Glockzin, Gabriel and Zeman, Florian and Croner, Roland S. and Koenigsrainer, Alfred and Pelz, Joerg and Strohlein, Michael A. and Rau, Beate and Arnold, Dirk and Koller, Michael and Schlitt, Hans J. and Piso, Pompiliu (2018) Perioperative Systemic Chemotherapy, Cytoreductive Surgery, and Hyperthermic Intraperitoneal Chemotherapy in Patients With Colorectal Peritoneal Metastasis: Results of the Prospective Multicenter Phase 2 COMBATAC Trial. CLINICAL COLORECTAL CANCER, 17 (4). pp. 285-296. ISSN 1533-0028, 1938-0674
Full text not available from this repository. (Request a copy)Abstract
The prospective phase 2 COMBATAC (COMBined Anticancer Treatment of Advanced Colorectal cancer) trial evaluated perioperative systemic chemotherapy + cetuximab combined with cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in 26 patients with peritoneal metastatic colorectal cancer. The combined treatment regimen is safe and feasible, and is associated with acceptable morbidity and mortality rates. The survival rates are comparable to published data after CRS/HIPEC. Background: Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) as parts of an interdisciplinary treatment concept including systemic chemotherapy can improve survival of selected patients with peritoneal metastatic colorectal cancer (pmCRC). Nevertheless, the sequence of the therapeutic options is still a matter of debate. Thus, the COMBATAC (COMBined Anticancer Treatment of Advanced Colorectal cancer) trial was conducted to evaluate a combined treatment regimen consisting of preoperative systemic polychemotherapy + cetuximab followed by CRS + HIPEC and postoperative systemic polychemotherapy + cetuximab. Patients and Methods: The COMBATAC trial is a prospective, multicenter, open-label, single-arm, single-stage phase 2 trial. Twenty-six patients with synchronous or metachronous colorectal or appendiceal peritoneal carcinomatosis were included. Enrollment was terminated prematurely by the sponsor because of slow recruitment. Progression-free survival as primary end point and overall survival were estimated by the Kaplan-Meier method. Also evaluated were morbidity according to Common Terminology Criteria for Adverse Events v4.0 and feasibility of the combined treatment concept. Results: Median progression-free survival for the intention-to-treat population (n = 25) was 14.9 months. Median overall survival was not reached during the study duration. Ninety-two adverse events were documented in 16 patients, including 14 serious adverse events in 9 patients. The overall morbidity rate was 64%, and the grade 3/4 morbidity rate was 44%. Of all grade 3/4 morbidity events, 36.4% were related to systemic chemotherapy and 22.7% to surgery, whereas 40.9% were not directly related. There was no treatment-related mortality. Conclusion: The results of the COMBATAC trial show that the multimodal treatment concept consisting of perioperative systemic chemotherapy and CRS + HIPEC is safe and feasible. Progression-free survival in selected patients with colorectal or appendiceal peritoneal metastasis might be improved.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | FOLFIRI PLUS BEVACIZUMAB; CANCER-PATIENTS; 1ST-LINE TREATMENT; MITOMYCIN-C; CURATIVE TREATMENT; AMERICAN SOCIETY; RANDOMIZED-TRIAL; COLON-CANCER; OPEN-LABEL; CARCINOMATOSIS; Cetuximab; Colorectal cancer; CRS; HIPEC; Multimodality treatment |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Chirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 09 Oct 2019 05:58 |
| Last Modified: | 09 Oct 2019 05:58 |
| URI: | https://pred.uni-regensburg.de/id/eprint/13488 |
Actions (login required)
 |
View Item |
