Abstract
We performed a Phase II trial to evaluate the activity and tolerability of docetaxel as a single agent in the treatment of advanced non-small cell lung cancer (NSCLC). Forty-four patients with metastatic and/or locally advanced NSCLC received i.v. docetaxel 100 mg/m2 every 3 weeks for a median of 4 (range 1–11) cycles. All patients received premedication with oral dexamethasone 8 mg twice daily for 5 days starting the day before chemotherapy. Seven partial responses were observed among 35 evaluable patients, and the overall response rate was 20% (95% CI 8-37). The median response duration was 5 months, median survival time was 10 months and the estimated 1-year survival rate was 42%. Treatment was generally well tolerated. Febrile neutropenia occurred in 10 patients (23%); neutropenic infection occurred in 4 patients, and led to 2 toxic deaths (both patients had borderline exclusion criteria). The corticosteroid premedication effectively reduced the overall incidence (34%) and severity (4% severe) of fluid retention, and delayed the median time to onset from cycle 4 to cycle 7. This study shows the promising efficacy of docetaxel as monotherapy in advanced NSCLC, and combination chemotherapy regimens incorporating docetaxel are now being evaluated in this clinical setting.
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Ginsberg RJ, Vokes EE, Raben A: Non-small cell lung cancer. In: de Vita Jr FT, Hellman S, Rosenberg SA (eds) Principles and Practice of Oncology. 5th edition. Lippincott-Raven, Philadelphia, 1997, pp 858-911.
Feigal EG, Christian M, Cheson B, Grever M, Friedman MA: New chemotherapeutic agents in non-small cell lung cancer. Semin Oncol 20(2): 185-201, 1993
Non-Small Cell Lung Cancer Collaborative Group: Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomized clinical trials. BMJ 311: 899-909, 1995
Feld R, Ginsberg RJ, Payne DG, Shepherd FA: Lung. In: Abeloff MD, Armitage JO, Lichter AS, Niederhuber JE (eds) Clinical Oncology. Churchill Livingstone, New York/Edinbourg/London/Melbourne/Tokyo, 1995, pp 1083- 1152
Ringel I, Horwitz SB: Studies with RP 56976 (Taxotere): a semisynthetic analogue of taxol. J Natl Cancer Inst 83: 288- 291, 1991
Fossella FV, Lee JS, Murphy WK, Lippman SM, Calayag M, Pang A, Chasen M, Shin DM, Glisson B, Benner S, Huber M, Perez-Soler R, Hong WK, Raber M: Phase II study of docetaxel for recurrent or metastatic non-small cell lung cancer. J Clin Oncol 12: 1238-1244, 1994
Fossella F, Lee JS, Bérille J, Hong WK: Summary of phase II data of docetaxel (Taxotere®), an active agent in the first and second line treatment of advanced non-small cell lung cancer. Semin Oncol 22(Suppl)4: 22-29, 1995
Francis PA, Rigas JR, Kris MG, Pisters KNW, Orazem JP, Woolley KJ, Heelan RT: Phase II trial of docetaxel in patients with stage II and IV non-small cell lung cancer. J Clin Oncol 12: 1232-1237, 1994
Miller VA, Rigas JR, Francis PA, Grant SC, Pisters KMW, Venkatraman ES, Woolley K, Heelan RT, Kris MG: Phase II trial of a 75 mg/m2 dose of docetaxel with prednisone premedication for patients with advanced non-small cell lung cancer. Cancer 75: 968-972, 1995
Fleming T: One sample multiple testing procedure for phase II clinical trials. Biometrics 38: 143-151, 1989
Hryniuk WM: Average relative dose intensity and the impact on design of clinical trials. Semin Oncol 14: 65-74, 1987
Fukuoka M, Niitani H, Suzuki A, Motomiya M, Hasegawa K, Nishiwaki Y, Kuriyama T, Ariyoshi Y, Negoro S, Masuda N, Nakajima S, Taguchi T: A phase II study of CPT-11, a new derivative of camptothecin, for previously untreated non-small cell lung cancer. J Clin Oncol 10: 16-20, 1992
Edelman MJ, Gandara DR: Promising new agents in the treatment of non-small cell lung cancer. Cancer Chemother Pharmacol 37: 385-393, 1996
Kris M, Cohen E, Gralla R: An analysis of 134 phase II trials in non-small cell lung cancer (Abstr). IV World Conference on Lung Cancer, Toronto, 1985, p 39
Rigas JR: Single-agent docetaxel in previously untreated non-small cell lung cancer. Oncology 11: 17-21, 1997
Pizzo PA: Management of fever in patients with cancer and treatment-induced neutropenia. N Engl J Med 328: 1323- 1332, 1990
Van Oosterom AT, Dieras V, Tubiana-Hulin M, Kalla S, Coombes RC, Alakl M, Murawsky M: Taxotere® in previously treated patients with metastatic breast carcinoma: strati fication for anthracycline resistance (Abstr 231). Proc Am Soc Clin Oncol 15: 141, 1996
van Zandwijk N, Giaccone G: Treatment of metastatic non-small cell lung cancer. Curr Opin Oncol 8: 120-125, 1996
Albain KS, Crowley J, Leblanc M, Livingston R: Survival determinants in extensive stage non-small cell lung cancer: the Southwest Oncology Group experience. J Clin Oncol 9: 1618-1626, 1991
Bonomi P, Kim K, Chang A, Johnson D: Phase III trial comparing etoposide cisplatin versustaxol with cisplatin-granulocyte-colony stimulating factor versustaxol-cisplatin in advanced non-small cell lung cancer: an Eastern Cooperative Oncology Group trial (Abst 1145). Proc Am Soc Clin Oncol 15: 382, 1996
Giaccone G, Splinter T, Postmus P, Diaz Fuente M, Van Zandwijk N, de Bruyne C, Sahmoud T: Paclitaxel-cisplatin versusteniposide-cisplatin in advanced non-small cell lung cancer (Abstr 1109). Proc Am Soc Clin Oncol 15: 373, 1996
Le Chevalier T, Brisgand D, Douillard JY, Pujol JL, Alberola V, Monnier A, Riviere A, Lianes P, Chomy P, Cigolari S et al.: Randomized study of vinorelbine and cisplatin versusvindesine and cisplatin versusvinorelbine alone in advanced non-small cell lung cancer: results of a European multicenter trial including 612 patients. J Clin Oncol 12: 360-367, 1994
Wozniak AJ, Crowley JJ, Balcerzak SP, Weiss GRE, Laufman LR, Baker LH, Fisher RI, Bearman SI, Taylor SA, Livingston RB: Randomized phase III trial of cisplatin versuscisplatin plus navelbine in treatment of advanced non-small cell lung cancer: report of a South West Oncology Group study (Abst 1110). Proc Am Soc Clin Oncol 15: 374, 1996
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Latreille, J., Gelmon, K., Hirsh, V. et al. Phase II trial of docetaxel with dexamethasone premedication in patients with advanced non-small cell lung cancer: the Canadian experience. Invest New Drugs 16, 265–270 (1998). https://doi.org/10.1023/A:1006126505910
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DOI: https://doi.org/10.1023/A:1006126505910