Phase I and pharmacokinetic study of bendamustine hydrochloride in relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma

Cancer Science

Volumn 101, Issue 9, 2010, Pages 2054-2058

  Ogura, Michinori ^a   Uchida, Toshiki ^a   Taniwaki, Masafumi ^b   Ando, Kiyoshi ^c   Watanabe, Takashi ^d   Kasai, Masanobu ^a   Matsumoto, Yosuke ^b   Shimizu, Daisuke ^b   Ogawa, Yoshiaki ^c   Ohmachi, Ken ^c   Yokoyama, Hiroki ^d   Tobinai, Kensei ^d  

^a NAGOYA DAINI RED CROSS HOSPITAL   (Japan)

^b KYOTO PREFECTURAL UNIVERSITY OF MEDICINE   (Japan)

^c TOKAI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^d NATIONAL CANCER CENTER HOSPITAL   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

BENDAMUSTINE;

ADULT; AGED; ANOREXIA; ARTICLE; CANCER RELAPSE; CANCER STAGING; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG ELIMINATION; DRUG EXCRETION; DRUG HALF LIFE; DRUG SAFETY; DYSPNEA; FATIGUE; FEMALE; GASTROINTESTINAL SYMPTOM; HEART PALPITATION; HISTOLOGY; HUMAN; HUMAN TISSUE; INTERSTITIAL PNEUMONIA; LEUKOPENIA; MALE; MANTLE CELL LYMPHOMA; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; NONHODGKIN LYMPHOMA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; THORAX PAIN; TREATMENT RESPONSE; VOMITING;

ADULT; AGED; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG RESISTANCE, NEOPLASM; FEMALE; HUMANS; LEUKOPENIA; LUNG DISEASES, INTERSTITIAL; LYMPHOMA, B-CELL; LYMPHOMA, MANTLE-CELL; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; MOLECULAR STRUCTURE; NEUTROPENIA; NITROGEN MUSTARD COMPOUNDS; RECURRENCE; TREATMENT OUTCOME;

EID: 77955937622     PISSN: 13479032     EISSN: 13497006     Source Type: Journal    
DOI: 10.1111/j.1349-7006.2010.01633.x     Document Type: Article

References (23)

1. Strumberg D, Harstrick A, Doll K, Hoffmann B, Seeber S. Bendamustine hydrochloride activity against doxorubicin-resistant human breast carcinoma cell lines. Anticancer Drugs 1996, 7:415-21.
2. Niemeyer CC, Bailey B, Riefert J. SDX-105 (bendamustine is a clinically active chemotherapeutic agent with a distinct mechanism of action. Proc Am Assoc Cancer Res 2004, 45:1129.
3. Leoni LM, Bailey B, Reifert J. Bendamustine (Treanda) displays a distinct pattern of cytotoxicity and unique mechanistic features compared with other alkylating agents. Clin Cancer Res 2008, 14:309-17.
4. Heider A, Niederle N. Efficacy and toxicity of bendamustine in patients with relapsed low-grade non-Hodgkin's lymphomas. Anticancer Drugs 2001, 12:725-9.
5. Friedberg JW, Cohen P, Chen L. Bendamustine in patients with rituximab-refractory indolent and transformed non-Hodgkin's lymphoma: results from a phase II multicenter, single-agent study. J Clin Oncol 2008, 26:204-10.
6. Kahl B, Carbone PP, Bartlett N, Leonard J, Chen L. Bendamustine is effective therapy in patients with rituximab-refractory indolent B-cell non-Hodgkin's lymphoma: results from a multicenter study. Cancer 2010, 116:106-14.
7. Bremer K. High rates of long-lasting remissions after 5-day bendamustine chemotherapy cycles in pre-treated low-grade non-Hodgkin's-lymphomas. J Cancer Res Clin Oncol 2002, 128:603-9.
8. Robinson KS, Williams ME, van der Jagt RH. Phase II multicenter study of bendamustine plus rituximab in patients with relapsed indolent B-cell and mantle cell non-Hodgkin's lymphoma. J Clin Oncol 2008, 26:4473-9.
9. Rummel MJ, Niederle N, Maschmeyer G, Banat A, Von Gruenhagen U. Bendamustine plus rituximab is superior in respect of progression free survival and CR rate when compared to CHOP plus rituximab as first-line treatment of patients with advanced follicular, indolent, and mantle cell lymphomas: final results of a randomized phase III study of the Stil (Study Group Indolent Lymphomas, Germany). Blood 2009, 114:405. (ASH Annual Meeting Abstracts)
10. Rasschaert M, Schrijvers D, Van den Brande J. A phase I study of bendamustine hydrochloride administered day 1 + 2 every 3 weeks in patients with solid tumours. Br J Cancer 2007, 96:1692-8.
11. Rasschaert M, Schrijvers D, Van den Brande J. A phase I study of bendamustine hydrochloride administered once every 3 weeks in patients with solid tumors. Anticancer Drugs 2007, 18:587-95.
12. Schoffski P, Hagedorn T, Grunwald V. Repeated administration of short infusions of bendamustine: a phase I study in patients with advanced progressive solid tumours. J Cancer Res Clin Oncol 2000, 126:41-7.
13. Bergmann MA, Goebeler ME, Herold M. Efficacy of bendamustine in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase I/II study of the German CLL Study Group. Haematologica 2005, 90:1357-64.
14. Lissitchkov T, Arnaudov G, Peytchev D, Merkle K. Phase I/II study to evaluate dose limiting toxicity, maximum tolerated dose, and tolerability of bendamustine HCl in pre-treated patients with B-chronic lymphocytic leukaemia (Binet stages B and C) requiring therapy. J Cancer Res Clin Oncol 2006, 132:99-104.
15. World Health Organization Classification of Tumors. Pathology and Genetics of Tumors of Hematopoietic and Lymphoid Tissues. 2001, 119-187. Jaffe ESHarris NLStein HVardiman JW. 3rd edn, Geneva, Switzerland, International Agency for Research on Cancer (IARC) Press
16. Oken MM, Creech RH, Tormey DC. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982, 5:649-55.
17. Rummel MJ, Al-Batran SE, Kim SZ. Bendamustine plus rituximab is effective and has a favorable toxicity profile in the treatment of mantle cell and low-grade non-Hodgkin's lymphoma. J Clin Oncol 2005, 23:3383-9.
18. Common Terminology Criteria for Adverse Events v3.0 (CTCAE) 2006, http://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcaev3.pdf, Cancer Therapy Evaluation Program, Bethesda, MD, National Cancer Institute, US National Institutes of Health, Available from URL
19. Cheson BD, Horning SJ, Coiffier B. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI sponsored international working group. J Clin Oncol 1999, 17:1244-53.
20. Teichert J, Baumann F, Chao Q. Characterization of two phase I metabolites of bendamustine in human liver microsomes and in cancer patients treated with bendamustine hydrochloride. Cancer Chemother Pharmacol 2007, 59:759-70.
21. Herold M, Schulze A, Niederwieser D. Bendamustine, vincristine and prednisone (BOP) versus cyclophosphamide, vincristine and prednisone (COP) in advanced indolent non-Hodgkin's lymphoma and mantle cell lymphoma: results of a randomised phase III trial (OSHO# 19). J Cancer Res Clin Oncol 2006, 132:105-12.
22. Owen JS, Melhem M, D'Andrea D, Darwish M. Population pharmacokinetics of bendamustine and metabolites in patients with indolent non-Hodgkin lymphoma. Pharmacol Ther 2008, 83(Suppl 1):S54.
23. Matthias M, Preiss R, Sohr R, Possinger K. Pharmacokinetics of bendamustine in patients with malignant tumors. Proc Am Soc Clin Oncol 1995, 14:458.