Phase II study of topotecan with cisplatin in Japanese patients with small cell lung cancer

Anticancer Research

Volumn 31, Issue 10, 2011, Pages 3449-3456

  Hosomi, Yukio ^a   Shibuya, Masahiko ^a   Niho, Seiji ^b   Ichinose, Yukito ^c   Kiura, Katsuyuki ^d   Sakai, Hiroshi ^e   Takeda, Koji ^f   Kudo, Shinzo ^g   Eguchi, Kenji ^h   Matsui, Kaoru ⁱ   Masuda, Noriyuki ^j   Ando, Masahiro ^k   Watanabe, Koshiro ^l  

^a TOKYO METROPOLITAN KOMAGOME HOSPITAL   (Japan)

^b NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

^c NATIONAL KYUSHU CANCER CENTER   (Japan)

^d OKAYAMA UNIVERSITY HOSPITAL   (Japan)

^e SAITAMA CANCER CENTER   (Japan)

^f OSAKA CITY GENERAL HOSPITAL   (Japan)

^g OSAKA CITY UNIVERSITY HOSPITAL   (Japan)

^h TOKAI UNIVERSITY HOSPITAL   (Japan)

ⁱ OSAKA PREFECTURAL MEDICAL CENTER FOR RESPIRATORY AND ALLERGIC DISEASES   (Japan)

^j KITASATO UNIVERSITY HOSPITAL   (Japan)

^k Tsuboi Cancer Center Hospital   (Japan)

^l YOKOHAMA MUNICIPAL CITIZEN'S HOSPITAL   (Japan)

more..

Author keywords

Cisplatin; Small cell lung cancer; Topotecan

Indexed keywords

CISPLATIN; GRANULOCYTE COLONY STIMULATING FACTOR; TOPOTECAN;

ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTICLE; CANCER SURVIVAL; CLINICAL ARTICLE; CONSTIPATION; DIARRHEA; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; EXTENSIVE DISEASE SMALL CELL LUNG CANCER; FATIGUE; FEMALE; FEVER; HICCUP; HUMAN; JAPANESE; LEUKOPENIA; LUNG SMALL CELL CANCER; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA AND VOMITING; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; SURVIVAL RATE; SURVIVAL TIME; THROMBOCYTOPENIA; TREATMENT RESPONSE; WEIGHT REDUCTION;

ADULT; AGED; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; ASIAN CONTINENTAL ANCESTRY GROUP; CISPLATIN; FEMALE; HUMANS; JAPAN; LUNG NEOPLASMS; MALE; MIDDLE AGED; SMALL CELL LUNG CARCINOMA; SURVIVAL ANALYSIS; TOPOTECAN; TREATMENT OUTCOME; YOUNG ADULT;

EID: 80054741764     PISSN: 02507005     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (27)

1. Adjei AA, Marks RS and Bonner JA: Current guidelines for the management of small cell lung cancer. Mayo Clin Proc 74: 809-816, 1999. (Pubitemid 29362588)
2. Pujol JL, Carestia L and Daures JP: Is there a case for cisplatin in the treatment of small-cell lung cancer? A meta-analysis of randomized trials of a cisplatin-containing regimen versus a regimen without this alkylating agent. Br J Cancer 83(1): 8-15, 2000.
3. Sundstrom S, Bremnes RM, Kaasa S, Aasebo Ulf, Hatlevoll R, Dahle R, Boye B, Wang M, Vigander T, Vilsvik J, Skovlund E, Hannisdal E and Aamdal S: Cisplatin and etoposide regimen Is superior to cyclophosphamide, epirubicin, and vincristine regimen in small-cell lung cancer: Results from a randomized phase III trial with 5 years' follow-up. J Clin Oncol 20(24): 4665-4672, 2002.
4. 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(2): 85-91, 2002. (Pubitemid 34438898)
5. Kollmannsberger C, Mross K, Jakob A, Kanz L and Bokemeyer C: Topotecan a novel topoisomerase I inhibitor: Pharmacology and clinical experience. Oncology 56: 1-12, 1999. (Pubitemid 29043890)
6. Kaufmann SH, Peereboom D, Buckwalter CA, Svingen PA, Grochow LB, Donehower RC and Rowinsky EK: Cytotoxic effects of topotecan combined with various anticancer agents in human cancer cell line. J Nati Cancer Inst 88(11): 734- 741, 1996.
7. Rowinsky EK, Kaufmann SH, Baker SD, Grochow LB, Chen TL, Peereboom D, Bowling MK, Sartorius SE, Ettinger DS, Arlene E and Donehower C: Sequences of topotecan and cisplatin: phase I, pharmacologic, and in vitro studies to examine sequence dependence. J Clin Oncol 14: 3074-3084, 1996. (Pubitemid 26408800)
8. Huinink WB, Gore M, Carmichael J, Gordon A, Malfetano J, Hudson I, Broom C, Scarabelli C, Davidson N, Spanczynski M, Bolis G, Malmstrom H, Coleman R, Fields SC and Heron J-F: Topotecan versus paclitaxel for the treatment of recurrent epithelial ovarian cancer. J Clin Oncol 15: 2183-2193, 1997. (Pubitemid 27251118)
9. Long III HJ, Bundy BN, Grendys EC, Benba JA, McMeekin DS, Sorosky J, Miller DS, Eaton LA and Fiorica J: Randomized phase III trial of cisplatin with or without topotecan in carcinoma of the uterine cervix: A Gynecologic Oncology Group Study. J Clin Oncol 23: 4626-4633, 2005. (Pubitemid 46224065)
10. Ardizzoni A, Manegold C, Debruyne C, Gaafar R, Buchholz E, Smit EF, Lianes P, Velde Gt, Bosquee L, Legrand C, Neumaier C, King K and Giaccone G: 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 9: 143-150, 2003. (Pubitemid 36109726)
11. Miller AA, Hargis JB, Lilenbaum RC, Field SZ, Rosner GL and Schilsky RL: 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. (Pubitemid 24379664)
12. Sorenson M, Jensen PB, Herrstedt J, Hirsch FR and Hansen HH. A dose escalating study of topotecan preceding cisplatin in previously untreated patients with small- cell lung cancer. Ann Oncol 11: 829-835, 2000.
13. Heigener DF, Freitag L, Eschbach C, Huber RH, Fink T, Hummler S, Banik N and Wolf M: Topotecan/cisplatin (TP) compared to cisplatin/etoposide (PE) for patients with extensive disease-small cell lung cancer (ED-SCLC): Final results of a randomized phase III trial. J Clin Oncol ASCO Ann Meet Proc 26: 7513, 2008.
14. Eckardt JR, Pawel J, Papai Z, Tomova A, Tzekova V, Crofts TE, Brannon S, Wissel P and Ross G: Open-Label, Multicenter, Randomized, phase III study comparing oral topotecan/cisplatin versus etoposide/cisplatin as treatment for chemotherapy-naive patients with extensive disease small cell lung cancer. J Clin Oncol 24: 2044-2051, 2006. (Pubitemid 46622113)
15. Kudoh S, Fujiwara Y, Takeda Y, Ymamoto H, Kinoshita A, Ariyoshi Y, Furuse K and Fukuoka M: Phase II study of irinotecan combination with cisplatin in patients with previously untreated small-cell lung cancer. J Clin Oncol 16: 1068-1074, 1998. (Pubitemid 28108742)
16. Ichinose Y, Seto T, Nishiwaki Y, Kiura K, Sakai H, Yokoyama A, Segawa Y, Ando M and Watanabe K: Phase I study of Topotecan and Cisplatin in patients with small cell lung cancer. Jpn J Clin Oncol 41(2): 197-203, 2011.
17. Homepage/Web site [Edited 9 Aug 2006], Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events Version 3.0. [cited 2006 Aug. 9]. Available at; http://ctep.cancer.gov/protocolDevelopment/electronic- applications/ctc.htm.
18. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC and Geyther SG: New guidelines to evaluate the response to treatment in solid tumor (RECIST Guidelines). J Natl Cancer Inst 92: 205-216, 2000. (Pubitemid 30099779)
19. Miller AA, Lilenbaum RC, Lynch TJ, Rosner GL, Ratain MJ, Green MR and Schilsky RL: Treatment-related fatal sepsis from topotecan/cisplatin and topotecan/paclitaxel. J Clin Oncol 4(6): 1964-1965, 1996.
20. Rowinsky EK, and Verweij J: Review of Phase I Clinical study with topotecan. Sem Oncol 24: S20-3-S20-10, 1997.
21. Schiller JH, Kim KM, Hutson P, DeVore R, Glick J, Stewart J, and Johnson D: Phase II study of topotecan in patients with extensive- stage small- cell carcinoma of the lung: An eastern cooperative oncology group trial. J Clin Oncol 14: 2345-2352, 1996. (Pubitemid 26264887)
22. Lara PN Jr. Natale R, Crowley J, Lenz HL, Redman MW, Carleton JE, Jett J, Langer CJ, Kuebler P, Dakhil SR, Chansky K and Gandara DR: Phase III trial of irinotecan/cisplatin compared with etoposide/cisplatin in extensive stage small cell lung cancer: Clinical and pharmacogenomic results from SWOG S0124. J Clin Oncol 27: 2530-2535, 2009.
23. Hanna N, Bunn Jr. PA, Langer C, Einhorn L, Guthrie T Jr., Beck T, Ansari R, Ellis P, Byene M, Morrison M, Hariharan S, Wang B and Sandler A: Randomized phase III trial comparing irinotecan/cisplatin with etoposide/cisplatin in patients with previously untreated extensive stage disease small cell lung Cancer. J Clin Oncol 24: 2038-2043, 2006. (Pubitemid 46622112)
24. Han JY, Lee DH, Lee SY, Park CG, Kim HY, Kim EA, Yoon SM, Lee HGi and Lee JS: A phase II study of dose-intensified weekly concomitant administration of cisplatin and irinotecan in chemo-naive patients with extensive disease small cell lung cancer. Med Oncol 22: 281-290, 2005.
25. Lee JE, Park HS, Jung SS, Kim JO and Kim SY: Phase II study of 3-week schedule of irinotecan combined with cisplatin in previously untreated extensive stage small cell lung cancer. Oncology 73: 76-80, 2007. (Pubitemid 351465604)
26. Bas SH, Ryoo HM, Do YR, Song HS, Kwon KY, Kim MK, Lee KH, Hyun MS, Lee WS, Hur InK, Baek JH and Park KU: A Phase II study of biweekly irinotecan and cisplatin for patients with extensive stage disease small cell lung cancer. Lung Cancer 59: 76-80, 2008.
27. Thatcher N, Chang A, Parikh P, Pereira JR, Ciuleanu T, Pawel JV, Thongprasert S, Tan EH, Pemberton K, Archer V and Carroll K: Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small cell lung cancer: results from a randomized, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer). Lancet 366: 1527-1537, 2005. (Pubitemid 41540110)