Safety and Feasibility of Additional Tumor Debulking to First-Line Palliative Combination Chemotherapy for Patients with Multiorgan Metastatic Colorectal Cancer.

Autor: Gootjes EC; Department of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands., van der Stok EP; Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, The Netherlands., Buffart TE; Department of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.; Department of Gastrointestinal Oncology, Antoni van Leeuwenhoek, Amsterdam, The Netherlands., Bakkerus L; Department of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.; Department of Medical Oncology, Radboud University Hospital, Nijmegen, The Netherlands., Labots M; Department of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands., Zonderhuis BM; Department of Surgery, VU University Medical Center, Amsterdam, The Netherlands., Tuynman JB; Department of Surgery, VU University Medical Center, Amsterdam, The Netherlands., Meijerink MR; Department of Radiology and Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands., van de Ven PM; Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands., Haasbeek CJA; Department of Radiotherapy, VU University Medical Center, Amsterdam, The Netherlands., Ten Tije AJ; Department of Medical Oncology, Amphia Hospital, Breda, The Netherlands., de Groot JB; Department of Medical Oncology, Isala, The Netherlands., Hendriks MP; Department of Medical Oncology, Northwest Clinics, Alkmaar, The Netherlands., van Meerten E; Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands., Nuyttens JJME; Department of Radiotherapy, Erasmus MC Cancer Institute, Rotterdam, The Netherlands., Grunhagen DJ; Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, The Netherlands., Verhoef C; Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, The Netherlands., Verheul HMW; Department of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.; Department of Medical Oncology, Radboud University Hospital, Nijmegen, The Netherlands.
Jazyk: angličtina
Zdroj: The oncologist [Oncologist] 2020 Aug; Vol. 25 (8), pp. e1195-e1201. Date of Electronic Publication: 2020 Jun 16.
DOI: 10.1634/theoncologist.2019-0693
Abstrakt: Introduction: Local treatment of metastases is frequently performed in patients with multiorgan metastatic colorectal carcinoma (mCRC) analogous to selected patients with oligometastatic disease for whom this is standard of care. The ORCHESTRA trial (NCT01792934) was designed to prospectively evaluate overall survival benefit from tumor debulking in addition to chemotherapy in patients with multiorgan mCRC. Here, we report the preplanned safety and feasibility evaluation after inclusion of the first 100 patients.
Methods: Patients were eligible if at least 80% tumor debulking was deemed feasible by resection, radiotherapy and/or thermal ablative therapy. In case of clinical benefit after three or four cycles of respectively 5-fluorouracil/leucovorin or capecitabine and oxaliplatin ± bevacizumab patients were randomized to tumor debulking followed by chemotherapy in the intervention arm, or standard treatment with chemotherapy.
Results: Twelve patients dropped out prior to randomization for various reasons. Eighty-eight patients were randomized to the standard (n = 43) or intervention arm (n = 45). No patients withdrew after randomization. Debulking was performed in 82% (n = 37). Two patients had no lesions left to treat, five had progressive disease, and one patient died prior to local treatment. In 15 patients (40%) 21 serious adverse events related to debulking were reported. Postoperative mortality was 2.7% (n = 1). After debulking chemotherapy was resumed in 89% of patients.
Conclusion: Tumor debulking is feasible and does not prohibit administration of palliative chemotherapy in the majority of patients with multiorgan mCRC, despite the occurrence of serious adverse events related to local treatment.
Implications for Practice: This first prospective randomized trial on tumor debulking in addition to chemotherapy shows that local treatment of metastases is feasible in patients with multiorgan metastatic colorectal cancer and does not prohibit administration of palliative systemic therapy, despite the occurrence of serious adverse events related to local treatment. The trial continues accrual, and overall survival (OS) data and quality of life assessment are collected to determine whether the primary aim of >6 months OS benefit with preserved quality of life will be met. This will support evidence-based decision making in multidisciplinary colorectal cancer care and can be readily implemented in daily practice.
(© 2020 The Authors. The Oncologist published by Wiley Periodicals LLC on behalf of AlphaMed Press.)
Databáze: MEDLINE
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