Rituximab monotherapy with eight weekly infusions for relapsed or refractory patients with indolent B cell non-Hodgkin lymphoma mostly pretreated with rituximab: A multicenter phase II study

Cancer Science

Volumn 102, Issue 9, 2011, Pages 1698-1705

  Tobinai, Kensei ^a   Igarashi, Tadahiko ^b   Itoh, Kuniaki ^c   Kurosawa, Mitsutoshi ^d   Nagai, Hirokazu ^e   Hiraoka, Akira ^f,m   Kinoshita, Tomohiro ^g,i   Uike, Naokuni ^h   Ogura, Michinori ^i,n   Nawano, Shigeru ^j   Mori, Shigeo ^k   Ohashi, Yasuo ^l  

^a NATIONAL CANCER CENTER HOSPITAL   (Japan)

^b GUNMA PREFECTURAL CANCER CENTER   (Japan)

^c NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

^d HOKKAIDO CANCER CENTER   (Japan)

^e NATIONAL HOSPITAL ORGANIZATION NAGOYA MEDICAL CENTER   (Japan)

^f OSAKA MEDICAL CENTER FOR CANCER AND CARDIOVASCULAR DISEASES   (Japan)

^g NAGOYA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^h NATIONAL KYUSHU CANCER CENTER   (Japan)

ⁱ AICHI CANCER CENTER HOSPITAL   (Japan)

^j International University of Health and Welfare Mita Hospital   (Japan)

^k TEIKYO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^l UNIVERSITY OF TOKYO   (Japan)

^m Osaka Chuo Byoin   (Japan)

ⁿ NAGOYA DAINI RED CROSS HOSPITAL   (Japan)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTIHISTAMINIC AGENT; ANTIPYRETIC AGENT; CD20 ANTIGEN; RITUXIMAB;

ABDOMINAL PAIN; ACUTE PANCREATITIS; ANOREXIA; ANTIGEN EXPRESSION; ARTICLE; BLOOD TOXICITY; BRONCHOPNEUMONIA; BRONCHOSPASM; CANCER SURGERY; CHILL; CLINICAL ARTICLE; COLON ADENOCARCINOMA; COMPUTER ASSISTED TOMOGRAPHY; CONSTIPATION; CYTOPENIA; DIARRHEA; DIZZINESS; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG ERUPTION; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG WITHDRAWAL; DYSPEPSIA; DYSPNEA; ECZEMA; ERYTHEMA; EYELID ECZEMA; FEBRILE NEUTROPENIA; FEMALE; FEVER; FOLLOW UP; HEPATITIS B; HERPES VIRUS INFECTION; HERPES ZOSTER; HUMAN; HYPERBILIRUBINEMIA; HYPERKALEMIA; HYPOALBUMINEMIA; HYPOKALEMIA; IMMUNOGLOBULIN BLOOD LEVEL; INFECTION; INFUSION REACTION; LEUKOPENIA; LIVER CIRRHOSIS; MALE; MONOTHERAPY; MOUTH DISEASE; MULTICENTER STUDY; NEUTROPENIA; NONHODGKIN LYMPHOMA; OCCULT BLOOD; OROPHARYNGEAL DISCOMFORT; OROPHARYNGEAL PAIN; PHARYNX DISEASE; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGNOSIS; PROGRESSION FREE SURVIVAL; PRURITUS; SCROTAL SWELLING; SIDE EFFECT; STOMATITIS; THROMBOCYTOPENIA; TREATMENT RESPONSE; URTICARIA; VOMITING; WEIGHT REDUCTION;

ADULT; AGED; ANTIBODIES, MONOCLONAL, MURINE-DERIVED; ANTINEOPLASTIC AGENTS; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; LYMPHOMA, B-CELL; MIDDLE AGED; RECURRENCE; RETREATMENT;

EID: 80051813429     PISSN: 13479032     EISSN: 13497006     Source Type: Journal    
DOI: 10.1111/j.1349-7006.2011.02001.x     Document Type: Article

References (37)

1. Czuczman MS, Grillo-Lopez AJ, White CA et al. Treatment of patients with low-grade B-cell lymphoma with the combination of chimeric anti-CD20 monoclonal antibody and CHOP chemotherapy. J Clin Oncol 1999; 17: 268-76.
2. Hiddemann W, Kneba M, Dreyling M et al. Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) significantly improves the outcome for patients with advanced-stage follicular lymphoma compared with therapy with CHOP alone: results of a prospective randomized study of the German low-grade lymphoma study group. Blood 2005; 106: 3725-32.
3. Tobinai K, Ogura M, Itoh K et al. Randomized Phase II study of concurrent and sequential combinations of rituximab plus CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) chemotherapy in untreated indolent B-cell non-Hodgkin lymphoma: 7-year follow-up results. Cancer Sci 2010; 101: 2579-85.
4. Coiffier B, Lepage E, Briere J et al. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med 2002; 346: 235-42.
5. Habermann TM, Weller EA, Morrison VA et al. Rituximab-CHOP versus CHOP alone or with maintenance rituximab in older patients with diffuse large B-cell lymphoma. J Clin Oncol 2006; 24: 3121-7.
6. Horning JS. Follicular lymphoma, survival and rituximab: is it time to declare victory? J Clin Oncol 2008; 26: 4537-8.
7. Liu Q, Fayad L, Cabanillas F et al. Improvement of overall and failure-free survival in stage IV follicular lymphoma: 25years of treatment experience at the University of Texas M.D. Anderson cancer center. J Clin Oncol 2006; 24: 1582-9.
8. Fisher RI, LeBlanc M, Press OW et al. New treatment options have changed the survival of patients with follicular lymphoma. J Clin Oncol 2005; 23: 8447-52.
9. McLaughlin P, Grillo-López AJ, Link BK et al. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol 1998; 16: 2825-33.
10. Igarashi T, Kobayashi Y, Ogura M et al. Factors affecting toxicity, response and progression-free survival in relapsed patients with indolent B-cell lymphoma and mantle cell lymphoma treated with rituximab: a Japanese phase II study. Ann Oncol 2002; 13: 928-43.
11. Hainsworth JD, Litchy S, Burris HA 3rd et al. Rituximab as first-line and maintenance therapy for patients with indolent non-Hodgkin's lymphoma. J Clin Oncol 2002; 20: 4261-7.
12. Forstpointner R, Unterhalt M, Dreyling M et al. Maintenance therapy with rituximab leads to a significant prolongation of response duration after salvage therapy with a combination of rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) in patients with recurring and refractory follicular and mantle cell lymphomas: results of a prospective randomized study of the German low grade lymphoma study group (GLSG). Blood 2006; 108: 4003-8.
13. van Oers MH, Klasa R, Marcus RE et al. Rituximab maintenance improves clinical outcome of relapsed/resistant follicular non-Hodgkin lymphoma in patients both with and without rituximab during induction: results of a prospective randomized phase 3 intergroup trial. Blood 2006; 108: 3295-301.
14. Hochster H, Weller E, Gascoyne RD et al. Maintenance rituximab after cyclophosphamide, vincristine, and prednisone prolongs progression-free survival in advanced indolent lymphoma: results of the randomized phase III ECOG1496 study. J Clin Oncol 2009; 27: 1607-14.
15. Ghielmini M, Schmitz SF, Cogliatti SB et al. Prolonged treatment with rituximab in patients with follicular lymphoma significantly increases event free survival and response duration compared with the standard weekly × 4 schedule. Blood 2004; 103: 4416-23.
16. Salles G, Seymour JF, Offner F et al. Rituximab maintenance for 2years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial. Lancet 2011; 377: 42-51.
17. Coiffier B, Haioun C, Ketterer N et al. Rituximab (anti-CD20 monoclonal antibody) for the treatment of patients with relapsing or refractory aggressive lymphoma: a multicenter phase II study. Blood 1998; 92: 1927-32.
18. Tobinai K, Igarashi T, Itoh K et al. Japanese multicenter phase II and pharmacokinetic study of rituximab in relapsed or refractory patients with aggressive B-cell lymphoma. Ann Oncol 2004; 15: 821-30.
19. Piro LD, White CA, Grillo-López AJ et al. Extended rituximab (anti-CD20 monoclonal antibody) therapy for relapsed or refractory low-grade or follicular non-Hodgkin's lymphoma. Ann Oncol 1999; 10: 655-61.
20. Davis TA, Grillo-López AJ, White CA et al. Rituximab anti-CD20 monoclonal antibody therapy in non-Hodgkin's lymphoma: safety and efficacy of re-treatment. J Clin Oncol 2000; 18: 3135-43.
21. Igarashi T, Ohtsu T, Fujii H et al. Re-treatment of relapsed indolent B-cell lymphoma with rituximab. Int J Hematol 2001; 73: 213-21.
22. Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics 1982; 38: 143-51.
23. Jaffe ES, Harris NL, Stein H, Vardiman JW. World Health Organization Classification of Tumours: Pathology and Genetics of Tumours of Haematopoietic and Lymphoid Tissues. Lyon: IARC Press, 2001.
24. Oken MM, Creech RH, Tormey DC et al. Toxicity and response criteria of the eastern cooperative oncology group. Am J Clin Oncol 1982; 5: 649-55.
25. Tobinai K, Watanabe T, Ogura M et al. Phase II study of oral fludarabine phosphate in relapsed indolent B-cell non-Hodgkin's lymphoma. J Clin Oncol 2006; 24: 174-80.
26. Tobinai K, Kobayashi Y, Narabayashi M et al. Feasibility and pharmacokinetic study of a chimeric anti-CD20 monoclonal antibody (IDEC-C2B8, rituximab) in relapsed B-cell lymphoma. Ann Oncol 1998; 9: 527-34.
27. Tobinai K, Kohno A, Shimada Y et al. Toxicity grading criteria of the Japan clinical oncology group (JCOG). Jpn J Clin Oncol 1993; 23: 250-7.
28. Cheson BD, Horning SJ, Coiffier B et al. 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.
29. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53: 457-81.
30. Mantel L. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep 1966; 50: 163-70.
31. Carbone PP, Kaplan HS, Musshoff K et al. Report of the Committee on Hodgkin's Disease Staging Classification. Cancer Res 1971; 31: 1860-1.
32. Solal-Celigny P, Roy P, Colombat P et al. Follicular lymphoma international prognostic index. Blood 2004; 104: 1258-65.
33. Maloney DG, Grillo-Lopez AJ, White CA et al. IDEC-C2B8 (rituximab) anti-CD20 monoclonal antibody therapy in patients with relapsed low-grade non-Hodgkin's lymphoma. Blood 1997; 90: 2188-95.
34. Foran JM, Rohatiner AZ, Cunningham D et al. European phase II study of rituximab (chimeric anti-CD20 monoclonal antibody) for patients with newly diagnosed mantle-cell lymphoma and previously treated mantle-cell lymphoma, immunocytoma, and small B-cell lymphocytic lymphoma. J Clin Oncol 2000; 18: 317-24.
35. Martin A, Conde E, Arnan M et al. R-ESHAP as salvage therapy for patients with relapsed or refractory diffuse large B-cell lymphoma: the influence of prior exposure to rituximab on outcome. A GEL/TAMO study. Haematologica 2008; 93: 1829-36.
36. Gisselbrecht C, Glass B, Mounier N et al. Salvage regimens with autologous transplantation for relapsed large B-cell lymphoma in the rituximab era. J Clin Oncol 2010; 28: 4184-90.
37. van Oers MH, Van Glabbeke M, Giurgea L et al. Rituximab maintenance treatment of relapsed/resistant follicular non-Hodgkin's lymphoma: long-term outcome of the EORTC 20981 phase III randomized intergroup study. J Clin Oncol 2010; 28: 2853-8.