Real-World Study: Panitumumab N01 vs Cetuximab Plus FOLFOX in First-Line RAS Wild-Type mCRC

Browse trials for

• Colorectal Neoplasms 5,755

Keywords

• colorectal cancer
• EGFR inhibitor
• first line

Colorectal Neoplasms

5,755 studies on the registry are indexed under Colorectal Neoplasms; 1,495 are open to participants now.

This study's planned enrollment of 610 is above the median of 250 across 1,261 observational studies indexed under Colorectal Neoplasms.

Lead sponsor

Fujian Medical University Union Hospital is the lead sponsor of 107 studies on the registry; 78 are open to participants now.

Study population

Groups and cohorts

• Panitumumab N01

  Panitumumab N01 plus FOLFOX

  Drug: Panitumumab N01

• Cetuximab

  Cetuximab or Cetuximab N01 plus FOLFOX

  Drug: Cetuximab (EGFR inhibitor)

Interventions

• DrugPanitumumab N01

  Panitumumab N01 plus FOLFOX

• DrugCetuximab (EGFR inhibitor)

  cetuximab or cetuximab N01 plus FOLFOX

Primary outcomes

1. overall survival

   Time from the index-date (initial diagnosis of RAS wild-type mCRC) to death from any cause. Patients alive or lost-to-follow-up will be censored at the date of last valid follow-up.

   Time frame: From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of death from any cause, assessed up to 30 months

2. Incremental Cost-Utility Ratio (ICUR)

   Ratio of incremental direct medical costs versus incremental quality-adjusted life-years (QALYs) between the Panitumumab N01 arm and the cetuximab/cetuximab N01 arm; unit: CNY per QALY. Only costs generated after Panitumumab N01 is listed for national medical reimbursement are included.

   Time frame: From date of treatment initiation until date of study completion, death, or loss to follow-up, whichever comes first, assessed up to 30 months

Secondary outcomes

1. 2-Year Overall Survival Rate

   Cumulative probability of being alive at 24 complete months after index-date, estimated by the Kaplan-Meier method. All-cause death is the event; subjects who are lost-to-follow-up or still alive before 24-month time-point are censored.

   Time frame: From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of death from any cause, assessed up to 24 months

2. Real-World Progression-Free Survival

   Time from index-date to the earliest documented disease progression (per real-world clinical evidence: imaging, pathology, clinical notes indicating PD / new lesion) or death from any cause, whichever occurs first. Censored at last evaluable assessment for patients without events.

   Time frame: From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of first documented disease progression or death from any cause, whichever comes first, assessed up to 30 months

3. Duration of Treatment

   Time from first dose of study drug (Panitumumab N01 / cetuximab / cetuximab N01) to permanent discontinuation of study drug for any reason (disease progression, adverse event, patient preference, economic reason, death).

   Time frame: From date of first administration of study drug (panitumumab N01 or cetuximab / cetuximab N01) until date of permanent treatment discontinuation for any cause, assessed up to 30 months

4. Time To Next Treatment

   Time from index-date to initiation of next-line systemic anti-tumor therapy or death, whichever occurs first. Maintenance therapy is not counted as next-line treatment.

   Time frame: From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of initiation of next-line systemic anticancer therapy or death from any cause, whichever comes first, assessed up to 30 months

5. Objective Response Rate

   Proportion of participants achieving best overall response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1, sustained for at least 4 weeks, from index-date until documented disease progression or initiation of participant's new anti-tumor therapy.

   Time frame: From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of disease progression or initiation of new anticancer therapy, whichever comes first, assessed up to 30 months

6. Complete Response Rate

   Proportion of participants achieving best overall Complete Response (CR) per RECIST 1.1, sustained for at least 4 weeks, from index-date until documented disease progression or initiation of participant's new anti-tumor therapy.

   Time frame: From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of disease progression or initiation of new anticancer therapy, whichever comes first, assessed up to 30 months

7. Disease Control Rate

   Proportion of participants achieving best overall response of CR, PR or Stable Disease (SD) per RECIST 1.1, sustained for at least 4 weeks, from index-date until documented disease progression or initiation of participant's new anti-tumor therapy

   Time frame: From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of disease progression or initiation of new anticancer therapy, whichever comes first, assessed up to 30 months

8. Early Tumor Shrinkage Rate

   Proportion of participants with ≥30 % reduction in sum of longest diameters of measurable target lesions at Week 8 ± 7 days after participant's first study-drug dose (RECIST 1.1). No minimum duration of response required.

   Time frame: At 8 weeks ±7 days after the participant's first study-drug dose

9. Depth of Response

   Maximum percentage-reduction from baseline in sum of longest diameters of target lesions among participants with tumour shrinkage. Formula: (baseline sum - minimum on-treatment sum of target-lesion longest diameters) / baseline sum × 100 %.

   Time frame: From baseline assessment until the time point of maximum tumor shrinkage during the entire treatment period, assessed up to 30 months

10. Conversion Resection Rate

    Percentage of participants who had MDT-confirmed initially unresectable metastatic colorectal cancer at baseline and subsequently received curative-intent resection of all primary plus metastatic lesions after receiving ≥1 cycle of study treatment.

    Time frame: From participant's baseline MDT assessment until completion of participant's curative-intent surgery

11. Cancer-Specific Survival

    Time from index-date to death attributable to colorectal cancer or treatment-related complications. Deaths from other causes are treated as competing events; participants lost-to-follow-up or remaining alive are censored. Estimated via Fine-Gray competing-risk model

    Time frame: From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of death caused by colorectal cancer or its treatment-related complications, assessed up to 30 months

12. Treatment-Emergent Adverse Event (TEAE) Incidence

    Proportion of participants experiencing at least one TEAE (any adverse event newly occurring or worsening from first study-drug dose through 28 days ± 7 days after last study-drug dose), graded per CTCAE 6.0.

    Time frame: From participant's first study-drug dose to 28 days ± 7 days after participant's last study-drug dose

13. Per-Patient Full-Cycle Direct Medical Costs

    Per-participant total direct anti-tumour-related medical costs from index-date to death, including targeted-drug cost, chemotherapy cost, pre-medication cost, adjunctive-drug cost, lab-imaging costs, inpatient costs, outpatient costs and adverse-event-management costs.

    Time frame: From date of treatment initiation until date of study completion, death, or loss to follow-up, whichever comes first, assessed up to 30 months

14. Per-Patient Medical-Insurance-Fund Payment Amount

    Per-participant total amount paid by medical-insurance funds (pooling fund, catastrophic-insurance, medical-assistance, supplementary-enterprise-insurance)

    Time frame: From date of treatment initiation until date of study completion, death, or loss to follow-up, whichever comes first, assessed up to 30 months

15. EQ-5D-5L Health-Utility Value

    Health-state utility value derived from the Chinese EQ-5D-5L value set, covering mobility, self-care, usual-activities, pain-discomfort, anxiety-depression; score range -0.594 \~ 1.0 (1 = full health, 0 = death; negative values represent states worse-than-death).

    Time frame: Assessed at baseline, weekly for the first 2 months of treatment, every 3 months (±7 days) during subsequent treatment, and every 6 months (±14 days) after disease progression, through study completion, up to 30 months

16. FACT-EGFRI-18

    Patient-reported 18-item FACT-EGFRI-18 questionnaire evaluating EGFR-inhibitor-associated physical, social-family and functional symptom burden over the prior 7 days; total score and sub-domain scores (physical well-being, social-family well-being, functional well-being). Higher scores represent lower symptom burden and better quality-of-life

    Time frame: At baseline within 28 days before the participant's first study-drug dose; weekly for the first 2 months of the participant's treatment; every 3 months ± 7 days thereafter; up to 28 days ± 7 days after the participant's last study-drug dose

17. PRO-CTCAE Adverse-Event Outcomes

    Patient-reported adverse-event frequency and severity collected via PRO-CTCAE questionnaire over prior 7 days. Endpoints include overall AE incidence, frequency-grade distribution and severity-grade distribution of individual symptoms.

    Time frame: At participant's baseline; weekly for the first 2 months of the participant's treatment; every 3 months ± 7 days thereafter; up to 28 days ± 7 days after the participant's last study-drug dose

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be shared. This study uses de-identified clinical and medical insurance settlement data. Data sharing is prohibited by local data security and medical privacy regulations