Initial Panitumumab Plus Fluorouracil, Leucovorin, and Oxaliplatin or Plus Fluorouracil and Leucovorin in Elderly Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer: The PANDA Trial by the GONO Foundation
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Le résumé fourni par la source
PURPOSE To verify whether both doublet chemotherapy with a modified schedule of fluorouracil, leucovorin, and oxaliplatin (mFOLFOX) and monochemotherapy with fluorouracil plus leucovorin (5-FU + LV) achieve satisfactory efficacy when both regimens are combined with panitumumab (PAN) as initial treatment of elderly patients with RAS/ BRAF wild-type metastatic colorectal cancer (mCRC). PATIENTS AND METHODS PANDA (ClinicalTrials.gov identifier: NCT02904031 ) was an open-label, randomized phase II noncomparative trial in previously untreated patients age 70 years and older with unresectable RAS/ BRAF wild-type mCRC. Patients were randomly assigned 1:1 to mFOLFOX + PAN (arm A) or 5-FU + LV + PAN (arm B) for up to 12 cycles, followed by PAN maintenance. The primary end point was progression-free survival (PFS). In each arm, assuming a null hypothesis of median PFS time ≤6 months and target PFS ≥9.65, 90 patients per arm were needed to achieve 90% power and 5% type I error (one-sided Brookmeyer-Crowley test). RESULTS Between July 2016 and April 2019, 91 patients were randomly assigned to arm A and 92 to arm B. At a median follow-up of 50.0 months (IQR, 45.6-56.4), median PFS was 9.6 and 9.0 months for arm A and B, respectively ( P < .001 in each arm). Overall response rate was 69% and 52%, whereas median overall survival was 23.5 and 22.0 months in arm A and B, respectively. The overall rate of grade >2 chemotherapy-related adverse events was 60% and 37%, respectively. Baseline G8 and Chemotherapy Risk Assessment Scale for High-Age Patients scores were prognostic, but they were not associated with efficacy and safety of the two arms. CONCLUSION Both mFOLFOX and 5-FU + LV + PAN are reasonable options as initial therapy of elderly patients with RAS/ BRAF wild-type mCRC. 5-FU + LV + PAN is associated with a better safety profile.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Initial Panitumumab Plus Fluorouracil, Leucovorin, and Oxaliplatin or Plus Fluorouracil and Leucovorin in Elderly Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer: The PANDA Trial by the GONO Foundation
- Date Crossref
- 01/12/2023
- Éditeur
- American Society of Clinical Oncology (ASCO)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Istituto Oncologico Veneto pays non établi dans la noticeÉtablissement de santé
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Ospedale Martini pays non établi dans la noticeÉtablissement de santé
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Istituti di Ricovero e Cura a Carattere Scientifico pays non établi dans la noticeÉtablissement de santé
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Fondazione IRCCS Istituto Nazionale dei Tumori pays non établi dans la noticeÉtablissement de santé
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University of Pisa Department of Translational Research and New Technologies in Medicine and Surgery pays non établi dans la noticeUniversité ou école supérieure
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Policlinico Tor Vergata Medical Oncology Unit pays non établi dans la noticeÉtablissement de santé
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University of Cagliari Department of Medical Sciences and Public Health pays non établi dans la noticeUniversité ou école supérieure
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Istituto Oncologico Veneto, Ospedale Martini et Istituti di Ricovero e Cura a Carattere Scientifico, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.