Comparative Safety of Targeted Therapies for Metastatic Colorectal Cancer between Elderly and Younger Patients: a Study Using the International Pharmacovigilance Database

Gouverneur, Amandine; Claraz, Pauline; Rousset, Marine; Arnaud, M; Fourrier‐Réglat, Annie; Pariente, Alexandre; Aparicio, Thomas; Miremont-Salamé, Ghada; Noïze, Pernelle

doi:10.1007/s11523-017-0529-y

Cited by 17 publications

(20 citation statements)

References 35 publications

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“…No new safety concerns emerged from this study. Diarrhea, asthenia, stomatitis, nausea, and hypertension were the most frequently occurring TEAEs of any grade, consistent with VELOUR and previously published real-world studies [5,[15][16][17][18][19]. Anti-VEGF class effects were uncommon, and rates remained similar to those reported in VELOUR.…”

Section: Discussionsupporting

confidence: 86%

“…Furthermore, patients in VELOUR had received only one prior line of therapy for metastatic disease. The OZONE population could have received > 1 line of therapy (55.2% had received > 1 prior line) and thus was consistent with the patients enrolled on more recent, real-world studies [15][16][17][18][19].…”

Section: Discussionsupporting

confidence: 72%

“…Whilst studies such as these are required for registration purposes, Phase III RCTs have limitations, particularly when considering the rigorously controlled patient populations that are recruited, which often do not closely reflect patients in the clinic. PASSs evaluate the safety and effectiveness of therapies in a comparatively less selected population and are therefore useful for extending the knowledge of recently approved compounds in real-life practice, providing complementary information to formal clinical development [11,12,[15][16][17][18][19]. OZONE evaluated the use of aflibercept plus FOLFIRI in routine clinical practice in patients with mCRC after failure of an oxaliplatin-based regimen, mirroring real-life patient management.…”

Section: Discussionmentioning

confidence: 99%

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Safety and Effectiveness of Aflibercept + Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) for the Treatment of Patients with Metastatic Colorectal Cancer (mCRC) in Current Clinical Practice: OZONE Study

Chau

Fakih

García‐Alfonso

et al. 2020

Cancers

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For patients with metastatic colorectal cancer (mCRC) that have failed a first-line oxaliplatin-based regimen, the preferred treatment option is an irinotecan-based regimen. This prospective, observational, noncomparative, post-authorization safety study (OZONE) evaluated the safety and effectiveness of aflibercept plus fluorouracil, leucovorin, and irinotecan (FOLFIRI) in patients with mCRC treated in daily practice after failure of an oxaliplatin-based regimen. Patients were grouped by age, renal impairment, hepatic impairment, race, number, and type of prior anticancer therapy. Of 766 treated patients enrolled, 59.5% were male, 94.8% had an Eastern Cooperative Oncology Group performance status of 0-1, all received previous chemotherapy (97.8% including oxaliplatin), and 58.6% had prior exposure to bevacizumab. At least one grade ≥ 3 treatment-emergent adverse event (TEAE) was reported in 68.3% of patients. Neutropenia, hypertension, diarrhea, and asthenia were the most frequently occurring grade ≥ 3 TEAEs. Antivascular endothelial growth factor class events were infrequent. Subgroup analyses did not reveal major differences in the safety profile according to age, renal and hepatic status, race, or prior anticancer therapy. For the total population, median overall survival was 12.5 months, median progression-free survival was 6.1 months, and overall response rate was 16.3%. Aflibercept in combination with FOLFIRI is a safe and efficacious regimen administered in current clinical practice to patients with mCRC previously treated with oxaliplatin. The study results, conducted in real-world clinical practice with a less selected patient population, are aligned with the VELOUR (NCT00561470) trial and no new safety issues were identified.

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Section: Discussionsupporting

confidence: 86%

Section: Discussionsupporting

confidence: 72%

Section: Discussionmentioning

confidence: 99%

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Safety and Effectiveness of Aflibercept + Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) for the Treatment of Patients with Metastatic Colorectal Cancer (mCRC) in Current Clinical Practice: OZONE Study

Chau

Fakih

García‐Alfonso

et al. 2020

Cancers

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“…As in clinical trials, older patients may be partly excluded from receiving treatment with targeted therapies in real‐life settings. The unwillingness of physicians to prescribe anticancer medications in older adults may be greater with regard to newer medications, as recently demonstrated by McCleary et al 11 However, there is increasing evidence of a satisfactory benefit‐risk ratio of such medications in this population . Except for age, other factors that may influence the decision to prescribe conventional chemotherapy alone or a treatment including a targeted therapy were related to mCRC.…”

Section: Discussionmentioning

confidence: 98%

“…The unwillingness of physicians to prescribe anticancer medications in older adults may be greater with regard to newer medications, as recently demonstrated by McCleary et al 11 However, there is increasing evidence of a satisfactory benefitrisk ratio of such medications in this population. 9,10,12,[22][23][24] Except for age, other factors that may influence the decision to prescribe conventional chemotherapy alone or a treatment including a targeted therapy were related to mCRC. Intensive treatment, including a targeted therapy, may be avoided in patients with a history of cancer because of previous exposure to chemotherapy or radiotherapy.…”

Section: Discussionmentioning

confidence: 99%

Treatment Modalities and Survival in Older Adults with Metastatic Colorectal Cancer in Real Life

Gouverneur

Bezin

Jové

et al. 2019

J American Geriatrics Society

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OBJECTIVES Metastatic colorectal cancer (mCRC) is increasingly treated with targeted therapies, but little is known about real‐life mCRC treatment in older adults. The aims were to describe the real‐life first‐line treatment modalities in older adult mCRC patients, to identify factors associated with treatment modalities, and to evaluate survival with regard to treatment modalities. PATIENTS AND METHODS A cohort of mCRC patients aged 65 years and older at diagnosis was identified between 2009 and 2013 using French national healthcare insurance system claims data. Treatment modalities were: treatment with one or more anticancer medication vs best supportive care and, among treated patients, treatment with targeted therapy vs conventional chemotherapy alone. Multivariate logistic regression was used to identify factors associated with treatment by anticancer medication and by targeted therapy. Cox proportional hazards models were used to assess the independent effect of treatment modalities on overall survival while adjusting for baseline covariates identified with logistic regression. RESULTS A total of 503 patients were included with a median age of 78 years (54% were men). Of these, 299 (59%) were treated with anticancer medications. Among treated patients, 131 (44%) received targeted therapy. In multivariate analysis, age 75 years or older, renal failure, malnutrition, and five or more concomitant medications were associated with a lower likelihood of treatment with anticancer medications. Among treated patients, age 75 years or older, history of cancer, lymph node metastases, and a single metastatic site were associated with a lower likelihood of treatment with targeted therapy. Multivariate Cox proportional hazards models found that treatment with any anticancer medication tended to be associated with a lower risk of death; treatment with targeted therapy was not significantly associated. CONCLUSION A more appropriate prescription of anticancer medications in the older adult will require the definition of more explicit criteria to avoid undertreatment. The real benefit of targeted therapies vs conventional chemotherapy alone needs to be confirmed in this population. J Am Geriatr Soc 67:913–919, 2019.

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Tumors: Colorectal

Aparicio

2021

Encyclopedia of Gerontology and Population Aging

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Comparative Safety of Targeted Therapies for Metastatic Colorectal Cancer between Elderly and Younger Patients: a Study Using the International Pharmacovigilance Database

Abstract: ADRs related to targeted therapies used for mCRC treatment were different across age groups; yet, not systematically more reported or worse in elderly patients. Selected elderly patients could, therefore, be treated with these targeted therapies.

Cited by 17 publications

References 35 publications

Safety and Effectiveness of Aflibercept + Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) for the Treatment of Patients with Metastatic Colorectal Cancer (mCRC) in Current Clinical Practice: OZONE Study

Safety and Effectiveness of Aflibercept + Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) for the Treatment of Patients with Metastatic Colorectal Cancer (mCRC) in Current Clinical Practice: OZONE Study

Treatment Modalities and Survival in Older Adults with Metastatic Colorectal Cancer in Real Life

Tumors: Colorectal

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