Rocio Garcia-Carbonero MD, PhD is a consultant in Medical Oncology at Hospital Universitario Doce de. Octubre, where she leads the GI and NE Oncology Unit.

Dr García-Carbonero on Outcomes With Fruquintinib in mCRC Subgroups

“We demonstrated improved PFS and DCR [with fruquintinib vs placebo] in all the [metastatic] subgroups. This is good news; [patients with] certain sites of metastasis that can have a poor prognosis, but they all can benefit from fruquintinib therapy.”

Rocío García-Carbonero, MD, a medical oncologist and leader of both the Gastrointestinal Tumor and Neuroendocrine Units at Hospital Universitario 12 de Octubre, a well as an associate professor at Universidad Complutense of Madrid, discussed findings from a subgroup analysis of the phase 3 FRESCO-2 trial (NCT04322539), which evaluated fruquintinib (Fruzaqla) for the treatment of patients with metastatic colorectal cancer (mCRC).

2025 ESMO Gastrointestinal Cancers Congress

, García-Carbonero presented data from a subgroup analysis of FRESCO-2 that examined fruquintinib vs placebo, both in combination with best supportive care, in patients with mCRC with disease metastasis to various sites, including the liver-only, lung-only, bone with/without other metastases, and peritoneum with/without other metastases, García-Carbonero began. Patients who received fruquintinib experienced an improvement in overall survival (OS) across most key subgroups, she explained.

Patients with liver-only metastases who in the investigational (n = 19) and control (n = 10) arms experienced a median OS of 8.5 months vs 3.1 months, respectively (HR, 0.256; 95% CI, 0.079-0.824; 

 = .0760). The median OS in the investigational arm in patients with lung-only metastases (n = 25) was 14.1 months compared with not estimable in the control arm (n = 16; HR, 0.998; 95% CI, 0.208-4.792; 

 = .9561). Patients in the bone metastases subgroup experienced a median OS of 7.6 months with fruquintinib (n = 51) vs 3.4 months with placebo (n = 27; HR, 0.399; 95% CI, 0.215-0.741; 

 = .0065). In the peritoneal metastases subgroup, the median OS values were 5.4 months and 4.2 months in the investigational (n = 67) and control (n = 38) arms, respectively (HR, 0.669; 95% CI, 0.395-1.134; 

The OS data were more prognostic than predictive, García-Carbonero noted. In the lung-only metastasis cohort, OS data were immature due to a lack of events, although a trend n favor of fruquintinib was reported, she added. The median progression-free survival (PFS) and disease control rates (DCR) were also improved with fruquintinib vs placebo across subgroups, she concluded.

Videos

Rocío García-Carbonero, MD, discusses fruquintinib for the treatment of patients with metastatic colorectal cancer.

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

In today’s episode, we spoke with Rocío García-Carbonero, MD, PhD, about treatment trends in colorectal cancer (CRC) and other gastrointestinal (GI) malignancies, spotlighting key takeaways from the 2025 ESMO GI Cancers Congress. Dr García-Carbonero is a medical oncologist and head of the Medical Oncology Department at Hospital Universitario 12 de Octubre in Madrid, Spain.

In our conversation, Dr García-Carbonero discussed a subgroup analysis from the phase 3 FRESCO-2 trial (NCT04322539), which evaluated fruquintinib (Fruzaqla) in previously treated metastatic CRC (mCRC). She reviewed efficacy outcomes by metastatic site, including liver-only, lung-only, bone, and peritoneal disease. Fruquintinib demonstrated improvements in overall survival and progression-free survival across all subgroups, underscoring its feasibility in later-line settings for patients with mCRC. She also addressed prognostic differences between metastatic sites, noting that all patient groups derived benefit from treatment. Dr García-Carbonero also shared findings from PROMETCO, the first international, prospective, real-world study in mCRC, which is examining real-world outcomes for this patient population.

Additionally, at the meeting Dr García-Carbonero participated in a multidisciplinary, case-based session focused on GI and neuroendocrine neoplasms. She outlined the clinical distinctions between well-differentiated neuroendocrine tumors and poorly differentiated neuroendocrine carcinomas (NECs), using a case of poorly differentiated NEC of the colon to illustrate diagnostic and therapeutic considerations. She cautioned against the use of somatostatin receptor PET imaging in poorly differentiated disease and underscored the importance of molecular profiling, noting that over 20% of patients may harbor actionable alterations or markers, such as 

 mutations, microsatellite instability, or 

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Podcasts

Rocío García-Carbonero, MD, PhD, discusses trends in colorectal cancer and other gastrointestinal malignancies, presented at the 2025 ESMO GI Cancers Congress.

Advancing Treatment Strategies and Real-World Perspectives for mCRC and GI Neuroendocrine Neoplasms; With Rocío García-Carbonero, MD, PhD

Dr García-Carbonero on Considerations for Poorly Differentiated GI Neuroendocrine Carcinoma

"There are now emerging targeted therapies for many of these alterations. We need to continue shifting the field toward a more molecularly driven approach, as I believe our patients will significantly benefit from it."

Rocío García-Carbonero, MD, a medical oncologist at Hospital Universitario 12 de Octubre and associate professor at Universidad Complutense of Madrid, highlighted key diagnostic and molecular considerations in the management of poorly differentiated gastrointestinal (GI) neuroendocrine carcinomas during a case-based discussion. These tumors are characterized by aggressive clinical behavior and poor prognosis, necessitating precise diagnostic strategies and a shift toward molecularly informed treatment approaches.

One critical diagnostic consideration addressed was the appropriate use of imaging modalities. Although 25% of audience participants indicated they would order a gallium PET scan for this case, García-Carbonero emphasized that this modality is inappropriate for poorly differentiated tumors. Gallium PET imaging evaluates somatostatin receptor expression and is reserved for well-differentiated neuroendocrine tumors, not those lacking receptor expression, as seen in poorly differentiated disease.

Additionally, García-Carbonero underscored the clinical utility of molecular profiling in this tumor subtype. Approximately 20% of poorly differentiated neuroendocrine carcinomas harbor potentially actionable molecular alterations. Identifying these alterations can inform the selection of targeted therapies, offering an alternative to conventional cytotoxic chemotherapy. In the presented case, a BRAF mutation was identified, illustrating the relevance of genetic analysis. Other possible genomic alterations include microsatellite instability-high status, high tumor mutational burden, and RAS mutations—each associated with emerging therapeutic options.

García-Carbonero advocated for broader adoption of molecular profiling to better personalize treatment for patients with this aggressive malignancy. As targeted therapies continue to evolve, integrating molecular diagnostics into routine clinical evaluation could optimize outcomes and expand treatment possibilities beyond standard chemotherapy regimens.

Rocío García-Carbonero, MD, outlines diagnostic and molecular considerations for poorly differentiated GI neuroendocrine carcinoma.


Dr García-Carbonero on Outcomes With Fruquintinib in R/R mCRC by Metastatic Sites

"We see that fruquintinib improved overall survival in all [metastatic] subgroups. Survival [outcomes] with fruquintinib are much better in [patients with] lung [metastases] than in [those with] liver or bone [metastases], and the worst [outcomes] were in [patients with] peritoneal disease. However, these are more prognostic rather than predictive factors, because within each subgroup, fruquintinib improves survival vs placebo."

Rocío García-Carbonero, MD, of Hospital Universitario 12 de Octubre, discussed updated findings from a prespecified subgroup analysis of the phase 3 FRESCO-2 trial (NCT04322539), which evaluated fruquintinib (Fruzaqla) vs placebo in patients with refractory metastatic colorectal cancer (mCRC). The subgroup analysis focused on outcomes by site of baseline metastases.

 included outcomes stratified by liver, lung, bone, and peritoneal metastatic involvement. In this analysis, fruquintinib demonstrated improved overall survival (OS), progression-free survival (PFS), and disease control rate (DCR) across all metastatic subgroups when compared with placebo. The OS benefit was observed in patients with liver-only metastases (HR, 0.256; 95% CI, 0.079-0.824; P = .0760); those with bone metastases with or without other metastatic sites (HR, 0.399; 95% CI, 0.215-0.741; P = .0065); and those with peritoneal metastases with or without other metastatic sites (HR, 0.669; 95% CI, 0.395-1.134; 

 = .2453). An OS benefit was not observed within the lung-only metastases subgroup (HR, 0.998; 95% CI, 0.208-4.792; 

 = .9561); however, García-Carbonero explained that data for this subgroup were immature. The median OS in the lung-only subgroup was 14.1 months for fruquintinib vs not evaluable for placebo.

Importantly, the findings were derived from a post hoc analysis with small patient numbers, precluding definitive conclusions. Nonetheless, García-Carbonero emphasized that the data support the broad applicability of fruquintinib in the refractory mCRC setting, even in patients with metastases associated with poorer prognosis.

Rocío García-Carbonero, MD, discusses a subgroup analysis of fruquintinib vs placebo in patients with refractory metastatic colorectal cancer.

Dr Garcia-Carbonero on the Phase 2b VIRAGE Trial in Metastatic PDAC

Rocio Garcia-Carbonero, MD, medical oncologist, coordinator, Gastrointestinal (GI) Tumor Unit, the Hospital Universitario Doce de Octubre, associate professor, Universitario Doce de Octubre, discusses the rationale for the phase 2b VIRAGE trial (NCT05673811) investigating nab-paclitaxel (Abraxane) and gemcitabine plus or minus VCN-01 in patients with metastatic pancreatic ductal adenocarcinoma (PDAC), highlighting which unmet needs may be met in this population with the initiation of this trial.

Garcia-Carbonero shared insights on this open-label, randomized investigation at the 

. Metastatic PDAC has a high fatality rate despite recent treatment advancements, and the field has seen minimal improvement in standard care over recent decades, she begins. Current treatment regimens offer only modest survival benefits, with overall survival for these patients rarely exceeding 1 year, Garcia-Carbonero explains.

To improve survival rates, it is essential to deepen the field’s understanding of the disease’s biology and develop innovative treatment strategies, according to Garcia-Carbonero. These strategies should aim to improve long-term survival, not just extend survival by a few weeks or months, she reports.

Garcia-Carbonero says she has high hopes for VCN-01 due to its unique mechanism of action, which differs from traditional chemotherapy. Unlike chemotherapy, which targets and kills cancer cells directly but often leads to temporary and limited responses, VCN-01 aims to induce a robust immune response against the cancer, Garcia-Carbonero states. By harnessing the body’s immune system to fight the tumor, investigators hope to achieve a more durable and sustained treatment response, she says.

The rationale behind this trial is based on the potential for immune-based therapy to provide longer-lasting effects than chemotherapy, she continues. If investigators can successfully stimulate the immune system to recognize and attack cancer cells, it could lead to significantly improved survival rates, she says. This approach might extend life expectancy beyond what is currently possible and improve the quality of life for patients by reducing the harsh adverse effects often associated with chemotherapy, Garcia-Carbonero concludes.

Rocio Garcia-Carbonero, MD, discusses the rationale for the phase 2b VIRAGE trial in patients with metastatic pancreatic cancer.

Rocio Garcia-Carbonero, MD, PhD, Universidad de Sevilla, discusses the quality of life results from the RAISE study.

The RAISE study was a phase III randomized, double-blind study of FOLFIRI plus ramucirumab or placebo in patients with metastatic colorectal cancer (mCRC) after first-line therapy with bevacizumab, oxaliplatin, or fluoropyrimidine.

Quality of life scores were calculated based on physical functioning, role functioning, emotional functioning, fatigue, appetite loss, and constipation. Results found that there was a transient worsening in quality of life for the FOLFIRI plus ramucirumab arm compared to the placebo plus FOLFIRI arm. However, differences in most quality of life scores were not significantly significant between the two arms.

Rocio Garcia-Carbonero, MD, PhD, Universidad de Sevilla, discusses the quality of life results from the RAISE study.

The RAISE study was a phase III randomized, double-blind study of FOLFIRI plus ramucirumab or placebo in patients with metastatic colorectal cancer (mCRC) after first-line therapy with bevacizumab, oxaliplatin, or fluoropyrimidine.

Rocio Garcia-Carbonero, MD, PhD

Articles

Dr García-Carbonero on Outcomes With Fruquintinib in mCRC Subgroups

Advancing Treatment Strategies and Real-World Perspectives for mCRC and GI Neuroendocrine Neoplasms; With Rocío García-Carbonero, MD, PhD

Dr García-Carbonero on Considerations for Poorly Differentiated GI Neuroendocrine Carcinoma

Dr García-Carbonero on Outcomes With Fruquintinib in R/R mCRC by Metastatic Sites

Dr Garcia-Carbonero on the Phase 2b VIRAGE Trial in Metastatic PDAC

Dr. Garcia-Carbonero on Quality of Life Impact of FOLFIRI Plus Ramucirumab in mCRC