Randomized phase II trial of gemcitabine-cisplatin with or without trastuzumab in HER2-positive non-small-cell lung cancer

Annals of Oncology

Volumn 15, Issue 1, 2004, Pages 19-27

  Gatzemeier, Ulrich ^a   Groth, G ^a   Butts, C ^b   Van Zandwijk, N ^c   Shepherd, F ^d   Ardizzoni, A ^e   Barton, C ^f   Ghahramani, P ^f   Hirsh, V ^g  

^a KRANKENHAUS GROSSHANSDORF   (Germany)

^b CROSS CANCER INSTITUTE   (Canada)

^c NETHERLANDS CANCER INSTITUTE   (Netherlands)

^d PRINCESS MARGARET HOSPITAL   (Canada)

^e UNIVERSITY OF GENOA   (Italy)

^f ROCHE PRODUCTS LTD   (United Kingdom)

^g MCGILL UNIVERSITY   (Canada)

Author keywords

Cisplatin; Gemcitabine; HER2; Non small cell lung cancer; Trastuzumab

Indexed keywords

CISPLATIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; GEMCITABINE; TRASTUZUMAB;

ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; APPETITE DISORDER; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; BLOOD TOXICITY; CANCER GRADING; CANCER GROWTH; CANCER STAGING; CANCER SURVIVAL; CARDIOTOXICITY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE EXACERBATION; DIZZINESS; DOSE RESPONSE; DRUG ACCUMULATION; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; EPISTAXIS; FATIGUE; FEMALE; FLUORESCENCE IN SITU HYBRIDIZATION; GASTROINTESTINAL TOXICITY; HUMAN; LEUKOPENIA; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; NAUSEA; NEUTROPENIA; PARESTHESIA; PERIPHERAL NEUROPATHY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TASTE DISORDER; THROMBOCYTOPENIA; TINNITUS; VOMITING;

EID: 0942287963     PISSN: 09237534     EISSN: None     Source Type: Journal    
DOI: 10.1093/annonc/mdh031     Document Type: Article

References (34)

1. American Cancer Society. Cancer facts and figures 2001. Atlanta, GA: American Cancer Society 2001.
2. Micheli A, Mugno E, Krogh V et al. Cancer prevalence in European registry areas. Ann Oncol 2002; 13: 840-865.
3. 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.
4. Pegram M, Hsu S, Lewis G et al. Inhibitory effects of combinations of HER-2/neu antibody and chemotherapeutic agents used for treatment of human breast cancers. Oncogene 1998; 18: 2241-2251.
5. Bunn PA Jr, Helfrich B, Soriano AF et al. Expression of Her-2/neu in human lung cancer cell lines by immunohistochemistry and fluorescence in situ hybridization and its relationship to in vitro cytotoxicity by trastuzumab and chemotherapeutic agents. Clin Cancer Res 2001; 7: 3239-3250.
6. Hirsch FR, Helfrich B, Franklin WA et al. Preclinical studies of gemcitabine and trastuzumab in breast and lung cancer cell lines. Clin Breast Cancer 2002; 3 (Suppl 1): S12-S16.
7. Slamon DJ, Leyland-Jones B, Shak S et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that over-expresses HER2. N Engl J Med 2001; 344: 783-792.
8. Burstein HJ, Bunnell CA, Winer EP. New cytotoxic agents and schedules for advanced breast cancer. Semin Oncol 2001; 28: 344-358.
9. O'Shaughnessy JA, Vukelja S, Marsland T et al. Gemcitabine and trastuzumab for HER-2 positive metastatic breast cancer: preliminary results of a phase II study. Breast Cancer Res Treat 2001; 69: 302 (Abstr 523).
10. Cobleigh MA, Vogel CL, Tripathy D et al. Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J Clin Oncol 1999; 17: 2639-2648.
11. Mass RD. The role of HER-2 expression in predicting response to therapy in breast cancer. Semin Oncol 2000; 27 (Suppl 11): 46-52.
12. Shi D, He G, Cao S et al. Overexpression of the c-erbB-2/neu-encoded p185 protein in primary lung cancer. Mol Carcinog 1992; 5: 213-218.
13. Harpole DH Jr, Marks JR, Richards WG et al. Localized adenocarcinoma of the lung: oncogene expression of erbB-2 and p53 in 150 patients. Clin Cancer Res 1995; 1: 659-664.
14. Salgia R, Skarin AT. Molecular abnormalities in lung cancer. J Clin Oncol 1998; 16: 1207-1217.
15. Scheurle D, Jahanzeb M, Aronsohn RS et al. HER-2/neu expression in archival non-small cell lung carcinomas using FDA-approved HercepTest. Anticancer Res 2000; 20: 2091-2096.
16. Hirsch FR, Franklin WA, Veve R et al. HER2/neu expression in malignant lung tumors. Semin Oncol 2002; 29 (Suppl 4): 51-58.
17. Cox G, Vyberg M, Melgaard B et al. Herceptest: HER2 expression and gene amplification in non-small cell lung cancer. Int J Cancer 2001; 92: 480-483.
18. Tateishi M, Ishida T, Mitsudomi T et al. Prognostic value of c-erbB-2 protein expression in human lung adenocarcinoma and squamous cell carcinoma. Eur J Cancer 1991; 27: 1372-1375.
19. Kern JA, Slebos RJ, Top B et al. C-erbB-2 expression and codon 12 K-ras mutations both predict shortened survival for patients with pulmonary adenocarcinomas. J Clin Invest 1994; 93: 516-520.
20. Noguchi M, Murakami M, Bennett W et al. Biological consequences of overexpression of a transfected c-erbB-2 gene in immortalized human bronchial epithelial cells. Cancer Res 1993; 53: 2035-2043.
21. Sandler AB, Nemunaitis J, Denham C et al. Phase III trial of gemcitabine plus cisplatin versus cisplatin alone in patients with locally advanced non-small-cell lung cancer. J Clin Oncol 2000; 18: 122-130.
22. Cardenal F, Lépez-Cabrerizo MP, Antón A et al. Randomized phase III study of gemcitabine-cisplatin versus etoposide-cisplatin in the treatment of locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 1999; 17: 12-18.
23. Dy GK, Adjei AA. Novel targets for lung cancer therapy: part 1. J Clin Oncol 2002; 20: 2881-2894.
24. Mass RD, Press M, Anderson S et al. Improved survival benefit from Herceptin (trastuzumab) in patients selected by fluorescence in situ hybridization (FISH). Proc Am Soc Clin Oncol 2001; 20: 22a (Abstr 85).
25. Langer CJ, Adak S, Thor A et al. Phase II Eastern Cooperative Oncology Group (ECOG) pilot study of paclitaxel (P), carboplatin (C), and trastuzumab (T) in HER-2/neu (+) advanced non-small cell lung cancer (NSCLC): early analysis of E2598. Proc Am Soc Clin Oncol 2001; 20: 315a (Abstr 1257).
26. Tran HT, Herbst RS, Glisson BS et al. Herceptin in combination with cisplatin and gemcitabine in patients (pts) with HER2 overexpressing, untreated, advanced, non-small-cell lung cancer (NSCLC): final report of a phase II trial. Proc Am Soc Clin Oncol 2002; 21: 307a (Abstr 1226).
27. Zinner R, Glisson BS, Pisters KM et al. Cisplatin and gemcitabine combined with Herceptin in patients (pts) with her2 overexpressing, untreated, advanced, non-small-cell lung cancer (NSCLC): a phase II trial. Eur J Cancer 2001; 37 (Suppl 6): S154 (Abstr 560).
28. Safran H, Ramanathan R, Schwartz J et al. Herceptin and gemcitabine for metastatic pancreatic cancers that overexpress HER-2/neu. Eur J Cancer 2001; 37 (Suppl 6): S310 (Abstr 1148).
29. Small EJ, Bok R, Reese DM et al. Docetaxel, estramustine, plus trastuzumab in patients with metastatic androgen-independent prostate cancer. Semin Oncol 2001; 28 (4 Suppl 15): 71-76.
30. Seidman A, Hudis C, Pierri MK et al. Cardiac dysfunction in the trastuzumab clinical trials experience. J Clin Oncol 2002; 20: 1215-1221.
31. Seidman AD, Fornier MN, Esteva FJ et al. Weekly trastuzumab and paclitaxel therapy for metastatic breast cancer with analysis of efficacy by HER2 immunophenotype and gene amplification. J Clin Oncol 2001; 19: 2587-2595.
32. Vogel CL, Cobleigh MA, Tripathy D et al. Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressiong metastatic breast cancer. J Clin Oncol 2002; 20: 719-726.
33. Cook-Bruns N. Retrospective analysis of the safety of Herceptin immunotherapy in metastatic breast cancer. Oncology 2001; 61 (Suppl 2): 58-66.
34. Singal PK, Iliskovic N. Doxorubicin-induced cardiomyopathy. N Engl J Med 1998; 339: 900-905.