| Title: |
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 |
| Authors: |
Lonardi S.; Rasola C.; Lobefaro R.; Rossini D.; Formica V.; Scartozzi M.; Frassineti G. L.; Boscolo G.; Cinieri S.; Di Donato S.; Pella N.; Bergamo F.; Raimondi A.; Arnoldi E.; Antonuzzo L.; Granetto C.; Zustovich F.; Ronzoni M.; Leo S.; Morano F.; Loupakis F.; Buggin F.; Zagonel V.; Fassan M.; Cremolini C.; Boni L.; Pietrantonio F.; Aprile G.; Ardizzoia A.; Aschele C.; Baldini E.; Ballestrero A.; Bertolini A.; Bordonaro R.; Buonadonna A.; Clavarezza M.; Corsi D.; Cortesi E.; De Braud F.; Falcone A.; Favaretto A.; Frassineti L.; Frassoldati A.; Frisinghelli M.; Gamucci T.; Gianni L.; Giovanardi F.; Gori S.; Grande R.; Leone F.; Luciani A.; Milandri C.; Sartore-Bianchi A.; Silvestris N.; Tamburini E.; Tomasello G.; Tonini G.; Tortora G.; Vergani C.; Zaniboni A. |
| Contributors: |
S. Lonardi; C. Rasola; R. Lobefaro; D. Rossini; V. Formica; M. Scartozzi; G.L. Frassineti; G. Boscolo; S. Cinieri; S. Di Donato; N. Pella; F. Bergamo; A. Raimondi; E. Arnoldi; L. Antonuzzo; C. Granetto; F. Zustovich; M. Ronzoni; S. Leo; F. Morano; F. Loupaki; F. Buggin; V. Zagonel; M. Fassan; C. Cremolini; L. Boni; F. Pietrantonio; G. Aprile; A. Ardizzoia; C. Aschele; E. Baldini; A. Ballestrero; A. Bertolini; R. Bordonaro; A. Buonadonna; M. Clavarezza; D. Corsi; E. Cortesi; F. De Braud; A. Falcone; A. Favaretto; L. Frassineti; A. Frassoldati; M. Frisinghelli; T. Gamucci; L. Gianni; F. Giovanardi; S. Gori; R. Grande; F. Leone; A. Luciani; C. Milandri; A. Sartore-Bianchi; N. Silvestri; E. Tamburini; G. Tomasello; G. Tonini; G. Tortora; C. Vergani; A. Zaniboni |
| Publisher Information: |
American Society of Clinical Oncology |
| Publication Year: |
2023 |
| Collection: |
The University of Milan: Archivio Istituzionale della Ricerca (AIR) |
| Subject Terms: |
Settore MED/06 - Oncologia Medica; Settore MEDS-09/A - Oncologia medica |
| Description: |
PURPOSETo 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 METHODSPANDA (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).RESULTSBetween 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 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.CONCLUSIONBoth 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. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/37535876; info:eu-repo/semantics/altIdentifier/wos/WOS:001112788800016; volume:41; issue:34; firstpage:5263; lastpage:5273; numberofpages:11; journal:JOURNAL OF CLINICAL ONCOLOGY; https://hdl.handle.net/2434/1059759 |
| DOI: |
10.1200/JCO.23.00506 |
| Availability: |
https://hdl.handle.net/2434/1059759; https://doi.org/10.1200/JCO.23.00506 |
| Rights: |
info:eu-repo/semantics/openAccess |
| Accession Number: |
edsbas.BF06C1B9 |
| Database: |
BASE |