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Clinical Trial
. 2017 Sep;24(9):2632-2638.
doi: 10.1245/s10434-017-5897-0. Epub 2017 May 30.

Short-Course Radiotherapy Followed by Neoadjuvant Bevacizumab, Capecitabine, and Oxaliplatin and Subsequent Radical Treatment in Primary Stage IV Rectal Cancer: Long-Term Results of a Phase II Study

C Bisschop  1 , T H van Dijk  2 , J C Beukema  3 , R L H Jansen  4 , H Gelderblom  5 , K P de Jong  6 , H J T Rutten  7   8 , C J H van de Velde  9 , T Wiggers  2 , K Havenga  2 , G A P Hospers  10
Affiliations
Clinical Trial

Short-Course Radiotherapy Followed by Neoadjuvant Bevacizumab, Capecitabine, and Oxaliplatin and Subsequent Radical Treatment in Primary Stage IV Rectal Cancer: Long-Term Results of a Phase II Study

C Bisschop et al. Ann Surg Oncol. 2017 Sep.

Abstract

Background: In a Dutch phase II trial conducted between 2006 and 2010, short-course radiotherapy followed by systemic therapy with capecitabine, oxaliplatin, and bevacizumab as neoadjuvant treatment and subsequent radical surgical treatment of primary tumor and metastatic sites was evaluated. In this study, we report the long-term results after a minimum follow-up of 6 years.

Methods: Patients with histologically confirmed rectal adenocarcinoma with potentially resectable or ablatable metastases in liver or lungs were eligible. Follow-up data were collected for all patients enrolled in the trial. Overall and recurrence-free survival were calculated using the Kaplan-Meier method.

Results: Follow-up data were available for all 50 patients. After a median follow-up time of 8.1 years (range 6.0-9.8), 16 patients (32.0%) were still alive and 14 (28%) were disease-free. The median overall survival was 3.8 years (range 0.5-9.4). From the 36 patients who received radical treatment, two (5.6%) had a local recurrence and 29 (80.6%) had a distant recurrence.

Conclusions: Long-term survival can be achieved in patients with primary metastatic rectal cancer after neoadjuvant radio- and chemotherapy. Despite a high number of recurrences, 32% of patients were alive after a median follow-up time of 8.1 years.

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Figures

Fig. 1
Fig. 1
Overall survival (months) in a the total study population (N = 50) and b subgroups that did (N = 36) and did not (N = 14) receive radical treatment of primary tumor and/or distant metastases
Fig. 2
Fig. 2
Recurrence-free survival (months) for a patients who received surgical treatment of all tumor sites (N = 40) and b subgroups with (N = 11) or without (N = 29) pathological complete response after surgical treatment in the study. CR complete response
Fig. 3
Fig. 3
Swimmers plot illustrating overall survival of all individual patients in the study. Survival is divided into three periods: treatment phase, recurrence-free survival, and survival after first recurrence
See this image and copyright information in PMC

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