| Added by | JPPOUGET |
|---|---|
| Group name | EquipeJPP |
| Item Type | Journal Article |
| Title | Efficacy and Safety of Two Neoadjuvant Strategies With Bevacizumab in MRI-Defined Locally Advanced T3 Resectable Rectal Cancer: Final Results of a Randomized, Noncomparative Phase 2 INOVA Study |
| Creator | Borg et al. |
| Author | Christophe Borg |
| Author | Georges Mantion |
| Author | Frank Boudghène |
| Author | Françoise Mornex |
| Author | François Ghiringhelli |
| Author | Antoine Adenis |
| Author | David Azria |
| Author | Jacques Balosso |
| Author | Meher Ben Abdelghani |
| Author | Jean Baptiste Bachet |
| Author | Véronique Vendrely |
| Author | Yves François |
| Author | Thierry Conroy |
| Author | Emmanuel Rio |
| Author | Bernard Roullet |
| Author | Dominique Spaëth |
| Author | Laurent Quero |
| Author | Zaher Lakkis |
| Author | Mathieu Coudert |
| Author | Miruna Ionescu-Goga |
| Author | Alexandre Tanang |
| Author | Thierry André |
| Abstract | BACKGROUND: Recurrence and distant metastases remain a significant issue in locally advanced rectal cancer (LARC). Several multimodal strategies are assessed in clinical trials. PATIENTS AND METHODS: Patients with mid/low magnetic resonance imaging-defined high-risk LARC were randomized to arm A (12-week bevacizumab + FOLFOX-4 then bevacizumab-5-fluorouracil [5-FU]-radiotherapy [RT] before total mesorectal excision [TME]) or arm B (bevacizumab-5-FU-RT then TME). Long-term efficacy and safety up to 5 years' follow-up are reported. No comparison between arms was planned. RESULTS: Overall, 91 patients (46 in arm A and 45 in arm B) were included. Main results have been presented previously. During the late follow-up period (> 4 weeks after surgery), 4 patients (8.7%) in arm A and 4 (8.9%) in arm B experienced grade 3/4 adverse events related to bevacizumab; the most frequent were 2 anastomotic fistulas (both in arm A) and abscesses (1 in arm A and 2 in arm B). At 5 years' follow-up, 9 (19.6%) and 11 (24.4%) patients in arms A and B developed a fistula in the year after surgery, and 2 (4.3%) in arm A at > 1 year after surgery. Most resolved before study end. Five-year disease-free survival was 70% and 64.3% in arms A and B, respectively. Five-year overall survival was 90.5% (95% confidence interval, 76.7, 96.3) in arm A and 72.7% (95% confidence interval, 56.0, 83.9) in arm B. CONCLUSION: Neoadjuvant bevacizumab + FOLFOX-4 may have the potential to increase survival outcomes when followed by bevacizumab-5-FU-RT and TME in LARC. Bevacizumab-5-FU-RT then TME was associated with a higher-than-projected rate of anastomotic fistulas. Further research of neoadjuvant strategies in LARC is encouraged. |
| Publication | Clinical Colorectal Cancer |
| Volume | 18 |
| Issue | 3 |
| Pages | 200-208.e1 |
| Date | 2019-09 |
| Journal Abbr | Clin Colorectal Cancer |
| Language | eng |
| DOI | 10.1016/j.clcc.2019.04.006 |
| ISSN | 1938-0674 |
| Short Title | Efficacy and Safety of Two Neoadjuvant Strategies With Bevacizumab in MRI-Defined Locally Advanced T3 Resectable Rectal Cancer |
| Library Catalog | PubMed |
| Extra | Number: 3 PMID: 31311761 |
| Tags | Adenocarcinoma, Adolescent, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Bevacizumab, Capecitabine, Chemoradiotherapy, Adjuvant, clinic, Female, Fistula, Fluorouracil, Follow-Up Studies, Humans, Leucovorin, Lymphatic Metastasis, Magnetic Resonance Imaging, Male, Middle Aged, Neoadjuvant chemotherapy, Neoadjuvant Therapy, Neoplasm Recurrence, Local, Radiotherapy, Rectal cancer, Rectal Neoplasms, Survival Rate, Young Adult |
| Date Added | 2023/11/23 - 12:48:11 |
| Date Modified | 2023/11/23 - 12:48:11 |
| Notes and Attachments | PubMed entry (Attachment) Texte intégral (Attachment) |
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