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Your search keyword '"de Groot, D. J.A."' showing total 2 results
Start Over Author "de Groot, D. J.A."
2 results on '"de Groot, D. J.A."'

1. Perioperative Systemic Therapy Versus Cytoreductive Surgery and HIPEC Alone for Resectable Colorectal Peritoneal Metastases: Patient-Reported Outcomes of a Randomized Phase II Trial

Author

Bakkers, C., Rovers, K. P., Rijken, A., Simkens, G. A.A.M., Bonhof, C. S., Nienhuijs, S. W., Burger, J. W.A., Creemers, G. J.M., Brandt-Kerkhof, A. R.M., Tuynman, J. B., Aalbers, A. G.J., Wiezer, M. J., de Reuver, P. R., van Grevenstein, W. M.U., Hemmer, P. H.J., Punt, C. J.A., Tanis, P. J., Mols, F., de Hingh, I. H.J.T., Thijs, A. M.J., Lurvink, R. J., Madsen, E. V.E., van Meerten, E., Kusters, M., Versteeg, K. S., Kok, N. F.M., Buffart, T. E., Boerma, D., Los, M., de Wilt, J. H.W., Verheul, H. M.W., Kruijff, S., de Groot, D. J.A., Koopman, M., Surgery, Medical Oncology, Hematology, Gastroenterology & Hepatology, Psychiatry, and Erasmus MC other

Abstract

Background: As part of a randomized phase II trial in patients with isolated resectable colorectal peritoneal metastases (CPMs), the present study compared patient-reported outcomes (PROs) of patients treated with perioperative systemic therapy versus cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS–HIPEC) alone. Also, PROs of patients receiving perioperative systemic therapy were explored. Patients and Methods: Eligible patients were randomized to perioperative systemic therapy (experimental) or CRS–HIPEC alone (control). PROs were assessed using EORTC QLQ-C30, QLQ-CR29, and EQ-5D-5L questionnaires at baseline, after neoadjuvant treatment (experimental), and at 3 and 6 months postoperatively. Linear mixed modeling was used to compare five predefined PROs (visual analog scale, global health status, physical functioning, fatigue, C30 summary score) between arms and to longitudinally analyze PROs in the experimental arm. Results: Of 79 analyzed patients, 37 (47%) received perioperative systemic therapy. All predefined PROs were comparable between arms at all timepoints and returned to baseline at 3 or 6 months postoperatively. The experimental arm had worsening of fatigue [mean difference (MD) + 14, p = 0.001], loss of appetite (MD + 15, p = 0.003), hair loss (MD + 18, p < 0.001), and loss of taste (MD + 27, p < 0.001) after neoadjuvant treatment. Except for loss of appetite, these PROs returned to baseline at 3 or 6 months postoperatively. Conclusions: In patients with resectable CPM randomized to perioperative systemic therapy or CRS–HIPEC alone, PROs were comparable between arms and returned to baseline postoperatively. Together with the trial’s previously reported feasibility and safety data, these findings show acceptable tolerability of perioperative systemic therapy in this setting.

Published
2023

2. Perioperative or adjuvant mFOLFIRINOX for resectable pancreatic cancer (PREOPANC-3):study protocol for a multicenter randomized controlled trial

Author

van Dam, J. L., Verkolf, E. M.M., Dekker, E. N., Bonsing, B. A., Bratlie, S. O., Brosens, L. A.A., Busch, O. R., van Driel, L. M.J.W., van Eijck, C. H.J., Feshtali, S., Ghorbani, P., de Groot, D. J.A., de Groot, J. W.B., Haberkorn, B. C.M., de Hingh, I. H., van der Holt, B., Karsten, T. M., van der Kolk, M. B., Labori, K. J., Liem, M. S.L., Loosveld, O. J.L., Molenaar, I. Q., Polée, M. B., van Santvoort, H. C., de Vos-Geelen, J., Wumkes, M. L., van Tienhoven, G., Homs, M. Y.V., Besselink, M. G., Wilmink, J. W., Groot Koerkamp, B., van Dam, J. L., Verkolf, E. M.M., Dekker, E. N., Bonsing, B. A., Bratlie, S. O., Brosens, L. A.A., Busch, O. R., van Driel, L. M.J.W., van Eijck, C. H.J., Feshtali, S., Ghorbani, P., de Groot, D. J.A., de Groot, J. W.B., Haberkorn, B. C.M., de Hingh, I. H., van der Holt, B., Karsten, T. M., van der Kolk, M. B., Labori, K. J., Liem, M. S.L., Loosveld, O. J.L., Molenaar, I. Q., Polée, M. B., van Santvoort, H. C., de Vos-Geelen, J., Wumkes, M. L., van Tienhoven, G., Homs, M. Y.V., Besselink, M. G., Wilmink, J. W., and Groot Koerkamp, B.

Abstract

BACKGROUND: Surgical resection followed by adjuvant mFOLFIRINOX (5-fluorouracil with leucovorin, irinotecan, and oxaliplatin) is currently the standard of care for patients with resectable pancreatic cancer. The main concern regarding adjuvant chemotherapy is that only half of patients actually receive adjuvant treatment. Neoadjuvant chemotherapy, on the other hand, guarantees early systemic treatment and may increase chemotherapy use and thereby improve overall survival. Furthermore, it may prevent futile surgery in patients with rapidly progressive disease. However, some argue that neoadjuvant therapy delays surgery, which could lead to progression towards unresectable disease and thus offset the potential benefits. Comparison of perioperative (i.e., neoadjuvant and adjuvant) with (only) adjuvant administration of mFOLFIRINOX in a randomized controlled trial (RCT) is needed to determine the optimal approach. METHODS: This multicenter, phase 3, RCT will include 378 patients with resectable pancreatic ductal adenocarcinoma with a WHO performance status of 0 or 1. Patients are recruited from 20 Dutch centers and three centers in Norway and Sweden. Resectable pancreatic cancer is defined as no arterial contact and ≤ 90 degrees venous contact. Patients in the intervention arm are scheduled for 8 cycles of neoadjuvant mFOLFIRINOX followed by surgery and 4 cycles of adjuvant mFOLFIRINOX (2-week cycle of oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, irinotecan 150 mg/m2 at day 1, followed by 46 h continuous infusion of 5-fluorouracil 2400 g/m2). Patients in the comparator arm start with surgery followed by 12 cycles of adjuvant mFOLFIRINOX. The primary outcome is overall survival by intention-to-treat. Secondary outcomes include progression-free survival, resection rate, quality of life, adverse events, and surgical complications. To detect a hazard ratio of 0.70 with 80% power, 252 events are needed. The number of events is expected to be reached after the inclusion of

Published
2023

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