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

Volumn 98, Issue 3, 2003, Pages 542-553

  Danson, Sarah ^a   Middleton, Mark R ^a   O'Byrne, Kenneth J ^b   Clemons, Mark ^a   Ranson, Malcolm ^a   Hassan, Jurjees ^a   Anderson, Heather ^a,c   Burt, Paul A ^a   Fairve Finn, Corrine ^a   Stout, Ronald ^a   Dowd, Isabel ^a   Ashcroft, Linda ^a   Beresford, Cheryl ^c   Thatcher, Nicholas ^a,c  

^a CHRISTIE HOSPITAL   (United Kingdom)

^b LEICESTER ROYAL INFIRMARY   (United Kingdom)

^c WYTHENSHAWE HOSPITAL   (United Kingdom)

Author keywords

Carboplatin; Chemotherapy; Gemcitabine; Nonsmall cell lung carcinoma (NSCLC)

Indexed keywords

CARBOPLATIN; CISPLATIN; DEXAMETHASONE; GEMCITABINE; IFOSFAMIDE; METOCLOPRAMIDE; MITOMYCIN; ONDANSETRON; PACLITAXEL; VINBLASTINE;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ARTICLE; BLOOD TOXICITY; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE COURSE; EDEMA; FLU LIKE SYNDROME; HEARING IMPAIRMENT; HUMAN; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MUCOSA INFLAMMATION; NEUTROPENIA; PERFORMANCE; PERIPHERAL NEUROPATHY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RASH; THORAX PAIN; THROMBOCYTOPENIA; TINNITUS; TREATMENT OUTCOME;

ADENOCARCINOMA; ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; ANXIETY; CARBOPLATIN; CARCINOMA, LARGE CELL; CARCINOMA, NON-SMALL-CELL LUNG; CISPLATIN; DEOXYCYTIDINE; DISEASE PROGRESSION; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; IFOSFAMIDE; LUNG NEOPLASMS; MALE; MIDDLE AGED; MITOMYCIN; MITOMYCINS; NEOPLASM STAGING; QUALITY OF LIFE; SURVIVAL RATE; TIME FACTORS; VINBLASTINE;

EID: 0037623677     PISSN: 0008543X     EISSN: None     Source Type: Journal    
DOI: 10.1002/cncr.11535     Document Type: Article

References (40)

1. Non-small cell lung cancer collaborative group. Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual data from 52 randomized clinical trials. BMJ. 1995;311:899-909.
2. Ellis PA, Smith IE, Hardy JR, et al. Symptom relief with MVP (mitomycin C, vinblastine and cisplatin) chemotherapy in advanced non-small cell lung cancer. Br J Cancer. 1995;71:366-370.
3. Bunn PA, Kelly K. New chemotherapeutic agents prolong survival and improve quality of life in non-small cell lung cancer: a review of the literature and future directions. Clin Cancer Res. 1998;4:1087-1100.
4. Thatcher N, Ranson M, Lee SM, Niven R, Anderson H. Chemotherapy in non-small cell lung cancer. Ann Oncol. 1995;6:83-95.
5. National Institute for Clinical Excellence. Guidance on the use of docetaxel, paclitaxel, gemcitabine and vinorelbine for the treatment of non-small cell lung cancer. Technology appraisal guidance, no.26. London: National Institute of Clinical Excellence, 2001,
6. Cullen MH, Billingham LJ, Woodroffe CM, et al. Mitomycin, ifosfamide and cis-platin in unresectable non-small cell lung cancer: effects on survival and quality of life. J Clin Oncol. 1999;17:3188-3194.
7. Ruckdeschel JC, Finkelstein DM, Ettinger DS, et al. A randomised trial of the four most active regimens for metastatic non small cell lung cancer. J Clin Oncol. 1986;4:14-22.
8. Rapp E, Pater JL, Willan A, et al. Chemotherapy can prolong survival in patients with advanced non-small cell lung cancer: report of a Canadian multicenter randomised trial. J Clin Oncol. 1988;6:633-641.
9. Rinaldi M, Crino L, Scagliotti GV, et al. A three-weeldy schedule of gemcitabine-cisplatin in advanced non-small-lung cancer with two different cisplatin dose levels: a Phase II randomised trial. Ann Oncol. 2000;11:1295-1300.
10. Hardy JR, Noble T, Smith IE. Symptom relief with moderate dose chemotherapy (mitomycin C, vinblastine and cisplatin) in advanced non small cell lung cancer. Br J Cancer. 1989;60:764-766.
11. Peters GJ, Bergman AM, Ruiz van Haperen VWT, Veerman G, Kuiper CM, Braakhuis BJ. Interaction between cisplatin and gemcitabine in vitro and in vivo. Semin Oncol. 1995;11:72-79.
12. Crino L, Scagliotti GV, Ricci S, et al. Gemcitabine and cisplatin versus mitomycin, ifosfamide and cisplatin in advanced non-small-cell lung cancer: a randomised Phase III study of the Italian Lung Cancer Project. J Clin Oncol. 1999;17:3522-3530.
13. Klatersky J, Sculler JP, Lacrois H, et al. A randomised study comparing cisplatin or carboplatin with etoposide in patients with advanced non-small-cell lung cancer: European Organization for Research and Treatment of Cancer protocol 07861. J Clin Oncol. 1990;8:1556-1562.
14. Bonomi PD, Finkelstein DM, Ruckdeschel JC, et al. Combination chemotherapy versus single agents followed by combination chemotherapy in Stage IV non-small cell lung cancer: a study of the Eastern Cooperative Oncology Group. J Clin Oncol. 1989;7:1602-1613.
15. Jelic S, Mitrovic L, Radosavljevic D, et al. Survival advantage for carboplatin substituting cisplatin in combination with vindesine and mitomycin C for Stage IIIB and IV squamous cell bronchogenic carcinoma: a randomised Phase III study. Lung Cancer. 2001;34:1-13.
16. Rosell R, Gatzemeier U, Betticher DC, et al. Phase III randomised trial comparing paclitaxel/carboplatin with paclitaxel/cisplatin in patients with advanced non-small-cell lung cancer: a cooperative multinational trial. Ann Oncol. 2002;13:1539-1549.
17. Schiller JH, Harrington D, Belani CP, et al. Comparison of four chemotherapy regimens for advanced non-small cell lung cancer. N Engl J Med. 2002;346:92-98.
18. Carmichael J, Allerheiligen S, Walling J. A Phase I study of gemcitabine and carboplatin in non-small cell lung cancer. Semin Oncol. 1996;23:55-59.
19. Carmichael J, Langley R, Osborne L, et al. A Phase I study to investigate the alternative sequencing of the combination gemcitabine followed by carboplatin in NSCLC. Eur J Cancer. 1997;33:230.
20. Ng EW, Sandler AB, Robinson L, Einhom LH. A Phase II study of carboplatin plus gemcitabine in advanced non-small-cell lung cancer (NSCLC): a Hosier Oncology Group study. Am J Clin Oncol. 1999;22:550-553.
21. 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;18:498.
22. Jovtis S, Brocato N, Balbiani L, et al. First-line therapy with gemcitabine (GEMTRO) (G) and carboplatin (C) in patients (pts) with advanced non-small cell lung cancer (NSCLC): a Phase II study. Proc Am Soc Clin Oncol. 1999;18:510.
23. Sederholm C. A Phase III study in advanced non-small cell lung cancer (NSCLC) comparing gemcitabine with gemcitabine in combination with carboplatin. Data from an ongoing study by the Swedish Lung Cancer Study Group (SLUSG). Proc Am Soc Clin Oncol. 2001;20:1294.
24. Mountain CF. Revisions in the International System for Staging Lung Cancer. Chest. 1997;111:1710-1717.
25. British Thoracic Surgery and Society of Cardiothoracic Surgeons of Great Britain and Ireland Working Party. Guidelines on the selection of patients with lung cancer for surgery. Thorax. 2002;56:89-108.
26. 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.
27. Anderson H, Hopwood, Stephens RJ, et al. Gemcitabine plus best supportive care (BSC) vs BSC in inoperable non-small cell lung cancer - a randomised trial with quality of life as the primary outcome. Br J Cancer. 2000;83:447-453.
28. Hopwood P, Howell A, Macquire P. Psychiatric morbidity in patients with advanced cancer of the breast: prevalence measured by two self-rating questionnaires. Br J Cancer. 1991;64:349-352.
29. Aaronsen 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.
30. World Health Organisation. The WHO handbook for reporting results of cancer treatment, no. 48. Geneva: World Health Organization, 1979.
31. Crino L, Clerici M, Figoli F, et al. Chemotherapy of advanced non-small-cell lung cancer: a comparison of three active regimens. A randomised trial of the Italian Oncology Group for Clinical Research (G.O.I.R.C.). Ann Oncol. 1995;6:342-353.
32. Sandler AB, Nemunaitis J, Denham C, et al. Phase III trial of gemcitabine plus cisplatin versus cisplatin alone in patients with locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol. 2000;18:122-130.
33. Cardenal F, Paz Lopez-Cabrenizo M, Anton A, et al. Randomised Phase III study of gemcitabine plus cisplatin versus etoposide plus cisplatin in the treatment of locally advanced or metastatic non-small cell lung cancer. J Clin Oncol. 1999;17:12-17.
34. Parente B, Barrosa A, Conde S, Guimaraes T, Seada J. A prospective study of gemcitabine and carboplatin as first-line therapy in advanced non-small cell lung cancer: toxicity of a three-versus a four-week schedule. Semin Oncol. 2001;28:10-14.
35. Rudd RM, Gower NH, James LE, et al. Phase III randomised comparison of gemcitabine and carboplatin (GC) with mitomycin, ifosfamide and cisplatin (MIP) in advanced non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol. 2002;21:1164.
36. Hespanhol V, Queiroga H, Magalhaes A, Santos AR, Coelho M, Marques A. Survival predictors in advanced non-small cell lung cancer. Lung Cancer. 1995;13:253-267.
37. Takigawa N, Segawa Y, Okahara M, et al. Prognostic factors for patients with advanced non-small cell lung cancer: univariate and multivariate analyses including recursive partitioning and amalgamation. Lung Cancer. 1996;15:67-77.
38. Ganz PA, Figlin RA, Haskell CM, La Soto N, Siau J. Supportive care versus supportive care and combination chemotherapy in metastatic non-small cell lung cancer. Does chemotherapy make a difference? Cancer. 1989;63:1271-1278.
39. Sweeney CJ, Zhu J, Sandler AB, et al. Outcome of patients with a performance status of 2 in Eastern Cooperative Oncology Group Study E1594. Cancer. 2001;92:2639-2647.
40. Lilenbaum RC, Herndon J, List M, et al. Single agent versus combination chemotherapy in advanced non-small cell lung cancer: a CALGB randomised trial of efficacy, quality of life and cost-effectiveness. Proc Am Soc Clin Oncol. 2002;21:2.