scholarly journals 4CPS-277 Cetuximab versus bevacizumab in metastatic colorectal cancer: a comparative effectiveness and patient reported outcomes multi-cohort study

Author(s):  
RP Marques ◽  
AR Godinho ◽  
P Heudtlass ◽  
HL Pais ◽  
A Quintela ◽  
...  
2020 ◽  
Author(s):  
Teresa Troiani ◽  
Stefania Napolitano ◽  
Marinella Terminiello ◽  
Pietro Paolo Vitiello ◽  
Fortunato Ciardiello ◽  
...  

BACKGROUND In metastatic colorectal cancer (mCRC) treatment-related health symptoms may have a strong impact on patient’s quality of life (QoL). It has been shown that a considerable number of health care providers underestimates symptom intensity. In this context, the systematic collection of electronic patient-reported outcomes (ePROs) has been demonstrated to be a valid, reliable, feasible and precise approach to tabulating symptomatic toxicities and to detect symptoms missed by clinicians. OBJECTIVE We aimed to evaluate feasibility as well as patients’ acceptance of remote technology system to detect and monitoring chemotherapy-related adverse events in metastatic colorectal cancer outpatients. METHODS We enrolled 8 mCRC outpatients who received an oncological treatment. A wearable device (smart watch) allowing automatic vitals measurement (blood pressure, heart rate, oxygen saturation, respiratory rate, pedometer and sleeping monitor) has been provided to all patients. Moreover, two mobile applications have been developed: the first one to monitor vital measurements recorded by the wearable device, the second one to identify treatment-related toxicities and QoL parameters using a 30-items questionnaire (some taken from EORTCQLQ-C30 and others composed by the investigators). Clinicians filled the electronic health records (EHR) at each visit with symptoms reported by patients, physical examination and any treatment modifications. RESULTS a total of 8 patients were enrolled, 2 women (25%) and 6 men (75%); median age was 54 years (range 35-69). Compliance was 77%. Overall concordance between ePRO and symptoms detected by clinicians was 80%; in 15% of cases of electronic patient-reported outcomes (ePROs) included symptoms missed during the visit, while in 5% of cases clinicians reported toxicities not recorded by patients. Regarding the symptoms that led to treatment modifications and/or suspension, the concordance between ePROs and clinician’s evaluation during the visit was 100%. CONCLUSIONS In our pilot experience this type of ePROs is feasible and well tolerated, showing high compliance (80%), and allowing identification of toxicities missed by clinicians in 15% of cases. These data suggest that the integration of ePROs with EHR may improve the management of cancer patients. These strategies should be prioritized to optimize active oncological treatments and supportive care in order to improve patient’s QoL and reduce inappropriate hospitalization.


2018 ◽  
Vol 36 (8) ◽  
pp. 773-779 ◽  
Author(s):  
Michael J. Overman ◽  
Sara Lonardi ◽  
Ka Yeung Mark Wong ◽  
Heinz-Josef Lenz ◽  
Fabio Gelsomino ◽  
...  

Purpose Nivolumab provides clinical benefit (objective response rate [ORR], 31%; 95% CI, 20.8 to 42.9; disease control rate, 69%; 12-month overall survival [OS], 73%) in previously treated patients with DNA mismatch repair–deficient (dMMR)/microsatellite instability–high (MSI-H) metastatic colorectal cancer (mCRC); nivolumab plus ipilimumab may improve these outcomes. Efficacy and safety results for the nivolumab plus ipilimumab cohort of CheckMate-142, the largest single-study report of an immunotherapy combination in dMMR/MSI-H mCRC, are reported. Patients and Methods Patients received nivolumab 3 mg/kg plus ipilimumab 1 mg/kg once every 3 weeks (four doses) followed by nivolumab 3 mg/kg once every 2 weeks. Primary end point was investigator-assessed ORR. Results Of 119 patients, 76% had received ≥ two prior systemic therapies. At median follow-up of 13.4 months, investigator-assessed ORR was 55% (95% CI, 45.2 to 63.8), and disease control rate for ≥ 12 weeks was 80%. Median duration of response was not reached; most responses (94%) were ongoing at data cutoff. Progression-free survival rates were 76% (9 months) and 71% (12 months); respective OS rates were 87% and 85%. Statistically significant and clinically meaningful improvements were observed in patient-reported outcomes, including functioning, symptoms, and quality of life. Grade 3 to 4 treatment-related adverse events (AEs) occurred in 32% of patients and were manageable. Patients (13%) who discontinued treatment because of study drug-related AEs had an ORR (63%) consistent with that of the overall population. Conclusion Nivolumab plus ipilimumab demonstrated high response rates, encouraging progression-free survival and OS at 12 months, manageable safety, and meaningful improvements in key patient-reported outcomes. Indirect comparisons suggest combination therapy provides improved efficacy relative to anti–programmed death-1 monotherapy and has a favorable benefit-risk profile. Nivolumab plus ipilimumab provides a promising new treatment option for patients with dMMR/MSI-H mCRC.


2014 ◽  
Vol 101 (11) ◽  
pp. 1468-1474 ◽  
Author(s):  
J. R. Rees ◽  
J. M. Blazeby ◽  
S. T. Brookes ◽  
T. John ◽  
F. K. Welsh ◽  
...  

2020 ◽  
Vol 9 (16) ◽  
pp. 1117-1129
Author(s):  
Francois-Xavier Lamy ◽  
Michael Batech ◽  
Emmanuelle Boutmy ◽  
Philippe Ronga ◽  
Shaista Salim ◽  
...  

Aim: To test the noninferiority of cetuximab administered every 2 weeks (Q2W) versus once weekly (Q1W) in treating metastatic colorectal cancer (mCRC) with regard to overall survival (OS). Patients: Patients receiving cetuximab plus chemotherapy for mCRC in a line-agnostic setting. Methods: This cohort study in IBM MarketScan followed patients from initiation of cetuximab for mCRC until the end of the data availability period, proxy-based death or loss of insurance coverage for >30 days. Results: The hazard ratio for OS was 0.94 (0.85–1.03), and the inferiority hypothesis was rejected at p < 0.001. No significant differences were noted in rates of safety events between Q2W and Q1W. Conclusion: Our real-world study confirmed the noninferiority of cetuximab administered Q2W versus Q1W for OS.


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