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.

Autor:	Lonardi S; Medical Oncology 1, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy., Rasola C; Medical Oncology 1, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy., Lobefaro R; Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy., Rossini D; Unit of Medical Oncology 2, University Hospital of Pisa, Pisa, Italy.; Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy., Formica V; Medical Oncology Unit, Policlinico Tor Vergata, Roma, Italy., Scartozzi M; Department of Medical Sciences and Public Health, Medical Oncology Unit, 'Azienda Ospedaliero Universitaria' of Cagliari, University of Cagliari, Cagliari, Italy., Frassineti GL; Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori' (IRST), Meldola, Italy., Boscolo G; Medical Specialties Department, Oncology and Oncological Haematology, ULSS 3 Serenissima, Mirano, Italy., Cinieri S; Department of Medical Oncology, Hospital 'Senatore Perrino', Brindisi, Italy., Di Donato S; Department of Medical Oncology, General Hospital, Prato, Italy., Pella N; Department of Oncology, ASUFC University Hospital, Udine, Italy., Bergamo F; Medical Oncology 1, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy., Raimondi A; Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy., Arnoldi E; Department of Oncology, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy., Antonuzzo L; Clinical Oncology Unit, Careggi University Hospital, Florence, Italy.; Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy., Granetto C; Medical Oncology, ASL CN1, Cuneo, Italy., Zustovich F; Dipartimento di Oncologia Clinica, UOC Oncologia di Belluno, AULSS 1 Dolomiti, Ospedale S. Martino, Belluno, Italy., Ronzoni M; Oncologia Medica, IRCCS Ospedale San Raffaele, Milano, Italy., Leo S; Medical Oncology Unit, Vito Fazzi Hospital, Lecce, Italy., Morano F; Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy., Loupakis F; Medical Oncology 1, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy., Buggin F; Medical Oncology 1, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy., Zagonel V; Medical Oncology 1, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy., Fassan M; Department of Medicine (DIMED), Surgical Pathology & Cytopathology Unit, University of Padova, Padova, Italy.; Veneto Institute of Oncology IOV-IRCCS, Padova, Italy., Cremolini C; Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy., Boni L; IRCCS Ospedale Policlinico San Martino, Genova, Italy., Pietrantonio F; Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
Jazyk:	angličtina
Zdroj:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2023 Dec 01; Vol. 41 (34), pp. 5263-5273. Date of Electronic Publication: 2023 Aug 03.
DOI:	10.1200/JCO.23.00506
Abstrakt:	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.
Databáze:	MEDLINE
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