A multicenter, phase II study of full-dose THP-COP therapy for elderly patients with newly diagnosed, advanced-stage, aggressive non-Hodgkin lymphoma.

Abstract

The cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP) regimen, containing doxorubicin (DXR), which is a key drug for aggressive non-Hodgkin lymphoma (NHL), is a standard chemotherapeutic regimen; however, its administration in elderly patients is often intolerable. Pirarubicin (tetrahydropyranyl adriamycin [THP]) is an anthracycline developed in Japan. We have conducted a phase II trial of a full-dose THP-COP (modified CHOP regimen with DXR replaced by THP) regimen for elderly patients with newly diagnosed, advanced-stage, aggressive NHL. Patients aged 70-79 years old with previously untreated NHL according to the Working Formulation (D through H and J), disease stage I with a bulky mass or stage II-IV, and performance status of 0-1 were eligible. The THP-COP regimen, which consisted of 750-mg/m2 cyclophosphamide, 50-mg/m2 THP, 1.4-mg/m2 vincristine (capped at 2.0 mg) on day 1, and 100-mg prednisolone daily on days 1 to 5, was delivered every 3 weeks for 6 cycles. The primary endpoint was complete response (CR) rate. Twenty-nine patients were enrolled in the study. The CR rate was 65.5% (95% confidence interval, 45.7-82.1%). The 3-year failure-free and overall survival rates were 54.1% and 53.9%, respectively. The most frequent observed grade 3 or 4 toxicity was neutropenia, which occurred in 80% of the patients. Grade 3 cardiac dysfunction was observed in one patient. The full-dose THP-COP regimen exhibited similar efficacy and safety, and a tendency for less cardiac toxicity, when compared with the standard CHOP regimen in elderly Japanese patients with newly diagnosed, advanced-stage, aggressive NHL.

• Authors: Ken Ohmachi, Michinori Ogura, Yoshitoyo Kagami, Yosuke Imai, Takayuki Hirose, Tomohiro Kinoshita, Hirokazu Nagai, Kazunori Ohnishi, Tomomitsu Hotta
• Journal: Journal of clinical and experimental hematopathology : JCEH (J Clin Exp Hematop) Vol. 62 Issue 4 Pg. 202-207 ( 2022) ISSN: 1880-9952 [Electronic] Japan
• PMID: 36575000 (Publication Type: Clinical Trial, Phase II, Multicenter Study, Journal Article)

Chemical References

• Vincristine
• Cyclophosphamide
• pirarubicin
• Doxorubicin
• Prednisone
• Prednisolone

Topics

• Aged
• Humans
• Vincristine (adverse effects)
• Lymphoma, Non-Hodgkin (diagnosis)
• Cyclophosphamide
• Doxorubicin (therapeutic use)
• Prednisone
• Prednisolone (therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects)
• Treatment Outcome