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VCAP-AMP-VECP compared with biweekly CHOP for adult T-cell leukemia-lymphoma: Japan Clinical Oncology Group Study JCOG9801.

AbstractPURPOSE:
Our previous phase II trial for treating human T-lymphotropic virus type I-associated adult T-cell leukemia-lymphoma (ATLL) with vincristine, cyclophosphamide, doxorubicin, and prednisone (VCAP), doxorubicin, ranimustine, and prednisone (AMP), and vindesine, etoposide, carboplatin, and prednisone (VECP) showed promising results. To test the superiority of VCAP-AMP-VECP over biweekly cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP), we conducted a randomized controlled trial exclusively for ATLL.
PATIENTS AND METHODS:
Previously untreated patients with aggressive ATLL were assigned to receive either six courses of VCAP-AMP-VECP every 4 weeks or eight courses of biweekly CHOP. Both treatments were supported with granulocyte colony-stimulating factor and intrathecal prophylaxis.
RESULTS:
A total of 118 patients were enrolled. The complete response (CR) rate was higher in the VCAP-AMP-VECP arm than in biweekly CHOP arm (40% v 25%, respectively; P = .020). Progression-free survival rate at 1 year was 28% in the VCAP-AMP-VECP arm compared with 16% in the CHOP arm (P = .100, two-sided P = .200). Overall survival (OS) at 3 years was 24% in the VCAP-AMP-VECP arm and 13% in the CHOP arm (P = .085, two-sided P = .169). For VCAP-AMP-VECP versus biweekly CHOP, grade 4 neutropenia, grade 4 thrombocytopenia, and grade 3 or 4 infection rates were 98% v 83%, 74% v 17%, and 32% v 15%, respectively. There were three toxic deaths in the VCAP-AMP-VECP arm.
CONCLUSION:
The longer OS at 3 years and higher CR rate with VCAP-AMP-VECP compared with biweekly CHOP suggest that VCAP-AMP-VECP might be a more effective regimen at the expense of higher toxicities, providing the basis for future investigations in the treatment of ATLL.
AuthorsKunihiro Tsukasaki, Atae Utsunomiya, Haruhiko Fukuda, Taro Shibata, Takuya Fukushima, Yoshifusa Takatsuka, Shuichi Ikeda, Masato Masuda, Haruhisa Nagoshi, Ryuzo Ueda, Kazuo Tamura, Masayuki Sano, Saburo Momita, Kazunari Yamaguchi, Fumio Kawano, Shuichi Hanada, Kensei Tobinai, Masanori Shimoyama, Tomomitsu Hotta, Masao Tomonaga, Japan Clinical Oncology Group Study JCOG9801
JournalJournal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 25 Issue 34 Pg. 5458-64 (Dec 01 2007) ISSN: 1527-7755 [Electronic] United States
PMID17968021 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Nitrosourea Compounds
  • Granulocyte Colony-Stimulating Factor
  • Vincristine
  • Etoposide
  • Doxorubicin
  • Cyclophosphamide
  • Carboplatin
  • ranimustine
  • Prednisone
Topics
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
  • Carboplatin (administration & dosage)
  • Cyclophosphamide (administration & dosage)
  • Doxorubicin (administration & dosage)
  • Drug Administration Schedule
  • Etoposide (administration & dosage)
  • Female
  • Granulocyte Colony-Stimulating Factor (administration & dosage)
  • Humans
  • Leukemia-Lymphoma, Adult T-Cell (drug therapy)
  • Male
  • Middle Aged
  • Nitrosourea Compounds (administration & dosage)
  • Prednisone (administration & dosage)
  • Survival Rate
  • Vincristine (administration & dosage)

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