Bevacizumab-Erlotinib As Maintenance Therapy in Metastatic Colorectal Cancer. Final Results of the Gercor Dream Study

Chibaudel, Benoist; Tournigand, Christophe; Samson, Benoît; Scheithauer, Werner; Mésange, Paul; Lledo, Gérard; Viret, F.; Ramée, Jean François; Tubiana-Mathieu, Nicole; Dauba, Jérôme; Dupuis, Olivier; Rinaldi, Yves; Mabro, May; Aucoin, Nathalie; Latreille, Jean; Bonnetain, Franck; Louvet, Christophe; Larsen, Annette K.; Thewis, André; Gramont, Aimery de

doi:10.1093/annonc/mdu333.1

Cited by 9 publications

(5 citation statements)

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“…Among 700 patients enrolled in the DREAM study (27), 429 (61.3%) received an induction therapy with modified FOLFOX7 plus bevacizumab, using the same dose of oxaliplatin (100 mg/m²) than in the present study, although a lower dose of 5-FU infusion. In those patients, the ORR was 52.2% and the median PFS was 9.4 months (28). Thus, the addition of aflibercept to an oxaliplatin stop-and-go strategy in patients with unresectable mCRC seems to increase PFS to the same degree as bevacizumab (from <9 to 9.5 months) and to slightly increase the tumor ORR (Table VII).…”

Section: Discussionmentioning

confidence: 89%

Efficacy of aflibercept with FOLFOX and maintenance with fluoropyrimidine as first‑line therapy for metastatic colorectal cancer: GERCOR VELVET phase�II study

et al. 2019

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Aflibercept in combination with 5-fluorouracil (5-FU)/irinotecan improves overall survival in the second-line therapy of patients with metastatic colorectal cancer (mCRC). In this study, we evaluated the effects of aflibercept in first-line therapy with FOLFOX followed by maintenance with fluoropyrimidine. VELVET was a prospective, single-arm multicenter phase II study (completed). Patients with previously untreated, unresectable, evaluable or measurable mCRC, with an age ≥18 years, and an ECOG performance status of 0-2 received 6 cycles of modified FOLFOX7 (5-FU/folinic acid and oxaliplatin) with aflibercept at 4 mg/kg every 2 weeks followed by maintenance therapy with fluoropyrimidine with aflibercept until disease progression or limiting toxicity. The reintroduction of oxaliplatin was performed at first progression. The primary endpoint was progression-free survival (PFS) at 6 months. From May, 2013 to May, 2014, 49 patients were included and 48 were evaluable for response. In total, 33 patients (67.4%) were alive without progression at 6 months. The Kaplan-Meier survival 6-month and 1-year PFS rates were 79.1 and 36.1%, respectively, and the median PFS was 9.3 months (95% CI, 8.3-12.5). The objective response rate was 59.2% (N=29/49). The most common (≥10%) grade 3-4 adverse events were hypertension (23%), fatigue (15%), neutropenia (12%), neuropathy (12%) and stomatitis (10%). Three (6%) treatment-related deaths occurred: One from stroke, one from pulmonary embolism and one from neutropenic sepsis. On the whole, this study demonstrates the efficacy of aflibercept in combination with an oxaliplatin-based regimen in the first-line therapy of patients with mCRC. A strict monitoring of blood pressure and immediate management of hypertension during therapy is mandatory.

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Section: Discussionmentioning

confidence: 89%

Efficacy of aflibercept with FOLFOX and maintenance with fluoropyrimidine as first‑line therapy for metastatic colorectal cancer: GERCOR VELVET phase�II study

et al. 2019

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“…Preliminary evidence from small phase II studies suggests that erlotinib may have activity in patients with mCRC [32], but given its unfavorable toxicity profile when used in combination with chemotherapy, we doubt that it will be further investigated in mCRC. The Nordic ACT trial [15] and the GERCOR DREAM trial [33] This study demonstrated that, as opposed to lung cancer where erlonitib maintenance is associated with improved outcomes, erlotinib did not improve outcomes when added to bevacizumab in the maintenance setting. Additionally, grade 3/4 adverse events, especially diarrhea, rash, and anorexia, were more common in the erlotinib arm.…”

Section: Maintenance With Epidermal Growth Factor Receptor (Egfr) Inhmentioning

confidence: 83%

“…Additionally, grade 3/4 adverse events, especially diarrhea, rash, and anorexia, were more common in the erlotinib arm. Similarly the phase III DREAM trial [33] evaluated the use of maintenance erlotinib/bevacizumab (experimental arm) versus bevacizumab alone in patients who had stable disease or better on bevacizumab-based induction chemotherapy. An updated analysis of this study suggested that maintenance erlotinib/bevacizumab was associated with a survival benefit over maintenance bevacizumab alone.…”

Section: Maintenance With Epidermal Growth Factor Receptor (Egfr) Inhmentioning

confidence: 99%

Maintenance Therapy for Colorectal Cancer: Which Regimen and Which Patients?

Mikhail

Bekaii‐Saab

2015

Drugs

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The introduction of therapeutic agents such as irinotecan, oxaliplatin, and more recently biologic agents such as vascular endothelial growth factor and epidermal growth factor receptor (EGFR) inhibitors has significantly improved survival of patients with metastatic colorectal cancer. These novel agents have also contributed to added toxicities. Therefore, several studies have evaluated the role of maintenance therapy with less intensive regimens in patients who experienced stable disease or treatment response following induction therapy as a strategy to reduce toxicity and improve quality of life. The success of such strategies, however, requires assurance that their survival would not be compromised. We therefore reviewed studies that have explored the various strategies of treatment de-escalation with an emphasis on survival and toxicity outcomes. Recent studies evaluated the role of maintenance therapy with chemotherapy only, chemotherapy plus bevcizumab, bevacizumab only, and EGFR inhibitors. Current evidence suggests that maintenance strategies offer significant benefit to patients by providing continuous clinical benefit while minimizing the risks associated with continuous therapy. Strategies to improve selection of patients for maintenance therapy versus identifying subgroups of patients that will benefit from a chemotherapy-free interval need to continue to be studied. Finally, as our understanding of the molecular and genetic drivers of colorectal cancer continues to expand, refining these strategies to include more target-specific agents should become more routine.

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“…Maintenance with antiangiogenic agent and EGF receptor agent. Of the 701 patients registered in the GERCOR DREAM phase III trial across three countries (France, Canada, Austria), 452 were randomized to receive a maintenance therapy with bevacizumab (7.5 mg/kg, every 3 weeks) or bevacizumab (same dose) and erlotinib (150 mg/day continuously), an EGFR tyrosine kinase inhibitor [Chibaudel et al 2014b]. After a median follow up of 50 months, the combination therapy led to an improvement of maintenance PFS (primary endpoint), maintenance OS, and RR.…”

Section: Single-agent Maintenancementioning

confidence: 99%

“…Abbreviations: IT, induction therapy;chemo, chemotherapy;ox, oxaliplatin, FU, fluoropyrimidine;bev, bevacizumab;cetux, cetuximab;maint., maintenance. OPTIMOX2 [Chibaudel et al 2009]; COIN [Adams et al 2011]; CAIRO3 [Koopman et al 2013]; SAKK 41/06 [Koeberle et al 2013]; AIO KRK 0207 [Arnold et al 2014]; COIN-B [Wasan et al 2014]; OPTIMOX1 [Tournigand et al 2006]; DREAM [Chibaudel et al 2014b]; ACT-1 [Johnsson et al 2013]; NORDIC VII [Tveit et al 2012]; MACRO-2 [Alfonso et al 2014]; MACRO [Diaz-Rubio et al 2012].…”

Section: Second-line Therapymentioning

confidence: 99%

Therapeutic strategy in unresectable metastatic colorectal cancer: an updated review

et al. 2015

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Systemic therapy is the standard care for patients with unresectable advanced colorectal cancer (CRC), but salvage surgery of metastatic disease should be considered in the case of adequate tumor shrinkage. Several drugs and combinations are now available for use in treating patients with advanced CRC, but the optimal sequence of therapy remains unknown. Moreover, the administration of antitumor therapy can be modulated by periods of maintenance or treatment breaks rather than delivered as full therapy until disease progression or unacceptable toxicity, followed by reintroduction of prior full therapy when required, before switching to other drugs. Consequently, randomized strategy trials are needed to define the optimal treatment sequences. Molecular testing for Kirsten rat sarcoma viral oncogene homolog (KRAS) and neuroblastoma RAS viral oncogene homolog (NRAS) is mandatory but not sufficient to select appropriate patients for epidermal growth factor receptor (EGFR) monoclonal antibody (MoAb) therapy.

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Bevacizumab-Erlotinib As Maintenance Therapy in Metastatic Colorectal Cancer. Final Results of the Gercor Dream Study

Cited by 9 publications

References 0 publications

Efficacy of aflibercept with FOLFOX and maintenance with fluoropyrimidine as first‑line therapy for metastatic colorectal cancer: GERCOR VELVET phase�II study

Efficacy of aflibercept with FOLFOX and maintenance with fluoropyrimidine as first‑line therapy for metastatic colorectal cancer: GERCOR VELVET phase�II study

Maintenance Therapy for Colorectal Cancer: Which Regimen and Which Patients?

Therapeutic strategy in unresectable metastatic colorectal cancer: an updated review

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