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Poster display session

3673 - Phase II randomized trial of capecitabine + radiation therapy with/ without bevacizumab as preoperative treatment for patients with resectable locally advanced rectal adenocarcinoma: Final results of 3 and 5-year disease free survival, distant relapse free survival and overall survival.

Date

09 Sep 2017

Session

Poster display session

Presenters

Cristina Gravalos

Citation

Annals of Oncology (2017) 28 (suppl_5): v158-v208. 10.1093/annonc/mdx393

Authors

C. Gravalos1, J. Capdevila2, L. Layos3, C. Pericay4, M. Martínez-Villacampa5, C. López López6, F. Losa7, M.J. Safont8, A. Gómez-España9, V. Alonso10, P. Escudero11, J. Gallego12, B. García-Paredes13, A. Palacios14, S. Biondo15, R. Salazar16, E. Aranda Aguilar17

Author affiliations

  • 1 Medical Oncology, University Hospital 12 De Octubre, 28041 - Madrid/ES
  • 2 Gastrointestinal And Endocrine Tumor Unit, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 3 Medical Oncology, Instituto Catalán de Oncología. Hospital Germans Trias i Pujol, 08916 - Badalona/ES
  • 4 Medical Oncology, Corporació Sanitària Parc Taulí, 08208 - Sabadell/ES
  • 5 Medical Oncology, Instituto Catalán de Oncología. Hospital Duran i Reynals, Barcelona/ES
  • 6 Medical Oncology, Hospital Universitario Marqués de Valdecilla, Santander/ES
  • 7 Medical Oncology, Hospital de Sant Joan Despí Moisès Broggi, Barcelona/ES
  • 8 Medical Oncology, Hospital General Universitario de Valencia, Valencia/ES
  • 9 Medical Oncology, IMIBIC, Reina Sofía Hospital, University of Córdoba, CIBERONC Instituto de Salud Carlos III. Spain, Cordoba/ES
  • 10 Medical Oncology, Hospital Miguel Servet, Zaragoza/ES
  • 11 Medical Oncology, Hospital Clinico Universitario Lozano Blesa, 50009 - Zaragoza/ES
  • 12 Medical Oncology, Hospital General Universitario de Elche, Alicante/ES
  • 13 Medical Oncology, Hospital Universitario Clínico San Carlos. CIBERONC Instituto de Salud Carlos III, Madrid/ES
  • 14 Radiation Oncology, Hospital Reina Sofía, Córdoba/ES
  • 15 General And Digestive Surgery, Hospital Universitario de Bellvitge, Barcelona/ES
  • 16 Medical Oncology, Institut Català d'Oncologia Hospital Duran i Reynals, 08907 - Barcelona/ES
  • 17 Medical Oncology, University Hospital Reina Sofia. CIBERONC Instituto de Salud Carlos III, 14004 - Cordoba/ES
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Resources

Abstract 3673

Background

Combined modality treatment with preoperative radiation therapy (RT) + capecitabine is a standard of care for locally advanced rectal adenocarcinoma. However, new strategies to improve outcomes are necessary. We previously reported neither differences in pathologic complete response (primary objective) nor in safety results with preoperative RT + capecitabine with or without Bev. We present now the Disease-free survival (DFS), distant relapse free survival (RFS) and Overall Survival (OS) data at 3 and 5 years.

Methods

Patients (pts) were randomized in a 1:1 ratio to 5 weeks (w) of RT 45 Gy with concurrent capecitabine 825 mg/m2 bid x 5 d/w with Bevacizumab (Bev) 5 mg/kg q2w (3 doses) (arm A) or without Bev (arm B). Adjuvant systemic chemotherapy administration was upon investigatoŕs criteria.

Results

Ninety pts were included (44 in arm A and 46 in arm B). Preoperative treatment compliance was similar in both arms. Seventy-five pts received adjuvant systemic chemotherapy: 34 (77.3%) in arm A and 41 (89.1%) in arm B (p = 0.1313). One pt (arm B) developed local relapse. Eleven pts in arm A and 10 in arm B developed distant metastasis. With a median follow-up of 63.5 and 63.5 months for arms A and B, respectively, median DFS, median RFS and median OS have not been reached for both arms. DFS at 3 y and 5 y was 75.0% and 68.2% (arm A) vs 71.7% and 69.6% (arm B), respectively (5-y DFS, p = 0.9820). Distant RFS at 3 y and 5 y was 81.0% and 76.2% (arm A) vs 80.4% and 78.3% (arm B), respectively (5y-distant RFS, p = 0.6923). OS was 88.6% and 81.0% (arm A) vs 95.7% and 87.0% (arm B) at 3 and 5y, respectively (5-y OS, p = 0.3350). Five pts had a second malignancy (1 in arm A, 4 in arm B), without significant differences between arms.

Conclusions

In our study, the addition of bevacizumab to capecitabine and radiotherapy in the neoadjuvant setting for locally advanced rectal cancer does not confer benefits in DFS, RFS or OS.

Clinical trial identification

NCT0104384

Legal entity responsible for the study

The Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD)

Funding

Roche

Disclosure

All authors have declared no conflicts of interest.

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