Treatment Options to Avoid Autologous SCT Consolidation

The prospective, randomized TRIANGLE trial (NCT02858258) trial included 870 patients aged 65 years or younger with previously untreated MCL who were fit enough for autologous SCT. There were three study arms. The primary end point was failure-free survival (FFS), and the secondary end point was OS.[7,8] The three arms included:Summary: When patients received ibrutinib and a high-dose chemoimmunotherapy regimen (including cytarabine), the addition of ibrutinib led to superior outcomes by 5% for OS. Autologous SCT did not add efficacy to the ibrutinib-containing regimens but did add toxicity.

The prospective, randomized TRIANGLE trial (NCT02858258) trial included 870 patients aged 65 years or younger with previously untreated MCL who were fit enough for autologous SCT. There were three study arms. The primary end point was failure-free survival (FFS), and the secondary end point was OS.[7,8] The three arms included:Summary: When patients received ibrutinib and a high-dose chemoimmunotherapy regimen (including cytarabine), the addition of ibrutinib led to superior outcomes by 5% for OS. Autologous SCT did not add efficacy to the ibrutinib-containing regimens but did add toxicity.

Arm A: Standard therapy at the start of the trial with R-CHOP/R-DHAP followed by autologous SCT consolidation and rituximab maintenance therapy.

The prospective, randomized TRIANGLE trial (NCT02858258) trial included 870 patients aged 65 years or younger with previously untreated MCL who were fit enough for autologous SCT. There were three study arms. The primary end point was failure-free survival (FFS), and the secondary end point was OS.[7,8] The three arms included:Summary: When patients received ibrutinib and a high-dose chemoimmunotherapy regimen (including cytarabine), the addition of ibrutinib led to superior outcomes by 5% for OS. Autologous SCT did not add efficacy to the ibrutinib-containing regimens but did add toxicity.

Arm A+I: Ibrutinib plus R-CHOP/R-DHAP followed by autologous SCT consolidation and ibrutinib plus rituximab maintenance therapy.

The prospective, randomized TRIANGLE trial (NCT02858258) trial included 870 patients aged 65 years or younger with previously untreated MCL who were fit enough for autologous SCT. There were three study arms. The primary end point was failure-free survival (FFS), and the secondary end point was OS.[7,8] The three arms included:Summary: When patients received ibrutinib and a high-dose chemoimmunotherapy regimen (including cytarabine), the addition of ibrutinib led to superior outcomes by 5% for OS. Autologous SCT did not add efficacy to the ibrutinib-containing regimens but did add toxicity.

Arm I: Ibrutinib plus R-CHOP/R-DHAP with no consolidation and ibrutinib plus rituximab maintenance therapy.

The prospective, randomized TRIANGLE trial (NCT02858258) trial included 870 patients aged 65 years or younger with previously untreated MCL who were fit enough for autologous SCT. There were three study arms. The primary end point was failure-free survival (FFS), and the secondary end point was OS.[7,8] The three arms included:Summary: When patients received ibrutinib and a high-dose chemoimmunotherapy regimen (including cytarabine), the addition of ibrutinib led to superior outcomes by 5% for OS. Autologous SCT did not add efficacy to the ibrutinib-containing regimens but did add toxicity.

With a median follow-up of 53 months, results were published in abstract form. The 3-year OS rate was 90% for arm A+I versus 85% for arm A (HR, 0.61; P = .0069), and the 3-year OS rate was 91% for arm I versus 85% for arm A (HR, 0.59; P = .0041).[8][Level of evidence A1]

The prospective, randomized TRIANGLE trial (NCT02858258) trial included 870 patients aged 65 years or younger with previously untreated MCL who were fit enough for autologous SCT. There were three study arms. The primary end point was failure-free survival (FFS), and the secondary end point was OS.[7,8] The three arms included:Summary: When patients received ibrutinib and a high-dose chemoimmunotherapy regimen (including cytarabine), the addition of ibrutinib led to superior outcomes by 5% for OS. Autologous SCT did not add efficacy to the ibrutinib-containing regimens but did add toxicity.

Also published in abstract form, after a median follow-up of 53 months, the role of autologous SCT was evaluated by comparing the FFS of arm A+I (with autologous SCT) with the FFS of arm I (without autologous SCT) (86% vs. 85%, respectively; HR, 0.86; P = .56), which was not significantly different.[8][Level of evidence B1]

The prospective, randomized TRIANGLE trial (NCT02858258) trial included 870 patients aged 65 years or younger with previously untreated MCL who were fit enough for autologous SCT. There were three study arms. The primary end point was failure-free survival (FFS), and the secondary end point was OS.[7,8] The three arms included:Summary: When patients received ibrutinib and a high-dose chemoimmunotherapy regimen (including cytarabine), the addition of ibrutinib led to superior outcomes by 5% for OS. Autologous SCT did not add efficacy to the ibrutinib-containing regimens but did add toxicity.

Toxicity was highest in the autologous SCT arms, as expected.

The ECOG 4151 trial (NCT03267433), published in abstract form, included 650 patients younger than 71 years with previously untreated MCL who were eligible for autologous SCT. The trial allowed any standard induction therapy regimen. Most patients received R-CHOP or R-DHAP induction therapy, and 27% received BR. All patients received rituximab maintenance therapy. Patients found to have measurable residual disease (MRD)–negative MCL in the blood and marrow (80%, n = 516) were randomly assigned to receive either autologous SCT plus 3 years of maintenance therapy with rituximab or 3 years of maintenance therapy with rituximab alone.[9]Summary: With the introduction of ibrutinib and other BTK inhibitors that can be used during induction therapy, maintenance therapy, or at relapse, most patients can avoid autologous SCT.

The ECOG 4151 trial (NCT03267433), published in abstract form, included 650 patients younger than 71 years with previously untreated MCL who were eligible for autologous SCT. The trial allowed any standard induction therapy regimen. Most patients received R-CHOP or R-DHAP induction therapy, and 27% received BR. All patients received rituximab maintenance therapy. Patients found to have measurable residual disease (MRD)–negative MCL in the blood and marrow (80%, n = 516) were randomly assigned to receive either autologous SCT plus 3 years of maintenance therapy with rituximab or 3 years of maintenance therapy with rituximab alone.[9]Summary: With the introduction of ibrutinib and other BTK inhibitors that can be used during induction therapy, maintenance therapy, or at relapse, most patients can avoid autologous SCT.

With a median follow-up of 42 months, there was no difference in 3-year OS rates, at 82.1% for patients who received autologous SCT and 82.7% for patients who did not receive autologous SCT (HR, 1.11; 95% CI, 0.71–1.74; P = .66). This OS HR crossed the futility boundary.[9][Level of evidence A1]

A retrospective analysis included 1,265 patients aged 65 years or younger with MCL who were transplant-eligible. The analysis showed no benefit for autologous SCT in time-to-next treatment (HR, 0.84; 95% CI, 0.68–1.03) or OS (HR, 0.86; 95% CI, 0.63–1.18).[10][Level of evidence C3]