Open AccessRandomized phase II study of concurrent and sequential rituximab and CHOP chemotherapy in untreated indolent B‐cell lymphoma
Author(s) -
Ogura Michinori,
Morishima Yasuo,
Kagami Yoshitoyo,
Watanabe Takashi,
Itoh Kuniaki,
Igarashi Tadahiko,
Hotta Tomomitsu,
Kinoshita Tomohiro,
Ohashi Yasuo,
Mori Shigeo,
Terauchi Takashi,
Tobinai Kensei
Publication year - 2006
Publication title -
cancer science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.035
H-Index - 141
eISSN - 1349-7006
pISSN - 1347-9032
DOI - 10.1111/j.1349-7006.2006.00173.x
Subject(s) - rituximab , medicine , chop , regimen , neutropenia , gastroenterology , lymphoma , vincristine , surgery , chemotherapy , oncology , cyclophosphamide
CHOP combined with rituximab (R‐CHOP) is regarded as one of the most effective treatments for indolent B‐cell non‐Hodgkin lymphoma (B‐NHL), however, its optimal combination schedule remains unknown. We performed a randomized phase II study to explore a more promising schedule in untreated, advanced indolent B‐NHL. Patients were randomized to receive either six courses of CHOP concurrently with rituximab (Arm C), or six courses of CHOP followed by six courses of weekly rituximab (Arm S). A total of 69 patients received the concurrent ( n = 34) or sequential ( n = 35) regimen. Overall response rate (ORR) in Arm C was 94% (95% confidence interval [CI], 79 to 99), including a 66% complete response (CR) compared with 97% (95% CI, 85–100), including a 68% CR in Arm S. Patients in Arm C experienced more grade 4 neutropenia (85% versus 70%) and experienced more grade 3 or greater non‐hematological toxicities (21% versus 12%). Both arms were tolerated well. With a median follow‐up of 28.2 months, the median progression‐free survival (PFS) time was 34.2 months in Arm C, and was not reached in Arm S. R‐CHOP is highly effective in untreated indolent B‐NHL, either concurrent or in a sequential combination. Both combination schedules deserve further investigation. ( Cancer Sci 2006; 97: 305 – 312)