Comparison of a standard regimen (CHOP) with three intensive chemotherapy regimens for advanced non-Hodgkin's lymphoma: trial

Comparison of a standard regimen (CHOP) with three intensive chemotherapy regimens for advanced non-Hodgkin's lymphoma

Phase 3N = 899

Population

Advanced-stage intermediate-grade or high-grade non-Hodgkin's lymphoma; 1138 patients registered, 899 eligible, each treatment group with at least 218 patients.

Design

Prospective, randomized phase III trial initiated by the Southwest Oncology Group and the Eastern Cooperative Oncology Group comparing CHOP with m-BACOD, ProMACE-CytaBOM and MACOP-B. Study end points were response rate, time to treatment failure, overall survival and severe or life-threatening toxicity. Pre-registry; no trial acronym or registry number in the PubMed record.

Arms

CHOP (control): CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone)
m-BACOD (experimental): Low-dose methotrexate with leucovorin rescue, bleomycin, doxorubicin, cyclophosphamide, vincristine and dexamethasone
ProMACE-CytaBOM (experimental): Prednisone, doxorubicin, cyclophosphamide and etoposide, followed by cytarabine, bleomycin, vincristine and methotrexate with leucovorin rescue
MACOP-B (experimental): Methotrexate with leucovorin rescue, doxorubicin, cyclophosphamide, vincristine, prednisone and bleomycin

People

Fisher RI, senior author Miller TP, Southwest Oncology Group and Eastern Cooperative Oncology Group

Δ 36-month Alive without disease at 3 years+5 pointsΔ 36-month OS−2 pointsΔ Fatal toxic reactions+4 points

Show the numbers

Results reported for Comparison of a standard regimen (CHOP) with three intensive chemotherapy regimens for advanced non-Hodgkin's lymphoma
Endpoint	Analysis	m-BACOD / ProMACE-CytaBOM / MACOP-B	CHOP	Effect
Alive without disease at 3 yearsEligible patients (899); the abstract does not label the analysis population	primaryFisher 1993	46% at 3 y	41% at 3 y	P=0.35Three-year proportion alive without disease: 44 percent of all patients; no significant difference between groups.
OSEligible patients (899); the abstract does not label the analysis population	primaryFisher 1993	52% at 3 y	54% at 3 y	P=0.90Three-year overall survival was 52 percent in all patients; the abstract states there was no subgroup in which survival was improved by a third-generation regimen.
Fatal toxic reactionsEligible patients (899); the abstract does not label the analysis population	primaryFisher 1993	5%	1%	P=0.09

Results reported for Comparison of a standard regimen (CHOP) with three intensive chemotherapy regimens for advanced non-Hodgkin's lymphoma
Endpoint	Analysis	m-BACOD / ProMACE-CytaBOM / MACOP-B	CHOP	Effect
Alive without disease at 3 yearsEligible patients (899); the abstract does not label the analysis population	primaryFisher 1993	46% at 3 y	41% at 3 y	P=0.35Three-year proportion alive without disease: 44 percent of all patients; no significant difference between groups.
OSEligible patients (899); the abstract does not label the analysis population	primaryFisher 1993	52% at 3 y	54% at 3 y	P=0.90Three-year overall survival was 52 percent in all patients; the abstract states there was no subgroup in which survival was improved by a third-generation regimen.
Fatal toxic reactionsEligible patients (899); the abstract does not label the analysis population	primaryFisher 1993	5%	1%	P=0.09

Appears in

1993 CHOP vs three intensive regimens in advanced lymphoma (1993)

Sources

Fisher RI, Gaynor ER, Dahlberg S, Oken MM, Grogan TM, Mize EM, et al. Comparison of a standard regimen (CHOP) with three intensive chemotherapy regimens for advanced non-Hodgkin's lymphoma. N Engl J Med. 1993;328(14):1002-6.
PubMed DOI