ, Verweij J et al. Clinical pharmacokinetics and metabolism of irinotecan (CPT-11). Clin Cancer Res 2001; 7: 2182-2194.
22. Han JY, Lim HS, Shin ES et al. Comprehensive analysis of UGT1A polymorphisms predictive for pharmacokinetics and treatment outcome in patients with non-small-cell lung cancer treated with irinotecan and cisplatin. J Clin Oncol 2006; 24: 2237-2244.
23. Cardenal F, Domine M, Massutí B et al. Three-week schedule of irinotecan and cisplatin in advanced non-small cell lung cancer: a multicentre phase II study. Lung Cancer 2003; 39: 201-207.
24. Stewart D, Benerjee S, Dahrouge S et al. Irinotecan dose-response relationships in non-small cell lung cancer and resistance mechanisms. Proc Am Soc Clin Oncol 2001; 20: 271b (Abstr 2836).
25. Baggstrom MQ, Stinchcombe TE, Fried DB et al. Third-generation chemotherapy agents in the treatment of advanced non-small cell lung cancer: a meta-analysis. J Thorac Oncol 2007; 2: 845-853.
26. Sculier JP, Meert AP. Third-generation chemotherapy agents in the treatment of advanced non-small cell lung cancer: ameta-analysis. J Thorac Oncol 2008; 3: 320.
27. Stinchcombe T, Fried D. Third-generation chemotherapy agents in the treatment of advanced non-small cell lung cancer: a meta-analysis. J Thorac Oncol 2008; 3: 320-321.
28. Sasse EC, Lima JP, Santos LV, Sasse AD. Irinotecan plus platinum analog (IP) compared to etoposide plus platinum analog (EP) in extensive stage small cell lung cancer (ED-SCLC): systematic review with meta-analysis. J Clin Oncol 2009; 27 (Suppl): 15s (Abstr 8105).