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MFOLFIRINOX vs mFOLFOX6 Survival in Gastric/GEJ Cancer

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Modified Chemo Regimen Shows Promise In Gastric Cancer Treatment

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Barcelona, Spain – A Modified Chemotherapy Regimen Is Showing Promise In treating Her2-Negative Metastatic Gastric and
Gastroesophageal Adenocarcinoma. The Phase 3 Iriga Trial, Unveiled At The 2025 Esmo Gastrointestinal Cancers Congress,
Indicates That Mfolfirinox Significantly Boosts The Objective Response Rate (Orr) Compared To Mfolfox6.

While Mfolfox6 Is A Standard Treatment, The Iriga Trial Explored Whether Adding Irinotecan To The Regimen (Creating Mfolfirinox)
Could Offer Additional Benefits.

Key Findings From The Iriga Trial

The Study, Led By Daria Gavrilova, Md, Involved Patients Wiht Advanced Gastric Or Gastroesophageal Adenocarcinoma Who Had Not
Previously Undergone Systemic Therapy For Advanced Disease.

Key Results Include:

  • Objective Response Rate: Mfolfirinox Showed A Significantly Higher Orr At 31.2% Versus 19.3% With Mfolfox6 (P =.014).
  • Progression-Free survival (Pfs): Although Numerically Improved With Mfolfirinox (7.20 Months Vs 6.83 Months), The
    Difference Was Not Statistically Significant Overall.However, Patients With Grade 1 Or 2 disease Showed A Significant
    Betterment In Pfs With Mfolfirinox (9.9 Months Vs 8.4 Months).
  • Overall Survival (os): No Significant Difference Was Observed Between The Two Regimens, With Mfolfirinox At 13.40
    Months And Mfolfox6 At 13.23 Months.

Gavrilova Noted That Despite the Improved Response Rate, The Overall Population Did Not Experiance A Significant Benefit In
Overall Or Progression-Free Survival.

Detailed Study Design

The Iriga Trial Was A Single-Center, Open-Label, Randomized Phase 3 Study. It Enrolled 326 Patients Who Were Randomly Assigned
To Receive Either Mfolfirinox Or Mfolfox6.

The Primary Endpoint Was Progression-Free Survival, With Secondary Endpoints Including Overall Survival, Objective Response Rate,
And Toxicity.

“The Trial’s Rigorous design And Comprehensive Data Analysis Provide Valuable Insights Into Optimizing Treatment strategies For
Gastric Cancer,” Says Dr. Elena Ramirez,A Leading Oncologist At The National Cancer Institute,Commenting On the Study’s
Impact.

Safety Profile

Mfolfirinox Was Associated With A Higher Incidence Of Treatment-Related Toxicities. Common Adverse Effects Included Asthenia,
Nausea, And Diarrhea. Grade 3 Or 4 adverse Events Were Also More Prevalent In The Mfolfirinox Arm, Especially Neutropenia.

“While The Improved Response Rate With Mfolfirinox Is Encouraging, Clinicians Must Carefully Consider The Increased Risk Of
Toxicities When Making Treatment Decisions,” Adds Ramirez.

Subgroup Analysis Highlights

Further Analysis Revealed Varying Hazard Ratios (Hr) For Progression-Free Survival Across Different Subgroups:

  • Gender: Hr Was 0.83 For Women and 0.79 For Men.
  • Age: Hr Was 0.77 For Those under 65 Years And 0.79 For Those 65 Years Or Older.
  • Histological Grade: Hr Was 0.83 For Those With Histological Grade 3 Plus Signet Ring Cell Disease.

These findings Suggest That Certain Patient Subgroups May benefit more From Mfolfirinox Than Others.

Comparative Overview Of mfolfirinox And Mfolfox6

For A Clearer Comparison, Hear’s A Table Summarizing Key Aspects Of The Two Regimens:

Treatment Objective Response rate Median Pfs Median Os Common Adverse Effects
Mfolfirinox 31.2% 7.20 Months (9.9 Months In Grade 1/2) 13.40 Months Asthenia, Nausea, Diarrhea
Mfolfox6 19.3% 6.83 Months (8.4 Months In Grade 1/2) 13.23 Months Asthenia

Did You Know? Gastric Cancer Is the Fifth Most common Cancer Worldwide, Making
Advancements In Its Treatment Crucial.

Pro Tip: Always Discuss Potential Treatment Options And Their Associated Risks With Your
Oncologist To Make Informed Decisions.

How Might These Findings Change Your Approach To Gastric Cancer Treatment? What Further Research Would Help Clarify The Benefits
of Mfolfirinox?

Understanding Gastric Cancer: An Evergreen Viewpoint

Gastric Cancer, Also Known As Stomach Cancer, Remains A Significant Global Health Challenge. Early Detection And
Personalized Treatment Strategies Are Critical For Improving Patient Outcomes.

  • Risk Factors: Include H. Pylori Infection, Diet High In Smoked Or pickled Foods, And Family History.
  • Prevention: Focuses On Eradicating H. Pylori, Adopting A Healthy Diet, And Avoiding Tobacco Use.
  • Treatment Advances: Beyond Chemotherapy, Immunotherapy And Targeted Therapies Are Showing Promise.

According To The American Cancer Society, The 5-Year Survival Rate For Gastric Cancer Is About 32%, But This Can Vary
Significantly Depending On The Stage At Diagnosis.

Frequently Asked Questions About Gastric Cancer Treatment

  • What Is Mfolfirinox?
    Mfolfirinox Is A Chemotherapy Regimen Consisting of Irinotecan, Oxaliplatin, Leucovorin, And Fluorouracil (5-Fu), Used To
    Treat Gastric Cancer.
  • How Does Mfolfirinox Compare To Mfolfox6 In Gastric Cancer Treatment?
    Mfolfirinox Showed A Higher Objective response Rate But No Significant Difference In Overall Survival Compared to Mfolfox6 In
    The Iriga Trial.
  • What Are The Common Side Effects Of Mfolfirinox?
    Common Side Effects Of mfolfirinox Include Asthenia, Nausea, Diarrhea, And Neutropenia.
  • Who Is most Likely To Benefit From Mfolfirinox Treatment?
    Patients With Grade 1 Or 2 gastric Adenocarcinoma Showed A Significant Improvement In Progression-Free Survival With
    Mfolfirinox.
  • What Is Her2-Negative Metastatic Gastric Cancer?
    Her2-Negative Metastatic Gastric Cancer Refers To Gastric Cancer That Has Spread To Other Parts Of The Body And Does Not
    Overexpress The Her2 Protein.

What Are Your Thoughts On This Study? Share This Article And Join The Conversation!

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MFOLFIRINOX vs mFOLFOX6: A Comparative Look at Survival Outcomes in Gastric/GEJ Cancer

The treatment landscape for Gastric Cancer (GC) and Gastroesophageal Junction (GEJ) Cancer has seen significant advancements. Chemotherapy regimens play a crucial role in both the neoadjuvant (pre-surgery) and adjuvant (post-surgery) settings, as well as for advanced or metastatic disease.Two prominent chemotherapy regimens used are MFOLFIRINOX and mFOLFOX6. This article provides a detailed comparison of these regimens, focusing on survival benefits, side effects, and considerations for patients with gastric cancer.

Understanding MFOLFIRINOX and mFOLFOX6 Regimens

MFOLFIRINOX: The Multi-Drug Cocktail

MFOLFIRINOX is a more intensive and often multi-drug regimen compared to mFOLFOX6. It typically incorporates a combination of cytotoxic agents, including:

  • Oxaliplatin: A platinum-based chemotherapy drug.
  • Irinotecan: A topoisomerase I inhibitor.
  • Leucovorin: A folate derivative that enhances the effects of fluorouracil.
  • Fluorouracil (5-FU): A pyrimidine analog, an antimetabolite agent.
  • Docetaxel: A taxane, or microtubule inhibitor.

mFOLFOX6: A Widely Used standard

mFOLFOX6 generally comprises the following drugs:

  • Oxaliplatin: Same as MFOLFIRINOX.
  • Leucovorin: Same as MFOLFIRINOX.
  • Fluorouracil (5-FU): Same as MFOLFIRINOX.

Comparing these two regimens will show which protocol is more beneficial: a combination of drugs or a lesser amount of drugs for the treatment of advanced gastric adenocarcinoma.

Comparative Survival Rates: Key Outcomes

The efficacy of these regimens is often evaluated by metrics like Overall Survival (OS),Progression-Free Survival (PFS),and response rates.

Metric MFOLFIRINOX mFOLFOX6 notes
Overall Survival (OS) Often Shows Superiority Comparable or Lower MFOLFIRINOX may demonstrate better OS in certain studies for the treatment of gastric cancer stages, but results varies by patient populations.
Progression-free Survival (PFS) Generally higher Possibly lower MFOLFIRINOX frequently exhibits improved PFS, meaning a longer time before the cancer worsens. Consider the patient’s performance status.
objective Response Rate (ORR) Higher Generally lower MFOLFIRINOX may lead to a higher percentage of patients experiencing a measurable tumor shrinkage.

Real-World Examples and Case Studies

Several clinical trials, such as the PRODIGE 11 trial, have assessed these regimens. These studies provide valuable insights. While specific findings vary by trial design, the trend shows that MFOLFIRINOX is more effective; though, data must be analyzed to ensure patients are getting the best treatment with the least amount of side effects.

Side Effects and Tolerability Comparison

A critical factor in choosing a chemotherapy regimen is its tolerability. While MFOLFIRINOX may offer improved survival rates,it can also be associated with more intense side effects.

Common Side Effects

  • MFOLFIRINOX: Patients often experience a higher incidence of neutropenia, diarrhea, and alopecia (hair loss).
  • mFOLFOX6: Generally milder, with fewer severe side effects, but can cause common issues such as vomiting, peripheral neuropathy and fatigue.

The choice between MFOLFIRINOX and mFOLFOX6 often involves a trade-off between efficacy and side effects. Patient factors, such as overall health, and the patient’s preferences are critical when the gastric cancer treatment is selected.

Patient Selection and Considerations

Choosing the right regimen depends significantly on the individual patient.

  • performance Status: Patients with a good performance status (able to perform most daily activities) may be better candidates for MFOLFIRINOX, as they may be able to tolerate the side effects.
  • contraindications: Patients with certain pre-existing conditions (e.g., significant neuropathy or liver problems) may not be suitable for MFOLFIRINOX.
  • Treatment Goals & Risk Tolerance: The need to weigh the potential for improved survival with the the increased chance of experiencing more severe side effects.

Careful consideration should be given to the best treatment for gastric cancer

Practical Tips for Managing Treatment

  • Consultation with Oncologist: Decisions about which treatment will be best for patients should always be conducted with a consultation with the patient’s oncologist.
  • Nutritional support: Proper nutrition is crucial to maintaining energy levels. discuss a diet plan with your doctor.
  • supportive Medications: Anti-nausea drugs and other supportive medications can definitely help manage side effects.

careful consideration must be implemented when selecting between MFOLFIRINOX and mFOLFOX6. Although MFOLFIRINOX has exhibited superior survival rates compared to mFOLFOX6 for the treatment of Gastric/GEJ cancer, the side effects must be taken into consideration. Proper consultation with an oncologist must be administered before any treatment decision is administered. The medical personnel and patient team need to make a collaborative and informed decision to ensure the patient is being administered the best treatment available based on the patient’s circumstances.

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Economy

Fruquintinib for Metastatic CRC: Real-World Evidence

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Fruquintinib Shows Promise in Refractory mCRC: real-world Data Unveiled at GI Cancers Congress

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Barcelona, Spain – New data presented at the 2025 SMO Gastrointestinal Cancers Congress highlights the role of fruquintinib (Fruzaqla) in treating refractory metastatic colorectal cancer (mCRC). The real-world study from Portugal offers valuable insights into the drug’s effectiveness and safety outside of controlled clinical trials.

Fruquintinib, a targeted therapy, has gained attention following its approval by both the FDA in November 2023 and the European Commission in June 2024 for mCRC patients who have weary standard treatment options. These approvals were based on the pivotal FRESCO-2 trial. Now,real-world evidence is emerging to further define its utility.

Real-World outcomes of Fruquintinib in mCRC

A prospective, non-interventional cohort study conducted across five Portuguese centers between January 2024 and March 2025, examined the outcomes of mCRC patients treated with fruquintinib in a real-world setting. The study, led by dr. Filipa R. Verdasca from Unidada Local de Saúde de São José in Lisbon, included 23 evaluable patients.These patients experienced a median overall survival (OS) of 4.0 months (95% CI, 0.47-7.53) and a median progression-free survival (PFS) of 3.0 months (95% CI,0.96-5.04).

Notably,these results differ from the FRESCO-2 trial,where fruquintinib demonstrated a median OS of 7.4 months and a median PFS of 3.7 months, compared to placebo.The researchers suggest that the shorter OS observed in the real-world cohort might be attributed to the diverse comorbidities and clinical practices inherent in a real-world patient population.

Did You Know? Real-world data frequently enough provides a more accurate reflection of a treatment’s performance in everyday clinical practice compared to highly controlled clinical trials.

Deeper Dive into Patient Characteristics

The median age of patients in the Portuguese study was 61 years, with a majority being male (70%) and having left-sided tumors (57%). Most patients had undergone primary tumor resection (87%). The ECOG performance status, a measure of a patient’s overall well-being, was 0 for 30% of patients, 1 for 57%, and 2 for 13%. Genetic analysis revealed that 43% had RAS, BRAF, and HER2 wild-type disease, while 48% harbored NRAS or KRAS mutations.

At the start of the study, the number of metastatic sites varied: 35% had one site, 13% had two, 30% had three, and 22% had at least four. Common metastatic locations included the liver (57%), lung (61%), and lymph nodes (48%). Most patients (61%) had received three prior lines of therapy, with 35% having received at least four.

Safety Profile in the Real World

The real-world data indicated a manageable safety profile for fruquintinib, with 73.9% of patients experiencing any-grade treatment-related adverse events (TRAEs). However, grade 3/4 TRAEs were reported in 17.4% of patients. Common side effects included fatigue, hypertension, anemia, diarrhea, and mucositis. Discontinuation of treatment due to toxicity occurred in 39% of patients, and 30% required dose reductions.

Study authors pointed out that while the rate of grade 3 or higher adverse events was lower in the FRESCO-2 trial (63%), the real-world cohort experienced higher rates of treatment discontinuations (39% vs.20%) and dose reductions (30% vs. 24%). This suggests that the frailty and tolerability challenges frequently enough seen in clinical practice may play a significant role.

Pro Tip: managing side effects proactively and adjusting the dosage of fruquintinib based on individual patient needs can improve tolerability and optimize treatment outcomes.

Comparative Efficacy and Safety: Trial vs. Real-World

To better understand the nuances between clinical trial and real-world application,consider the following comparison:

Outcome FRESCO-2 Trial Real-World Study (Portugal)
Median Overall Survival (OS) 7.4 months 4.0 months
Median Progression-Free Survival (PFS) 3.7 months 3.0 months
Treatment Discontinuation Rate 20% 39%
Dose Reduction Rate 24% 30%

Future Directions

The researchers plan to expand their study with increased patient accrual and longer follow-up to further evaluate the safety and long-term outcomes of fruquintinib in real-world settings. These efforts will provide a more comprehensive understanding of the drug’s role in the treatment landscape of refractory mCRC.

What are your thoughts on the differences observed between the clinical trial and real-world data? How can these insights be used to improve patient care for those with refractory mCRC?

Understanding Fruquintinib: FAQs and Key information

What is the mechanism of action of fruquintinib?

Fruquintinib is a highly selective and potent oral vascular endothelial growth factor receptor (VEGFR) inhibitor.It works by blocking the signals that promote blood vessel growth,thereby inhibiting tumor growth and spread.

Who is a candidate for fruquintinib treatment?

Fruquintinib is indicated for adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.

What are the potential benefits of fruquintinib?

Fruquintinib has demonstrated the ability to improve overall survival and progression-free survival in patients with refractory mCRC, offering a valuable treatment option for those who have exhausted other therapies.

How is fruquintinib administered?

Fruquintinib is administered orally. The typical starting dose is 5 mg once daily, taken 21 days on and 7 days off, in a 28-day cycle. Dosage adjustments may be necessary based on individual patient tolerability and adverse events.

What monitoring is required during fruquintinib treatment?

Regular monitoring of blood pressure, liver function, and other potential side effects is essential during fruquintinib treatment.Patients should also be educated about the signs and symptoms of adverse events and instructed to report them promptly to their healthcare provider.

Here are a few People also Ask (PAA) related questions for the provided text:

Fruquintinib for Metastatic CRC: Real-World Evidence Unveiled

Understanding Fruquintinib in Metastatic Colorectal cancer

Fruquintinib, a highly selective inhibitor of vascular endothelial growth factor receptors (VEGFRs) -1, -2, and -3, has emerged as a significant treatment option for metastatic colorectal cancer (mCRC). This article dives deep into the real-world evidence (RWE) supporting its use,moving beyond clinical trials to examine its impact on patients’ lives.Understanding Fruquintinib efficacy in mCRC is critical for oncologists and patients alike. We’ll explore survival outcomes, adverse events, and the practical aspects of incorporating Fruquintinib into treatment plans. The focus remains on providing actionable insights on topics like Fruquintinib mechanism of action, efficacy in later-line therapy, and patient selection criteria.

The Role of VEGFR Inhibition

Fruquintinib’s mechanism of action, targeting VEGFRs, is central to its effectiveness. these receptors play a crucial role in angiogenesis, the formation of new blood vessels that tumors need to grow and spread. by selectively inhibiting VEGFRs, Fruquintinib starves the tumor, potentially slowing its progression and improving patient outcomes. Learn more about angiogenesis.This targeted approach differentiates it from other therapies and offers a potentially more favorable safety profile in some cases.

Clinical Trial vs. Real-World Data

While clinical trials provide a controlled habitat to assess drug efficacy, real-world data (RWD) offers a broader viewpoint. RWD includes data collected from routine clinical practice, allowing for a better understanding of how a drug like Fruquintinib performs across diverse patient populations and in the context of various treatment settings.

Key Findings from Real-World Studies of Fruquintinib

Real-world studies and analysis of patient outcomes offer valuable insights into Fruquintinib’s performance in diverse patient populations. The data provides a more comprehensive understanding of Fruquintinib efficacy in metastatic colorectal cancer.

efficacy and Survival Outcomes

Real-world studies demonstrate Fruquintinib’s impact on survival outcomes in patients with mCRC. These studies frequently analyse overall survival (OS) and progression-free survival (PFS), providing crucial indicators of treatment effectiveness.

Key points include:

  • Improved overall survival (OS) compared to standard of care in the third-line or later setting.
  • Progression-free survival (PFS) that offers a window of disease control.
  • Response rates in the real world are comparable to those observed in clinical trials.

Safety and Tolerability

While clinical trials provide safety data, RWE expands this understanding. Real-world studies provide details on the incidence and management of adverse events. The data emphasizes the need for careful patient monitoring and proactive adverse effect management.

Patient Subgroups and Treatment Outcomes

Different patient subgroups may respond differently to Fruquintinib. The study of patient subgroups helps customize treatment plans. This includes consideration of prior therapies, patient performance status, and the presence of specific genetic mutations. Analyzing subgroup data informs more personalized treatment approaches.

Patient Subgroup Outcomes (Example)
Patients with prior EGFR-inhibitor exposure Potential altered response
Patients with poor performance status May experience more adverse effects

Practical Considerations in Fruquintinib Treatment

Implementing Fruquintinib therapy requires careful consideration of various factors. Here are the most vital.

Patient Selection and eligibility

Patient selection is critical for maximizing Fruquintinib’s benefits. Oncologists must assess factors such as previous treatment history, performance status, and the presence of specific genetic mutations. The study carefully analyzes eligibility criteria, risk factors, and how to personalize recommendations to specific patient needs.

Dosage, Management, and Management of Adverse Events

Fruquintinib is administered orally. Proper dosage, timing, and safety guidelines are vital for optimal benefit. Common side effects include fatigue,hand-foot syndrome,and hypertension. proactive strategies and treatment modifications can help patients manage these potential adverse events and maintain quality of life.

Integrating Fruquintinib into the Treatment Pathway

As a later-line treatment option, Fruquintinib often follows other therapies such as chemotherapy, targeted therapies, and immunotherapy. The article explores its place in the overall treatment sequence, considering how to optimize its sequencing, avoid redundancy, and identify the best time to administer Fruquintinib.

Case Study: Real-World Example

A 62-year-old patient with metastatic colorectal cancer, who had previously received multiple lines of chemotherapy and failed to respond to targeted therapies, was started on Fruquintinib. The patient had stage IV disease at diagnosis. Prior therapies included FOLFOX, FOLFIRI, and bevacizumab and cetuximab. The patient experienced disease progression after each line of therapy. After initiating Fruquintinib,his disease stabilized,and he achieved a six-month progression-free survival. Despite some fatigue and manageable hypertension, the patient’s quality of life was considerably improved. This case highlights the potential for fruquintinib to offer a meaningful benefit in patients with heavily pretreated mCRC.This is a true example that showcases the impact that the fruquintinib treatment could bring into a more detailed context.

Future Directions and Emerging Research

The field of mCRC treatment is constantly evolving. This includes what will be coming in the future.

  • Combination Therapies: Research exploring Fruquintinib in combination with other agents like chemotherapy or immunotherapy.
  • Biomarker Advancement: The ongoing search for biomarkers to identify patients most likely to respond to Fruquintinib.
  • Long-Term Outcomes: Studies focusing on long-term survival and quality of life in Fruquintinib-treated patients.

Conclusion

The current RWE supports Fruquintinib as an effective option for patients with mCRC in the later-line setting. By understanding the real-world implications of treatment, clinicians and patients can collaborate to make informed decisions. Patients should consult their medical teams for a personalized assessment of Fruquintinib’s suitability.

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