Oncotarget

Research Papers:

Induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery in locally advanced rectal cancer: preliminary results of a phase II study

Francesca De Felice _, Giancarlo D’Ambrosio, Daniela Musio, Franco Iafrate, Ilaria Benevento, Marco Marzo, Marialaura Mancini, Federica Urbano, Marcella Iannitti, Francesco Marampon, Nadia Bulzonetti, Enrico Cortesi and Vincenzo Tombolini

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Oncotarget. 2018; 9:33702-33709. https://doi.org/10.18632/oncotarget.26101

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Abstract

Francesca De Felice1, Giancarlo D’Ambrosio2, Daniela Musio1, Franco Iafrate1, Ilaria Benevento1, Marco Marzo1, Marialaura Mancini1, Federica Urbano1, Marcella Iannitti1, Francesco Marampon1, Nadia Bulzonetti1, Enrico Cortesi1,* and Vincenzo Tombolini1,*

1Department of Radiological Sciences, Oncology and Pathology, Policlinico Umberto I, “Sapienza” University of Rome, Rome, Italy

2Department of General Surgery, Policlinico Umberto I, “Sapienza” University of Rome, Rome, Italy

*These authors have contributed equally to this work

Correspondence to:

Francesca De Felice, email: [email protected]

Keywords: rectal cancer; induction chemotherapy; mutation; chemoradiotherapy; complete response

Received: August 01, 2018     Accepted: August 24, 2018     Published: September 14, 2018

ABSTRACT

Background and purpose: To report preliminary results of induction chemotherapy (IC) followed by neoadjuvant chemoradiotherapy (CRT) and surgery in locally advanced rectal cancer (LARC) patients.

Materials and methods: This is the preliminary evaluation of a phase II study. Patients with histologically proven rectal adenocarcinoma, stage II-III disease, who met the inclusion criteria, received induction FOLFOXIRI (5-FU, leucovorin, oxaliplatin and irinotecan) regimen in combination with targeted agents followed by CRT and surgery. Analysis of the first 8 patients was required to confirm the treatment feasibility before the accrual of 20 additional patients.

Results: The first 8 patients were evaluated. The median follow-up time was 23 months. There were no treatment-related deaths. Trimodality strategy was well tolerated with high compliance and a good level of toxicity. There were no evidence of febrile neutropenia and any grade 4 adverse events were recorded. Three patients had pathologic complete response (pCR) and 1 patient had a nearly pCR (ypT1 ypN0).

Conclusion: Preliminary results are encouraging. FOLFOXIRI regimen plus targeted agents followed by CRT and surgery seems a safe approach. Longer follow-up and higher number of patients are mandatory to confirm such findings.


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