Pierre Boisselier1, Marie-Christine Kaminsky2, Simon Thézenas3, Olivier Gallocher4, Sandrine Lavau-Denes5, Muriel Garcia-Ramirez6, Marc Alfonsi7, Didier Cupissol8, Hélène de Forges9, Chloé Janiszewski9, Lionnel Geoffrois2, Christian Sire10, Pierre Senesse11,12. 1. Radiotherapy Department, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France. 2. Radiotherapy Department, Lorraine Cancer Institute, Vandœuvre-Lès-Nancy, France. 3. Biometrics Unit, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France. 4. Radiotherapy Department, Clinique Pasteur, Toulouse, France. 5. Clinical Research Unit, Dupuytren University Hospital, Limoges, France. 6. Radiotherapy Department, Libourne Hospital Center, Libourne, France. 7. Radiotherapy Department, Sainte Catherine Institute, Avignon, France. 8. Oncology Department, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France. 9. Clinical Research and Innovation Department, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France. 10. Radiotherapy Department, Bretagne Sud Hospital, Lorient, France. 11. Clinical Nutrition and Gastroenterology Department, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France. 12. IRCM, University of Montpellier, Inserm, and ICM, Montpellier, France.
Abstract
BACKGROUND: In a previous phase II study an immunonutrient supplement was found to reduce severe acute toxicities for head and neck squamous cell cancer (HNSCC) patients treated with concomitant cisplatin and radiotherapy. OBJECTIVES: The primary objective of the present study was to evaluate efficacy of the same immunonutrient supplement on severe mucositis. Secondary objectives included tolerance, compliance to oral supplementation, chemotherapy interruptions and delays, quality of life, and progression-free survival (PFS) and overall survival (OS) at 1, 2, and 3 y. METHODS:Between November 2009 and June 2013, 180 HNSCC patients eligible for adjuvant chemotherapy after surgery with curative intent were included in our double-blind phase III multicenter trial. They were assigned to receive oral supplementation (3 sachets/d) of either a formula enriched with l-arginine and omega-3 (n-3) fatty and ribonucleic acids (experimental arm), or an isocaloric isonitrogenous control (control arm), for 5 d before each of 3 cycles of cisplatin. Intention-to-treat (ITT) and per-protocol (PP) analyses were undertaken, along with subgroup analyses of ≥75% compliant patients, to compare the incidence of acute mucositis (Radiation Therapy Oncology Group and WHO scales) and 36-mo survival. RESULTS: At 1 mo after terminating chemoradiotherapy (CRT), no differences were observed in the incidence of grade 3-4 mucositis between treatment groups, in the ITT, PP (172 patients), and subgroup (≥75% compliance, n = 112) analyses. The immunomodulating supplement did not significantly improve survival in the ITT and PP analyses at 3 y after CRT. Among ≥75% compliant patients, however, OS at 3 y was significantly improved in the immunomodulating formula group (81%; 95% CI: 67%, 89%) compared with controls (61%; 95% CI: 46%, 73%; P = 0.034), as well as PFS (73%; 95% CI: 58%, 83% compared with 50%; 95% CI: 36%, 63%; P = 0.012). CONCLUSIONS: Although this immunomodulating formula failed to reduce severe mucositis during CRT, the findings suggest that the long-term survival of compliant HNSCC patients was improved.This trial was registered at clinicaltrials.gov as NCT01149642.
RCT Entities:
BACKGROUND: In a previous phase II study an immunonutrient supplement was found to reduce severe acute toxicities for head and neck squamous cell cancer (HNSCC) patients treated with concomitant cisplatin and radiotherapy. OBJECTIVES: The primary objective of the present study was to evaluate efficacy of the same immunonutrient supplement on severe mucositis. Secondary objectives included tolerance, compliance to oral supplementation, chemotherapy interruptions and delays, quality of life, and progression-free survival (PFS) and overall survival (OS) at 1, 2, and 3 y. METHODS: Between November 2009 and June 2013, 180 HNSCCpatients eligible for adjuvant chemotherapy after surgery with curative intent were included in our double-blind phase III multicenter trial. They were assigned to receive oral supplementation (3 sachets/d) of either a formula enriched with l-arginine and omega-3 (n-3) fatty and ribonucleic acids (experimental arm), or an isocaloric isonitrogenous control (control arm), for 5 d before each of 3 cycles of cisplatin. Intention-to-treat (ITT) and per-protocol (PP) analyses were undertaken, along with subgroup analyses of ≥75% compliant patients, to compare the incidence of acute mucositis (Radiation Therapy Oncology Group and WHO scales) and 36-mo survival. RESULTS: At 1 mo after terminating chemoradiotherapy (CRT), no differences were observed in the incidence of grade 3-4 mucositis between treatment groups, in the ITT, PP (172 patients), and subgroup (≥75% compliance, n = 112) analyses. The immunomodulating supplement did not significantly improve survival in the ITT and PP analyses at 3 y after CRT. Among ≥75% compliant patients, however, OS at 3 y was significantly improved in the immunomodulating formula group (81%; 95% CI: 67%, 89%) compared with controls (61%; 95% CI: 46%, 73%; P = 0.034), as well as PFS (73%; 95% CI: 58%, 83% compared with 50%; 95% CI: 36%, 63%; P = 0.012). CONCLUSIONS: Although this immunomodulating formula failed to reduce severe mucositis during CRT, the findings suggest that the long-term survival of compliant HNSCCpatients was improved.This trial was registered at clinicaltrials.gov as NCT01149642.
Authors: Eunbo Sim; Jin-Min Kim; Seung-Min Lee; Moon Jae Chung; Si Young Song; Eun Sun Kim; Hoon Jai Chun; Mi-Kyung Sung Journal: Asian Pac J Cancer Prev Date: 2022-02-01
Authors: Alfred Adiamah; Katie E Rollins; Audrey Kapeleris; Neil T Welch; Syed Y Iftikhar; Simon P Allison; Dileep N Lobo Journal: Clin Nutr Date: 2021-10-01 Impact factor: 7.324