Medical Oncology consultant at Vall d'Hebron University Hospital

 and senior investigator at Vall d'Hebron Institute of Oncology.

Dr Elez on the Rationale for Evaluating QOL Outcomes With ICI Doublets in mCRC

"When we are using a doublet and adding an extra drug, we have this potential to have even maybe more toxicity, but no other impact in terms of quality of life. [Instead], we see there is a trend of improvement for those patients [who received the doublet]."

Elena Élez, MD, PhD, a medical oncology consultant at Vall d’Hebron University Hospital and a senior investigator at Vall d’Hebron Institute of Oncology, discussed the rationale for evaluating the role of, and quality of life (QOL) outcomes with, combination checkpoint blockade in patients with microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC) through the phase 3 CheckMate 8HW trial (NCT04008030).

Recent studies in mCRC have focused on optimizing post-induction treatment strategies and refining frontline immunotherapy for microsatellite instability-high (MSI-H) disease, Elez began.

One such study is the CheckMate 8HW trial, which evaluated nivolumab (Opdivo) plus ipilimumab (Yervoy) vs nivolumab in patients with MSI-H mCRC. The study had previously reported data showing the superiority of the nivolumab and ipilimumab combination compared to chemotherapy. The awaited comparison was between the doublet and nivolumab monotherapy, and the recently presented results cover this comparison across all lines of treatment.

2025 ESMO Gastrointestinal Cancers Congress

revealed that patients receiving the doublet regimen (n = 296) achieved a significant progression-free survival (PFS) benefit when compared with those who received nivolumab monotherapy (n = 286; HR, 0.62; 95% CI, 0.48-0.81; 

 = .0003). Élez emphasized that a critical part of the recent presentation was the quality-of-life data comparing the doublet against the monotherapy.

Although the use of a doublet adds the potential for increased toxicity, the trial showed that patients in the investigational arm experienced a numerical benefit in terms of QOL, depending on the scale used. Élez noted that there was a trend favoring the doublet across several QOL assessment tools, including the EORTC QLQ-C30 (for all patients), the QLQ-CR29 (for those with CRC), and QOL (for patients with any illness). This positive trend in QOL, despite the addition of an extra drug, is considered an important outcome. Élezconcluded that they did not observe a negative impact on QOL and instead saw a trend of improvement for patients dealing with the disease, even with the addition of a second agent.

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Elena Élez, MD, PhD, discusses quality of life outcomes with combination checkpoint blockade in patients with microsatellite instability-high mCRC.

Dr Élez on Health-Related QOL With Nivolumab Plus Ipilimumab in mCRC 

“[These QOL data] are important because when we are using a doublet, the addition of an extra drug has the potential to [introduce] more toxicity and [affect] quality of life [QOL]. [Instead], we saw that there was a trend towards QOL improvement with the doublet [of ipilimumab plus nivolumab compared with nivolumab monotherapy].”

Elena Élez, MD, PhD, a medical oncology consultant at Vall d’Hebron University Hospital and a senior investigator at Vall d’Hebron Institute of Oncology, discussed health-related quality of life (QOL) data from the phase 3 CheckMate 8HW trial (NCT04008030) of nivolumab (Opdivo) plus ipilimumab (Yervoy) vs nivolumab in patients with microsatellite instability-high metastatic colorectal cancer (mCRC).

 revealed that patients who received the doublet (n = 296) experienced a significant progression-free survival benefit compared with those who received nivolumab monotherapy (n = 286; HR, 0.62; 95% CI, 0.48-0.81; 

 = .0003). Additionally, patients in the investigational arm experienced a numerical benefit in terms of QOL, depending on which scale was used, Élez explained.

Global health status per the EORTC QLQ-C30 scale showed a general improvement in both arms starting at week 7; patients in the combination arm exceeded the minimally important change from baseline threshold starting at week 21. Mean change from baseline in terms of EORTC QLQ-C30 physical functioning scores also showed a trend towards improvement starting at week 7, as did fatigue scores. Patients in the combination and monotherapy arms exceeded the minimally important change from baseline threshold for fatigue starting at weeks 21 and 85, respectively.

It is important that these QOL trends favor the doublet, because the addition of an extra drug to nivolumab introduces the potential for additional toxicity and could negatively affect patient QOL, Élez noted. However, this was not observed in their analysis, she concluded.

Elena Élez, MD, PhD, discusses health-related QOL data with nivolumab plus ipilimumab in mCRC.

®! I’m your host today, Jax DiEugenio.

In today’s episode, we had the pleasure of speaking with Elena Élez, MD, PhD, about the evolving role of immunotherapy for patients with microsatellite instability–high (MSI‑H) metastatic colorectal cancer (mCRC). Dr Élez is a medical oncology consultant at Vall d’Hebron University Hospital and a senior investigator at Vall d’Hebron Institute of Oncology in Barcelona, Spain.
In our exclusive interview, Dr Élez discussed recent data comparing nivolumab (Opdivo) monotherapy with nivolumab plus ipilimumab (Yervoy) across multiple lines of therapy in patients with MSI-H mCRC. She detailed efficacy and quality‑of‑life outcomes, noting that the combination appeared to offer enhanced clinical benefit without a negative effect on tolerability. Dr Élez also highlighted the importance of tailoring immunotherapy strategies based on patient characteristics and treatment goals and reflected on the nuances of sequencing single‑agent vs combination checkpoint blockade.
Additionally, Dr Élez reviewed several investigator‑initiated trials presented at the 2025 ESMO Gastrointestinal Cancers Congress, including studies exploring immunotherapy in localized rectal cancer, novel biomarker‑driven treatment approaches, and the integration of liquid biopsy to refine patient selection in mCRC. She emphasized how these findings may inform future clinical practice and contribute to ongoing optimization of immunotherapy in gastrointestinal cancers.

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Elena Élez, MD, PhD, discusses the evolving role of immunotherapy for patients with microsatellite instability–high metastatic colorectal cancer. 

Elena Élez, MD, PhD

Articles

Dr Elez on the Rationale for Evaluating QOL Outcomes With ICI Doublets in mCRC

Dr Élez on Health-Related QOL With Nivolumab Plus Ipilimumab in mCRC

The Role of Combination Checkpoint Blockade Is Evolving in MSI-H mCRC: With Elena Élez, MD, PhD