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CALGB 50303

Dose-Adjusted EPOCH-R Compared With R-CHOP as Frontline Therapy for Diffuse Large B-Cell Lymphoma: Clinical Outcomes of the Phase III Intergroup Trial Alliance/CALGB 50303

Phase 3N = 524NCT00118209

Population
Previously untreated diffuse large B-cell lymphoma; 524 registered and 491 eligible patients in the final analysis; 74% stage III or IV.
Design
Intergroup phase III trial, 2005 to 2013: six cycles of DA-EPOCH-R or R-CHOP. Primary objective progression-free survival; secondary objectives response rate, overall survival and safety.
Primary endpoint
PFS
Arms
  • R-CHOP (control): Six cycles of R-CHOP
  • DA-EPOCH-R (experimental): Six cycles of dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab
People
Bartlett NL, senior author Leonard JP, Alliance for Clinical Trials in Oncology / CALGB intergroup
PFSHR 0.93 (95% CI 0.68–1.27)Δ 24-month PFS+3.4 pointsOSHR 1.09 (95% CI 0.75–1.59)Δ 24-month OS+0.8 pointsΔ Grade 3-4 febrile neutropenia+17.3 pointsΔ Grade 3-4 neuropathy+15.3 points
Show the numbers
Results reported for CALGB 50303
EndpointAnalysisDA-EPOCH-RR-CHOPEffect
PFSEligible patients included in the final analysis (491 of 524 registered)primarymedian follow-up 5 yearsBartlett 201978.9% at 2 y (73.8–84.2%)75.5% at 2 y (70.2–81.1%)HR 0.93 (95% CI 0.68–1.27)P=.65Two-year PFS rates; hazard ratio for DA-EPOCH-R relative to R-CHOP as reported.
OSEligible patients included in the final analysis (491 of 524 registered)primarymedian follow-up 5 yearsBartlett 201986.5% at 2 y (82.3–91.0%)85.7% at 2 y (81.4–90.2%)HR 1.09 (95% CI 0.75–1.59)P=.64Two-year OS rates; hazard ratio for DA-EPOCH-R relative to R-CHOP as reported.
Grade 3-4 febrile neutropeniaEligible patients included in the final analysis (491 of 524 registered)primaryBartlett 201935%17.7%P<.001The abstract gives P < .001 for grade 3 and 4 adverse events as a group being more common with DA-EPOCH-R.
Grade 3-4 neuropathyEligible patients included in the final analysis (491 of 524 registered)primaryBartlett 201918.6%3.3%P<.001The abstract gives P < .001 for grade 3 and 4 adverse events as a group being more common with DA-EPOCH-R.
Results reported for CALGB 50303
EndpointAnalysisDA-EPOCH-RR-CHOPEffect
PFSEligible patients included in the final analysis (491 of 524 registered)primarymedian follow-up 5 yearsBartlett 201978.9% at 2 y (73.8–84.2%)75.5% at 2 y (70.2–81.1%)HR 0.93 (95% CI 0.68–1.27)P=.65Two-year PFS rates; hazard ratio for DA-EPOCH-R relative to R-CHOP as reported.
OSEligible patients included in the final analysis (491 of 524 registered)primarymedian follow-up 5 yearsBartlett 201986.5% at 2 y (82.3–91.0%)85.7% at 2 y (81.4–90.2%)HR 1.09 (95% CI 0.75–1.59)P=.64Two-year OS rates; hazard ratio for DA-EPOCH-R relative to R-CHOP as reported.
Grade 3-4 febrile neutropeniaEligible patients included in the final analysis (491 of 524 registered)primaryBartlett 201935%17.7%P<.001The abstract gives P < .001 for grade 3 and 4 adverse events as a group being more common with DA-EPOCH-R.
Grade 3-4 neuropathyEligible patients included in the final analysis (491 of 524 registered)primaryBartlett 201918.6%3.3%P<.001The abstract gives P < .001 for grade 3 and 4 adverse events as a group being more common with DA-EPOCH-R.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.930.68–1.27
OS1.090.75–1.59
Primary publication: Bartlett NL, Wilson WH, Jung SH, Hsi ED, Maurer MJ, Pederson LD, et al. Dose-Adjusted EPOCH-R Compared With R-CHOP as Frontline Therapy for Diffuse Large B-Cell Lymphoma: Clinical Outcomes of the Phase III Intergroup Trial Alliance/CALGB 50303. J Clin Oncol. 2019;37(21):1790-1799. PubMedDOI

Appears in

Sources

  1. Bartlett NL, Wilson WH, Jung SH, Hsi ED, Maurer MJ, Pederson LD, et al. Dose-Adjusted EPOCH-R Compared With R-CHOP as Frontline Therapy for Diffuse Large B-Cell Lymphoma: Clinical Outcomes of the Phase III Intergroup Trial Alliance/CALGB 50303. J Clin Oncol. 2019;37(21):1790-1799.

    PubMedDOI