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Bending the Curve Trial by Trial
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Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone in patients with newly diagnosed diffuse large B-cell non-Hodgkin lymphoma: a phase 3 comparison of dose intensification with 14-day versus 21-day cycles

Phase 3N = 1,080

Population
Previously untreated bulky stage IA to stage IV diffuse large B-cell lymphoma, aged 18 years or older.
Design
Randomised, unmasked phase 3 trial in 119 UK centres; central one-to-one allocation by minimisation to six cycles of R-CHOP every 14 days plus two further rituximab infusions, or eight cycles of R-CHOP every 21 days. Primary outcome overall survival. Registered as ISRCTN 16017947 (registry record: phase III, target enrolment 1080, no ClinicalTrials.gov number).
Primary endpoint
OS
Arms
  • R-CHOP-21 (control, n = 540): Eight cycles of R-CHOP every 21 days
  • R-CHOP-14 (experimental, n = 540): Six cycles of R-CHOP every 14 days plus two further rituximab infusions
People
Cunningham D, senior author Linch D
OSHR 0.90 (95% CI 0.70–1.15)Δ 24-month OS+1.9 pointsPFSHR 0.94 (95% CI 0.76–1.17)Δ 24-month PFS+0.6 points
Show the numbers
Results reported for Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone in patients with newly diagnosed diffuse large B-cell non-Hodgkin lymphoma: a phase 3 comparison of dose intensification with 14-day versus 21-day cycles
EndpointAnalysisR-CHOP-14R-CHOP-21Effect
OSAll patients allocated (1080); the abstract does not label the analysis populationprimarymedian follow-up 46 monthsCunningham 201382.7% at 2 y (79.5–85.9%)80.8% at 2 y (77.5–84.2%)HR 0.90 (95% CI 0.70–1.15)P=0.3763Hazard ratio for R-CHOP-14 relative to R-CHOP-21 as reported. Median follow-up IQR 35 to 57 months.
PFSAll patients allocated (1080); the abstract does not label the analysis populationprimarymedian follow-up 46 monthsCunningham 201375.4% at 2 y (71.8–79.1%)74.8% at 2 y (71.0–78.4%)HR 0.94 (95% CI 0.76–1.17)P=0.5907Secondary outcome; hazard ratio for R-CHOP-14 relative to R-CHOP-21 as reported.
Results reported for Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone in patients with newly diagnosed diffuse large B-cell non-Hodgkin lymphoma: a phase 3 comparison of dose intensification with 14-day versus 21-day cycles
EndpointAnalysisR-CHOP-14R-CHOP-21Effect
OSAll patients allocated (1080); the abstract does not label the analysis populationprimarymedian follow-up 46 monthsCunningham 201382.7% at 2 y (79.5–85.9%)80.8% at 2 y (77.5–84.2%)HR 0.90 (95% CI 0.70–1.15)P=0.3763Hazard ratio for R-CHOP-14 relative to R-CHOP-21 as reported. Median follow-up IQR 35 to 57 months.
PFSAll patients allocated (1080); the abstract does not label the analysis populationprimarymedian follow-up 46 monthsCunningham 201375.4% at 2 y (71.8–79.1%)74.8% at 2 y (71.0–78.4%)HR 0.94 (95% CI 0.76–1.17)P=0.5907Secondary outcome; hazard ratio for R-CHOP-14 relative to R-CHOP-21 as reported.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.90.7–1.15
PFS0.940.76–1.17
Primary publication: Cunningham D, Hawkes EA, Jack A, Qian W, Smith P, Mouncey P, et al. Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone in patients with newly diagnosed diffuse large B-cell non-Hodgkin lymphoma: a phase 3 comparison of dose intensification with 14-day versus 21-day cycles. Lancet. 2013;381(9880):1817-26. PubMedDOI

Appears in

Sources

  1. Cunningham D, Hawkes EA, Jack A, Qian W, Smith P, Mouncey P, et al. Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone in patients with newly diagnosed diffuse large B-cell non-Hodgkin lymphoma: a phase 3 comparison of dose intensification with 14-day versus 21-day cycles. Lancet. 2013;381(9880):1817-26.

    PubMedDOI