European Organization for Research and Treatment of Cancer (EORTC) 08957 phase II study of topotecan in combination with cisplatin as second-line treatment of refractory and sensitive small cell lung cancer

Clinical Cancer Research

Volumn 9, Issue 1 I, 2003, Pages 143-150

  Ardizzoni, Andrea ^a   Manegold, Christian ^b   Debruyne, Channa ^c   Gaafar, Rabab ^d   Buchholz, Erika ^b   Smit, Egbert F ^e   Lianes, Pilar ^f   Ten Velde, Guul ^g   Bosquee, Lionel ^h   Legrand, Catherine ^c   Neumaier, Carlo ^a   King, Kathrine ⁱ   Giaccone, Giuseppe ^e  

^a UNIVERSITY OF GENOA   (Italy)

^b Thoraxklinik ^*  (Germany)

^c EORTC DATA CENTER   (Belgium)

^d NATIONAL CANCER INSTITUTE   (Egypt)

^e VU UNIVERSITY AMSTERDAM   (Netherlands)

^f HOSPITAL UNIVERSITARIO 12 DE OCTUBRE   (Spain)

^g MAASTRICHT UNIVERSITY MEDICAL CENTER   (Netherlands)

^h Centre Hospitalier Regional de La Citadelle   (Belgium)

ⁱ GLAXOSMITHKLINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CARBOPLATIN; CISPLATIN; TOPOTECAN;

ADULT; AGED; ALLERGY; ALOPECIA; ANEMIA; ANOREXIA; ARTHRALGIA; ARTICLE; BLEEDING; BONE MARROW SUPPRESSION; CANCER CHEMOTHERAPY; CARDIOTOXICITY; CLINICAL TRIAL; CONSTIPATION; DIARRHEA; DOSE RESPONSE; DRUG ACTIVITY; DRUG DOSE REDUCTION; DYSURIA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; HEADACHE; HUMAN; HYPERTENSION; HYPOTENSION; INFECTION; LETHARGY; LEUKOPENIA; LUNG SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALAISE; MALE; NAUSEA; NEUROTOXICITY; NEUTROPENIA; PAIN; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; STOMATITIS; THROMBOCYTOPENIA; VOMITING;

ADULT; AGED; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, SMALL CELL; CISPLATIN; FEMALE; FOLLOW-UP STUDIES; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; RECURRENCE; TIME FACTORS; TOPOTECAN;

EID: 12244253729     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (31)

1. Simon, G., Ginsberg, R. J., and Ruckdeschel, J. C. Small cell lung cancer. Chest Surg. Clin. N. Am., 11: 165-188, 2001.
2. Grant, S. C., Gralla, R. J., Kriss, M. G., Orazem, J., and Kitsis, E. A. Single agent chemotherapy trials in small cell lung cancer, 1970-1990: the case for studies in previously treated patients. J. Clin. Oncol., 10: 484-498, 1992.
3. Postmus, P. E., and Smit, E. F. Treatment of relapsed small cell lung cancer. Semin. Oncol., 28: 48-52, 2001.
4. Figoli, F., Veronesi, A., Ardizzoni, A., Canobbio, L., Bruschi, G., Mazza, F., Zagonel, V., Lo Re, G., Rosso, R., and Monfardini, S. Cisplatin and etoposide as second line chemotherapy in patients with small cell lung cancer. Cancer Investig., 6: 1-5, 1988.
5. Albain, K. S., Crowley, J. J., Hutchins, L., Gandara, D., O'Bryan, R. M., Von Hoff, D. D., Griffin, B., and Livingston, R. B. Predictors of survival following relapse or progression of small cell lung cancer. Cancer (Phila.), 72: 1184-1191, 1993.
6. Roth, B. J., Johnson, D. H., Einhorn, L. H., Schacter, L. P., Cherng, N. C., Cohen, H. J., Crawford, J., Randolph, J. A., Goodlow, J. L., Broun, G. O., et al. Randomized study of cyclophosphamide, doxorubicin, and vincristine versus etoposide versus alteration of these regimens in small cell lung cancer: Phase III trial of Southeastern Cancer Study Group. J. Clin. Oncol., 10: 282-291, 1992.
7. Fukuoka, M., Furuse, K., Saijo, N., Nishiwaki, Y., Ikegami, H., Tamura, T., Shimoyama, M., and Suemasu, K. Randomized trial of cyclophosphamide, doxorubicin, and vincristine versus cisplatin and etoposide versus alteration of these regimens in small cell lung cancer. J. Natl. Cancer Inst. (Bethesda), 83: 855-861, 1991.
8. Giaccone, G., Donadio, M., Bonardi, G., Testore, F., and Calciati, A. Teniposide in the treatment of small cell lung cancer: the influence of prior chemotherapy. J. Clin. Oncol., 6: 1264-1270, 1988.
9. Postmus, P. E., Smit, E. F., Kirkpatrick, A., and Splinter, T. A. Testing the possible non-cross resistance of two equipotent combination chemotherapy regimens against small cell lung cancer: a Phase II study of the EORTC Lung Cancer Cooperative Group. Eur. J. Cancer Clin. Oncol., 29A: 204-207, 1993.
10. Postmus, P. E., Berendsen, H. H., Van Zandwijk, N., Splinter, T. A., Burghouts, J. T., and Bakker, W. Retreatment with the induction regimen in small cell lung cancer relapsing after an initial response to short term chemotherapy. Eur. J. Cancer Clin. Oncol., 23: 1409-1411, 1987.
11. Ardizzoni, A., Hansen, H., Dombernowsky, P., Gamucci, T., Kaplan, S., Postmus, P., Giaccone, G., Schaefer, B., Wanders, J., and Verweij, J. Topotecan, a new active drug in the second-line treatment of small cell lung cancer (SCLC): a Phase II study in patients with refracory and sensitive disease. J. Clin. Oncol., 15: 2090-2096, 1997.
12. Perez-Soler, R., Glisson, B. S., Lee, J. S., Fossella, F. V., Murphy, W. K., Shin, D. M., and Hong, W. K. Treatment of patients with small cell lung cancer refractory to etoposide and cisplatin with the topoisomerase I poison topotecan. J. Clin. Oncol., 14: 2785-2790, 1996.
13. Eckardt, J. R., Palmer, M. C., Fanucci, M. P., Gralla, R., Martins, H., Poulin, R., and Fields, S. Z. Single agent oral topotecan as first-line treatment for patients with extensive disease small cell lung cancer ineligible for standard therapy: a Phase II study (Abstract). Lung Cancer, 29: 10, 2000.
14. Depierre, A., Von Pawel, J., Hans, K., Moro, D., Clark, P., Gatzemeier, U., Paillot, N., Scheithauer, W., Carmichael, J., and Santoro, A. Evaluation of topotecan (Hycamtin) in relapsed small cell lung cancer (SCLC): a multicenter Phase II study (Abstract). Lung Cancer, 18: 35, 1997.
15. Von Pawel, J., Schiller, J. H., Shepherd, F. A., Fields, S. Z., Kleisbauer, J. P., Chrysson, N. G., Stewart, D. J., Clark, P. I., Palmer, M. C., Depierre, A., Carmichael, J., Krebs, J. B., Ross, G., Lane, S. R., and Gralla, R. Topotecan versus cyclophosphamide, doxorubicin and vincristine for the treatment of recurrent small cell lung cancer. J. Clin. Oncol., 17: 658-667, 1999.
16. Miller, A. A., Hargis, J. B., Lilenbaum, R. C., Fields, S. Z., Rosner, G. L., and Schilsky, R. Phase I study of topotecan and cisplatin in patients with advanced solid tumors: a cancer and leukemia group B study. J. Clin. Oncol., 12: 2743-2750, 1994.
17. WHO Handbook for Reporting Results of Cancer Treatment. WHO Offset Publication No. 48. Geneva: WHO, 1979.
18. Simon, R. Optimal two-stage designs for Phase II clinical trials. Controlled Clin. Trials, 10: 1-10, 1989.
19. Kaplan, E. L., and Meier, P. Non-parametric estimation for incomplete observations. J. Am. Stat. Assoc., 53: 457-481, 1958.
20. Johnson, R. K., Mccabe, F. L., and Young, Y. Combination regimens with topotecan in animal tumor models. Ann. Oncol., 3 (Suppl. 1): 85, 1992.
21. Kauffman, S. H. Antagonism between camptothecin and topoisomerase II-directed chemotherapeutic agents in a human leukemia cell line. Cancer Res., 51: 1129-1136, 1991.
22. Miller, A. A., Lilenbaum, R. C., Lynch, T. J., Rosner, G. L., Ratain, M. G., Green, M. R., and Schilsky, R. L. Treatment-related fatal sepsis from topotecan/cisplatin and topotecan/paclitaxel. J. Clin. Oncol., 14: 1964-1965, 1996.
23. Rowinsky, E. K., Kaufmann, S. H., Baker, S. D., Grochow, L. B., Chen, T. L., Peereboom, D., Bowling, M. K., Sartorius, S. E., Ettinger, D. S., Forastiere, A. A., and Donehower, R. C. Sequence of topotecan and cisplatin: Phase I, pharmacologic, and in vitro studies to examine sequence dependence. J. Clin. Oncol., 14: 3074-3084, 1996.
24. Sorensen, M., Jensen, P. B., Herrstedt, J., Hirsch, F. R., and Hansen, H. H. A dose escalating study of topotecan preceding cisplatin in previously untreated patients with small cell lung cancer. Ann. Oncol., 11: 829-835, 2001.
25. Von Pawel, J., Gatzemeier, U., Pujol, J. L., Moreau, L., Bildat, S., Ranson, M., Richardson, G., Steppert, C., Riviere, A., Camlett, I., Lane, S., and Ross, G. Phase II comparator study of oral versus intravenous topotecan in patients with small cell lung cancer. J. Clin. Oncol., 19: 1743-1749, 2001. mc
26. Palshof, T., Riviere, A., Moreau, L., Breton, J. L., Hearn, S., Fields, S. Z., and Ross, G. Phase II study of oral topotecan with cisplatin in advanced, non-resectable NSCLC: a promising combination (Abstract). Lung Cancer, 29: 36, 2000.
27. Smit, E. F., Fokkema, E., Biesma, B., Groen, H. J., Snoek, W., and Postmus, P. E. A Phase II study of paclitaxel in heavily pretreated patients with small cell lung cancer. Br. J. Cancer, 77: 347-351, 1998.
28. Groen, H. J., Fokkema, E., Biesma, B., Kwa, B., van Putten, J. W., Postmus, P. E., and Smit, E. F. Paclitaxel and carboplatin in the treatment of small cell lung cancer patients resistant to cyclophosphamide, doxorubicin, and etoposide: a non-cross-resistant schedule. J. Clin. Oncol., 17: 927-932, 1999.
29. Kakolyris, S., Mavroudis, D., Tsavaris, N., Souglakos, J., Tsiafaki, P., Kalbakis, K., Agelaki, S., Androulakis, N., and Georgoulias, V. Paclitaxel in combination with carboplatin as salvage treatment in refractory small cell lung cancer (SCLC): a multicenter Phase II study. Ann. Oncol., 12: 193-197, 2001.
30. Masuda, N., Fukuoka, M., Kusunoki, Y., Matsui, K., Takifuji, N., Kudoh, S., Negoro, S., Nishioka, M., Nakagawa, K., and Takada, M. CPT-11: a new derivative of camptothecin for the treatment of refractory or relapsed small cell lung cancer. J. Clin. Oncol., 10: 1225-1229, 1992.
31. Noda, K., Nishiwaki, Y., Kawahara, M., Negoro, S., Sugiura, T., Yokoyama, A., Fukuoka, M., Mori, K., Watanabe, K., Tamura, T., Yamamoto, S., and Saijo, N. Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive small cell lung cancer. N. Engl. J. Med., 346: 85-91, 2002.