A randomized, phase II trial of two dose schedules of carboplatin/ paclitaxel/cetuximab in stage IIIB/IV non-small-cell lung cancer (NSCLC)

Annals of Oncology

Volumn 20, Issue 6, 2009, Pages 1068-1073

  Socinski, M A ^a   Saleh, M N ^b   Trent, D F ^c   Dobbs, T W ^d   Zehngebot, L M ^e   Levine, M A ^f   Bordoni, R ^b   Stella, P J ^g  

^a UNIVERSITY OF NORTH CAROLINA   (United States)

^b Georgia Cancer Specialists   (Georgia)

^c Virginia Cancer Institute   (United States)

^d Tennessee Cancer Specialists   (United States)

^e FLORIDA HOSPITAL CANCER INSTITUTE   (United States)

^f GREATER BALTIMORE MEDICAL CENTER   (United States)

^g Ann Arbor Hematology Oncology   (United States)

Author keywords

Biomarkers; Cetuximab; Combination therapy; EGFR; NSCLC

Indexed keywords

CARBOPLATIN; CETUXIMAB; DOCETAXEL; GEMCITABINE; PACLITAXEL; PEMETREXED;

ACNEIFORM DERMATITIS; ACNEIFORM RASH; ADULT; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; BLOOD TOXICITY; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER STAGING; CANCER SURVIVAL; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEHYDRATION; DOSAGE SCHEDULE COMPARISON; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG ERUPTION; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; FEBRILE NEUTROPENIA; HUMAN; INTERSTITIAL PNEUMONIA; LARGE CELL CARCINOMA; LUNG ADENOCARCINOMA; LUNG NON SMALL CELL CANCER; LUNG SQUAMOUS CELL CARCINOMA; MAJOR CLINICAL STUDY; MONOTHERAPY; MOTOR NEUROPATHY; MULTIPLE CYCLE TREATMENT; MYALGIA; NEUROPATHY; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY FAILURE; SENSORY NEUROPATHY; THERAPY DELAY; TREATMENT RESPONSE;

EID: 66149192655     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdn745     Document Type: Article

References (21)

1. World Health Organization. Data and Statistics 2007. http://www.who.int/ healthinfo/statistics/bodgbddeathdalyestimates.xls (31 October 2008, date last accessed).
2. Socinski MA. Antibodies to the epidermal growth factor receptor in non-small cell ling cancer: Current status of matuzumab and panitumumab. Clin Cancer Res 2007; 13: 4597s-4601s.
3. Shepherd FA, Pereira JR, Ciuleanu T et al. Erlotinib in previously treated non-small cell lung cancer. N Engl J Med 2005; 353: 123-132.
4. Raben D, Helfrich B, Chan DC et al. The effects of cetuximab alone and in combination with radiation therapy and/or chemotherapy in lung cancer. Clin Cancer Res 2005; 11: 795-805.
5. Inoue K, Slaton JW, Perrotte P et al. Paclitaxel enhances the effects of the antiepidermal growth factor receptor monoclonal antibody ImClone C225 in mice with metastatic human bladder transitional cell carcinoma. Clin Cancer Res 2000; 6: 4874-4884.
6. Hanna N, Lilenbaum R, Ansari R et al. Phase II trial of cetuximab in patients with previously treated non-small cell lung cancer. J Clin Oncol 2006; 24: 5253-5258.
7. Rosell R, Robinet G, Szczesna A et al. Randomized phase II study of cetuximab plus cisplatin/vinorelbine compared with cisplatin/vinorelbine alone as first-line therapy in EGFR-expressing advanced non-small-cell lung cancer. Ann Oncol 2008; 19: 362-369.
8. Herbst RS, Chansky K, Kelly K et al. A phase II randomized selection trial evaluating concurrent chemotherapy plus cetuximab or chemotherapy followed by cetuximab in patients with advanced non-small cell lung cancer. J Clin Oncol 2007; 25 (Suppl): (Abstr 7545).
9. Butts CA, Bodkin D, Middleman EL et al. Randomized phase II study of gemcitabine plus cisplatin or carboplatin, with or without cetuximab, as first-line therapy for patients with advanced or metastatic non small-cell lung cancer. J Clin Oncol 2007; 25: 5777-5784.
10. Borghaei H, Langer CJ, Millenson M et al. Phase II trial of cetuximab (C225) in combination with monthly carboplatin (Cb) and weekly paclitaxel (Pac) in patients with advanced NSCLC: Promising early results. J Clin Oncol 2008; 26 (20 Suppl): (Abstr 8104).
11. Ramalingam S, Perry MC, La Rocca RV et al. Comparison of outcomes for elderly patients treated with weekly paclitaxel in combination with carboplatin versus the standard 3-weekly paclitaxel and carboplatin for advanced nonsmall cell lung cancer. Cancer 2008; 113: 542-546.
12. Belani CP, Ramalingam S, Perry MC et al. Randomized, phase III study of weekly paclitaxel in combination with carboplatin versus standard every-3-weeks administration of carbopaltin and paclitaxel for patients with previously untreated advanced non-small-cell lung cancer. J Clin Oncol 2008; 26: 468-473.
13. 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.
14. Brookmeyer R, Crowley J. A confidence interval for the median survival time. Biometrics 1982; 38: 29-41.
15. Thienelt CD, Bunn PA, Hanna N et al. Multi-center phase I/II study of cetuximab with paclitaxel and carboplatin in untreated patients with stage IV non-small cell lung cancer. J Clin Oncol 2005; 23: 8786-8793.
16. Lynch T, Patel T, Dreisbach L et al. A Randomized Multicenter Phase III Study of Cetuximab in Combination with Taxane/Carboplatin Versus Taxane/ Carboplatin Alone as First-Line Treatment for Patients with Advanced/ Metastatic Non-Small Cell Lung Cancer. Journal of Thoracic Oncology 2007; 2 (Suppl 4): S340-S341.
17. Pirker R, Szcezesna A, Von Pawell J et al. FLEX: A randomized, multicenter, phase III study of cetuximab in combination with cisplatin/ vinorelbine (CV) versus CV alone in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC). J Clin Oncol 2008; 26 (20 Suppl): (Abstr 3).
18. 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(2): 92-98.
19. Mass RD, Press MF, Anderson S et al. Evaluation of clinical outcomes according to HER2 detection by fluorescence in situ hybridization in women with metastatic breast cancer treated with trastuzumab. Clin Breast Cancer 2005; 6(3): 240-246.
20. Hirsch FR, Herbst RS, Olsen C et al. Increased EGFR gene copy number detected by fluorescent in situ hybridization predicts outcome in non-small-cell lung cancer patients treated with cetuximab and chemotherapy. J Clin Oncol 2008; 26: 3351-3357.
21. Khambata-Ford S, Garrett CR, Meropol NJ et al. Expression of epiregulin and amphiregulin and K-ras mutation status predict disease control in metastatic colorectal cancer patients treated with cetuximab. J Clin Oncol 2007; 25: 3230-3237.