Four cycles of R-CHOP followed by two applications of rituximab based on negative interim PET/CT: an analysis of a prospective trial.

Abstract

BACKGROUND:

R-CHOP with or without radiotherapy is the standard treatment for limited-stage diffuse large B-cell lymphoma (DLBCL). To prevent overtreatment, we assessed whether four cycles of CHOP plus six applications of rituximab was adequate with negative interim PET/CT and the role of consolidation radiotherapy specifically for patients with Waldeyer's ring DLBCL. One hundred and twenty-nine patients with limited-stage DLBCL were enrolled in this open-label, nonrandomized, single-arm, phase 2 clinical trial (NCT01804127).

METHODS:

All patients were initially treated with 4 cycles of R-CHOP and underwent interim PET/CT. Patients with negative PET/CT (Deauville scores 1-2) received 2 additional cycles of rituximab monotherapy, unless they had any risk factors (primary mediastinal large B-cell lymphoma, extranodal primary or bulky disease). Otherwise, patients received another 2 cycles of R-CHOP. Patients with partial response on interim PET/CT received another 4 cycles of R-CHOP. No radiotherapy was conducted in Waldeyer's ring DLBCL patients with negative PET/CT. The primary endpoint was 3-year progression-free survival (PFS). Overall survival (OS) in this study was compared with those from a historical study (NCT 00854568159).

RESULTS:

One hundred fifteen interim PET/CT scans (89.1%) were negative after 4 cycles of R-CHOP. An elevated lactate dehydrogenase level was significantly associated with positive interim PET/CT (P < 0.05). A trend of inferior outcome was observed in patients with positive interim PET/CT in terms of 3-year PFS (78.6% vs. 91.9%, P = 0.24) and 3-year OS (85.7% vs. 95.6%, P = 0.16). There were no PFS or OS differences found between patients treated with 4R-CHOP+2R and those treated with 6R-CHOP from a historical control study. Patients with Waldeyer's ring DLBCL and negative interim PET/CT achieved a 3-year PFS of 87.2% and a 3-year OS of 89.7%.

CONCLUSIONS:

Our results suggested that for interim PET/CT-negative patients without risk factors, the extra 2 cycles of CHOP might be omitted, and radiotherapy might also be omitted in patients with Waldeyer's ring DLBCL without compromising the efficacy. These results need to be confirmed in a randomized study.

TRIAL REGISTRATION:

clinicaltrials.gov ,  NCT01804127 . Date of first registration: 05/03/2013.

• Authors: Jia Jin, Dongmei Ji, Zuguang Xia, Kai Xue, Qunling Zhang, Yizhen Liu, Junning Cao, Xiaonan Hong, Juan J Gu, Ye Guo, Fangfang Lv
• Journal: BMC cancer (BMC Cancer) Vol. 22 Issue 1 Pg. 403 (Apr 13 2022) ISSN: 1471-2407 [Electronic] England
• PMID: 35418080 (Publication Type: Clinical Trial, Journal Article)
• Copyright: © 2022. The Author(s).

Chemical References

• Fluorodeoxyglucose F18
• Rituximab
• Vincristine
• Doxorubicin
• Cyclophosphamide
• Prednisone

Topics

• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Cyclophosphamide (therapeutic use)
• Doxorubicin (therapeutic use)
• Fluorodeoxyglucose F18 (therapeutic use)
• Humans
• Lymphoma, Large B-Cell, Diffuse (diagnostic imaging, drug therapy, radiotherapy)
• Positron Emission Tomography Computed Tomography
• Prednisone (therapeutic use)
• Prospective Studies
• Rituximab
• Vincristine (therapeutic use)