Originally published as JCO Early Release 10.1200/JCO.2007.11.9958 on October 29 2007

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VCAP-AMP-VECP Compared With Biweekly CHOP for Adult T-Cell Leukemia-Lymphoma: Japan Clinical Oncology Group Study JCOG9801

Kunihiro 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

From the Nagasaki University, Nagasaki; Imamura Bun-in Hospital; Kagoshima University, Kagoshima; National Cancer Center Research Institute; National Cancer Center Hospital, Tokyo; Sasebo City General Hospital, Sasebo; Ryukyu University, Nishihara; St Marianna University, Yokohama; Nagoya City University; National Hospital Organization Nagoya Medical Center, Nagoya; Fukuoka University, Fukuoka; Saga University, Saga; National Hospital Organization Nagasaki Medical Center, Ohmura; Kumamoto University; and National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan

Address reprint requests to Kunihiro Tsukasaki, MD, PhD, Nagasaki University Graduate School of Biomedical Science, 1-12-4 Sakamoto, Nagasaki 852-8523, Japan; e-mail: tsukasak{at}net.nagasaki-u.ac.jp

Purpose: 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.

published online ahead of print at www.jco.org on October 29, 2007.

Supported by Grants-in-Aid No. 2S-1, 5S-1, 8S-1, 11S-1, 14S-1, 17S-1, 1-1, 4-5, 7-29, and 9-10 from the Cancer Research from the Ministry of Health, Labor and Welfare of Japan (1990 to present), for the Second-Term Ten-Year Strategy for Cancer Control from the Ministry of Health and Welfare (1994 to 2004) and for Basic Research from the Science and Technology Agency (1991 to 1993).

Presented in part at the 47th Annual Meeting of the American Society of Hematology, December 10-13, 2005, Atlanta, GA.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.