Randomized phase 2 study of subcutaneous amifostine versus epoetin-α given 3 times weekly during concurrent chemotherapy and hyperfractionated radiotherapy for limited-disease small cell lung cancer

Cancer

Volumn 113, Issue 7, 2008, Pages 1623-1631

  Han, Hye Suk ^a   Han, Ji Youn ^a   Yu, Sun Young ^a   Pyo, Hong Ryull ^a   Kim, Hyae Young ^a   Cho, Kwan Ho ^a   Lee, Dae Ho ^a   Kim, Heung Tae ^a   Lee, Jin Soo ^a  

^a National Cancer Center   (South Korea)

Author keywords

Amifostine; Concurrent chemoradiotherapy; Epoetin ; Small cell lung cancer

Indexed keywords

AMIFOSTINE; ANTINEOPLASTIC AGENT; RADIOPROTECTIVE AGENT; RECOMBINANT ERYTHROPOIETIN;

AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG ADMINISTRATION; FEMALE; HUMAN; LUNG TUMOR; MALE; MIDDLE AGED; MULTIMODALITY CANCER THERAPY; PHASE 2 CLINICAL TRIAL; RADIATION DOSE FRACTIONATION; RANDOMIZED CONTROLLED TRIAL; SMALL CELL CARCINOMA; SUBCUTANEOUS DRUG ADMINISTRATION; SURVIVAL;

AGED; AMIFOSTINE; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, SMALL CELL; COMBINED MODALITY THERAPY; DOSE FRACTIONATION; DRUG ADMINISTRATION SCHEDULE; EPOETIN ALFA; FEMALE; HUMANS; INJECTIONS, SUBCUTANEOUS; LUNG NEOPLASMS; MALE; MIDDLE AGED; RADIATION-PROTECTIVE AGENTS; SURVIVAL ANALYSIS;

EID: 54049111029     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.23790     Document Type: Article

References (36)

1. Pignon JP, Arriagada R, Ihde DC, et al. A meta-analysis of thoracic radiotherapy for small-cell lung cancer. N Engl J Med. 1992;327:1618-1624.
2. Warde P, Payne D. Does thoracic irradiation improve survival and local control in limited-stage small-cell carcinoma of the lung? A meta-analysis. J Clin Oncol. 1992;10:890-895.
3. Chua YJ, Steer C, Yip D. Recent advances in management of small-cell lung cancer. Cancer Treat Rev. 2004;30:521-543. (Pubitemid 39157853)
4. Kurup A, Hanna NH. Treatment of small cell lung cancer. Crit Rev Oncol Hematol. 2004;52:117-126. (Pubitemid 39410539)
5. Turrisi AT 3rd, Kim K, Blum R, et al. Twice-daily compared with once-daily thoracic radiotherapy in limited small-cell lung cancer treated concurrently with cisplatin and etoposide. N Engl J Med. 1999;340:265-271. (Pubitemid 29063268)
6. Noda K, Nishiwaki Y, Kawahara M, et al. Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive small-cell lung cancer. N Engl J Med. 2002;346:85-91. (Pubitemid 34438898)
7. Han JY, Cho KH, Lee DH, et al. Phase II study of irinotecan plus cisplatin induction followed by concurrent twice-daily thoracic irradiation with etoposide plus cisplatin chemotherapy for limited-disease small-cell lung cancer. J Clin Oncol. 2005;23:3488-3494.
8. Bensadoun RJ, Schubert MM, Lalla RV, Keefe D. Amifostine in the management of radiation-induced and chemoinduced mucositis. Support Care Cancer. 2006;14:566-572.
9. Kouvaris JR, Kouloulias VE, Vlahos LJ. Amifostine: the first selective-target and broad-spectrum radioprotector. Oncologist. 2007;12:738-747. (Pubitemid 47036208)
10. Yuhas JM, Spellman JM, Culo F. The role of WR-2721 in radiotherapy and/or chemotherapy. Cancer Clin Trials. 1980;3:211-216. (Pubitemid 10010778)
11. Kemp G, Rose P, Lurain J, et al. Amifostine pretreatment for protection against cyclophosphamide-induced and cisplatin-induced toxicities: results of a randomized control trial in patients with advanced ovarian cancer. J Clin Oncol. 1996;14:2101-2112. (Pubitemid 26230113)
12. Sasse AD, Clark LG, Sasse EC, Clark OA. Amifostine reduces side effects and improves complete response rate during radiotherapy: results of a meta-analysis. Int J Radiat Oncol Biol Phys. 2006;64:784-791.
13. Schuchter LM, Hensley ML, Meropol NJ, Winer EP; American Society of Clinical Oncology Chemotherapy and Radiotherapy Expert Panel. 2002 update of recommendations for the use of chemotherapy and radiotherapy protectants: clinical practice guidelines of the American Society of Clinical Oncology. J Clin Oncol. 2002;20:2895-2903.
14. Antonadou D, Throuvalas N, Petridis A, Bolanos N, Sagriotis A, Synodinou M. Effect of amifostine on toxicities associated with radiochemotherapy in patients with locally advanced non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2003;57:402-408. (Pubitemid 37040936)
15. Komaki R, Lee JS, Milas L, et al. Effects of amifostine on acute toxicity from concurrent chemotherapy and radiotherapy for inoperable non-small-cell lung cancer: report of a randomized comparative trial. Int J Radiat Oncol Biol Phys. 2004;58:1369-1377. (Pubitemid 38438296)
16. Gridelli C, Cigolari S, Maiorino A, et al. Amifostine plus cisplatin plus vinorelbine in the treatment of advanced non small cell lung cancer: a multicenter phase II study. Lung Cancer. 2000;28:237-244. (Pubitemid 30254231)
17. Antonadou D, Coliarakis N, Synodinou M, et al. Clinical Radiation Oncology Hellenic Group. Randomized phase III trial of radiation treatment ± amifostine in patients with advanced-stage lung cancer. Int J Radiat Oncol Biol Phys. 2001;51:915-922. (Pubitemid 33028882)
18. Senzer N. A phase III randomized evaluation of amifostine in stage IIIA/IIIB non-small cell lung cancer patients receiving concurrent carboplatin, paclitaxel, and radiation therapy followed by gemcitabine and cisplatin intensification: preliminary findings. Semin Oncol. 2002;29(suppl 19):38-41. (Pubitemid 36173245)
19. Leong SS, Tan EH, Fong KW, et al. Randomized double-blind trial of combined modality treatment with or without amifostine in unresectable stage III non-small-cell lung cancer. J Clin Oncol. 2003;21:1767-1774. (Pubitemid 46638590)
20. Movsas B, Scott C, Langer C, et al. Randomized trial of amifostine in locally advanced non-small-cell lung cancer patients receiving chemotherapy and hyperfractionated radiation: Radiation Therapy Oncology Group trial 98-01. J Clin Oncol. 2005;23:2145-2154. (Pubitemid 46218706)
21. Wood PA, Hrushesky WJ. Cisplatin-associated anemia: an erythropoietin deficiency syndrome. J Clin Invest. 1995;95:1650-1659.
22. Kosmidis P, Krzakowski M; The ECAS Investigators. Anemia profiles in patients with lung cancer: what have we learned from the European Cancer Anaemia Survey (ECAS)? Lung Cancer. 2005;50:401-412.
23. Cascinu S, Fedeli A, Del Ferro E, Luzi Fedeli S, Catalano G. Recombinant human erythropoietin treatment in cisplatin-associated anemia: a randomized, double-blind trial with placebo. J Clin Oncol. 1994;12:1058-1062. (Pubitemid 24145337)
24. Henry DH, Abels RI. Recombinant human erythropoietin in the treatment of cancer and chemotherapy-induced anemia: results of double-blind and open-label follow-up studies. Semin Oncol. 1994;21(suppl 3):21-28. (Pubitemid 24172366)
25. Demetri GD, Kris M, Wade J, Degos L, Cella D. Quality-of-life benefit in chemotherapy patients treated with epoetin alfa is independent of disease response or tumor type: results from a prospective community oncology study. Procrit Study Group. J Clin Oncol. 1998;16:3412-3425. (Pubitemid 28481641)
26. World Health Organization. WHO Handbook for Reporting Results of Cancer Treatment: WHO Offset Pub. No. 48. Geneva: World Health Organization; 1979.
27. Koukourakis MI, Kyrias G, Kakolyris S, et al. Subcutaneous administration of amifostine during fractionated radiotherapy: a randomized phase II study. J Clin Oncol. 2000;18:2226-2233. (Pubitemid 30350214)
28. Anne PR, Machtay M, Rosenthal DI, et al. A phase II trial of subcutaneous amifostine and radiation therapy in patients with head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2007;67:445-452. (Pubitemid 46108306)
29. Jellema AP, Slotman BJ, Muller MJ, et al. Radiotherapy alone, versus radiotherapy with amifostine 3 times weekly, versus radiotherapy with amifostine 5 times weekly: a prospective randomized study in squamous cell head and neck cancer. Cancer. 2006;107:544-553. (Pubitemid 44107215)
30. Komaki R, Lee JS, Kaplan B, et al. Randomized phase III study of chemoradiation with or without amifostine for patients with favorable performance status inoperable stage II-III non-small cell lung cancer: preliminary results. Semin Radiat Oncol. 2002;12(suppl 1):46-49. (Pubitemid 34246068)
31. Shaw LM, Turrisi AT, Glover DJ, et al. Human pharmacokinetics of WR-2721. Int J Radiat Oncol Biol Phys. 1986;12:1501-1504. (Pubitemid 16030648)
32. Cassatt DR, Fazenbaker CA, Kifle G, Bachy CM. Effects of dose and schedule on the efficacy of ethyol: preclinical studies. Semin Oncol. 2003;30(suppl 18):31-39. (Pubitemid 38120497)
33. Dunst J. The use of epoetin alfa to increase and maintain hemoglobin levels during radiotherapy. Semin Oncol. 2001;28(2 suppl 8):42-48. (Pubitemid 32522237)
34. Henke M, Laszig R, Rube C, et al. Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: randomised, double-blind, placebo-controlled trial. Lancet. 2003;362:1255-1260. (Pubitemid 37324251)
35. Machtay M, Pajak TF, Suntharalingam M, et al. Radiotherapy with or without erythropoietin for anemic patients with head and neck cancer: a randomized trial of the Radiation Therapy Oncology Group (RTOG 99-03). Int J Radiat Oncol Biol Phys. 2007;69:1008-1017. (Pubitemid 47625834)
36. Wright JR, Ung YC, Julian JA, et al. Randomized, double-blind, placebo-controlled trial of erythropoietin in non-small-cell lung cancer with disease-related anemia. J Clin Oncol. 2007;25:1027-1032. (Pubitemid 46596751)