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Clinical Trial
. 2006 Apr;97(4):305-12.
doi: 10.1111/j.1349-7006.2006.00173.x.

Randomized phase II study of concurrent and sequential rituximab and CHOP chemotherapy in untreated indolent B-cell lymphoma

Michinori Ogura  1 , Yasuo Morishima, Yoshitoyo Kagami, Takashi Watanabe, Kuniaki Itoh, Tadahiko Igarashi, Tomomitsu Hotta, Tomohiro Kinoshita, Yasuo Ohashi, Shigeo Mori, Takashi Terauchi, Kensei Tobinai
Affiliations
Clinical Trial

Randomized phase II study of concurrent and sequential rituximab and CHOP chemotherapy in untreated indolent B-cell lymphoma

Michinori Ogura et al. Cancer Sci. 2006 Apr.

Abstract

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.

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Figures

Figure 1
Figure 1
(A) Time to response (TTR) and (B) time to complete response (TTCR). Medians were estimated by the Kaplan‐Meier method. A total of 63 patients (Arm C [‐], 30; Arm S [‐‐‐], 33) were analyzed for TTR, and 44 patients (Arm C, 21; Arm S, 23) for TTCR with per protocol sets of data. Median TTRs in Arm C and Arm S were 61 days (95% confidence interval [CI] 59 to 65 days) and 62 days (95% CI 60–70 days), respectively. The 75th percentile TTRs in Arm C and Arm S were 66 days (95% CI 63 to 76 days) and 140 days (95% CI 66–135 days), respectively (P = 0.0994, log–rank test). Median TTCRs in Arm C and Arm S were 136 days (95% CI 65 to 213 days) and 140 days (95% CI 134–227 days), respectively. The 75th percentile TTCRs in Arm C and Arm S were 228 days (95% CI 141 to 293 days) and 295 days (95% CI 153–323 days), respectively (P = 0.2201, log–rank test).
Figure 2
Figure 2
Progression‐free survival (PFS). Medians were estimated by the Kaplan‐Meier method. The upper limit of the 95% confidence interval (CI) for Arm C has not yet been determined. A total of 65 patients (Arm C, 32; Arm S, 33) were analyzed with per protocol sets of data. The median PFS time for patients in Arm C (‐) was 34.2 months (95%CI, 27.1 months, inestimable), whereas that for patients in Arm S (…) had not yet been reached, with a median follow‐up time of 28.2 months. Log–rank test, P = 0.220. (o) Censored.
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