Journal of Gastrointestinal Cancer

, Volume 43, Issue 4, pp 553–561 | Cite as

Phase II Trial of Concomitant Neoadjuvant Chemotherapy with Oxaliplatin and Capecitabine and Intensity-Modulated Radiotherapy (IMRT) in Rectal Cancer

  • Joan Manel Gasent Blesa
  • Javier Garde Noguera
  • Juan Bautista Laforga Canales
  • Vicent Giner Bosch
  • Antonio Alberola
  • Miguel Soler Tortosa
  • Miguel Peris Godoy
  • Jose Luis Sanchez
  • Mariano Provencio Pulla
  • Vicente Alberola Candel
Original Research

Abstract

Introduction and Purpose

The purposes of this study are to evaluate the activity and safety of preoperative intensity-modulated radiotherapy and concurrent capecitabine and oxaliplatin (Xelox), the accuracy of preoperative magnetic resonance (MRI) for predicting pathologic results, and the correlation between carcinoembryonic antigen (CEA) and the existence of a pathologic complete response (pCR).

Patients and Methods

Twenty-seven patients (pt) with T3/T4N0/N+ rectal cancer were included. Capecitabine was administered at 825 t.i.d. mg/m2 the days of the radiotherapy (RT), and oxaliplatin was administered weekly at 50 mg/m2. RT was planned to 50.4 Gy. Surgery was scheduled 6 to 8 weeks after completion of Xelox RT. Before the intervention, a pelvic MRI was performed and a CEA level was determined.

Results

After Xelox RT, 7 pt had pCR (26%), 2 pt progression disease, and 18 pt tumor downstaging. Presurgical MRI did not predict the pathological result in 21 pt. Main side effects were diarrhea grade (G) 3 in four pt, hand and foot G1 five Pt and G2 four pt. Paresthesias G1 ten pt, G2 seven pt, and leukopenia six pt G1. Median RT dose was 49.7 Gy (47.5–50.4 Gy). At a mean follow-up of 22.5 months, four pt presented metastatis. Mean pretreatment CEA was 6.8 ng/mL (2.1–17.0). A difference statistically significant when compared pretreatment CEA with presurgical CEA (p < 0.001) was detected. We found a nadir of <5 ng/mL as significantly associated with pCR (p = 0.036).

Conclusion

Preoperative chemoradiotherapy with oxaliplatin and capecitabine is safe and well tolerated, and offers an interesting ratio of pCR and of tumor downstaging. Presurgical CEA level should be studied as predictors of pCR.

Keywords

Rectal cancer Neoadjuvant Preoperative MRI CEA nadir 

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Copyright information

© Springer Science+Business Media, LLC 2012

Authors and Affiliations

  • Joan Manel Gasent Blesa
    • 1
  • Javier Garde Noguera
    • 1
  • Juan Bautista Laforga Canales
    • 1
  • Vicent Giner Bosch
    • 2
  • Antonio Alberola
    • 1
  • Miguel Soler Tortosa
    • 3
  • Miguel Peris Godoy
    • 4
  • Jose Luis Sanchez
    • 5
  • Mariano Provencio Pulla
    • 6
  • Vicente Alberola Candel
    • 1
  1. 1.Hospital de DéniaDéniaSpain
  2. 2.Departament d’Estadística AplicadaUniversitat Politécnica de ValènciaValenciaSpain
  3. 3.Radiotherapy DepartmentHospital de la RiberaAlziraSpain
  4. 4.Internal Hospital de Dénia, MarinaSaludDéniaSpain
  5. 5.Universidad Católica de ValenciaValenciaSpain
  6. 6.Hospital Universitario Puerta de HierroMadridSpain

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