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Intensified Total Neoadjuvant Therapy in Patients With Locally Advanced Rectal Cancer: A Phase II Trial.
F De Felice1, G D'Ambrosio2, F Iafrate3
1Department of Radiotherapy, Policlinico Umberto I "Sapienza" University of Rome, Rome, Italy.
Clinical Oncology (Royal College of Radiologists (Great Britain))
|June 28, 2021
Summary
This study evaluated total neoadjuvant therapy for locally advanced rectal cancer, combining targeted agents with FOLFOXIRI chemotherapy and chemoradiotherapy. The treatment demonstrated promising efficacy and safety, with a high pathological complete response rate and good tolerability.
Area of Science:
- Oncology
- Gastroenterology
- Surgical Oncology
Background:
- Locally advanced rectal cancer (LARC) requires effective treatment strategies.
- Neoadjuvant therapy aims to improve surgical outcomes and reduce recurrence.
- Optimizing neoadjuvant regimens is crucial for enhancing patient response and survival.
Purpose of the Study:
- To assess the efficacy and safety of total neoadjuvant therapy (TNT) in LARC patients.
- To evaluate a regimen combining targeted agents with FOLFOXIRI induction chemotherapy, followed by chemoradiotherapy (CRT) and surgery.
- To determine the pathological complete response (pCR) rate and other clinical outcomes.
Main Methods:
- A single-arm, single-centre phase II clinical trial was conducted.
- Patients received induction chemotherapy with FOLFOXIRI plus either bevacizumab (mutated Ras-BRAF) or panitumumab/cetuximab (wild-type Ras-BRAF).
- This was followed by intensified oxaliplatin-5-fluorouracil-based CRT and surgical resection.
Main Results:
- Twenty-eight LARC patients were enrolled; 92.9% completed the planned TNT strategy.
- A pathological complete response (pCR) was observed in 32.1% of patients, with an additional 7.2% achieving near-pCR.
- The regimen was well-tolerated, with no febrile neutropenia or grade 4 adverse events reported. All patients underwent radical resection.
Conclusions:
- Total neoadjuvant therapy combining FOLFOXIRI, targeted agents, and intensified CRT shows promising clinical activity in LARC.
- The treatment regimen is well-tolerated and achieves high rates of pathological response and complete resection.
- This phase II study supports further investigation in phase III trials for LARC management.
