Multicenter, randomized, phase 2 study of zoledronic acid in combination with docetaxel and carboplatin in patients with unresectable stage IIIB or stage IV non-small cell lung cancer

Lung Cancer

Volumn 67, Issue 3, 2010, Pages 330-338

  Pandya, Kishan J ^a   Gajra, Ajeet ^b,c   Warsi, Ghulam M ^d   Argonza Aviles, Eliza ^d   Ericson, Solveig G ^d   Wozniak, Antoinette J ^e  

^a UNIVERSITY OF ROCHESTER MEDICAL CENTER   (United States)

^b State University New York College of Environmental Science and Forestry   (United States)

^c SYRACUSE VA MEDICAL CENTER   (United States)

^d NOVARTIS PHARMA AG   (Switzerland)

^e WAYNE STATE UNIVERSITY   (United States)

Author keywords

Antitumor activity; Bisphosphonate; Bone metastases; Chemotherapy; Lung cancer; Neoplasm; Zoledronic acid

Indexed keywords

CARBOPLATIN; DOCETAXEL; ZOLEDRONIC ACID;

ABDOMINAL PAIN; ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; APPETITE; ARTHRALGIA; ARTICLE; ASTHENIA; BACKACHE; BONE METASTASIS; BONE PAIN; CANCER STAGING; CONSTIPATION; CONTROLLED STUDY; COUGHING; DEHYDRATION; DEPRESSION; DIARRHEA; DISEASE COURSE; DIZZINESS; DRUG EFFICACY; DRUG FATALITY; DRUG POTENTIATION; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSGEUSIA; DYSPNEA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; FOLLOW UP; HEADACHE; HUMAN; HYPOTENSION; INOPERABLE CANCER; INSOMNIA; JAW OSTEONECROSIS; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROPATHY; NEUTROPENIA; OSTEOMYELITIS; OVERALL SURVIVAL; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STOMATITIS; THORAX PAIN; VOMITING; WEIGHT REDUCTION;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CANADA; CARBOPLATIN; CARCINOMA, NON-SMALL-CELL LUNG; DIPHOSPHONATES; FEMALE; HUMANS; IMIDAZOLES; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM STAGING; TAXOIDS; UNITED STATES;

EID: 75949084758     PISSN: 01695002     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.lungcan.2009.04.020     Document Type: Article

References (36)

1. The NCCN non-small cell lung cancer clinical practice guidelines in oncology (version 2.2008).© 2008 National Comprehensive Cancer Network, Inc., http://www.nccn.org [accessed 06.03.08].
2. D'Addario G., Pintilie M., Leighl N.B., Feld R., Cerny T., and Shepherd F.A. Platinum-based versus non-platinum-based chemotherapy in advanced non-small cell lung cancer: a meta-analysis of the published literature. J Clin Oncol 23 (2005) 2926-2936
3. Kelly K., Crowley J., Bunn P.A., Presant C.A., Grevstad P.K., Moinpour C.M., 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
4. Schiller J.H., Harrington D., Belani C.P., Langer C., Sandler A., Krook J., et al. Comparison of four chemotherapy regimens for advanced non-small cell lung cancer. N Engl J Med 346 (2002) 92-98
5. Scagliotti G.V., De Marinis F., Rinaldi M., Crino L., Gridelli C., Ricci S., et al. Phase III randomized trial comparing three platinum-based doublets in advanced non-small cell lung cancer. J Clin Oncol 20 (2002) 4285-4291
6. Fossella F., Pereira J.R., von Pawel J., Pluzanska A., Gorbounova V., Kaukel E., 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
7. Jensen N.V., Hansen O., Jensen A.B., and Rose C. Carboplatin versus carboplatin plus docetaxel in first line treatment of advanced non-small cell lung cancer (NSCLC). Quality of life, costs and health resources. Proc Am Soc Clin Oncol 21 322a (2002) [abstr. 1285]
8. Booton R., Lorigan P., Anderson H., Baka S., Ashcroft L., Nicolson M., et al. A phase III trial of docetaxel/carboplatin versus mitomycin C/ifosfamide/cisplatin (MIC) or mitomycin C/vinblastine/cisplatin (MVP) in patients with advanced non-small cell lung cancer: a randomised multicentre trial of the British Thoracic Oncology Group (BTOG1). Ann Oncol 17 (2006) 1111-1119
9. Tsavaris N., Kosmas C., Skopelitis E., Gennatas K., Zorbala A., Papas P., et al. A phase II study of the docetaxel-carboplatin chemotherapy regimen in advanced non-small cell lung cancer. Lung 183 (2005) 405-416
10. Ramalingam S., Dobbs T.W., Einzig A.I., Wojtowicz-Praga S., Cascino M., Bonomi P., et al. Carboplatin and docetaxel in advanced non-small cell lung cancer: results of a multicenter phase II study. Cancer Chemother Pharmacol 53 (2004) 439-444
11. Millward M.J., Boyer M.J., Lehnert M., Clarke S., Rischin D., Goh B.C., et al. Docetaxel and carboplatin is an active regimen in advanced non-small cell lung cancer: a phase II study in Caucasian and Asian patients. Ann Oncol 14 (2003) 449-454
12. Belani C.P., Einzig A., Bonomi P., Dobbs T., Capozzoli M.J., Earhart R., et al. Multicenter phase II trial of docetaxel and carboplatin in patients with stage IIIB and IV non-small cell lung cancer. Ann Oncol 11 (2000) 673-678
13. Coleman R.E. Skeletal complications of malignancy. Cancer 80 (1997) 1588-1594
14. Rogers M.J., Gordon S., Benford H.L., Coxon F.P., Luckman S.P., Monkkonen, et al. Cellular and molecular mechanisms of action of bisphosphonates. Cancer 88 (2000) 2961-2978
15. MacDonald C.D., Pickering L.M., Mansi J.L., and Colston K.W. Anti-cancer effects of bisphosphonates in lung cancer cell lines. J Clin Oncol 22 Suppl. (2004) [abstr. 7289]
16. Ozturk O.H., Bozcuk H., Burgucu D., Ekinci D., Ozdogan M., Akca S., et al. Cisplatin cytotoxicity is enhanced with zoledronic acid in A549 lung cancer cell line: preliminary results of an in vitro study. Cell Biol Int 31 (2007) 1069-1071
17. Rosen L.S., Gordon D., Tchekmedyian S., Yanagihara R., Hirsh V., Krzakowski M., et al. Zoledronic acid versus placebo in the treatment of skeletal metastases in patients with lung cancer and other solid tumors: a phase III, double-blind, randomized trial-the Zoledronic Acid Lung Cancer and Other Solid Tumors Study Group. J Clin Oncol 21 (2003) 3150-3157
18. Li Y.Y., Chang J.W.C., Chou W.C., Liaw C.C., Wang H.M., Huang J.S., et al. Zoledronic acid is unable to induce apoptosis, but slows tumor growth and prolongs survival for non-small-cell lung cancers. Lung Cancer 59 (2008) 180-191
19. Matczak E., Hirsh V., Lipton A., Cook R.J., Langer C., Hei Y.J., et al. Effects of zoledronic acid on survival in patients with lung cancer and high baseline N-telopeptide (NTX) levels: stratified by baseline bone alkaline phosphatase (BALP). J Clin Oncol 24 Suppl. (2006) [abstr. 7228]
20. Ullén A., Lennartsson L., Harmenberg U., Hjelm-Eriksson M., Kälkner K.M., Lennernäs B., et al. Additive/synergistic antitumoral effects on prostate cancer cells in vitro following treatment with a combination of docetaxel and zoledronic acid. Acta Oncol 44 (2005) 644-650
21. Witters L.M., Crispino J., Fratterrigo T., Green J., and Lipton A. Effect of the combination of docetaxel, zoledronic acid, and a COX-2 inhibitor on the growth of human breast cancer cell lines. Am J Clin Oncol 26 Suppl. 2 (2003) S92-S97
22. Therasse P., Arbuck S.G., Eisenhauer E.A., Wanders J., Kaplan R.S., Rubinstein L., et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92 (2000) 205-216
23. Common terminology criteria for adverse events (CTCAE) v3.0 online instructions and guidelines. Cancer Therapy Evaluation Program (CETP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI), National Institutes of Health (NIH), https://webapps.ctep.nci.nih.gov/webobjs/ctc/webhelp/welcome_to_ctcae [updated 09.08.06, accessed 29.07.07].
24. Diel I.J., Solomayer E.F., Costa S.D., Gollan C., Goerner R., Wallwiener D., et al. Reduction in new metastases in breast cancer with adjuvant clodronate treatment. N Engl J Med 339 (1998) 357-363
25. Diel I., Solomayer E.F., Gollan C.H., Gollan F., Schutz F., and Bastert G. Bisphosphonates in the reduction of metastases in breast cancer-results of the extended follow-up of the first study population. Proc Am Soc Clin Oncol 19 82a (2000) [abstr. 314]
26. Powles T., Paterson S., Kanis J.A., McCloskey E., Ashley S., Tiday A., et al. Randomized, placebo-controlled trial of clodronate in patients with primary operable breast cancer. J Clin Oncol 20 (2002) 3219-3224
27. Saarto T., Blomqvist C., Virkkunen P., and Elomaa I. Adjuvant clodronate treatment does not reduce the frequency of skeletal metastases in node-positive breast cancer patients: 5-year results of a randomized controlled trial. J Clin Oncol 19 (2001) 10-17
28. Kanis J.A., Powles T., Paterson A.H., McCloskey E.V., and Ashley S. Clodronate decreases the frequency of skeletal metastases in women with breast cancer. Bone 19 (1996) 663-667
29. Mason M.D., Sydes M.R., Glaholm J., Langley R.E., Huddart R.A., Sokal M., et al. Oral sodium clodronate for nonmetastatic prostate cancer-results of a randomized double-blind placebo-controlled trial: Medical Research Council PR04 (ISRCTN61384873). J Natl Cancer Inst 99 (2007) 765-776
30. Mystakidou K., Katsouda E., Parpa E., Kelekis A., Galanos A., and Vlahos L. Randomized, open label, prospective study on the effect of zoledronic acid on the prevention of bone metastases in patients with recurrent solid tumors that did not present with bone metastases at baseline. Med Oncol 22 (2005) 195-201
31. ClinicalTrials.gov: a service of the US National Institutes of Health, www.clinicaltrials.gov [accessed 01.08.07].
32. Fabbri F., Brigliadori G., Carloni S., Ulivi P., Vannini I., Tesei A., et al. Zoledronic acid increases docetaxel cytotoxicity through pMEK and Mcl-I inhibition in a hormone-sensitive prostate carcinoma cell line. J Transl Med 6 (2008) 43-52
33. Gnant M, Mlineritsch B, Schippinger W, Luschin-Ebengreuth G, Poestlberger S, Menzel C, et al. Adjuvant ovarian suppression combined with tamoxifen or anastrozole, alone or in combination with zoledronic acid, in premenopausal women with hormone-responsive, stage I and II breast cancer: first efficacy results from ABCSG-12. Presented at: 44th annual meeting of the American Society of Clinical Oncology, Chicago, IL, May 30-June 3; 2008 [abstr. LBA4].
34. Bamias A., Kastritis E., Bamia C., Moulopoulos L.A., Melakopoulos I., Bozas G., et al. Osteonecrosis of the jaw in cancer after treatment with bisphosphonates: incidence and risk factors. J Clin Oncol 23 (2005) 8580-8587
35. Ruggiero S., Gralow J., Marx R.E., Hoff A.O., Schubert M.M., Huryn J.M., et al. Practical guidelines for the prevention, diagnosis, and treatment of osteonecrosis of the jaw in patients with cancer. J Oncol Pract 2 (2006) 7-14
36. Rosen L.S., Gordon D., Tchekmedyian N.S., Yanagihara R., Hirsh V., Krzakowski M., et al. Long-term efficacy and safety of zoledronic acid in the treatment of skeletal metastases in patients with nonsmall cell lung carcinoma and other solid tumors: a randomized, phase III, double-blind, placebo-controlled trial. Cancer 100 (2004) 2613-2621