Mean overall survival gain with aflibercept plus FOLFIRI vs placebo plus FOLFIRI in patients with previously treated metastatic colorectal cancer

Joulain, Florence; Proskorovsky, Irina; Allegra, Carmen J.; Tabernero, Josep; Hoyle, Martin; Iqbal, Sheikh Usman; Cutsem, Éric Van

doi:10.1038/bjc.2013.523

Cited by 32 publications

(24 citation statements)

References 23 publications

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“…[11] Finite mixture models allow for estimation of survival differences between treatment groups while differentiating the truly nonrecurrent cases from those women who did experience a recurrence but were misclassified because they did not receive SCS, chemotherapy or hospice care. Finite mixture models have been used to model cancer survival, [12,13] and have many applications in other areas of health services, biology, marketing, and engineering. [14–17] This approach distinguishes between individuals with a greater probability to be in one group as compared to another, such as those with longer vs. shorter survival.…”

Section: Methodsmentioning

confidence: 99%

Secondary Surgery Versus Chemotherapy for Recurrent Ovarian Cancer

Bickell¹,

Egorova²,

Prasad-Hayes³

et al. 2018

American Journal of Clinical Oncology

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Objective The best course of treatment for recurrent ovarian cancer is uncertain. We sought to determine whether secondary cytoreductive surgery for first recurrence of ovarian cancer improves overall survival compared to other treatments. Methods We assessed survival using Surveillance, Epidemiology and End Results-Medicare data for advanced stage ovarian cancer cases diagnosed from January 1, 1997- December 31, 2007 with survival data through 2010 using multinomial propensity weighted finite mixture survival regression models to distinguish true from misclassified recurrences. Of 35,995 women ages 66 years and older with ovarian cancer, 3439 underwent optimal primary debulking surgery with 6 cycles of chemotherapy; 2038 experienced a remission. Results 1635 out of 2038 (80%) women received treatment for recurrence of whom 72% were treated with chemotherapy only, 16% with surgery and chemotherapy and 12% received hospice care. Median survival of women treated with chemotherapy alone, surgery and chemotherapy, or hospice care was 4.1 years, 5.4 years, and 2.2 years, respectively (p<0.001). Of those receiving no secondary treatments, 75% were likely true nonrecurrences with median survival of 15.9 years and 25% misclassified with 2.4 years survival. Survival among women with recurrence was greater for those treated with surgery and chemotherapy compared to chemotherapy alone (HR=1.67; 95% confidence interval: 1.13–2.47). Women who were older with more comorbidities and high grade cancer had worse survival. Conclusions Secondary surgery with chemotherapy to treat recurrent ovarian cancer increases survival by 1.3 years compared to chemotherapy alone and pending ongoing randomized trial results, may be considered a standard of care.

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Section: Methodsmentioning

confidence: 99%

Secondary Surgery Versus Chemotherapy for Recurrent Ovarian Cancer

Bickell¹,

Egorova²,

Prasad-Hayes³

et al. 2018

American Journal of Clinical Oncology

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“…The efficacy of intravenous aflibercept in combination with FOLFIRI in patients with mCRC who had progressed on or after completing treatment with an oxaliplatin-based regimen was evaluated in a pivotal, double-blind, multinational, phase 3 trial (VELOUR) [26], with these data supported by additional analyses [15,[30][31][32][33][34]. In addition, a global real-world Aflibercept Safety and Quality of life Program (ASQoP), which also included a French study (AFEQT), is evaluating aflibercept in a clinical setting similar to that of the VELOUR trial [35].…”

Section: Therapeutic Efficacy Of Afliberceptmentioning

confidence: 99%

“…Consistent with this finding, hazard ratios (HRs) for overall survival assessed at a 6-month intervals during the course of the VELOUR trial showed a continuous, consistent improvement with aflibercept plus FOLFIRI relative to placebo plus FOLFIRI (from 0.860 at B6 months to 0.676 at [18 months) [34]. Therefore, in order to assess the survival benefit beyond the end of the trial, mean overall survival was estimated by extrapolating survival curves from the VELOUR trial [31]. In the ITT population, with the best fit of statistical distribution (log-logistic), the estimated mean overall survival over 5 years was 19.5 months with aflibercept plus FOLFIRI and 16.5 months with placebo plus FOLFIRI (difference 3.0 months; 95 % CI 1.2-4.9) [31].…”

Section: Overall Survivalmentioning

confidence: 99%

“…Therefore, in order to assess the survival benefit beyond the end of the trial, mean overall survival was estimated by extrapolating survival curves from the VELOUR trial [31]. In the ITT population, with the best fit of statistical distribution (log-logistic), the estimated mean overall survival over 5 years was 19.5 months with aflibercept plus FOLFIRI and 16.5 months with placebo plus FOLFIRI (difference 3.0 months; 95 % CI 1.2-4.9) [31].…”

Section: Overall Survivalmentioning

confidence: 99%

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Aflibercept: A Review in Metastatic Colorectal Cancer

Syed

McKeage

2015

Drugs

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Aflibercept is a recombinant fusion protein that acts as a soluble decoy receptor for vascular endothelial growth factor (VEGF), a key regulator of angiogenesis. It binds to all isoforms of VEGF-A as well as VEGF-B and placental growth factor, and, thus, prevents them from binding to and activating their cognate receptors. In the USA and EU, intravenously administered aflibercept in combination with an infusion of leucovorin, fluorouracil and irinotecan (FOLFIRI) is approved for the treatment of patients with metastatic colorectal cancer that is resistant to or has progressed after treatment with an oxaliplatin-containing regimen. The efficacy of aflibercept in this indication was assessed in a multinational, pivotal phase 3 trial (VELOUR), in which the approved regimen of aflibercept 4 mg/kg every 2 weeks plus FOLFIRI significantly prolonged median overall survival by 1.44 months compared with FOLFIRI alone (primary endpoint). The addition of aflibercept also significantly prolonged progression-free survival and significantly increased the objective response rate compared with FOLFIRI alone. Addition of aflibercept to FOLFIRI was associated with anti-VEGF-related adverse events and an increased incidence of FOLFIRI-related adverse events, but the tolerability of the combination was generally acceptable in this pre-treated population. The most common grade 3 or 4 adverse events with aflibercept plus FOLFIRI included neutropenia, diarrhoea and hypertension. In conclusion, aflibercept plus FOLFIRI is a useful treatment option for patients with metastatic colorectal cancer previously treated with an oxaliplatin-containing regimen, with or without bevacizumab.

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“…A study was conducted to evaluate the mean OS gain with aflibercept plus FOLFIRI compared with placebo plus FOLFIRI in previously treated patients with mCRC [86]. The objective of the study was to analyze the implications of such survival estimations in the context of the VELOUR trial by generating mean OS differences between both study groups using parametric survival analyses.…”

Section: Aflibercept As Second-line Treatmentmentioning

confidence: 99%

Current controversies in the management of metastatic colorectal cancer

Vera

Alonso

Gállego

et al. 2015

Cancer Chemother Pharmacol

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The factors affecting the decisions for the treatment for patients with metastatic colorectal cancer (mCRC) are related to the patient, the tumor, and the treatment itself. Both cetuximab and panitumumab are anti-EGFR monoclonal antibody options for patients with RAS wild-type tumors. Several trials comparing these agents with bevacizumab are analyzed in this paper. The liver is the most common site of metastases in patients with CRC, and perioperative chemotherapy has been shown to yield benefits in this setting. In the second-line treatment for mCRC, maintenance with bevacizumab after progression following first-line treatment is convenient in some groups of patients with mCRC. Also, aflibercept has demonstrated benefits in response rate, progression-free survival, and overall survival in second-line treatment, whereas regorafenib provides benefits to patients progressing on all standard therapies. Several novel therapeutic options for patients with mCRC are under development, and these are discussed.

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Mean overall survival gain with aflibercept plus FOLFIRI vs placebo plus FOLFIRI in patients with previously treated metastatic colorectal cancer

Cited by 32 publications

References 23 publications

Secondary Surgery Versus Chemotherapy for Recurrent Ovarian Cancer

Secondary Surgery Versus Chemotherapy for Recurrent Ovarian Cancer

Aflibercept: A Review in Metastatic Colorectal Cancer

Current controversies in the management of metastatic colorectal cancer

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