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      STRATEGIC-1: Multi-line therapy trial in unresectable wild-type KRAS/NRAS/BRAF metastatic colorectal cancer—A GERCOR-PRODIGE randomized open-label phase III study.

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          Background: The management of unresectable metastatic colorectal cancer (mCRC) is a comprehensive treatment strategy involving several lines of therapy, maintenance, salvage surgery, and treatment-free intervals. Besides chemotherapy (fluoropyrimidine, oxaliplatin, irinotecan), anti-angiogenic and anti-epidermal growth factor receptor (EGFR) agents have become available. Ultimately, strategy trials are needed to define the optimal use and the best sequencing of these agents. Methods: Patients with previously untreated RAS/BRAF wild-type unresectable mCRC were randomly assigned (1:1 ratio) to receive either FOLFIRI-cetuximab followed by mFOLFOX6-bevacizumab (arm A) or OPTIMOX-bevacizumab followed by FOLFIRI-bevacizumab followed by EGFR mab +/- irinotecan (arm B). This trial was designed as a superiority study (hypothesis arm B > arm A) with Duration of Disease Control (DDC) as primary endpoint, defined as the sum of PFS of each active sequence of treatment (Chibaudel B, J Clin Oncol, 2011). Secondary endpoints were overall survival (OS), Time to Failure of Strategy (TFS), Progression-free survival (PFS) and response rate (RECIST version 1.1) per sequence, salvage surgery rate, safety, and Quality of life (QoL). Results: Between October 2013 and May 2019, 263 eligible patients were randomized (arm A, n = 131; arm B, N = 132). After a median follow-up of 51.2 months (95% CI 43.3-57.4), 188 events for DDC were observed. Efficacy outcomes are presented in table. Median DDC was similar in both arms (HR 0.97, 95% CI 0.72-1.29; P = 0.805). Salvage surgery for metastasis (+/- radiofrequency ablation) was done in 36 (27.5%) patients in arm A and 28 (21.2%) in arm B. Median time until definitive deterioration of QoL (global health status) were 18.3 and 18.0 months (P = 0.628). The safety profiles were consistent with the established safety profiles of each treatment regimen. Conclusions: STRATEGIC-1 is the first randomized phase III study comparing multi-line standard treatment strategies in patients with KRAS/NRAS/BRAF wild-type mCRC. This study did not meet its primary endpoint of DDC. The treatment strategy starting with FOLFIRI-cetuximab followed by mFOLFOX6-bevacizumab led to higher response rates and to a trend for better median OS exceeding 3 years. These findings may add to our understanding of treatment sequencing in mCRC. Clinical trial information: NCT01910610. [Table: see text]

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          Author and article information

          Journal of Clinical Oncology
          American Society of Clinical Oncology (ASCO)
          June 01 2022
          June 01 2022
          : 40
          : 16_suppl
          : 3504
          [1 ]Department of Medical Oncology, Franco-British Institute, Levallois-Perret, France;
          [2 ]Clinique Sainte-Anne, Strasbourg, France;
          [3 ]Department of Medical Oncology, Hopital Saint-Antoine, APHP, Paris, France;
          [4 ]Methodology and Quality of Life Unit in Oncology (INSERM UMR 1098), University Hospital of Besançon, Besançon, France;
          [5 ]Digestive Oncology, Hopital Duchenne, Boulogne-Sur-Mer, France;
          [6 ]Medical Oncology Department, Hôpital Privé des Côtes d'Armor, Plerin, France;
          [7 ]Cancerology Institute, Hôpital Privé Jean Mermoz, Lyon, France;
          [8 ]Pôle d'Oncologie Médicale, Groupe Hospitalier Public du Sud de l'Oise, Creil, France;
          [9 ]Clinique Victor Hugo, Le Mans, France;
          [10 ]Medical Oncology Department, Groupe Hospitalier Paris Saint-Joseph, Paris, France;
          [11 ]Department of Medical Oncology, CH de Mont-de-Marsan, Hospital Layné, Mont-De-Marsan, France;
          [12 ]Medical Oncology Department, Institut Mutualiste Montsouris, Paris, France;
          [13 ]CH Annecy-Genevois, Annecy, France;
          [14 ]Medical Oncology Department, Lille Metropole Cancer Institute, Villeneuve D'ascq, France;
          [15 ]Medical Oncology Department Head, Henri Mondor University Hospital, Créteil, France;
          [16 ]Multidisciplinary Group in Oncology (GERCOR), Paris, France;
          [17 ]Cancer center, The Chaim Sheba Medical Center, Ramat Gan, Affiliated with the Sackler School of Medicine, Tel Aviv University, Ramat Gan, Israel;
          [18 ]Bon Secours Hospital Cork, Cancer Trials Ireland, and University College Cork, Cork, Ireland;
          [19 ]Medical Oncology Department, Centre Georges-François Leclerc, University of Bourgogne Franche-Comté, Dijon, France;
          © 2022


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